9000 9001 Evolution, FromIntro-11 9001 Certification ... · PDF fileISO 9001 Quality Procedures Manual Bizmanualz.com 600 Index Page 1 of 26 9000 9001 Evolution, From

ISO 9001 Quality Procedures Manual Bizmanualz.com

600 Index Page 1 of 26

9000 9001 Evolution, From .........................................................................Intro-11 9000 Family Standards, Current ISO ...........................................................Intro-16 9001 Application Depends Organization, ISO .............................................Intro-40 9001 Certification, Final Steps Achieving ISO .............................................Intro-42 9001 Certification, Starting Journey ISO .....................................................Intro-34 9001 Certification, Understanding ISO .......................................................Intro-31 9001 CERTIFIED, BECOMING ISO ................................................................Intro-31 9001 Data Documents, ISO .........................................................................Intro-42 9001 Documentation, Avoiding ISO ............................................................Intro-28 9001 Documents, Creating First Level ISO ..................................................Intro-36 9001 Evolution, From 9000 .........................................................................Intro-11 9001 Improves Competitiveness, Employing ISO .......................................Intro-23 9001 Improves Documentation Record Keeping, Employing ISO..............Intro-28 9001 Improves Organizational Culture, Employing ISO .............................Intro-26 9001 Journey, Phase Next Step ISO ............................................................Intro-37 9001 MATURITY, IMPROVEMENT THROUGH ISO .......................................Intro-45 9001 OVERVIEW, ISO ..................................................................................Intro-17 9001 Process Approach, Employ ISO ..........................................................Intro-43 9001 QMS MANUAL ACCREDITATION, USING YOUR ISO ..........................Intro-51 9001 QMS, Using Auditing ISO ....................................................................Intro-44 9001 Records Continual Improvement, Using ISO .....................................Intro-43 9001 Requirements Documents, Understand Specific ISO ........................Intro-43 9001 Standard, ISO .....................................................................................Intro-35 9001 Success, Management Commitment Vital ISO ..................................Intro-40 9001, BENEFITS USING ISO .........................................................................Intro-23 9001, Training Documents Important ISO ..................................................Intro-41 9001, Understanding Goal Implementing ISO ............................................Intro-9 9001:2000, Update ISO ...............................................................................Intro-12 9001:2008, Update ISO ...............................................................................Intro-12 9001:2015, Update ISO ...............................................................................Intro-12

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Acceptance Distribution, Infrastructure Inspection ...................................QP0700 Acceptance, Order ......................................................................................QP1080 Acceptance, Product ...................................................................................QP1090-1-4.4 Accreditation Forum, International ............................................................Intro-32 ACCREDITATION, USING YOUR ISO 9001 QMS MANUAL ..........................Intro-51 Achieve Stability, Using Data Analysis ........................................................Intro-47 Achieving ISO 9001 Certification, Final Steps ............................................Intro-42 Achieving Stability Allows Focus on Regularly Occurring Problems ...........Intro-49 Acquisition List, Asset .................................................................................QP0700-2 Acquisition, Infrastructure ..........................................................................QP0700 Acquisition, Resource..................................................................................QP1090-1-3.1.3

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Acronyms, Definitions .................................................................................QP1090-1-1.7 Action Log, Corrective .................................................................................QP1040-2 Action Report, Corrective ...........................................................................QP1040-1 Action Report, Preventive ...........................................................................QP0600-3 Action, Corrective .......................................................................................QP1030 Action, Determining Need Corrective .........................................................QP1040 Action, Initiating Corrective ........................................................................QP1040 Action, Nonconformity Corrective ..............................................................QP1040 Action, Risk-Based Thinking Preventive ......................................................Intro-14 Action, Taking Corrective ............................................................................QP1040 Actions Review, Risk Management .............................................................QP0600 Additional ISO System Components of Continual Improvement ...............Intro-39 Additional Plans ..........................................................................................QP1090-1-6 Agenda, Management Review ....................................................................QP1060 Allocation, Budget .......................................................................................QP1090-1-3.2.4 Allocation, Resource ...................................................................................QP1090-1-3.2.3 Allocation, Schedule ....................................................................................QP1090-1-3.2.2 Allows Focus Regularly Occurring Problems, Achieving Stability ..............Intro-49 Analysis Achieve Stability, Using Data ........................................................Intro-47 Analysis Continual Improvement, Data ......................................................QP1200 Analysis Introduction, Situational ...............................................................QP0500 Analysis Report, Situational ........................................................................QP0500-3 Analysis Report, Situational ........................................................................QP0500 Analysis Worksheet, Competitive ...............................................................QP0500-2 Analysis Worksheet, SWOT .........................................................................QP0500-1 Analysis, Data ..............................................................................................QP1200 Analysis, Situational ....................................................................................QP0500 Analyzing the Data ......................................................................................QP0500 Application Depends Organization, ISO 9001 .............................................Intro-40 Approach, Employ ISO 9001 Process ..........................................................Intro-43 Approach, Using Process .............................................................................Intro-24 Approval, Document ...................................................................................QP1000 Approved External Provider List .................................................................QP1120-1 Article Inspection Report, First ...................................................................QP1210-2 Assessing the Company’s Situation ............................................................QP0500 Assessment Guidelines, Risk .......................................................................QP0600 Assessment Management Worksheet, Risk ...............................................QP0600-1 Assessment, Project ....................................................................................QP1100 Assessment, Risk .........................................................................................QP0600 assessment, Tools used risk ........................................................................Intro-15 Asset Acquisition List ..................................................................................QP0700-2 Asset Form, Nonconforming .......................................................................QP0700-4 Asset Inventory Database ...........................................................................QP0700-5 Asset Requisition/Disposal Form ................................................................QP0700-1




Assumptions Constraints Risks, Inputs .......................................................QP1090-1-1.2 Assurance, Quality ......................................................................................QP1090-1-5.4 Attributes, Scoring ......................................................................................QP0500 Audit Checklist, External Provider ..............................................................QP1120-2 Audit Checklist, Quality ...............................................................................QP1020-3 Audit Plan ....................................................................................................QP1020-2 Audit Planning, Internal ..............................................................................QP1020 Audit Program .............................................................................................QP1020-1 Audit Program, Internal ..............................................................................QP1020 Audit Report ................................................................................................QP1020-4 Audit Report, Internal .................................................................................QP1020 Audit, Conducting Internal ..........................................................................QP1020 Auditing ISO 9001 QMS, Using ....................................................................Intro-44 Auditor Job Description, Internal Quality ...................................................QP1070-B Audits, Internal............................................................................................QP1020 Audits, Reviews ...........................................................................................QP1090-1-5.5 Authorization, Product Release ..................................................................QP1140-2 Authorization, Return Goods ......................................................................QP1030-3 Avoiding the ISO 9001 “Documentation Nightmare” .................................Intro-28 Awareness, Competence ............................................................................QP1070 Awareness, Employee .................................................................................QP1070

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BACKGROUND .............................................................................................Intro-9 Background, ISO ..........................................................................................Intro-10 BECOMING ISO 9001 CERTIFIED .................................................................Intro-31 BENEFITS OF USING ISO 9001 .....................................................................Intro-23 Breakdown Structure, Work .......................................................................QP1090-1-3.2.1 Budget Allocation ........................................................................................QP1090-1-3.2.4 Budget Control ............................................................................................QP1090-1-3.3.3 Budget Summary, Schedule ........................................................................QP1090-1-1.4 Building QMS System Management Resources, Phase Three ...................Intro-40 Building the Project Plan .............................................................................QP1090 Business Customer, Important Person .......................................................Intro-25

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Calibration Database ...................................................................................QP1170-2 Calibration Document .................................................................................QP1170-1 Calibration System ......................................................................................QP1170 Calibration, Control Subcontractor .............................................................QP1170 Cause, Investigating ....................................................................................QP1040 Causes, Phase Four Finding Root ................................................................Intro-48




Certificates Cofc Cofa, Items Received .......................................................QP1210 Certification, Final Steps Achieving ISO 9001 .............................................Intro-42 Certification, Goal Improvement ................................................................Intro-23 Certification, ISO Role Gaining ....................................................................Intro-31 Certification, Starting Journey ISO 9001 .....................................................Intro-34 Certification, Understanding ISO 9001 .......................................................Intro-31 CERTIFIED, BECOMING ISO 9001 ................................................................Intro-31 Change Control, Production ........................................................................QP1140 Change Design & Development Review, Verification and Testing .............QP1110 Change Notice, Engineering ........................................................................QP1110 Change Notice, Engineering ........................................................................QP1110-1 Changes to Orders ......................................................................................QP1080 Changes, Design ..........................................................................................QP1110 Changes, Requesting Design .......................................................................QP1110 Changes, Temporary Document .................................................................QP1000 Checklist Electromechanical Devices, Design Completion .........................QP1100-2 Checklist Non-Electromechanical Devices, Design Completion .................QP1100-3 Checklist, Design Review .............................................................................QP1100-1 Checklist, External Provider Audit ..............................................................QP1120-2 Checklist, Inspection/Testing ......................................................................QP1140-1 Checklist, Quality Audit ...............................................................................QP1020-3 Checklist, Sample Verification ....................................................................QP1100-4 Closeout Plan, Project .................................................................................QP1090-1-3.5 Closure, Verification ....................................................................................QP1040 Cofa, Items Received Certificates Cofc .......................................................QP1210 Cofc Cofa, Items Received Certificates .......................................................QP1210 Collecting Management System Data, Phase Two ....................................Intro-46 Collection, Data ...........................................................................................QP1200 Commitment Vital ISO 9001 Success, Management .................................Intro-40 Commitment, Management’s QMS ............................................................QP1060 Committee, Risk Management ...................................................................QP0600 Common Special, Phase Three Separating .................................................Intro-47 Communication Plan ...................................................................................QP1070-6 Communication, Effective ...........................................................................Man Prep Company’s Situation, Assessing ..................................................................QP0500 Competence and Awareness ......................................................................QP1070 Competence Documented Information ......................................................QP1070 Competence Matrix, Employee ..................................................................QP1070-1 Competitive Analysis Worksheet ................................................................QP0500-2 Competitiveness, Employing ISO 9001 Improves .......................................Intro-23 Completing Phase One Quality Policy, Objectives, and Documents ..........Intro-37 Completion Checklist Electromechanical Devices, Design .........................QP1100-2 Completion Checklist Non-Electromechanical Devices, Design .................QP1100-3 Completion, Design .....................................................................................QP1130




Compliance ISO Documentation, Focus ISO ...............................................Intro-41 Compliance, Simplify ISO ............................................................................Intro-44 Components Continual Improvement, Additional ISO System ..................Intro-39 Components, QMS ......................................................................................QP0500 Conditions, Out-Of-Tolerance .....................................................................QP1170 Conducting the Internal Audit ....................................................................QP1020 Configuration Management........................................................................QP1090-1-5.1 Consider Selecting Registrar, Other Factors ...............................................Intro-33 Constraints Risks, Inputs Assumptions .......................................................QP1090-1-1.2 Contents, Quality Manual ...........................................................................Intro-14 Context of the Organization .......................................................................Intro-17 Continual Improvement ..............................................................................QP1200 Continual Improvement Documents, Drafting ...........................................Intro-38 Continual Improvement Processes, Sketch Out .........................................Intro-38 Continual Improvement, Additional ISO System Components ..................Intro-39 Continual Improvement, Data Analysis ......................................................QP1200 Continual Improvement, Using ISO 9001 Records .....................................Intro-43 Control Database, Document .....................................................................QP1000-2 Control of Nonconforming Outputs ............................................................QP1030 Control of Subcontractor Calibration .........................................................QP1170 Control, Budget ...........................................................................................QP1090-1-3.3.3 Control, Completing Phase One Quality Policy Objectives Document ......Intro-37 Control, Documented Information .............................................................QP1000 Control, External Property ..........................................................................QP1160 Control, Infrastructure ................................................................................QP0700 Control, Manufacturing ..............................................................................QP1140 Control, Monitoring-Measuring Resources ................................................QP1170 Control, Production .....................................................................................QP1140 Control, Production Change ........................................................................QP1140 Control, Quality ...........................................................................................QP1090-1-3.3.4 Control, Schedule ........................................................................................QP1090-1-3.3.2 Controls Cost-Benefit Worksheet, Risk .......................................................QP0600-2 Corrective Action ........................................................................................QP1030 Corrective Action Log ..................................................................................QP1040-2 Corrective Action Report ............................................................................QP1040-1 Corrective Action, Determining Need .........................................................QP1040 Corrective Action, Initiating ........................................................................QP1040 Corrective Action, Nonconformity ..............................................................QP1040 Corrective Action, Taking ............................................................................QP1040 Cost-Benefit Worksheet, Risk Controls .......................................................QP0600-2 Create an ISO Implementation Plan ...........................................................Intro-34 Creating the First Level of ISO 9001 Documents ........................................Intro-36 Credit .........................................................................................................QP1080 Critical External Provider-Contractor Evaluations ......................................QP1120-3




Culture, Employing ISO 9001 Improves Organizational ..............................Intro-26 Current ISO 9000 Family of Standards ........................................................Intro-16 Customer Order ..........................................................................................QP1080-1 Customer Satisfaction .................................................................................QP1190 Customer Satisfaction General ...................................................................QP1190 Customer Satisfaction Review ....................................................................QP1190 Customer Satisfaction Survey .....................................................................QP1190 Customer Satisfaction Survey .....................................................................QP1190-2 Customer Service ........................................................................................QP1080 Customer Service Log ..................................................................................QP1190-3 Customer Supplied Items, Receipt Inspection Stocking .............................QP1160 Customer, Important Person Business .......................................................Intro-25

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Data Analysis ...............................................................................................QP1200 Data Analysis Achieve Stability, Using ........................................................Intro-47 Data Analysis and Continual Improvement ................................................QP1200 Data Collection ............................................................................................QP1200 Data Documents, Importance .....................................................................Intro-28 Data Documents, ISO 9001 .........................................................................Intro-42 Data, Analyzing ...........................................................................................QP0500 Data, Phase Two Collecting Management System .....................................Intro-46 Data, Reporting Monitoring Measurement ................................................QP1180 Database, Asset Inventory ..........................................................................QP0700-5 Database, Calibration ..................................................................................QP1170-2 Database, Document Control .....................................................................QP1000-2 Decision Making, Fact-Based ......................................................................Intro-26 Define Your ISO Processes ..........................................................................Intro-35 Definition Review, Project ..........................................................................QP1090 Definition, Project .......................................................................................QP1090 Definitions and Acronyms ...........................................................................QP1090-1-1.7 DEFINITIONS, ISO ........................................................................................Intro-53 Deliverables, Project Design Outputs .........................................................QP1090-1-1.3 Departmental Procedures and Responsibilities. ........................................Intro-20 Depends Organization, ISO 9001 Application .............................................Intro-40 Deployment Plan .........................................................................................QP1090-1-4.5 Description, Internal Quality Auditor Job ...................................................QP1070-B Description, President Job ..........................................................................QP1070-A Descriptions, Sample Job ............................................................................QP1070-5 Design and Development ............................................................................QP1100 Design and Development ............................................................................QP1100 Design and Development Review ...............................................................QP1100 Design Changes ...........................................................................................QP1110




Design Changes, Requesting .......................................................................QP1110 Design Completion ......................................................................................QP1130 Design Completion Checklist for Electromechanical Devices .....................QP1100-2 Design Completion Checklist for Non-Electromechanical Devices .............QP1100-3 Design Development Review Verification Validation Testing, Change .....QP1110 Design Inputs ..............................................................................................QP1100 Design Outputs Deliverables, Project .........................................................QP1090-1-1.3 Design Release Form, Product ....................................................................QP1130-1 Design Review Checklist ..............................................................................QP1100-1 Design Transfer and Documentation ..........................................................QP1130 Design Validation and Testing.....................................................................QP1100 Design Verification ......................................................................................QP1100 Detailed Inspection .....................................................................................QP1210 Determination Requisition, Order ..............................................................QP1220 Determining Need for Corrective Action ....................................................QP1040 Development Plan, Employee .....................................................................QP1070-2 Development Review Verification Validation Testing, Change Design .....QP1110 Development Review, Design .....................................................................QP1100 Development, Design ..................................................................................QP1100 Development, Design ..................................................................................QP1100 Development, Employee .............................................................................QP1070 Development, Identification Traceability System.......................................QP1150 Devices, Design Completion Checklist Electromechanical .........................QP1100-2 Devices, Design Completion Checklist Non-Electromechanical .................QP1100-3 Direction, Establishing Known ....................................................................Intro-27 Disposal, Infrastructure...............................................................................QP0700 Disposition, Nonconformance ....................................................................QP1030 Distribution, Document ..............................................................................QP1000 Distribution, Infrastructure Inspection Acceptance ...................................QP0700 Document Approval ....................................................................................QP1000 Document Changes, Temporary .................................................................QP1000 Document Control Database ......................................................................QP1000-2 Document Control, Completing Phase One Quality Policy Objectives ......Intro-37 Document Distribution ...............................................................................QP1000 Document Format .......................................................................................QP1000 Document Request .....................................................................................QP1000-1 Document Revisions ...................................................................................QP1000 Document, Calibration ................................................................................QP1170-1 Documentation ...........................................................................................QP1090-1-5.3 Documentation Record Keeping, Employing ISO 9001 Improves..............Intro-28 Documentation, Avoiding ISO 9001 ............................................................Intro-28 Documentation, Design Transfer ................................................................QP1130 Documentation, Focus ISO Compliance ISO ...............................................Intro-41 Documentation, Policies Procedures Forms Key ........................................Intro-47




Documentation, QMS .................................................................................Intro-13 Documented Information ...........................................................................Intro-19 Documented Information ...........................................................................QP1000 Documented Information Control ..............................................................QP1000 Documented Information, Competence .....................................................QP1070 Documented Information, Management Review .......................................QP1060 Documents Important ISO 9001, Training ..................................................Intro-41 Documents, Creating First Level ISO 9001 ..................................................Intro-36 Documents, Drafting Continual Improvement ...........................................Intro-38 Documents, External ...................................................................................QP1000 Documents, Importance Data .....................................................................Intro-28 Documents, ISO 9001 Data .........................................................................Intro-42 Documents, Level IV Forms other ...............................................................Intro-21 Documents, Understand Specific ISO 9001 Requirements ........................Intro-43 Drafting Continual Improvement Documents ............................................Intro-38

- E -

Effective Communication ............................................................................Man Prep Effective Management Systems, Implementing .........................................Intro-50 Effectiveness, Supplier Relationships Enhance...........................................Intro-25 Effectiveness, Training ................................................................................QP1070 Electromechanical Devices, Design Completion Checklist .........................QP1100-2 Electronic Orders, Internet .........................................................................QP1080 Employ the ISO 9001 Process Approach .....................................................Intro-43 Employee Awareness ..................................................................................QP1070 Employee Competence Matrix ...................................................................QP1070-1 Employee Development ..............................................................................QP1070 Employee Development Plan ......................................................................QP1070-2 Employee Group Training Record ...............................................................QP1070-3 Employee Orientation .................................................................................QP1070 Employee Performance ..............................................................................QP1070 Employee Requirements, Monitoring Measuring ......................................QP1170 Employee Selection .....................................................................................QP1070 Employee Training ......................................................................................QP1070 Employing ISO 9001 Improves Competitiveness ........................................Intro-23 Employing ISO 9001 Improves Documentation and Record Keeping ........Intro-28 Employing ISO 9001 Improves Organizational Culture ...............................Intro-26 Engineering Change Notice .........................................................................QP1110 Engineering Change Notice .........................................................................QP1110-1 Enhance Effectiveness, Supplier Relationships...........................................Intro-25 Equal, ISO Stands ........................................................................................Intro-10 Establishing a Known Direction ..................................................................Intro-27 Estimates .....................................................................................................QP1090-1-3.1.1




Evaluation, External Provider......................................................................QP1120 Evaluation, Performance ............................................................................Intro-21 Evaluations, Critical External Provider-Contractor .....................................QP1120-3 Evolution of the Plan ...................................................................................QP1090-1-1.5 Evolution, From 9000 9001 .........................................................................Intro-11 Exclusions ....................................................................................................QM External Documents ....................................................................................QP1000 External Interfaces ......................................................................................QP1090-1-2.1 External Property Control ...........................................................................QP1160 External Provider Audit Checklist ...............................................................QP1120-2 External Provider Evaluation.......................................................................QP1120 External Provider Files ................................................................................QP1120 External Provider List, Approved ................................................................QP1120-1 External Provider Notice .............................................................................QP1120 External Provider Performance Log ............................................................QP1120-4 External Provider Purchase Orders .............................................................QP1120 External Provider Removal .........................................................................QP1120 External Provider Screening ........................................................................QP1120 External Provider-Contractor Evaluations, Critical .....................................QP1120-3

- F -

Fact-Based Decision Making .......................................................................Intro-26 Factors Consider Selecting Registrar, Other ...............................................Intro-33 Family Standards, Current ISO 9000 ...........................................................Intro-16 Files, External Provider ...............................................................................QP1120 Final Steps in Achieving ISO 9001 Certification ..........................................Intro-42 Final Verification and Release .....................................................................QP1140 Finding Root Causes, Phase Four ................................................................Intro-48 First Article Inspection Report ....................................................................QP1210-2 First Level ISO 9001 Documents, Creating .................................................Intro-36 Five Risk Management, Phase ....................................................................Intro-49 FMEA .........................................................................................................QP0600 Focus on ISO Compliance - Not Unnecessary ISO Documentation ............Intro-41 Focus Regularly Occurring Problems, Achieving Stability Allows ...............Intro-49 Follow-Up, Post-Sale ...................................................................................QP1190 Follow-Up, Purchase Order .........................................................................QP1220-4 Form, Asset Requisition/Disposal ...............................................................QP0700-1 Form, Nonconforming Asset .......................................................................QP0700-4 Form, Product Design Release ....................................................................QP1130-1 Format, Document ......................................................................................QP1000 Forms and other Documents ......................................................................Intro-21 Forms Key Documentation, Policies Procedures ........................................Intro-47 Forms other Documents, Level IV ...............................................................Intro-21




Forum, International Accreditation ............................................................Intro-32 Four Finding Root Causes, Phase ................................................................Intro-48 From 9000 to 9001: An Evolution ...............................................................Intro-11

- G -

Gaining Certification, ISO Role ....................................................................Intro-31 General Information ...................................................................................Intro-17 General Monitoring & Measuring Requirements .......................................QP1180 General, Customer Satisfaction ..................................................................QP1190 General, Identification Traceability ............................................................QP1150 Generally Technical, ISO Standards ............................................................Intro-10 Get a Handle on Your ISO 9001 Data Documents ......................................Intro-42 Goal Implementing ISO 9001, Understanding ............................................Intro-9 Goods Authorization, Return ......................................................................QP1030-3 Goods, Returned .........................................................................................QP1030 Group Training Record, Employee ..............................................................QP1070-3 Guidelines, Risk Assessment .......................................................................QP0600

- H / I -

Handling Maintenance, Storage .................................................................QP1170 Identification & Traceability .......................................................................QP1150 Identification / Traceability System Development .....................................QP1150 Identification and Segregation....................................................................QP1030 Identification and Traceability – General ...................................................QP1150 Identification, Product Needs .....................................................................QP1090 Identification/Traceability Review ..............................................................QP1150 Identifying / Tracing Items ..........................................................................QP1150 Implementation Plan, Create ISO ...............................................................Intro-34 Implementing Effective Management Systems ..........................................Intro-50 Implementing ISO 9001, Understanding Goal ............................................Intro-9 Importance of Data Documents .................................................................Intro-28 Importance of Selecting a Registrar ............................................................Intro-33 Important ISO 9001, Training Documents ..................................................Intro-41 Improvement ..............................................................................................Intro-22 Improvement Certification, Goal ................................................................Intro-23 Improvement Documents, Drafting Continual ...........................................Intro-38 Improvement Processes, Sketch Out Continual .........................................Intro-38 IMPROVEMENT THROUGH ISO 9001 MATURITY ........................................Intro-45 Improvement, Additional ISO System Components Continual ..................Intro-39 Improvement, Continual .............................................................................QP1200 Improvement, Data Analysis Continual ......................................................QP1200 Improvement, Phase One Realizing Need Process .....................................Intro-45




Improvement, Process ................................................................................QP1090-1-5.8 Improvement, Using ISO 9001 Records Continual .....................................Intro-43 Improvement, Using Maturity Model Start Process ...................................Intro-46 Improves Competitiveness, Employing ISO 9001 .......................................Intro-23 Improves Documentation Record Keeping, Employing ISO 9001..............Intro-28 Improves Organizational Culture, Employing ISO 9001 ..............................Intro-26 Individual Training Record ..........................................................................QP1070-4 Information Control, Documented .............................................................QP1000 Information, Competence Documented .....................................................QP1070 Information, Documented ..........................................................................Intro-19 Information, Documented ..........................................................................QP1000 Information, General ..................................................................................Intro-17 Information, Management Review Documented .......................................QP1060 Infrastructure ..............................................................................................QP1090-1-4.3 Infrastructure Acquisition ...........................................................................QP0700 Infrastructure Control .................................................................................QP0700 Infrastructure Disposal................................................................................QP0700 Infrastructure Inspection, Acceptance, & Distribution ...............................QP0700 Infrastructure Maintenance ........................................................................QP0700 Infrastructure Planning ...............................................................................QP0700 Initiating Corrective Action .........................................................................QP1040 Inputs, Assumptions, Constraints, and Risks ..............................................QP1090-1-1.2 Inputs, Design .............................................................................................QP1100 Inspection Acceptance Distribution, Infrastructure ...................................QP0700 Inspection and Testing ................................................................................QP1140 Inspection Report, First Article ...................................................................QP1210-2 Inspection Report, Receiving ......................................................................QP1210-3 Inspection Stocking Customer Supplied Items, Receipt ............................QP1160 Inspection, Detailed ....................................................................................QP1210 Inspection, Receiving ..................................................................................QP1210 Inspection/Testing Checklist .......................................................................QP1140-1 Instructions, Usage .....................................................................................Man Prep Instructions, Work.......................................................................................Intro-20 Intellectual Property ...................................................................................QP1160 Interfaces, External .....................................................................................QP1090-1-2.1 Internal Audit Planning ...............................................................................QP1020 Internal Audit Program ...............................................................................QP1020 Internal Audit Reporting .............................................................................QP1020 Internal Audit, Conducting ..........................................................................QP1020 Internal Audits.............................................................................................QP1020 Internal Quality Auditor Job Description ....................................................QP1070-B Internal Structure ........................................................................................QP1090-1-2.2 International Accreditation Forum .............................................................Intro-32 Internet (Electronic) Orders ........................................................................QP1080




Introduction ................................................................................................Man Prep Introduction, Situational Analysis ...............................................................QP0500 Inventory Database, Asset ..........................................................................QP0700-5 Investigating Cause .....................................................................................QP1040 ISO 9000 Family Standards, Current ...........................................................Intro-16 ISO 9001 Documents, Creating First ..........................................................Intro-36 ISO 9001 Application Depends on the Organization ..................................Intro-40 ISO 9001 Certification, Final Steps Achieving .............................................Intro-42 ISO 9001 Certification, Starting Journey .....................................................Intro-34 ISO 9001 Certification, Understanding .......................................................Intro-31 ISO 9001 CERTIFIED, BECOMING ................................................................Intro-31 ISO 9001 Documentation, Avoiding ............................................................Intro-28 ISO 9001 Documents, Creating First Level ..................................................Intro-36 ISO 9001 Improves Documentation Record Keeping, Employing..............Intro-28 ISO 9001 Improves Organizational Culture, Employing .............................Intro-26 ISO 9001 Improves Competitiveness, Employing .......................................Intro-23 ISO 9001 Journey, Phase Next Step ............................................................Intro-37 ISO 9001 MATURITY, IMPROVEMENT THROUGH .......................................Intro-45 ISO 9001 OVERVIEW ...................................................................................Intro-17 ISO 9001 Process Approach, Employ ..........................................................Intro-43 ISO 9001 QMS MANUAL ACCREDITATION, USING YOUR ..........................Intro-51 ISO 9001 QMS, Using Auditing ....................................................................Intro-44 ISO 9001 Records Continual Improvement, Using .....................................Intro-43 ISO 9001 Requirements Documents, Understand Specific........................Intro-43 ISO 9001 Success, Management Commitment Vital ..................................Intro-40 ISO 9001, BENEFITS USING .........................................................................Intro-23 ISO 9001, Training Documents Important ..................................................Intro-41 ISO 9001, Understanding Goal Implementing ............................................Intro-9 ISO 9001:2000, Update ...............................................................................Intro-12 ISO 9001:2008, Update ...............................................................................Intro-12 ISO 9001:2015, Update ...............................................................................Intro-12 ISO Background ...........................................................................................Intro-10 ISO Compliance ISO Documentation, Focus ...............................................Intro-41 ISO Compliance, Simplify ............................................................................Intro-44 ISO DEFINITIONS .........................................................................................Intro-53 ISO Documentation, Focus ISO Compliance ...............................................Intro-41 ISO Has No Role in Gaining Certification ....................................................Intro-31 ISO Implementation Plan, Create ...............................................................Intro-34 ISO Processes, Define Your .........................................................................Intro-35 ISO Standards Are Generally Technical .......................................................Intro-10 ISO Stands for Equal ....................................................................................Intro-10 ISO System Components Continual Improvement, Additional..................Intro-39 Items Received With Certificates (Cofc Or Cofa) ........................................QP1210 Items, Identifying Tracing ...........................................................................QP1150




Items, Receipt Inspection Stocking Customer Supplied .............................QP1160 Items, Unsuitable Missing ...........................................................................QP1160 IV Forms other Documents, Level ...............................................................Intro-21

- J K -

Job Description, Internal Quality Auditor ...................................................QP1070-B Job Description, President ..........................................................................QP1070-A Job Descriptions, Sample ............................................................................QP1070-5 Journey ISO 9001 Certification, Starting .....................................................Intro-34 Journey, Phase Next Step ISO 9001 ............................................................Intro-37 Keeping, Employing ISO 9001 Improves Documentation Record..............Intro-28 Key Documentation, Policies Procedures Forms ........................................Intro-47 Known Direction, Establishing ....................................................................Intro-27

- L -

Labeling, Packaging .....................................................................................QP1140 Leadership ...................................................................................................Intro-18 List, Approved External Provider ................................................................QP1120-1 List, Asset Acquisition .................................................................................QP0700-2 Log, Corrective Action .................................................................................QP1040-2 Log, Customer Service .................................................................................QP1190-3 Log, External Provider Performance ...........................................................QP1120-4 Log, Nonconforming Output .......................................................................QP1030-2 Log, Purchase Order ....................................................................................QP1220-3 Log, Receiving .............................................................................................QP1210-1

- M -

Maintenance, Infrastructure .......................................................................QP0700 Maintenance, Storage Handling .................................................................QP1170 Making, Fact-Based Decision ......................................................................Intro-26 Management Actions Review, Risk .............................................................QP0600 Management Commitment is Vital to ISO 9001 Success ...........................Intro-40 Management Committee, Risk ...................................................................QP0600 Management Plan, Risk ..............................................................................QP1090-1-3.4 Management Resources, Phase Three Building QMS System ...................Intro-40 Management Review ..................................................................................QP1060 Management Review Agenda .....................................................................QP1060 Management Review Documented Information ........................................QP1060 Management Review Meeting ...................................................................QP1060-1 Management System Data, Phase Two Collecting .....................................Intro-46 Management System Management System, Quality .................................Intro-14




Management System, Quality Management System .................................Intro-14 Management Systems, Implementing Effective .........................................Intro-50 Management Worksheet, Risk Assessment ...............................................QP0600-1 Management, Configuration.......................................................................QP1090-1-5.1 Management, Participative ........................................................................Intro-27 Management, Phase Five Risk ....................................................................Intro-49 Management, Requirements ......................................................................QP1090-1-3.3.1 Management, Risks Opportunities .............................................................QP0600 Management, Subcontractor ......................................................................QP1090-1-5.7 Management’s QMS Commitment .............................................................QP1060 Managerial Process Plans ...........................................................................QP1090-1-3 MANUAL ACCREDITATION, USING YOUR ISO 9001 QMS ..........................Intro-51 Manual Contents, Quality ...........................................................................Intro-14 Manual Objectives, Quality Policies ............................................................Intro-19 Manual, Your Quality ..................................................................................Man Prep Manufacturing Control ...............................................................................QP1140 Manufacturing, Preproduction Planning ....................................................QP1110 Map, Network .............................................................................................QP0700-6 Matching, Recordkeeping ...........................................................................QP1220 Material Problem Report ............................................................................QP1160-1 Matrix, Employee Competence ..................................................................QP1070-1 Maturity Model Start Process Improvement, Using ..................................Intro-46 MATURITY, IMPROVEMENT THROUGH ISO 9001 .......................................Intro-45 Measurement Data, Reporting Monitoring ................................................QP1180 Measuring Employee Requirements, Monitoring ......................................QP1170 Measuring Requirements, General Monitoring..........................................QP1180 Meeting, Management Review ..................................................................QP1060-1 Methods, Tools, and Techniques ................................................................QP1090-1-4.2 Metrics, Project ...........................................................................................QP1090-1-3.3.6 Missing Items, Unsuitable ...........................................................................QP1160 Model Start Process Improvement, Using Maturity ..................................Intro-46 Model, Process ............................................................................................QP1090-1-4.1 Monitoring and Measuring – Employee Requirements .............................QP1170 Monitoring Measurement Data, Reporting ................................................QP1180 Monitoring Measuring Requirements, General..........................................QP1180 Monitoring/Measurement, Review Process ...............................................QP1180 Monitoring-Measurement ..........................................................................QP1180 Monitoring-Measuring Resources Control .................................................QP1170 Most Important Person in Your Business: The Customer...........................Intro-25

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Need Corrective Action, Determining .........................................................QP1040 Need Process Improvement, Phase One Realizing .....................................Intro-45




Needs Identification, Product .....................................................................QP1090 Network Map ..............................................................................................QP0700-6 Next Step ISO 9001 Journey, Phase ...........................................................Intro-37 Nonconformance Disposition .....................................................................QP1030 Nonconformance Report ............................................................................QP1030 Nonconformance Report ............................................................................QP1030-1 Nonconforming Asset Form ........................................................................QP0700-4 Nonconforming Output Log ........................................................................QP1030-2 Nonconforming Outputs, Control ...............................................................QP1030 Nonconformity and Corrective Action ........................................................QP1040 Nonconformity, Process ..............................................................................QP1180 Non-Electromechanical Devices, Design Completion Checklist .................QP1100-3 Notice, Engineering Change ........................................................................QP1110 Notice, Engineering Change ........................................................................QP1110-1 Notice, External Provider ............................................................................QP1120

- O -

Objectives Document Control, Completing Phase One Quality Policy ......Intro-37 Objectives, Purpose Scope ..........................................................................QP1090-1-1.1 Objectives, Quality ......................................................................................QP0500 Objectives, Quality Policies Manual ............................................................Intro-19 Objectives, Quality Policy............................................................................Intro-14 Occurring Problems, Achieving Stability Allows Focus Regularly ..............Intro-49 One Quality Policy Objectives Document Control, Completing Phase .......Intro-37 One Realizing Need Process Improvement, Phase ....................................Intro-45 Ongoing Control ..........................................................................................QP1160 Operation ....................................................................................................Intro-21 Opportunities ..............................................................................................QP0500 Opportunities Management, Risks .............................................................QP0600 Order Acceptance .......................................................................................QP1080 Order Determination and Requisition ........................................................QP1220 Order Follow-Up, Purchase .........................................................................QP1220-4 Order Log, Purchase ....................................................................................QP1220-3 Order Placement .........................................................................................QP1220 Order, Customer .........................................................................................QP1080-1 Order, Purchase ..........................................................................................QP1220-2 Orders, Changes ..........................................................................................QP1080 Orders, External Provider Purchase ............................................................QP1120 Orders, Internet Electronic .........................................................................QP1080 Organization, Context .................................................................................Intro-17 Organization, ISO 9001 Application Depends .............................................Intro-40 Organization, Project ..................................................................................QP1090-1-2 Organizational Culture, Employing ISO 9001 Improves ..............................Intro-26




Orientation, Employee ................................................................................QP1070 other Documents, Level IV Forms ...............................................................Intro-21 Other Factors to Consider When Selecting a Registrar ..............................Intro-33 Out Continual Improvement Processes, Sketch .........................................Intro-38 Out-Of-Tolerance Conditions ......................................................................QP1170 Output Log, Nonconforming .......................................................................QP1030-2 Outputs Deliverables, Project Design .........................................................QP1090-1-1.3 Outputs, Control Nonconforming ...............................................................QP1030 OVERVIEW, ISO 9001 ..................................................................................Intro-17 Overview, Project ........................................................................................QP1090-1-1

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Packaging and Labeling ...............................................................................QP1140 Participative Management .........................................................................Intro-27 Performance Evaluation .............................................................................Intro-21 Performance Log, External Provider ...........................................................QP1120-4 Performance, Employee .............................................................................QP1070 Person Business Customer, Important .......................................................Intro-25 Phase 2 – the Next Step in the ISO 9001 Journey .......................................Intro-37 Phase Five – Risk Management ..................................................................Intro-49 Phase Four – Finding Root Causes ..............................................................Intro-48 Phase One – Realizing the Need for Process Improvement .......................Intro-45 Phase Three – Separating the Common from the Special ..........................Intro-47 Phase Three of Building a QMS System – Management and Resources ....Intro-40 Phase Two – Collecting Management System Data ...................................Intro-46 Placement, Order ........................................................................................QP1220 Plan Roll-Out ...............................................................................................QP1130 Plan, Audit ...................................................................................................QP1020-2 Plan, Building Project ..................................................................................QP1090 Plan, Communication ..................................................................................QP1070-6 Plan, Create ISO Implementation ...............................................................Intro-34 Plan, Deployment ........................................................................................QP1090-1-4.5 Plan, Employee Development .....................................................................QP1070-2 Plan, Evolution ............................................................................................QP1090-1-1.5 Plan, Evolution the ......................................................................................QP1090-1-1.5 Plan, Production ..........................................................................................QP1130 Plan, Project ................................................................................................QP1090-1 Plan, Project Closeout .................................................................................QP1090-1-3.5 Plan, Project Tracking .................................................................................QP1090-1-3.3 Plan, Reviewing Project...............................................................................QP1090 Plan, Risk Management ..............................................................................QP1090-1-3.4 Plan, Startup ................................................................................................QP1090-1-3.1 Plan, Work ...................................................................................................QP1090-1-3.2




Planning.......................................................................................................Intro-18 Planning Manufacturing, Preproduction ....................................................QP1110 Planning, Infrastructure ..............................................................................QP0700 Planning, Internal Audit ..............................................................................QP1020 Planning, Preproduction .............................................................................QP1130 Planning, Project .........................................................................................QP1090 Plans, Additional .........................................................................................QP1090-1-6 Plans, Managerial Process ..........................................................................QP1090-1-3 Plans, Supporting Process ...........................................................................QP1090-1-5 Plans, Technical Process .............................................................................QP1090-1-4 Policies Manual Objectives, Quality ............................................................Intro-19 Policies, Procedures and Forms are Key Documentation ...........................Intro-47 Policy Objectives Document Control, Completing Phase One Quality .......Intro-37 Policy Objectives, Quality............................................................................Intro-14 Policy, Quality .............................................................................................QP0500 Post-Sale Follow-Up ....................................................................................QP1190 Post-Sale Satisfaction Report ......................................................................QP1190-1 Preproduction Planning ..............................................................................QP1130 Preproduction Planning and Manufacturing ..............................................QP1110 President Job Description ...........................................................................QP1070-A Preventive Action Report ............................................................................QP0600-3 Preventive Action, Risk-Based Thinking ......................................................Intro-14 Problem Report, Material ...........................................................................QP1160-1 Problem Resolution.....................................................................................QP1090-1-5.6 Problems, Achieving Stability Allows Focus Regularly Occurring ..............Intro-49 Procedures Forms Key Documentation, Policies ........................................Intro-47 Procedures Responsibilities., Departmental ..............................................Intro-20 Procedures, Quality.....................................................................................Man Prep Procedures, Quality.....................................................................................QM Procedures, Quality.....................................................................................QP0500 Process Approach, Employ ISO 9001 ..........................................................Intro-43 Process Approach, Using .............................................................................Intro-24 Process Improvement .................................................................................QP1090-1-5.8 Process Improvement, Phase One Realizing Need .....................................Intro-45 Process Improvement, Using Maturity Model Start ...................................Intro-46 Process Model .............................................................................................QP1090-1-4.1 Process Monitoring/Measurement, Review ...............................................QP1180 Process Nonconformity ...............................................................................QP1180 Process Plans, Managerial ..........................................................................QP1090-1-3 Process Plans, Supporting ...........................................................................QP1090-1-5 Process Plans, Technical .............................................................................QP1090-1-4 Process, Starting Sales ................................................................................QP1080 Processes, Define Your ISO .........................................................................Intro-35 Processes, Quality .......................................................................................QM




Processes, Quality .......................................................................................QP0500 Processes, Sketch Out Continual Improvement .........................................Intro-38 Product Acceptance ....................................................................................QP1090-1-4.4 Product Design Release Form .....................................................................QP1130-1 Product Needs Identification ......................................................................QP1090 Product Realization .....................................................................................QP1140 Product Release Authorization ...................................................................QP1140-2 Product Test ................................................................................................QP1100-5 Production Change Control.........................................................................QP1140 Production Control ......................................................................................QP1140 Production Plan ...........................................................................................QP1130 Program, Audit ............................................................................................QP1020-1 Program, Internal Audit ..............................................................................QP1020 Project Assessment .....................................................................................QP1100 Project Closeout Plan ..................................................................................QP1090-1-3.5 Project Definition ........................................................................................QP1090 Project Definition Review ...........................................................................QP1090 Project Design Outputs, Deliverables .........................................................QP1090-1-1.3 Project Metrics ............................................................................................QP1090-1-3.3.6 Project Organization ...................................................................................QP1090-1-2 Project Overview .........................................................................................QP1090-1-1 Project Plan .................................................................................................QP1090-1 Project Plan, Building ..................................................................................QP1090 Project Plan, Reviewing...............................................................................QP1090 Project Planning ..........................................................................................QP1090 Project Staff Training ..................................................................................QP1090-1-3.1.4 Project Tracking Plan ..................................................................................QP1090-1-3.3 Property Control, External ..........................................................................QP1160 Property, Intellectual ..................................................................................QP1160 Provider Audit Checklist, External ..............................................................QP1120-2 Provider Evaluation, External......................................................................QP1120 Provider Files, External ...............................................................................QP1120 Provider List, Approved External ................................................................QP1120-1 Provider Notice, External ............................................................................QP1120 Provider Performance Log, External ...........................................................QP1120-4 Provider Purchase Orders, External ............................................................QP1120 Provider Removal, External ........................................................................QP1120 Provider Screening, External .......................................................................QP1120 Provider-Contractor Evaluations, Critical External .....................................QP1120-3 Purchase Order ...........................................................................................QP1220-2 Purchase Order Follow-Up ..........................................................................QP1220-4 Purchase Order Log .....................................................................................QP1220-3 Purchase Orders, External Provider ............................................................QP1120 Purchase Requisition ...................................................................................QP1220-1




Purchasing ...................................................................................................QP1220 Purchasing Review ......................................................................................QP1220 Purpose, Scope, and Objectives ..................................................................QP1090-1-1.1

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QMS Commitment, Management’s ............................................................QP1060 QMS Components .......................................................................................QP0500 QMS Documentation ..................................................................................Intro-13 QMS MANUAL ACCREDITATION, USING YOUR ISO 9001 ..........................Intro-51 QMS System Management Resources, Phase Three Building ...................Intro-40 QMS, Using Auditing ISO 9001 ....................................................................Intro-44 Quality Assurance .......................................................................................QP1090-1-5.4 Quality Audit Checklist ................................................................................QP1020-3 Quality Auditor Job Description, Internal ...................................................QP1070-B Quality Control ............................................................................................QP1090-1-3.3.4 Quality Management System vs. Management System .............................Intro-14 Quality Manual Contents ............................................................................Intro-14 Quality Manual, Your ..................................................................................Man Prep Quality Objectives .......................................................................................QP0500 Quality Policies, Manual and Objectives.....................................................Intro-19 Quality Policy ..............................................................................................QP0500 Quality Policy Objectives Document Control, Completing Phase One .......Intro-37 Quality Policy vs. Objectives .......................................................................Intro-14 Quality Procedures......................................................................................Man Prep Quality Procedures......................................................................................QM Quality Procedures......................................................................................QP0500 Quality Processes ........................................................................................QM Quality Processes ........................................................................................QP0500 Quality Scope ..............................................................................................QP0500

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Realization, Product ....................................................................................QP1140 Realizing Need Process Improvement, Phase One ....................................Intro-45 Receipt, Inspection, and Stocking of Customer Supplied Items .................QP1160 Received Certificates Cofc Cofa, Items .......................................................QP1210 Receiving & Inspection ................................................................................QP1210 Receiving and Inspection Report ................................................................QP1210-3 Receiving and Stocking ...............................................................................QP1210 Receiving Log ..............................................................................................QP1210-1 Receiving/Inspection Review ......................................................................QP1210 Record Keeping, Employing ISO 9001 Improves Documentation..............Intro-28 Record, Employee Group Training ..............................................................QP1070-3




Record, Individual Training .........................................................................QP1070-4 Recordkeeping and Matching .....................................................................QP1220 Records Continual Improvement, Using ISO 9001 .....................................Intro-43 References ..................................................................................................QP1090-1-1.6 Registrar, Importance Selecting ..................................................................Intro-33 Registrar, Other Factors Consider Selecting ...............................................Intro-33 Regularly Occurring Problems, Achieving Stability Allows Focus ..............Intro-49 Relationships Enhance Effectiveness, Supplier...........................................Intro-25 Release Authorization, Product ..................................................................QP1140-2 Release Form, Product Design ....................................................................QP1130-1 Release, Final Verification ...........................................................................QP1140 Removal, External Provider ........................................................................QP1120 Report, Audit ...............................................................................................QP1020-4 Report, Corrective Action ...........................................................................QP1040-1 Report, First Article Inspection ...................................................................QP1210-2 Report, Internal Audit .................................................................................QP1020 Report, Material Problem ...........................................................................QP1160-1 Report, Nonconformance ...........................................................................QP1030 Report, Nonconformance ...........................................................................QP1030-1 Report, Post-Sale Satisfaction .....................................................................QP1190-1 Report, Preventive Action ...........................................................................QP0600-3 Report, Receiving Inspection ......................................................................QP1210-3 Report, Situational Analysis ........................................................................QP0500-3 Report, Situational Analysis ........................................................................QP0500 Reporting.....................................................................................................QP1090-1-3.3.5 Reporting Monitoring/Measurement Data ................................................QP1180 Request, Document ....................................................................................QP1000-1 Requesting Design Changes ........................................................................QP1110 Requirements Documents, Understand Specific ISO 9001 ........................Intro-43 Requirements Management .......................................................................QP1090-1-3.3.1 Requirements, General Monitoring Measuring..........................................QP1180 Requirements, Monitoring Measuring Employee ......................................QP1170 Requisition, Order Determination ..............................................................QP1220 Requisition, Purchase ..................................................................................QP1220-1 Requisition/Disposal Form, Asset ...............................................................QP0700-1 Resolution, Problem....................................................................................QP1090-1-5.6 Resource Acquisition...................................................................................QP1090-1-3.1.3 Resource Allocation ....................................................................................QP1090-1-3.2.3 Resources Control, Monitoring-Measuring ................................................QP1170 Resources, Phase Three Building QMS System Management ...................Intro-40 Responsibilities, Roles .................................................................................QP1090-1-2.3 Responsibilities., Departmental Procedures ..............................................Intro-20 Return Goods Authorization .......................................................................QP1030-3 Returned Goods ..........................................................................................QP1030




Review Agenda, Management ....................................................................QP1060 Review Checklist, Design .............................................................................QP1100-1 Review Documented Information, Management .......................................QP1060 Review Meeting, Management ..................................................................QP1060-1 Review of Process Monitoring/Measurement............................................QP1180 Review Verification Validation Testing, Change Design Development ......QP1110 Review, Customer Satisfaction ...................................................................QP1190 Review, Design Development .....................................................................QP1100 Review, Identification Traceability .............................................................QP1150 Review, Management .................................................................................QP1060 Review, Project Definition ..........................................................................QP1090 Review, Purchasing .....................................................................................QP1220 Review, Receiving/Inspection .....................................................................QP1210 Review, Risk Management Actions .............................................................QP0600 Reviewing the Project Plan .........................................................................QP1090 Reviews and Audits .....................................................................................QP1090-1-5.5 Revisions, Document ..................................................................................QP1000 Risk Assessment ..........................................................................................QP0600 Risk Assessment / Management Worksheet ..............................................QP0600-1 Risk Assessment Guidelines ........................................................................QP0600 risk assessment, Tools used ........................................................................Intro-15 Risk Controls Cost-Benefit Worksheet ........................................................QP0600-2 Risk Management Actions and Review .......................................................QP0600 Risk Management Committee ....................................................................QP0600 Risk Management Plan ...............................................................................QP1090-1-3.4 Risk Management, Phase Five ....................................................................Intro-49 Risk-Based Thinking vs. Preventive Action .................................................Intro-14 Risks & Opportunities Management ...........................................................QP0600 Risks, Inputs Assumptions Constraints .......................................................QP1090-1-1.2 Role Gaining Certification, ISO ....................................................................Intro-31 Roles and Responsibilities ...........................................................................QP1090-1-2.3 Roll-Out, Plan ..............................................................................................QP1130 Root Causes, Phase Four Finding ................................................................Intro-48

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Sales Process, Starting ................................................................................QP1080 Sample Job Descriptions .............................................................................QP1070-5 Sample Verification Checklist .....................................................................QP1100-4 Satisfaction General, Customer ..................................................................QP1190 Satisfaction Report, Post-Sale .....................................................................QP1190-1 Satisfaction Review, Customer ...................................................................QP1190 Satisfaction Survey, Customer ....................................................................QP1190 Satisfaction Survey, Customer ....................................................................QP1190-2




Satisfaction, Customer ................................................................................QP1190 Schedule Allocation .....................................................................................QP1090-1-3.2.2 Schedule and Budget Summary ..................................................................QP1090-1-1.4 Schedule Control .........................................................................................QP1090-1-3.3.2 Scope .........................................................................................................QM Scope Objectives, Purpose ..........................................................................QP1090-1-1.1 Scope, Quality .............................................................................................QP0500 Scoring Attributes .......................................................................................QP0500 Screening, External Provider .......................................................................QP1120 Segregation, Identification ..........................................................................QP1030 Selecting Registrar, Importance ..................................................................Intro-33 Selecting Registrar, Other Factors Consider ...............................................Intro-33 Selection, Employee ....................................................................................QP1070 Separating Common Special, Phase Three .................................................Intro-47 Service Log, Customer .................................................................................QP1190-3 Service, Customer .......................................................................................QP1080 Situation, Assessing Company’s ..................................................................QP0500 Situational Analysis .....................................................................................QP0500 Situational Analysis Introduction ................................................................QP0500 Situational Analysis Report .........................................................................QP0500-3 Situational Analysis Report .........................................................................QP0500 Sketch Out the Continual Improvement Processes ....................................Intro-38 Software, Test .............................................................................................QP1170 Special, Phase Three Separating Common .................................................Intro-47 Specific ISO 9001 Requirements Documents, Understand........................Intro-43 Stability Allows Focus Regularly Occurring Problems, Achieving ..............Intro-49 Stability, Using Data Analysis Achieve ........................................................Intro-47 Staff Training, Project .................................................................................QP1090-1-3.1.4 Staffing ........................................................................................................QP1090-1-3.1.2 Standard, ISO 9001 .....................................................................................Intro-35 Standards Generally Technical, ISO ............................................................Intro-10 Standards, Current ISO 9000 Family ...........................................................Intro-16 Stands Equal, ISO ........................................................................................Intro-10 Start Process Improvement, Using Maturity Model ...................................Intro-46 Start with Clause Four of the ISO 9001 Standard .......................................Intro-35 Starting the Journey to ISO 9001 Certification ...........................................Intro-34 Starting the Sales Process ...........................................................................QP1080 Startup Plan .................................................................................................QP1090-1-3.1 Step ISO 9001 Journey, Phase Next ...........................................................Intro-37 Steps Achieving ISO 9001 Certification, Final ............................................Intro-42 Stocking Customer Supplied Items, Receipt Inspection ............................QP1160 Stocking, Receiving .....................................................................................QP1210 Storage, Handling, and Maintenance .........................................................QP1170 Strategy .......................................................................................................QP0500




Strengths .....................................................................................................QP0500 Structure, Internal .......................................................................................QP1090-1-2.2 Structure, Work Breakdown .......................................................................QP1090-1-3.2.1 Subcontractor Calibration, Control .............................................................QP1170 Subcontractor Management .......................................................................QP1090-1-5.7 Success, Management Commitment Vital ISO 9001 ..................................Intro-40 Summary, Schedule Budget ........................................................................QP1090-1-1.4 Supplied Items, Receipt Inspection Stocking Customer .............................QP1160 Supplier Relationships Enhance Effectiveness............................................Intro-25 Support........................................................................................................Intro-18 Supporting Process Plans ............................................................................QP1090-1-5 Survey, Customer Satisfaction ....................................................................QP1190 Survey, Customer Satisfaction ....................................................................QP1190-2 SWOT .........................................................................................................QP0500 SWOT Analysis Worksheet ..........................................................................QP0500-1 System Components Continual Improvement, Additional ISO..................Intro-39 System Data, Phase Two Collecting Management .....................................Intro-46 System Development, Identification Traceability.......................................QP1150 System Management Resources, Phase Three Building QMS ...................Intro-40 System Management System, Quality Management .................................Intro-14 System, Calibration .....................................................................................QP1170 System, Quality Management System Management .................................Intro-14 Systems, Implementing Effective Management .........................................Intro-50

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Taking Corrective Action .............................................................................QP1040 Technical Process Plans ..............................................................................QP1090-1-4 Technical, ISO Standards Generally ............................................................Intro-10 Techniques, Methods Tools ........................................................................QP1090-1-4.2 Temporary Document Changes ..................................................................QP1000 Test Software ..............................................................................................QP1170 Test, Product ...............................................................................................QP1100-5 Testing, Change Design Development Review Verification Validation .....QP1110 Testing, Design Validation...........................................................................QP1100 Testing, Inspection ......................................................................................QP1140 Thinking Preventive Action, Risk-Based ......................................................Intro-14 Threats ........................................................................................................QP0500 Three Building QMS System Management Resources, Phase ...................Intro-40 Three Separating Common Special, Phase .................................................Intro-47 THROUGH ISO 9001 MATURITY, IMPROVEMENT .......................................Intro-45 Tools Techniques, Methods ........................................................................QP1090-1-4.2 Tools used for risk assessment ...................................................................Intro-15 Traceability General, Identification ............................................................QP1150




Traceability Review, Identification .............................................................QP1150 Traceability System Development, Identification.......................................QP1150 Traceability, Identification ..........................................................................QP1150 Tracing Items, Identifying ...........................................................................QP1150 Tracking Plan, Project .................................................................................QP1090-1-3.3 Training Documents Are Important in ISO 9001.........................................Intro-41 Training Effectiveness .................................................................................QP1070 Training Record, Employee Group ..............................................................QP1070-3 Training Record, Individual .........................................................................QP1070-4 Training, Employee .....................................................................................QP1070 Training, Project Staff .................................................................................QP1090-1-3.1.4 Transfer Documentation, Design ................................................................QP1130 Try to Simplify ISO Compliance ...................................................................Intro-44 Two Collecting Management System Data, Phase ....................................Intro-46

- U V -

Understand Specific ISO 9001 Requirements for Documents ....................Intro-43 Understanding ISO 9001 Certification ........................................................Intro-31 Understanding the Goal of Implementing ISO 9001 ..................................Intro-9 Unsuitable or Missing Items .......................................................................QP1160 Update to ISO 9001:2000 ............................................................................Intro-12 Update to ISO 9001:2008 ............................................................................Intro-12 Update to ISO 9001:2015 ............................................................................Intro-12 Usage Instructions ......................................................................................Man Prep used risk assessment, Tools ........................................................................Intro-15 Using and Auditing ISO 9001 QMS ..............................................................Intro-44 Using Data Analysis to Achieve Stability .....................................................Intro-47 Using ISO 9001 Records for Continual Improvement .................................Intro-43 USING ISO 9001, BENEFITS .........................................................................Intro-23 Using Your ISO 9001 QMS Manual And Accreditation ...............................Intro-51 Using the Maturity Model to Kick Start Your Process Improvement .........Intro-46 Using the Process Approach .......................................................................Intro-24 Validation Testing, Change Design Development Review Verification .....QP1110 Validation Testing, Design...........................................................................QP1100 Validation, Verification ...............................................................................QP1090-1-5.2 Verification and Closure ..............................................................................QP1040 Verification and Validation .........................................................................QP1090-1-5.2 Verification Checklist, Sample ....................................................................QP1100-4 Verification Release, Final ...........................................................................QP1140 Verification Validation Testing, Change Design Development Review .....QP1110 Verification, Design .....................................................................................QP1100 Vital ISO 9001 Success, Management Commitment .................................Intro-40




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Weaknesses ................................................................................................QP0500 What is the Goal, Improvement or Certification? ......................................Intro-23 Work Breakdown Structure ........................................................................QP1090-1-3.2.1 Work Instructions .......................................................................................Intro-20 Work Plan ....................................................................................................QP1090-1-3.2 Worksheet, Competitive Analysis ...............................................................QP0500-2 Worksheet, Risk Assessment Management ...............................................QP0600-1 Worksheet, Risk Controls Cost-Benefit .......................................................QP0600-2 Worksheet, SWOT Analysis .........................................................................QP0500-1 YOUR ISO 9001 QMS MANUAL ACCREDITATION, USING ..........................Intro-51 Your ISO Processes, Define .........................................................................Intro-35 Your Quality Manual ...................................................................................Man Prep




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