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Quality Management System ISO 9001:2008 Awareness Program

ISO 9001 2008 Awareness

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Page 1: ISO 9001 2008 Awareness

Quality Management System

ISO 9001:2008 Awareness Program

Page 2: ISO 9001 2008 Awareness

2

What is Quality ?

“ THE TOTALITY OF FEATURES AND CHARACTERISTICS OF A PRODUCT OR SERVICE THAT BEAR UPON

ITS ABILITY TO SATISFY STATED OR IMPLIED NEEDS “

Fitness for use Conformance to requirements Accuracy Perfection Zero Defect Adequacy Cost Effectiveness

Page 3: ISO 9001 2008 Awareness

What is System ?

A group of interacting, interrelated, or interdependent elements forming a complex whole

Set of detailed methods ,procedures and routines established or formulated to carry out a specific activity , perform a duty , or solve a problem

Page 4: ISO 9001 2008 Awareness

What is QMS ?

Quality Management System

A System of coordinated activities which is meant to “direct” and “control” an organization with regard to quality.

Page 5: ISO 9001 2008 Awareness

What is ISO ?

International Organization for Standardization

Founded in 1946 in Geneva , Switzerland

ISO is a non-governmental organization that forms a bridge between the public

and private sectors.

"ISO", derived from the Greek. ISO, meaning "equal". Whatever the country,

whatever the language, the short form of the organization's name is always ISO.

"ISO", is a system audit not for product audit

ISO is composed of more than 90 members countries

World's largest developer and publisher of International Standards.

ISO 9000

OHSAS18001

ISO14001

SA8000

QS90

Page 6: ISO 9001 2008 Awareness

ISO 9000 STANDARDS

ISO 9001:2008 - Quality Management Systems Requirements

ISO 9000:2000 - Quality Management Systems fundamentals and vocabulary

ISO 9004:2000 - Quality Management System guidelines for performance improvements

ISO 19011:2000- Guide for Auditing Management System

Page 7: ISO 9001 2008 Awareness

ISO 9001: 2008

ISO 9000 series evolution: 1987- initial publishing 1994- first revision 2000- Second revision 2008- Current edition

Page 8: ISO 9001 2008 Awareness

Based on eight

quality

management

principles

Based on eight

quality

management

principles

LeadershipLeadership

Process

approachProcess

approach

Involvement

of peopleInvolvement

of people

System

approach to

Management

System

approach to

ManagementContinual

improvementContinual

improvement

Factual

approach to

decision

making

Factual

approach to

decision

making

Mutual

beneficial

supplier

relationship

Mutual

beneficial

supplier

relationship

Customer

focusCustomer

focus

Principles of Standards

Page 9: ISO 9001 2008 Awareness

Customer Focus

DETERMINE CUSTOMER NEEDS & EXPECTATIONS

DETERMINE CUSTOMER NEEDS & EXPECTATIONS

REQUIREMENTSREQUIREMENTS

CUSTOMER SATISFACTIONCUSTOMER SATISFACTIONPrinciple 1

Organizations

Depends on

Customers .

Page 10: ISO 9001 2008 Awareness

Leadership

Principle 2

Leaders must set the direction of the organization

Leaders must create and maintain internal environment that encourages people to achieve the organization’s objectives

Page 11: ISO 9001 2008 Awareness

Involvement of People

Principle 3

Must help people to develop and use their abilities

Must encourage the involvement of people at all level

Page 12: ISO 9001 2008 Awareness

Process Approach

Principle 4

Activities+

Resources

Input Output

A desired result is more efficiently achieved when resources and activities are managed as a process

A desired result is more efficiently achieved when resources and activities are managed as a process

Control

Page 13: ISO 9001 2008 Awareness

Process A

Process B Process D

InputOutputControl

Process C

Processes – understand interaction

Page 14: ISO 9001 2008 Awareness

Process

Any activity that takes “inputs” and converts them to “outputs”

Process Approach

The systematic identification and management of these activities and the interaction between activities.

Page 15: ISO 9001 2008 Awareness
Page 16: ISO 9001 2008 Awareness

Example - Purchasing Process

Performance Measurements

• Delivery status – On-time, On spec, etc

• Supplier evaluation

Performance Measurements

• Delivery status – On-time, On spec, etc

• Supplier evaluation

Outputs• Receipt of

Material on right condition

• Right Quality Right Quantity

• Right Time

Outputs• Receipt of

Material on right condition

• Right Quality Right Quantity

• Right Time

Purchasing Procedure

Purchasing Procedure

Interactions to• Storage• Inspection and

Testing• Manufacturing• Finance

Interactions to• Storage• Inspection and

Testing• Manufacturing• Finance

Inputs• Demand for

material • Item specs

and Date• Supplier

source• Suppliers

capability to meet our requirements

Inputs• Demand for

material • Item specs

and Date• Supplier

source• Suppliers

capability to meet our requirements

Page 17: ISO 9001 2008 Awareness

System Approach to Management

Principle 5

Identifying , understanding and managing a system of interrelated process for a given objective improves the organization effectiveness and efficiency

Page 18: ISO 9001 2008 Awareness

Deming’s wheel

(P.D.C.A.)

Deming’s wheel

(P.D.C.A.)

ISO9000

PLAN DO

ACT CHECK ContinualImprovement

Customer Focus

Continual improvement of the organization's overall performance should be a permanent objective of the organization.

Continual Improvement

Principle 6

Page 19: ISO 9001 2008 Awareness

The “Plan-Do-Check-Act” Cycle(Deming’s Cycle)

Page 20: ISO 9001 2008 Awareness

Factual Approach to decision making

Principle 7

Effective decisions are based on the analysis of data and information

Page 21: ISO 9001 2008 Awareness

Mutual beneficial supplier relationships

Principle 8

An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value

Page 22: ISO 9001 2008 Awareness

Continual improvement of theQuality Management System

CU

STO

MER

S

ManagementResponsibility

Measurement,Analysis andImprovement

ResourceManagement

Product /Service

Realization

InputData

ProductService

OutputData

Req

uire

men

ts

Satis

factio

n

CU

STO

MER

S

ISO 9001:2008 Requirements

Page 23: ISO 9001 2008 Awareness

The Structure

0 Introduction1 Scope2 Normative reference3 Terms and definitions4 Quality management system requirements5 Management responsibility6 Resource management7 Product realization8 Measurement, analysis and improvement

Page 24: ISO 9001 2008 Awareness

System Requirements / Structure of the Standard

Provision of resources(6.1)

Human resources(6.2)

Infrastructures(6.3)

Work environment(6.4)

6 Resource Management

General requirements (4.1)

Documentation Requirements(4.2)

Management Commitment(5.1)

Customer focus (5.2)

Quality policy(5.3)

Planning(5.4)

Responsibility, authority & communication(5.5)

Management Reviews (5.6)

5 Management Responsibility

8 Measurement Analysis & improvement

4 Quality Management System

7 Product Realization

General (8.1)

Monitoring & measurement(8.2)

Control of NCP(8.3)

Analysis of data(8.4)

Improvements(8.5)

Planning(7.1)

Customer related processes(7.2)

Design & development(7.3)

Purchasing(7.4)

Production & service provision(7.5)

Control of monitoring & measuring devices(7.6)

Page 25: ISO 9001 2008 Awareness

4.0 Quality Management System

4.1 General requirements

Establish , document , implement and maintain a QMS and continually improve its effectiveness in accordance with the standard

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4.0 Quality Management System

4.1 General Requirements

Determine the processes necessary for QMS

Determine the sequence and interaction of processes

Determine criteria & methods to ensure effective operation & control of the processes

Ensure availability of resources and information needed to support the operation & monitoring of the processes

Measure , monitor and analyze processes

Implement action necessary to achieve planned results & continual improvement

Page 27: ISO 9001 2008 Awareness

4.2 Documentation Requirements

• Extent • Size and type of

organization• Complexity and

interaction of processes• Competence of

personnel

• Note3 (Documentation may be in any type of media)

• To Include• Documented procedures

required by standard• Documents required by

organization to ensure effective operation and control process

• Note 1 (Where the term “documented procedure” appears)

4.0 Quality Management System

General

Page 28: ISO 9001 2008 Awareness

• 4.2.2 Quality Manual– The organization shall establish a Quality Manual that

include:• Scope of QMS• Documented procedures or reference to them• Description of interaction between the process of QMS

4.2 Documentation Requirements

4.0 Quality Management System

Page 29: ISO 9001 2008 Awareness

4.2 Documentation Requirements

4.0 Quality Management System

4.2.3 Control of Documents

Documented procedures to: Approve documents prior to issue Review , update as necessary and re-approve documents To identify the changes and the current revision status of documents To ensure documents remain legible , readily identifiable Ensure relevant versions of applicable documents are available at

points of use Ensure that the documents of external origin are identified and

distribution controlled Obsolete documents are prevented from unintended use and

identified if kept for any reason

Documents required by the quality management system shall be controlled

Page 30: ISO 9001 2008 Awareness

4.2 Documentation Requirements

4.0 Quality Management System

4.2.4 Control of Records Records must be established and maintained Records must be legible , readily identifiable and retrievable Documented procedure for control of identification , storage ,

retrieval ,retention time and disposition of quality records

Page 31: ISO 9001 2008 Awareness

• 5.1 Management Commitment

• 5.2 Customer Focus

• 5.3 Quality policy

• 5.4 Planning– 5.4.1Quality

objectives– 5.4.2 Quality

Planning

• 5.5 Responsibility, authority and communication

– 5.5.1 Responsibility & authority

– 5.5.2 Management representative

– 5.5.3 Internal communication

• 5.6 Management Review– 5.6.1 General– 5.6.2 Review input– 5.6.3 Review output

5.0 Management Responsibility

Page 32: ISO 9001 2008 Awareness

5.1 Management Commitment

• Provide evidence of commitment to the development and improvement of QMS by:

– Communicating the importance of meeting customer and legal/regulatory requirements.

– Establishing quality policy and objectives.– Management Reviews– Provision of resources.

5.0 Management Responsibility

Page 33: ISO 9001 2008 Awareness

5.2 Customer Focus

• Top Management shall ensure that customer needs & expectations are determined, converted into requirements & fulfilled with the aim of achieving customer satisfaction

5.0 Management Responsibility

Page 34: ISO 9001 2008 Awareness

5.3 Quality Policy• Appropriate to the purpose of

organization.• Commitment to meeting

requirements and continual improvements

• Frame work for establishing and reviewing quality objectives

• Communicated and understood at appropriate levels

• Is reviewed for continuing suitability

5.0 Management Responsibility

Page 35: ISO 9001 2008 Awareness

• Establish quality objectives at relevant functions and levels

• Objectives must be measurable and consistent with the quality policy including the commitment to continual improvement

• Include those needed to meet requirements for product

5.4 Planning5.4.1 Quality Objectives (Cont)

5.0 Management Responsibility

Page 36: ISO 9001 2008 Awareness

5.4 Planning5.4.1 Quality Objectives (Cont)

Quality Objectives should be:• Set• Measurable• Achievable• Realistic• Timed

5.0 Management Responsibility

Page 37: ISO 9001 2008 Awareness

5.4.2 Quality Management System Planning

• Identify and plan processes needed to achieve quality objectives• Plan the development of QMS• Plan the implementation of

QMS• Plan the improvement of QMS

5.0 Management Responsibility

Page 38: ISO 9001 2008 Awareness

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and authority

Functions and their interaction, responsibilities and authorities shall be defined and communicated to facilitate effective quality management

5.0 Management Responsibility

Page 39: ISO 9001 2008 Awareness

5.5.2 Management Representative

• Member of the management who has responsibility and authority for – ensuring that processes of the QMS are established

and maintained– Reporting on performance of QMS including needs for

improvement– Promoting awareness of customer needs and

requirements• Note: Responsibilities may include liaison with

external parties in relation to QMS

5.0 Management Responsibility

Page 40: ISO 9001 2008 Awareness

5.5.3 Internal Communication

• Ensure communication between various levels and functions regarding the processes of the QMS and their effectiveness

5.0 Management Responsibility

Page 41: ISO 9001 2008 Awareness

5.6 Management Review5.6.1 General

• Review of QMS by top management at planned interval to;– ensure QMS suitability,

adequacy and effectiveness– Evaluate the need for

changes to QMS including policy and objectives

Records from Management Reviews shall be maintained (see 4.2.4).

5.0 Management Responsibility

Page 42: ISO 9001 2008 Awareness

5.6.2 Review Input

• Review performance and improvement opportunities related to:– Audit results– Customer feedback– Process performance and product conformance– Status of preventive and corrective actions– Follow up actions from earlier reviews– Change that could affect the QMS– Recommendations for improvement

5.0 Management Responsibility

Page 43: ISO 9001 2008 Awareness

5.6.3 Review Output

• Output to include actions related to – improvement of the effectiveness QMS and its

processes– improvement of product related to customer

requirements– resource needs

5.0 Management Responsibility

Page 44: ISO 9001 2008 Awareness

• 6.1 Provision of resources• 6.2 Human resources

– 6.2.1 General– 6.2.2 Competence, awareness and training

• 6.3 Infrastructure• 6.4 Work environment

6.0 Resource Management

Page 45: ISO 9001 2008 Awareness

6.1 Provision of Resources

• The organization shall determine and determine the resources needed for :– implement and maintain the QMS and

continually improve its effectiveness.– Enhance customer satisfaction by

meeting customer requirements.

6.0 Resource Management

Page 46: ISO 9001 2008 Awareness

6.2 Human Resources6.2.1 General

• Those who have responsibilities defined in the QMS must be competent on the basis of appropriate education, training, skills and experience

6.0 Resource Management

Page 47: ISO 9001 2008 Awareness

6.2.2 Competency, Awareness and Training

• Identify competency needs• Provide required training• Evaluate the effectiveness of

training provided• Ensure staff is aware of

relevance and importance of their activities and contribution to achieving quality objectives

• Maintain appropriate records of education, training, qualification and experience

6.0 Resource Management

Page 48: ISO 9001 2008 Awareness

6.3 Infrastructure

• Identify, provide and maintain the infrastructure needed to achieve product conformity

• This shall include :– Workspace & associated utilities– Equipment, hardware and software– Supporting services (transport or

communication)

6.0 Resource Management

Page 49: ISO 9001 2008 Awareness

6.4 Work Environment

• The organization shall determine and manage the work environment needed to achieve conformity to product requirements.

6.0 Resource Management

Page 50: ISO 9001 2008 Awareness

• 7.1 Planning of product realization• 7.2 Customer related processes• 7.3 Design & development• 7.4 Purchasing• 7.5 Production & service operation• 7.6 Control of measuring & monitoring devices

7.0 Product Realization

7 Product Realization

Page 51: ISO 9001 2008 Awareness

7.1 Planning of Product Realization

• Sequence of process to achieve product• Consistent with QMS and documented to suit

method of operations• Quality objectives and requirements for the

product• The need for processes, documentation, resources

and facilities specific to the product• Verification and validation activities and

acceptance criteria• Records

7.0 Product Realization

Page 52: ISO 9001 2008 Awareness

7.2 Customer Related Processes

7.2.1 Determination of requirements related to the product

7.2.2 Review of product requirements7.2.3 Customer communication

7.0 Product Realization

Page 53: ISO 9001 2008 Awareness

7.2.1 Determination of requirements related to the product

• Product requirements specified by the customer including requirements for delivery and post-delivery activities

• Requirements not specified but necessary for intended or specified use

• Obligations related to product, including regulatory and legal requirements

• any additional requirements determined by the organization

7.0 Product Realization

Page 54: ISO 9001 2008 Awareness

7.2.2 Review of requirements related to the product

• Review identified requirements and ensure before commitment to supply product that;– Product requirements are defined– For verbal orders requirements are confirmed– Difference between tender and contract are

resolved– Organization has ability to meet the

requirements

– Records of the results arising from the review shall be recorded.

7.0 Product Realization

Page 55: ISO 9001 2008 Awareness

7.2.3 Customer Communication

• Identify and implement arrangements for communication with customers relating to:– product information– inquiry, contract or order handling, including

amendments– Customer feedback including complaints

7.0 Product Realization

Page 56: ISO 9001 2008 Awareness

7.3 Design & Development

• 7.3.1 Design & development planning• 7.3.2 Design & development inputs• 7.3.3 Design & development outputs• 7.3.4 Design & development review• 7.3.5 Design & development verification• 7.3.6 Design & development validation• 7.3.7 Control of design and development

changes

7.0 Product Realization

Page 57: ISO 9001 2008 Awareness

7.4 Purchasing

• 7.4.1 Purchasing process

• 7.4.2 Purchasing information

• 7.4.3 Verification of purchased product

7.0 Product Realization

Page 58: ISO 9001 2008 Awareness

7.4.1 Purchasing Process

• Purchased product meets requirements• Type & extend of control depends on effect

purchased product may have on realization processes and their output

• Selects suppliers based on their ability to supply conforming product

• Define criteria for selection and periodic evaluation and re-evaluation of suppliers

• Results of evaluation and follow up actions must be recorded

Page 59: ISO 9001 2008 Awareness

7.4.2 Purchasing Information

• Purchasing information shall describe the product to be purchased, including where appropriate:

– Requirements for approval of product,procedures, processes and equipment.

– Requirements for qualification of personnel.

– Quality management system requirements.

Page 60: ISO 9001 2008 Awareness

7.4.3 Verification of Purchased

Product• Identify and implement activities needed

to verify purchased product• Where organization or its customer

purpose verification at supplier premises, organization must specify in purchasing information:– verification arrangements– method of product release.

Page 61: ISO 9001 2008 Awareness

7.5 Production & Service Provision

• 7.5.1Control of production and service provision

• 7.5.2Validation of processes for production and service

provision• 7.5.3 Identification and traceability• 7.5.4Customer Property• 7.5.5Preservation of Product

Page 62: ISO 9001 2008 Awareness

7.5.1 Control of production and service provision

Control production & services operations through:

• Availability of information specifying product characteristics

• Work instructions available where necessary

• Use and maintenance of suitable equipment

• Availability & use measuring and monitoring devices

• Implementation of monitoring activities

• Implementation of defined processes for release, delivery and post delivery activities

Page 63: ISO 9001 2008 Awareness

7.5.2 Validation of Processes

Validation arrangements must be defined and must include as applicable– qualification of the process– qualification of equipment and

personnel– use of defined methodologies &

procedure– requirements for record– re-valuation

Page 64: ISO 9001 2008 Awareness

7.5.3 Identification & Traceability

• Where appropriate identify product through all stages of operations

• Identify status with respect to measurement & monitoring requirements

• Where traceability is required control & record unique identification of product

I can not remember

Page 65: ISO 9001 2008 Awareness

7.5.4 Customer Property

• Care for customer’s property being under organization’s control or being used by organization

• Identification, verification, protection & maintenance of customer property provided for use or incorporation

• Any customer property that is lost, damaged or found un- suitable must be recorded & reported to customer

• Customer Property - tangible / intangible

Page 66: ISO 9001 2008 Awareness

7.5.5 Preservation of Product

• Preserve conformity of product during internal processing and final delivery to intended destination

• Include identification, handling, packaging, storage and protection

• This applies to constituent parts of product

Page 67: ISO 9001 2008 Awareness

7.6 Control of monitoring & measuring devices

• Calibrate & adjust measuring and monitoring devices at specified intervals as prior to use

• Traceability to international or national standards. Where no such standard exist record the basis

• Safeguard MMD from adjustments invalidating calibration

• Protect MMD from damage or deterioration during handling, maintenance or storage

• Record results of calibration• Assess validity of previous results when

devices found to be out of calibration

Page 68: ISO 9001 2008 Awareness

8 Measurement, Analysis and Improvement

• 8.1 General• 8.2 Monitoring &

Measurement– 8.2.1 Customer

satisfaction

– 8.2.2 Internal audit– 8.2.3 Monitoring and

measurement of

processes– 8.2.4 Monitoring and

measurement of

product

• 8.3 Control of non-conforming

product• 8.4 Analysis of data• 8.5 Improvement

– 8.5.1 Continual

improvement– 8.5.2 Corrective action– 8.5.3 Preventive action

Page 69: ISO 9001 2008 Awareness

8.1 General

• Define, plan & implement measurement and monitoring activities needed to assure conformance and achieve improvement

• This include determination of the need and use of applicable methodologies and statistical techniques

Page 70: ISO 9001 2008 Awareness

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

• Organization shall monitor information on customer satisfaction and /or dis-satisfaction

• The methodologies for obtaining and utilizing such information must be determined

Page 71: ISO 9001 2008 Awareness

8.2.2 Internal Audit

• Conduct periodic internal audit to determine if QMS:– Conforms to the requirements of the

standard– Has been effectively implemented &

maintained • Plan the audit program

considering:– Status and importance of the activity– results of previous audits

• Define audit scope, frequency and methodologies performed by personnel not performing audited work

Page 72: ISO 9001 2008 Awareness

• The documented procedure must cover:– Responsibilities &

authorities for conducting audits

– Ensuring independence– Recording results and

reporting to management– Timely corrective actions– Follow up to verify & report

implementation of verification results

8.2.2 Internal Audit

Page 73: ISO 9001 2008 Awareness

8.2.3 Measurement and Monitoring of

Processes

• Apply suitable methods for measurement and monitoring of those realization processes necessary to meet customer’s requirements.

Page 74: ISO 9001 2008 Awareness

• Measure & monitor product characteristics to verify conformance at appropriate stages of realization processes

• Evidence of conformity with the acceptance criteria must be documented, records must indicate the authority responsible for release of product

• Release or delivery must not proceed until all the specified activities have been completed unless otherwise approved by the customer

8.2.3 Measurement and Monitoring of

Product

VERIFIED 19/5/01 PASSED

HOLD

Page 75: ISO 9001 2008 Awareness

8.3 Control of Non conforming Product

• Documented procedures for control of non conforming product to prevent unintended use or delivery

• Non conforming product shall be corrected

• Re-verify after correction

• If non-conformance detected after delivery take appropriate action

• It is often required that the proposed rectification be reported for concession to the customer, the end user, regulatory or other body

Page 76: ISO 9001 2008 Awareness

8.4 Analysis of Data

• Collect & analyze data, determine suitability and effectiveness of QMS and to identify improvements that can be made

• Data from measurement & monitoring & other related sources

• Analyze data provide info on:– Customer satisfaction and/or

dissatisfaction– Conformance to customer requirement– Process, product characteristics and their

trends– Suppliers

Page 77: ISO 9001 2008 Awareness

8.5 Improvement8.5.1 Continual improvement

• Planning for Continual Improvement• The organization must plan and manage

processes necessary for continual improvement of the QMS

• Facilitate continual improvement using:– quality policy– objectives– audit results– analysis of data– corrective actions– preventive actions

• Management Review

Page 78: ISO 9001 2008 Awareness

8.5.2 Corrective Action

• Organization must take corrective action to eliminate the causes of non-conformance to prevent recurrence

• Action appropriate to the impact of problem

• Documented procedures shall define requirements for:– identifying non conformities– determine the causes– evaluating the need for corrective action– determine corrective action needed and

implemented– Recording results of action

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• Organization must identify preventive action to eliminate the causes of potential non conformances to prevent occurrences

• Actions appropriate to the impact of potential problem

• Documented procedures must define the requirements for– Identification of potential non-

conformances and their causes– Determining and ensuring

implementation of preventive action needed

– Recording results of action taken

8.5.3 Preventive Action

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Situation Warranting Corrective Action

• Identification of major non-conformance.• Large number of minor non-conformities.• The reoccurrence of a problem with a process or

activity.• Non-conformities observed during audits.• Customer Complaints.

• Non-conforming deliveries from vendors.

Page 81: ISO 9001 2008 Awareness

Stages of Corrective & Preventive Action

• REPORTING • INVESTIGATION • ACTION• FOLLOWUP• CLOSING

Page 82: ISO 9001 2008 Awareness

EXPECTED BENEFITS

Transparency in working at all level Data availability : Hidden Factors are

openCreates AccountabilityPlanning & scheduling improved Rework & Rejection are known and

being controlled Customer feedback through regular

surveys Employees Participation enhanced Continuos Improvements Program

launchedMarket Reputation

Page 83: ISO 9001 2008 Awareness

Thank You !