ASQ Monthly Dinner Meeting

Jay Stahan January 12, 2016

ASQ Monthly Dinner Meeting Sections 1510, 1515

January 12, 2016

Topic: ISO 9001:2015 Revision Review

ISO 9001:2015 Presentation


• Quick Summary Review of ISO 9001 through the years

• Compare change from 2008 Revision to 2015 Revision

• Some Examples of how changes can be implemented

• Quick Review of Impact to Sector ISO QMS Standards


AGENDA


Source Materials:•READ Lots of Articles•ATTENDED Many Webinars



ISO 9001 Through the Years

•Foundation Mil Std 9858, BS5750

•1987 (20 Elements; 3 Models (Design/Mfgr; Mfgr; Final Test/Insp))

•1994 (20 Elements; Some Clarifications; ease-up Docs)

•2000 (1 Model; Process Approach; 20 Elements Gone)

•2008 (Minor Clarifications)

•2015 (New focus areas eg., Risk Based Thinking and Context of the Organization, but many facets of 2008 still apply; 2015 “less prescriptive standard” overall)

•Compare/Contrast Evolution to Baldrige Award Criteria



What does ISO Leadership say about the 2015 Revision

https://youtu.be/UrVIVoDq7Sg

VIDEO





Standard Clauses

ISO 9001:2008•0. Introduction•1. Scope•2. Normative Reference•3. Terms and Definitions•4. Quality Management Systems•5. Management Responsibility•6. Resource Management•7. Product Realization•8. Measurement, Analysis & Improvement

ISO 9001:2015•0. Introduction•1. Scope•2. Normative Reference•3. Terms and Definitions•4. Context of the Organization•5. Leadership•6. Planning for the Q M S•7. Support•8. Operation•9. Performance Evaluation•10. Improvement

ISO 9001:2015 format design per ISO Joint Technical Coordination Group’s Requirements, as per ISO Guide 83. ISO 9001 and 14001 now revised.


Some Rearranging, however, some NEW requirements


Terminology ChangesISO 9001:2008 ISO 9001:2015

Products Products and Services

Exclusions Not Used (refer Clause A.5)

Management Rep Not Used

Documentation, Quality Manual, Procedures, Records

Documented Information (Q-Manual, Specific Procedures not identified)

Work Environment Environment for the operation of processes

Monitoring and Measuring Equipment

Monitoring and measuring resources

Purchased Product Externally provided products and services

Supplier External Provider

(Not Used) Interested Party

Preventive Action Not Used



4. Context of the Organization – High Level – Strategic• New Section with New Requirements• Organizations must determine external and internal

issues impacting its purpose and strategic direction• Consider external context issues: legal, technological,

competitive, market, cultural, social, and economic environments

• Consider internal context issues: values, culture, knowledge, and performance of the organization

• Organization shall determine a) interested parties (aka Stakeholders ?), and b) needs/expectations of the interested parties (“Customer Req’mts” Not used)

• Must “demonstrate with evidence” all the above…



4. Context of the Organization – Interested Parties

“Interested Party” Examples of (not in standard)

“Needs and Expectations” Examples of (not in standard)

Customers (and their Customers) Product/Service Quality; Price; On-Time Delivery

Owners/Share Holders Sustained Profitability; ROI

Employees Safe and pleasant work environment; Job security; Competitive compensation

External Provider ( Vendor, Personnel Agency, ISO Registrar)

Continuous Operations; Sustainable markets and business

Competitors Be more competitive/innovative; Ethical behavior (impacts all in the industry)

Society; Regulators Ethical behavior; Compliance with regulations

Credit to QSG 2015



5. Leadership and Commitment• Greater accountability for Top Mgt. re: Q M S…• Top Management shall demonstrate Leadership:

• Ensure integration of QMS requirements into the organization’s business processes

• Promoting awareness of the Process Approach

• Assuring the QMS achieves its intended results (PDCA)

• Supporting other management roles to demonstrate Leadership





6. Planning the Q M S • Quality Objectives: shall establish quality objectives

at relevant functions, levels, processes; be monitored; maintain documented information

• Actions to address risks and opportunities• Integrate/implement Actions into Q M S• Evaluate the effectiveness of these Actions (PDCA)• Risk Based Thinking, Risk Assessment:Notation (from the standard): Options to address risks and

opportunities can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

• “Preventive Actions” has been removed



7. Support• Resources, People (Competence, Training),

Infrastructure, Monitoring and Measuring activities basically unchanged

• Communication/Awareness now in this section (from Management Responsibility Section)

• Documentation: now “Documented Information”• Documented Information:

“The Organization shall maintain documented information to the extent necessary to support the operation of processes and retain documentation to the extent necessary to have confidence that the processes are being carried out as planned”

• No requirement for a Quality Manual nor any specific Quality Procedures are identified



8. Operation• (The current Product Realization section)• Products and “Services”• “Design” process remains, but sections on

“Verification and Validation” removed• Section has few Impactful changes: same

overall flow remains: Customer Requirements > Design > Externally Provided Products and Services (Purchasing) > Production/Service Controls > ID Traceability > Preservation > Non-Conformances ID’d and Controlled



9. Performance Evaluation• Performance Evaluation:

• “The Organization shall determine what needs to be monitored/measured”

Includes…• Customer Satisfaction Information• Process Performance• External Provider Performance• Internal Audits• Management Review, including

checking the QMS for alignment with the strategic direction of the organization – this is NEW!!



10. Improvement- Determine and Select Opportunities for Improvement…-“Examples of Improvement can include Correction, Corrective Action, Continual Improvement, Breakthrough Change, Innovation, and Re-organization.”-“Corrective Action” is in this section-“Retain Documented Information” as evidence results of Corrective Action

NOTE**: Improvement can be effected •Reactively (e.g. corrective action), •Incrementally (e.g. continual improvement)•Step-by-step (e.g. breakthrough)•Creatively (e.g. innovation)•Re-organization (e.g. transformation)

** - “bullets” for emphasis



Term: “Documented Information” “Retaining” Doc. Info. = Records “Maintain” Doc. Info. applies to…

Quality Objectives Quality Policy

Fitness for purpose of monitoring and measuring resources Quality Objectives

Evidence of Competence Scope of the Q M S

Conformity of Products/Services

Review of Customer Requirements

Design and Development Process

Design and Development Changes

Evaluation/Performance of External Providers

Product/Service ID and Traceability

Pre and Post Delivery Change Authorizations

Conformity with Acceptance Criteria

Authorized Release of Products/Services

Non-conformances and C/A

Internal Audits

Management Reviews



• Risk Based Thinking• No “Preventive Action sub-clause”. P/A is expressed

through a Risk-Based Approach to formulating Q M S requirements

• Risk-based approach has facilitated some reduction in prescriptive requirements and their replacement by performance-based requirements

• There is no requirement for formal Risk Management or a documented Risk Management Process

• Actions taken to address Risks and Opportunities shall be proportionate to the potential impact on the conformity of products and services



• Risk Based Thinking• From my Registrar:

• Misconception: Risk assessment replaces Preventive Action

• Truth: Risk Assessment is the initiating process and preventive action is the result

• Root Cause of Preventive Action is Risk Assessment

• ISO 31000 (Risk Management Principles and Guidelines) a useful reference

• So now what ????



Risk Based Thinking• Remember from the Planning Section…• Quality Objectives: shall establish quality objectives at

relevant functions, levels, processes • Develop Actions to address Risks• “Retain” documented information (Records) • Plan Do Check Act (PDCA)• “Waterfall Effect” / Cascading Objectives

Company ObjectivesDepartment ObjectivesIndividual Objectives

StatedObjectives

Assess Risk


‘WaterFall”: Example of Goals/Obj. Functional Level


Failure Mode and Effects Analysis (FMEA)Risk Based Thinking: Tools…




Risk Based Thinking: Tools…

PROBABILITY

SER IOUSNESS

RISK MATRIX

Risk Based Approach: Tools…


Probability

Seriousness


Risk Register Ranking Matrix


Risk Based Thinking: Tools…


If you have 3rd-party QMS software, check for updates…Risk Modules




QMed Corp

Hi-level Process Flow Chart Assess Risks


Use Flowcharts for Risk Assessment


BaldrigeCriteria

EnterpriseRisk Mgt.

QMS Risk Mgt.



Other Sector ISO QMS Standards…

ISO/TS 16949:2009 – Automotive (US, German, French, Italian)•Follows Section format of ISO 9001:2008 with additions Supplemental Engineering Specs, APQP, PPAP, MSA, Error Proofing, FMEA.•No timeline for Revision – under study by the IATF (Int’l Automotive Task Force)



ISO 13485:2003 – Medical Device Manufacturing•Follows format of ISO 9001:2008 with Additions – Cleanliness/contamination, Batch Records, Production Validations, Installations, Servicing, Sterility, Implantables, less emphasis upon Continual Improvement and Customer Satisfaction compared to Regulatory Compliance•Revision 2014 not approved; postponed•Revision 2016 (3rdedition Final Draft Vote (10/15 – 12/15)).•ISO 13485:2016 – future European regulations and 21CFR820 come into force (implications for software controls enhanced, documentation requirements; validations for pre-clinical and clinical evaluations; validation of packaging and distribution requirements; Customer communications and complaint handling)

Other Sector ISO QMS Standards…ISO 9001:2015 Presentation


ISO AS9100:2009 – Aerospace•Follows format of ISO 9001:2008 with Additions – •Revision due 2016 2nd quarter•Will follow ISO 9001:2015 format•Will consider emerging International requirements, Product Safety, Counterfeit Parts, and Configuration Management






ISO TL9000:2008 – Telecommunications•Includes Release 5.5 Handbook•Complaint Tracking and reporting via U of Texas (Dallas)•Published for benchmarking•No timetable for updating to ISO:2015 format




ISO 14001:2015 – Environmental Standards•Now released/published•Follows format of ISO 9001:2015


• Top Management Involvement• Context of the Organization• Risk Based Thinking• Optional Changes to current documentation:

• Retain Q-Manual?• Retain Management Representative?• Revise Vocabulary?

SUMMARY of changes 9001:2008 > 9001:2015…



• My Registrar’s Summary:• No need to change numbering of your

documents – create a cross-reference table

• Must incorporate Risk Analysis• Determine Controls for External providers• Reduced documentation requirements • Increased focus on Leadership being

actively involved

SUMMARY of changes 9001:2008 > 9001:2015…



• Involve your Registrar• Gap Analysis• Update existing Q M S• Develop Implementation Plan &

Timetable• 3 years for Recertification (by Sept.

2018)

From my Registrar:FINAL THOUGHTS on Conversion Plan:




FOR ADDITONAL INFORMATION, CHECK OUT ASQ NATIONAL’S WEBSITE

Documents

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