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Quick Summary Review of ISO 9001 through the years ISO 9001:2015 Presentation AGENDA 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 Jay Stahan January 12, 2016
Citation preview
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
Jay Stahan January 12, 2016
• 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
ISO 9001:2015 Presentation
AGENDA
Jay Stahan January 12, 2016
Source Materials:•READ Lots of Articles•ATTENDED Many Webinars
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
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
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
What does ISO Leadership say about the 2015 Revision
https://youtu.be/UrVIVoDq7Sg
VIDEO
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
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.
ISO 9001:2015 Presentation
Some Rearranging, however, some NEW requirements
Jay Stahan January 12, 2016
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
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
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…
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
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
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
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
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
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
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
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
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
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
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
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!!
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
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
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
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
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
• 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
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
• 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 ????
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
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
ISO 9001:2015 Presentation
‘WaterFall”: Example of Goals/Obj. Functional Level
ISO 9001:2015 Presentation
Failure Mode and Effects Analysis (FMEA)Risk Based Thinking: Tools…
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
ISO 9001:2015 Presentation
Risk Based Thinking: Tools…
PROBABILITY
SER IOUSNESS
RISK MATRIX
Risk Based Approach: Tools…
Jay Stahan January 12, 2016
Probability
Seriousness
ISO 9001:2015 Presentation
Risk Register Ranking Matrix
Jay Stahan January 12, 2016
Risk Based Thinking: Tools…
ISO 9001:2015 Presentation
If you have 3rd-party QMS software, check for updates…Risk Modules
Jay Stahan January 12, 2016
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
QMed Corp
Hi-level Process Flow Chart Assess Risks
ISO 9001:2015 Presentation
Use Flowcharts for Risk Assessment
Jay Stahan January 12, 2016
BaldrigeCriteria
EnterpriseRisk Mgt.
QMS Risk Mgt.
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
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 9001:2015 Presentation
Jay Stahan January 12, 2016
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
Jay Stahan January 12, 2016
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
Other Sector ISO QMS Standards…
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
Other Sector ISO QMS Standards…
ISO 9001:2015 Presentation
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
Jay Stahan January 12, 2016
Other Sector ISO QMS Standards…
ISO 9001:2015 Presentation
ISO 14001:2015 – Environmental Standards•Now released/published•Follows format of ISO 9001:2015
Jay Stahan January 12, 2016
• 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…
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
• 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…
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
• 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:
ISO 9001:2015 Presentation
Jay Stahan January 12, 2016
ISO 9001:2015 Presentation
FOR ADDITONAL INFORMATION, CHECK OUT ASQ NATIONAL’S WEBSITE