Why Is ISO 9001:2015 the Best Blueprint for Building the Most Powerful QMS. Presenter: Michael Prior, CQA

Transcription

1 Why Is ISO 9001:2015 the Best Blueprint for Building the Most Powerful QMS Presenter: Michael Prior, CQA

2 Agenda Understanding ISO 9001:2015 Methods for Implementation Central Nervous System (CNS) & Risk Based Thinking ISO 9001:2015 for a more powerful QMS

3 Annex SL High Level Structure (aka Annex SL) for various ISO management system standards. The new structure is set up with 10 clauses (vs. the 8 clauses in ISO 9001:2008.) Discipline-specific requirements will be focused on clause 8 Operation. The other 9 clauses address common elements for all management system standards: Quality, Environment, Safety, IT security.

4 v in relation to v All requirements of 2008 secure in 2015 Difference in presentation to suit Annex SL Requirements split into different sections Net additions in v.2015 Context of Organization Risk based thinking,(not just risk management) Management of Change Knowledge Management

5 4. Context of Organization Determine issues impacting purpose Determine and monitor stakeholder needs Determine scope of QMS, processes Address risks Documented information on operation of processes Retained Documented information: confidence re effective processes

6 5. Leadership Demonstrate Leadership and commitment to QMS Customer focus: Meet requirements, monitor and address risks, satisfaction Establish and communicate quality policy Organizational roles, responsibilities, authorities

7 6. Planning Determine, address risks and opportunities Quality Objectives, plans for achievement Potential consequences (risks) of changes Changes carried out in a planned manner

8 7. Support Resources: People, Infrastructure, Environment Monitoring & Measuring Resources: identified, suitable, maintained, calibrated, traceable, safeguarded Organizational Knowledge Competence: ensure, with evidence Ensure awareness of persons Internal & External communications

9 7. Support Documented Information Required by Standard Required by Organization for effective QMS Appropriate ID, format, review and approval Available where and when, protected Controlled distribution, preservation, legibility, access, retrieval, use, changes, retention, disposal

10 8. Operation 8.1 Operational Planning & Control 8.2 Requirements for products & services: Communications with customers Determine customer, legal, organizational needs Review all requirements, ensure ability to meet Address changes Confirm customer requirements

11 8. Operation 8.3 Design & Development: Planning Inputs Design & development Controls Design & development Outputs Design & development changes

12 8. Operation 8.4 Externally provided processes, products, services: Used in products, dropped shipped, outsourced processes Within Control of Org QMS, Verify compliance Adequate info to ext providers, approval of processes, release of product Monitor performance of providers

13 8. Operation 8.5 Production & service provision: Controlled conditions: documented info, monitoring & measurement, validation & revalidation, prevent human error, releasedelivery-post delivery activities ID and Traceability, inspection status Property of customers, external providers Preservation

14 V8. Operationision 8.5 Production & service provision: Post Delivery: risk, product life, customer feedback Review and control changes, keep records 8.6 Release of products and services 8.7 Control of nonconforming Outputs: Appropriate action(s): correction, containment, suspension, inform customer, concession--- Retained documentation

15 9. Performance Evaluation 9.1 Monitor-Measure, analysis, evaluation Determine what, how, when, done & evaluated Customer satisfaction Evaluate: conformity, satisfaction, QMS, external providers 9.2 Internal Audit: QMS conforms- own and 9001 effectively ---Frequency, reporting, importance, criteria, scope, correction & corrective action---

16 9. Performance Evaluation 9.3 Management Review: Inputs: outstanding actions, changes to issues, info on performance customer satisfaction, objectives, processes, audits, external providers, risks and opportunities, improvement opportunities Outputs: improvement improvements, changes, resource needs

17 10. Improvement Improve products; performance of QMS; correcting, preventing, reducing undesirables 10.2 NC and Corrective Actions: Control and correct NC, deal w/ consequences Check if need to eliminate cause, and prevent Review effectiveness, update risks, records 10.3 Continual Improvement

18 Implementing the new standard New standard has not eliminated any of the old requirements Added several new requirements chief of which: Context of Organization Risk Based Thinking Knowledge Management Management of Change

19 Implementing the new standard Also added, expanded, clarified many detailed requirements. Many not so visible: Examples: Need to identify documents, to review and control changes for production, to implement actions to prevent human error

20 Implementing the new standard Compliance Alert: It is organization s job to demonstrate compliance to all the old and the new. Not Auditor s, to find it. Auditor will fully know all the requirements, including many smaller new ones. All auditor has to do is to ask how do you comply, and show me evidence

21 Implementing the new standard Study all requirements to understand, so can address all the changes. Allow enough time. Make a plan Plan by end of 2015 Start implementing early Finish end 2016 Plan to fit Surveillance/ Recert dates Official switch with Change of Registration Scope

22 Implementing the new standard v not changing any time soon so embrace it Align section numbers Gives flexibility to make your own plans Huge opportunity: Build a great QMS/ business operating system.

23 How to build a really powerful QMS Risk based thinking not just risk management. Combine with knowledge management, management of change. Use concept of Central Nervous System: Sensors for risk (opportunities) spread all over Signals processed, outputs trigger responses Build a digital nervous system (Bill Gates 1999)

24 Central Nervous System (CNS)

25 Application of CNS to QMS Eyes and Ears= Risk Analysis: Get signals, build knowledge base Response mechanisms: Root Cause Analysis (RCA) Local Solution Generation Effective Solution Implementation Need Global application of solution? Effective global solution generation, application

26 Risk Assessment

27 RCA

28 Local Prevention

29 Global Prevention

30 Management of Change MOC

31 MoC (Cont..)

32 CONCLUSION The standard is all growed up. Users are allowed to think! Don t have to explain the difference between corrective and preventive actions for 5 years to the same person Don t have to argue that you need more than 5 documented procedures to run a plant with 100 people What else will this standard do for you??

33 RISK BASED THINKING and: PLANNING, DOING, CHECKING, ACTING

34 THANK YOU!! Michael Prior, CQA Director of Business Development Quality Institute of America, (QIA) 8951 Ruthby, Houston, TX 77061, Suite 12 (W) , (F) , (C) Visit us at or