ASQ Madison, WI Section Using your ISO 9001:2008 QMS to Plan for the 2015 Changes

Transcription

1 ASQ Madison, WI Section 1217 Using your ISO 9001:2008 QMS to Plan for the 2015 Changes

2 SESSION AGENDA High Level Review of Requirements Historical Perspective Basic Requirements Change It s a Process Inputs, Processes, Outputs Plan, Do, Check, Act Key Components of Your QMS Next steps Information Sources

3 Annex SL - High Level Structure 1 - Scope 2 - Normative References 3 - Terms and definitions 4 - Context of the Organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance Evaluation 10 Improvement

4 ISO 9001 Common Clauses 4 Context of the Organization Understanding the organization and its context Understanding the needs and expectation of interested parties Determining the scope of the QMS 4.4 Quality management system and its processes

5 ISO 9000 Common Clauses 5 Leadership Leadership and commitment 5.2 Quality policy Organizational roles, responsibilities and authorities

6 ISO 9000 Common Clauses 6 Planning for the QMS Actions to address risk 6.2 Quality objectives and planning to achieve Planning of changes

7 ISO 9000 Common Clauses 7 Support 7.1 Resources Competence Awareness 7.4 Communication Documented information

8 ISO 9000 Common Clauses 8 Operation 8.1 Operational Planning/Control 8.2 Requirements for Products and Services 8.3 Design and Development 8.4 Control of Externally Provided Process/Products/Services 8.5 Production and Service Provision 8.6 Release of Products/Services 8.7 Control of Nonconforming Outputs

9 ISO 9000 Common Clauses 9 Performance Evaluation Monitoring, measurement, analysis and evaluation Internal audit Management review

10 ISO 9000 Common Clauses 10 Improvement 10.1 General Nonconformity and corrective action Continual improvement

11 A HISTORICAL PERSPECTIVE

12 AVOIDING THE CLIFF ISO 9001:2008 ISO 9001:2015

13 Customers Customers BASIC PRINCIPLES OF QMS Improvement of QMS Management Responsibility Resource Management Measurement, analysis & improvement Requirements Satisfaction Product Realization

14 BASICS OF YOUR QMS Quality management system 4 The organization shall establish, document, implement and maintain a quality management system in accordance with the requirements of this International Standard

15 BASICS OF YOUR QMS Quality management system 4 These processes shall be managed by the organization in accordance with the requirements of this International Standard

16 CHANGE IT S A PROCESS INPUTS ACTIVITIES OUTPUTS

17 IT S THERE FOR A REASON! Document Control Control of documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system

18 PLANNING Quality management system planning Top management shall ensure that The planning of the quality management system is carried out in order to meet the requirements given in 4.1 and,

19 PLANNING The integrity of the quality management system is maintained when changes to the quality management system are planned and implemented

20 PLANNING Management Representative a) ensuring that processes needed for the quality management system are established, implemented and maintained

21 PLANNING Management review General This review shall include assessing the need for changes to the quality management system

22 PLANNING Review input The input to management review shall include information on f) changes that could affect the quality management system

23 PLANNING Review output The output of from the management review shall include any decisions and actions relating to a) Improvement of the effectiveness of the quality management system and its processes c) Resource needs

24 PLANNING RESOURCE NEEDS Competency, awareness and training a) determine the necessary competence of personnel performing work affecting quality

25 CHECKING Internal audit The organization shall conduct internal audits at planned intervals to determine whether the quality management system a) conforms to the planned arrangements (see 7.1) to the requirements of this International Standard and to the quality management requirements established by the organization

26 CHECKING Internal audit cont d An audit programme shall be planned, taking into consideration the status and importance of the processes

27 CHECKING Internal audit 2015 wording An audit programme shall be planned, taking into consideration the importance of the processes, customer feedback and changes

28 HOW ABOUT YOUR ORGANIZATION? What (likely) key changes in ISO 9001:2015 are going to require decisions and actions from your Organization s management review of the QMS?

29 KEEPING INFORMED Keep informed NQA website NQA blog NQA Linkedin NQA Newsletter

30

31 NQA USA BLOG

32 LinkedIn & Face Book

33 QUESTIONS? CONTACT INFO: NAME: ANDY NICHOLS PHONE: (248)