quality managment system ISO 9001 basic concepts.pptx

ISO 9001:2015 in brief

1. ISO 9001:2015 Awareness Training 1 Day Training Course

2. Upon completion of this Module, Learners will be able to: Know and understand the requirements of ISO 9001:2015 LEARNING OBJECTIVES

3. ISO 9001:2015, clauses 4, 5 & 6 ISO 9001:2015, clause 7 ISO 9001:2015, clauses 8, 9, 10 agenda

4. ISO 9001:2015 overview and clauses 4, 5 and 6 Process approach Risk-based thinking Quality management principles Structure of ISO 9001:2015 Scope ISO 9001:2015 requirements: Context of the organisation Leadership Planning Session 1

5. ISO 9001:2015 Aim: Is to provide organisations with the necessary information to build success over the long term and to create the conditions for sustainable development through the Ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements Facilitating opportunities to enhance customer satisfaction Addressing risks and opportunities associated with its context and objectives The ability to demonstrate conformity to specified quality management system requirements (ISO 9001:0.1)

6. the elements of a single process

7. PDCA cycle and ISO 9001:2015 ACT Organization and its context (4) Needs and Expectations of Interested Parties (4) Customer requirements Operation (8) Support & Performance Evaluation (7 & 9) Planning (6) Improvement (10) Leadership (5) PLAN DO CHECK Results of th e QMS Quality Management System (4) Customer satisfaction Products and Services -

8. Risk is the effect of uncertainty on an expected result ISO 9001:2015 incorporates risk into requirements for the QMS  The extent of risk is determined by the organisation “Risk-based thinking” is considering risk qualitatively (and quantitatively) depending on the organisation’s context “RISK BASED THINKING”

9. Quality management principles Customer focus Leadership Engagement of people Process approach Improvement Evidence-based decision making Relationship management

10. The structure of ISO 9 001:2015 ISO 9001 Quality management system - requirements Introduction 1 Scope 2 Normative references 3 Terms and definitions 4 Context of the organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the QMS 4.4 Quality management system and its processes

11. The structure of ISO 9 001:2015 (CONTINUED) 5 Leadership 5.1 Leadership and commitment 5.2 P olicy 5.3 Organizational roles, responsibilities and authorities 6 Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 7 Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information

12. The structure of ISO 9 001:2015 (CONTINUED) 8 Operation 8.1 Operational planning and control 8.2 Requirements for products and services 8.3 Design and development of products and services 8.4 Control of externally provided processes, products and services 8.5 Production and service provision 8.6 Release of products and services 8.7 Control of nonconforming outputs

13. The structure of ISO 9 001:2015 (CONTINUED) 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review 10 Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement Annex A Clarification of new structure, terminology and concepts Annex B Other International Standards on quality management and quality management systems developed by ISO/TC 176  

14. Need to demonstrate the ability to consistently provide product or service that meets customer, and applicable statutory and regulatory requirements b) Aim to enhance customer satisfaction through the effective application of the QMS and continual improvement For organisations that: SCOPE

15. Application The requirements are generic and applicable to all organisations, regardless of type, size and product or service provided No “exclusions”, but… … Requirements which do not apply Must not affect the ability or responsibility to provide products or services to meet customer requirements and legal requirements Must be justified and evidence be provided

16. ISO 9001:2015 Clauses 2 & 3 Normative references ISO 9000:2015 is indispensable for the application of ISO 9001 Terms and definitions Terms and definitions in ISO 9000:2015 apply

17. 4 CONTEXT OF THE ORGANIZATION 4.1 Understanding of the organization and its context 4.3 Determining the scope of the QMS 4.4 Quality management system and its processes 4.2 Understanding the needs and expectations of interested parties 4. Context of the organisation

18. 5 LEADERSHIP 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities 5. Leadership

19. Top management is to: Ensure the integration of the QMS into the business processes (5.1.1c) Promote the process approach and risk-based thinking (5.1.1d) Demonstrate leadership and commitment to customer focus (5.1.2) Establish, implement and maintain a quality policy that is appropriate to the context and supports the strategic direction (5.2.1) Review the QMS to ensure alignment with strategic direction (9.3.1) 5. LEADERSHIP (CONTINUED)

20. 6 PLANNING 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6. Planning

21. Any changes to the QMS must be carried out in a planned and systematic manner (6.3) 6. Planning (continued)

22. PURPOSE The International Standard sets the requirements for a QMS that brings together generally recognised key quality management principles. These have been amended from previous versions of the QMS Standards The purpose of this workshop is to enable you to consider these principles, their impact, the use and benefits in formulating a QMS METHOD You will be divided into teams and asked to consider each of the quality management principles: Customer focus Leadership Engagement of people Process approach Improvement Evidence-based decision making Relationship management WORKSHOP 1: qm PRINCIPLES

23. METHOD, continued What do these mean in reality? How can each of these be applied in organisations? OUTPUT You will be asked to present your conclusions for discussion by the whole class TIME ALLOWED Reading and preparation of findings: 30 minutes Feedback: 3 0 minutes WORKSHOP 1: qm PRINCIPLES (CONTINUED)

24. ISO 9001:2015 Clause 7 ISO 9001:2015 requirements: Support Resources Competence Awareness Communication Documented information SESSION 2

25. 7 SUPPORT 7.1 Resources 7.3 Awareness 7.5 Documented information 7.2 Competence 7.4 Communication 7. Support

26. 7.1 Resources 7.1.1 General 7.1.3 Infrastructure 7.1.5 Monitoring and measuring resources 7.1.2 People 7.1.4 Environment for the operation of processes 7.1.6 Organizational knowledge 7.1 resources

27. The resources needed for the establishment, implementation, maintenance and continual improvement of the QMS must be provided (7.1) People needed for the effective implementation of the QMS are to be determined and provided (7.1.2) The infrastructure needed for the effective implementation of the QMS is to be determined, provided and maintained (7.1,3) The environment needed for the effective implementation of the QMS is to be determined, provided and maintained (7.1,4) The resources needed to ensure valid and reliable results when monitoring and measurement is used are to be determined and provided (7.1.5.1) 7.1 Resources (continued)

28. 7.1 Resources (continued) Measuring equipment must be identified, calibrated and/or verified (7.1.5.2) The knowledge necessary for the organisation’s processes must be determined, maintained and made available to the extent necessary (7.1.6) All those working under the organisation’s control (internal and external) must be aware of, and comply with, the policy and objectives (7.3) Internal and external communication must ensure that QMS requirements are met (7.4 ) Concepts of “ documents ” and “ records ” are merged into documented information . Document control applies to all documented information

29. QMS must include : Documented policy (5.2) and objectives (6.2) Documented information required by standard (7.5.1a) Documented information necessary for effectiveness of the QMS (7.5.1b) QMS

30. 4.3 Scope of the QMS 4.4.2 To support the operation of processes 5.2.2 Quality policy 6.2.1 Quality objectives 7.1.5.1 Evidence of fitness for purpose of monitoring and measurement resources 7.1.5.2 Basis for calibration or verification when no appropriate standards exist 7.2 Evidence of competence 7.4.1 Evidence of its communications 8.1 Extent necessary to provide confidence that processes have been carried out as planned and that products/services meet requirements Documented information

31. 8.2.3.2 Results of reviews of requirements related to products and services 8.3.2 To demonstrate that design and development requirements have been met 8.3.3 Design and development inputs 8.3.4 Design and development control activities 8.3.6 Design and development changes, reviews, authorisations and actions to prevent adverse impacts 8.4.1 Control of externally supplied products and services 8.5.1 Characteristics of products, services, activities and results 8.5.2 To enable traceability 8.5.3 Issues concerning property of customers or suppliers of external services Documented information (continued)

32. 8.5.6 Results of reviews of changes to products and services 8.6 Release of products and services 8.7.2 Control of nonconforming outputs 9.1.1 Evidence of the monitoring, measurement, analysis and evaluation results. 9.2.2 Evidence of the implementation of the audit programme and the audit results. 9.3.3 Evidence of the results of management reviews 10.1 Evidence of the nature of the nonconformities and the results of any corrective action. Documented information (continued)

33. Workshop 2: organisational knowledge PURPOSE To identify the knowledge necessary for the operation of processes within your organisation in order to achieve conformity of products and services TASK Clause 7.1.6 Organisational knowledge addresses the need to determine and maintain the knowledge obtained by your organisation, including by your personnel, to ensure that it can achieve conformity of products and services The process for considering and controlling past, existing and additional knowledge needs to take account of the organization’s context, including its size and complexity, the risks and opportunities it needs to address, and the need for accessibility of knowledge The balance between knowledge held by competent people and knowledge made available by other means is at the discretion of the organisation, provided that conformity of products and services can be achieved Identify and list the organisational knowledge that is relevant to the purpose of your organisation and that affect the ability to achieve planned results Determine how this knowledge may be acquired and accessed OUTPUT Feedback of your findings to the class TIME ALLOWED Reading and preparation of findings: 15 minutes Feedback: 10 minutes

34. ISO 9001:2015: Clauses 8, 9 & 10 Operation Performance evaluation Improvement Session 3

35. 8 OPERATION 8.1 Operational planning and control 8.3 Design and development of products and services 8.5 Production and service provision 8.2 Requirements for products and services 8.4 Control of externally provided processes, products and services 8.6 Release of products and services 8.7 Control of non-conforming outputs 8. OPERATION

36. The organisation must: Plan, implement and control the processes needed to meet requirements for the provision of clause 6 (8.1) Determine the resources needed (8.1c) Communicate information to customers on products and services (8.2.1) Obtain customer feedback (8.2.1c) Establish contingency plans when relevant (8.2.1e) Determine requirements related to products (8.2.2) 8. Operation (continued)

37. The organisation must: Review requirements related to products (8.2.3) Inform relevant persons when requirements are changed (8.2.4) Establish, implement and maintain an appropriate design and development process (8.3.1) Plan design and development stages and controls (8.3.2) Determine the requirements for inputs to design and development (8.3.3 ) 8. Operation (continued)

38. The organisation must: control the design and development process (8.3.4) ensure design and development outputs meet requirements (8.3.5) identify, review and control design and development changes (8.3.6) ensure that externally provided process, products and services conform to requirements (8.4.1) determine and apply criteria for the evaluation, selection, monitoring, and re-valuation of external providers (8.4.1 ) 8. Operation (continued)

39. The organisation must: Control production and service provision (8.5.1) Appoint competent persons with required qualifications (8.5.1e) Implement actions to prevent human error (8.5.1g) Identify outputs to ensure conformity of products and services (8.5.2) Identify the status of outputs with respect to monitoring and measurement requirements (8.5.2) 8. Operation (continued)

40. The organisation must: Control the unique identification of outputs when traceability is a requirement (8.5.3) Preserve the outputs during production and service provision to ensure conformity to requirements (8.5.4) Meet requirements for post-delivery activities (8.5.5) Review and control changes for production and service provision (8.5.6) Implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met (8.6) Release products and services to customers only when planned arrangements have been satisfactorily completed (unless approved) (8.6) Identify and control outputs that do not conform to requirements are prevented from unintended use (8.7.1) 8. Operation (continued)

41. 9 PERFORMANCE EVALUATION 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review 9. Performance evaluation

42. Customer perceptions of the degree to which requirements have been met must be monitored (9.1.2) Appropriate data and information from monitoring and measurement activities must be analysed and evaluated (9.1.3 ) 9. Performance evaluation (continued)

43. Management review is required at planned intervals (9.3.1) Management review is to consider QMS continuing alignment with strategic direction of the organisation (9.3.1) Inputs to the review to include: Changes in external and internal issues Information on performance and effectiveness of QMS including: Trends in customer satisfaction and feedback from interested parties Meeting of objectives Process performance and product / service conformity Nonconformity and corrective actions Results of monitoring and measurement Audit results Performance of external providers Adequacy of resources Effectiveness of actions to address risks and opportunities Opportunities for improvement 9. Performance evaluation (continued)

44. 10 IMPROVEMENT 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement 10. Improvement

45. Determine and select opportunities for improvement (10.1) 10. Improvement (continued)

46. END OF session 3 QUESTIONS END OF COURSE