Improving global standard to be a key driver of innovation. Colin MacNee. 2012, 2013, 2014 Duncan MacNee Limited.

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1 Improving global standard to be a key driver of innovation Colin MacNee

2 Caveat The views expressed are my own and do not represent BSI CQI IAF IBM IRCA ISO IT Governance

3 Content Where we ve come from A Brief History of ISO 9001 Scopes: 1987, 1994, 2000 Examples of requirements: 1987, 2000 Trends Where we re going Annex SL Examples of 21 st Century changes Leadership Relevant Interested Parties Relevant Requirements External provision QMS Scope Requirements Appendices ISO DIS 9001:2015 Other

4 Where we ve come from

5 A Brief History of ISO 9001

6 Scopes ISO 9001:1987 Quality systems - Model for quality assurance in design/development, production, installation and servicing This International Standard specifies the quality system requirements for use where a contract between two parties requires the demonstration of a supplier's capability to design and supply product. ISO 9001:1994 Quality systems - Model for quality assurance in design, development, production, installation and servicing This International Standard specifies quality system requirements for use where a supplier s capability to design and supply conforming product needs to be demonstrated. ISO 9001:2000 Quality management systems - Requirements This International Standard specifies requirements for a quality management system where an organization: a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements.

7 1987: some examples of requirements The supplier shall provide secure storage areas or stock rooms tom prevent damage or ISO 9001:1987 Quality systems - Model for quality assurance in design/development, production, installation and servicing Management representative 4.2 Quality system...quality plans and a quality manual Contract review 4.6 Purchasing Assessment of sub-contractors 4.10 Inspection and testing Receiving inspection and testing 4.15 Handling, storage, packing and delivery Storage deterioration of product, pending use or delivery.

8 2000: some examples of requirements ISO 9001:2000 Quality management systems Requirements 5 Management responsibility 5.1 Management commitment Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, 7 Product realization 7.1 Planning of product realization 7.2 Customer-related processes Determination of requirements related to the product Review of requirements related to the product Customer communication 8 Measurement, analysis and improvement Customer satisfaction 8.4 Analysis of data

9 Trends ,600,000 1,400,000 1,200,000 1,000, , , , ,000 0 ISO management system certificates Others ISO ISO 9001

10 Where we re going

11 Annex SL

12 Current Situation The aim is to enhance the consistency and alignment of ISO MSS by providing a unifying and agreed upon high level structure, identical core text and common terms and core definitions. The 3 major ISO MSSs in development all using Annex SL* ISO 9001 expected late 2015 ISO expected late 2015 ISO [OHSAS 18001] expected late 2016 * ISO/IEC Directives, Part 1 Consolidated ISO Supplement Procedures specific to ISO (Fifth edition, 2014)

13 MSS High Level Structure 1 of 3 Introduction 1. Scope 2. Normative references 3. Terms and definition 4. Context of the organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation 10. Improvement Appendix Bibliography

14 MSS High Level Structure 2 of 3 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 XXX management system 4.4 XXX management system 5. Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organization roles, responsibilities and authorities 6. Planning 6.1 Actions to address risks and opportunities 6.2 XXX objectives and planning to achieve them

15 MSS High Level Structure 3 of 3 7. Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information General Creating and updating Control of documented information 9. Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review 10. Improvement 10.1 Nonconformity and corrective action 10.2 Continual improvement 8. Operation 8.1 Operational planning and control

16 MSS - Common Terms (and Definitions) Organization Interested party (preferred term) Stakeholder (admitted term) Requirement Management system Top management Effectiveness Policy Objective Risk Competence Documented information Process Performance Outsource (verb) Monitoring Measurement Audit Conformity Nonconformity Corrective action Continual improvement

17 Design Specification for the revision of ISO 9001: Strategic intent and purpose of the revision This revision of the standard is being undertaken to reflect the changes in the environment in which it is used and ensure the standard is fit for its purpose. The revision will: a) take account of changes in quality management systems practices and technology since the last major revision to ISO 9001 (in the year 2000) and to provide a stable core set of requirements for the next 10 years or more. b) ensure that requirements in this standard reflect the changes in the increasingly complex, demanding, and dynamic environments in which organizations operate 3. Requirements for the revision process WG 24 is required to identify, develop and reach consensus on solutions to meet the strategic purpose and intent stated in section 2 above. The following provisions apply: a) The revised standard will remain generic and be relevant to all sizes and types of organization operating in any sector b) The revised standard needs to be capable of being applied by the widest possible range of organizations with varying degrees of maturity of their quality systems

18 Examples of 21st Century changes Leadership Relevant Interested Parties Relevant Requirements External provision QMS Scope Requirements

19 Leadership* (Top management) 5.1 Leadership and commitment Top management shall demonstrate leadership and commitment by: Ensuring (i.e. someone else can do it) the quality policy and quality objectives are established for the quality management system and are compatible with the strategic direction and the context of the organization; the quality policy is communicated, understood and applied within the organization; integration of the quality management system requirements into the organization s business processes; the resources needed for the quality management system are available; the quality management system achieves its intended results; Doing (i.e. they must do it themselves) taking accountability of the effectiveness of the quality management system; promoting awareness of the process approach; communicating the importance of effective quality management and of conforming to the quality management system requirements; engaging, directing and supporting persons to contribute to the effectiveness of the quality management system; promoting continual improvement ; supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility; * Note: This structure is based on ISO DIS 9001:2015

20 Implications: Organisations - internal audit must include top management Implementers - Helping top management provide objective evidence of compliance; changing meeting agendas/minutes, creating/updating communication channels/methods Quality professionals - Making top management aware of their responsibilities; communicating, coaching, training Top management - being audited as a matter of routine (they can t delegate) Auditors - auditing top management (as opposed to the management representative) is now compulsory What objective evidence would an auditor seek to demonstrate conformance? Will an auditor need new personal skills to deal with top management?

21 Scope ISO 9001: 2000 through 2015: 'This International Standard specifies requirements for a quality management system where an organization: a) needs to demonstrate its ability to consistently provide product or service that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

22 Interested parties and relevant 4.2 Understanding the needs and expectations of interested parties Due to their impact or potential impact on the organisation s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine: a) the interested parties that are relevant to the quality management system; b) the requirements of these interested parties that are relevant to the quality management system.

23 Parties ALL Parties Interested Parties Relevant Interested Parties Relevant Interested Parties Requirements Relevant Interested Parties Relevant Requirements

24 External provision ISO 9001:2000 had a simplistic view of the supply chain supplier organization customer It is recognised that the supply chain can be complex It is also recognised that the Organization can be complex: It can be a division, a function or a sub-unit It can be a partnership, an alliance or a joint-venture It can be The scope of the quality management system needs to reflect this. Therefore, Outsourcing and Purchasing have been replaced by Externally provided products and services Everything undertaken outside the QMS scope is External Provision

25 MSS Scope Design Logistics Design Logistics Headquarters Headquarters Manufacture Manufacture Sales Sales IT IT

26 Requirements The order of the determination of requirements has changed to reflect modern business. ISO 9001: Customer-related processes Determination of requirements related to the product Review of requirements related to the product Customer communication ISO DIS 9001: Determination of requirements for products and services Customer communication Determination of requirements related to products and services Review of requirements related to products and services Organizations display their offering (usually on the internet) and customers select or customise the product or service.

27 Thank You Any Questions?

28 Appendix 1 ISO DIS 9001:2015

29 What we know so far Adoption of Annex SL High Level Structure Identical Core Text Common Terms and Core Definitions ISO 9001:2008 text Changes made for the CD Changes made for the DIS

30 Possible* ISO 9001: of 4 Foreword Introduction 0.1 General 0.2 The ISO standards for quality management 0.4 Plan-Do-Check-Act cycle 0.5 Risk-based thinking 0.6 Compatibility with other management system standards 1 Scope 2 Normative references 3 Terms and definitions Annex A (informative) Clarification of new structure, terminology and concepts Annex B (informative) Quality management principles Annex C (informative) The ISO portfolio of quality management standards Bibliography *Note: Local This e Data: structure is based on ISO DIS 9001:2015

31 Possible* ISO 9001: of 4 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 quality management system 4.4 Quality management system 5. Leadership 5.1 Leadership and commitment Leadership and commitment for the quality management system Customer focus 5.2 Policy 5.3 Organization roles, responsibilities and authorities 6. Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes *Note: Local This e Data: structure is based on ISO DIS 9001:2015

32 Possible * ISO 9001: of 4 7. Support 7.1 Resources General People Infrastructure Environment for the operation of processes Monitoring and measuring resources Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information General Creating and updating Control of documented information 9. Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation General Customer satisfaction 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 8. Operation *Note: Local This e Data: structure is based on ISO DIS 9001:2015

33 Possible * ISO 9001: of 4 8. Operation 8.1 Operational planning and control 8.2 Determination of requirements for products and services Customer communication Determination of requirements related to products and services Review of requirements related to products and services 8.3 Design and development of products and services General Design and development planning Design and development inputs Design and development controls Design and development outputs Design and development changes 8.4 Control of externally provided products and services General Type and extent of control of external provision Information for external providers 8.5 Production and service provision Control of production and service provision Identification and traceability Property belonging to customers or external providers Preservation Post-delivery activities Control of changes 8.6 Release of products and services 8.7 Control of nonconforming process outputs, products and services *Note: Local This e Data: structure is based on ISO DIS 9001:2015

34 Appendix 2 Other

35 Free Resources CQI ISO 9001:2015 Review IRCA ISO 9001:2015 IRCA Annex SL ISO Online Browsing Platform (OBP) https://www.iso.org/obp/ui/ ISO Quality management ISO Survey BSI Draft Review System (DRS)

36 ISO MSS Certificates Worldwide 2008 revision Year ISO ,571 70, , , , , , , , , , , , , , ,322 1,063,751 1,118,510 1,079,647 1,101,272 ISO ,491 4,433 7,887 13,994 22,847 36,464 49,440 64,996 90, , , , , , , , ,844 ISO/TS ,019 17,047 27,999 35,198 39,320 41,240 43,946 47,512 50,071 ISO ,403 5,065 8,026 12,985 13,234 16,425 18,834 19,849 22,237 ISO/IEC 1 Data ,797 7,732 9,246 12,935 15,626 17,355 19,577 from the ISO Survey 2011 (see ISO ,122 8,185 13,838 18,580 19,351 23,231 ISO ,981 TOTAL 46,571 70, , , , , , , , , , , ,118 1,066,938 1,166,095 1,238,881 1,371,163 1,467,044 1,446,130 1,504,213

37 w w w.apcergroup.com

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