1. ISO 9001: 2008 Boosting quality to differentiate yourself from the competition CER BL November 2008

2. ISO 9001 - Periodic Review

3. 3 ISO 9001 2008 - NOV 2008 - CER BL- internal presentation ISO 9001:2008 – Periodic Review ► ISO 9001, like all standards is subject to periodic review to determine whether it is still relevant, whether it needs to be updated or whether it should be discarded ► The review period is around 5-6 years and for ISO 9001 it is designed such that whenever there are significant changes to be done (major revision) the next revision will be less significant (minor) ► Since the revisions issued in 2000 (implemented in 2003) were major, the next one will be minor; changes are more based on the clarification of the existing requirements rather than including new ones New version released on the 15th of November 2008 New version released on the 15th of November 2008

4. 4 ISO 9001 2008 - NOV 2008 - CER BL- internal presentation Principles and Phases: Standards Value ► ISO standards are developed according to the following Principles. Consensus - The views of all interests are taken into account Industry wide - Global solutions to satisfy industries and customers worldwide. Voluntary - Voluntary involvement of all interests in the market-place. ► There are three main phases in the ISO standards development process as follows. The need for a standard is usually expressed by an industry sector, which communicates this need to a national member body. Once the need for an International Standard has been recognized and formally agreed, the first phase involves definition of the technical scope of the future standard. Consensus-building phase: Countries negotiate the detailed specifications within the standard. Formal approval of the resulting draft International Standard

5. 5 ISO 9001 2008 - NOV 2008 - CER BL- internal presentation The way it is done ► A text corresponding to an approved work item is developed as necessary through the preparatory and/or committee stages until consensus is reached in the committee. ► The text is submitted to all ISO member bodies for a five-month vote as a draft International Standard (DIS) and is approved if two-thirds of the P-members vote affirmatively and not more than a quarter of all votes cast are negative. ► A final text is prepared taking into account member body comments on the DIS and this text is issued for formal vote as a final draft International Standard (FDIS). ► If the text is again approved by two-thirds of the P-members voting and if not more than a quarter of all votes cast are negative, then the text is approved and the Central Secretariat publishes the International Standard.

6. 6 ISO 9001 2008 - NOV 2008 - CER BL- internal presentation TC 176 ► Secretariat: SCCSCC ► Secretary: Mr. David Zimmerman ► Chairperson: Mr. Gary Cort (Canada) until end 2013 ► 65 participating countries ► 10 observing countries ► Standardization in the field of quality management (generic quality management systems and supporting technologies), as well as quality management standardization in specific sectors at the request of the affected sector and the ISO Technical Management Board. Note : ► ISO/TC 176 is also entrusted with an advisory function to all ISO and IEC technical committees to ensure the integrity of the generic quality system standards and the effective implementation of the ISO/IEC sector policy on quality management systems deliverables.

7. ISO 9001 – History and challenges

8. 8 ISO 9001 2008 - NOV 2008 - CER BL- internal presentation History ► BS 5750 During WWII, there were quality problems in many British high-tech industries such as munitions, where bombs were exploding in factories during assembly. The adopted solution was to require factories to document their manufacturing procedures and to prove by record-keeping that the procedures were being followed. The name of the standard was BS 5750, and it was known as a management standard because it didn't specify what to manufacture, but how to manage the manufacturing process. ► ISO 9001: 1987 In 1987 the International Organization for Standardization adopted BS 5750 as an international standard. BS 5750 became ISO 9001." ISO 9001:1987 had the same structure as the UK Standard BS 5750, with three 'models' for quality management systems, the selection of which was based on the scope of activities of the organization:

9. 9 ISO 9001 2008 - NOV 2008 - CER BL- internal presentation History ► ISO 9001: 1994 ISO 9000:1994 emphasized quality assurance via preventative actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures.quality assurance Still based around Ministry of Defence (MoD) requirements and terminology. ► ISO 9001:2000 ISO 9001:2000 combines the three standards 9001, 9002, and 9003 into one Easy to understand and the resulting systems tend to be more practical, less bureaucratic, less emphasis on procedures The 2000 version made a radical change in thinking through the concept of process approach Objective is to improve effectiveness via process performance measurement Expectations of continual process improvement and customer satisfaction are explicit.process improvement

10. 10 ISO 9001 2008 - NOV 2008 - CER BL- internal presentation ISO 10012 ISO 10012 ISO 9000:2000 Family ISO 9000 ISO 9000 Quality management systems - Fundamentals & vocabulary ISO 9004 ISO 9004 Quality management systems - Guidelines for performance improvement ISO 9001 ISO 9001 Quality management systems - Requirements Technical Reports Technical Reports ISO 10012 ISO 10012 Measurement ISO 19011 ISO 19011 Audits Guidelines Annexes A & B for information only

11. 11 ISO 9001 2008 - NOV 2008 - CER BL- internal presentation Relationship with ISO 9004 Consistent pair Complement each other Can be used as stand alone Different scope - similar structure ISO 9004 ISO 9004 ISO 9001 ISO 9001 Focuses on effectiveness And is certifiable Aims on improving performance and efficiency

12. 12 ISO 9001 2008 - NOV 2008 - CER BL- internal presentation A desired result is achieved more efficiently when activities and related resources are managed as a process PROCESS “set of interrelated or interacting activities which transforms inputs into outputs PROCESS “set of interrelated or interacting activities which transforms inputs into outputs INPUTOUTPUT RESOURCES CONTROLS PRODUCT PROCESS EFFECTIVENESS Extent to which planned activities are realised and planned results achieved PROCESS EFFICIENCY Relationship between the result achieved and the resources used ISO 9001:2000 Process Approach

13. 13 ISO 9001 2008 - NOV 2008 - CER BL- internal presentation Identifying, understanding and managing interrelated processes as a system contributes to the organisation’s effectiveness and efficiency in achieving its objectives Process A Process B Process C Process D RR RR I I I C C CC I O I I O O O I = INPUT O= OUTPUT R = RESOURCES C= CONTROLS ISO 9001:2000 System approach to management

14. 14 ISO 9001 2008 - NOV 2008 - CER BL- internal presentation Continual improvement cycle P lan C heck A ct DoDo The model of a Quality Management System provided in this standard follows the methodology known as “Plan-Do-Check-Act” (PDCA)

15. 15 ISO 9001 2008 - NOV 2008 - CER BL- internal presentation Concept of integration ► ISO 9001:2008, ISO 14001:2004 & OHSAS 18001:2007 standards based on PDCA concept, therefore having similar structure: Policy Planning Implementation and operation Performance assessment Improvement Management review

16. 16 ISO 9001 2008 - NOV 2008 - CER BL- internal presentation Evolution 1984198719972000200320082013 ISO 9001:1987 ISO 9001:2000 ISO 9001:2008 Correspondence to customers needs Quality Policy Fulfil Objectives Customer focus Continuing Improvement Management Review Fulfil Req. in Regulations Process Identification Risk Management Compliance with Leglislation and regulation Stable processes Focus on results and performance Global market demand ISO 9001:2013 Mutual standard 9001/14001/ 18001/SA8000 Focus Supplier Evaluation Quality Management Sustainability