What’s New For 2008

ISO 9001:2008 What’s New for 2008

Rationale for updates …. •   •     • 

ISO Review process: Requires continual review to keep standards up to date. Must be initiated within 5 years of publication of the standard. User inputs: Global user questionnaire/survey Market justification study Suggestions arising from the ISO/TC 176 interpretations process Opportunities for increased compatibility with ISO 14001 Current trends: Keeping up with recent developments in management system practices

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Next generation of “ISO 9000” • Summary:  ISO 9001:2008 already published – no major changes expected for 2009.  A Final Draft International Standard (FDIS) has been drafted with small changes to ISO 9001 with the target of issuing ISO 9001:2008 by the end of the year. (Publication: 15 November 2008).  More significant changes are planned for ISO 9004 (“revision”) to be published in 2009 at the earliest. • Design specifications for ISO 9001 and ISO 9004 approved by ISO/TC176/SC2 in 2005 and revised for ISO 9001 in 2007. • ISO 9004 DIS is currently being circulated for comments.

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ISO 9001 • Main objectives of ISO 9001:2008  To provide greater clarity and ease of use • Incorporate improvements to address the interpretations and clarifications requested by users through the ISO/TC178 interpretations process.  To improve compatibility with ISO 14001:2004

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What do we mean by “Amendment” to ISO 9001? • Aim is to emphasize that no MAJOR changes to the requirements are being made to ISO 9001.  Focus is on changes that improve clarity, translatability, and ease of use; address ambiguities that resulted in requests for interpretations; improve consistency with the ISO 9000 family, and improve compatibility with ISO 14001:2004. • No formal ISO distinction between a “revision” and an “amendment”. • Amendment is something used to address known issues, but not to create new or delete existing requirements. ARMY/UPSI

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High-benefit and Low-impact Changes High benefit

Low-impact

Address a widely expressed specific user need by improving clarity and eliminating confusion (for example, improve compatibility with ISO 14001, reduce the need for official interpretation).

No increased or reduced requirement.

Corrects an error in existing standard.

No changes in intent of requirement.

Is consistent within the ISO 9000 family of standards, including ISO 9001.

No impact on most users.

Improves translation into other languages.

No need for additional education or training for users.

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Only minimal or marginal changes of an organization’s documentation needed.

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Key strategies for ISO 9001:2008

• ISO 9001:2008 Process Approach model will be maintained. • The standard will remain generic and be applicable to all sizes and types of organization operating in any sector. • Compatibility with ISO 14001:2004 to be maintained and if possible enhanced. • Changes will be restricted to limit impact on users. ARMY/UPSI

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Compatibility with ISO 14001

• “Compatibility” means that common elments of the standards can be implemented by organizations in a shared manner, in whole or in part, without unnecessary duplication or the imposition of conflicting requirements. • When maintaining compatibility with ISO 14001:2004 the following do not necessarily represent potential conflicts:  Different text in common elements or terminology  Different numbering of the clauses.  Different models and structure.  Inclusion of guidance, notes or annexes. ARMY/UPSI

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Compatibility with Sector specific and other standards • Sector standards based on ISO 9001:2000.  Example ISO/TS 16949; AS 9100; TL 9000; ISO/TS 29001 • Other management system standards that are based on ISO 9001:2000 and use its structure and text.

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Other decisions already made for ISO 9001:2008 … • The current scope, purpose, title and field of application of the standard will be unchanged. • No new requirements included. • The eight Quality Management Principles (as contained in ISO 9000:2005) will be applied, unchanged. • Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008.

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Implementation • ISO 9001:2008 changes have a limited impact on users. Some arrangements regarding implementation are needed. • To reflect the limited scope of changes the term “implementation” is used to make a clear distinction with the former “transition”.

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Joint IAF-ISO communiqué •

The agreed implementation plan for ISO 9001:2008 in relation to accredited certification is therefore the following: 2) Certification to ISO 9001:2008 will only be issued after publication of ISO 9001:2008 (expected before the end of 2008) and after a routine surveillance or recertification audit against ISO 9001:2008. 2) One year after publication of ISO 9001:2008, all certification issue (new certificate and recertification) must be to ISO 9001:2008. 3) Two years after publication of ISO 9001:2008, existing ISO 9001:2000 certification will not be valid. ARMY/UPSI

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Changes made to standard using notes Clauses

Two new notes

4.1

Revised

4.2.1

New

6.2.1

New

6.4

New

7.2.1

New

7.3.1

New

7.3.3

New

7.5.4

Revised

7.6

Deleted 2000 note, added new note

8.2.1

New

8.2.2

Revised

8.2.3

New ARMY/UPSI

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ISO 9001:2008

The Changes …

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Overview • The changes of the ISO 9001:2008 do not contain new requirements. • There are specifications and clarifications in the text of the new standard.

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Principles • Process approached unchanged. • Eight quality management principles unchanged. • No major changes.

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Main modifications • Outsourcing process defined. • Training to achieve competence. • Work environment includes physical and environmental factors. • Process measurement focused to effectiveness.

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4.1 General requirement outsourcing • Type and nature of control to the outsourced processes shall ensure the conformity to requirement. Outsourcing has to be a well managed part of the quality management system.

Relationship to clause 7.4 (Purchasing) ARMY/UPSI

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4.2.1 General documentation requirement

• Notes included to emphasize that “documentation” can also include “records” and that mandatory procedures may be in the form of combined documents, or that requirements may be covered by more than one document.

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4.2.3 Document control • Note to clarify that only external documents affecting the QMS need to be controlled.

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5.5.2 Management Representative • Top management shall appoint a member of the organization’s management. Outsourcing of the Management Representative (MR) is NOT conforming.

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6.2.1 General • Note: Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system. Not just the core process. This include the support processes.

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6.2.2 Competence, training and awareness

• Provide training to achieve the necessary competence. • Ensure that the necessary competence has been achieved. Necessary competence affecting conformity to product quality requirements.

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6.3 Infrastructure • Clarifies that this includes information systems. Support services (such as transport, communication or information systems)

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6.4 Work environment

• Work environment includes physical, environmental and other factors.

Broader scope and not limited to product quality only. The term “work environment” relates to conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting, or weather)

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7.2.1 Determination of requirements related to product

• Note: Post-delivery activities include, for example, actions under warranty provision, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal. Product requirements includes post-delivery activities. ARMY/UPSI

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7.3.1 Design and development planning

• Note: Design and development review, verification and validation have distinct purposes but may be conducted and recorded either separately or in any combination, as suitable for the product and the organization. Clarification

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7.3.3 Design and development output

• Note: Information for production and service provision can include details for the preservation of product.

Clarification

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7.5.4 Customer property

• Note: Customer property can include intellectual property and personal data.

Intellectual property and personal data as useful part of customer property.

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7.6 Control of monitoring and measuring devices

• Re-titled. • Replace “devices” with “equipment”. • Explanation of its applicability to software.

Note: Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.

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8.2.1 Customer satisfaction

• Note: Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, dealer reports.

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8.2.2 Internal Audit

• A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. • Records of the audits and their results shall be maintained (see 4.2.4) • The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. ARMY/UPSI

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8.2.3 Monitoring and measurement of process • When planned results are not achieved, correction and corrective action shall be taken, as appropriate. • Note: When determining suitable methods, it is advisable that the organization consider the type and extent of monitoring and measurement appropriate to each of its processes in relation to their impact on the conforminity to product requirements and on the effectiveness of the quality management system. Focus changed from product conformity to the impact on the conformity and effectiveness. ARMY/UPSI

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Implementation Guidance for ISO 9001:2008

• To help with the move from ISO9001:2000 to the ISO 9001:2008, you may analyse the clarifications using the comparisons table, contained in annex B of ISO 9001:2008 and see the Implementation Guidance obtainable from www.iso.org or www.iso.org/tc176/sc2. THANK YOU ARMY/UPSI

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