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Time line The changes What is ISO-IAF saying? What happens next?

Time line The changes What is ISO-IAF saying? What happens next?. Time Line ISO 9001:2008 Changes. Drafted by ISO/TC 176/SC 2 Voting began on August 7 th , 2008 Voting terminated on October 7 th , 2008 Issued in November 2008. ISO 9001:2008 Changes. Summary of Changes

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Time line The changes What is ISO-IAF saying? What happens next?

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  1. Time line • The changes • What is ISO-IAF saying? • What happens next?

  2. Time LineISO 9001:2008 Changes • Drafted by ISO/TC 176/SC 2 • Voting began on August 7th, 2008 • Voting terminated on October 7th, 2008 • Issued in November 2008

  3. ISO 9001:2008 Changes • Summary of Changes • Changes are minimal, such as: • Rewording of the text (with no impact) • To provide consistency in terminology • Clarification of approach/application • Subtle, but could have some implications

  4. ISO 9001:2008 Changes Rewording of the text Example 7.5.3 - Identification and traceabilityUsed to be:Where traceability is a requirement, the organization shall control and record the unique identification of the product Now reads:Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records

  5. Other Examples: 4.1 General requirements 4.2.1 General (Documentation requirements) 7.5.2 Validation of processes for production and service provision 7.5.4 Customer property 7.5.5 Preservation of product 7.6 c Identification of calibration status 8.1 a Measurement to demonstrate conformity to product requirements 8.2.2 Internal audit 8.2.4 Authorizing release of product 8.3 Control of nonconforming product ISO 9001:2008 Changes Rewording of the same text

  6. 6.2 Human resourcesThe words “product quality” are not used, replaced by “conformity to product requirements”This is now the same as in 6.3 Infrastructure and 6.4 Work environment. 7.6 Control of monitoring and measuring equipmentNo longer uses the term “devices”, the term now used throughout is “equipment”This also as been reflected in 7.5.1 d ISO 9001:2008 Changes To provide consistency in terminology

  7. ISO 9001:2008 Changes Clarification of approach/application Some examples are as follows: 1.1 General (Note 1) - now states what the term “product” means 4.1 General requirements: - section e) clarifies that an organization monitors and measures processes “where applicable” - Notes 2 & 3 clarify what an outsourced process is and the types of control that may be required 4.2 Documentation requirements – a document might include more than one procedure and a requirement may be covered by more than one procedure (e.g. Corrective Action)

  8. ISO 9001:2008 Changes Subtle, but could have some implications 0.1 General - now states “the design & implementation of the QMS is influenced by its business environment, changes in that environment, or the risks associated with that environment 6.3 Infrastructure - section c) now includes “information systems” to supporting services 7.2.1 Determination of requirements related to product - new note added addressing post delivery activities, such as warranty provisions, maintenance services, recycling or final disposition

  9. ISO 9001:2008 Changes Subtle, but could have some implications (Continued) 7.5.4 Customer property - the Note now states that “Customer property can include intellectual property and personal data” 7.6 Control of monitoring and measuring equipment - new Note added stating “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”

  10. ISO 9001:2008 Changes What is ISO & IAF saying? ISO – International Organization for Standardization IAF – International Accreditation Forum

  11. ISO 9001:2008 Changes In a recent announcement Ref 1152 dated August 20, 2008, a Joint IAF-ISO Communiqué was published: • ISO 9001:2008 does not contain any new requirements • Accredited certification to the ISO9001:2008 may now be granted since ISO9001:2008 has been released as an International Standard

  12. What Happens Next?ISO 9001:2008 Changes In a same Joint IAF-ISO Communiqué it was stated that: • Effective November 2009 all accredited certifications issued shall be to ISO9001:2008 • Effective November 2010 any existing certification issued to ISO9001:2000 shall not be valid

  13. For Additional Information . . . . . • Review LRQA’s ISO 9001:2008 Client Information Note – click here • Visit our website at www.lrqausa.com/iso-9001-2008-published.aspx • LRQA ISO 9001 Training courses offer a classroom environment to learn about the new standard • Or, give us a call at 281-398-7370 We look forward to being of service to you!

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