Move to ISO 9001:2008

Will you be ready for your transition audit to ISO 9001:2008? Although it was announced as not containing any new requirements, you still need to examine it to see how it might affect your quality management system.

Since ISO 9001:2008 provides clarified requirements and new notes, these changes might cause your organization to interpret the requirements differently. Your certification body will expect to see evidence during the transition audit that you have carefully considered these differences and revised your quality management system as appropriate.

For example, in clause:

4.1 Quality Management System (General Requirements) – Have you examined Note 2 to see if the new explanation of an outsourced process will cause you to identify more outsourced processes? Will the new Note 3 cause you to alter the type and extent of control over your outsourced processes?

5.5.2 Management Representative – Will this clarified requirement cause you to appoint a new management representative; one that is a member of your organization’s own management?

6.2.1 Human Resources (General) – Did the new Note for this clause expand your view of the personnel expected to be competent based on their direct or indirect effect on conformity to product requirements?

6.3 Infrastructure – Has the new example of supporting services caused you to add information systems to your internal audit schedule?

6.4 Work Environment – Did the new Note for this clause result in you considering more conditions that might affect the work environment?

7.2.1 Determination of Requirements Related to the Product – Did the new Note for this clause expand your view of what should be considered as a post-delivery activity?

7.3.3 Design and Development Outputs – Did the new Note for this clause result in product preservation requirements, e.g., packaging, being considered as part of your design and development output?

7.5.4 Customer Property – Did the revised Note for this clause cause you to expand the category of customer property to include personal data?

7.6 Control of Monitoring and Measuring Equipment – Has the new Note for this clause clarified how to confirm the ability of computer software for the intended application?

8.2.1 Customer Satisfaction – Has the new Note for this clause identified more input sources for monitoring the customer’s perception as to how well you are meeting their requirements?

8.2.2 Internal Audit – Has the revised requirement to ensure any necessary “corrections and corrective actions” are taken caused you to re-examine your audit procedure?

8.2.3 Monitoring and Measurement of Processes – Has the new Note for this clause resulted in a consideration of the impact of your monitoring and measurement methods on conformity to product requirements and the effectiveness of the quality management system?

8.5.2 Corrective Action – Has the revised requirement to review the effectiveness of the action taken caused you to update your corrective action process?

8.5.3 Preventive Action – Has the revised requirement to review the effectiveness of the action taken caused you to update your preventive action process?

Evidence

What would be credible evidence to share with an auditor as proof that you have considered all the differences between ISO 9001:2000 and ISO 9001:2008? For starters, do you have a copy of the new standard? See its Annex B for a table that identifies all the text changes from the 3rd edition to the new 4th edition.

Have you reviewed the differences and modified your quality management system as appropriate? The changes to the clauses discussed above may affect your organization. Planned changes should be addressed at your Management Reviews and captured in the meeting minutes.

Some changes are simple. For example, two of the ISO 9001:2008 clause titles were modified (6.2.2 and 7.6). If your quality manual uses the clause structure of the standard, you may want to revise those section titles to show your consideration of the changes.

And, did you reflect the changes as appropriate in your documented procedures? Have you gone over the differences with your internal auditors? Do you have proof of this training?

Resources

For an explanation of all the ISO 9001:2008 differences, see this PDF file at my web site.

ISO has developed an introduction and support package of documents that provide guidance on ISO 9001:2008.

Guidance on ISO 9001:2000 sub-clause 1.2 “Application”

Guidance on the documentation requirements of ISO 9001:2008

Guide to the Terminology used in ISO 9001 and ISO 9004

Guidance on the concept and use of the process approach for management systems

Guidance on ‘Outsourced processes’

Implementation guidance for ISO 9001:2008

Frequently Asked Questions (FAQs)

Transition Schedule

ISO and IAF announce schedule for implementation of certification to ISO 9001:2008