A question on Maintaining the Integrity of the QMS (5.4.2)

S

silentrunning

My Internal Auditor came up with a good question. In ISO 9001:2008, Section 5.4.2 it states "Top management shall ensure that....b. the integrity of the QMS is maintained when changes to the QMS are planned and implemented". What can you use for a verification? Last year I used the Document Change Log and showed the effectiveness of the changes. Somehow this year that just doesn't seem adequate. I get the feeling that the intent of the clause goes deeper. Any suggestions?

:thanx:

Doug
 
J

JRKH

Re: A question on maintaining integrity (5.4.2)

Correct me if I'm wrong but the intent of this clause is that the QMS remain both comprehensive and effective. So the use of the change log and the effectiveness of the changes is fine. You might also want to add an abbreviated "Gap analysis" in order to demonstrate that the changes did not result in any failures in continuity of the system across functions.

Peace
James
 
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John Broomfield

Leader
Super Moderator
Re: A question on maintaining integrity (5.4.2)

My Internal Auditor came up with a good question. In ISO 9001:2008, Section 5.4.2 it states "Top management shall ensure that....b. the integrity of the QMS is maintained when changes to the QMS are planned and implemented". What can you use for a verification? Last year I used the Document Change Log and showed the effectiveness of the changes. Somehow this year that just doesn't seem adequate. I get the feeling that the intent of the clause goes deeper. Any suggestions?

:thanx:

Doug

Doug,

5.4.2 requirements may kick-in when, for example:

  • Changing the system to meet an new objective
  • Acquiring another company
  • Extending the system to include a new line of business
  • All the design engineers quit

As an auditor I would expect to see evidence of planning to safeguard the integrity of the system.

Evidence may include such things as the results of process design, system analysis (aka, gap analysis) and supply chain management.

I would not refer to this clause for minor changes to the system.

Often I see new objectives with no evidence of preventive action or changes to the system so the organization can be assured of fulfilling their new objective.

John
 
G

Geoff Withnell

My Internal Auditor came up with a good question. In ISO 9001:2008, Section 5.4.2 it states "Top management shall ensure that....b. the integrity of the QMS is maintained when changes to the QMS are planned and implemented". What can you use for a verification? Last year I used the Document Change Log and showed the effectiveness of the changes. Somehow this year that just doesn't seem adequate. I get the feeling that the intent of the clause goes deeper. Any suggestions?

:thanx:

Doug

In addition to the other responders comments, all good, I would expect that any changes to the QMS would be specifically addressed during Management Review. If they were significant changes, what risks were identified when the changes were being processed? Have these risks materialized, and what steps taken? Etc.

Geoff Withnell
 
S

samsung

All excellent responses so far. just to add, the intent of the clause is to accentuate the importance of change management. If changes are allowed to happen without considering their impacts on other system elements, such changes may adversely affect the organization's ability to achieve it's objectives. e.g. if a new raw material or a new technology or a new practice is to be introduced, the impacts of the corresponding changes in other processes (start to end) need to be determined and compensated for without adversely affecting their capability to achieve the planned results.
 
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