Auditing Top management: 6.3 ISO 9001

G

Graciel

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#1
#1
Hi guys.
About item 6.3 iso 9001 change management, do you guys audit this with quality team or does the top management has to show how they conduct this item?
 
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John C. Abnet

John C. Abnet

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#2
#2
Good day @Graciel ;
Is it safe to assume you are speaking of INTERNAL audits?

Obviously "Top Management" shall have accountability for the overall effectiveness of the management system. However, in regard to WHO gets audited...I would counsel that your internal audits simply verify if the aspect of the management system being audited is indeed effective. Who is needed to be involved to confirm if the aspects identified in "planning of changes" is effectively taking place? Do you need to audit any specific individual or are you able to simply confirm that the controls are in place and effective by reviewing the evidence?

Are you focusing on the clause (e.g. 6.3) or the organization's processes that interact with change planning? For example: if you have a "stamping" process, who is the process owner? Are required change planning aspects being applied if/when changes occur in "stamping".

Don't get too focused on the specific clause. Instead, see how your organization's processes are performing, which is the ultimate goal of a QMS.

Food for thought.

Hope this helps.
Be well.
 
Kronos147

Kronos147

Trusted Information Resource
#5
#5
Graciel said:
Hi guys.
About item 6.3 iso 9001 change management, do you guys audit this with quality team or does the top management has to show how they conduct this item?
Click to expand...
What are the documented processes of the organization?

Which process(es) are accountable for the requirements of 6.3?

I ask these questions because it seems like the internal audit is going clause by clause, and opposed to process by process.
 
Mikey324

Mikey324

Quite Involved in Discussions
#6
#6
@Graciel ,

I believe what @Kronos147 said may be correct. Are you doing a clause by clause internal audit? If so, you are most likely not covering your actual processes. For example, 6.3 covers planning for change. However, process change is mentioned in multiple clauses (7.5.3.2 c, 8.2.4, 8.3.6, 8.5.6, etc). That's why you need to audit your organizations process for controlling change. Changes can occur in a complex management process, manufacturing, a support process. The change control process of the organization should consider the entirety.
 
malasuerte

malasuerte

Quite Involved in Discussions
#7
#7
Mikey324 said:
@Graciel ,

I believe what @Kronos147 said may be correct. Are you doing a clause by clause internal audit? If so, you are most likely not covering your actual processes. For example, 6.3 covers planning for change. However, process change is mentioned in multiple clauses (7.5.3.2 c, 8.2.4, 8.3.6, 8.5.6, etc). That's why you need to audit your organizations process for controlling change. Changes can occur in a complex management process, manufacturing, a support process. The change control process of the organization should consider the entirety.
Click to expand...
Send me your resume! LOL!
 
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