Auditing Senior Management to determine the Effectiveness of Management Processes

B

Blaest

What would be the correct answer according to the standard to the following:

I would like to audit senior management to determine the effectiveness of their management processes. Which 5 specific areas would I focus on?

1)
2)
3)
4)
5)
 

Coury Ferguson

Moderator here to help
Trusted Information Resource
What would be the correct answer according to the standard to the following:

I would like to audit senior management to determine the effectiveness of their management processes. Which 5 specific areas would I focus on?

1)
2)
3)
4)
5)

1) Commitment

2) Management Reviews

3) Communication to all levels

4) Objectives and Goals

4a) Are the Objectives reviewed and adjusted to meet organizational
changes...

4b) Are the goals obtainable...

5) Resources

Those are my suggestions.
 

SRQAAuditor

Starting to get Involved
Hi there, so auditing management to verify the system is effective is a great idea. I have followed this approach with ISO 13485:
Section 4 Quality Management System (looking at sub-clauses like document control, documented quality manual and quality records)
Section 5 Management Controls (looking at sub-clauses like management commitment, policy, management review (verify system is working here and in control)
Section 6 Resource Controls or Management (check sub-clauses like sufficient personnel, including internal auditors; competence, awareness and training; look at skill retention times, and more)
Section 7 Product Management (lots of sub-clauses like verification of process to build product; purchasing controls; calibration; design controls;
Section 8 Measurement Analysis and Improvement (various sub-clauses like controlling measurements, provision of feedback, complaints, internal audits, nonconforming product and corrective and preventive action.)
Through all of these sections, look for opportunities for improvement and how they are controlled and documented.
Those are the five sections I would suggest. Enjoy!
 

Ron Rompen

Trusted Information Resource
IMO, the most important of these is #4 (Goals) and the subquestions that are driven by that.
Are the goals realistic and obtainable
Do they reflect the business plan and objectives of the company
If the goals haven't been met, are there any actions being taken and documented to correct the situation (treat this like it was an 8D for a nonconformance)
If the goals are changed (especially to a lower goal) is there documented justification for it? It is too easy to just 'downsize' a goal if it becomes apparant that you're not going to hit your original target.
 
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