ISO9001:2015 Clause 9.1 - What the external auditor will look at?

skb76

Involved In Discussions
#1
1) clause9.1.1 (The organization shall evaluate the performance and the effectiveness of the quality management system)
~the question form (internal/external auditor may sound like;
-show me how you evaluate the quality performance and the effectiveness of the quality management system?

2) clause9.1.3c (the performance and effectiveness of the quality management system)
~the question form (internal/external auditor may sound like;
-How to prove/ensure conformity and effectiveness of the QMS?

based on the clause above; actually what the external auditor will look on?

p/s advise

thanks in advance :) !
 
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Golfman25

Trusted Information Resource
#2
Too me that is duplicative of many other requirements. I have never had an auditor specifically ask. Basically, it's management review, metrics, internal audits, etc.
 
#3
Who knows? Auditors ask to see all kinds of things, often nothing to do with the actual clause... However, what you should do is KNOW what you do to meet this requirement which demonstrates the performance and effectiveness of the QMS. If you understand this, it'll be simple and if you don't, come back and ask about what you don't know!
 

Golfman25

Trusted Information Resource
#4
To Andy's point. I have auditors ask for things I had no clue what they wanted. What I did find helpful is working thru the clauses and identifying where/how we complied with each one. That way it was just a matter of cross referencing the clause to the documents/evidence.
 

Mikey324

Quite Involved in Discussions
#5
To Andy's point. I have auditors ask for things I had no clue what they wanted. What I did find helpful is working thru the clauses and identifying where/how we complied with each one. That way it was just a matter of cross referencing the clause to the documents/evidence.
I did the same thing. It really helps to show the auditor that you understand the requirement, in the way that it applies to you organization.
 

tony s

Information Seeker
Trusted Information Resource
#6
Performance is defined as "measurable result". So, when an organization evaluate "performance" this could mean that an organization is evaluating its:
  • process expected outputs (4.4.1a);
  • performance indicators (4.4.1c);
  • quality objectives (6.2);
  • customer satisfaction goals (9.1.2)
Effectiveness is the "extent to which planned activities are realized and planned results are achieved". Evaluation of "effectiveness" can be done thru:
  • internal audit (9.2.1b);
  • review of the actions to address risks and opportunities (6.1.2b.2);
  • management review (9.3.2c)
 

Big Jim

Super Moderator
#7
Performance is defined as "measurable result". So, when an organization evaluate "performance" this could mean that an organization is evaluating its:
  • process expected outputs (4.4.1a);
  • performance indicators (4.4.1c);
  • quality objectives (6.2);
  • customer satisfaction goals (9.1.2)
Effectiveness is the "extent to which planned activities are realized and planned results are achieved". Evaluation of "effectiveness" can be done thru:
  • internal audit (9.2.1b);
  • review of the actions to address risks and opportunities (6.1.2b.2);
  • management review (9.3.2c)
Excellent lists. To the first list I suggest you add 9.1.3 Analysis and Evaluation.
 

MajorBVNaik

Involved In Discussions
#8
To Andy's point. I have auditors ask for things I had no clue what they wanted. What I did find helpful is working thru the clauses and identifying where/how we complied with each one. That way it was just a matter of cross referencing the clause to the documents/evidence.
I feel that the quality manual should cover and explain how an organization will implement all the shall requirements in the standard
 

tony s

Information Seeker
Trusted Information Resource
#10
I feel that the quality manual should cover and explain how an organization will implement all the shall requirements in the standard
During the time where a quality manual is required, i.e. 2000 and 2008 versions of ISO 9001, both versions didn't intend for the organizations to describe how the clauses/requirements of the standard were implemented. Both the 2000 and 2008 versions have the same statement for a quality manual in clause 4.2.2:

The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.

For organizations that utilized the outline of the standard as the basis for structuring their quality manual, are obligated to unnecessarily revise, for example, their 2008 quality manual to align with the 2015 clause structure. Maybe, this is why the 0.1 section of 2015 mentioned this:

It is not the intent of this International Standard to imply the need for:
— uniformity in the structure of different quality management systems;
alignment of documentation to the clause structure of this International Standard;
— the use of the specific terminology of this International Standard within the organization.
 
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