Quality Policy - Standards and reference numbers

John C. Abnet

Teacher, sensei, kennari
Staff member
#11
Good day @qualitysteve.
Easy targets for auditors include Control of Documents and Quality Policy. The auditor is (as you're implying) completely off base. I recommend you provide a fact based ...(actual requirement of the standard as compared to your organization's actual system) refutation of the stated nonconformance, to your registration body. Ask (require) the auditor/registration body to state the actual verbatim rule that is implied when the auditor states ..."...requirement is now to continually improve the QMS."
If your refutation is rejected by the auditor, then you can make a formal complaint to the registration body. There is no room for an auditor's opinion in the world of international standards and their audits.
Be well.
 
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Golfman25

Trusted Information Resource
#12
Just had an ISO 9001:2015 surveillance audit and the auditor wrote this. I don't see this as a nonconformance. What difference does it make if I add the word "effectiveness" to the policy.


Auditor statement:

The Quality Policy indicates a commitment to continually improve the effectiveness of the QMS. The requirement is now to continually improve the QMS. There is a difference. An organization can improve a QMS without improving the effectiveness of the QMS
Wow. This is what kills these standards. Assuming this isn't semantics (which it essentially is), is the reverse of his statement true? If you improve the effectiveness of the QMS by definition you improve the QMS. You are in effect going beyond the requirements of the standard.

Here's the thing I would watch out for. How are you measuring the effectiveness of the QMS? If your continual improvements aren't moving those measurements, I suppose technically they could "get you."

I am sure there are bigger issues in your company.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#13
Wow. This is what kills these standards. Assuming this isn't semantics (which it essentially is), is the reverse of his statement true? If you improve the effectiveness of the QMS by definition you improve the QMS. You are in effect going beyond the requirements of the standard.



Here's the thing I would watch out for. How are you measuring the effectiveness of the QMS? If your continual improvements aren't moving those measurements, I suppose technically they could "get you."

I am sure there are bigger issues in your company.
I must not get out much, as I have never seen an auditor parse this sort of thing so minutely in a report, though technically he is right.

Nor have I ever seen an auditor advocate including the date of the standard in the references. In fact, what I have seen is to leave out those references to the standard. After all, why are we doing this? For the standard, or for the customer? Keeping in mind the standard is asking for sound business practices, after all... again, I must not get out much (only 40 weeks a year).

And Golfman is right: there are bigger things to focus on.
 

Jean_B

Trusted Information Resource
#14
When to include a revision identifier (version, iteration, specific name depends on company/industry practice) can be determined based on how you should read the reference.

In the case of the semi using a revision identifier is actually useful, as an update of ISO 9000 to a newer revision at the factory does not mean the semi in the field automatically meets the claim of being built in compliance with these new requirements. (I do agree they should use the correct revision for the system under which it was built :rolleyes:).

The same holds for the essential requirements. If you use it in submission, then it is your claim that it complies (present tense) with these standards, and thus specific revisions are important. It is not a plan or intent document (e.g. checklist). If a standard you claim compliance with updates, you usually cannot substantiate your claim for compliance to the newest standard immediately. If you split revisions off to a seperate list, then be careful of this effect. Updating the revisions in that list before implementing changes effectively means you are claiming compliance where you are not compliant. There's no need to explain to anybody here the trouble that can land you in.
  • Thus if it is a intent (plan) document that will call upon the then current/applicable revision an undated/unrevisioned reference is appropriate. These do entail checking for, interpreting and adjusting to the latest changes/current state every time you use it, and thus is good for process map (procedure) level matters and low frequency use.
  • If it is an 'aligned' document (e.g. work instruction to a test standard), for which the check, interpretation and adjustement took place at review/approval, then a dated/revision reference is appropriate.
    • Come review time, the reviewer should check whether the use of that specific revision is appropriate. Sometimes you would not updated to the latest (e.g. testhouses needing to be able to test to both/either 60601-1 edition 3.0 and 3.1 for their customers due to jurisdictional differences, thus having split instructions), generally you should do so. This is (partly) why you are expected to define review periods for documents.
    • You would control external documents (such as standards) on their status, and if that system indicates an update you would look for these kinds of instructions and review them to assess whether they need updates as the previous point, but sometimes before that instruction's specific review period is up.
      • Note that general interpretation (see Marcello's link) says: "If the referenced document is amended or revised, the dated references to it will need to be reviewed to assess whether they should be updated or not." Thus you need a robust system which not only looks for regular revision updates to the external document, but includes associated corrigenda and amendments.
    • Claiming compliance to an unrevisioned reference in a procedure (e.g. EN ISO 14971 in the procedure) without claiming a revisioned reference (EN ISO 14971:2012) in an underlying instruction opens up the possibility that you will be found non-compliant with your claimed unrevisioned reference. (Good example warning, as (EN) ISO 14971 is expected to be updated in a few years. I'm expecting to hear some of these pop up at that time again. :popcorn:)
  • If it is a record, then a dated/revision reference is practically mandatory, as you cannot change the past to conform to future states (as implied by undated/unrevisioned reference).
  • Certain reports covering time ranges/analyses may block off time ranges and their related revisions or simply refer to the general topic through an undated/unrevisioned reference, but thus cannot build on the dated/revision dependent content.
 
B

BhupinderSinghPawa

#15
Quality Policy need not mention the exact standards. While drafting Quality Policy I sampled quite a few publically available quality policies, and none of them mentioned the standards.

The Quality Objectives or Business Objectives can mention that you need to achieve EN ISO 13485:2016 certificate and CE Mark for product by a specified timeline. This is to align organization activities towards the goal. Besides, the auditor's were looking for evidence on management commitment to achieve the 13485:2016 certification, availability of complete QMS and atleast 1 Management Review and 1 Internal Quality Audit, prior to the NB Stage 1 Audit. Having the Quality Objective helped in same.
 
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