QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to Do?

[amjadrana]

Quality manual

The purpose of establishing a quality management system is to help a company improve its systems effectively. The management system can be verified and audited by a third party but it's sole purpose is to improve the internal working of an organization. Quality manual is an important part of the quality management system. Instead of having a quality manual that does not help an organization, it is better not to have any quality manual at all. The auditors would also like to see an effective quality manual that works for an organization.

The quality manual should describe the company, its working, policy, important objectives and what is does to improve the quality of its products and services. It should be a document that can be presented to other interested parties like vendors, customers.

Registrars and auditors interpret QMS differently. That is my opinion and I hope that I will be able to contribute to this forum.

 

[deamonn]

No, no, no, no and no.

Quality manuals should not be developed with auditors in mind. The primary users and readers of an organization's quality manual should be the employees, customers and suppliers.

What documents are developed with auditors in mind?

 

[Wes Bucey]

What documents are developed with auditors in mind?

In my opinion, NO DOCUMENTS are created with auditors in mind. If the document doesn't fit your business model, it should not be created. If your business model does NOT include the "required documents" to meet a Standard, you should be questioning WHY you are trying to shoehorn your operation to fit a Standard.

Practically speaking, if you want to do business with customers which require your organization to be registered to a specific Standard, all documents required to meet that Standard are really "customer requirements" and NOT "auditor requirements."

It's a tough dilemma. Many supplier organizations are victims of "customer extortion." Only the supplier can decide whether to submit to the extortion or do business elsewhere.

 

[Sidney Vianna]

What documents are developed with auditors in mind?

According to some covers, the only documents that are really important for the external auditors are the checks your accounts payable dept. write to cover their invoices....

Sorry, but I could not resist.

On a serious note, Good external auditors understand that whatever system the organization developed to complywith a Standard, such as ISO 9001:2000, has to work for them (the organization) They are the ones deploying and "living" the system, day in, day out.
So, external auditors have to assess if the system developed by the organization satisfies the applicable stanadrd(s), but the organization MUST NOT develop any document with the auditor in mind, but the actual USERS of the document/process.
Good auditors adapt, learn and assess a multitude of management systems. Bad auditors are inflexible and "demand" things to "please" them, rather than assess effectiveness of the system at hand.

 

[Laura M]

I just had an auditor tell a client that they "had" to have a statement in their quality manual regarding infrastructure and work environment. This org is small, and had documentation in both weekly minutes and an annual meeting of what their next plans are for the facility. The auditor refused to accept that. The president says - let's take a walk, I'll show you what we do to maintain the facility and machinery. The auditor said, "the only allowable exclusions are in Section 7. By not addressing it in words, you have treated it like an exclusion. There are no elements that you can't address without written words. Do me a favor, just paraphrase the standard and for infrastructure and work environment where is says 'you shall' write 'we do.' While you're at it, reorganize your manual, and number it to meet the standard."

He absolutely would not accept that the facility addressed work environment and infrastructure. He did not say - 'how do you feel this requirement has been addressed?' When they tried to get him to discuss it, he got very defensive, and said, 'you can't throw meeting notes at me to show me a requirement is met.' When they said we believe that physically we have addressed the intent of this ISO element - his response was that it was a matter of opinion. The frustrating part is its easier to 'conform' to his 'opinion' than appeal. Any comments?

 

[Wes Bucey]

Single comment: Bummer!

Single question: Appeal to whom? auditor's manager? registrar's top management? In my opinion, simple phone call and email might get you resolution you need; if not, you may be persuaded to "suck it up" this time, but vow to change registrars for next time.

 

[ralphsulser]

My opinion is that if you can show how it is addressed and provide evidence of meeting the "Shall" that should satisfy the audit requirement. This is what we were taught in the RAB accredited Lead Auditor course for ISO9001/TS16949. After all, anyone can state in the QM, but that does not porvide objective evidence the requirement has been satisfied.

 

[Sidney Vianna]

I just had an auditor tell a client that they "had" to have a statement in their quality manual regarding infrastructure and work environment.

I disagree with the auditor statement. Remember, the auditor can not dream/create their own requirements. When it comes to the MINIMUM content of a quality manual, ISO 9001:2000 requires:

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

A minimalist approach to a quality manual could be satisfied in a couple of pages. I am not inferring that this should be the approach to take, but, back to the case in question, ask (POLITELY) your auditor where is the requirement that the manual must include what he wants?​

 

[cathyo]

Cathy O

Man....I hope I am doing this right....I have been following along in Elsmar cove for some time now....excellent resource for all types of info and I would like to contribute...but have never done this before....hope this gets out there .

My opinion is the same as other peoples....that if you can show how it is addressed (documented) and provide objective evidence....in what ever form that may be.... of meeting the "Shall" that should satisfy the audit requirement.

Sounds like your auditor was having a REAL bad day!

 

[Laura M]

Oh we asked all right. He went to the standard an read out loud to us Section 4.1 with emphasis on "....establish, DOCUMENT, implement...." and SEction 4.2.1 "documents needed by the organization....."
Then he read Section 6.2 (in its entirety), out loud, indicating it was a non-excludable requirement. We indicated that we didn't exclude it, it was accomodated my discussing in our management meeting what we did to maintain these 2 items.

He was an old style 1994 auditor - spent more time pouring through procedures than asking questions. Unfortunately I had calmed many of this organizations fears of ISO, and an auditor with this attitude made them comment "this is what we were afraid of." As it turns out one of the unique ways we addressed the standard in their quality manual was by putting a matrix in the appendix of their manual listing the ISO requirements and the internal documents that addressed it. For Infrastructure and Work Environment we referenced the Management Meeting minutes. That's when he said "you can't throw minutes in front of me to prove you meet a requirement. That's not acceptable."

What can an org do when they know they are right, but the more they question the auditor he was displaying extreme aggrivation and raising his voice to the point of the org worrying if they are going to get recommended for registration or not.