Where in the quality manual do I put our Quality Objectives and our Quality Policy

#11
Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic

We follow ISO 9001 and we input our quality objectives in section 6 under Planning . Quality Policy we list it under section 5 Management.
 
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EthanLoh

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#12
Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic

I am referring to ISO 13485: 2016, clause 5.6.1 Management review, General.

The organization shall document procedures for management review. Top management shall review the organization’s quality management system at documented planned intervals to ensure its continuing suitability, adequacy and effectiveness. The review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

There is no clear definition for planned intervals. Auditor expected management review to be conducted a least on an annually basis. Some of my clients do it twice a year. Some even do it on a monthly basis.

PS: I am no familiar with ISO 9001. I am only an ISO 13485 auditor :)
 
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AMIT BALLAL

Trusted Information Resource
#13
Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic

Hi!

You may add "Quality policy" in your manual since it will not be changed that frequently.

I would recommend not to include Quality objectives in your Quality manual. You can give reference to the document including quality objectives. Eg. Refer XX-XXXX-XXXX document for quality objectives. This helps since quality objectives get changed more frequently. And it's not good and feasible to keep revising the quality manual so frequently.
 
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Golfman25

Trusted Information Resource
#15
Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic

Auditors can expect what ever they want. That's NOT a requirement...
While it isn't spelled out in the standard, I think it's one of those morphed "best practices." I don't think I've met an auditor who would be good with management review less than annually.
 
#16
Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic

While it isn't spelled out in the standard, I think it's one of those morphed "best practices." I don't think I've met an auditor who would be good with management review less than annually.
Annually isn't a "best practice" by any stretch of the imagination. Auditors who think like that shouldn't be auditing.
 

Golfman25

Trusted Information Resource
#17
Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic

Annually isn't a "best practice" by any stretch of the imagination. Auditors who think like that shouldn't be auditing.
So are you saying an auditor wouldn't issue a non-conformance if MR was don't at least annually? I would thing you'd have a hard time tap dancing around that.
 
#18
Re: Where in the quality manual do I put our Quality Objectives and our Quality Polic

So are you saying an auditor wouldn't issue a non-conformance if MR was don't at least annually? I would thing you'd have a hard time tap dancing around that.
What's the requirement they'd cite? If someone wrote it in a procedure, sure, but not in the standard...
 
#19
It is a requirement of the QMS that quality objectives be established consistent with the quality policy. Unless your objectives and policy never change than a review Does take place annually at the Management Review. MR minutes are maintained as documented information so you can show people that objectives and policy are reviewed annually.
 

Teyla

Starting to get Involved
#20
The structure of our Manual is built according to the standard.

1. Cover page
2. Introduction
3. Scope
4. Normative references, etc.

You get the picture. :)

So, the quality policy and objectives are the part of the chapter 5.

I was in doubt defining them in the Manual, since it requires the changes in the Manual every year at least. But, we use the tool for "building" the Manual and doing the change is very easy - click on the chapter and I do my changes, then save them and there is the new Manual version. Exported to PDF.
 
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