Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

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.
 

EthanLoh

Involved In Discussions
#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 :)
 
Last edited:
#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.
 
Last edited:
#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.
 
#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...
 

Yukon

Involved In Discussions
#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.
 


Top Bottom