Quality Policy does not include a commitment to comply with legal requirements

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malasuerte

Involved In Discussions
#13
So, how do you reconcile that with the ISO 9001 requirement that reads: "Top management shall establish a quality policy that includes a commitment to satisfy applicable requirements...." Obviously legal requirements are a subset of applicable requirements.
"applicable requirements" to Quality. That's how you reconcile it.

The Quality Policy should be meaningful and useable for the organization - A technician on the floor should be able to relate that QP to how well he maintains a tool, or does their step in the process.

There are other places that can maintain the policy for meeting legal, statutory, regulatory, etc. "applicable requirements".
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#14
Applicable requirements is perfect. A legal requirement would be specific to your company if mentioned in a decided court case. If you have not had any legal cases decided against your company, legal requirements is too broad a statement. Government laws will not mention a specific company or product, but a court case might.
 
#15
I have never heard of "legal requirements" in a QMS having anything to do with my company's previous court cases.

It's only been about requirements to meet a law, in my experience. These include local, state, federal and any country the product will be sold and used in.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#16
"applicable requirements" to Quality. That's how you reconcile it.

The Quality Policy should be meaningful and useable for the organization - A technician on the floor should be able to relate that QP to how well he maintains a tool, or does their step in the process.

There are other places that can maintain the policy for meeting legal, statutory, regulatory, etc. "applicable requirements".
Sorry, but you fail to understand a basic, foundational concept in ISO 9001. I have highlighted the text below and it should be self-explanatory. Let me know, otherwise.

Screenshot 2022-06-23 135838.png
 

Sidney Vianna

Post Responsibly
Leader
Admin
#17
A legal requirement would be specific to your company if mentioned in a decided court case.
No, a legal requirement, in the context of ISO 9001 is any product-related requirement for a regulated type of device or service, which must demonstrate conformity, prior to be allowed in the market place. European Directives are one example of product related legal requirements.
 

malasuerte

Involved In Discussions
#18
Sorry, but you fail to understand a basic, foundational concept in ISO 9001. I have highlighted the text below and it should be self-explanatory. Let me know, otherwise.

@Sidney Vianna Cool insult! Been doing this for 25+ years as an auditor, educator and now director without issue - ever! But go ahead an assume "I fail to understand basic....". Great way to treat people; you must be a real treat to work with!

What you are highlighting is fine and relevant, but does NOT mean those have to be part of the Quality Policy. It says the QMS needs to demonstrate those. Not write them into the Quality Policy.

I have F&BL, Recycling, Safety, Conflict Minerals, Envionmental, FuSa policies that address all of these and I bring them up in every customer or 3rd party audit.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#19
@Sidney Vianna Cool insult! Been doing this for 25+ years as an auditor, educator and now director without issue - ever! But go ahead an assume "I fail to understand basic....". Great way to treat people; you must be a real treat to work with!
Post responsibly. That's my motto. You said that the ISO 9001 requirement that the quality policy must have a commitment to satisfy all applicable requirements does not include LEGAL requirements. That's a poor interpretation of the standard and it will be challenged anytime of the day, as long as I am here. Own up to your words.
 

malasuerte

Involved In Discussions
#20
Post responsibly. That's my motto. You said that the ISO 9001 requirement that the quality policy must have a commitment to satisfy all applicable requirements does not include LEGAL requirements. That's a poor interpretation of the standard and it will be challenged anytime of the day, as long as I am here. Own up to your words.
LOL - I own every single one of my words! You are wrong - I own that 100%!!

Legal requirements, etc. do NOT have to be in the Quality Policy. Period!
 
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