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

B

bdshira

#1
#1
Hi all,

I had ISO audit yesterday, and we got comment that our quality policy does not include a commitment to comply with legal requirements.
I couldn't find a requirement for that. Is this a must requirement?
 
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M

Minko57

Starting to get Involved
#2
#2
bdshira said:
Hi all,

I had ISO audit yesterday, and we got comment that our quality policy does not include a commitment to comply with legal requirements.
I couldn't find a requirement for that. Is this a must requirement?
Click to expand...
1. ISO 9001:2015 Clause 5.2.1(c)
2. ISO 14001:2015 Clause 5.2 (d)
3. ISO 37001:2016 Clause 5.2 (b)
4. ISO 19600:2014 Clause 5.1.2
5. ISO 13485:2016 Clause 5.2 and 5.3 (b)
 
B

BoardGuy

#4
#4
There is no need to reference legal as part of the quality policy. Per ISO 9000:2015 quality policy is defined as: Policy related to quality.

Legal is usually related to regulatory or statutory requirements for product or the management system under ISO 9001 but which have little to do with quality. This is why you auditor could not find a non-conformance with your QP for not having it referenced.
 
Last edited by a moderator:
Randy

Randy

Super Moderator
#5
#5
Oops, I misunderstood the initial post and BoardGuy is correct, in the QMS there's no requirement to commit to meet compliance obligations (legal) specifically, it's only implied
 
I

itsbiodiversity

Involved In Discussions
#6
#6
Unless I missed it the OP has not specified what ISO audit. If 17025 the Quality Policy is covered in Section 4.2.2

The laboratory's management system policies related to quality, including a quality policy statement, shall be defined in a quality manual (however named). The overall objectives shall be established, and shall be reviewed during management review. The quality policy statement shall be issued under the authority of top management. It shall include at least the following:

a) lab mgmt commitment to good professional practice and to the quality of its testing and calibration in servicing its customers
b) the management's statement of the laboratory's standard of service
c) the purpose of the management system related to quality.
d) a requirement that all personnel concerned with activities familiarize themselves with quality docs and implement the policies and procedures in their work and
e) the lab mgmt commitment to comply with this International Standard and to continually improve the mgmt system effectiveness.

Perhaps the auditor is getting caught up in section 4.1.1 which states:
the lab or org of which it is part shall be an entity that can be held legally responsible.


That has nothing to do with the quality policy.
 
A

Arif Basha

Registered
#7
#7
bdshira said:
Hi all,

I had ISO audit yesterday, and we got comment that our quality policy does not include a commitment to comply with legal requirements.
I couldn't find a requirement for that. Is this a must requirement?
Click to expand...
Hi , Hope you got an answer for this question , if so please share how you fixed this.
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Leader
Admin
#9
#9
Randy said:
Oops, I misunderstood the initial post and BoardGuy is correct, in the QMS there's no requirement to commit to meet compliance obligations (legal) specifically, it's only implied
Click to expand...
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.
 
Ed Panek

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#10
#10
In the USA congress makes laws that other government agencies in turn create regulatory requirements from. The office of law revision council reviews the laws Congress passes and creates statutory/regulatory language to enforce them. I am trying to think of a law that is not already in the Code of Federal Regulations but can't.
 
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