Requirements for Review and Approval of QMS Documents

J

jhinckley

#1
We recently received a minor NC related to the above. The statement of nonconformity was as follows:

Other than the change history and approval of the quality manual there is no evidence of review and approval of quality system documents prior to issuance or revision.

Absent a true document management system, what would be the best way to address this NC?
 
Elsmar Forum Sponsor
#2
Re: Review and approval of QMS documents

We recently received a minor NC related to the above. The statement of nonconformity was as follows:

Other than the change history and approval of the quality manual there is no evidence of review and approval of quality system documents prior to issuance or revision.

Absent a true document management system, what would be the best way to address this NC?
What was the reference requirement the NC was made against?
 

Pancho

wikineer
Super Moderator
#3
Re: Review and approval of QMS documents

We recently received a minor NC related to the above. The statement of nonconformity was as follows:

Other than the change history and approval of the quality manual there is no evidence of review and approval of quality system documents prior to issuance or revision.

Absent a true document management system, what would be the best way to address this NC?
Hi again, Jim,

ISO 9001 itself doesn't require "evidence of review and approval". In clause 4.2.3, it requires you to "define the controls needed to (a) approve documents for adequacy prior to use, and (b) to review and update as necessary...".

Does your procedure define any controls at all for approval and review? Maybe you are missing defining such controls, but if so, the wording of the NC seems incorrect to me.

Alternatively, does your procedure for document control require some other evidence? If so, maybe the NC is against your own procedure.
 
K

kgott

#4
Re: Review and approval of QMS documents

ISO 9001 itself doesn't require "evidence of review and approval".
.

I'm misisng something here Pancho. How does a document get approved for either issue or re-issue without some evidence thats its approved?

thanks
 

Pancho

wikineer
Super Moderator
#5
Re: Review and approval of QMS documents

How does a document get approved for either issue or re-issue without some evidence thats its approved?
Evidence is provided by records. If a record isn't kept, then the evidence may be lost.

The OP's auditor did say "other than the change history". Thus there likely is version control in the system and edits are recorded. If the editor can approve, then that does provide evidence of approval, of course. But if in the OP's doc control procedure the approval has to come from another party then the change history may not provide the required evidence.
 
J

Jeff Frost

#6
Re: Review and approval of QMS documents

jhinckley,

The documented procedure must identify the approval process (4.2.3.a) and though a formal record is not required for the review and update (4.2.3.b) there must be some form of evidence that review/update has taken place. The procedure is the document control method for your company, so it should address all requirements of 4.2.3 including what will serve as evidence of review/update approval.
 

Helmut Jilling

Auditor / Consultant
#7
Jhinckley,

I think we need a little more info. You stated the NC, but give us the whole NC statement nad the objective evidence cited. Without seeing what the auditor felt was incorrect, we are limited to guessing as to what to correct.

Cl 4.2.3, like any other clause, does require evidence that the requirements have been met. But, there are many ways to achieve that. It is possible that the auditor was reachiing for more than what is required, but I am inclined to give the auditor the benfit of the doubt until I understand what evidence he saw that led to the nonconformity. Of course, the nature of this finding, the way it was written, could imfer that the auditor was a bit of a rookie and heavily focused on the doc control requirements...

Can you give us the rest of the details, and we'll try to help more specifically.
 
R

Richard Davison

#8
I had a minor NC for exactly the same thing. Our solution (accepted by the auditor) is that I email all new or revised documents to our MD requesting that he review and approve them prior to release. His reply email confirming is sufficient to confirm review and approval.
 

insect warfare

QA=Question Authority
Trusted Information Resource
#9
We recently received a minor NC related to the above. The statement of nonconformity was as follows:

Other than the change history and approval of the quality manual there is no evidence of review and approval of quality system documents prior to issuance or revision.
The way I'm reading this is that (and if I am incorrect let me know) that you have controls in your QM for review and approval of the QM itself, but regarding the rest of your QMS documentation, you have a lack thereof. Sound about right?

Absent a true document management system, what would be the best way to address this NC?
The best way to address it would be to identify what gaps you have and initiate actions in order to achieve whatever it is you need to do to have an "effective" document management system. Depending on how primitive your system is, you may need more planning than you think. BTW, I'm not sure there is such a thing as a "true document management system", so I use the operative word "effective" because what works here does not usually work there, and vice versa.

The worst way to address the NC is to try and circumvent it without giving the PDCA process its due diligence first (not recommended)...

Hope this helps :rolleyes:
Brian
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#10
I had a minor NC for exactly the same thing. Our solution (accepted by the auditor) is that I email all new or revised documents to our MD requesting that he review and approve them prior to release. His reply email confirming is sufficient to confirm review and approval.
I would accept that as evidence of approval. I would go on to ask if this person was the only one/last one to approve in all cases, or if others had to be included for various document types and levels.
 
Thread starter Similar threads Forum Replies Date
D Engineering Drawing Review and Approval Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
T Inspection Form Review And Approval - FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
L ISO 9001 Document Review and Approval Form Requirements Document Control Systems, Procedures, Forms and Templates 6
J Supplier Purchase Order Review and Approval Requirements IATF 16949 - Automotive Quality Systems Standard 3
A MDR - Legacy Device Review Timeframe and Requirements EU Medical Device Regulations 3
K AS9100D 8.2.1 Review Requirements for Products and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S List of requirements for Management Review in IATF 16949 IATF 16949 - Automotive Quality Systems Standard 10
J ISO 9001:2015 8.2.3 - Review of Requirements (Clarification on compliance) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
B IATF 16949 Cl. 8.2.3.1.1 - Review of the Requirements for Products and Services IATF 16949 - Automotive Quality Systems Standard 15
T Document Review And Sign Off Second Person Review - FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
L IVD Reagent Techncial File Review Requirements (IVDD Annex III) EU Medical Device Regulations 4
W Evidence for Review of Requirements - AS9100 Clause 7.2.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G ISO 14001 & Product Design Process Environmental Aspect Review Requirements ISO 14001:2015 Specific Discussions 7
H Form that will satisfy Design Review and Design Verification Requirements (7.3) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G Review of Requirements related to the Product (7.2.2) ISO 13485:2016 - Medical Device Quality Management Systems 1
A Review of requirements related to the product - 7.2.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
E AS9100 7.2.2 Review of Requirements Related to the Product AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J FDA Annual Product Review (APR) Requirements US Food and Drug Administration (FDA) 1
M 21 CFR Part 210-211 Sec. 211.192 Production Record Review Requirements Document Control Systems, Procedures, Forms and Templates 5
M 7.6.3.1 Requirements for Capability to Perform Tests Correctly - Review of Records IATF 16949 - Automotive Quality Systems Standard 10
M 7.2.2 Review of Requirements Related to the Product (Design-Manufacturing Service) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
V Document Review Requirements for SQF 2000 (Safe Quality Food Standard) Various Other Specifications, Standards, and related Requirements 3
S TS 16949 Requirements for Timely Review of Engineering Specifications IATF 16949 - Automotive Quality Systems Standard 6
F Periodic Review Requirements for Software - Medical DeviceS Software Quality Assurance 2
U Medical Device Design Review Records Requirements Design and Development of Products and Processes 16
R FDA CDRH Premarket Review Requirements - Submission Cover Sheet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Fulfilling ISO 9001 Document Review Requirements Document Control Systems, Procedures, Forms and Templates 21
M AS9100 7.2.2 Review of Requirements - Order & Product Review Records AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
G Audit Nonconformance - 7.2.2 - Contract Review (Review of Requirements) Contract Review Process 16
B Differentiating between "Review of Requirements" and "Contract Review" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
T Periodic Quality Manual and Procedure Review Requirements General Auditing Discussions 5
S TS 16949 Clause 5.6 - Management Review Requirements - Without a meeting? IATF 16949 - Automotive Quality Systems Standard 17
M Management Review Input and Output Content Requirements Quality Management System (QMS) Manuals 2
O Management Review Inputs and Outputs - AS9100 Registration Audit Requirements Management Review Meetings and related Processes 16
F Review of Requirements Related to the Product - Clause 7.2.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C AS9100 7.2.2 Review of requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
C Review and Implementation of Customer Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
J Purchase Order Review to meet the requirements of clause 7.4.2 in a small company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
M TS16949-Requirements of 5.6 Management Review Management Review Meetings and related Processes 3
R Medical Device Product Requirements Document (PRD) a "Design Review"? Design and Development of Products and Processes 4
U Management Review requirements - ISO 9001 Clause 5.6 and URAC requirements Management Review Meetings and related Processes 7
J IVD Directive - Review and Update Essential Requirements Documentation EU Medical Device Regulations 5
T Feasibility Review - How are you meeting 7.2.2 and 7.2.2.2 requirements? IATF 16949 - Automotive Quality Systems Standard 18
Q Management Review Requirements - TS 16949 Clause 5.6.1 Management Review Meetings and related Processes 17
T Management Review and Audit Data Requirements Management Review Meetings and related Processes 11
A At what stage do you review new product statutory / regulatory requirements? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
G Management Review 5.6.3 b) Improvement of product related to customer requirements Management Review Meetings and related Processes 7
H 7.2.2 Review of Requirements Related to the Product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T Feasibility review prior to quoting - Requirements Review - 7.2.2 Feasibility Help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6

Similar threads

Top Bottom