Please review my ISO 9001 Quality Manual and Registrar comments

ScottK

Not out of the crisis
Staff member
Super Moderator
#1
the file is attached in pdf.

Our registrars comments are:
Your quality manual is not conform with the requirements of the ISO 9001.

We don't find:

The process approach
Scope of certification is not clearly defined, Normative reference is missing (TPED?,....), design according ASME B31.3?
You work follow EN stadards?
Term and definitions are missing

You don't follow the structure prescribed in the ISO standard.

The quality policy is not in accordance with §5.3 of ISO 9001 and is not signed by the President
disregard the last finding - it is, in fact, signed just not in the manual itself. It's a separate document. If he asked for my document control procedure along with the manual he would have seen how that works.

The structure??? it's a regurgitation of the standard.

Thanks for any input.
 

Attachments

Last edited:
Elsmar Forum Sponsor

ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Re: Fellow Mods - would you please review my QM

I'm leery about posting this for the entire population right now so I hope you don't mind me keeping somewhat private for now.

the file is attached in pdf.

Our registrars comments are:


disregard the last finding - it is, in fact, signed just not in the manual itself. It's a separate document. If he asked for my document control procedure along with the manual he would have seen how that works.

The structure??? it's a regurtation of the standard.

Thanks for any input.

oh - and the quality policy has been found acceptable by a DNV auditor for our other facility for the last 6 years or so.
 

SteelMaiden

Super Moderator
Super Moderator
#3
Re: Fellow Mods - would you please review my QM

Hey Dis! how ya doin? first, let me say that if what you put in your post was a direct and true copy of what they sent to you, I'd tell them to go back to school and learn grammar.:mad: I'll be the first to admit that my spelling and grammar are not always the best, but at least I don't sound totally ignorant.

Where does it say in any of the ISO standards that a quality (or any other) policy has to be signed? This is a pet peeve of mine. My quality policy is not signed. But, the Env. manager caved and our Environmental policy is.

If it is good enough for one CB it should be good enough for another. It is not like DNV is some fly by night operation that has only been around for the last 6 months and is unlikely to be around when it is time to recert.:rolleyes:
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Re: Fellow Mods - would you please review my QM

Hey Dis! how ya doin? first, let me say that if what you put in your post was a direct and true copy of what they sent to you, I'd tell them to go back to school and learn grammar.:mad: I'll be the first to admit that my spelling and grammar are not always the best, but at least I don't sound totally ignorant.

Where does it say in any of the ISO standards that a quality (or any other) policy has to be signed? This is a pet peeve of mine. My quality policy is not signed. But, the Env. manager caved and our Environmental policy is.

If it is good enough for one CB it should be good enough for another. It is not like DNV is some fly by night operation that has only been around for the last 6 months and is unlikely to be around when it is time to recert.:rolleyes:

ah - please pass on the grammar - the auditors are Belgian.

I have a whole response drafted - I'll post it below so people can give me feedback on that too...
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#5
Re: Fellow Mods - would you please review my QM

my draft response so far...

Please allow me to respond to your concerns line by line...

"The process approach" I know of no requirement that this actually be in the quality manual. If it is please point out the clause that requires it. Rather I have conducted training for all employees where the process approach was a subject of the discussion. There is evidence of this training with signed rosters and a PowerPoint I used for training.

"Scope of certification is not clearly defined." The scope of the QMS is in section I paragraph 1.
1. Company, Inc. Butler, NJ Facility has implemented, maintains and continually improves a Quality Management System (QMS) that meets the requirements of all customers and is in compliance with ISO9001:2000. It complies with but it is not limited to the requirements of CSA B51-97 and the European Pressure Equipment Directive (97/23/EC).
Would you prefer this to be rephrased? Do you feel I need to add something?

"Normative Reference"? The CEN definition of Normative Reference is: “Normative document to which reference is made in the standard in such a way as to make it indispensable for the application of the standard.” We reference ISO9001:2000, CSA B51-97 and 97/23/EC in the scope. These standards require quality management systems so they are normative references for the QMS. Would you like this summarized in another manner? Any other standard referenced for a process is referenced in the document requiring the standard.

"design according ASME B31.3" stated in section I paragraph 2 is stated "as applicable".

"You work follow EN standards?" I’m not sure exactly what you mean by this, please rephrase.

Terms and Definitions are included in individual procedures as needed. I felt no necessity for terms and definitions in the quality manual the way it is written. If you feel otherwise please let me know what you feel needs to be defined.

"Structure prescribed in the ISO standard" Please reference a clause that prescribes the structure of the QM. 4.2.2 is very open and there are myriad style of quality manuals. Our quality manual is structured almost exactly as the ISO standard, clause for clause. It's just the numbering that is different.

The quality policy has been as such for many years and has been acceptable to (registrar) for PED certification. It is also acceptable to DNV Registrars for our PA operation’s ISO9001 registration that has stood since we purchased them. Thus we saw no need to change. And it is, in fact, signed off by the president and all senior management, in accordance with our document control procedure.

I look forward to your response.
please note - our registrar has been our CE marking notified body for years. We have long relationship with them.


I'm not going to deny that out QP isn't great, I'd love to re-write it in my own style.
 
Last edited:
A

Aaron Lupo

#6
Re: Please review my ISO-9001 QM and registrar comments

Just a suggestion, you may want to soften your response a bit seems very combative. Other than that it looks good. Read it and see how you would feel if this was a response you received from one of your suppliers. JMHO
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#7
Re: Please review my ISO-9001 QM and registrar comments

Just a suggestion, you may want to soften your response a bit seems very combative. Other than that it looks good. Read it and see how you would feel if this was a response you received from one of your suppliers. JMHO
heh... I already softened it up once...

I still haven't sent it. I'll tweak some points a bit more.


Does the Normative Reference part make sense?
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#8
Re: Fellow Mods - would you please review my QM

Hey Dis! how ya doin?
oh yeah - I'm doing well. And yourself?

you know... on other boards where my nick is still "discordian" they shorten it "disco"... I was a punker during the disco era. :mad:
 
Last edited by a moderator:

Jim Wynne

Staff member
Admin
#9
Re: Please review my ISO-9001 QM and registrar comments

A few observations:
Your quality manual is not conform with the requirements of the ISO 9001.

We don't find:

The process approach
4.2.2(c) of the standards says that the quality manual must include "a description of the interaction between processes of the quality management system." While your 4.1 and 4.2 indicate that your QMS addresses the identification of processes and interactions, there's no reference to where the evidence might be found. The standard is pretty unambiguous about the requirement for description of interactions to be included in the manual.

Scope of certification is not clearly defined, Normative reference is missing (TPED?,....), design according ASME B31.3?
The "scope of certification" isn't called for in the standard; what is called for is "...the scope of the quality management system..." Those are two different things. Nonetheless, while you do have an initial section alleging to include a scope, I don't see one. What you need is a simple statement that explains who and what the QMS applies to.

There is no requirement in the standard for normative references, but even so, you cite some, so I have no idea what they think is missing. Just ask for the specific language of the standard they're referencing.

You work follow EN stadards?
I think this must be related to normative references, but who knows? The fact that the auditors might be Belgian is no excuse for lack of clarity and misspelling.

Term and definitions are missing
No requirement.

You don't follow the structure prescribed in the ISO standard.
There is no "structure prescribed."

The quality policy is not in accordance with §5.3 of ISO 9001 and is not signed by the President
Except for the signature part, I tend to agree. I don't see "...a commitment to comply with requirements and continually improve the effectiveness..." of the QMS. Your policy has a "belief" statement (We believe that...") which is not the same as a commitment. We don't always do what we believe in. I also don't see how the policy "...provides a framework for establishing and reviewing quality objectives." We don't see the policy until page 5 of the manual, which is a little curious, as the policy should be the foundation of the QMS, and not an afterthought intended to satisfy the requirement for the existence of a policy.

As far as a response is concerned, I wouldn't waste a lot of explanation at the outset; you should just reject their findings and demand something that (A) cites the specific clause(s) in the standard allegedly violated, (B) cites the specific findings that they object to and precisely how they fail to conform and (C) is devoid of anything made up, such as the requirement for a signature on the quality policy.
 
Last edited:

ScottK

Not out of the crisis
Staff member
Super Moderator
#10
Re: Please review my ISO-9001 QM and registrar comments

Jim -

what if I just include the word "scope" in the first paragraph of section I?
It's got "where", "what", and "how"... maybe another slight rephrase to add "why"?

as far as the QP - I agree. But It was here when I came so I'm stuck defending it. I would love to re-write it but no one else does because it is accepted by DNV. It's on page 5 because I'm following the "prescribed format" of the standard :frust:

I think I know how to address 4.2.2c. I'll have to beef up "planning of realization processes" with a flow chart and reference that.

thanks for the feedback.
 
Thread starter Similar threads Forum Replies Date
L Please review my ISO 9001:2015 Internal Audit Plan Process Audits and Layered Process Audits 7
S New Interaction of Processes ISO 9001:2015 - Please Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M New Quality Policy for ISO 9001:2015 - Please Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R ISO 13485 Mind Map attached - Please review and comment ISO 13485:2016 - Medical Device Quality Management Systems 1
O ISO 9001 Quality Systems Manual (QSM) advice - Please review Quality Management System (QMS) Manuals 8
A ISO 9001 Process Maps - Please Review Process Maps, Process Mapping and Turtle Diagrams 15
S Please review my Risk Analysis Table ISO 14971 - Medical Device Risk Management 13
S Please Review my APQP Training Material APQP and PPAP 4
M Continual Improvement Procedure - Please review Document Control Systems, Procedures, Forms and Templates 1
P Please Review my Design and Development Plan Design and Development of Products and Processes 2
B Please review my Vernier Caliper Gauge R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
N Please Review My Tracking System Document Control Systems, Procedures, Forms and Templates 12
M Quality Policy Draft - Please review Misc. Quality Assurance and Business Systems Related Topics 24
F Please review my Process Flow / PFMEA / Control Plan FMEA and Control Plans 12
A Sequence and Interaction of the Processes - Please review my Process Map ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
insect warfare Please Review my Quality Manual Draft Quality Management System (QMS) Manuals 11
Q Method of Document Management (Control) in Engineering - Please Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Incoming (Receiving) Inspection Procedure - Please Review Supplier Quality Assurance and other Supplier Issues 7
B Please review my QMS Overview Map ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
B Product Realisation Process Map - Need some help, please review and comment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
W Please review and critique our new Document Control Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
M Can anybody help me with Management Review scenario please? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
H Supplier Monthly Performance Score Card - Please Review Document Control Systems, Procedures, Forms and Templates 6
W Cpk, GD&T & Minitab? Please review my methods Capability, Accuracy and Stability - Processes, Machines, etc. 16
A Wolfram Mathematica 8 - Review or Opinions Please Quality Tools, Improvement and Analysis 1
A Development Project Template - Please Review and Critique Design and Development of Products and Processes 3
B 5 Why help needed Please kindly review Problem Solving, Root Cause Fault and Failure Analysis 15
6 Food Safety Objectives - Please Review Food Safety - ISO 22000, HACCP (21 CFR 120) 4
G Uncertainty Calculation in Excel - Please review my calculation General Measurement Device and Calibration Topics 2
J Quality Objective Measureables - Please Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
Colin Simple Preventive Action Procedure - Service Company (Please Review) Preventive Action and Continuous Improvement 20
Y Sample Data Charts (Excel table) - Please review Statistical Analysis Tools, Techniques and SPC 34
J Internal Audit Schedule - Please review my Internal Audit Schedule Internal Auditing 19
S Document Control Procedure Please Review Document Control Systems, Procedures, Forms and Templates 37
J Resume Critique - Please review my resume Career and Occupation Discussions 5
J Management Review "planned interval" define please ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
ScottK Soliciting Feedback for my final Black Belt project -please review my Project Charter Funny Stuff - Jokes and Humour 4
N Please review this Quality Policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Process description template - Please review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
K Risk Management Procedure - Please review AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
N Please review my Quality Policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
K Please Review my Product Realization Map ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
9 ECR (Engineering Change Request) process - Please critique / review Document Control Systems, Procedures, Forms and Templates 10
J Contract Review - Please help me define the requirement 7.2.2 Info needed Contract Review Process 9
M Quality Manual - please review Quality Management System (QMS) Manuals 6
R Please review my process map Process Maps, Process Mapping and Turtle Diagrams 5
W Global Phased PPAP and APQP Training - Please Review and Comment Training - Internal, External, Online and Distance Learning 8
H Please Review my Quality Manual (short manual) Quality Management System (QMS) Manuals 7
M Configuration Management - Please review my procedure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
K Interpretation of 'Breakpoint' in MSA - Please review my data Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1

Similar threads

Top Bottom