SBS - The best value in QMS software

Please review my ISO 9001 Quality Manual and Registrar comments

ScottK

Not out of the crisis
Staff member
Super Moderator
#21
Re: Please review my ISO-9001 Quality Manual and Registrar comments

I sent the auditor the support documents.
hopefully this will demonstrate that the QMS is a lot more robust that he seems to think.

Still - it's not right to try to change to the scope of the audit a week prior.
 
Elsmar Forum Sponsor

ScottK

Not out of the crisis
Staff member
Super Moderator
#22
Re: Please review my ISO-9001 Quality Manual and Registrar comments

Hi,
our pleasure joining this discussion.
the manual is brief and incomplete with shortcomings pointed out by many and regisrars final note.
some of the additional notes from our end are as follows
interaction of process to be loud and clear to breed confidence in any one who or runs through /refres your manual.
QMS effectiveness depends on involvement and participation.Quality representative sounds like quality incharge and is viewed as policing person.management representative(QMS) would be right term,in our opinion,if not wrong.
clause references missing(hope it was not preliminary draft)
connectivity,identification,traceability,though not mandatory are the life line for flawless performance and effectiveness.manual does not give clear clue to these.
quality organisation is different than organisational structure-it is unclear how system beeps for effectiveness on continual basis in the complete relisation cycle.
registrars have some times divergent views and expectation from system and manual.but the fact that documentation is a business in black and white,probably QMS 9001:2000 international standards quality requirements needs to be adequate and understandable by the complete supply chain and the all associated with product realisation cyle.
auditable objectives,action plan in place to achieve them and provision to review to upgrade is one of the prominant essense,that may draw your attention during audits.
management review frequency is another bothering factor.any way either before or after the audit-it is once in a year in your case, one gets a feeling that management commitement takes a back seat.
excuse me for frank comments.high regards for the upfront approach with which you have clarified your position.we all wish that QMS in your organisation be more and more effective-a bonaza for the team.
one more angle, though out of the scope of this discussion, is how much your people adore it and their contribution to upgrade , revise or review the connected documents.you will know the best to draw real satisfaction.
system again is not only for them who are in your organisation for pretty long tine but also for them who join fresh and get a message to be serious and committed to your quality objectives.
regards again.progressive post.
appreciation sends a wave of joy but points for improvement builds futture prospects.
Thanks that you are also giving more learning to all of us who participate to your cause.
thanks for your comments.
one note I must point... you (and our auditor) are way off base as far as particiption. That's a poor assumption without reading the procedures and job descriptions. I've got tremendous participation at every level.
how many companies of less than 150 people have 8 trained internal auditors?
And the manual does not state that management review is once a year. It says "periodic". Quality objectives are (re)established annualy but MR can happen more often.
 
C

CliffK

#23
Re: Please review my ISO-9001 Quality Manual and Registrar comments

Hi,
our pleasure joining this discussion.
the manual is brief and incomplete... etc. etc.
:mg:

Please re-read the requirements for a quality manual in element 4.2.2 of ISO 9001:2000.

Feel free to put all of the things you cite into your own quality manual, but don't call a quality manual that lacks them incomplete or say that it has shortcomings, unless your are referring to one or more of: (1)scope, (2)procedures or reference to same or, (3)interaction of processes.

If the manual contains those three things, it is complete according to ISO 9001:2000.

Please, anyone, chime in and tell me of an instance where an employee has told you he's dedicated to quality because the quality manual was so inspiring. Then put me in touch with the author of that document. I'd like to plagiarize it!:cool:
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#24
Re: Please review my ISO-9001 Quality Manual and Registrar comments

Please, anyone, chime in and tell me of an instance where an employee has told you he's dedicated to quality because the quality manual was so inspiring. Then put me in touch with the author of that document. I'd like to plagiarize it!
:agree1:Soon to be published: "Chicken soup for the quality soul.":D
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#25
Re: Please review my ISO-9001 Quality Manual and Registrar comments

now I'm being told we have to reference the likes of ISO10005, 10006, 10007, 10013, 19011, and more in our quality manual.

Aren't these guidances, not standards?

:frust: :frust: :frust: :frust: :frust: :frust: :frust:
 

Stijloor

Staff member
Super Moderator
#26
Re: Please review my ISO-9001 Quality Manual and Registrar comments

now I'm being told we have to reference the likes of ISO10005, 10006, 10007, 10013, 19011, and more in our quality manual.

Aren't these guidances, not standards?

:frust: :frust: :frust: :frust: :frust: :frust: :frust:
ScottK,

Where did that come from? ISO 9001:2000 clearly states what MUST be included.
The rest is up to you. Discussed so many times here on The Cove.

Stijloor.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#27
Re: Please review my ISO-9001 Quality Manual and Registrar comments

ScottK,

Where did that come from? ISO 9001:2000 clearly states what MUST be included.
The rest is up to you. Discussed so many times here on The Cove.

Stijloor.
I'm just sharing my current experience.
 
C

CliffK

#29
Re: Please review my ISO-9001 Quality Manual and Registrar comments

Scott,

Did this come from your new bunch of auditors? It's just bad.

Why are you going through this if you already have ISO 9001 registration? I think you need to find an alternative.

Cliff Kachinske
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#30
Re: Please review my ISO-9001 Quality Manual and Registrar comments

Scott,

Did this come from your new bunch of auditors? It's just bad.

Why are you going through this if you already have ISO 9001 registration? I think you need to find an alternative.

Cliff Kachinske
We're not registered!
Next week is supposed to be the registration audit!

I owe you an mail. I can give you the scoop.
 
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