QMS Manual for TS 16949 - Sequence for Writing the QMS Manual

W

William Battles

#1
QMS Manual for TS 16949

I have been in the lerch to prepare a quality manual and the other day it occurred to me (maybe this is not feasible for all), All the info we need is in the
QS 9000 System. Why not pattern our manuals of of the Flow Charts, FMEAS, and Control Plans? We could do our process maps, models etc. and write the quality manual from there. Mind you I haven't got it all figured out, but it helped me put things in perspective. Thoughts, Comments, Criticisms Please!
 
Elsmar Forum Sponsor
S

SteelWoman

#2
William, as I think (it's Friday, what do I know?!) I might have discussed in a previous post, we're going the same route here - moving from QS to TS it occurred to me that TS did NOT require the same kind of "quality manual" per se as QS did - and our TS quality manual will BE the sum of our flow charts, diagrams, few procedures, matrixes, etc. Instead of the traditional element by element, spit it back document that I always found quite useless in QS. (though others have and will disagree with me on that point).

Anyway, that's where we're headed, though note that we ain't there yet! Our "transition" audit is scheduled for April 2004.
 
I

isogirl - 2004

#3
Hey there...I'm new to this site, just arrived today and I'm extremely happy I found it! I have to change our QS over to TS and boy oh boy I have really felt very alone in this ISO world. (No one here wants to deal with this can of worms). It's great to see these discussions going on. I've learned a lot in just a few minutes here.

Now down to business: In mulling over how to layout our Quality Manual, I figured as SteelWoman did...away with the boring, un-efficient element-by-element book that lies in the corner coated with dust. No one reads the darn thing 'til audit time anyway.

Now I just need to convince the implementation team at our 1st meeting next week. I think I will start with sample process flowcharts to get the ball rolling. Do those of you with experience here agree? I need a boost to get going.
 
#4
It's All Here

Welcome to the Cove, Mr. Battles and isogirl. :bigwave:

Try this thread:
TS 16949 Quality Manual

It's rather large (up to 128 posts now) but it contains just about every possible opinion on quality manuals. In addition, there are a number of different style quality manuals available for download (it'll cost you US$25 but it's worth it for download access at the Cove).

Also, read the
Quality Manual Structure thread. 168 posts of very good information. Between the two you should have no problem figuring out what is best for your company.
Good Luck!
 
I

isogirl - 2004

#5
Icy Mountain, thanks for the welcome and the advice. I've found an abundance of information here. I've read through the threads you suggested and downloaded your manuals and a couple of process maps to get ideas from. Now I will try and digest all of this info quickly (our prelim audit is scheduled for Feb. '03) and come up with a plan of my own.

As I work, I will continue to stay logged on, as I have become addicted to the Cove! :)
 
R

Randy Stewart

#6
ISOGIRL,
Welcome first of all.
My suggestion is that you lay it out as an Operations Manual. Here's a hint: start your systems integration process now. Does your company have a 5S initiative? How about ISO 14001 or Safety?
I know, your prelim is Feb. and this seems like a lot of extra work that will take time you don't have. But, if you do this stuff up front, it becomes a useable tool and you'll benefit in the long run.
If you have to, leave your old one in place, just make sure all the "SHALLS" are addressed and start mapping the new one.
We went from a 67 page monster to 12 pages, and it includes all I've mentioned above. Think 1 stop shopping.
 
I

isogirl - 2004

#7
Randy,

Thanks for the welcome and advice. Talk about time I don't have!! As luck would have it :rolleyes: "we" are also implementing ISO 14001. In a mad rush. We lost our Q1 in September because we weren't registered. I am new here as of June and didn't know anything about it until that fateful day. Seems someone dropped the ball somewhere. I've gotten a manual together, gone through the desk audit and on-site review. I am attending 14001 auditor training tomorrow and Friday. Our final registration audit is set for Nov 19th & 20th. Whew!

So, back to the subject at hand: Yes, 14001 will be in place. Someone here suggested the very same thing as you. Keep the old with references and work on the new. That may be the route I'll have to take. I'm getting a headache just thinking about it all.
 
D

Don Wood - 2011

#8
Qm

You DO NOT need to create an element-by-element manual, I actively discourage people from creating them, and it could well be that your auditor, if handed one for TS2, will take it as a sign that you've missed the point of TS2/ISO9K:2K and haven't considered the vastly more important issue of the sequence and interaction of your QMS processes and dig a bit more thoroughly into your QMS than they would otherwise. The manual should reflect how your processes truly operate- nothing more, nothing less. Anything you add over and above that just makes it easier for your auditors to catch you out on a difference between what your manual says and what you actually do.
DW
 
G

Gayle215

#9
I have sugggested referencing our procedures in the manual through a cross-reference matrix. The quality managers don't want to make any reference to any documents but, simply have the process flows. I think the "documents needed by your organization to ensure effective planning, operation and control of processes" would indicate that you have to have something information. Perhaps I'm totally off course.
 
S

SteelWoman

#10
I think I could argue that the "documents needed by the organization to ensure effective" anything is pretty much up to the organization. If you can run a facility on all flow charts or only control plans or only notes scribbled on the bathroom wall, if you can demonstrate that your organization can run effectively on that, then so be it.
 
Thread starter Similar threads Forum Replies Date
S Seeking: Example TS 16949 QMS (Quality Management System) Manual Quality Management System (QMS) Manuals 1
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
V Looking for a consolidated Manual for QMS, FSMS and Environmental system Food Safety - ISO 22000, HACCP (21 CFR 120) 1
alonFAI Update an existing QMS manual or write a new one for AS9100C Certification? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
F Process Maps as a complete QMS Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Quality Manual - Description of the Interaction between Processes of the QMS ISO 13485:2016 - Medical Device Quality Management Systems 27
M ISO 9001 QMS Manual and Procedures for Laboratory wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Shared Processes - How do I reflect them in my QMS Procedures and Manual? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
L Developing a QMS Manual for AS9100 and ISO 9001 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
F Must the AS9100C quality manual contain the procedures and QMS documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
B Writing a QMS Manual for our FAA 145 Repair Station AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
T Language Translations or Services QMS manual template Quality Management System (QMS) Manuals 6
A Integrated Management System QMS, EMS & OHSAS Manual Occupational Health & Safety Management Standards 12
W ISO 13485, ISO 9001, and AS9100 Combined QMS Manual Quality Management System (QMS) Manuals 14
T Upgrading of QMS from ISO 9001 to ISO 13485 - Quality Manual Revision ISO 13485:2016 - Medical Device Quality Management Systems 5
K QMS Manual Format and some more help - Oil field company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
F Should I remove references to AS9120 / ISO 9001 from my Quality Manual and QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
J Looking for stand-alone QMS manual & procedures for ISO 14001 as a guidance document. Document Control Systems, Procedures, Forms and Templates 8
Q Writing a QMS (Quality Management System) Manual from Scratch Quality Management System (QMS) Manuals 2
S Please review my small company automotive manufacturer QMS Manual Quality Management System (QMS) Manuals 3
K Recommendations on Re-Write of Quality (QMS) Manual Quality Management System (QMS) Manuals 17
Q Inclusion of company safety manual and procedures in QMS Document Control Systems, Procedures, Forms and Templates 8
T TS16949 QMS Manual - Quality Systems Manual example or template Quality Management System (QMS) Manuals 25
K Quality Manual Review - Please Review my QMS Manual and Comment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
C API Q1 Quality Manual Example - Trying to convert an existing ISO 9001 QMS Oil and Gas Industry Standards and Regulations 30
R New QMS Manual - Service Company - Seeking Review and Comments Service Industry Specific Topics 0
rvin59 OHSAS 18001 - QMS - EMS Combined Manual Structure help Occupational Health & Safety Management Standards 5
C Medical Device QMS manual - MDD, AIMD, 21 CFR part 820, CMDCS, and the new ISO 13485 Quality Management System (QMS) Manuals 3
H My Quality Management Systems (QMS) Manual - Please review - Opinions appreciated! Quality Management System (QMS) Manuals 14
Q Can Exclusions be Made in QMS Manual - We make NO implantable devices Quality Management System (QMS) Manuals 1
M Structuring an ISO 9001:2000 QMS Manual Quality Management System (QMS) Manuals 3
C Combined QMS (Quality Management Systems) Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R ISO 9001:2000 vs. QS 9000 Quality (QMS - aka QM) Manual Quality Management System (QMS) Manuals 6
D How do you structure your QA (QMS) Manual? A Historical Discussion Quality Management System (QMS) Manuals 51
D QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to Do? Quality Management System (QMS) Manuals 455
D Offsite storage of QMS documents ISO 13485:2016 - Medical Device Quality Management Systems 9
L Exemption from the Regulation COVID-19 and QMS requirements EU Medical Device Regulations 2
DuncanGibbons Model-Based procedures and Architecting the QMS as a System Document Control Systems, Procedures, Forms and Templates 2
SocalSurfer Can you recommend an enterprise QMS for new AS9100 startup AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
H Expanding our business and the implications to our QMS Manufacturing and Related Processes 2
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
M QMS for a repair/servicing company ISO 13485:2016 - Medical Device Quality Management Systems 2
A Is there a better way to do a complete assessment of our QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
qualprod Managing a "special" customer into the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q AS9100:2016 D - Intent of 8.4.3 (K) - Implement QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
qualprod From paper to Electronic (records) in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A QMS Overhaul - Reorganizing and Renaming Documents - Internal References Document Control Systems, Procedures, Forms and Templates 18
qualprod Documented actions and changes in the QMS by COVID 19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
DuncanGibbons Enterprise Architecture for QMS Conceptualization AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3

Similar threads

Top Bottom