Separate Document Listing the whole of QMS Documents

Hello to all!

This is just my first post in this forum. I find it really nice to be in a place where one can share thoughts on ISO standard.

So, just a query to start with. It is more o less known that version 2015 of ISO 9001 is much more flexible in it's requirements on documentation in comparison with it's predecessors, right? However, specifically with regard to retaining a document in which the whole of all QMS documents and records will be listed, in a form of a simple table:

1. PMS 1.1
2. PMS 1.2
...
3. RMS 1.1
4. RMS 1.2
...
Where PMS "Procedure of Management System", and RMS "Record of Management System", and practically, all other possible documentation of the QMS which could be included, would you think it would be mandatory?
I really can't find a clause affirming that, but neither I am 100% sure about it.

Thank you in advance.

 

No. It's not mandatory. It can add value though. The list can be used as a quick reference if you need to know if you are using the current versions of documents. Typically, the list will include the document revision levels.

 

Jennifer,

I, like Andy, also inherited a QMS, which was documented before 2008 by a 3rd party entity and had resulted in a totally bureaucratic system; you could even call it repelling. Theses days, I am striving to start it from zero, optimally adjust it on the needs of the company, make it functional and have it offer added value, being currently on the way to making a decent QMS manual. The said document of all controlled documents (please open https://www.dropbox.com/s/t3rzrmpxpatdk7f/Capture.JPG?dl=0
for a more precise glimpse on it), numbers 32 procedures, 64 Records, 53 Work Instructions, a great part of which have proven to be meaningful or useless. All documents in the QMS file system keep the same naming format, i.e. "PQM11 Management Planning Procedure".
That being said, I am glad that standard's 2015 version give that freedom to document the QMS as best suits our needs.

All in all, I think you all agree that there is no meaning retaining it.

 

Hi

We have an electronic QMS, each page is titled but the system controls the versions. Our project quality plans all state that the project will follow the latest version of any process or procedure on the QMS unless otherwise stated. What we do have is a table with the sections of the standard on the left side of a table with the relevant QMS processes or procedures that when followed show we are compliant with that particular section of the standard. Auditors seem to like this and if they raise something against a particular section it is easy to find what we say we do to comply.

 

I think people are not interested whether this document (number) is instruction and other one form.
On the other hand, even process approach is a very old story, people still are not familiar with that.
Therefore I will change document numbering to stick it directly to process.
Documents are prepared and used by various departments, but sometimes these are parts of a same single process.

 

Good day Andy/all;
From my many years (22) at numerous levels within 1st tier automotive manufacturing (quality tech --> VP of operations) I have seen numerous methods of management system structure and have an opinion.

In a dynamic organization we must remember my "CAP" reference...
* Customers
* Associates
* Products

The organization can (likely will) periodically change "CAPs", and, therefore it will help if the management system is structured to endure these changes.

The most frequent/obvious change that takes place is "A" (Associates). It is for this reason that I do indeed recommend a numbering structure.
Without it, local vernaculars, various dialect, tribal knowledge, colloquialisms, "company-ees", etc.. can and do quickly arise, which, over time, can cause confusion, particularly for new associates (e.g. how many times do each of us continue to hear a management system referred to as "QS9000" or an ERP system referred to
"the AS 400" when it long since changed to SAP, or a part referred to as "a banana clip" simply because of its shape, and contrary to the name on the drawing, customer orders, etc., etc..etc..).

My experience is that...
a) any "upper" level procedure (who-what-when) documentation be limited but be numbered according to the activity, clause, or "group" that they apply to.

b) any instruction point of work level (how) documentation simply be numbered generically and sequentially (e.g. wi-0001; wi-0002; etc..etc...)

c) any record keeping forms (evidence) documentation simply be numbered generically and sequentially (e.g. F-0001; F-0002, etc..etc...).

This ensures that what one individual refers to as the "how to label" instruction which someone else calls "lot control instruction" and others call "bar code instruction" is all able to be identified by a discrete assigned identifier. Another example would be "how to measure height", when indeed there may be numerous documents/curriculum [applicable to some organizations] where "how to measure height" may have various meanings and applications depending on WHAT is being measured. As you can see, confusion can easily occur.

Providing a discrete identifier also makes it easy to consistently reference these items on controls plans (or other documents) when they are indeed part of applied controls such as "evaluation method" or "control method" or "reaction plan" . The same applies for the training process, wherein, it is helpful for certain curriculums to be associated with company roles to ensure that as new individuals move into these roles A discrete identifier ensures it is clear what documentation applies.

Large organizations are a great model (SAE, ASTM ,Toyota, GM, etc..etc..), where obviously lack of discrete identification of controlled would be difficult at best.

The important thing to remember is that the author(s) of the management system will not always be with the organization. It is necessary, therefore, to use terms of identification that will outlive them when the organization changes its "CAP".

Be well.