Processes required for the Quality Management System (QMS)

[Lorenzo36]

First of all, I want to thank all of you for input.

The management team is not suggesting that we have procedures for every process; the concern is whether it’s an ISO requirement, once we identify QMS processes. We obviously do not want non-value added activities in any of our process, including creating procedures that we may not need. For instance, management doesn’t feel the need to create procedures for HR or Accounting which are support processes; in our assessment we determined that over the years these two have functioned without any issues. We do know, however, that certain procedures are required (6) by ISO, i.e. Control of Doc, Control of Records, etc, etc (all implemented). In addition, we also know we should standardize some of our other Key Processes, which we have (Supplier Management, Receiving, Manufacturing, Design, Contract Review and Shipping – to name a few).

I've read the ISO 9001:2008 standard (and ISO 9000:2005 QMS Fundamental and Vocabulary), and I cannot find any requirements to help us make a well informed decision related to our problem.

So, again, if we identify HR and Accounting as a support process in our diagram (or Chart - QUALITY MANAGMEMT SYSTEM PROCESS), should we have procedures for those two? If yes, then procedures will be created. If no, then great!

Your thoughts?

[insect warfare]

As long as they have functioned without any issues, I would say then that you already seem to have it well under control.

Brian

[AndyN]

In Reply to Parent Post by Lorenzo36

First of all, I want to thank all of you for input.

The management team is not suggesting that we have procedures for every process; the concern is whether it’s an ISO requirement, once we identify QMS processes. We obviously do not want non-value added activities in any of our process, including creating procedures that we may not need. For instance, management doesn’t feel the need to create procedures for HR or Accounting which are support processes; in our assessment we determined that over the years these two have functioned without any issues. We do know, however, that certain procedures are required (6) by ISO, i.e. Control of Doc, Control of Records, etc, etc (all implemented). In addition, we also know we should standardize some of our other Key Processes, which we have (Supplier Management, Receiving, Manufacturing, Design, Contract Review and Shipping – to name a few).

I've read the ISO 9001:2008 standard (and ISO 9000:2005 QMS Fundamental and Vocabulary), and I cannot find any requirements to help us make a well informed decision related to our problem.

So, again, if we identify HR and Accounting as a support process in our diagram (or Chart - QUALITY MANAGMEMT SYSTEM PROCESS), should we have procedures for those two? If yes, then procedures will be created. If no, then great!

Your thoughts?

Do either of these processes affect customers' satisfaction? Do they affect your organization's ability to have product made to the customers' satisfaction or without adversely affecting you internally?

Once again, it's not a case of what we think, yes or no, it's up to your team to consider the impact and risk of not having these processes (not departments which is how you have put it to us) effectively supporting the core processes...

[Sidney Vianna]

In Reply to Parent Post by Lorenzo36

So, again, if we identify HR and Accounting as a support process in our diagram (or Chart - QUALITY MANAGMEMT SYSTEM PROCESS), should we have procedures for those two?

Lorenzo, if you want a clear answer, you must ask a direct and properly worded question.

If you are asking if ISO 9001:2008 requires you to have a documented procedure describing the support processes, now identified in your diagram, the answer is a CLEAR NO.

But, as others have extensively explained, only your organization can answer the question if a documented procedure should be developed to assist in controlling processes (support, core or otherwise).

[insect warfare]

Hi Lorenzo,

Use what Andy said about the risk and impact of not documenting these processes, and evaluate it against the factors that I quoted from ISO TR 10013 in post #8 of this thread, and this should make for easier decision-making on the part of your management team.

Brian

[ssz102]

these support process and management process had definited, so you sholud be develop some work instructions for these process to all of employee understand them requirements or needs

[AndyN]

In Reply to Parent Post by ssz102

these support process and management process had definited, so you sholud be develop some work instructions for these process to all of employee understand them requirements or needs

It is not required for all employees to know all processes and neither is it necessary or required to create work instructions to achieve this. It is management's responsibility to decide what and how to document their processes.

[JaneB]

In Reply to Parent Post by Lorenzo36

I've read the ISO 9001:2008 standard (and ISO 9000:2005 QMS Fundamental and Vocabulary), and I cannot find any requirements to help us make a well informed decision related to our problem.

I feel for you - that's one of the most common difficult points that people with limited exposure to ISO 9001 across a range of implementations can find immensely hard to figure out. It may be that you are not fully appreciating that it's a generic Standard (ISO 9001) in contrast with the vast majority of Standards which are both prescriptive and specific.

9001 says what you must do, but doesn't prescribe how.

In this case (as with others) the criteria for making that 'well informed decision' need to come from you (not the Standard).

It just says you need (besides the other parts in clause 4.2.1 which I assume you can read as well as anyone:

documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes

OK, 'necessary' is a broad term. I get that. But it is also powerful, in that it puts the power and the responsibility in your hands (which is where it ought to be) to decide.

Just as an illustration, what's necessary in, say, a 5-person company selling recycled plastics to China isn't going to be the same as what's necessary in, say, a multinational, global accounting business.

Bottom line: there isn't a single, simple answer. Nor a single, set of clear criteria. Your company: you decide. (Provided of course you meet the mininum stipulated requirements)