Processes required for the Quality Management System (QMS)

L

Lorenzo36

#1
We are registered to ISO 9001:2008, and during a recent QMS audit, our company was issued a finding related to 4.1(a) – determine the processes needed for the QMS. Accordingly to the auditor, some of our SUPPORT PROCESSES, i.e. Human Resources, were not clearly defined within our QMS. We corrected this by implementing a new diagram (or chart) identifying KEY PRODUCTION PROCESSES, SUPPORT PROCESSES and MANAGEMENT PROCESSES. This will suffice to correct the finding.

However, it raised other questions from our Management Team. For example, now that we’ve identified the support process, such as HR, Information Technology, Accounting – do we need to have procedures/instructions for each of those processes? Another example, for management processes, we included our annual Management Review – do we need a procedure for this as well? For the examples I mention we currently do not have procedures and instruction. Do we need procedures for each and every process identified in the new chart we’ve created?

Any thoughts / comments are greatly appreciated.
 
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C

Chance

#2
Re: Processes need for the Quality Management System

There is no requirement written in the ISO 9001 standard that requires you to document HR, IT and Accounting processes. But I am sure you guys have these processes set up and running. It is just not documented. If not, how do you operate then?

For Management review, the standard requires you to have it done in a regular basis. There are inputs required to it. Please read the standard. As long as you document what the inputs are and document the outcome as well, you should be okay. For us, we have created a procedure for clarity of what and who is going to present what during the Management Review meeting.
Hope this helps.
 

somashekar

Staff member
Super Moderator
#3
Re: Processes need for the Quality Management System

Look at your business processes and map them to the ISO9001 standards requirements. Ensure that all the requirements as stated in the standard have a mapping from your business process, as the ISO9001 requirements are the most common sense and PDCA oriented, sequentially placed steps to an organization's operations, management and continued maintenance.
All of your processes will be having a procedure (the way that process is executed)
The only question that you have to answer is....
Are these procedures well understood and performed consistently by all the associated personnel ?
If yes, you have a procedure that stands justified to meet your requirement.
If no, you will have to document it and control it in order to meet your requirement.
Where the standard demands a documented procedure, you will have them.
For the rest you will determine if you want them based on your own levels of maturity.
 

insect warfare

QA=Question Authority
Trusted Information Resource
#4
Re: Processes need for the Quality Management System

The answer to your question is posed by another - does your management team think that having a procedure for Management Review will add value somehow (please note that ISO 9001 paragraph 5.6.1 does require Management Review records...)?

If so, document accordingly...but don't complicate things just for the heck of it, and certainly don't do it for the auditor's sake...:nope:. There are many documentation horror stories out there that laughably resemble snowballs coming down the mountain, and for them it usually started with an innocent assumption that non-value added documents are somehow necessary.

The documentation requirements for ISO 9001:2008 are clearly defined in section 4.2.1 (they are just expanded on in the rest of section 4). Read it again, free the clutter from your mind, and you will see the forest for the trees...believe it.

Hope I've Helped...:rolleyes:
Brian
 
#5
We can't tell you if you need a documented process or procedure - your organization has to decide!

Points to consider are - if a key player (process owner) is not available, how does anyone else know how to do that process? With many organizations facing retirement of their aging workforce, it's a good opportunity to ensure knowledge retention, too.

If a process isn't operated consistently across affected personnel is another reason to document something, too.
 
#6
Re: Processes need for the Quality Management System

The answer to your question is posed by another - does your management team think that having a procedure for Management Review will add value somehow
Brian: Good points, but often directly asking management isn't a good thing - it could be like asking someone if they need to wear a seat belt while driving in a car! If they look at past performance, they will say NO! If they understand risk/consequences of not doing something. When a question is asked, the answer should come in terms of their understanding of risk. So, just maybe, there's a different question to be asked first.
 
C

Chance

#7
Re: Processes need for the Quality Management System

Brian: Good points, but often directly asking management isn't a good thing - it could be like asking someone if they need to wear a seat belt while driving in a car! If they look at past performance, they will say NO! If they understand risk/consequences of not doing something. When a question is asked, the answer should come in terms of their understanding of risk. So, just maybe, there's a different question to be asked first.
Perhaps identify the risks and present to Management and see what their inputs are.
 

insect warfare

QA=Question Authority
Trusted Information Resource
#8
True Andy, very true...

And then I just remembered this from ISO TR 10013 (Guidelines for QMS Documentation) section 4.2:

The purposes and benefits of having quality management system documentation for an organization include, but
are not limited to, the following:
a) describing the quality management system of the organization;
b) providing information for cross-functional groups so that they may better understand interrelationships;
c) communicating to employees managements commitment to quality;
d) helping employees to understand their role within the organization, thus giving them an increased sense of purpose and importance of their work;
e) providing mutual understanding between employees and management;
f) providing a basis for expectations of work performance;
g) stating how things are to be done in order to achieve specified requirements;

h) providing objective evidence that specified requirements have been achieved;
i) providing a clear, efficient framework of operation;
j) providing a basis for training new employees and periodic re-training of current employees;
k) providing a basis for order and balance within the organization;
l) providing consistency in operations based on documented processes;
m) providing a basis for continual improvement;
n) providing customer confidence based on documented systems;
o) demonstrating to interested parties the capabilities within the organization;
p) providing a clear framework of requirements for suppliers;
q) providing a basis for auditing the quality management system;

r) providing a basis for evaluating the effectiveness and continuing suitability of the quality management system.

Any one of these can become a reason to document something...
So, it can basically come down to how it will benefit your organization...

Hope I've Helped...:rolleyes:
Brian

 
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L

Lorenzo36

#9
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?
 
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