What does "effective implementation of quality management system" mean?

jelly1921

Quite Involved in Discussions
#1
7.1.2 People

The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.

What activities effective implementation of its quality management system include? Does not it include the operation and control of its processes?

Thanks

Jelly
 
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BoardGuy

Quite Involved in Discussions
#2
Re: implementation of QMS not include the operation and control of its processes?

[FONT=&quot]Just a new requirement to remind management that it has to “provide persons necessary for effective implementation of QMS” and “operation and control” of its processes.[/FONT]
 
J

Julie O

#3
Like BoardGuy, I'm not sure they really meant anything very substantive when they wrote it. I can see it being interpreted a number of different ways. How are you interpreting "its" in "the operation and control of its processes"?

I think the QMS has been implemented when the procedures have been written and the appropriate personnel have been trained on them. I think whether it has been effectively implemented could be another question, one that might be answered from more than one perspective.
 
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Colin

Quite Involved in Discussions
#4
The 'effective implementation' of the system has been a requirement of the internal audit clause for a long time.

An organisation could have a management system which technically meets the requirements of the standard but in practice, it brings no benefit to the organisation. Usually this comes about when someone has imported a system form another company or the system was written without the involvement of those who actually perform the tasks.

This is reason to make sure that the system is properly implemented when it has been developed, not just emailed to 'all @'.

Anyone can write a good looking system which addresses all of the clauses of the standard but if it doesn't reflect what really happens, it lacks credibility.
 

howste

Thaumaturge
Super Moderator
#5
From the ISO 9000:2015 definition:
effectiveness
extent to which planned activities are realized and planned results are achieved
It seems there are two parts:
1) Did you do what you planned?
2) Did you achieve the results you wanted?

I tend to focus more on the second part - the results. Again, going to a definition in ISO 9000:2015...
objective
result to be achieved

Note 1 to entry: An objective can be strategic, tactical, or operational.
Note 2 to entry: Objectives can relate to different disciplines (such as financial, health and safety, and environmental objectives) and can apply at different levels (such as strategic, organization-wide, project, product and process).
Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended outcome, a purpose, an operational criterion, as a quality objective or by the use of other words with similar meaning (e.g. aim, goal, or target).
Note 4 to entry: In the context of quality management systems quality objectives are set by the organization, consistent with the quality policy, to achieve specific results.
As part of our QMS 9001:2015 requires that we establish objectives, in other words we establish goals and targets. This is done at various functions, levels, and processes in the QMS (6.2). We establish metrics and monitor, measure, analyze, and evaluate the results (9.1.1a&b). Internal audits look for effectiveness (9.2.1b), so they should be looking at process metrics. Top Management reviews information about the objectives (clause 9.3.2C2) to determine if the QMS is effective.

The short answer to the question is, we establish quality objectives (targets and goals) for our QMS processes and we regularly evaluate these. If we did what we planned and met the goals, our QMS is effective. If not, we take actions to improve.
 

jelly1921

Quite Involved in Discussions
#6
As I understand:
As the process approach, QMS is formed by the processes. If the processes run well, then QMS could be implemented effectively. In other words, if the QMS is NOT implemented effectively, then it must imply some of processes run not well. IF we want to make QMS gets intended results, we must control the processes.
When we setup objectives, we usually set the targets on the processes, goals on QMS. The goals on QMS are achieved by achieving the targets of the processes.
So, the effective implementation of its quality management system is the purpose, "The organization shall determine and provide the persons necessary for the operation and control of its processes" is the way to achieve this purpose. Therefore, The organization shall determine and provide the persons necessary for the operation and control of its processes to ensure its quality management system implemented effectively is make sense.

But the standard does request in that way.

I don't know why.
 

howste

Thaumaturge
Super Moderator
#7
Therefore, The organization shall determine and provide the persons necessary for the operation and control of its processes to ensure its quality management system implemented effectively is make sense.

But the standard does request in that way.

I don't know why.
You want them to specify cause and effect. I tend to agree that effective processes lead to an effective QMS. But the standard writers didn't write it that way. I suppose it's possible to have processes which individually look effective (meet process goals), but do not work together to achieve organization effectiveness (process goals conflict with each other or don't contribute to organizational goals). Maybe this is why they wrote it the way they did - to ensure that both the processes and QMS as a whole are effective.
 

Paul Simpson

Trusted Information Resource
#8
7.1.2 People

The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.

What activities effective implementation of its quality management system include? Does not it include the operation and control of its processes?

Thanks

Jelly
As others have noted 7.1.2 is a general catch all question and follows on from the requirement for top management to provide resources (5.1 e).

All 7.1.1 - 7.1.6 (including 7.1.2 for people) do is break the general obligation down into a few specific areas of 'resource' and, in the case of people the detail about people is covered in clause 7.2. (and touched on in a couple of other clauses).
 
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