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Sequence of ISO 9001:2015 Implementation Steps

#1
Hi,

For the ISO 9001:2015 implementation is it doable to implement (run awareness and start documenting) in parts or should implementation start at the end of document completion?

There is a couple of different views within the organization I work with so I would appreciate the help.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Hi,

For the ISO 9001:2015 implementation is it doable to implement (run awareness and start documenting) in parts or should implementation start at the end of document completion?

There is a couple of different views within the organization I work with so I would appreciate the help.
Hello NASHII, I am confused with your question.

It is reasonable to view implementation as a series of steps. It makes sense to document the steps as you go, but I don't know of anyone who expects to have everything documented until the process has been determined to be set and, ideally, capable. In my view, for example it is perfectly okay to record competencies for the process steps before the process outcomes, and material qualifications and process/inspection equipment qualification/calibration might well occur before then.

So as you can see, documentation should logically be done as the activities are accomplished. When the process comes on line we can expect all of the associated documentation to be in place.

I hope this helps!
 
#3
Hello NASHII, I am confused with your question.

It is reasonable to view implementation as a series of steps. It makes sense to document the steps as you go, but I don't know of anyone who expects to have everything documented until the process has been determined to be set and, ideally, capable. In my view, for example it is perfectly okay to record competencies for the process steps before the process outcomes, and material qualifications and process/inspection equipment qualification/calibration might well occur before then.

So as you can see, documentation should logically be done as the activities are accomplished. When the process comes on line we can expect all of the associated documentation to be in place.

I hope this helps!
Thank you Jen.
Yes it does help and yes the question is a bit...off.

I am working with fairly new people to the standard and currently it is being driven to seem like we need to be rolling out documentation and getting competencies at the end of capturing all our processes in correct documentation.. When we should start implementing processes as we go.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Thank you Jen.
Yes it does help and yes the question is a bit...off.

I am working with fairly new people to the standard and currently it is being driven to seem like we need to be rolling out documentation and getting competencies at the end of capturing all our processes in correct documentation.. When we should start implementing processes as we go.
Thank you Jen.
Yes it does help and yes the question is a bit...off.

I am working with fairly new people to the standard and currently it is being driven to seem like we need to be rolling out documentation and getting competencies at the end of capturing all our processes in correct documentation.. When we should start implementing processes as we go.
Hello NASHII, I am relieved to not have totally misunderstood your question.

In my view it is not reasonable to expect this or that documentation at a particular stage of a process implementation, except of course the end. Let us consider evidence of competencies: there are competencies for process operators, maintenance and equipment/instrument calibration staff, which would be very reasonably expected to be recorded at different times of process implementation. The only reasonable expectation is that persons working in/in support of that process are documented as qualified at the time they perform their particular duties. The same works for equipment, materials and so on.

I welcome any and all Covers to add to this discussion as it is possible I have not considered any important perspective.
 

mattador78

Quite Involved in Discussions
#6
Hello NASHII, I am relieved to not have totally misunderstood your question.

In my view it is not reasonable to expect this or that documentation at a particular stage of a process implementation, except of course the end. Let us consider evidence of competencies: there are competencies for process operators, maintenance and equipment/instrument calibration staff, which would be very reasonably expected to be recorded at different times of process implementation. The only reasonable expectation is that persons working in/in support of that process are documented as qualified at the time they perform their particular duties. The same works for equipment, materials and so on.

I welcome any and all Covers to add to this discussion as it is possible I have not considered any important perspective.
For our AS9100 implementation that's exactly what we did built the system up until we were happy it was ready and then ran it looked for the breaks, fixed them and away we went with approval. As with all things you have to start it at some point and if anyone tells me they started it perfectly i don't think I'd believe them. You think its perfect until someone finds a hole without looking for it, that was what we found more often than not. i think sometimes you can look at standards or requirements and think that you have to be doing that perfectly straight away instead of figuring out how your company or staff need to do it to get the job done.
 

Pancho

wikineer
Super Moderator
#7
Hi,

For the ISO 9001:2015 implementation is it doable to implement (run awareness and start documenting) in parts or should implementation start at the end of document completion?

There is a couple of different views within the organization I work with so I would appreciate the help.
Seini1, further to Jen's good comments, I suggest you see it this way:

Your company already has a QMS in place, else it wouldn't be in business. Your company's QMS is not compliant with the standard, and it is not documented, and it doesn't work as you'd like. But it exists. In this perspective, there is no question of implementation. What you're doing is documenting and improving, and at some point in this quest, your system will be compliant with the standard.

The funny thing is that as part of this quest, you'll create a continuous improvement process. With this process, if it works, there is never an "end of document completion". A compliant QMS is always improving, and most such improvements will be documented. So, yes, implement improvements as soon as practical. Once you close all your gaps with a compliant system in all your processes, you'll get a certificate, and you'll be well on your way to Quality.
 
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