Informational "Context of the Organization" in ISO 9001:2015 Clause 4.1

[Jen Kirley]

For a smaller company, I think incorporating this into the management review meeting minutes makes sense.

I think it makes sense with larger organizations too. That would be the group who reviews issues, interested parties etc.

But it's true that this tool was made for smaller organizations, or those who do not have another (or better) idea on how to do it. Overall I am tryinng to encourage people that this does not need to be rocket science. Don't overthink it.

 

[Kronos147]

...I am tryinng to encourage people that this does not need to be rocket science. Don't overthink it.

Me too!

 

[J.Enger]

I still have issues with this clause. Is this looking for a statement, or a list of different items ( as shown in the first few posts of this thread) or a combination of both? I feel like it should be a combination of both with the statement being a broad overview in 4.1 and then a list of the interested parties etc listed in 4.2. Or am i just not understanding this well enough?

 

[J.Enger]

Another thing I see as examples are PEST diagrams but I dont see how that fully describes the requirements of the clauses.

For 4.3 Determining the Scope, I have "This QMS is designed to ensure the manufacturing and assembly of precision aerospace components for commercial aircraft, defense, space, and medical diagnostics and implants are in accordance with all customer, statutory, and regulatory requirements." But again, the more i reread the clauses, i feel like that's not what i should have there.

 

[Jen Kirley]

I still have issues with this clause. Is this looking for a statement, or a list of different items ( as shown in the first few posts of this thread) or a combination of both? I feel like it should be a combination of both with the statement being a broad overview in 4.1 and then a list of the interested parties etc listed in 4.2. Or am i just not understanding this well enough?

There isn't a particular format that is required for this. I made a modified SWOT to list them, it can be included as part of Management Review where issues are to be reviewed.

 

[somashekar]

I still have issues with this clause. Is this looking for a statement, or a list of different items ( as shown in the first few posts of this thread) or a combination of both? I feel like it should be a combination of both with the statement being a broad overview in 4.1 and then a list of the interested parties etc listed in 4.2. Or am i just not understanding this well enough?

Context can also be an interesting true story about your company having reference to interested parties (role players) and your circumstances (the script)

 

[Zearl]

Context can also be an interesting true story about your company having reference to interested parties (role players) and your circumstances (the script)

Sounds like a SWOT first, then based on results write a story for the Quality Manual.
We actually have 2 high levels documents....a QM that has no procedures, just our approach to the QMS, and a QMS Guide, which has level one procedures with a link to the QM. So it would be easy to put the story under CONTEXT OF THE ORGANIZATION AND EXPECTATIONS OF INTERESTED PARTIES, with the key results of the SWOT.

 

[armani]

For Jen Kirley (and Risk based QMS planner template):

I am still struggling to correctly understand ur template....
a). can u please provide a completed one (e.g. for Strategic mgm or Customer service process?
b). how did u determine the 6 risks u are talking about?
c). the 6 risks are actually describing the consequences , I am right? (e.g. loss of records as an effect / consequence of a wrong activity...or loss of records as a cause?)
d). how is high level SWOT related with SWOT for processes? They must be corelated ...how?
Sorry for burdening u, but I really want to understand ur model...seems very interesting!

 

[qpled]

Context can also be an interesting true story about your company having reference to interested parties (role players) and your circumstances (the script)

As a fan of RPG's I like this method a lot and will be using it during my next mgmt review meeting!

 

[howste]

As a fan of RPG's I like this method a lot and will be using it during my next mgmt review meeting!

I hope you mean Role Playing Games and not Rocket-Propelled Grenades! That would be an interesting meeting...