Context of the Organization-ISO9001:2015

hi Mam am new here and I'd like to ask if you have a sample for clause 4.1 and 4.2 of ISO 9001:2015

 

So, what I have done to cover these practically is ....

For the Context - I have put together a 2016 plan.
It looks at the macro and micro environment of the economy in general and of our industry.
- done a PESTLE and SWOT analyses
- identified interested parties
- described the strategy for the business and substantiated this with budgets for the year.
- looked at my training plan, equipment purchase plan
- set KPIs and objectives for the business including inter alia, turnover, profitability, sales targets, production efficiency targets, reject and rework targets, cost of quality targets, staffing breakdown and service to breakdown targets.
- Looked at utility costs, and set some targets for utility use for the year.

In terms of interested parties -
We have really listed these with a short paragraph on each - (they are picked up in supplier management, customer management, the financials and our legal and regulatory register)
The list includes -
Shareholders
Staff
Customers
Suppliers
Governmental bodies
Regulatory bodies
Financial institutions

This may or may not be how others may see this or reconcile this, but certainly, its the route we are taking.

Hope this adds some value, and welcome to the forum - (I am looking forward to when its the size of the old Cove)

 

The context IS the macro and micro environment. Or to quote yourself -

This leads to the strategy, of which,

Then using both the idea of a good business plan and the requirements of the standard, I discuss the resources required, the planning, the evaluation.

The objectives are set from this plan.

The concept of RBT is excellent IMHO. Let me elaborate
We have been discussing whether or not to continue with a product line.
There is a certain quantum of fall out. The question we then ask is - what is the acceptable level of quality in terms of cost should we proceed with this product. Does the opportunity costs vs return make the product viable. If so, we need to accept that there will be a level of fall out that is commercially acceptable. The QMS measurements and the business plan will need to take this into account.

I am not saying this is particularly correct for every organization or every interpretation possibly, but it is the method I have chosen to follow - in keeping with the notes 1 - 3 in 4.1.

 

Andy, I think you summed it better than anyone could.

within in the requirements of the standard.

 

ie PESTLE analysis and SWOT analysis.

Maybe its me .... but this seems pretty straight forward. No, I think you get it.

 

OK, so I'm finally rolling my sleeves up on analyzing the 2015 standard to determine what changes we need to make to our QMS.

After reading this thread thus far, I'm not sure I know whether I need to change anything. I read section 4.1 and think that if an organization is not doing the things required of section 4.1, it is just working in an ivory tower and is unlikely to be in business long (to say nothing of establishing or continuing ISO 9001 certification). When I ask myself whether we are "determining [and monitoring information about] external and internal issues relevant to [our] purpose and strategic direction", etc., etc., I believe the answer is "yes" as I continually observe our management team and staff engaged in conversations about the types of issues covered in 4.1. How could any organization do otherwise?

But then (as with many of the requirements of the ISO 9001 standard), I am left to wonder how much time and effort I should put into documenting that context given that is constantly changing and not specifically required to be documented. My philosophy is that I don't want to add anything (process, document, record, etc.) to our QMS solely to provide evidence of conformity to the ISO 9001 standard if it is not specifically required and does not otherwise not add value.

Thoughts?

 

Perhaps I should retract the phrase "constantly changing" in favor of the word "dynamic" or perhaps "constantly evolving." If the context of an organization wasn't dynamic, why would we be required to monitor information about it? If the competitive landscape is part of the context of the organization, might that not be dynamic (depending on the industry)? Is it possible that laws governing the products or services produced might change?

Regardless, thanks for suggesting management review as an appropriate place to document.

 

anyone with idea on how to link Context - interested parties expectation - address risk and opportunity?
appreciate if u can recommend tool of each:
Context - PESTLE model?
interested parties expectation -??
address risk and opportunity-??

 

You nailed It!!
This is what Context of the Organization is.
This is what I will use. Very clear concise and to the point!

 

The standard says you have to monitor and review all of these issues.
This looks like a full time job

 

Does it have to be this long.

I think context should be the vision statement.
Only a couple of lines. That's it!
Do we need only to list one or two items as the standard need the organization to monitor and review.
Now there is no definition of monitor or review.
this means we could look at it one and give the thumbs up or down in a meeting and meet the standard
Maybe I am way off base, but I do not think so.

 

The vision statement is usually expressed as a goal, rarely does it encompass the particular environment of the business. I agree it should be short and sweet, but I do not think (most) vision (or mission) statements would really cut it.