Minimal Documentation Method & 4.2

QC-Mike

Registered
At my previous employer (mfg) a mentor/consultant helped me successfully implement ISO 9001:2015 into a non existent QMS. He assisted with authoring our QMS manual with the intent of having minimal documentation outside of the required documented information (it worked). He explained that alot of the procedures and ways of satisfying ISO standards were written into the manual. I am now at a larger company and they have asked me to implement ISO into their system as well. I understand that I can’t implement ISO in the same exact way however I have ran into 2 issues that I can’t figure out based on my previous experiences…I’m having a hard time zooming out and implementing when there is already a complex list of documented procedures and systems.

Do I need to reference stand alone procedures within the manual when they satisfy a clause but are too complex to incorporate? If so how would I simply reference them within the manual?
I would to incorporate as much as I can into the manual to show compliance with the standard in the same format as the standard itself but I am aware of when I can’t.

Previously I was instructed to list specific critical customers by name along with some specific requirements under the customer related clause in 4.2 regarding interested parties and their requirements. Do I have to get specific about customers down to providing their names and 5-10 specific requirements (C of A required, Vendor quality manual specifics, Change Notice Requirements, etc) or can I simply state “customers” and state what they may require as a whole?
 
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Big Jim

Admin
To start with a quality manual is no longer required. It was is the iterations before the 2015 version. When that was presented when the 2015 version was being introduced the head of the committee responsible for writing the standard stated that most companies would still have one.

When a manual was required there were three things that had to be in it. A description of the interaction of processes (IOP), the scope statement with justification for any exclusions, and either the written procedures or a reference of the written procedures.

It was most common for the procedures to be in a separate manual but many time they were included in the manual.

At that time, there were six topics that were required to have written procedures. Control of documents, control of records, internal audit, control of nonconforming product, corrective actions, and preventive actions.

Currently there is no requirement to have any written procedures.

Of course, back then as well as now, an organization is permitted to have as many written procedures as they feel they need to have an effective quality management system.

If you read through the standard you will find where you need to keep documents and records. Pay attention to the actual language though. What were once referred to as documents are now know as maintained documented information and what was once know as records are now known as retained documented information.

A quality management system with minimal documentation would be one that only uses the documents and records required by the standard. You may choose to have more if you see benefit to doing so.

Generally speaking, the larger the organization the more you will find you need to keep the enterprise under control.

One last little tidbit. The 2015 version realigned the numbering system of the requirements. Documents and records are no longer in element 4.2. They are now in element 7.5.

I would suggest you obtain a copy of ISO 9001:2015, and as an aid with example of how met, a copy of ISO 9002:2016. Getting aquainted with both of them should help you tremendously.
 

Randy

Super Moderator
Here's what Jim was referencing about the "old" manual that's no longer required, but, if you follow this as a checklist so to speak you'll be OK, olny 10,000 others have done so already (I made up the number)

ISO 9001:2008
4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions
b) the documented procedures established for the quality management system, or reference to them, and

c) a description of the interaction between the processes of the quality management system.
 

qualitymanagerTT

Involved In Discussions
...

Previously I was instructed to list specific critical customers by name along with some specific requirements under the customer related clause in 4.2 regarding interested parties and their requirements. Do I have to get specific about customers down to providing their names and 5-10 specific requirements (C of A required, Vendor quality manual specifics, Change Notice Requirements, etc) or can I simply state “customers” and state what they may require as a whole?

It depends on the complexity of the requirements of various customers - if you can catch all of them with a short list, then go ahead (and remember to update the Q Manual whenever those requirements change). If there are complex, differing requirements then I'd suggest referencing (e.g., see document "Customer Requirements" for each customer).
 

Big Jim

Admin
A little explanation about what element 4.2 says and what it doesn't say.

It says you need to determine who your interested parties are and what their requirements are.

It DOES NOT say that you need to document that. There is no requirement about documented information attached to 4.2.

I strongly recommend that you obtain a copy of ISO 9002:2016, which is a guidance document on how to set up a quality management system to meet ISO 9001:2015. Then review what it says about element 4.2. An exhaustive list of potential interested parties is presented there. If I remember correctly some 18 different categories are mentioned. Many of them overlap and most certainly not all are needed for any oe company. I usually see a list of about four or five.

Customers would be one of the categories. You DO NOT need to list all of your customers and provide details about them.

Someone is just making things harder than is required.
 

John Broomfield

Leader
Super Moderator
implement ISO 9001:2015 into a non existent QMS

If the company is already satisfying its customers chances are that it already works as a system conforming to most if not all the requirements of ISO 9001.

That is the most important take away. Instead of studying what the organization already does to understand and fulfill requirements many of us tend to write a procedure based on what is specified by a clause in ISO 9001.

Is that why we keep saying “implement ISO 9001”?
 
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