Informational Required Documents/Records in ISO 9001:2015

[Big Jim]

ISO 9001:2015 does not require that an organization have documents. The standard requires (referenced 41 times) that the organization maintain "documented information" aka records.

Your information is incomplete. Look at the very first post on this thread and READ THE ISO 9001:2015 STANDARD.

 

[Dogsbody]

After reading......
It appears that as long as everyone knows our processes, we do not need to have anything in writing. I did not see anything that states we need to have processes in writing, although some should be.

Have I missed something?

I think you are right. New standard does not require documented procedures but it will be wise thing to do. Our company has reduced number of Work Instructions in use by replacing them with Process Flow Chart. They are easy to read and understand and key inspect points are highlighted in red .

 

[Big Jim]

I think you are right. New standard does not require documented procedures but it will be wise thing to do. Our company has reduced number of Work Instructions in use by replacing them with Process Flow Chart. They are easy to read and understand and key inspect points are highlighted in red .

You are right. You don't need to have documented procedures. You get to determine if any of your procedures require documentation. However, if you do determine that you need them then they are auditable.

 

[Dogsbody]

You are right BigJim any documents you need are auditable - issue/rev control, approvals, traceability - just like in 2008 standard. Change to process flow chart was major improvement in our business, so much easier and less paper, critical inspect points highlited.

 

[qualprod]

I think you are right. New standard does not require documented procedures but it will be wise thing to do. Our company has reduced number of Work Instructions in use by replacing them with Process Flow Chart. They are easy to read and understand and key inspect points are highlighted in red .

Dogdsbody
When the standards is less restrictive respect to have all documented, doesn´t mean to convert WI´s to flowcharts, it refers that they can be absent.
In my case for 7.1.3 infraestructure, I used to have a procedure for maintenance , additionally some forms to control maintenance, now they have gone. Now when I was audited, I showed only evidences (invoices of suppliers , payments to suppliers, etc.)
All maintenance services are provided by external suppliers.
But .. Sometimes is worth to have documents for some processes.
My two cents.

 

[John Broomfield]

qualprod,

I’ve often wondered why some people over-document their management systems.

After all no system standard has required more documentation than what is necessary for effective control.

Perhaps over-documentation is a symptom of someone “who knows best” sitting in an office writing procedures and work instructions?

Is it better to work with the people involved and listen to them as they show us what is necessary for control?

John

 

[Sidney Vianna]

I’ve often wondered why some people over-document their management systems.

In my experience, there are many reasons, the primary one being the fact that many organizations "outsourced" the responsibility of ISO 9001 compliance and certification to external consultants, who, being paid by the hour or the day, had no shame in overdocumenting the client's system in order to benefit their own bank accounts.

Another reason being in the days of ISO-ignorance, some people kept promoting the much maligned ISO 9001 is "say-what-you-do & do-what-you-say" mantra, which also led to over documenting. Let's not forget the myth also promoted by charlatans that stated that you should document your system to enable a situation where you could lose all of your employees in an afternoon and, the next morning, their replacements could operate the company without a hitch. What a joke...

Over documenting quality systems has been a real problem; almost as nocive as under documenting it.

 

[L.Soad]

Over documenting quality systems has been a real problem; almost as nocive as under documenting it.

How to choose which information to document then? Over documenting is easy, because you try to write all that is done. BAM, easy.
I guess the answers come with your QMS improvement, but when you try to implement a system from scratch (like I’m doing now), it's easy to be lost in the documents you need to have or don't.

I try to think as: is there a risk that it will not be done correctly? If yes = document it.
Does only 1 person know how to do X? If yes = document it.
(EDIT) Also: Is there often a loss of time because this action has been done incorectly, poorly, etc? If yes = document it.

I hope it'll work for the auditors.

Soad

 

[John Broomfield]

Soad,

So, second guessing the auditors?

Here, perhaps, we see the value of becoming a competent (or at least well-trained) auditor before documenting a management system.

As a rule, if you can show that “it works” for your company and it’s customers the auditor will be happy.

John

 

[Sidney Vianna]

How to choose which information to document then?

It should be the result of a risk based determination; complexity of the activity, competence level of the people doing it, degree of automation, need for knowledge preservation and management, etc...

Over documenting is easy, because you try to write all that is done. BAM, easy.

Not easy, because you can never account for all possible scenarios and it will stifle process improvements. Hundreds of procedures, forms, etc it consumes a lot of time, effort, energy, money, etc. to be sustained.

I hope it'll work for the auditors.

That's another mistake; it has to work FOR THE ORGANIZATION and the workforce. Never make decisions on system design based on what (external) auditors would like or want to see.