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Required Documents/Records in ISO 9001:2015
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Required Documents/Records in ISO 9001:2015
Required Documents/Records in ISO 9001:2015
Required Documents/Records in ISO 9001:2015
Required Documents/Records in ISO 9001:2015
Required Documents/Records in ISO 9001:2015
Required Documents/Records in ISO 9001:2015
Required Documents/Records in ISO 9001:2015
Required Documents/Records in ISO 9001:2015
Required Documents/Records in ISO 9001:2015
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iso 9001:2015, required documents, required procedures, required records
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  Post Number #9  
Old 3rd February 2014, 06:22 PM
kat

 
 
Total Posts: 3
Re: Required Documents/Records in ISO 9001:2015

Back when TS16949 made the change from all the required procedures to the 7 - it was an opportunity to change to more process owner and practical oriented "procedures" and system. In other words, we tore the old system down and kept only the part that was needed and relevant.
It sounds like the change to the "new ISO9001-2015" may be an opportunity to do the same. With my recent change, I have inherited a system that is dis-jointed and the majority of the people still look at any ISO as "let's open the box and see what we have to do to meet the requirements". "OK, that's done put it away until it is time again." ISO9001 (and 14001) are not a part of the operating business, they are lines to be checked. So it looks like I may be able to use the new issue to help the culture and mind shift I am working on here.
Thanks to kat for your informative Post and/or Attachment!

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  Post Number #10  
Old 3rd February 2014, 08:14 PM
John Broomfield's Avatar
John Broomfield

 
 
Total Posts: 2,461
Lightbulb Re: Required Documents/Records in ISO 9001:2015

Quote:
In Reply to Parent Post by drgnrider View Post

After reading through CD-ISO-9001, unless I am missing something, these are all that I see that will be required:

what we currently refer to as documents:
- [4.3] Scope & justifications for exclusions (limited to 7.1.4 and 8)
- [5.2] Quality Policy
- [6.2.a-g] Quality Objectives and information

what we currently refer to as records:
- [7.1.4] Evidence of fitness of monitoring & measurement equipment
- [7.2.d] Evidence of employee competence
- [7.5.b] Information determined by the organization as being necessary
- [8.1.c] Information that processes have been completed as planned
- [8.2.3] Basically Order intake & processing)
- [8.4.2] Provider evaluations (ability to provide)
- [8.4.3] (Basically Purchase Order)
- [8.4.3] Provider evaluations (performance)
- [8.6.2] Unique identification for traceability
- [8.6.3] Customer property lost, damaged, or unsuitable
- [8.6.6] Review of change
- [8.7] Evidence of conformity
- [8.7] Person releasing to customer
- [8.8] Nonconforming goods and actions taken
- [9.1.1] Records that monitoring and measurement have been completed
- [9.2.f] Audits were held and results
- [9.3] Results of Management Review
- [10.1.a] Nature of nonconformance's and actions taken
- [10.1.b] Results of Corrective Actions

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?
drgnrider,

One small point. Rather than "knowing your processes" you need to know your undocumented procedures.

Please compare the definitions of process and procedure.

Briefly, process is the work and procedure is the specified easy to carry out the work.

John

Last edited by John Broomfield; 4th February 2014 at 03:39 AM.
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  Post Number #11  
Old 21st May 2014, 12:42 PM
AlanC

 
 
Total Posts: 37
Re: Required Documents/Records in ISO 9001:2015

Hi All,
I think the new standard gives flexibility to change the QMS to a more purpose driven one which meets business requirements. Process mapping our business rather than a series of procedures has helped to link the areas together and highlights the gaps. However, I'm not clear on the risk side of things. What will the audit requirement look like, and more importantly what will the business requirement look like, as anyone got examples from the other areas, financial etc that use this approach to point me in the right direction
thanks
  Post Number #12  
Old 22nd May 2014, 09:40 AM
01mercy

 
 
Total Posts: 75
Re: Required Documents/Records in ISO 9001:2015

I read this discussion and I was just thinking the other way around.
Not what the stripped requirements on documentation would mean internally, but what it would mean if you would get audited.

Internally you would be challenged indeed to take the responsibility to determine what is significant to put under the flag of control.
However... if you would get audited, I think there will be some interesting discussions with the ISO auditor and customers on what is really significant for your company.
  Post Number #13  
Old 8th October 2014, 12:01 AM
element79's Avatar
element79

 
 
Total Posts: 15
Re: Required Documents/Records in ISO 9001:2015

Hi Covers! Has there been a change to the list of required records posted by the OP based on the released DIS?

I noticed that results/records of Preventive Actions are missing. Is this really the case (PA records not needed anymore) or has it just been reworded to fit the risk management direction of the DIS? Thanks.

-A.
  Post Number #14  
Old 8th October 2014, 04:09 AM
pldey42's Avatar
pldey42

 
 
Total Posts: 429
Re: Required Documents/Records in ISO 9001:2015

Risk management and risk-based thinking replace PA, and they require "documented information" as appropriate.

Just 2c
Pat
  Post Number #15  
Old 8th October 2014, 04:24 AM
pldey42's Avatar
pldey42

 
 
Total Posts: 429
Re: Required Documents/Records in ISO 9001:2015

Quote:
In Reply to Parent Post by drgnrider View Post

After reading through CD-ISO-9001, unless I am missing something, these are all that I see that will be required:

what we currently refer to as documents:
- [4.3] Scope & justifications for exclusions (limited to 7.1.4 and 8)
- [5.2] Quality Policy
- [6.2.a-g] Quality Objectives and information

what we currently refer to as records:
- [7.1.4] Evidence of fitness of monitoring & measurement equipment
- [7.2.d] Evidence of employee competence
- [7.5.b] Information determined by the organization as being necessary
- [8.1.c] Information that processes have been completed as planned
- [8.2.3] Basically Order intake & processing)
- [8.4.2] Provider evaluations (ability to provide)
- [8.4.3] (Basically Purchase Order)
- [8.4.3] Provider evaluations (performance)
- [8.6.2] Unique identification for traceability
- [8.6.3] Customer property lost, damaged, or unsuitable
- [8.6.6] Review of change
- [8.7] Evidence of conformity
- [8.7] Person releasing to customer
- [8.8] Nonconforming goods and actions taken
- [9.1.1] Records that monitoring and measurement have been completed
- [9.2.f] Audits were held and results
- [9.3] Results of Management Review
- [10.1.a] Nature of nonconformance's and actions taken
- [10.1.b] Results of Corrective Actions

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?
For me this is a long-overdue breath of fresh air. The focus at last moves from documented procedures, to processes that work, supported with appropriate documented information - which can be procedures, records, either or both. Indeed, a completed record might sometimes be an example to follow, which communicates the process better than does a procedure.

To audit a non-documented procedure the auditor might interview a few people who execute it and ask them what it is. If they all say substantially the same thing, it's communicated - somehow - systematically. Then the auditor needs evidence it's systematically executed - observation perhaps, or maybe records - and evidence that it's effective - records, almost certainly.

(The auditor might also wonder how it's communicated, if not in writing. I've seen some orgs do it by osmosis: never parachute people in to senior positions and have everyone learn from the ground up by copying their seniors. The procedures can become second nature, not written because "everyone does it that way." When the culture is well led, nobody changes the process except through discussion with colleagues and change that's managed, if informally. It can work, especially when everyone is focused upon common objectives expressed in the quality policy and measurable goals. Critically, such systems can be responsive and adaptive in changing market and customer conditions, and good at responding to disruptive events.)

The only part of this that documented procedures helped with was the first, communicating - and even that wasn't guaranteed, so auditors were often wise to do all the above anyhow. For intelligent organizations and auditors, there's little change but to remove excessive focus upon 5 or 6 mandatory documented procedures.

Just my 2c
Pat
  Post Number #16  
Old 8th October 2014, 04:46 AM
John Broomfield's Avatar
John Broomfield

 
 
Total Posts: 2,461
Yin Yang Re: Required Documents/Records in ISO 9001:2015

Pat,

Undocumented procedures have been recognized for 14 years now but you have to study the definition of procedure.

Grant you, the six orphan processes, that belonged to no one, probably needed their documented procedures so people could understand, use and improve these often new processes.

BTW, I could see no specified requirement in the DIS for records of risk management or of the ephemeral "risk-based thinking".

John
Thank You to John Broomfield for your informative Post and/or Attachment!
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