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ISO 9001 Work Instruction Requirements

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Related Topic Tags
work instructions (wi), iso 9001 - quality management systems
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  Post Number #1  
Old 17th September 2008, 02:58 PM
Joseph A Smith

 
 
Total Posts: 9
Please Help! ISO 9001 Work Instruction Requirements

Hello all,
I need a bit of advice on my work instruction requirements for ISO 9000. I am in the infancy stages of implementing ISO 9000 to a small custom fabrication company. I presented a very basic WI to my management team and was asked if we could use one standard set of work instruction for all jobs and N/A the processes that did not pertain to that job. We do several large repetitive jobs that have a basic work instruction sheet. However, we are a custom fabricator and do a lot of onezy / twozy jobs. I could not find anything in the standard that addressed this question.
Thanks for the help

Joe

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  Post Number #2  
Old 17th September 2008, 03:40 PM
Colin's Avatar
Colin

 
 
Total Posts: 1,403
Re: Advice on my work instruction requirements for ISO 9000

Joe, the most relevant clause of ISO 9001 regarding work instructions is 7.5.1 b) where it states that work instructions may be provided 'where necessary'.

In other words, have them if you need them and don't if not. If you can demonstrate that not having them does not adversely affect quality, you don't need them. If you do need them, it is up to you how you format them. If crossing out some steps works for you, go ahead.
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  Post Number #3  
Old 18th September 2008, 05:24 AM
antoine.dias's Avatar
antoine.dias

 
 
Total Posts: 510
Re: ISO 9001 Work Instruction Requirements

Hello Joseph,

On top of what Colin answered the following requirement of ISO 9001 is also applicable :
" The quality management system documentation shall include
4.2.1.d) documents needed by the organization to ensure the effective planning, operation and control of its processes."

Also for this requirement it is up to you to decide if you need them and ( when you do ) how they are formatted.

Best regards,

Antoine
  Post Number #4  
Old 18th September 2008, 11:40 AM
Randy's Avatar
Randy

 
 
Total Posts: 8,273
Re: ISO 9001 Work Instruction Requirements

Do you even need them? If your guys are at a Journeyman level when it comes to competence what's the WI going to do other than complicate things?

Are your folks able to do the work correctly and in the required fashion without a piece of paper telling them how to do it? If so where's the gain?

Don't encumber your folks and yourself with BS paperwork if you really don't need it. Keep it simple.
Thanks to Randy for your informative Post and/or Attachment!
  Post Number #5  
Old 19th September 2008, 08:24 AM
Joseph A Smith

 
 
Total Posts: 9
Re: ISO 9001 Work Instruction Requirements

Colin,Antoine,Randy
I came out of the AS world where we had WI for everything. The current situation and lack of quality may require at least key characteristic, in process, and final inspection. My goal here is to keep it simple but have controls in place. My mechanics do need some structure. Thanks for the help with this one. Iím sure there will be more to come.
  Post Number #6  
Old 6th November 2008, 02:44 AM
aliakbar

 
 
Total Posts: 10
Re: ISO 9001 Work Instruction Requirements

Let me describe a very interesting situation. Advice is more then welcome,

Mine is a technical service provider company.When the unit reaches the hospital, we install,service,repair and perform field modification at customer premises and we have written in our manuals that
our work instructions are as per the technical service manuals provided by our sole supplier.

we have checksheets for preventive maintenance for under-warranty units but not for all.

will this satisfy auditors that manuals given by manufacturer are available and have all the work instructions

is it good enough ?
  Post Number #7  
Old 6th November 2008, 03:09 AM
JaneB's Avatar
JaneB

 
 
Total Posts: 3,517
Re: ISO 9001 Work Instruction Requirements

Joseph, the simple answer is yes, but I second the advice not to have them unless you need them.

There was a model at one time (hopefully now recognised as obsolete) that dictated 'everyone'' had to have so many tiers of documentation and dictated that work instructions would always exist.

Some places need procedures + work instructions. Some don't.

The fewer your procedures/WIs, the more attention one generally pays to how competency is ascertained and maintained.

As an alternative to documents, models or examples could serve instead of WIs (eg, 'it should look like this'). I understand about the 'onesies and twosies' - the key point here would be that presumably they'll go through a similar process (define requirements, identify how to meet them, do it, check it, verify it's right). But there'd be no value in having WIs for all.

PS - few people ever find the Standard exactly addresses their unique situation - because it's generic. But when you next read through the Standard, pay close attention to the words/phrases 'as necessary', 'as appropriate', 'if needed' etc. These are your clues to the fact that it needs to be interpreted and applied for your business. Also, look closely at the front bits (which people often skip), particularly 0.1 and 1.2. More clues.
  Post Number #8  
Old 6th November 2008, 07:42 AM
kmyers's Avatar
kmyers

 
 
Total Posts: 83
Re: ISO 9001 Work Instruction Requirements

Quote:
In Reply to Parent Post by Randy View Post

Do you even need them? If your guys are at a Journeyman level when it comes to competence what's the WI going to do other than complicate things?

Are your folks able to do the work correctly and in the required fashion without a piece of paper telling them how to do it? If so where's the gain?

Don't encumber your folks and yourself with BS paperwork if you really don't need it. Keep it simple.
I agree wholeheartedly with Randy on this. I work for a company and we provide machining with very tight tolerances. We only hire operators who already possess the skill to do thier job, whereas giving them an instruction they must follow written by people who know less than they do will only complicate things and cause animosity.
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