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Quality Procedures - General Detail Level and Record Keeping Requirements

M

medicalqm

#1
Hello,

I took responsibility for implementing (and achieving certification for) an ISO 9001 system for a very small (10< employees) UK manufacturer a few months ago. So far I've drafted a quality manual, distinguished and documented the primary and secondary supporting processes, and, in co-operation with my colleagues, written the first 9-10 work instructions. Now I want to turn to the quality procedures, and I'm wondering how many to include.

Some people say you can 'get away with' perhaps only 6-8, including the six 'mandatory' procedures relating to control of documents, records, corrective and preventive action, etc. In addition to this, it's up to to the company to decide how much of their operations to document and control under the QMS with the quality procedures.

What I'd like to know is, if I choose to have quality procedures for, say, sales account handling, or order processing, or technical file management, or product storage, how much detail do I then have to provide in them, and do there have to be designated records? I'd like to include these important activities, but I may not be able to justify it if I then have to include an unnecessary level of detail and impose yet more record-keeping requirements on my colleagues.

I'm quite new to ISO 9001, so sorry if this question doesn't quite make sense! Thanks in advance for any advice this forum can provide - it must be a question a few people have considered in the past.
 
Last edited by a moderator:
F

fiona_young

#2
every department like HR,FIN,ADM, R&D...should have responsibility in accordance with ISO. Read ISO carefully, and list the requirements and assign the requirements to related deparment. ask department leaders to write their procedures. You can modify them. although there are less than 10 employee, you should have "department"(even if there is only one person).
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
every department like HR,FIN,ADM, R&D...should have responsibility in accordance with ISO. Read ISO carefully, and list the requirements and assign the requirements to related deparment. ask department leaders to write their procedures. You can modify them. although there are less than 10 employee, you should have "department"(even if there is only one person).
Sorry, but you are not correct. As long as you think departments rather than processes, you won't have understood one of the ISO 9000 principles of process approach to a quality management system. Too many companies go through the motions of "implementing" ISO 9001 without understanding the basics. The end result? Dysfunctional and low performing systems that never make an impact on the organization's business and fail to gather top management support.
 
E

esalsan

#4
medicalqm,

The procedures need to work for you. I write procedures that are one page long with 4 columns: 1) species who is responsible for doing it
; 2) contains a workflow diagram with key activities; 3) contains a brief description of the activity; 4) specifies what record is generated (if any); 5) where that record is stored.

Plus title of procedure, code, revision number and a box in the footer providing a summary of changes (should changes be made...)

Keep it simple, you can always add detail when you needed it. Hope it helps!
 
M

medicalqm

#5
Thanks very much elsalsan - I'll bear those elements in mind as I compose the procedures with colleagues. I think noting your recommendation to make procedures work for me I'm going to restrict the number of formal QPs to avoid controlling more activities than the QMS in fact needs to.
 
#6
Medicalqm - welcome. Interesting that you'd go for work instructions first, and not the procedures...in the conventional sense, WIs give more detail to certain aspects of a process or procedure.

You've asked for general detail level which I don't believe is being answered. I've used the example of a recipe to describe the level of detail:

My Marks and Spencer cake baking book tells me to "beat sugar and butter until light and fluffy, then gradually add egg". It doesn't tell you what do to stop the mixture curdling, which it will, if too much egg is added, too quickly. What is it relying upon? Experience! So, write your documents - as you've described 'with' other people, to get this balance of competency and detail.
 
M

medicalqm

#7
AndyN, thanks very much for your response. Yes it might seem a little odd to do the WIs first, but there were some fairly low-level things like the instructions for ensuring traceability when delivering equipment for product trials that we were already doing and that our directors wanted to have formalised quickly.

I'll take on board the balance between competency and detail you illustrate so graphically!
 
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