Helping rewrite the Quality Manual and Procedures - Hints wanted

[dmbickham]

Hi, Okay I am helping rewrite the Quality Manual and Procedures and don;t have any experience in writing these. Is there any newbie info I can access. Any help would be great!:mg:

 

[Claes Gefvenberg]

Welcome to the Cove dmbickham, I copied your post in the New Folks - Please Take a Minute & Introduce Yourself/Say Hello! (2009-2010) thread and put it here, in the hope of attracting more answers to your query (I am assuming that you are talking about an ISO 9001 based system - If not, let us know and we will move it again).

Now... Could you tell us a bit about your task and what the manual and procedures currently look like? What local support do you have?

/Claes

 

[Marc]

As a starter, there is an entire forum here dedicated to Quality Manual discussions which you might want to look through: ISO 10013 - Quality Management System (QMS) Manuals forum

For some procedure related discussion threads, here's a bit of a listing of existing related discussion threads: Procedure related discussion threads.

You can also find sample files here: Post File Attachments listing

 

[John Broomfield]

Hi, Okay I am helping rewrite the Quality Manual and Procedures and don;t have any experience in writing these. Is there any newbie info I can access. Any help would be great!:mg:

A few tips:

Describe the management system and how it works to assure quality and improve quality. Use the present tense (avoid shall - just report what is). Write it for employees not for auditors. Keep the parts that change more frequently in the back as enclosures under their own revision control. Try the tri-fold (or similar) brochure approach with pictures of people enjoying their work and using their system. Do not rewrite the standard(s).

 

[dmbickham]

Thank you for your support, I am working for a manufacturing company that currently has ISO/TS 16949 certification, but is looking to go to medical also. I have been given procedures that were written 10 years ago and am trying to fix some issues. I have no experience with ISO cert's at all and may be pulling my hair out...LOL

I don't want to seem pushy but the procedures here seem more like work instructions combined. I thought the procedures explained how the company manages a section. not the details of "how" to do it.

Plz let me know if I am way off.

any help is great
Dawn

 

[Claes Gefvenberg]

I am working for a manufacturing company that currently has ISO/TS 16949 certification

I am assuming that you are talking about an ISO 9001 based system - If not, let us know and we will move it again.

Ouch... My assumption was wrong, then. Ok, I'm moving it on to the ISO/TS 16949 forum. Oh, and don't pull your hair out, you may miss it when it's gone.

/Claes

 

[Brizilla]

A few tips:

Describe the management system and how it works to assure quality and improve quality. Use the present tense (avoid shall - just report what is). Write it for employees not for auditors. Keep the parts that change more frequently in the back as enclosures under their own revision control. Try the tri-fold (or similar) brochure approach with pictures of people enjoying their work and using their system. Do not rewrite the standard(s).

Also, I like to write it for our customers. I like to fancy mine up a little bit, add colors, a history of the company, pictures of the building and add some pictures of the manufacturing process. After it's done I PDF it and put it on our website to use as a downloadable selling tool and for all those people who request a copy you just politely tell them it's available for download on your website.

 

[Nort1]

Good Luck
Be more careful how you want to approach this project due to the 'Medical' hint.

My 2cents are as follows:
Use ISO13485:2003 as guideline.
Map the company flow, who is doing what and how this is communicated.
Establish a 4-Tier documentation system (I used this approach several times successfully)
Tier 1 QSM
Tier 2 Procedures (Describing "What" needs to be done)
To make auditing easier, use the section out of the standard as your document numbers - if possible. (Can be up to 30 to 40 documents)
Tier 3 Work-Instructions (Describing "How" it is done)
Tier 4 Forms / Templates

When you review the existing documents, verify that the processes are still valid.
Maybe this can get you started.

Norbert.
PS. Keep your hair.

 

[Citizen Kane]

Hi !

You should first have in mind to write it for using it, not just as a simple document is good to have. Make it readable and easy to be understood. Also, not just take each of the standard's statements, but apply and modify them so it can fit and explain best what the user of the manual should do.

A mistake is also to take a quality manual from another company and adjusted to you by changing minor things as names and so on - this is the case in whitch you only want a document.