QMS for Life Sciences
Elsmar Cove Forum Sponsor
Social Distancing - It's not just YOUR life - It's ALL of OUR lives!
Me <——————— 6 Feet ———————-> You

Quality Manual Format (Originator - James Gutherson)

D

Don Winton

#2
I would suggest that first, you review Marc's documentation map at the Cove. Second, why not create a hybrid of ISO 9002 and what you are currently doing (combine and translate into your language). It has been my best experience that the quality manual should be a collection of policies. The actual procedures detail what you will do. The standard says WHAT you shall do. You decide what you WILL do. I would like to be able to offer more, but without more deatils of what you do now, I cannot help at this time. By e-mail or post, I will provide what I can.

Best Regards,

Don

[This message has been edited by Don Winton.]
 
S

Scott Knutson

#3
James -
While I don't have any hard copy examples that I could show you, I have seen several different approaches to quality manuals, including a 3" by 5" booklet that just stated all of that company's policies. I just finished some work with a company that did their manual as a flow diagram. Ultimately, you can put your manual together any way you like, since the standard just says that you "shall prepare a quality manual covering the requirements of this internation standard."
 

Marc

Captain Nice
Staff member
Admin
#4
I don't have any examples, but I will say your 'key to survival' will be a cross-reference matrix linking ISO clauses to your document.
 
D

Don Winton

#5
James,
Scott is absolutely correct. The range and scope of your QM is entirely up to you. You decide the format and content. Also, follow Marc's advice and be sure to cross-reference the QM to the applicable sections of ISO 9002.
Don
 

barb butrym

Quite Involved in Discussions
#7
Why not share your words of wisdom with all of us, Don ?

Lets get this forum active...daily...some times there is very little activity and gets discouraging.
 
J

James Gutherson

#8
Barb,
Sorry I dragged Don away from the public forum, He just had a few comments on a multi-page document I sent to him which would not have made sence to others.
Don, I will collate our correspondance and post it here if that is allright with you?
You'll just have to give me a few days as I got a major audit due today, and my High School Reunion over the weekend! (It's Friday already here in Australia)
James Gutherson.
 
D

Don Winton

#10
James, Post as you see fit. Any comments I publish (e-mail or otherwise) are subject to public domain. Comments welcome!!
 
Top Bottom