Requirements for Implementing an ISO 9001:2008 Quality Management System (QMS)

G

gayathrisatheesh

#1
Ours is a product manufacturing co. and I am looking for details and preparations required in terms of process, audits, documentation, production for ISO 9001 2008/2009:agree:
 
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harry

Super Moderator
#2
Re: Requirements for implementing an ISO 9001: 2008 quality management system

Welcome to the forum, Gayathri.

Apart from having appropriate training, investment in reading and research at the Cove will go a long way to help you in your undertaking.

For starters like yourself, this link and another will make a good start. (Click on the words in blue for the link)
 
#3
Re: Requirements for implementing an ISO 9001: 2008 quality management system

Ours is a product manufacturing co. and iam looking for details and prepartions required in terms of process, audits, documentation, production for ISO 9001 2008/2009:agree:
Do you have a copy of ISO 9001:2008 (not 2009) and also ISO 9004? If not, you should get yourself one. We cannot post them here since they are copyrighted. But you will find sources if you do an internet search for them.
 
D

DrM2u

#4
Re: Requirements for implementing an ISO 9001:2008 quality management system

Ours is a product manufacturing co. and I am looking for details and preparations required in terms of process, audits, documentation, production for ISO 9001 2008/2009:agree:
Here is some of my advice:

DO NOT buy a 'canned', off-the-shelf quality management system because it will not work and will create more headaches in the future. Every effective QMS is particular and taylored to its organization's needs.

Like Andy said, get yourself copies of the standards (ISO 9000, ISO 9001 & ISO 9004). Reading them will help you understand the requirements, interpretations, definitions, etc. They will also be a handy reference during imprementation and future audits.

Like Harry suggested, invest time into reading through the forums and the attached files. You will find many 'what if', 'how to', 'what about' scenarios along with valuable insight and interpretations. You will also find many sample procedures, forms, probably even some quality manuals (if not, I'll post one). Look at the formats and identify what format makes most sense to you (ease of reading, editing, maintenance, distribution, retrieval, etc). Also look at the contents to see examples of how one requirement can be addressed in more than one way. Again, select something that makes sense and could be taylored to your organization's needs.

Last but not least, consider your customers' requirements when developing the QMS. Some of them can be integrated as bast-practices or GMP's, others are very specific. Regardless, they have to be reviewed and addressed (see clause 7.2).

I would be happy to look at and try to answer to more specific questions if you have any.
 

atitheya

Quite Involved in Discussions
#5
Re: Requirements for implementing an ISO 9001:2008 quality management system

Ours is a product manufacturing co. and I am looking for details and preparations required in terms of process, audits, documentation, production for ISO 9001 2008/2009:agree:
What details are you looking for?

Processes will be those working in your organisation.

For audits, you need to identify a team of people within your organisation and get them trained for Internal Quality Audit. Certification audits may be carried out by an identified certification body.

Documentation will include your planned QMS and then documentation done during operations, such as records.

Completely agreeing with what has been said in earlier posts, I suggest the following:

1. To start with, obtain a copy of ISO9000 - QMS Fundamentals & Vocabulary, 9001 - QMS Requirements, 9004 - QMS-Guidelines for Improvement and 19011-Guidelines for Auditing QMS & EMS.

2. Take some training on ISO9001 - There are awareness seminars, Internal Quality Audit training, Lead Assessors training conducted by various organisations.

3. As stated earlier, do not buy an 'off the shelf' QMS. If needed, take help from a consultant to develop and establish your own QMS. Remember! it is you (the organisation) who should develop and establish the QMS with the consultant's help and guidance.

4. Keep visiting this forum and participate in discussions, ask questions.
 

Bob the QE

Quite Involved in Discussions
#6
I am looking for input on selecting a webnar for training for transition from 2000 to ISO9001:2008. Has nay one had any good experiences? All input appreciated.
 

Stijloor

Staff member
Super Moderator
#7
I am looking for input on selecting a webinar for training for transition from 2000 to ISO 9001:2008. Has any one had any good experiences? All input appreciated.
Hi Bob,

No new requirements; just an editorial update.
Save your money, continue to do your good work.

Stijloor.
 
#8
Thanks, Jan:

This may cover what you're looking for, Bob:

http: // www. nqa-usa.com/resources/articles_detail.php?id=47 - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS
 
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J

John Martinez

#9
Re: Requirements for implementing an ISO 9001:2008 quality management system

Here is some of my advice:

DO NOT buy a 'canned', off-the-shelf quality management system because it will not work and will create more headaches in the future. Every effective QMS is particular and taylored to its organization's needs.

Like Andy said, get yourself copies of the standards (ISO 9000, ISO 9001 & ISO 9004). Reading them will help you understand the requirements, interpretations, definitions, etc. They will also be a handy reference during imprementation and future audits.

Like Harry suggested, invest time into reading through the forums and the attached files. You will find many 'what if', 'how to', 'what about' scenarios along with valuable insight and interpretations. You will also find many sample procedures, forms, probably even some quality manuals (if not, I'll post one). Look at the formats and identify what format makes most sense to you (ease of reading, editing, maintenance, distribution, retrieval, etc). Also look at the contents to see examples of how one requirement can be addressed in more than one way. Again, select something that makes sense and could be taylored to your organization's needs.

Last but not least, consider your customers' requirements when developing the QMS. Some of them can be integrated as bast-practices or GMP's, others are very specific. Regardless, they have to be reviewed and addressed (see clause 7.2).

I would be happy to look at and try to answer to more specific questions if you have any.
Without ISO 9000:2005 you do not have the whole picture.
 
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