New In ISO 9001, How to Continue the Implemented Standard

[Colin]

OK, so it sounds like you are going to attend the lead auditor course, this should give you an in-depth understanding of what the requirements of the standard are and enable you to determine whether an organisation meets those requirements by auditing them against it.

I suggest this is what you do to your own system - audit it against the requirements of ISO 9001:2008 and establish which elements meet the requirements and which don't - from there you can draw up an action plan which will identify which aspects of the system need changing and which are OK. You can then plan the work, including responsibilities and timescales and set to work.

When you have the system back in working order you can contact your CB (or another if you wish) and ask them to conduct the stage 1 audit, followed by the stage 2.

 

[Duke Okes]

1. Study the requirements you must meet (e.g., ISO 9001-2008).
2. Assess what the organization does compared to #1.
3. Develop a plan for closing the gap.
4. Implement the plan.

It is likely wise to involve others in the organization in all these steps.

 

[methoomirza]

OK, so it sounds like you are going to attend the lead auditor course, this should give you an in-depth understanding of what the requirements of the standard are and enable you to determine whether an organisation meets those requirements by auditing them against it.

I suggest this is what you do to your own system - audit it against the requirements of ISO 9001:2008 and establish which elements meet the requirements and which don't - from there you can draw up an action plan which will identify which aspects of the system need changing and which are OK. You can then plan the work, including responsibilities and timescales and set to work.

When you have the system back in working order you can contact your CB (or another if you wish) and ask them to conduct the stage 1 audit, followed by the stage 2.

Thanks yes of-course i am starting the Lead Auditor Course and try to best to understand it in-depth
First thing to analyze the gaps where happened and then prepare an action plan to remove them
But the thing is how start and what is the professional approach to analyze. Thanks

 

[methoomirza]

1. Study the requirements you must meet (e.g., ISO 9001-2008).
2. Assess what the organization does compared to #1.
3. Develop a plan for closing the gap.
4. Implement the plan.

It is likely wise to involve others in the organization in all these steps.

From where i can start like professionally, Documentation (From Master List)

 

[AndyN]

Do a system wide audit comparing the existing system of processes, controls, documentation etc. That is your starting point.

 

[Duke Okes]

From where i can start like professionally, Documentation (From Master List)

After you have read the standard sit down with your quality manual and master document list and see how they fit to the standard. That should help you get a high level view of how the requirements are met.

 

[Colin]

As Duke and Andy have said, you need to compare what your QMS says you do and compare that with what the standard requires you to do and audit the activities of the business to verify that is what people are doing.

I would suggest you follow the same 2 stage approach that your CB will take:

Stage 1 - does the documented system satisfy the requirements of the standard.
Stage 2 - are you complying with the system, and therefore the standard

e.g. have you got a documented procedure for controlling nonconforming product? does it satisfy all of the requirements of clause 8.3? has it been fully implemented and are people following it?

 

[methoomirza]

is there any example of the check list of the gap analysis? from where i can get some sort of help to create/manage about the check list of the gap analysis

Thanks

 

[Colin]

This is something you should learn on your lead auditor course but try a search in the 'post attachments list' (at the top of the page) and you will find plenty examples.

 

[somashekar]

is there any example of the check list of the gap analysis? from where i can get some sort of help to create/manage about the check list of the gap analysis

Thanks

You must be looking at integrating all the three into a single management system. Since you say that the company had the registration and did not continue, I guess you have access to the then manual and the procedures.
Please help us to help you by giving details about your product, process and facilities and current state of affairs, Since you say about ISO 14k and OHSAS 18k also, it will help if we know the place you come from to address some of the legal requirements.
Hope you can, and will see this thread go forward a long way as you begin to get more clarity and share more details.