I can't hardly improve on the excellent advice given by our Moderator.
Having said that, let me share the approach I used with a compnay that had little if any documented policies or procedures, and helped them achieve QS 9000 compliance in 13 months.
1)List all the basic elements or clauses of your chosen standard.
2)Interview everyone in the company that is involved or impacted by each clause.
3)Analyze how each clause does or does not get done.
4)Compare (3) with the requirements of the standard.
5)Determine the gap, and what requirements need yet to be met.
6)Go back to your interviewing process and collect ideas and suggestions on how the requirements can be met.
7)Test it, write it up, and see if you can do it better.
Above all else, keep it as simple and generic as possible. The more detailed it gets, the more traps and land mines you set for yourself.
Present and propose everything prior to implementation, to the top management staff. Don't allow anything to be done without their total endorsement.
Good Luck.
I envy you. It's a lot of fun, and when you finally nail the Cert to the wall, it will be hard to maintain your composure!
J Bruman
QA Manager
The danger of examining sample quality manuals is twofold:
1. You might be tempted to "borrow" one of the manuals you see by replacing the name of the company, etc., in the sample manual with the name of your company, etc., and thereby creating your company's quality manual. While this is not always a dangerous thing, the fact is that your company's quality manual should reflect what your organization does and how, not what another company does--even if the other company's QMS looks great. The problem with borrowing is that the resulting quality manual does not lead to the quality management system your company has or needs.
2. There is no guarantee that the samples you are looking at are very good. There are many software templates available on the market at a low price that promise to provide you with a step-by-step method to creating your quality manual. The problem is that few software programs are going to really customize the quality manual to suit your organization. Granted, the resulting quality manual would probably pass a registration assessment, but the QMS it helps create isn't going to help the employees do their work or the organization improve its performance because a quality manual that doesn't fit what your organization does is not going to be used. And if your company's management wants to implement ISO 9001 to improve how the organization works, then you want a quality manual that suits your company and its employees.
Having said that, I suggest that you do the following:
1. Read Subclause 4.2.2, Documentation Requirements--Quality Manual, of ISO 9001:2000 and all the other parts of ISO 9001:2000 that are specifically mentioned (Clause 1.2, Scope--Application) or are inferred (e.g., all of Clause 4.2, Documentation Requirements).
2. Become familiar with all of ISO 9001:2000 so that you understand what your organization will need to consider, develop and/or implement before and after creating the quality policy and quality manual, which are you top level QMS documents.
3. Seek assistance from ISO 9000 support groups and state ISO 9000 programs. Many states and localities have subsidized programs to assist small to mid-sized companies with ISO 9001 implementation and registration. What these programs do is provide low-cost training to employees of participating organizations, access to advisors who will assist your organization's implementation efforts and access to a group of other organizations going through the same processes. By understanding what ISO 9001 requires and provides through training, advisement and group discussions/support, you should have not problem developing a quality manual within 6 months.
4. Draft a quality manual that reflects the QMS your organization plans to implement. Use flowcharting techniques to define how your organization presently does work--its processes--on a macro-level and then determine what your organization needs to do to formalize those existing processes within an ISO 9001-based QMS and any gaps that need to be filled. Before you begin to build the full QMS structure--you should already have an informal QMS consisting of the processes your organization follows to satisfy customer specifications and correct product nonconformances--you should then draft a quality manual that matches the existing system and where you want to take it in formalizing the system.
If your organization is based in a location that makes use of a state or local support program difficult or impossible, then you should contact your local section of the American Society for Quality to see if it can help.
What I would also suggest is that, once you have become familiar with ISO 9001:2000 and what 4.2.2 requires and you attempt to make contact with a group that can help you through the process, you seek other organizations in the rubber industry or a similar sector that have similar operations and are similar in size, ask to see their quality manual(s) and then ask a lot of questions about how the manual drives the QMS. If you get blank stares or long pauses when you ask the second question, assume the quality manual was the result of a software program, an outside consultant who drafted the manual without input and feedback from the employees or is based on a sample that company borrowed from.
Having said that, are any other participants in the forum in the rubber industry or in an organization that might be similar in structure and processes or does anyone have connections with another organization that might be able to advise and assist this rubber company?
As for ISO/IEC 17025, which is used for the accreditation of calibration and testing laboratories, I am not sure why you want a sample quality manual for 17025. While ISO/IEC 17025 does contain additional requirements particular to laboratory quality elements, ISO 9001 provides the basic framework for an entire organization, not just its lab. So, unless your organization provides third-party lab services or otherwise faces customers requiring your lab to be accredited or to have an ISO/IEC 17025-conforming QMS, I would look at what is required by 17025 to see what additional elements could be included in the procedures for your lab(s), but build the quality manual initially for ISO 9001.
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Comments
firebrew 7/26/2001
I can't hardly improve on the excellent advice given by our Moderator.
Having said that, let me share the approach I used with a compnay that had little if any documented policies or procedures, and helped them achieve QS 9000 compliance in 13 months.
1)List all the basic elements or clauses of your chosen standard.
2)Interview everyone in the company that is involved or impacted by each clause.
3)Analyze how each clause does or does not get done.
4)Compare (3) with the requirements of the standard.
5)Determine the gap, and what requirements need yet to be met.
6)Go back to your interviewing process and collect ideas and suggestions on how the requirements can be met.
7)Test it, write it up, and see if you can do it better.
Above all else, keep it as simple and generic as possible. The more detailed it gets, the more traps and land mines you set for yourself.
Present and propose everything prior to implementation, to the top management staff. Don't allow anything to be done without their total endorsement.
Good Luck.
I envy you. It's a lot of fun, and when you finally nail the Cert to the wall, it will be hard to maintain your composure!
J Bruman
QA Manager
qdigest 7/24/2001
The danger of examining sample quality manuals is twofold:
1. You might be tempted to "borrow" one of the manuals you see by replacing the name of the company, etc., in the sample manual with the name of your company, etc., and thereby creating your company's quality manual. While this is not always a dangerous thing, the fact is that your company's quality manual should reflect what your organization does and how, not what another company does--even if the other company's QMS looks great. The problem with borrowing is that the resulting quality manual does not lead to the quality management system your company has or needs.
2. There is no guarantee that the samples you are looking at are very good. There are many software templates available on the market at a low price that promise to provide you with a step-by-step method to creating your quality manual. The problem is that few software programs are going to really customize the quality manual to suit your organization. Granted, the resulting quality manual would probably pass a registration assessment, but the QMS it helps create isn't going to help the employees do their work or the organization improve its performance because a quality manual that doesn't fit what your organization does is not going to be used. And if your company's management wants to implement ISO 9001 to improve how the organization works, then you want a quality manual that suits your company and its employees.
Having said that, I suggest that you do the following:
1. Read Subclause 4.2.2, Documentation Requirements--Quality Manual, of ISO 9001:2000 and all the other parts of ISO 9001:2000 that are specifically mentioned (Clause 1.2, Scope--Application) or are inferred (e.g., all of Clause 4.2, Documentation Requirements).
2. Become familiar with all of ISO 9001:2000 so that you understand what your organization will need to consider, develop and/or implement before and after creating the quality policy and quality manual, which are you top level QMS documents.
3. Seek assistance from ISO 9000 support groups and state ISO 9000 programs. Many states and localities have subsidized programs to assist small to mid-sized companies with ISO 9001 implementation and registration. What these programs do is provide low-cost training to employees of participating organizations, access to advisors who will assist your organization's implementation efforts and access to a group of other organizations going through the same processes. By understanding what ISO 9001 requires and provides through training, advisement and group discussions/support, you should have not problem developing a quality manual within 6 months.
4. Draft a quality manual that reflects the QMS your organization plans to implement. Use flowcharting techniques to define how your organization presently does work--its processes--on a macro-level and then determine what your organization needs to do to formalize those existing processes within an ISO 9001-based QMS and any gaps that need to be filled. Before you begin to build the full QMS structure--you should already have an informal QMS consisting of the processes your organization follows to satisfy customer specifications and correct product nonconformances--you should then draft a quality manual that matches the existing system and where you want to take it in formalizing the system.
If your organization is based in a location that makes use of a state or local support program difficult or impossible, then you should contact your local section of the American Society for Quality to see if it can help.
What I would also suggest is that, once you have become familiar with ISO 9001:2000 and what 4.2.2 requires and you attempt to make contact with a group that can help you through the process, you seek other organizations in the rubber industry or a similar sector that have similar operations and are similar in size, ask to see their quality manual(s) and then ask a lot of questions about how the manual drives the QMS. If you get blank stares or long pauses when you ask the second question, assume the quality manual was the result of a software program, an outside consultant who drafted the manual without input and feedback from the employees or is based on a sample that company borrowed from.
Having said that, are any other participants in the forum in the rubber industry or in an organization that might be similar in structure and processes or does anyone have connections with another organization that might be able to advise and assist this rubber company?
As for ISO/IEC 17025, which is used for the accreditation of calibration and testing laboratories, I am not sure why you want a sample quality manual for 17025. While ISO/IEC 17025 does contain additional requirements particular to laboratory quality elements, ISO 9001 provides the basic framework for an entire organization, not just its lab. So, unless your organization provides third-party lab services or otherwise faces customers requiring your lab to be accredited or to have an ISO/IEC 17025-conforming QMS, I would look at what is required by 17025 to see what additional elements could be included in the procedures for your lab(s), but build the quality manual initially for ISO 9001.