ISO 9001 Implementation - Starting From Scratch

[hrrvett]

Hello,

I am currently trying to implement ISO 9001 from scratch. I work for a sound equipment company that both designs and manufactures (speakers, microphones, guitars, amps, etc). There is very little in place. By that, I mean, generally the processes (9001 processes) are in place; however, there is no documentation to support it. In other words, there are no SOPs, OPs, WIs, records, etc. None. If all new staff was brought it, the company would not survive because no one would know how to do their job.

I am attempting to get all the documentation written for the company (with input and appropriate approvals). However, I am not sure which procedures are really the "quality" procedures and which are other procedures. In my mind, I would conside just about all SOPs, WIs, forms, etc to be included under the quality system because they all interact. However, I have seen companies that have "quality" documents and just other documents that span from production to admin to finance. Is that just because they are not including those areas in their ISO scope? (Obviously you cannot literally answer that but only hypothetize.)

Thus, is there a need to have basically two document systems? In my mind, no.

Also, very few of our products have part numbers on them. I am wondering if this is really a requirement of ISO. I understand ID and Traceability; however, if it is 'blatantly obvious' (not sure how I would quantify that) so as to not mix product, are part numbers are required? Or, are part numbers always required? Again, in my mind, it is required; however, I do not want to implement requirements that are unnecessary.

Lastly, the company owners are very squirmish on releasing organizational charts. (fear of competitors I believe) I don't really know of another way to document roles and responsibilities. Any thoughts? Again, it seems obvious to me; however, I don't want to pin the company in a corner if I don't have to.

Thank you in advance for your thoughts.

 

[Ted Schmitt]

Re: 9001 Implementation - Starting From Scratch

Hello,

I am currently trying to implement ISO 9001 from scratch. I work for a sound equipment company that both designs and manufactures (speakers, microphones, guitars, amps, etc). There is very little in place. By that, I mean, generally the processes (9001 processes) are in place; however, there is no documentation to support it. In other words, there are no SOPs, OPs, WIs, records, etc. None. If all new staff was brought it, the company would not survive because no one would know how to do their job.

I am attempting to get all the documentation written for the company (with input and appropriate approvals). However, I am not sure which procedures are really the "quality" procedures and which are other procedures. In my mind, I would conside just about all SOPs, WIs, forms, etc to be included under the quality system because they all interact. However, I have seen companies that have "quality" documents and just other documents that span from production to admin to finance. Is that just because they are not including those areas in their ISO scope? (Obviously you cannot literally answer that but only hypothetize.)

Thus, is there a need to have basically two document systems? In my mind, no.

Also, very few of our products have part numbers on them. I am wondering if this is really a requirement of ISO. I understand ID and Traceability; however, if it is 'blatantly obvious' (not sure how I would quantify that) so as to not mix product, are part numbers are required? Or, are part numbers always required? Again, in my mind, it is required; however, I do not want to implement requirements that are unnecessary.

Thank you in advance for your thoughts.

First of all, welcome to the Cove !!

Seems like you have a little work to do... but should be fun... implanting systems from scratch can be alot of fun (because you can do it exactly the way you and your organization want to).

How much QMS experience do you have?

There are plenty of threads here on the Cove which may help you answer initial questions. (see at the bottom of this page - similar threads). That should be a great way to start getting your hands "dirty".

Feel free to come back and ask a few more questions... lot´s of people willing to help !

 

[hrrvett]

Re: 9001 Implementation - Starting From Scratch

Thanks for the support!

I have not implemented an entire system from scratch before. However, I was part of the core team of a medical device company to perform the upgrade of 13485 from 1996 to 2003. I'm also a lead auditor for 13485:2003. I'm not super seasoned but feel pretty confident.

My concern is that this company is privately owned and is only adopting ISO as a customer requirement but I'm not sure they really understand the involvement and committment that comes with ISO. I want to bring them flexibility with ISO but I want to ensure that I'm still adhering as I do it.

Thanks again!

 

[Jim Wynne]

Re: 9001 Implementation - Starting From Scratch

Hello,
Also, very few of our products have part numbers on them. I am wondering if this is really a requirement of ISO. I understand ID and Traceability; however, if it is 'blatantly obvious' (not sure how I would quantify that) so as to not mix product, are part numbers are required? Or, are part numbers always required? Again, in my mind, it is required; however, I do not want to implement requirements that are unnecessary.

If you're manufacturing assemblies without part numbers, how are bills of material structured?

Lastly, the company owners are very squirmish on releasing organizational charts. (fear of competitors I believe) I don't really know of another way to document roles and responsibilities. Any thoughts? Again, it seems obvious to me; however, I don't want to pin the company in a corner if I don't have to.

Organization charts (per se) are not required; identification (hence delegation) of responsibility and authority is. I'm not clear on whether your owners just don't like org charts, or don't want anyone to know who's responsible for what. If it's the latter case, it doesn't make much sense and will cause problems. If it's the former, you can show responsibility and authority without a chart, and identify job titles as opposed to names (which is the better way in any case).

 

[Stijloor]

Re: 9001 Implementation - Starting From Scratch

Hello,

I am currently trying to implement ISO 9001 from scratch. I work for a sound equipment company that both designs and manufactures (speakers, microphones, guitars, amps, etc). There is very little in place. By that, I mean, generally the processes (9001 processes) are in place; however, there is no documentation to support it. In other words, there are no SOPs, OPs, WIs, records, etc. None. If all new staff was brought it, the company would not survive because no one would know how to do their job.....

Hello hrrvett,

Thank you for your post and welcome to The Cove!

Vitually all of your questions have been discussed elsewhere in The Cove.
Begin by taking some time and read/study some of the relevant threads here.

Please do not get bogged down into "ISO" issues right away. You may end up with way too much stuff that probably will not add a lick of value...trust me, I've seen it! You must first decide what is necessary to make your business system work. Look at what your customers need and expect, then look at what is required to sustain your business over the long run. You'll be surprised how close you are to what ISO 9001:2000 requires. I always end by saying: "Make it work for you and your business."

Good luck. Please come back, ask questions, help others, and do tell others about this great resource: The Cove Forums.

Stijloor.

 

[Marc]

Some thoughts: Implementing A Quality Management System (QMS)

 

[hrrvett]

Re: 9001 Implementation - Starting From Scratch

If you're manufacturing assemblies without part numbers, how are bills of material structured?

That's a good question. I believe everything technically does have a part number and therefore the BOMs are structured appropriately; however, some parts just are not physically identified as such. The only reason why things are continuing to be built correctly is because the people know their job. Obviously that is not good - people process and not system process. I believe everything should have a part number. However, is it acceptable to have a drawing with the characteristics of a part specify the part number and not for the specific part to have a number? In other words, there is traceability but it is just not direct traceability. Is that acceptable?

Organization charts (per se) are not required; identification (hence delegation) of responsibility and authority is. I'm not clear on whether your owners just don't like org charts, or don't want anyone to know who's responsible for what. If it's the latter case, it doesn't make much sense and will cause problems. If it's the former, you can show responsibility and authority without a chart, and identify job titles as opposed to names (which is the better way in any case).

The company doesn't want anyone to know who is responsible for what. They are worried about competitors stealing employees. I don't agree with it but I don't know what other solution to offer them other than 'we've got to document who does what - PERIOD.'

Thanks for your help!

 

[Jeff Frost]

Re: 9001 Implementation - Starting From Scratch

I will admit up front that I only scanned responses by others but do believe that the first place to start is with the understanding that ISO 9001 is a management system when implemented has the potential for producing product that meets or exceeds your customers quality requirements.

First start with the current management system at your organization and make a matrix of how the current system aligns with the ISO standard and remember that the standard does not require the organization to adopt ISO speak, only that the organization understand what is required by the standard and has implemented business model appropriate processes that conform to requirements.

Look at how the organization is currently performing its internal process, forget any thing you did at your last job for now, and develop the understanding for why it is done this way. Remember there is no one perfect way to do anything the standard requires.

Perform a gap analysis and fill any holes that may exist in the system based on the organization business model and what the standard requires. Remember that the organization does not need to reengineer their system to look like the ISO standard only to understand what is required, how they meet the requirements and what within the organization serves as objective evidence of conformity.