From nothing to ISO 9001 compliant in 10 weeks

[Marc]

Hang on... That could also work in your favour. In fact, I am almost certain that there is some kind of system around:

It may not be documented, and people may not be fully aware of it, but they must have ironed out reasonable ways to solve their tasks over the years. That is your starting point, so beware of reinventing the wheel before you know that it is not already there. When you start figuring your processes out, that system will emerge from the shadows, and as previously suggested, a gap analysis will show what else you need. <snip>

That's my take on it. In all the implementations I have done over the years the company had systems in place for most things. Internal Auditing was one of the few things companies did not typically have, but not much else was "missing". ISO 9001 is simply so generic that a company almost has to be doing everything required or they couldn't/wouldn't stay in business very long.

 

[thekellyg]

Thanks to all of you for your input! The company has been very successful since 1958 and there are all the appropriate processes in place to continue, but nothing is documented and there is zero communication between for instance, engineering and manufacturing. The manufacturing supervisor has several 4" binders with drawings of every part every manufactured in his 36 years here. He says the prints from engineering are useless for manufacturing and he makes notes on his own hand drawings to produce product that the customer accepts. This has never been communicated back to engineering before I did it yesterday. The org chart is very wide and the only depth is under the day and night production supervisors and even they report to the owner. No one has any authority of their own.

The customer coming to do an audit on Sept 11 is expecting compliance in specific areas and I am using their written request for specific information as my starting point.

Thanks again!

 

[normzone]

Yeah, the company is probably already doing much of what is required to be "compliant".

The usual gaps in such a case are in:

process documentation - we're doing it but it's all tribal knowledge
records - we did it but it's difficult to prove
monitoring and measuring - our equipment is reliable (we think)
control of nonconforming - that pile over there is the bad stuff

 

[Helmut Jilling]

There are consultants on this forum, Marc, myself and others, who could do a phone conversation with you, to kind of assess how "compliant" you actually are. It may be a good place to start. From that, you/we can build a compliance plan to get much of the system compliant by your deadline...Changing the culture, well...that may take a little longer....

 

[Marc]

My number is on every forum page at the bottom. Call any time. No charge to talk.

 

[Big Jim]

Yeah, the company is probably already doing much of what is required to be "compliant".

The usual gaps in such a case are in:

process documentation - we're doing it but it's all tribal knowledge
records - we did it but it's difficult to prove
monitoring and measuring - our equipment is reliable (we think)
control of nonconforming - that pile over there is the bad stuff

It may help to stay aware that you don't need written procedures for everything you do. The standard only require that six topics be covered by written procedures. Control of documents, control of records, internal audit, control of nonconforming material, corrective actions, and preventive actions.

You can have as many more is you think you need to be effective, but that is up to you.

Tribal knowledge isn't necessarily a bad thing.

 

[Crusader]

Is it possible? I've just started with a plastic extrusion company that has no documented anything and was just informed our largest customer is coming September 11 to do an audit. If we aren't compliant, they are pulling their business. :mg:

I've seen some companies only register a specific product line and not the whole company. That is possible.