Starting a Quality Department from Scratch and Implementing ISO 9001

[PaulJSmith]

Controls666,

It sounds like you're making good strides forward in a very short time. Good for you.

As mentioned by smryan, doing a Gap Analysis will be quite revealing, and help you to focus on areas that need attention. You can find such a document here on The Cove, using the green or blue "attachments" links at the top of the page.

Also, try to remind your management that what you're documenting is the Quality of the Management System, not the Management of the Quality System.

Good Luck.

 

[SuperGirl]

Control666,

Hang in there. It will be tough, but it will be worth it. I was hired at my company 4 years ago as the person to write and implement thier QMS, four years later we have a good system and are ISO 13485 certified. There will be bumps along the road, but keeping upper managment informed as you go along will greatly help. And, as others have said, you do have some sort of system in place, just document what it is you do.

The biggest thing though, is don't give up. There will be days were you don't know why your even bother, that it seems that no one really cares, but in the end, it will be worth it.

 

[Big Jim]

Congratulations. Your persistence paid off. It will be much easier with full support, as you already know.

 

[QHSE1808]

Hi Controls666,

I am in much the same boat as yourself and found myself in the deep end before long.. And as you've already discovered, this place is amazing for pointers, and some substantial help in some cases!

My highlight in starting was with a gap analysis, I've since written a first draft of a new IMS (lets not mention the two scrawled before hand!). I have a wealth of materials I found useful from online saved, I would be more than happy to share with you if you wished.

With the likes of LinkedIn, do not underestimate finding old colleagues who have been in HR, or have moved to HR, they have been great at pointing me in directions I wouldn't have expected, tend to be in the same industry, and your region legislations and companies are the same. Even another small company a friend works for, she spoke to their QHSE, and we ended up talking. As they say, it's not what you know...

 

[1Noob]

In the same boat bud.

I was thinking of starting at the processes since all the process are linked together and people already do it, y not just document it and organize it to create the QMS?

from that start point it covers 4.0/4.2....

 

[smryan]

That is pretty much sums up what most folks have said in a very concise nutshell.

 

[Controls666]

Good morning all,

Another question for the pro's : I'm looking for ISO and API Standard manuals on turbines and compressors. These are the kind of machines we normally work on and the idea is to merge some specific types with our ISO 9001. Tbh, I didn't even knew these manuals existed. but according to my boss, they do.

As far as the start of our ISO 9001 goes, I have convinced the management to forget about the "new department" certification, and just take the company as a whole. From the head office a budget was made available and I have already had a consultant coming over. Together we have made a draft of procedures that are needed and a review of what's already up an running. Things are looking brighter every week.
Thanks for the replies and help so far

 

[John Broomfield]

Good morning all,

Another question for the pro's : I'm looking for ISO and API Standard manuals on turbines and compressors. These are the kind of machines we normally work on and the idea is to merge some specific types with our ISO 9001. Tbh, I didn't even knew these manuals existed. but according to my boss, they do.

As far as the start of our ISO 9001 goes, I have convinced the management to forget about the "new department" certification, and just take the company as a whole. From the head office a budget was made available and I have already had a consultant coming over. Together we have made a draft of procedures that are needed and a review of what's already up an running. Things are looking brighter every week.
Thanks for the replies and help so far

Controls666,

As these are product manuals for turbines and compressors they are not system standards.

I would expect to see them used as a source of information for design, maintenance and operation of the turbines and compressors.

Which of these processes (design, maintenance and operation) is your boss seeking to improve with these manuals? Or are they to be used as input to training operators for competence?

I would consult with the relevant process owners.

John

PS: http://www.techstreet.com/api/publishers/25/browse

 

[Controls666]

Good Morning John

Thanks for the link, it was useful for the API manuals I was looking for. As for your question how he will use it, I have no answer. This will probably be used for visiting customers and as an manual for new employees I guess ( I can't think of other reasons as it has nothing to do with the ISO 9001 ).

 

[John Broomfield]

Good Morning John

Thanks for the link, it was useful for the API manuals I was looking for. As for your question how he will use it, I have no answer. This will probably be used for visiting customers and as an manual for new employees I guess ( I can't think of other reasons as it has nothing to do with the ISO 9001 ).

Controls666,

Now I regret providing the link!

Please ascertain from the process owners what documented information they need to run effective processes.

They are other members of the relevant process teams must be clear on the documented information they need and do not need.

John