New to ISO 9001 - Where to start implementation

[Sorsola]

Hi All

Me again!

4.2.4 Control of Records. AARRGH!!!

Just wanted an opinion on my idea on how to tackle this section.

I was thinking...

Create a table of some sort which details all the required records, retention periods, location of where the records are stored/latest record etc

Then, write procedures for all the required records, detail there where/how/who/why and what... and sum it all up as the following;

4.2.4 - Control of Records

Quality records are retained to demonstrate the effective operation of the Quality Management System and the achievement of the required service quality. Quality records are legible, securely stored, easily retrievable, and readily identifiable to the service and Quality Management System involved. Quality records are kept in computer files in such a way as to minimize deterioration or damage and to prevent loss. The identification, storage, protection, retrieval, retention and disposition of quality records are specified in the record retention procedure of the respective entities.

Any feedback/comments would be greatly appreciated. Apologies if this has come across as the ramblings of a mad woman. At the start of this project there were 6 people on my ISO team... 5 have been removed and I am now THE ISO team.

 

[John Broomfield]

Hi All

Me again!

4.2.4 Control of Records. AARRGH!!!

Just wanted an opinion on my idea on how to tackle this section.

I was thinking...

Create a table of some sort which details all the required records, retention periods, location of where the records are stored/latest record etc

Then, write procedures for all the required records, detail there where/how/who/why and what... and sum it all up as the following;

4.2.4 - Control of Records

Quality records are retained to demonstrate the effective operation of the Quality Management System and the achievement of the required service quality. Quality records are legible, securely stored, easily retrievable, and readily identifiable to the service and Quality Management System involved. Quality records are kept in computer files in such a way as to minimize deterioration or damage and to prevent loss. The identification, storage, protection, retrieval, retention and disposition of quality records are specified in the record retention procedure of the respective entities.

Any feedback/comments would be greatly appreciated. Apologies if this has come across as the ramblings of a mad woman. At the start of this project there were 6 people on my ISO team... 5 have been removed and I am now THE ISO team.

Easy, this is one process that is better served by a table than a flowchart.

Yes, a table can be a documented procedure.

Headings to your Filing and Archiving Procedure's table:

Filing (for immediate retrieval):

• Type of Record
• How identified
• Where kept
• By whom
• For how long

ARCHIVING (FOR PLANNED RETRIEVAL):

• WHO ARCHIVES
• IDENTIFICATION
• LOCATION
• FOR HOW LONG
• HOW DESTROYED

Electronic files and archives are subject to back-up and may be supported by powerful search tools. Cover this with your procedure for maintaining the computer network and ensure the back-ups are tested.

 

[JaneB]

Yup - good advice from John.

 

[Sorsola]

Hi

If anyone has a spare few minutes to look over this Record Control table and let me have any comments I'd appreciate it.

Not sure if it's TOO basic.

 

[Polly Pure Bread]

see attached sample (basic)

 

[John Broomfield]

Hi

If anyone has a spare few minutes to look over this Record Control table and let me have any comments I'd appreciate it.

Not sure if it's TOO basic.

How is each type of record identified in Filing and in ARCHIVING.

The identity often changes from filing to archiving.

In other words, what must the record retriever look for?

 

[Sorsola]

Hello

No questions from me at the moment. My QM and processes are in full swing and I have 2 new people on my ISO team. Yep...things are looking up.

I do have a favour to ask though. My company is an IT consultancy. We ONLY test other companies (mainly financial companies) software. We don't provide the software, write it, fix it or sell it. We're purely testers.

Now, if there's anyone else out there with a similar set up and you have a quality manual, I'd love to take a look. Section 7 is looming and it's looking a bit daunting and I'd like to see how other people have tackled this.

Thanks again all.

Sam

 

[Sorsola]

RANT ALERT!!!!!!!!

Hi All

So, a member of the British Standards Institute is coming to visit us tomorrow to discuss our ISO intentions.

The Senior Manager who originally decided on the ISO path has somehow managed to take a back seat and pass this all over to another Senior Manager.

I've just discussed tomorrows meeting with said manager, and this was the general outcome;

He hasn't read the ISO requirements
He hasn't even skimmed section 5 - Management Responsibilities
He doesn't intend to 'bring' anything to this meeting, he's there 'just to observe'

Question is - does anyone out there think there is any point with my company continuing with ISO whilst the 'mindset' is...well, as it is???

 

[B.Read - 2010]

If your management team won't spring for a copy of the standard then your first step is determine thier level of commitment. Registrars, surveillence audits, and general Cost of Quality are significantly more than the price of a copy of the standard.

This site is an excellent source of information.

Good Luck!

Bryan

 

[B.Read - 2010]

I just read your last post about the "passing of the buck". It sounds like you really need to determine Management's commitment. They are extremely important to a successful QMS. Without management support you will fail. They hold the purse strings and give teeth to all policy/procedures. Additionally, they have to back Quality when the tendency is to make a "business decisions" and overlook Quality.