ISO 9001 Registration Process - Timeline for obtaining ISO 9001 certification

[MarkDH]

Hi all,
I have a question concerning steps and a timeline for obtaining ISO 9001 certification.

Background: Our company began the process backa few years ago. At that time we established our QMS constisting of our Policy, Manual, Objectives, Procedures, Work Instructions, etc. Then when our Quality Manager did not work out, we put the goal of certification on the back burner and the QMS has been abandoned since.

Several months ago, our VP & General Manager approached me and offered me the opportunity to get us on track for the certification. In July I took a Lead Auditor Course for ISO 9001:2008. Unfortunately I have also been wearing many hats around here and have not been able to spend much time focusing on the QMS. With a new year brings new focus. My main goal for this year is to advance our initiative as much as possible.

My first thought was to regroup the management team and get our QMS up-to-date as quickly as possible. Once that is complete, the concern I have is how much evidence of implementation and effectiveness would you suggest prior to seeking certification? How many months worth of records for meeting quality objectives, corrective and preventative actions, continuous improvement, etc. should we have? Answers to these questions and any additional advice would be greatly appreciated.

This is my first post. I've been accessing the Cove from time to time since July and I must say you are all very knowledgeable and curtious.

Thank you --

 

[Jen Kirley]

Re: ISO 9001 Registration Process

My first thought was to regroup the management team and get our QMS up-to-date as quickly as possible. Once that is complete, the concern I have is how much evidence of implementation and effectiveness would you suggest prior to seeking certification? How many months worth of records for meeting quality objectives, corrective and preventative actions, continuous improvement, etc. should we have?

Good day Mark, welcome to the Cove!

Your plan seems sound to me. Have you contacted any registrars yet?

In general your registration process will take place in two steps, with a Stage 1 and then Stage 2 audit, which is the original certification audit. In the 1st stage your documentation will be reviewed to see if all the parts are there. We expect to see at least one full round of scheduled internal audits completed, corrective actions implemented (they don't have to all be finished), and at least one Management Review. The Management Review will be expected to include Key Performance Indexes, or metrics that indicate process performance. There should be the beginnings of some trending evident, but there is no set requirement for how much data is produced for these Stage 1 reviews. Your registrar can give you more details.

"Effectiveness" doesn't mean everything has to be perfect. It does, however mean your issues will be noticed and addressed internally, and hopefully before the internal auditor visits the process (though of course if that always happened we would never have any audit CARs!).

I hope this helps!

 

[AndyN]

Re: ISO 9001 Registration Process

Jennifer is on the money! Please don't contact any registrars yet. I would suggest that if you start selecting them and asking questions about records etc. you will be more confused! Well, possibly.

I'd suggest that you research a CB which is a good fit for you - the duration of the audit is pretty much defined for them (+/- a bit) and therefore, the costs may end up being very similar.

Since much of what you want to know hinges - in practice - on a specific CB/Registrar, then I'd suggest you do the research you need to approach at least one or two and ask them.

 

[MarkDH]

Re: ISO 9001 Registration Process

Thank you Jennifer and Andy

I have not contacted a registrar yet. I'm not really sure where to begin that process.

I plan on having an internal audit team selected and trained by the end of March. I've been putting together a lot of training materials such as an internal auditor ppt, audit objectives, checklists, etc. so that once I select my team the training should move along quickly.

I'm going to address the requirement for the Management Reviews this Friday and begin scheduling them about every 4-6 weeks.

Do you have any suggestions on a registrar? Our organization is about 80 employees and our processes are very complex. We are in the service industry and refurbish electronic circuit boards for many OEM such as Ricoh, Canon, Sharp and Toshiba. So we deal with many manufacturing requirements as well as customer-specific requirements.