ISO 9001 certification (registration) requirements - No commercial product or service

[Paul Simpson]

Re: ISO 9001 certification (registration) requirements - No commercial product or ser

I am a newbie to this site but I have to say you are all great! I learn a lot just by reading the posts.

Anyway, my company of 50 wants to implement a QMS according to ISO 9001:2000 standards. We want to achieve certification although we do not have a commercial product or service and will not until after well after the QMS is in place. Are there any accredited bodies that will certify the process w/o demonstration of product or service passing through? My understanding is that we can be "compliant" to the standard but not "certified". Can I get some help on this? Thanks.

Nick

Interesting!

It would help to know a little bit more about what it is you plan to do ....

I remember in a previous life a large certification body registering a company that hadn't operated at the time of their assessment. The reason for them needing certification was it was a condition in an Invitation to Tender that all short listed companies had to be ISO certified. The company in question was a joint venture set up to go into this type of business.

A case of Catch 22.

There were some very specific caveats in their contract.

• The company could only advertise their ISO certification in the particular ITT
• They had to have a first visit soon after they started work on the particular contract
• The customer was fully aware of the arrangements

On this basis they were assessed as compliant and subesquently confirmed this in follow up visits.

On this type of basis I would be happy to assess this type of company. Anyone else?

 

[wolfn]

Re: ISO 9001 certification (registration) requirements - No commercial product or ser

Thanks everyone for their responses. You confirmed what I had thought. Specifically, my company is transitioning from R&D to a product company. We have developed a prototype instrument in the life science arena and now are trying to build a commercial instrument. We believe that getting ISO certified will help with acceptance into the market.
I appreciate your help on this. You are great!

 

[Sidney Vianna]

Re: ISO 9001 certification (registration) requirements - No commercial product or ser

The company could only advertise their ISO certification in the particular ITT...

ITT? Another TLA?

On this type of basis I would be happy to assess this type of company. Anyone else?

The problem is not ASSESSING, but CERTIFYING/REGISTERING a QMS that has NOT been demonstrated. When exactly did this organization get certified? Before the initial assessment? Or after? It is confusing. You said one of the pre-conditions for them to be certified was to have the initial assessment immediately after they started the engagement. And they had to be CERTIFIED to bid on the job. So, they got certified without an assessment? I am confused.

 

[BradM]

Re: ISO 9001 certification (registration) requirements - No commercial product or ser

Thanks everyone for their responses. You confirmed what I had thought. Specifically, my company is transitioning from R&D to a product company. We have developed a prototype instrument in the life science arena and now are trying to build a commercial instrument. We believe that getting ISO certified will help with acceptance into the market.
I appreciate your help on this. You are great!

Nick, thanks for the response. ISO will enhance your products acceptance into national/international markets. All I am suggesting to you is keeping your eye on the correct goal. One must learn to walk before running. An effective QMS will not happen overnight. You can start right now assuring your system is what it is supposed to be. IMO, R&D by it's very nature, tends to not be as monitored/recorded as the production process needs to be. You will probably need to observe the processes a lot more, and identify variables that were not monitored previously.

Where are you with your system would you guess? 30%? 70%?

 

[wolfn]

Re: ISO 9001 certification (registration) requirements - No commercial product or ser

We are just beginning the QMS process. Our goal is to have a system in place that can follow product within 6-8 months. Many of the procedures are in place already but we will need to conduct a Gap assessment and go from there. We are beginning to work on a Quality Policy and will begin developing our Quality manual.

 

[Paul Simpson]

Re: ISO 9001 certification (registration) requirements - No commercial product or ser

ITT? Another TLA?

Sorry, Sidney, I thought I'd covered that with the capitals in the previous sentence but ITT is "Invitation to Tender"

The problem is not ASSESSING, but CERTIFYING/REGISTERING a QMS that has NOT been demonstrated. When exactly did this organization get certified? Before the initial assessment? Or after? It is confusing. You said one of the pre-conditions for them to be certified was to have the initial assessment immediately after they started the engagement. And they had to be CERTIFIED to bid on the job. So, they got certified without an assessment? I am confused.

In this case the first assessment was carried out against all applicable clauses of ISO 9001.1994 (as it was at the time - I did say it was a while ago!) before they responded to the ITT ( ).

The company was then certified with a contractual arrangement for a further assessment around 3 months after work on the contract started. This assessment covered all the other clauses.

I am still happy this is a valid approach (with the caveats posted before). What about the other CB / Registrar representatives?

 

[Jim Wynne]

Re: ISO 9001 certification (registration) requirements - No commercial product or ser

Sorry, Sidney, I thought I'd covered that with the capitals in the previous sentence but ITT is "Invitation to Tender"

That's usually referred to as "RFQ" (Request for Quote) in the US, hence the confusion.

In this case the first assessment was carried out against all applicable clauses of ISO 9001.1994 (as it was at the time - I did say it was a while ago!) before they responded to the ITT ( ).

The company was then certified with a contractual arrangement for a further assessment around 3 months after work on the contract started. This assessment covered all the other clauses.

I am still happy this is a valid approach (with the caveats posted before). What about the other CB / Registrar representatives?

It's not clear whether this example is apropos of the OP. Did the company you refer to have actual operating processes and products? If so, there's no comparison. If not, the "certification" granted was a crock, frankly, and just represented an opportunity for the CB to grab the contract.

 

[Paul Simpson]

Re: ISO 9001 certification (registration) requirements - No commercial product or ser

That's usually referred to as "RFQ" (Request for Quote) in the US, hence the confusion.

We use the RFQ TLA as well, Jim. The only difference with a Tender is it is usually a one hit approach where the tenderer puts their best bid in and the best tender is chosen.

In theory you don't revise a tender but a quote you can always go back and renegotiate.

It's not clear whether this example is apropos of the OP. Did the company you refer to have actual operating processes and products? If so, there's no comparison.

A bit more information has come in from the OP. There are similarities (and differences). The company I am describing had processes in place for the construction services they were providing. They did not have any evidence that these processes were working effectively because they had never used them in anger.

If not, the "certification" granted was a crock, frankly, and just represented an opportunity for the CB to grab the contract.

In your own inimitable fashion, Jim, you've hit the nail on the head. From memory the company went out to a range of CBs and chose their CB based on quotes and approach. There were a range of CBs who were prepared to certify this company.

Now IMHO the ability to be flexible and offer a company certification in this type of situation is not "grabbing the contract."

Interested to hear what others think .....Now where's the "retreat to the bunker" emoticon?

 

[Sidney Vianna]

Re: ISO 9001 certification (registration) requirements - No commercial product or ser

They did not have any evidence that these processes were working effectively because they had never used them in anger.

That is an expression we don't see every day over here. I think Randy misunderstood it, when he was introduced to this British terminology...Could it be?

 

[Randy]

Re: ISO 9001 certification (registration) requirements - No commercial product or ser

I am a newbie to this site but I have to say you are all great! I learn a lot just by reading the posts.

Anyway, my company of 50 wants to implement a QMS according to ISO 9001:2000 standards. We want to achieve certification although we do not have a commercial product or service and will not until after well after the QMS is in place. Are there any accredited bodies that will certify the process w/o demonstration of product or service passing through? My understanding is that we can be "compliant" to the standard but not "certified". Can I get some help on this? Thanks.

Nick

Yeah, I'm sorry, I mis-spoke a bit here.

You want to register a system prior to its operation? I dunno if that could honestly be done.

There are 3 Dimensions to the audit process, and you have to be able to pass an audit to get a certificate.

...Audit of Design (We look at the design of the system through the documentation that has been developed for it according to whatever the applicable requirements are. This may be called the document review or many other things. In general we refer to this as a Stage 1 Audit). This can be done, but it won't get you registered, it only opens the door.

...Audit of Implementation (We look at how the Design has been implemented and whether or not it has been implemented according to the Design. This is an operational audit which requires us to see things being done according to the procedures developed for operating the system. people got to be interviewed, we need to look at stuff, kick over the trrash can and all that. We'll ask ourselves..."Is this thing working?") This is normally called the registration audit or Stage 2 audit. This audit may not be possible based upon what you've said.

....Lastly, there is the Audit of Effectiveness. (This audit actually is done concurrent with the Audit of Implementation and looks to see if the system is performing according to the design parameters, whatever they may be. A great deal of the evidence needed here will come from the records generated by the organization either from meeting the requirements of the applicable standard or from any other requirement determined by the organization where evidence of meeting it is necessary. We're looking at performance of the system, it's elements and the ability of the system in meeting requirements). Odds are this isn't possible yet either.

I know that some of the above may seem to be "gobblety-goop", but in laymans terms that's generally how it works. You actually have to have everything up, running and doing so effectively and be able to prove it in order for the registration thing to happen.