Consultancy company - ISO 9001 Implementation and Design Exclusion

[dianamendes]

Hi everybody!

I am a new member extremely happy to have found this forum as i thing i will finally clarify my doubts!

So, i will try to make it simple. Here we go:

- We are a consultancy company with 17 employees, developing consultancy services but also providing design services, training courses and handbooks. We work with Human Factors. I was given the task to develop the QMS as the company want?s to be iso 9001 certified.

1) ITEM 7.3 - We have a "standard" handbook that has information on the "rules" to implement specific standards. This book can be "customized" according to what the Client wants: change the content, adapt to colors or logo to the Companies internal system, etc. i don?t consider this to be a Design product because the "concept" already exists. Therefore 7.3 would not be applicable to this specific product. Am I wrong?

2) ITEM 7.6 - We have 2 equipments that we use "on site": 1 for noise measuring and another for luminosity measuring. So we go to the client?s place and we need to check if the working area is according to specific standards. Only for indicative results we use these equipments. If the result are close from the limits we include that information in our report .When we right our report to the Client we clearly state that these are only indicative results and must be verified by specialized companies. So, these are not equipment used to measure our process ( production of HF studies) and neither our product ( HF studies). Do we need to calibrate them?

3) ITEM 8.2.4 - We work for an industry where very often we are obligated by the client to work with their own documentation, Quality System, etc AND they are the ones Reviewing and Approving our reports. These are their own requirements and in some cases our consultants cannot even show the report to the rest of the team in the headquarters (confidentiality policy).

So in this case:
- How can I ensure the product ( study/report) is reviewed before is delivered to the client?
- Am I in compliance with the Norm if I use the Client?s templates instead of ours (template for report, etc)?

Your comments would be very very usefull...Somehow i think sometimes the Norm is easier to implement in an industrial service with 3000 people!

P.S - I have some urgency in this matter...

 

[sagai]

Plenty of interesting questions you have indeed.

I am tempted to be with you for 1).
For 2) , well ... regardless what is in the standard ... I think it sounds a good practise to calibrate those to somehow increase your confidence that you do your best for your Customer, as well as it may raise your Customers satisfaction whilst he's getting similar measurements from authorized parties. So I think I would do so based on the information I have about it at the moment.
For 3)a, I think your Consultant review and approve in a certain way of those reports, so I would simple put the actually procedure in place,
For 3)b, I believe you can happily use any template as long as you determine this kind of document procedure on a smart way (e.g. not limiting to templates).
Cheers!

 

[Wes Bucey]

Hi everybody!

I am a new member extremely happy to have found this forum as i thing i will finally clarify my doubts!

So, i will try to make it simple. Here we go:

- We are a consultancy company with 17 employees, developing consultancy services but also providing design services, training courses and handbooks. We work with Human Factors. I was given the task to develop the QMS as the company want?s to be iso 9001 certified.

1) ITEM 7.3 - We have a "standard" handbook that has information on the "rules" to implement specific standards. This book can be "customized" according to what the Client wants: change the content, adapt to colors or logo to the Companies internal system, etc. i don?t consider this to be a Design product because the "concept" already exists. Therefore 7.3 would not be applicable to this specific product. Am I wrong?

2) ITEM 7.6 - We have 2 equipments that we use "on site": 1 for noise measuring and another for luminosity measuring. So we go to the client?s place and we need to check if the working area is according to specific standards. Only for indicative results we use these equipments. If the result are close from the limits we include that information in our report .When we right our report to the Client we clearly state that these are only indicative results and must be verified by specialized companies. So, these are not equipment used to measure our process ( production of HF studies) and neither our product ( HF studies). Do we need to calibrate them?

3) ITEM 8.2.4 - We work for an industry where very often we are obligated by the client to work with their own documentation, Quality System, etc AND they are the ones Reviewing and Approving our reports. These are their own requirements and in some cases our consultants cannot even show the report to the rest of the team in the headquarters (confidentiality policy).

So in this case:
- How can I ensure the product ( study/report) is reviewed before is delivered to the client?
- Am I in compliance with the Norm if I use the Client?s templates instead of ours (template for report, etc)?

Your comments would be very very usefull...Somehow i think sometimes the Norm is easier to implement in an industrial service with 3000 people!

P.S - I have some urgency in this matter...

What do you mean by "right" in this sentence?
When we right our report to the Client we clearly state that these are only indicative results and must be verified by specialized companies.
Is it merely a typo for "write"? I could make a case for using "right" but tell me if I need to.

 

[dianamendes]

Hi Wes Bucey!

My apologies! It is a mistake I want to say write and not right

Sagai

1) So If in the project planning stage I clearly state that the Client is the the reviewer and approver and i have Meeting Minutes proving this was planned with the client, then can this be accepted? It doesn?t really make sense that who creates a report is also who reviews it....

2) In the Documents Control Procedure I can state that we use our templates and exceptionally the Client?s templates IF this is planned and decided in the Project planning stage. Makes sense?

 

[Jim Wynne]

Welcome to the Cove.

- We are a consultancy company with 17 employees, developing consultancy services but also providing design services, training courses and handbooks. We work with Human Factors. I was given the task to develop the QMS as the company want?s to be iso 9001 certified.
1) ITEM 7.3 - We have a "standard" handbook that has information on the "rules" to implement specific standards. This book can be "customized" according to what the Client wants: change the content, adapt to colors or logo to the Companies internal system, etc. i don?t consider this to be a Design product because the "concept" already exists. Therefore 7.3 would not be applicable to this specific product. Am I wrong?

It seems that 7.3 might not be applicable to the "specific product," but you say that your firm provides design services, which would indicate to me that you probably can't exclude 7.3 completely. More information about your design activities would be good.

2) ITEM 7.6 - We have 2 equipments that we use "on site": 1 for noise measuring and another for luminosity measuring. So we go to the client?s place and we need to check if the working area is according to specific standards. Only for indicative results we use these equipments. If the result are close from the limits we include that information in our report .When we right our report to the Client we clearly state that these are only indicative results and must be verified by specialized companies. So, these are not equipment used to measure our process ( production of HF studies) and neither our product ( HF studies). Do we need to calibrate them?

7.6 says that calibration is required when necessary to ensure valid results. If you can make a case for not calibrating the devices because calibration wouldn't aid in ensuring valid results, then you don't have to calibrate them. Keep in mind that auditor interpretations of this requirement vary widely, though.

3) ITEM 8.2.4 - We work for an industry where very often we are obligated by the client to work with their own documentation, Quality System, etc AND they are the ones Reviewing and Approving our reports. These are their own requirements and in some cases our consultants cannot even show the report to the rest of the team in the headquarters (confidentiality policy).

So in this case:
- How can I ensure the product ( study/report) is reviewed before is delivered to the client?
- Am I in compliance with the Norm if I use the Client?s templates instead of ours (template for report, etc)?

If your consultants are reviewing the reports, they are getting reviewed. If you're constrained by confidentiality requirements, you can just write that into your documented procedure--explain how review occurs, along with the constraints.

If you've selected a registrar (certification body) it might be a good idea to discuss some of these questions with them.

 

[sagai]

You are getting a flavour of these things

My personal opinion is that I would be more confident if I would say that the Consultant is reviewing and approving that document and the actual manifestation (objective evidence) of such review and approve is the meeting minutes. i think review and approve can occur by the same person for the sake of ISO9001.
(It is a concept, details of course should be worked out)

I would not say that much for 3/b, because remember , every letter that you put into your QMS is increasing your chances to fail with.
I would say, if I should at all, "we may use our templates if necessary".
Cheers!

 

[dianamendes]

Sagai and Jim,

Thank you so much!
I think I know now how to "solve" this issue with the reviewer and approver

Jim, we do have design and for that I already have template that allows us to collect data for planning, verification,validation and changes in the design process. We design Central Control Rooms, both the working areas and the panels, sometimes even some equipment.

Best regards,

Diana

 

[Jim Wynne]

Sagai and Jim,

Thank you so much!
I think I know now how to "solve" this issue with the reviewer and approver

Jim, we do have design and for that I already have template that allows us to collect data for planning, verification,validation and changes in the design process. We design Central Control Rooms, both the working areas and the panels, sometimes even some equipment.

Best regards,

Diana

You're welcome. It sounds like you're on the right track. Feel free to come back and ask questions if you need help.