ISO 13485 and ISO9001 Quality Management Implementation Start

[jonbe]

Hi to you all,
I am new in ISO 9001 and ISO 13485 standards and I have just started in a small company (8 employers) that wants to start implementing a QMS and get certified in both standards. It is a small company that have already a product in the market and also is involved in different European Research projects with the same technology to develop new applications and products.
I don’t know which is the best way to start implementing the QMS because I see the company between R&D and manufacturing company. Should I
a) Analyze the manufacturing process as the key process and the R&D part of the design and development process inside the key process of the products or
b) Analyze the company like with two products, the product that is already in the market and the projects for R&D as a product/service?
Are the two options possibles or I am totally wrong?
Thanks in advance for any advice you can give me,

 

[somashekar]

~~~ Welcome to the COVE jonbe ~~~
It is good to get the scope of the QMS in complete clarity.
Say your scope of QMS tells something like ... "Design development manufacture and distribution of something something devices", you will see that flow of process and activity where it begins and how the next processes link with the previous.

 

[J0anne]

Personally I would start with a gap analysis.
That way, you can analyse the business while you note any gaps.

In looking at this big picture, you will learn a lot about what's there and what's not.
Question everyone and challenge everything during the process.

Then draw up a plan, based on the above.

Good luck.

 

[Ronen E]

Hi to you all,
I am new in ISO 9001 and ISO 13485 standards and I have just started in a small company (8 employers) that wants to start implementing a QMS and get certified in both standards. It is a small company that have already a product in the market and also is involved in different European Research projects with the same technology to develop new applications and products.
I don?t know which is the best way to start implementing the QMS because I see the company between R&D and manufacturing company. Should I
a) Analyze the manufacturing process as the key process and the R&D part of the design and development process inside the key process of the products or
b) Analyze the company like with two products, the product that is already in the market and the projects for R&D as a product/service?
Are the two options possibles or I am totally wrong?
Thanks in advance for any advice you can give me,

Hi,

If the purpose of your R&D process is mostly to create devices that you will later manufacture and/or market, I'd go with option a. However, if most of your R&D projects are provided to others as a service (not typically intended to result in product lines you own/operate), then option b is the way forward, IMO. Option b1 would be looking at it as selling finished designs, rather than selling R&D service (product vs. service).

Yes, it can be done both ways (none is fundamentally wrong). It's just a matter of what works better for you.

Cheers,
Ronen.

 

[jonbe]

Hi,

Thanks for the replies.

I thought the first step was to explain to the managers QMS and try to learn as much as I can about the company, specially how the see the company and their objectives, so I would first fix the quality objectives and make a thorough process map and process cards ( I understand that cards are not mandatory but I think they could be very helpful for the continual improvement, setting in each process indicators..). After that we could begin the gap analysis about the documentation and procedures. Do you agree with that planning?

Regarding the company point of view, if the case is the b) I have many doubts of how could we manage the QMS because the fabrication products and the R&D projects are very different product/service and the procedures may need two parts ( one for each type of product, specially in the procedures of the clause 7 product realization) and I think that it can make a mess and the documentation very heavy. I don't know if you have seen that kind of companies and how do they manage this question, I hope that as we advance in the study we could see the answer more clearly but if you could give me your point of view will be very helpful.

Thanks to all, I am new in this forum and it is very helpful.

 

[Ronen E]

Hi,

You got me a little confused.

1) You wrote that your company decided it wants to implement a QMS / ISO 9001 / ISO 13485, yet you need to "explain QMS to the managers". How come they decided to implement something they don't yet understand?

2) You wrote that your company already "has a product in the market" (is it Europe?). I assume it's a medical device. Unless it's a class 1 device your company is most likely already obliged to have a compliant QMS up and running. Otherwise it is in breach of the rules.

WRT your question on options a/b - sounds like option b is not really for you, so keep it simple and just go with option a. All I was saying was that there are no strict "right and wrong", it's up to you.

Cheers,
Ronen.

 

[irelandoem]

What I find very useful is to find a quality manual for a company similar enough to your own to see how they manage their system. Naturally you will have to tailor your QMS to your own companys needs, but this can be a good starting point