ISO 13485, ISO 9001, and AS9100 Combined QMS Manual

W

WisdomseekerSC

#1
I have taken on a big challenge with my new job...establishing ISO 13485 and AS9100 in an ISO 9001 compliant contract manufacturing company. We make precision products for a multitude of industries, including medical device OEM. Customers are desiring and in one case demanding our certification to relevant standards in their industry in order to remain a preferred approved supplier. Top management has weighed the benefits and elected to pursue the aerospace and medical device related standards. I was recruited for this enormous job :mg:. Not complaining (I like a challenge and being employed!). Anyway, I NEED A BRAVE EXPERT in the field to proof read the draft QMS manual that incorporates all these standards into one. Any takers????
 

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howste

Thaumaturge
Trusted Information Resource
#2
I took a relatively quick look through the manual. Here are a few comments intended as constructive criticism:

It looks like you have content from both Rev B and Rev C of the AS9100 standard. Was this intentional? Is the intent to get certification to Rev B first, then to Rev C?

There are some requirements of AS9100 that you are applying to all products. For example 8.3 has the AS9100 requirement for permanent identification or positive control of nonconforming product dispositioned as scrap. Do you really want this to apply to all product?

The manual introduction states that it "delineates authorities, interrelationships and responsibilities of the personnel responsible for performing within the system." It does define some responsibilities and authorities, but it doesn't describe the interrelationships of personnel. I'm guessing that this was mentioned for the ISO 13485 text in 5.5.1. However the manual in 5.5.1 says that this is done in organizational charts.

The manual for the most part is a restatement of standard requirements without any meat. It is mostly policy only, without much detail of "how" your company meets the requirements. Was that the intent? Who was the manual written for, and does it have the information they need?

The manual doesn't identify your company's processes and interactions. Instead it has a copy 'n pasted diagram from the standard that was never intended for this purpose.

I hope this helps...
 
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W

WisdomseekerSC

#3
Your comments have been helpful and I appreciate the feedback very much. I have reached the point where it is "hard to see the forest for the trees!"

The company started reformating the QMS Manual over a canned template before I began my work. The template was to AS9100B. Since then ISO 9001:2008 and AS9100C were published and I was to use the template they had begun using and update it with ISO 9001:2008, ISO 13485:2003 and AS9100C. Therefore, I guess it could contain a mixture of AS9100 B and C versions. I will review that issue.

Non-conforming products (unless accepted by customer concession)are scrapped and cannot be re-worked due to the nature of the materials (extruded polymers).

We do use organizational charts to visualize the interrelation of all personnel who manage, perform and verify work affecting quality. The actual org chart is referenced in the QMS as are many other more detailed documented ("How to") procedures.

The manual is an umbrella policy with reference to the detailed procedures (meat) that have been established for the QMS. Kind of an index using the standards as the basis for the manual. The detailed procedure document number assignments follow the numerical system found in the standards for simplicity and cross-reference :cool: The employees, customers and auditors find this very helpful to navigate and it makes my life less stressful too!

In my opinion... interactions and interfaces of the QMS processes we have established are described well with Figure 2 (I imagine most systems are designed in this manner). Do you have other suggestions or examples of what else I could use? This particular requirement (4.2.2c) is somewhat confusing to us :confused:.
 

howste

Thaumaturge
Trusted Information Resource
#4
Non-conforming products (unless accepted by customer concession)are scrapped and cannot be re-worked due to the nature of the materials (extruded polymers).
You realize that this means once you've determined it's scrap, that the product can't just be thrown in a scrap bin. It needs to be destroyed in some way. Do you want to do this for all product?
In my opinion... interactions and interfaces of the QMS processes we have established are described well with Figure 2 (I imagine most systems are designed in this manner). Do you have other suggestions or examples of what else I could use? This particular requirement (4.2.2c) is somewhat confusing to us :confused:.
If the writers of the standard wanted every company to do the same thing, they would have said to put this diagram in your manual. Instead it says:
The organization shall
a) determine the processes needed for the quality management
system and their application throughout the organization (see 1.2),
b) determine the sequence and interaction of these processes,
It seems unlikely to me that you have only four processes in your system and that their names are Management Responsibility, Resource Management, Product Realization, and Measurement, Analysis and Improvement.

It seems more likely that you have processes that could be named something like Purchasing, Receiving, Contract Review, Document Control, Internal Audit, etc. I've attached an example of another company's diagram describing their processes and interactions. I think it may help you to see the difference.

Again, I hope this helps.
 

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W

WisdomseekerSC

#5
We do mark and then chop-up all product scrap (render unusable) prior to disposal.

OK...the process map in your attachment does make sense! That's why I needed an expert to shed some light on the matter. An example makes a big difference.:paint: THANKS!!!
 
D

dullim

#6
I have taken on a big challenge with my new job...establishing ISO 13485 and AS9100 in an ISO 9001 compliant contract manufacturing company. We make precision products for a multitude of industries, including medical device OEM. Customers are desiring and in one case demanding our certification to relevant standards in their industry in order to remain a preferred approved supplier. Top management has weighed the benefits and elected to pursue the aerospace and medical device related standards. I was recruited for this enormous job :mg:. Not complaining (I like a challenge and being employed!). Anyway, I NEED A BRAVE EXPERT in the field to proof read the draft QMS manual that incorporates all these standards into one. Any takers????
I already go through your QMS Manual, but why you didn't mentioned on your Company Policy???????

Why only RND involve in ur ISO 13485 implementation.....how about Production??
 
W

WisdomseekerSC

#7
GREAT NEWS! :D We sucessfully registered to all three standards (ISO 9001:2008, AS 9100B and ISO 13485:2003) this past fall.

Our R&D section also serves as our advanced materials "specialty manufacturing" division for implantable materials, this is why only R&D was selected for the ISO 13485 certification this round. We will now pursue ISO 13485 registration for our other medical component manufacturing sites over the next couple years.

Also, as a result of auditor comments, I am revising the Quality Manual (see attached draft) to make it more concise and move away from restating the standards clause by clause. It includes our Quality Policy statement too.
 

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D

dullim

#8
GREAT NEWS! :D We sucessfully registered to all three standards (ISO 9001:2008, AS 9100B and ISO 13485:2003) this past fall.

Our R&D section also serves as our advanced materials "specialty manufacturing" division for implantable materials, this is why only R&D was selected for the ISO 13485 certification this round. We will now pursue ISO 13485 registration for our other medical component manufacturing sites over the next couple years.

Also, as a result of auditor comments, I am revising the Quality Manual (see attached draft) to make it more concise and move away from restating the standards clause by clause. It includes our Quality Policy statement too.
Congratulation......actually I still finalize my QMS, ISO 9001 and ISO 13485,our external audit just around the corner. I'm really scared even I had experience to establish ISO 9001 and ISO 14001, ISO 13485 is really new for me .

My doubt is, to choose the best Policy for my Company....the issue is , whether I can put wording "Continually" or not?? . Maybe you can guide and give some comment on below Policy:
1) "TO BE A LEADER IN MEDICAL AND DISPOSABLE PRODUCTS, COMMITTED TO MAINTAIN OUR QMS AND CONTINUALLY IMPROVING THE EFFECTIVENESS OF OUR PRODUCTS TO MEET CUSTOMER'S EXPECTATION AND LEGAL REQUIREMENTS"

2nd Option)" TO BE A LEADER IN MEDICAL AND DISPOSABLE PRODUCTS, COMMITTED TO MAINTAIN THE EFFECTIVENESS OF OUR QMS AND OUR PRODUCTS TO MEET CUSTOMER'S EXPECTATION AND LEGAL REQUIREMENTS"

So, what is ur opinion??
 

howste

Thaumaturge
Trusted Information Resource
#9
Of course you can use the word "continually" in your policy. Just because ISO 13485 doesn't use it, it doesn't ban you from using it. Also, if you are maintaining your ISO 9001 certificate, you need to have wording similar to that in there anyway.

Having said that, ISO 9001 clause 5.3 requires continual improvement of the effectiveness of the QMS, not the product. Neither statement you listed meets that requirement.
 
D

dullim

#10
Of course you can use the word "continually" in your policy. Just because ISO 13485 doesn't use it, it doesn't ban you from using it. Also, if you are maintaining your ISO 9001 certificate, you need to have wording similar to that in there anyway.

Having said that, ISO 9001 clause 5.3 requires continual improvement of the effectiveness of the QMS, not the product. Neither statement you listed meets that requirement.
Dear,
howste
Thanks on ur feedback

But why inside ISO 13485 standard, 5.3 Quality Policy, there is statement to explain the Reason for Differences (between ISO 9001), where its mentioned......
"the text of 5.3 of ISO 13485 eliminates from item b) the commitment to continually improve the effectiveness of the quality management system and substitutes the commitment to maintain the efectiveness of the quality management system. This substitution is consistent with the objective of current regulation and is intended to facilitate the harmonization of quallity managment system around the world"

So, could help me to justify as above statement against my Company's Policy????:bonk:

Best rgds
 
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