Hi everybody,
I’ve been tasked to write a quality manual according to ISO 9001:2000, I’ve never been in quality field before and I have no idea where to start, can you please help me and give me some advices or quality manual templates. I work for a society which is not in production phase yet (just development), so do we need to have a product on market before thinking of this whole thing of quality system and getting certified or can we do it even if we are not in production phase yet. Please help me understand.:confused:
Thanx a lot

Hi everybody,
I’ve been tasked to write a quality manual according to ISO 9001:2000, I’ve never been in quality field before and I have no idea where to start, can you please help me and give me some advices or quality manual templates. I work for a society which is not in production phase yet (just development), so do we need to have a product on market before thinking of this whole thing of quality system and getting certified or can we do it even if we are not in production phase yet. Please help me understand.:confused:
Thanx a lot

Blue_rain,

You posted this question two times before (May 21). My Fellow Covers have provided a lot of good answers and links to various sources. What exactly is it that you do not understand?

Stijloor.

I want to know if we need to have a product on market or no,

…I guess, you really need to have a product (and ofcourse a customer)… unless otherwise your company is involved in innovation or inventing things…

…anyway, just my thoughts… developing a quality management system in compliance with ISO 9001:2000 is not really an overnight job… if your company is really serious in acquiring an ISO certification, they have to give you training in this regards… afterall, it is also a requirements from the management system they want to acquire e.g. human resources which involves competence, awareness & training…

Any company can have a quality manual whether they manufacture a product or not.

I want to know if we need to have a product on market or no,

For registration/certification purposes you must have a working and effective quality management in place. That means a system that produces a product and/or service for customers. The quality manual is part of ISO 9001:2000 requirements. Its purpose is to provide a description of the quality management system and its processes.

Now, if you need a quality manual to provide evidence of a (yet to be implemented) quality management system including a (yet to be produced) product for the purpose of gaining the interest of prospective customers, that's entirely your choice.

You can write a quality manual, but without a working quality system, you can not be registered.

Hope this helps.

Stijloor.

We have previously discussed this here (and quite energetically, if I recall). I looked for the thread, Blue Rain, and could not find it. I don't think I was using the right search function.:)

If I recall, there were some legitimate points across the board, but in general, I believe the general idea was in agreement with Stijloor. You can have a quality policy, procedures and the like, but you need to be producing product to determine its effectiveness.

Did you do a search in the attachments here? I believe there are several examples of quality policies. Hopefully, you can find one near your desired product category.

I would also suggest a good start would be to purchase a copy of the standard. Then, as you read the sections, you will began to see the different areas you will need to address.

As you get to specific parts you are unsure about, you can come back here and check on the sections. For example, if you are unsure of Contract Review, Internal Auditing, Calibration, etc., there are specific forums which address those. Each of those forums are monitored by moderators who are top-notch in the field. Thus, they will provide additional assistance.

Just a couple of words of advice

1) Don't get discouraged. The advice given to doctoral students, authors with writers-block etc. is to write some each day. Just work on it each day, and keep the system flexible. Too, please don't forget to think...most of the time the standard says what to do, not how to do it. Look at your application and approach the standard with common sense and brevity. Your auditor will let you know if you have not covered something adequately, but it's difficult to let you know you have a bloated system.:D

2) Please always remember... this system belongs to your management. They are responsible for it, they need to support it, and most important they should make sure it has sufficient resources. Keep them informed, and make sure they understand it is their system. Namely, the success (or failure) of the system rests with them, not you.

3) One of the first indicators to see if your management is serious about this is to get you and other key people some training. Minimally, personally I would suggest some internal auditing training. The internal auditors in your organization are important to the continual improvement of the process (IMHO). Too, the more you see life through the eyes of an auditor, the more you understand the awesome task they have.

Anyway, thanks for dropping by. All here enjoy helping people, and seeing QMS become truly effective and helping the organization, and not becoming a weight tied around everyone's leg.:)

Copying your last paragraph
"You can write a quality manual, but without a working quality system, you can not be registered."
I can only add that is not a matter of choice, it is that Authorities like EASA or FAA auditors, in order to certify you as 145 facility, they need to see a product belonging to customer, is comming out from your production line. And my questiuon is How they expect me to have a product from a customer, since not yet certified, although I have everything in place like organization exposistion (quality plan) approved, and all personnel certified and equipment calibrated and, and but no product!!

Something not covered very well in the responses so far (mentioned once but not much emphasis) is that in ISO 9001:2000 the terms "product" and "service" are interchangable.

If you are a service provider and have no physical product, you need to activly be in business providing that service to be registered. That would be the circumstance in which you would not need a product.

I can only add that is not a matter of choice, it is that Authorities like EASA or FAA auditors, in order to certify you as 145 facility, they need to see a product belonging to customer, is coming out from your production line. And my question is How they expect me to have a product from a customer, since not yet certified, although I have everything in place like organization exposition (quality plan) approved, and all personnel certified and equipment calibrated and, and but no product!!

I feel your pain!:yes: That's kind of like the old trade-off where no one will hire you because you don't have experience. But you can't get experience if you can't get a job!:tg:

I would defer any type of response on the facility certification to the subject matter experts, but I would think you could get some kind of preliminary certification to begin to make product. As I said, though, that's merely conjecture on my part.

Something not covered very well in the responses so far (mentioned once but not much emphasis) is that in ISO 9001:2000 the terms "product" and "service" are interchangable.

If you are a service provider and have no physical product, you need to activly be in business providing that service to be registered. That would be the circumstance in which you would not need a product.


Good points, Jim, and good you pointed out the service element. I wish I could find that thread where we discussed this before, and too, it's always worth discussing again.:yes:

I must admit the "effectiveness" angle really never sank in well until I went through my 17025 training. OK, so you have a system, nice forms, procedures and the like. But is the program effective in achieving the results desired? I say it's a fair question.

I wish I could find that thread where we discussed this before, and too, it's always worth discussing again.

Brad, are you referring to this recent discussion? Implementing ISO 9001 in a Startup Business (http://elsmar.com/Forums/showthread.php?t=27530)

many thanx for everyone

Brad, are you referring to this recent discussion? Implementing ISO 9001 in a Startup Business (http://elsmar.com/Forums/showthread.php?t=27530)

Thank you, Harry, for the thread. That is a good one, but not the thread I was thinking about. We had a discussion regarding having a QMS, seeking registration, effectiveness and the like without producing a product/service. I spent about 15 minutes looking for it, but could not find it.:( I thought I remember it being three-four pages long.

Brad, is it this one (http://elsmar.com/Forums/showthread.php?t=27578)?

Again, and this is addressed to anyone is willing to help in that respect. I am not referring to a...Super-market business ISO certification, but for EASA 145 Repair facility certification that the authorities are demanding to see a repairable product (part) going in the production line, although I am not yet officially certified. In other worlds where is written that authorities need to see that.
I guess Brad understood but no solution! If this has been discussed already (for this specific problem, and I am not referring to ISO, please give me a reference. Thanks

...well, if you are referring to EASA 145 Repair Facility Certification, of course you’ll have to have a product to have a quality manual… (so many "have" there huh?)... :)

…anyway, we are only EASA Part 145 & 147 approval, so I cannot really give you the exact references for repair facility… but knowing one of our co-existing company here (SR Technics), they do have quality manual since they are considering their “services” as “products”.. and if you are going to read their quality manual (specifically for their repair facility certification), they’re discussing all about quality management system on their repair & maintenance activities…

…btw, this topic should be in AS9100 and other Aerospace Standards and Requirements forum, is it?

...

…btw, this topic should be in AS9100 and other Aerospace Standards and Requirements forum, is it?

Not according to the OP.........ISO 9000:2000

...ok...

Still, As it is known, In order to be examined for EASA 145 you need to provide your company quality plan for approval or "Organization Exposision" Quality plan for approval, but why I need an "electromechanical actuator" overhauled from a customer (elegaly since not yet approved) in order to prove my capability since everything else has been setup. And please no more of any ISO, I am talking about regulation! and relevant certification, that ISO 9XXX is not yet. Thank you again

And please no more of any ISO, I am talking about regulation! and relevant certification, that ISO 9XXX is not yet. Thank you again

Since you 'hi-jacked' a thread which was about ISO 9000, then that's why there are references to ISO, here. If you feel strongly about the 'purity' of the answers for your question, perhaps you can make your own thread...........

...I told you, I have a feeling that whether this inquiry is in the wrong thread, or you have the wrong thread for this inquiry?...

...why you need an “electromechanical actuator" overhauled from a customer?... let me guess, probably overhauling of this electromechanical actuator is part of your services being offered to your customer… and this is considered as “product”… and if we are on the same boat, we agreed that you’ll have to have a product to have a quality manual… and by having this overhauled electromechanical actuator from your customer means that you are producing a “product”, which involved processes that are controlled by your quality manual…

...and this is part of EASA 145 regulations...

...and no ISO has been mentioned on that regulations...

Since you 'hi-jacked' a thread which was about ISO 9000, then that's why there are references to ISO, here. If you feel strongly about the 'purity' of the answers for your question, perhaps you can make your own thread...........

AndyN,

Please forgive me if you sence a kind of "attack" in my expresion that was more a lack of good english language rather than but intention. My only concern is to get directly to the point avoiding reciprocation right from the start if possible. Something that my english doesn;t help I see.
Thanks anyway.:rolleyes:

...I told you, I have a feeling that whether this inquiry is in the wrong thread, or you have the wrong thread for this inquiry?...

...why you need an “electromechanical actuator" overhauled from a customer?... let me guess, probably overhauling of this electromechanical actuator is part of your services being offered to your customer… and this is considered as “product”… and if we are on the same boat, we agreed that you’ll have to have a product to have a quality manual… and by having this overhauled electromechanical actuator from your customer means that you are producing a “product”, which involved processes that are controlled by your quality manual…

...and this is part of EASA 145 regulations...

...and no ISO has been mentioned on that regulations...

Joshua sx1,

1. Facility is available and fully equipped
2. Personnel are available and fully certified
3. Quality plan "organization exposition" in place and approved
4. No product (Actuator) yet, since the customer (organization) need to see EASA certification first, to provide the part for repair.
5. To avoid further confusion we are ISO 9001/2000 certified, but as I said, it does not help.
6. Still the inspectors of EASA need to see a physical product (actuator) coming out of production line (repair) for certification of the company.
Question: are they right? Where is this written? Why they force me to illegally (no certification yet) process a part for repair.
If you feel tired with this, please accept my apology, besides this will be my last message for the subject from my side, except if there will be any response.

But again this inquiry is either in the wrong thread, or I have the wrong thread for this inquiry?...


Since you 'hi-jacked' a thread which was about ISO 9000, then that's why there are references to ISO, here. If you feel strongly about the 'purity' of the answers for your question, perhaps you can make your own thread...........

On the other hand, you ware kind enough to remove my teeth, although I had the pain in my leg just because I erroneously entered to a dentist office as quait new as I am!:biglaugh::thanks:

AndyN,

Please forgive me if you sence a kind of "attack" in my expresion that was more a lack of good english language rather than but intention. My only concern is to get directly to the point avoiding reciprocation right from the start if possible. Something that my english doesn;t help I see.
Thanks anyway.:rolleyes:

No problem, I just wanted to make sure the OP got their answer and you got yours, without the 'message' being diluted.

BTW your english is better than my - ' your language' - (I only speak a little French and Dutch);)