Do we need a product to have a quality manual (FAA/EASA 145 included)?

[blue_rain]

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.
Thanx a lot

[Stijloor]

Originally Posted by blue_rain

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.
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.

[blue_rain]

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

[joshua_sx1]

…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…

[Marc]

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

[Stijloor]

Originally Posted by blue_rain

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.

[BradM]

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.

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.

[Turbomark]

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!!