HELLO!
My name is Ivan.I am Quality Manager in aviation company,both Air Operator and Maintenance Organization JAR OPS 1 and Part 145 approved .Aviation regulations JAA's JAR OPS1/3 determines the requirements for Quality System of the Air Operator,and (EC) 2042/2003,which determines the requirements for the QS of the Maintenance Organizations.

In the same time I have read enough information about Standards in airspace and I'm certified ISO 9001:2000 auditor.

My quеstion is :Had anybody tried to integrate AS 9100 and Quality System, prescribed in mention above aviation regulations.

Very soon I'll be ready with the my suggestion (for your opinion) about similar Quality Manual, but I meet some difficulties to implement aviation product - a service,as a process ,which is subject of very frequently inspections of the Authorities and of the own QS of the Operators and MO , in contens of the typicaly ISO 9001:2000 Quality Manual. I'm ready to disscus this issue with the competent specialists in this area and I 'm ready to view and hear for any samples about this.

Thank you in avance!

HELLO!

My quеstion is :Had anybody tried to integrate AS 9100 and Quality System, prescribed in mention above aviation regulations.

Very soon I'll be ready with the my suggestion (for your opinion) about similar Quality Manual, but I meet some difficulties to implement aviation product - a service,as a process ,which is subject of very frequently inspections of the Authorities and of the own QS of the Operators and MO , in contens of the typicaly ISO 9001:2000 Quality Manual. I'm ready to disscus this issue with the competent specialists in this area and I 'm ready to view and hear for any samples about this.

Thank you in avance!

I'm a competent specialist in the area and AS9100 is a Quality System and it's based upon ISO 9001:2000.

Are you sure of your credentials and background?

Are you sure of your credentials and background? :topic: Let us not forget that we all started somewhere. None of us were 'competent' when we started. We took up a challenge, we learned and over time we each developed a certain amount of 'competence'.

My first ISO 9001 implementation about 17 years ago was based upon what I read in the standard. Nothing more. The registration audit was 'first audit' successful (and the company didn't even go through a pre-assessment). I would suggest that no one would have called me either experienced or 'competent' per se at the time. This isn't 'rocket science.

Hello
The Requirements for the Air Operator's Quality System are prescribed in JAA Regulation JAR OPS 1, Section 1 - 1.035 and in Section 2 Acceptived Means of Complience - AMC 1.035 .There are scope,subjects,contents of the Quality Assurance Programme,a mandatory inspections and etc.Each Quality Manager must include all of these items in his Annual Quality Audit Plan.All of the items, included in Approval EASA Form 6 and 13 for the MRO and Part M Subpart G CAMO - too.So ,because our present QM is based of the standard ISO 9001,but we are no sertified ISO 9001, and it need to be amend,having regard these requiered areas of focus to be monitored.And that is why I need to understand if anybody had done attempt to collect requirements for the ISO 9001,or 9100 Quality Manual and requirements of the Aviation Regulations concerned QS of the Air Operators ,Continuing Airworthiness MO (CAMO) and MRO in one Quality Manual and is ISO 9100 Quality Manual appropriated for this.

Forgive me, you weren't clear in your previous post. I thought you were asking about basing a 9001 QMS on AS9100.

I wish I could help you with this one regarding the JAA Regs.


On another note, a Quality Manual is a Quality Manual under ISO 9001 or AS9100. As long as you put the minimum information required in it you can add whatever you want.

Hello
The Requirements for the Air Operator's Quality System are prescribed in JAA Regulation JAR OPS 1, Section 1 - 1.035 and in Section 2 Acceptived Means of Complience - AMC 1.035 .There are scope,subjects,contents of the Quality Assurance Programme,a mandatory inspections and etc.Each Quality Manager must include all of these items in his Annual Quality Audit Plan.All of the items, included in Approval EASA Form 6 and 13 for the MRO and Part M Subpart G CAMO - too.So ,because our present QM is based of the standard ISO 9001,but we are no sertified ISO 9001, and it need to be amend,having regard these requiered areas of focus to be monitored.And that is why I need to understand if anybody had done attempt to collect requirements for the ISO 9001,or 9100 Quality Manual and requirements of the Aviation Regulations concerned QS of the Air Operators ,Continuing Airworthiness MO (CAMO) and MRO in one Quality Manual and is ISO 9100 Quality Manual appropriated for this.


Ivan, I very well understand your problem. Unfortunately, you did not indicate your country, however, I assume it must be within Europe since you referred to the EC-regulations.

I think the main problem of a one-manual-concept is that there are two parties that need to accept/approve the manual:
1. for JAR OPS/Part 145 etc. the competent authority
2. for EN 9100 the regulator (maybe even the customer)

Even if you manage to include all the requirements into one manual and to show compliance by means of cross-reference lists, it might become difficult if the manual needs to be amended, especially in those parts/procedures of the manual that cover both the aviation and the EN 9100 requirements. The handbook will need acceptance/approval by both parties........ What if the two parties do not agree with the requirement of each other?

I am currently trying to make a proposal to the competent authority for a one-manual-concept of a company that requires EN 9100 certification and Part 21 manufacturer and 145 maintenance approvals. In my opinion, one manual would be more suitable for the employees of the company. A lot of procedures/processes can be used for any of the certification/approval and I cannot see the sense of having different books with duplicated procedures (just think of the additional work involved in the control of the documents).

My idea is to have one general top quality management manual (EN 9100)which is supplemented by an Appendix that covers both Part 21 and Part 145.

Then there will be a pool of procedures/forms that will cover any procedures/forms required by EN 9100 and Part 21/145.

In addition, there will be cross-reference lists that show compliance of each of the requirements (EN 9100, Part 21, Part 145) against the different parts of the quality management manual.

Only those parts of the manual that affect the related certification/approval (see cross reference list) will be submitted to the regulator/competent authority for acceptance/approval.
Of course, there are still those procedures that are applicable for any of the requirements - it needs to be a well-figured-out system.

Hope that helps!

Regards, Angelika

Quality Systems of Air Operators and MRO ,are mandatory condition for issuing The Air Operator Certificate and continuing the Approvement ot the MRO.The requirements ,determining the manner of applying these QS,contents only specific subjects,to be checked.In these requirements haven't nothing mentioned about some clauses,included in ISO 9001.For instance, these QS have to monitor and check compliance with the aviation regulations,prescribed in relevant documents,definit aereas,and nonconformances(in aviation they are named "findings") have to be documented and Quality Mangers must issues CAR,and observes follow-up actions.There are no requirements about preventive actions,QS approvement,key indicators or somthing about Clauses of the ISO 9001 ,determining measuriement of the processes,not even about any processes,as it is prescribed in ISO 9001.So,because these QS are mandatory element of the aviation companies,some managers are not convinced that QS prescribed in ISO 9001 are nessesery to be implement.Thery are not convinced that ISO 9001 will improve all of the activities,till anybody will be availible to show them with measured evidences applicability of the ISO 9001 QS,and these managers decide to think about certification of ISO 9001.That is why I 'm trying to develop QS in my company based on the ISO 9001 or 9100,but meet all of the mandatory requirements in aviation regulations,That is what I had in my mind ,when I mentioned about "competent" person(may be this is not the most appropriate words and I want to apologyse anybody who it may concern )
How practicaly to connect the mandatory(scoped all of the issues considering flight safety,air worthiness of the A/C and Maintenance) QS of the aviation company with ISO 9001 or 9100 QS,which concern processes flowing in any organization?When I automaticaly include the scope of the subjects prescribed in JAR OPS 1.mandatory to being checked annualy,where is the most appropriate place in Quality Manual in Section 4 QMS -General equirements or Section 7 - cl.7.2.2 Review of requirements related to the product.

Angelika,Thank you for your advice.I'm from Bulgaria .
I'm preparing one manual concept,based on ISO 9100 and I'm intending to include in Section 4 QMS - Requirements in accordance with JAR OPS 1 1.035 and AMC OPS 1.035,and because we have and approved 145 MO too, as well requirements about the QS in the EC 2041/2003 Part M M.A 712 and Part 145- 145.A.65.After that I think to include in QM 7.1 Planning of product realization a commitment about ensuring safety and the compliance with mandatory scope of monitoring of the QS -the "Annual Quality Audit Plan " - as mandatory enclosed document,which is the most important document that Authority and EASA inspectors looking for.
But ,may be your suggestion about 2 parts of the QM,the first to satisfy JAA and EC requirements and second based on the ISO 9001 and involved all of the processes flowing in the Organization will be more convenient.I still don't image myself how it'll be seem
So when I 'll be ready with my suggestion about QM I'll share it for advices and opinions.I'm accepting any other suggestions and advices in this matter.
Best Regards

Angelika,Thank you for your advice.I'm from Bulgaria .
I'm preparing one manual concept,based on ISO 9100 and I'm intending to include in Section 4 QMS - Requirements in accordance with JAR OPS 1 1.035 and AMC OPS 1.035,and because we have and approved 145 MO too, as well requirements about the QS in the EC 2041/2003 Part M M.A 712 and Part 145- 145.A.65.After that I think to include in QM 7.1 Planning of product realization a commitment about ensuring safety and the compliance with mandatory scope of monitoring of the QS -the "Annual Quality Audit Plan " - as mandatory enclosed document,which is the most important document that Authority and EASA inspectors looking for.
But ,may be your suggestion about 2 parts of the QM,the first to satisfy JAA and EC requirements and second based on the ISO 9001 and involved all of the processes flowing in the Organization will be more convenient.I still don't image myself how it'll be seem
So when I 'll be ready with my suggestion about QM I'll share it for advices and opinions.I'm accepting any other suggestions and advices in this matter.
Best Regards

Ivan, I agree with both of your latest threads. Infact, aviation regulations do not require processes like "management review, continuous improvement, customer satisfaction and so on". However, if your customers require all that by demanding the EN 9100 certification, you have no choice but to find a way how to satisfy their demands. That's how things work nowadays...... The main differences between 9100 and aviation regulations are that, in addition to the "usual" realisation and support processes

a) 9100 requires strong, measurable processes, quality objectives, customer satisfaction, continous improvement, a more enhanced system for preventive and corrective actions" and so on

whereas

b) aviation regulations require more the airworthiness safety aspects like "occurrence reporting, issuing airworthiness certificates, control of aviation legislation" and so on.

So the best thing is to issue a matrix showing all the processes you need i.a.w. 9100 and to add the additional process of JAR OPS 1, Part 145 and Part M.

Then you have a basic instrument to work on your manual.

The reason for my issuing an appendix to the "main" quality manual is that I want to offer the competent authority the opportunity to approve the aviation-relevant part of the handbook - at least this is a requirement here in Germany.

However, these are all possible ways to proceed. In the end, first of all you should try to talk to the responsible person of the competent authority because in the end they will have to accept the concept of your manual.

I find it very interesting that you started this discussion because I, myself, have been struggling a lot in finding ways how to manage that all. However, assuming, that such things may be somewhat different all over the world, I have never asked that kind of question (I think there are only few persons from Europe who participate in this forum).

It would be really interesting to have further opinions on that.

I'm afraid though our comments will not really "fit" into the present title of our threads. Maybe one of the moderators can help?

Thanks a lot and kind regards from a sunny Germany.
:topic:Spring is about to come here and everybody immediately is in a much better mood!:

I sent 4 samples (attached file) - the contens of QM,and if anybody have suggestion about the appropriate contents of the future QM (please mix the items in the contens),in complience with the Aviation Regulations and ISO Standards ,please sent back .If the idea with 2 parts QM is more applicable,please confirm.

I recieve the message ,that in the Forum has been created new Thread"Integrating EN ISO 9001 with JAA Regulations, QS, CAMO & MRO ".I 'll send my previous message in this new Thread and continue to disscus the issue.I think ,that Angelika is quite right .May be Part 1 should be meet the requirements of the ISO 9100 QM and will be in the purpose to be use from the clients,subcontractors,suppliers(second party audits),surveys of the QS and will includes all of the processes,interconnections and ...Part 2 ,which is the subject of approval from the Authority should cover all of the aspects prescribed in JAA and EC Regulations,and shall content only links to the procedures or have already subscribed clauses in the Part 1.Because some issues like Management commitment,policy,internal audit,Auditors - requirements for qualification,are general issuesfor the both Parts.An Appendix with the mandatory procedures as it prescribed in ISO 9001,and In the Part 2 should be mark references to these procedure ,because "Document Management"."Management of the Records " and "Internal Audit" have to serve two Parts.What will be the result?:confused:Will see.:(
http://elsmar.com/Forums/attachment.php?attachmentid=8269&d=1203881261

For what it's worth:
It's been my experience that many of the Standards which an organization may choose to adopt for their operations have a lot of common elements (record-keeping for one example.)

The question facing organizations which choose to adopt several different Standards is whether to create a different "manual" for each Standard or try to integrate the various requirements into ONE manual.

The primary worry with the multiple manual solution (usually undertaken with a nod toward making auditing of a single Standard easier) is that it is cumbersome and inefficient for the employees of the organization.

One solution I have found (BEFORE AS9100) to combine both ISO 9001 and FAA requirements into one manual was to create a matrix of the two Standards showing where each element of each Standard could be found in the one Quality Manual appended as an exhibit in the back of the manual. FAA, in particular, had inspector/auditors who were adamant that the EXACT WORDING of some parts of the FAA regulations had to be included in the manual. With that in mind, I included sections which contained that boilerplate.

Over the years, my personal observation was that outside auditors for customers and ISO Standards were MUCH more flexible in looking at and interpreting a manual to meet their requirements than the inspector/auditors from FAA.



:topic:Most of the Standards and Regulations are compatible with each other, but I have found one instance where one Standard differed materially from the Standard upon which it was based. ISO 13485 (medical devices) specifically omits "continual improvement" even though it is based on !SO 9001. Some organizations combining both Standards (especially where medical devices are only a portion of the business of the organization) get around that by considering "continual improvement" as a "research and development" activity.

Hello Ivan
In my opinion, you should not be attempting to seek AS9100 approval for an operations and maintenance organisation. AS9100 is for the manufacture of aerospace components and if you do not do this then the standard is not applicable.

If you wish to have an external certification, you could consider a number of other operational / maintenance audits such as LOSA or something similar.