If I knew then what I know now
FLYBOYJ,
Two years ago our Certified FAA Part 145 Repair Station organization was required by a major customer (government contract) to become ISO 9001:2000 compliant. We were not required to have 3rd party registration either, but went for registration anyway and got it.
Per ISO 9001:2000 Quality Management Systems Requirements (clause 1.2 Application) allows for exclusions within clause 7 of the standard. We excluded only clause 7.3 Design and Development requirements since we do not manufacture anything either. All other clauses of the ISO standard are included and covered in our ISO Quality Management System (QMS) documented Quality Manual (QM) and Quality System Procedures Manual (QSPM) and under totally separate cover from our FAA Repair Station Inspection Procedures Manual, etc.
My FAA PMI has interest only in the required FAR PART 145 RSM too. And I don’t want him to care in the least about our ISO QMS. If my FAR and ISO manuals were all rolled into one document system (as AS-9110 implies), we’d have a nightmare from h*ll on our hands. My PMI’s favorite speech about manuals is, “Say what you do, and do what you say”; “That’s what I’ll be looking at when I come to perform surveillance at your repair stations.” “If it’s in your RSM, you better be doing it.” That is why I have two separate documented quality systems, one to satisfy FAA regulatory requirements and the other to satisfy the ISO standard.
I wrote our repair station’s FAR Part 145 manuals when the new regulation went into effect. My PMI was very pleased with it, because it covered all the SHALLS required for the FAA manual and his acceptance. ALL PROCEDURES are fully contained and documented within the Repair Station Manual System. When I began writing the ISO documented quality management system manuals, a considerable amount of my PROCEDURES/PROCESSES were already in place in the FAR QSPM. So where I had existing PROCESSES/PROCEDURES, I made reference in my ISO manual documentation back to the FAA QSPM.
For instance ISO clause 7.6 Control of monitoring and measuring devices is already covered in my FAA QSPM so I make reference only in my ISO manual back to my FAA manual for tool calibration control processes (procedures).
My ISO Registrar Auditors are happy
with this setup and find it to be in conformance with the standard. Again, my FAA PMI cares only about FAR manual content and doesn’t see any of the ISO manuals content. On the other hand my ISO 3rd party auditors see both the ISO and FAR manuals.
Through the process of learning the ISO language, I came to realize that SERVICE IS our PRODUCT, that ISO was originally written for manufacturers, and that the ISO language has transitioned to cover service industry as well. So when reading the word PRODUCT in the ISO standard, I translate the word to mean SERVICE.
Excluding clause 7.3 Design and Development (as mentioned above for justified reason) ALL OTHER SHALL STATEMENTS of ISO 9001:2000 are included in our QSM QM and QSPM. Again, with emphasis I state that all requirements of the standard (with the exception of 7.3) are included in our QMS, and we work all of these processes every day.
In conclusion (for this message), I’d like to say that had the decision been mine, I would have only accommodated the government (military) contract request for becoming ISO 9001:2000 COMPLIANT only. But it was not my decision to make. The only thing my Government Flight Representative (GFR) and in-house DCMA representatives are interested in, regarding ISO 9001:2000 compliance, is that we have QMS processes that we follow regarding the terms of the contract.
In my opinion the reason these government military aircraft contract terms require ISO compliance ONLY is that it simplifies (for the government) the writing and enforcing of the contract, because then the ISO manuals can be referenced in the contract, rather than all the content that ISO 9001:2000 contains.
FLYBOYJ, do you have a full set of the ISO standard (e.g. ISO 9000:2000, ISO 9001:2000, ISO 9004:2000)? How much time have you been given to become ISO compliant? Are you attempting to write the manuals yourself? Do you have FULL commitment, support (resources) and understanding from you Top Executive Management?
I’ve been where you are now, and work every day in FAA/EASA/ISO world of compliance/conformance. It ain't easy but it is possible!
Muleskinner – Quality Systems Director
FORUM MODERATOR @ The Cove
GIT-R-DONE! 
