My question is, the doc# UG.CAO.00132-001 only required to be meet by all foreign organisations located outside the EU?
The document states:
0.3. Scope and applicability
EASA is the Competent Authority for maintenance organisations having their principal place of business located outside the EU, as established by EASA Part 145.1 “General” and is therefore responsible for the final approval of these maintenance organisations and for establishing procedures detailing how EASA Part-145 applications and approvals are managed.
This user Guide is applicable to EASA Part-145 applicant and EASA Part-145 AMOs’ (hereafter referred as maintenance organisations) having their principal place of business located outside the EU Member States and which are not certified under the provisions of a bilateral agreement signed with the EU.
So the document applies to maintenance organizations physically outside of the EU.
Another question is, if our organization would like to calibrate our equipment in-house, is it really compulsory for the in-house calibration lab to be accredited to ISO17025 or traceability of our master is sufficient enough?
This document refers to compliance with EASA Part 145.A.40(b) which says:
(b) The organisation shall ensure that all tools, equipment and particularly test equipment, as appropriate, are controlled and calibrated according to an officially recognised standard at a frequency to ensure serviceability and accuracy. Records of such calibrations and traceability to the standard used shall be kept by the organisation.
In order to meet this requirement this document says:
10.2.3. Calibration in accredited laboratories
In order to comply with Part-145.A.40 (b) the maintenance organisation shall ensure that:
(a) tooling are periodically calibrated in accordance with the manufacturers’ published standards and recommendations.
(b) where no recommendations for calibration are published or where the calibration methods or standards are not specified, calibration is carried out in accordance with the requirements of the ISO 10012. This standard details both the generic requirements and guidance for the implementation of measurement management systems.
Both (a) and (b) above shall require the tooling to be calibrated in a test laboratory accredited to the ISO/IEC 17025 standard, by an accreditation body acceptable to the European Aviation Safety Agency.
Only a laboratory accredited by an “Accreditation body” which is signatory of the ILAC MRA is considered acceptable to EASA, considering that in this case traceability through the assessment and accreditation process under ISO/IEC 17025 has already been established.
It is clear from reading this that tooling is REQUIRED to be calibrated in a 17025 accredited laboratory. I believe the assumption here is that the organization has its tooling calibrated by an outside lab, not an internal lab. If an internal lab is used it MUST meet the same requirements.
Can you just verify your tools and jigs yourself without 17025 accreditation. There is an entire section of the document that deals with this:
10.2.5. Calibration in non-accredited laboratories
In exceptional cases the maintenance organisation may need to send tooling to a laboratory which is not accredited.
For this type of laboratory EASA considers that traceability through the assessment and accreditation process under ISO/IEC 17025 has not been established.
Therefore, the maintenance organisation shall demonstrate that:
the need to use a non-accredited laboratory, is evaluated and accepted by the assigned inspector. The assigned inspector shall report the use of non-accredited laboratory to EASA and;
The volume of tooling and equipment calibrated using a non-accredited laboratory shall be kept as lower as possible, and;
Its responsibilities are appropriately discharged by complying at least with the following conditions....
The "following conditions" is a 2 page checklist which allows you to demonstrate that you are following the requirements of 17025. It is basically going through the processes of accreditation, ending with this paragraph:
The MOE or referenced Tool Calibration Procedures Manual shall explain how the requirements of Part-145.A.40 are achieved, and how the maintenance organisation’s quality system ensures that the non-accredited calibration facility is complying with the minimum requirements in respect of the above topics.
No, you don't need to be 17025 accredited, but you have to have an equivalent system in place and be able to prove that you do.
