Calibration and Verification requirement for foreign EASA Part 145

#1
Hi everyone

Greetings

I am from a company that repair aircraft engine located in Asia.

As per EASA part 14 doc# UG.CAO.00132-001, it’s written the calibration needs to be done by an ISO17025 calibration lab.

My question is, the doc# UG.CAO.00132-001 only required to be meet by all foreign organisations located outside 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?

Other than that, we have a lot of jigs and fixtures in our repair shop. These jigs and fixture would fall under the verification only category as no calibration is done (no adjustment can be made). We would like to verify these jigs and fixtures internally. My question is, may I know does the verification of these jigs and fixtures also require to be verified by a lab under ISO17025? Can we just verify these tools and fixtures internally using a traceable CMM machine without having the lab to be ISO17025 accredited?
 
Elsmar Forum Sponsor

dwperron

Trusted Information Resource
#2
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.
 

AEOS_QA

Involved In Discussions
#3
The specific section 10.2 regarding "Tooling Calibration in a ILAC Accredited Laboratory", has a 24 month transition period so I hope some more guidance material may come out before the transition period ends in March 2018.

This will be a very costly requirement, especially in regards to sending specialised equipment to the OEM, as many of them are not ILAC approved.

The other big problem is Hydraulic and Oxygen Test stand flow meters which need to be removed and replaced with a 2nd calibrated unit to avoid costly downtime of the test stands. At least double the price for External ILAC calibration and double the actual units to be calibrated.
 
#4
this requirements are applicable to all foreign organisations located outside the EU
Calibration activity is non part 145 activity so your in house calibration shall be iso 17025 accredited
 
#5
This UG has now been revised with the removal of the "Non Accredited Labs" option.
The issue now is that the statement is : A calibration laboratory accredited to ISO/IEC 17025.......... where the scope of accreditation specifically covers the intended calibration" Ref 9.2.4
This now means that you must be ISO 17025 accredited with a scope that covers every single item you want too calibrate.

Makes life pretty difficult, especially for developing labs that wish to add capability it seems as you will only be able to perform the calibration once you add it to your Accredited Scope.
 
#6
Can you kindly guide me about the latest revision UG.CAO.00132-002

Does a calibration lab need to be 17025 accredited in all the scope to perform calibration? Or is there any concession on the final dates
 

dwperron

Trusted Information Resource
#7
This version still refers to EASA Part 145.1, so the requirement that the calibration lab be 17025 accredited still stands. Yes, the work must fall within their scope of accreditation. They did add two new options in section 9.2.4 in case a 17025 accredited lab is not used:

(c) original tool manufacturer identified in the approved maintenance data, provided it is supported by a calibration or accuracy statement, or;

(d) calibration entity which is acceptable in an EASA POAH or Production Organisation under bilateral agreement with the EU. This option is limited to tooling which are the ones specified by the maintenance data (not applicable to alternative tools in use by the production organisation)

As for a concession on the implementation date, section 0.5 reads:
A transition period until 31/12/2018 is provided for implementation of calibration requirements defined in paragraph 9.2.4.
 
#8
As the implementation date has now passed, any lab that is currently performing calibrations for a Foreign (Non EU) EASA 145 organisation should have a scope of accreditation that specifically covers the calibration being performed.
 
Thread starter Similar threads Forum Replies Date
T Calibration or Verification -> Cm and Cmk, etc. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
M Calibration or Verification? What terminology to use ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
V Calibration certificate verification Qualification and Validation (including 21 CFR Part 11) 3
G Assigning a calibration tolerance - An x-y coordinate machine - Uncertainty as my verification tolerance General Measurement Device and Calibration Topics 4
J Calibration/Verification Records (IATF 16949 7.1.5.2.1) IATF 16949 - Automotive Quality Systems Standard 5
D How to set equipment calibration/verification criteria General Measurement Device and Calibration Topics 1
E IATF 16949 Cl. 7.1.5.2.1 - Calibration and Verification Records Requirements IATF 16949 - Automotive Quality Systems Standard 1
J IATF 16949 Cl. 7.1.5.2.1 - Gauges (Measuring Jigs) Calibration/Verification Records IATF 16949 - Automotive Quality Systems Standard 6
M Clarification on Calibration/Verification Records 7.1.5.2.1d (IATF 16949) General Measurement Device and Calibration Topics 11
B Calibration/Verification Records - IATF 16949 section 7.1.5.2.1 f) IATF 16949 - Automotive Quality Systems Standard 6
P IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation IATF 16949 - Automotive Quality Systems Standard 12
J Pneumatic & Electrical Torque Tool - Calibration/Verification of 'Power Tools' General Measurement Device and Calibration Topics 2
Q Using Caliper A to verify Caliper B - Verification of Calibration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Verification instead of calibration?(ISO 9001:2008) Calibration Frequency (Interval) 10
K "Verification of Calibration" - CMM arm General Measurement Device and Calibration Topics 6
I Verification or calibration Fluke 8508a with 5720a? TUR not 4:1? Measurement Uncertainty (MU) 1
Q Number of Calibration Verification Points - Calipers, height gages, etc General Measurement Device and Calibration Topics 6
A Calibration/Verification of thermo-hygrometer in storage areas ISO 13485:2016 - Medical Device Quality Management Systems 9
G Is this Calibration or Verification ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
D How Working Standard Calibration result use in Verification of Equipment General Measurement Device and Calibration Topics 7
M Calibration Certification Qualification vs. Verification by Uncertified Staff General Measurement Device and Calibration Topics 6
AshleyE Torque Wrench Calibration/Verification General Measurement Device and Calibration Topics 24
G BRC (British Retail Consortium) - Calibration vs. Verification Food Safety - ISO 22000, HACCP (21 CFR 120) 4
G TS-16949 7.6.2 ? Calibration/Verification Records - Assessment of the Impact IATF 16949 - Automotive Quality Systems Standard 5
JodiB Balance Calibration Verification question General Measurement Device and Calibration Topics 9
JodiB Log Book for Analytical Balance Calibration Verification General Measurement Device and Calibration Topics 4
Uriel Alejandro How to Record Evidence for Verification/Calibration of Equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Establishing Ranges for Weights for Calibration Verification of a Micro-Balance Calibration Frequency (Interval) 1
H Analytical Balance Calibration and Verification General Measurement Device and Calibration Topics 9
D Precision Balance Verification and Calibration Process General Measurement Device and Calibration Topics 3
D Equipment Verification and Calibration Report Standard General Measurement Device and Calibration Topics 9
P Record Retention requirements of Calibration and Verification Service Providers ISO 13485:2016 - Medical Device Quality Management Systems 11
K Calibration and Verification Records - TS 16949 Clause 7.6.2 General Measurement Device and Calibration Topics 8
P Is it compulsory to send new measuring equipment for calibration / verification? Calibration Frequency (Interval) 3
D Calibration vs. Verification and Measurement Device Labeling General Measurement Device and Calibration Topics 10
M Basis used for Calibration or Verification of Measuring Equipment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D For Reference Only or Calibration/Verification - Tape Measures for cutting bar stock ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
M Methods for Verification/Calibration of Video (Optical) Extensometer General Measurement Device and Calibration Topics 2
C Updating our Laboratory Calibration / Verification Procedures IATF 16949 - Automotive Quality Systems Standard 5
R Verification vs. Calibration and what to do with the results of each General Measurement Device and Calibration Topics 3
B Difference between Calibration & Verification and How to calibrate Go/No Go gauge? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Audit and Calibration question - does verification alone meet the requirements? General Auditing Discussions 5
D Calibration vs. Verification - Can we calibrate dial indicators in-house? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P Internal Calibration or Verification - Personnel Requirements IATF 16949 - Automotive Quality Systems Standard 3
S Verification of calibration certificate Miscellaneous Environmental Standards and EMS Related Discussions 1
R Calibration (Verification) of RF cables General Measurement Device and Calibration Topics 2
M Telescoping Gage - Calibration or Verification General Measurement Device and Calibration Topics 5
L Difference between Calibration, Verification and Adjust (Adjustment) General Measurement Device and Calibration Topics 6
C Verification vs. Calibration of Dial Weight Dynamometer General Measurement Device and Calibration Topics 4
A Definition Calibration vs. Verification of Calibration vs. Verification - Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 47

Similar threads

Top Bottom