I need to answer about a specific request about accreditation (ISO 17025) of the test performed during FAT/SAT of the equipments (eg. classification of particles, flow rates, integrity tests of the filters, pressure, ISO 10648-2 tests…). I search about it in Europe accreditation body web site (eg. UKAS, COFRA, ACCREDIA, etc.), but I don’t find nothing.
Can you help me to understand if exist or not exist an accreditation programs about validation GMP tests of equipments?
My thought is that ISO 9001 QMS procedures should be sufficient.
Thanks in advance for your help.
The Contents of ISO 17025
The ISO 17025 standard itself is comprised of 5 elements:
- Scope
- Normative References
- Terms and Definitions
- Management Requirements
- Technical Requirements
Elements 4 and 5 contain the actual accreditation requirements
Accreditation Requirements
Management Requirements
- Organization
- Quality system
- Document control
- Review of requests, tenders and contracts
- Subcontracting of tests and calibrations
- Purchasing services and supplies
- Service to client
- Complaints
- Control of nonconforming testing and/or calibration work
- Corrective action
- Preventive action
- Control of records
- Internal audits
- Management reviews
Technical Requirements
- General
- Personnel - Accommodation and environmental conditions
- Test and calibration methods and method validation
- Equipment
- Measurement traceability
- Sampling
- Handling of test and calibration items
- Assuring the quality of test and calibration results
- Reporting the results
I think there exists an accreditation programs about validation GMP tests of equipments.
I too want to know If Iam wrong and the reasons for this.
Regards