ISO 17025 (formerly ISO guide 25) presents additional quality system requirements for accrediting laboratories who conduct calibration and/or testing. Oxebridge is pleased to offer implementation of ISO 17025 systems under the same methods as our other implementation services.
The ISO 17025 standard requires certain activities and confirmations which are dependent on third parties, such as round-robin proficiency testing. As a result, a “Rapid” implementation program is not possible for this standard. However, Oxebridge still attempts to conduct its portion of the implementation as quickly as possible, reducing your overall implementation time.
Oxebridge ISO 17025 Implementation Specialists are trained specifically in 17025, and will help your laboratory prepare for accreditation audits by the American Association for Laboratory Accreditation (A2LA) or similar accreditation body (AB).
The ISO 17025 Program follow a four-phase structure:
- Phase 1 – Information Capture. Oxebridge comes on-site to your facility and conducts interviews with your key management and staff to determine the nature of tests or calibrations your lab conducts, and to ascertain the current practices of your company, to see where you already comply with the standard. The notes taken from Phase 1 become the basis for the next phase.
- Phase 2 – Documentation Preparation. Oxebridge Specialists prepare an ISO 17025 compliant manual and supporting procedures, forms and other necessary documents based on the results of the Phase 1 interviews. Your resulting documentation is fully customized, based on the company’s current practices, and only introduces new or modified practices where the company either does not meet a requirement at all, or where current practice deviates from a requirement. Boilerplate documents are not used, and your staff are not assigned any writing duties!
- Phase 3 – Implementation and Training. Oxebridge Specialists return on-site and assist in implementing the resulting systems, train employees and internal auditors, and conduct the first round of required ISO 17025 internal audits. We facilitate a full management review, including a review of the objectives and improvement opportunities. At the end of Phase 3, your company is ready for third party accreditation auditing.
- Phase 4 – OPTIONAL – Audit Interfacing. For those clients wishing to be accredited by a third party Accreditation Body such as A2LA, Oxebridge will attend the audit and provide on-site assistance and facilitation of the audit, ensuring a smooth and effective audit by the AB.