ISO 17025 Registration

ISO 17025 provides the framework for a Quality Management System for a testing or calibration laboratory.

Accreditation

To become accredited, you must meet requirements for each test or calibration your laboratory performs. You will be audited by an accreditation body.

Dual Registration/Accreditation

The ISO 17025 standard states that if you comply with ISO 17025, you automatically comply with ISO 9001 requirements for laboratories. Many laboratories will want to get registration to ISO 9001 along with the 17025 accreditation. To address this request, some accreditation bodies and registrars are working out a partnership to use one auditor to perform both the 17025 audit and the ISO 9001 audit simultaneously. Talk to the accreditation body and the registrar to see if they can provide this service.

What is driving accreditation?

  • The automotive standards ISO/TS 16949 require testing and calibration laboratories to be accredited.
  • Laboratories may need a quality system that is recognized internationally.
  • The marketplace—laboratories must keep up with competitors who are becoming accredited.
  • Internal motives—laboratories can improve their internal systems.

The accreditation process

  • Chose an accreditation body.
    • Laboratory Accreditation Bureau
    • American Association for Laboratory Testing (A2LA)
    • Others
  • Establish Scope and Cost
    • Fill out the accreditation body survey identifying all analysis covered. The size of your laboratory, and the number of personnel.
  • Submit a quality manual and procedures to accreditation body
    • The assessor performs a gap analysis on the documentation.
    • The laboratory must take corrective action on any nonconformance.
  • Preassessment (optional)
    • The assessor visits the laboratory.
  • On-site accreditation assessment
    • Assessor audits the laboratory for objective evidence of compliance to 17025.
  • Report
    • Assessor prepares a report, documenting any nonconformances.
    • The laboratory must provide corrective action plans to the lead assessor.
    • A follow up audit may be required.
  • Certificate
    • After all corrective action plans are completed and approved, the certificate will be issued.
  • Maintaining Accreditation
    • Annual surveillance audits will be performed.
  • Renewal
    • Every 3 years a full system audit will be required to renew the certificate.

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