Commissioning, Qualification and Validation (CQV) in the life science pharmaceutical and medical device industries define a detailed and science-based process for the specification, design, and verification of new equipment or systems into a production pipeline. In...
Are you a laboratory? Do you perform any sampling, calibrations, or testing? Then, the International Organization for Standardization (ISO) asks you, Are you technically competent? Here we explain ISO/IEC 17025 accreditation of the general requirements for the competence of testing and calibration laboratories.
ISO 17025 provides detailed parameters for:
- Proficiency testing
- Metrological traceability, including the use of reference materials
- Uncertainty measurement
- In-house calibrations
- Management systems operations
An essential part of proper proficiency testing is using and maintaining a documented plan for three years of sampling activities. This document needs to include a yearly proficiency test (PT) or inter-laboratory comparison (ILC) covering the appropriate parameters, ranges, measurements, test technologies, inspections, methods, and uncertainty of measurements. You may use a PT/ILC provider if they are accredited to ISO/IEC 17043. However, if you choose to develop your own ILC, you need further approval from ANAB. Furthermore, a successful PT/ILC must be completed within 12 months of applying for ISO 17025 accreditation.
For more information and examples within a specific field and industry testing, see the ANAB administrative process rule (PR). Major fields with related parameters for testing scopes can be found in PR 2350, Preparing a Draft Scope of Accreditation for Testing Laboratories.
All testing and calibration results must be traceable whenever possible through NIST or another National Metrology Institute (NMI) to the International System of Units (SI units). This means that your metrological traceability, in order of preference, is through an NMI directly, an ISO/EIC 17025 accredited laboratory, using intrinsic standards, or from a weights and measures lab. Applicant and accredited laboratories should use ISO/IEC 17025 accredited calibration laboratory services whenever available. Acceptable ISO/IEC 17025 accredited calibration laboratories are those accredited by ANAB or another accreditation body that is a signatory of the International Laboratory Accreditation Cooperation (ILAC) MRA with the appropriate calibration services listed in the scope of accreditation. If your organization seeks to submit reference standards and equipment to a calibration provider not covered by the traceability hierarchy above, the laboratory shall use the ANAB FM 2808 and apply for the approval of that non-accredited calibration provider. To trace your metrology, use form FM 2807, the traceability and in-house calibration tracking document.
Metrological traceability using reference materials
Reference materials need to fall under:
- Certified Reference Materials (CRMs) from a reference material producer (RMP) accredited to ISO 17034
- Standard Reference Materials® (SRM) from NIST (called under trademark).
- CRM from another National Metrological Institute (NMI). Use of any CIPM-active NMI may be acceptable.
- The certified values assigned to CRMs are covered by entries in the Joint Committee for Traceability in Laboratory Medicine (JCTLM) database.
If you cannot obtain reference materials from those sources, other authoritative sources or reference methods, or materials from internal validation may be used—document validation of the materials and methods and equipment. For information on Uncertainty Measurement, see the ANAB guidance documents.
If you are already ISO 17025 accredited, ANAB allows you to calibrate your own equipment according to your document plan. In accordance, you will:
- Have the appropriate environment for carrying out the calibration.
- Appropriately trained personnel to both carry out and check the calibrations.
- Demonstration of competency to perform the undertaken calibrations.
- Reference standards, certified reference materials, or reference measuring instruments are traceable with appropriate measurement uncertainties.
- Documented procedure for each type of calibration.
- Appropriate means of recording and reporting the data and results of any calculations according to the requirements of ISO/IEC 17025.
- Estimate, evaluate, and maintain records of uncertainties for traceability realized internally that support tests associated with the scope of accreditation.
- Complete Form 2807, the traceability and in-house calibration tracking document.
Management systems options
As with quality assurance, your calibration and testing need to be documented, controlled, and tracked thoroughly. One option (A) is to independently meet all the specifications put forth in ISO 17025. The other option (B) is to use a management system that conforms to ISO 9001.
There are different accreditation requirements set forth by the ANSI National Accreditation Board (ANAB) for:
- Testing laboratories
- Calibration laboratories
- Stand-alone sampling organizations
- Dimensional Measurement laboratories
To apply for ANAB accreditation for ISO 17025, you will need to detail the items of concern and their measurements. There are different reporting requirements for the varying fields. They are as follows:
Testing laboratories concerning:
- Construction Material
- Electrical, Mechanical
- Product Safety
- Subsurface Munition
- Information Technology
Need to itemize measurements with the following information:
- Major field
- Specific Tests and/or properties measured
- Specification, standard, method, or test technique
- Items, materials, or products tested
- Key equipment or technology
Electromagnetic Compatibility (EMC) or Radio need to itemize the test method (date/revision), test specification(s), range, and any additional comments.
Environmental laboratories need to itemize the technology, specification/standard method/test technique, and analyte.
Calibration and Dimensional Measurement laboratories need to itemize:
- Expanded uncertainty of measurement (+/-)
- Reference standard, method, and/or equipment
Sampling organizations need to itemize:
- Items, materials, or products sampled
- Component, parameter, or characteristic sampled
- Specification, standard, method, or test technique
How we can help
PSC Biotech® has more than 25 years of experience in calibration programs, metrology, criticality analysis, risk assessment, process validation and can provide you with calibrated, validated equipment for your metrology needs. Contact us for more information on how our metrology services can help you in ISO 17025 accreditation.
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