Curious about the recent changes made in 2017 to ISO/IEC 17025 standard? In this article we will fill you in on all you need to know about the new standards for accredited calibration labs.
One significant change made to the ISO/IEC 17025 standard is its format. The revised format was created so that the standard could be more in line with the new ISO formatting guidelines. The new format is as follows:
- Normative references
- Terms and definitions
- General requirements
- Structural requirements
- Resource requirements
- Process requirements
- Management requirements
- Annex A: Metrological Traceability
- Annex B: Management System
UPDATED CLAUSE REQUIREMENTS
The main requirements of the updated standard are present in clauses 4 to 8.
Under clause 4, impartiality and confidentiality are discussed. The new standard emphasizes its expectations, of the laboratory, to plan and implement actions which addresses risks. The updated version of ISO/IEC 17025 standard has set specific requirements for risks and opportunities. For example, the first requirement mentioned in clause 4 states that the laboratory is required to identify and eliminate all risks related to impartiality frequently.
Another example of a revised requirement within the new standard states, in regards to confidentiality, that it is the responsibility of the laboratory to inform customers of the information it intends to publicly place. This must be done before it is placed in the public domain. This confidentiality requirement now extends out to anyone associated with laboratory personnel, such as committee members, contractors and individuals acting on behalf of the laboratory.
Clause 5 discusses a handful of structural requirements including, laboratory legal status, management structure and management identification, laboratory activity range, procedure documentation and much more.
One updated requirement within clause 5 of the standard expresses the expectation that all laboratories should be accredited and should include in their scope of accreditation, only testing, calibration, or sampling activities that are provided by utilizing their own resources. The new standard also states that all laboratories can only be accredited for activities they are competent in. The updated standard allows subcontracting only for outstanding situations, e.g., overload of work, sickness of personnel, or maintenance of equipment
Clause 6 covers all resource requirements regarding personnel, facilities, equipment, systems and support services. All of which are important to manage and perform laboratory activities.
The standard has always required the competency of personnel and proof of competency. ISO/IEC 17025 standard requires documentation of education, qualification, training, technical knowledge, skills and experience of all personnel directly involved with testing, calibration, or sampling activities. The standard also requires laboratories to authorize personnel to perform specific activities.
Similar to personnel requirements, the ISO/IEC 17025 standard requires all laboratories to document suitable facility and environment conditions. Documentation should include the monitoring, controlling and recording of all environmental conditions, along with tracking of access and use of areas and ways of implementing contamination prevention.
One major requirement update in this clause is the attention given to metrological traceability issues. The updated requirement states that additional information, including guidance on how to establish and demonstrate metrological traceability, needs to be provided.
Under clause 7, process requirements are explained and discuss the following items:
- Review of requests, tenders and contracts
- The updated standard requires all laboratories to inform the customer when a required testing, calibration or sampling method is considered inappropriate our outdated.
- Selection, verification and validation of methods
- Under the new standard requirements, it is essential that all laboratories use the latest valid version of a method unless it has been determined to be inappropriate.
- Update standards require an available sampling plan and a sampling method to be implemented when the laboratory carries out sampling. It is also a requirement to record and retain all sampling data.
- Handling of test of calibration items
- ISO/IEC 17025 requires a draft of procedures for the transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items.
- Technical records
- Updated standard requirements state that technical records should contain sufficient information to help identify factors that may be affecting a measurement result and measurement uncertainty. Requirements are also in place to ensure traceability of laboratory activities.
- Evaluation of measurement uncertainty
- All calibration laboratories are required to evaluate measurement uncertainty for all calibrations, including those arising from sampling.
- Assuring the validity of results
- The updated standard requires a procedure of recording keeping to be implemented. This will help monitor the validity of results.
- Reporting of results
- The standard requires there to be a results review and authorization of relevant technical records.
- The updated standard requires a documented process for receiving, evaluating, and making decisions on complaints.
- Nonconforming work
- The standard requires a nonconforming work procedure to be in place. This will ensure that all responsibilities and authorities for the management of nonconforming work are defined.
- Control of data – information management
Clause 8 discusses management system requirements and states that laboratories can choose between option a and option b for implementation of a management system.
In the updated standard, requirements for documentation have drastically reduced in Clause 8. The documentation requirements include:
- Management System policies and objectives
- Analysis of Customer feedback
- Corrective actions, non-conformities related records
- Internal audit and results records
- Management review input and output record
Noteably, the updated ISO/IEC 17025 standard no longer requires any documented procedures related to management system activities. There is also no requirement for Quality Manual in the updated standard.