ISO/IEC 17025:2017 includes many changes. There are three main points to keep in mind: more options, the involvement of risk, updates in current technology.
ISO/IEC 17025:2017 General requirements for the competence of testing and calibration was released in Nov 2017. All accredited labs have to move to the new standard by late 2020, three years after the final version was published. There are major differences with the formatting, phrasing, and numbering of sections from the 2012 standard. Reading through the 2017 edition and creating your cross-referencing table will help to find specific differences between the two versions.
Change in structure :
Chapter 4.General Requirements
The definition in ISO/IEC 17025:2017 is “Presence of objectivity” and is further clarified in a note saying, “Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory.“
In the context of testing or calibration Laboratories, Lab results cannot be influenced, or have the appearance of being influenced by any relationships the laboratory or the people involved in laboratory activities may have with the client.
Laboratory activities also cannot be influenced by any undue pressure being put on the people involved in conducting those laboratory activities
To safeguard impartiality, laboratories shall:
– Establish structure.
– Mitigate pressures.
– Identify & manage risks on an ongoing basis.
Risks may come from…….
– Its activities.
– Its relationship.
– The relationship of its personnel.
– The labs should also demonstrate how to minimize or eliminate those risks.
The lab shall be responsible through legally enforceable commitments for the management of all information obtained during the performance of lab activities.
The customer should be informed in writing if the laboratory intends to make publicly available any information about an assignment.
The laboratory personnel, providers, external personnel, etc. should also sign a confidentiality declaration.
Chapter 5. STRUCTURAL REQUIREMENTS
The requirements have been restructured. The most important changes are:
– The term “quality manager” is not mentioned, even though the functions are still included in the standard.
– The term “technical manager” is not mentioned, even though the functions are still included in the standard.
– It is no longer necessary to have deputies for key positions.
– The laboratory is obliged to write down the range of activities. The range of activities does not include those activities that have been permanently subcontracted.
– Following the new ISO 9001:2015 requires adequate communication processes regarding the effectiveness of the management system.
Chapter 6 RESOURCE REQUIREMENTS.
6.2 Personnel :
There are no substantial changes. The most prominent are:
– The need to supervise (before authorization) and to monitor (after authorization) that the personnel has been taken up.
– The need to assess the efficiency of training has been erased.
– The need to document job descriptions has been erased. However, it is required to define competence requirements for each function (not only managerial functions but all of those that have an impact on the results of the laboratory).
The most frequently used supervision/ monitoring methods for personnel are:
- Measuring samples known: reference standards, inter-comparison samples, etc.
- Blind samples.
- Inter/intra-laboratory comparisons.
- Exams (for intellectual knowledge) it is recommended to record these activities.
6.3 FACILITIES AND ENVIRONMENTAL CONDITIONS
There are no significant changes. When tests are performed in facilities outside its permanent control, the new standard requires that environmental and facilities related requirements be met.
- Standards, reference materials, reagents, and software are now also considered as equipment.
- Conditions to calibrate equipment are set:
➢ if accuracy or uncertainty affects the validity of results.
➢ if calibration is needed to establish metrological traceability.
- Reference to ISO 17034 has been included to emphasize the competence of RM producers.
6.5 Metrological traceability
Most of the notes have been erased, and a new Informative Annex on metrological traceability has been created. In Annex A, possibilities have been included on how to establish and demonstrate traceability:
- Through the use of an NMI.
- Accredited calibration laboratory.
- Whenever possible and cost-efficient, it is easier for the laboratory to use accredited calibration laboratories or NMIs; however, if this is not possible, it is advisable to assess their competence based on ISO/IEC 17025.
6.6 Externally provided products and services
This new item includes the previous concept of subcontracting, so purchasing and subcontracting are now compiled in one clause.
The laboratory should have a system to select, assess, monitor, and reassess external providers.
The laboratory shall ensure that all purchased products and services fulfill the requirements.
The laboratory shall make the following clear to the provider:
- What is to be bought,
- Acceptance criteria,
- Personnel competence needed, and activities that the laboratory intends to perform in the provider’s facilities.
Chapter 7. PROCESS REQUIREMENTS.
7.1 Review of requests, tenders and contracts
– Have a procedure for the review
– Inform customer when method requested by the customer is not appropriate or out of date
– Clearly defined a statement of conformity when requested by the customer
– Resolve any difference between the requestor tender and the contract before commencing work
– Inform customer if any deviation from the contract
– Repeat contract review if amended after work and communicate to all affected personnel.
– Cooperate with customers or their representatives in clarifying the customer’s request and in monitoring the laboratory’s performance about the work performed.
– Retain records of reviews
7.2 Selection, verification, and validation of methods
– Use appropriate methods and procedures for all laboratory activities
– Up to date methods, procedures and supporting documents are kept and made readily available to personnel
– Uses the latest version unless not possible to do
– Select the appropriate method when the customer does not specify
– Verify methods before introducing them to ensure it can achieve the required performance.
– Have an Action plan for method development
– Document, technically justify, authorize and accept by the customer if any deviation from methods
– Validate non –standard methods, the laboratory-developed methods and standard methods used outside their intended scope or modify
– Retain records of validation
- Sampling plan
- Sampling method
- Retain records
The laboratory shall have a sampling plan and method when it carries out sampling of substances, materials or products for subsequent testing or calibration. The sampling method shall address the factors to be controlled to ensure the validity of subsequent testing or calibration.
7.4 Handling of test or calibration items
- Have a procedure.
- Have a system for unambiguous identification.
- Records of the item.
- Facilities to maintain items.
The laboratory shall have a procedure for the transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items, including all provisions necessary to protect the integrity of the test or calibration item and to protect the interests of the laboratory and the customer. Precautions shall be taken to avoid deterioration, contamination, loss or damage to the item during handling, transporting, storing/waiting, and preparation for testing or calibration. Handling instructions provided with the item shall be followed.
The laboratory shall have a system for the unambiguous identification of test or calibration items. The identification shall be retained while the item is under the responsibility of the laboratory.
7.5 Technical Records
- Sufficient information
- Amendment can be tracked to previous versions or original observations
The laboratory shall ensure that technical records for each laboratory activity contain the results, report and sufficient.
information to facilitate, if possible, identification of factors affecting the measurement result and its associated measurement uncertainty and enable the repetition of the laboratory activity under conditions as close as possible to the original. The technical records shall include the date and the identity of personnel responsible for each laboratory activity and for checking data and results.
7.6 Evaluation of measurement uncertainty.
- Identify the contributions to measurement uncertainty.
- Evaluate for all calibrations (calibration lab).
- Evaluate measurement uncertainty where the test method precludes rigorous evaluation of measurement uncertainty.
Laboratories shall identify the contributions to measurement, uncertainty. When evaluating measurement uncertainty, all contributions that are of significance, including those arising from sampling, shall be taken into account using appropriate methods of analysis
7.7 Ensuring the validity of results
– Have a procedure for monitoring the validity of results.
– Monitor its performance by comparison with the results of other laboratories.
– Analyze and use data from monitoring to control and improve the laboratory’s activities.
– Take action when data from the monitoring are found to be outside pre-defined criteria.
Chapter 8. Management system requirements
8.1.2 Option A
As a minimum, the management system of the laboratory shall address the following:
- Management system documentation (see 8.2)
- Control of management system documents (see 8.3)
- Control of records (see 8.4)
- Actions to address risks and opportunities (see 8.5)
- Improvement (see 8.6)
- Corrective actions (see 8.7)
- Internal audits (see 8.8)
- Management reviews (see 8.9).
8.1.3 Option B
A laboratory that has established and maintains a management system, following the requirements of ISO 9001, and that is capable of supporting and demonstrating the consistent fulfillment of the requirements of Clauses 4 to 7, also fulfills at least the intent of the management system requirements specified in 8.2 to 8.9.