Checklist ISO 17025

Use this ISO 17025 Checklist to ensure compliance with the ISO 17025 standard for testing and calibration, facilitating reliable laboratory processes.

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Checklist ISO 17025

Checklist ISO 17025

Impartiality

Confidentiality

Structural Requirements

8. Does the laboratory have personnel, authorities, and resources sufficient to implement, maintain, and improve the management system, identify deviations, and laboratory procedures, initiate actions that prevent or minimize deviations, report performance and required improvements to laboratory management, and ensure the effectiveness of laboratory activities?

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General

Personnel

Facilities And Environmental Conditions

4. Have measures to control facilities been implemented, monitored, and periodically reviewed, including access to areas affecting laboratory activities preventing contamination, interference, or adverse effects with effective separation between areas with incompatible laboratory activities?

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Equipment

13. Are records maintained for equipment affecting laboratory activities, including software and firmware version, manufacturer, type and serial number, evidence of verification, location, calibration dates and results, adjustment results, acceptance criteria, date or interval of next scheduled calibration, reference materials with periods of validity, maintenance plans, performed maintenance, and any details about malfunctions, damage, modifications, or repair?

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Metrological Traceability

3. When metrological traceability to SI is not technically possible, will traceability be demonstrated to an appropriate reference? (for example, certified values of CRMs provided by a competent producer to non-SI values, or the results of reference measurements, specified methodologies, or consensus standards that have been accepted as providing measurement results fit for their intended use and backed by appropriate comparison).

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Externally-Provided Products And Services

2. Are procedures and records maintained for defining, reviewing, and approving the laboratory's requirements for external providers, defining criteria for evaluating, selecting, monitoring, and reevaluating external providers; and ensuring that products and services conform to the relevant requirements or standards before using them or providing them to customers; and for the actions to be taken following evaluations, monitoring, or reevaluations?

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3. Are requirements communicated to external providers, including products and services, acceptance criteria, competence, and personnel qualifications, and activities that the laboratory or its customers intend to perform at the external provider's premises?

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Review Of Requests, Tenders, And Contracts

1. Do procedures ensure that requirements are defined, documented, and understood, that the laboratory has the capability and resources to meet the requirements, that the customer is advised and approves when external providers are used, and that appropriate methods or procedures are selected?

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4. Are differences between the request and the contract resolved prior to the commencement of laboratory activities? Are contracts acceptable to both the laboratory and the customer, and do requested deviations not affect the integrity of the laboratory or the validity of its results?

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Selection And Verification Of Methods

Validation Of Methods

Sampling

3. Do sampling data records include a reference to the following: • sampling method • the date and time of the sampling • data that identifies and describes the sample • identification of the personnel • identification of the equipment used • environmental or transport conditions • diagrams or other means of identifying the sampling location (if needed) • deviations, additions, or exclusions from the method or sampling plan

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Handling Of Test Or Calibration Items

Technical Records

1. For each laboratory activity, do results, reports, factors affecting the results and measurement uncertainty, the date, and the identity of personnel performing the activity and checking results and data, allow repetition of the laboratory activity?

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Evaluation Of Measurement Uncertainty

Ensuring Validity Of Results

3. Is monitoring planned and reviewed and includes, where appropriate: • the use of reference materials or quality control materials • the use of alternative calibrated instruments that provide traceable results • functional checks of measuring and testing equipment • the use of check or working standards with control charts • intermediate checks on measuring equipment, replicated tests or calibrations, retesting or recalibration of retained items • the correlation of results for different characteristics of an item • reviews of reported results • intra-laboratory comparisons • tests of blind samples

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Reporting Of Results

Common Requirements For Reports (Test, Calibration, Or Sampling)

Specific Requirements For Test Reports

3. When necessary, relevant, and appropriate for interpreting test results, do reports also include: The measurement uncertainty of the same units as the measurand or in a relative term (when relevant to the validity or application of the results, or when instructed by the customer, or when measurement uncertainty affects conformity to a specification limit)

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Specific Requirements For Calibration Certificates

Reporting Sampling - Specific Requirements

Reporting Statements Of Conformity

Reporting Opinions And Interpretations

Complaints

Non-Conforming Work

Control Of Data And Information Management

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Management System Documentation

Control Of Management System Documents

Control Of Records

Corrective Actions

2. Will the laboratory also evaluate the need for action to eliminate the root cause of the non-conformity to prevent reoccurrence, implement any necessary actions, update the risk and opportunity outlook, and make any necessary changes to the management system?

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Internal Audits

8. Is a review of the management system carried out at planned intervals by laboratory management to ensure continued suitability, sufficiency, and effectiveness, and that it covers the stated policies and objectives related to meeting the requirements of the standard?

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Checklist ISO 17025

Use this ISO 17025 Checklist to ensure compliance with the ISO 17025 standard for testing and calibration, facilitating reliable laboratory processes.

1. Are laboratory activities undertaken impartially and structured to ensure impartiality?

2. Is laboratory management committed to remaining impartial?

3. Is the impartiality of laboratory activities not compromised by commercial, financial, or other pressures?

4. Does the laboratory engage in ongoing risk identification and address issues arising from activities, relationships, and personnel?

5. Can the laboratory demonstrate how it is eliminating or minimizing risks to impartiality?

1. Does the laboratory manage all information created or obtained through its activities through legally enforceable means?

2. Are customers informed in advance of any information that will be placed in the public domain?

3. Is customer information kept confidential unless the customer decides or agrees to make it public?

4. Is customer information not released unless required by law or authorized by contractual arrangements, with the customer being notified of any information released (unless prohibited by law)?

5. Is customer information sourced from outside the laboratory kept confidential, with the source of the information also kept confidential to the laboratory, except when disclosure is required by law?

6. Will personnel keep all information created or obtained through the course of their laboratory activities confidential, except when required by law to disclose?

1. Is the laboratory a legal entity, or a defined part of one, that is legally responsible for its own activities?

2. Have managers with overall responsibility for the laboratory been identified?

3. Has the laboratory defined and documented the full scope of activities it claims to be in compliance with the standard, excluding laboratory activities provided externally on an ongoing basis?

4. Do the premises of the laboratory and the activities performed there meet the requirements of the standard, customers, and regulators?

5. Is the laboratory's place within the parent organization, and the relationship between management, technical operators, and support staff defined?

6. Have the authority, responsibilities, and relationships of those who manage, perform, or verify the results of laboratory activity been specified?

7. Are laboratory procedures documented sufficiently to ensure consistent operations and valid results?

9. Is laboratory management ensuring that the management system is operating effectively meeting the needs of customers and other stakeholders, and maintaining the integrity of the management system when changes take effect?

1. Does the laboratory have sufficient staff, facilities, equipment, systems, and support services to manage and perform its activities?

1. Are all personnel associated with the laboratory competent and impartial in accordance with the management system?

2. Is documentation regarding competency requirements available, including education, qualification, training, technical knowledge, skills, and experience for each role that can influence laboratory activities?

3. Are personnel ensured to be competent to perform the laboratory activities they are responsible for and evaluate the significance of any deviations?

4. Have duties, responsibilities, and authorities been communicated to personnel?

5. Are procedures and records established for determining competence requirements, selecting personnel, training, supervision, authorizations, and competence monitoring?

6. Have methods been developed, modified, verified, and validated; results analyzed; and results reported, reviewed, and authorized for performing specific activities?

1. Are facilities and environmental conditions appropriate and not adversely affecting the validity of results?

2. Are the requirements for facilities and environmental conditions necessary for laboratory activities documented?

3. Are environmental conditions monitored, controlled, and recorded in accordance with applicable specifications, methods, or procedures, or when they affect the validity of results?

4. Have measures to control facilities been implemented, monitored, and periodically reviewed, including access to areas affecting laboratory activities preventing contamination, interference, or adverse effects with effective separation between areas with incompatible laboratory activities?

5. Have facilities and environmental conditions at sites outside the laboratory's permanent control been brought into compliance with the standard?

1. Does the laboratory have access to the equipment it needs for the correct performance of its activities?

2. Does equipment outside the control of the laboratory meet standard requirements?

3. Are procedures in place for handling, storage, use, and planned maintenance of equipment to keep it functioning properly and prevent contamination or deterioration?

4. Is equipment verified to conform to specified requirements before placing or returning it to service?

5. To provide accurate and valid measurements, is the equipment capable of achieving the required degrees of accuracy and/or measurement uncertainty?

6. Is equipment calibrated when the measurement accuracy or uncertainty affects the validity of results?

7. Has a calibration program been established, reviewed, and adjusted as necessary to maintain confidence in the calibrations?

8. Is equipment requiring calibration or with a defined period of validity labeled, coded, or otherwise identified as such?

9. Is the equipment that has been overloaded, mishandled, or is functioning poorly removed from service until fixed and verified to be functioning correctly again?

10. Are intermediate checks carried out as needed to confirm equipment performance?

11. Are calibration and reference material data, including reference values or correction factors, updated and implemented to meet specified requirements as appropriate?

12. Are measures taken to prevent unintended adjustments from occurring and affecting results?

1. Has metrological traceability been established through a documented, unbroken chain of calibrations?

2. Are measurement results traceable to SI units established through calibration provided by a competent laboratory or certified values of CRMs with traceability to SI units?

1. Are suitable external products and services used when incorporated into the laboratory's activities or provided directly to the customer?

3. Are requirements communicated to external providers, including products and services, acceptance criteria, competence, and personnel qualifications, and activities that the laboratory or its customers intend to perform at the external provider's premises?

1. Do procedures ensure that requirements are defined, documented, and understood, that the laboratory has the capability and resources to meet the requirements, that the customer is advised and approves when external providers are used, and that appropriate methods or procedures are selected?

2. Is the customer informed about requests for inappropriate or outdated methods?

3. When statements of conformity are requested, is the specification or standard and the decision rule clearly defined, and unless inherent in the specification or standard, is the customer in agreement with the decision rule?

4. Are differences between the request and the contract resolved prior to the commencement of laboratory activities? Are contracts acceptable to both the laboratory and the customer, and do requested deviations not affect the integrity of the laboratory or the validity of its results?

5. Is the customer informed about deviations from the contract?

6. When contracts are amended, does contract review repeat after work commences, and are amendments communicated to all affected personnel?

7. Does the laboratory clarify all customer requests and allow the customer to monitor performance?

8. Are records of reviews retained, including changes to the contract and discussions that took place with the customer?

1. Are methods and procedures appropriate for all laboratory activities, including when needed for evaluating measurement uncertainty and statistical techniques for data analytics?

2. Are methods and procedures kept current and up-to-date, and are they available to personnel?

3. Are the latest method versions used except when inappropriate or impossible, supplemented with additional details for consistency of application?

4. When the customer does not specify methods, does the laboratory select appropriate methods and inform the customer?

5. Does the laboratory verify that it can achieve the required performance before introducing a new method?

6. Are verification records kept, and is verification repeated when the issuing body changes the method?

7. Does method development proceed with periodic review to ensure that the needs of the customer are still being met?

8. Are changes to the development plan approved and authorized?

9. Do deviations from methods only occur when technically justified, documented, authorized, and accepted by the customer?

1. Will methods that are non-standard, laboratory-developed, or being used or modified outside of their standard scope be validated?

2. When validated methods are changed, will the effect of those changes be analyzed to see if they affect the original validation? If so, is the method revalidated?

3. Do the method performance characteristics satisfy the needs and specified requirements of the customer?

4. Do validation records include the validation procedure used, the specified requirements, the performance characteristics of the method, the results obtained, and a statement on the validity of the method and its suitability for the intended use?

1. Does the sampling plan and method address the factors that need to be controlled to ensure the validity of subsequent testing or calibrations?

2. Does the method describe the selection of samples or sites, the sampling plan, and the preparation and treatment of samples from a substance, material, or product?

1. Do procedures protect the integrity of the item and the interests of the laboratory and its customers?

2. Do procedures cover transportation, receipt, handling, handling instructions, protection, storage, retention, disposal, and precautions for avoiding deterioration, damage, contamination, or loss?

3. Are systems in place for unambiguously identifying items, including, if relevant, the subdivision and transfer of items?

4. Are item deviations from specified conditions recorded upon receipt?

5. When there are doubts about suitability or when the item does not conform to the provided description, is the customer consulted, and are instructions recorded?

6. When the deviation is acknowledged and the customer's instruction is to proceed with testing or calibration, does the laboratory include a disclaimer in the report that the results may be affected?

7. Are storage conditions maintained, monitored, and recorded?

1. For each laboratory activity, do results, reports, factors affecting the results and measurement uncertainty, the date, and the identity of personnel performing the activity and checking results and data, allow repetition of the laboratory activity?