Checklist ISO 17025

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

Checklist ISO 17025



Impartiality

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


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2. Is laboratory management committed to remaining impartial?


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


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


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


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Confidentiality

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


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


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


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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)?


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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?


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


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Structural Requirements

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


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


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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?


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


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


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


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


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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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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?


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General

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


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Personnel

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


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


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


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


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


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


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Facilities And Environmental Conditions

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


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


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


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


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Equipment

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


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


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


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


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


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


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


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


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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?


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


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


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


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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

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


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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?


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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

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


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


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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?


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


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


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


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


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Selection And Verification Of Methods

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


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


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


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


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


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


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


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


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


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Validation Of Methods

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


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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?


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


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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?


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Sampling

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


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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?


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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

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


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


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


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


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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?


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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?


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


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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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2. Are original observations, data, and calculations recorded at the time they are made and correlated with specific tasks?


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3. Can amendments be traced to original observations or previous record versions?


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4. Is original and amended data retained with the date included, an indication of which aspects were altered, and the identities of the personnel who made the changes?


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Evaluation Of Measurement Uncertainty

1. Will contributions of measurement uncertainty be identified?


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2. Are significant contributions accounted for when evaluating measurement uncertainty, including those from sampling?


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3. Are evaluations carried out on measurement uncertainty for all calibrations performed?


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4. When testing methods preclude rigorous evaluation, are estimates made based on an understanding of the theoretical principles or practical experience related to performing the method?


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Ensuring Validity Of Results

1. Do procedures for monitoring the validity of results exist?


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2. Is data from monitoring recorded in a manner that allows for trend detection through the application of statistical methodology, where possible, for reviewing results?


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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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4. Are comparisons of results with other laboratories used to monitor the laboratory's performance?


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5. Is monitoring planned and reviewed and includes participation in either (or both) proficiency testing and interlaboratory comparisons?


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6. Is an analysis of monitoring data used, where applicable, to control and improve laboratory activities?


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7. Are appropriate actions taken to prevent incorrect results from being reported when monitoring data is found to be outside the bounds of predefined criteria?


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Reporting Of Results

1. Does a review and authorization of results occur before release?


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2. Is reporting of results accurate, clear, unambiguous, and objective?


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3. Does it include all of the information requested by the customer and needed for interpretation?


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4. Are all reports retained as technical records?


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5. Are simplified reports provided when agreed to by the customer?


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6. Is all information reported in the following sections (through "Reporting Opinions and Interpretations" kept readily available?


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

1. Does the content of the report include the following: Title


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2. Does the content of the report include the following: Name and address of the laboratory


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3. Does the content of the report include the following:Location where laboratory activities are performed


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4. Does the content of the report include the following: Unique identification that recognizes all components as portions of a complete report with a clear identification of the end


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5. Does the content of the report include the following:Customer's name and contact information


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6. Does the content of the report include the following: Method used


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7. Does the content of the report include the following: A description of the item with unambiguous identification


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8. Does the content of the report include the following: Condition of the item (if necessary


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9. Does the content of the report include the following: Date of receipt of the item


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10. Does the content of the report include the following: Data of sampling of the item (if critical to the validity and acceptance of the results)


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11. Does the content of the report include the following: Dates of the performance of laboratory activities


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12. Does the content of the report include the following: Date of the issuance of the report


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13. Does the content of the report include the following: Reference to the sampling plan and sampling method if relevant to the validity and application of the results


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14. Does the content of the report include the following: Results with units of measurement (where appropriate)


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15. Does the content of the report include the following: Identification of the person who authorized the report


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16. Does the content of the report include the following: Clear identification of results from external providers


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17. Does the content of the report include the following: Additions, deviations, and exclusions from the method


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18. Does the content of the report include the following: A statement that the results only relate to the item tested, calibrated, or sampled


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19. Is the laboratory responsible for all information included in the report, except when provided by the customer?


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20. Is customer information clearly identified, and is a disclaimer included when it might affect the validity of results?


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21. When the customer is responsible for sampling, does the report state that the results apply to the sample as received?


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Specific Requirements For Test Reports

1. When necessary, relevant, and appropriate for interpreting test results, do reports also include: Information on specific test conditions (such as environmental conditions


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2. When necessary, relevant, and appropriate for interpreting test results, do reports also include: A statement of conformity with requirements or specifications


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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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4. When necessary, relevant, and appropriate for interpreting test results, do reports also include: Opinions and interpretations


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5. When necessary, relevant, and appropriate for interpreting test results, do reports also include: Additional information that may be required by certain methods, authorities, or customers


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6. If the laboratory is responsible for sampling, do test reports meet the requirements listed under "Reporting Sampling - Specific Requirements" below where necessary?


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Specific Requirements For Calibration Certificates

1. In addition to the "Common Requirements for Reports," will calibration certificates also include: The measurement uncertainty of the measurement result presented in the same unit as the measurand or in a term relative to it


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2. In addition to the "Common Requirements for Reports," will calibration certificates also include: Conditions under which the calibrations were made that might have affected the results


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3. In addition to the "Common Requirements for Reports," will calibration certificates also include:A statement that indicates how the measurements are metrologically traceable


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4. In addition to the "Common Requirements for Reports," will calibration certificates also include: Results before and after any adjustments or repair


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5. In addition to the "Common Requirements for Reports," will calibration certificates also include: A statement of conformity with requirements or specifications (where relevant), and if appropriate, opinions and interpretations?


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6. If the laboratory is responsible for sampling, do calibration certificates meet the requirements for "Reporting Sampling - Specific Requirements" below, where necessary?


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7. Do calibration certificates or labels not include any recommendation on calibration intervals unless agreed upon with the customer?


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Reporting Sampling - Specific Requirements

1. In addition to the "Common Requirements for Reports," when the laboratory is responsible for sampling, do the reports include:The date of sampling


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2. In addition to the "Common Requirements for Reports," when the laboratory is responsible for sampling, do the reports include:Unique identification of the items or materials sampled


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3. In addition to the "Common Requirements for Reports," when the laboratory is responsible for sampling, do the reports include:Location of sampling (including any diagrams, sketches, or photographs)


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4. In addition to the "Common Requirements for Reports," when the laboratory is responsible for sampling, do the reports include:Reference to the sampling plan and sampling method


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5. In addition to the "Common Requirements for Reports," when the laboratory is responsible for sampling, do the reports include:Details of any environmental conditions that might have affected the interpretation of the results


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6. In addition to the "Common Requirements for Reports," when the laboratory is responsible for sampling, do the reports include: Information required for evaluating measurement uncertainty for future testing and calibrations


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Reporting Statements Of Conformity

1. When a statement of conformity is provided to a customer, will the decision rule be documented and applied, taking into account any associated risk?


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2. Will the statement of conformity include: Which results does the statement apply to


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3. Will the statement of conformity include:Which specifications and standards are being met (or not met)


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4. Will the statement of conformity include: Which decision rule was applied (unless it is implicit in the standard or specification requested)?


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Reporting Opinions And Interpretations

1. Are opinions and interpretations only made by authorized personnel, and will the basis for these be documented?


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2. Are opinions and interpretations based on the results obtained and clearly identified as such?


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3. Are records created and retained when opinions and interpretations are verbally communicated to the customer?


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4. Are amendments to reports clearly identified?


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5. Where appropriate, is the reason for the amendment included in the report with unique identifiers and a reference to the original reports they are replacing?


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6. Are further reports issued and referenced as amended, with unique identifiers and a reference to the original reports they are replacing?


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Complaints

1. Is a documented process available for receiving, evaluating, and making decisions on complaints?


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2. Is the documented process available to any interested party?


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3. When a complaint is received, does the laboratory confirm whether it relates to their activities?


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4. Is the laboratory responsible for all decisions related to handling complaints?


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5. Is the process for receiving, validating, and deciding how to act in response to a complaint described, along with tracking and recording complaints and ensuring that appropriate actions were taken?


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6. Is the laboratory responsible for gathering and verifying information to validate the complaint?


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7. Whenever possible, does the laboratory acknowledge receipt of the complaint and provide the complainant with progress reports and a final outcome?


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8. Will communication of outcomes be made by, or reviewed and approved by, an individual or individuals not involved in the laboratory activities referenced in the complaint?


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9. Whenever possible, will the laboratory provide the complainant with formal notice of the end of the complaint?


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Non-Conforming Work

1. Are relevant procedures available and implemented when any aspect of laboratory activities does not conform to their own procedures or the requirements agreed upon with the customer?


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2. Do non-conforming work procedures define the responsibilities and authorizations for managing non-conforming work?


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3. Are actions undertaken based on risk levels calculated by the laboratory?


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4. Is the significance of the non-conforming work evaluated, including an analysis of the effect on previous results?


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5. Is a decision taken on the acceptability of the non-conforming work, and if necessary, is the customer notified and the work recalled?


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6. Do procedures define who is responsible for authorizing the resumption of work?


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7. Will records be created and retained of non-conforming work and actions taken in response?


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8. Will implementation of corrective action be undertaken when non-conforming work could reoccur, or if the laboratory does not have confidence in its own management system?


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Control Of Data And Information Management

1. Does the laboratory have access to the data and information it needs to perform its activities?


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2. Does the laboratory have a validated information management system for collecting, processing, recording, reporting, storing, and retrieving data?


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3. Before being used, are changes to the system and interfaces with other laboratory systems authorized, documented, and validated?


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4. Is the information system protected from unauthorized access, tampering, and loss?


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5. Is the information system operated in an environment that complies with supplier or laboratory requirements (or for non-computer systems, provides conditions that safeguard the accuracy of manual recordings and transcriptions)?


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6. Is it maintained in a manner that protects the integrity of the data it contains?


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7. Does it include recordings of system failures and the corrective actions taken in response?


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8. Does the laboratory make sure that providers and operators of off-site systems are compliant with all applicable standards and requirements?


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9. Are instructions, manuals, and reference data readily available to personnel?


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10. Are calculations and data transfers checked in an appropriate and systematic manner?


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Options

1. Does the management system support and work toward consistently meeting the requirements of the standard, ensuring the quality of laboratory results, and allowing other necessary conditions to be met?


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2. Are the following requirements being met, or does the laboratory maintain a management system in compliance with ISO 9001 that meets at least the intent of the clauses to follow (additional documentation may be required as well)?


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Management System Documentation

1. Are policies and objectives established, documented, acknowledged, and implemented throughout the laboratory in order to meet the standard?


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2. Do policies and objectives address competence, impartiality, and consistency?


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3. Is laboratory management continually improving the management system's effectiveness while providing evidence of its commitment to its further development?


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4. Do all documentation, processes, systems, and records reference the management system as needed?


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5. Can personnel access the parts of the management system that they need?


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Control Of Management System Documents

1. Are both internal and external documents relating to meeting the standard requirements controlled?


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2. Are documents approved by authorized personnel prior to issuance?


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3. Are they periodically reviewed and updated as necessary?


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4. Are changes and the current revision status identified, and are relevant versions of documents made available with their distribution controlled as necessary?


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5. Are documents uniquely identified, and is the unintended use of obsolete documents prevented?


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Control Of Records

1. Will records be retained to demonstrate fulfillment of the requirements of the standard?


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2. Are controls implemented for identification, storage, protection, backup, archives, retrieval, retention times, and disposal?


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3. Are controls likewise established for retention periods to satisfy contractual obligations, confidentiality agreements, access, and availability?


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4. Are risks and opportunities evaluated for the following purposes : to ensure that the management system is achieving its stated goals


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5. Are risks and opportunities evaluated for the following purposes : to achieve the laboratory objectives


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6. Are risks and opportunities evaluated for the following purposes : to prevent or minimize undesired influences and potential failures


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7. Are risks and opportunities evaluated for the following purposes : to realize improvements


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8. Are plans in place for taking action to address risks and opportunities, with an eye toward implementing actions into the management system and evaluating their effectiveness afterward?


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9. Are actions to address risks and opportunities proportional to the potential impact on the validity of the laboratory results?


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Corrective Actions

1. When nonconformities occur, will the laboratory react and take appropriate action to correct the issue and address its consequences?


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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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3. Are corrective actions taken commensurate with the impact of the non-conformity?


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4. Are records retained relating to the nature of the non-conformity, its causes, and any actions taken along with their outcomes?


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Internal Audits

1. Do internal audits take place at planned intervals to establish whether the management system is in conformity with the laboratory's requirements and activities, and the requirements of the standard?


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2. Do internal audits also confirm that the management system is being implemented and maintained effectively?


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3. Are internal audits planned and implemented with defined frequency, responsibilities, and reporting requirements?


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4. Do they consider the significance of the laboratory activities, changes affecting the laboratory, and the results of previous audits?


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5. Are the audit criteria and scope of each audit defined?


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6. Are results reported to the appropriate managers and corrective actions, when needed, promptly executed?


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7. Are records of the audit and related outcomes retained?


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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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9. Are inputs related to the following recorded: changes in internal and external issu


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10. Are inputs related to the following recorded: fulfillment of objectives


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11. Are inputs related to the following recorded: suitability of policies and procedures


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12. Are inputs related to the following recorded: status of actions undertaken from previous reviews


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13. Are inputs related to the following recorded: outcomes of recent internal audits


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14. Are inputs related to the following recorded: corrective actions undertaken


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15. Are inputs related to the following recorded: assessment by external bodies


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16. Are inputs related to the following recorded: changes in the volume, type, and range of laboratory activities


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17. Are inputs related to the following recorded: customer and personnel feedback


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18. Are inputs related to the following recorded: complaints


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19. Are inputs related to the following recorded: effectiveness of implemented improvements


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20. Are inputs related to the following recorded: sufficiency of resources


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21. Are inputs related to the following recorded: results of risk identification


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22. Are inputs related to the following recorded: outcomes of the assurance of the validity of the results


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23. Are inputs related to the following recorded: other relevant factors recorded


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24. Are outputs related to all decisions recorded : actions related to the effectiveness of the management system


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25. Are outputs related to all decisions recorded : improvements to the laboratory activities related to meeting the requirements of the standard


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26. Are outputs related to all decisions recorded : provision of required resources


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27. Are outputs related to all decisions recorded : any need for additional change recorded


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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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