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TR Calibration Quality Management System Audit Checklist Rev No: 4.0 Issue Date: 29 Nov 2018 Doc No: TRVMS-QTF-604-04" REFERENCED DOCUMENTS: NATA, ISO 9001:2015, ISO IEC 17025:2017.

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  • 4.1.1 Laboratory activities<br>• shall be undertaken impartially and structured and safeguarded to ensure impartiality

  • 4.1.2 Laboratory management<br>• shall be committed to impartiality

  • 4.1.3 Laboratory responsibility<br>• commercial, financial or other pressures must not compromise impartiality with regard to laboratory activities

  • 4.14 Risk identification<br>• the laboratory to undertake this on an on- going basis and include those arising from<br>• its activities<br>• its relationships<br>• relationships of personnel

  • 4.15 Risk mitigation<br>• the laboratory shall demonstrate how risk to impartiality is eliminated or minimised


  • 4.2.1 Laboratory responsibility<br>• through legally enforceable commitments, manage all information obtained or created during the performance of laboratory activities<br>• inform the customer in advance of the information it intends to place in the public domain<br>• maintain all customer information as confidential, except for that information the customer makes public or that agreed to be made public <br> between the laboratory and customer

  • 4.2.2 Release of customer information<br>• must not occur unless<br>- when required by law<br>- authorised by contractual arrangements<br>• customer to be notified of information provided (unless prohibited by law)

  • 4.2.3 Customer information from other sources<br>• shall be confidential between the customer and laboratory<br>• the source of this information shall remain confidential to the laboratory

  • 4.2.4 Confidentiality obligations of personnel<br>• shall keep confidential all information obtained or created during the performance of laboratory activities, except as required by law


  • 5.1 Legal status<br>• the laboratory shall be a legal entity, or a defined part of a legal entity

  • 5.2 Laboratory management<br>• identify management that has overall responsibility for the laboratory

  • 5.3 Scope of laboratory activities<br>• the laboratory to define and document the range of activities which it claims conformity to the Standard<br>• cannot include laboratory activities which are provided externally on an ongoing basis

  • 5.4 Conduct of laboratory activities and premises<br> • to be performed to meet the requirements of<br>- the Standard<br>- customer requirements<br>- regulatory authorities<br>- NATA<br>• activities include those conducted at<br>- permanent facilities<br>- sites away from permanent facilities<br>- temporary or mobile facilities<br>- customer premises

  • 5.5 Structure, personnel and documentation<br>a) define the laboratory’s place in any parent organisation, the relationship between management, technical operations and support services<br>b) specify the responsibilities, authorities and interrelationships of those who manage, perform or verify work affecting the results of laboratory activities<br>c) document procedures to the extent necessary to ensure consistent conduct of laboratory activities and the validity of results

  • 5.6 Personnel authorities and resources<br>a) available to implement, maintain and improve the management system<br>b) able to identify deviations in the management system or laboratory activity procedures<br>c) able to initiate actions to prevent or minimise deviations<br>d) report to laboratory management the performance of the management system and needs for improvement<br>e) ensure the effectiveness of laboratory activities

  • 5.7 Laboratory management responsibilities<br>a) ensure communication on the<br>effectiveness of the management system<br>and meeting customers’ and other requirements<br>b) ensure integrity of the management system is maintained when changes are planned and implemented



  • 6.1 Available resources<br>• laboratory to have available personnel, facilities, equipment, systems and support services necessary to manage and perform its laboratory activities


  • 6.2.1 Competence and impartiality<br>• all personnel (internal or external) associated with the laboratory that could influence the laboratory activities to be competent and act impartially in accordance with the management system

  • 6.2.2 Documentation of competency requirements<br>• to include education, qualification, training, technical knowledge, skills and experience for each role which influence the laboratory activities

  • 6.2.3 Competency<br>• ensure personnel are competent to perform laboratory activities for which they are responsible and to evaluate the significance of deviations

  • 6.2.4 Duties, responsibilities and authorities<br>• ensure these are communicated

  • 6.2.5 Procedures and records<br>a) for the determination of the competence requirements<br>b) for the selection of personnel <br>c) for training<br>d) for supervision<br>e) for authorisations<br>f) for the monitoring of competence

  • 6.2.6 Authorisations to perform specific activities<br>a) develop, modify, verify and validate methods<br>b) analyse results, including statements of conformity or opinions and interpretations<br>c) report, review and authorise results


  • 6.3.1 Suitability of facilities and environmental conditions<br>• appropriate and not adversely affect the validity of results

  • 6.3.2 Document<br>• the requirements for facilities and environmental conditions to perform laboratory activities

  • 6.3.3 Monitor, control and record<br>• the environmental conditions in accordance with the relevant specifications, methods and procedures or when they influence the validity of results

  • 6.3.4 Measures to control facilities<br>• to be implemented, monitored and periodically reviewed, including but not limited to<br>a) access to and use of areas affecting laboratory activities<br>b) prevention of contamination, interference or adverse influences on laboratory activities<br>c) effective separation between areas with incompatible laboratory activities

  • 6.3.5 Sites outside laboratory’s permanent control<br>• ensure facilities and environmental conditions comply with requirements of the Standard


  • 6.4.1 Availability of equipment<br>• laboratory has access to equipment for correct performance of laboratory activities

  • 6.4.2 Equipment outside control of laboratory<br>• the requirements of the Standard are met

  • 6.4.3 Procedure<br>• is available for handling, storage, use and planned maintenance to ensure proper functions and to prevent contamination or deterioration

  • 6.4.4 Verification<br>• ensure equipment conforms to specified requirements before being placed or returned into service

  • 6.4.5 Accuracy and/or measurement uncertainty (MU)<br>• to provide a valid result, equipment must be capable of achieving the required<br>- measurement accuracy; and/or<br>- MU

  • 6.4.6 Calibration<br>• equipment shall be calibrated when<br>• measurement accuracy or MU affects the validity of the results; and/or<br>• the equipment is necessary to establish metrological traceability of the results

  • 6.4.7 Calibration program<br>• shall be establish and reviewed and adjusted as necessary in order to maintain confidence in the status of calibration

  • 6.4.8 Labelling<br>• all equipment which requires calibration or has a defined period of validity shall be labelled, coded or otherwise identified

  • 6.4.9 Out-of-service<br>• overloaded, mishandled or poorly functioning equipment shall be isolated and not reused until verified that it performs correctly<br>• the effect of such defective equipment<br>shall be investigated and the management of non-conforming work initiated

  • 6.4.10 Intermediate checks<br>• shall be carried out when necessary to confirm performance of the equipment<br>• in accordance with a procedure

  • 6.4.11 Correction factors<br>• when calibration and reference material data include reference values or<br>correction factors, these are to be updated and implemented, as appropriate, to meet<br>specified requirements

  • 6.4.12 Unintended adjustments<br>• practicable measures are taken to prevent these from occurring and invalidating results

  • 6.4.13 Records<br>• shall be retained for equipment which can influence laboratory activities, including:<br>- identity, including software / firmware version<br>- manufacturer’s name, type and serial number or other identification<br>- evidence of verification<br>- location<br>- calibration dates and results, results of adjustments, acceptance criteria, due date of next calibration or interval<br>- documentation of reference materials, results, acceptance criteria, relevant dates and the period of validity<br>- maintenance plan and maintenance performed;<br>- details of damage, malfunction, modifications or repair


  • 6.5.1 Establish metrological traceability<br>• the laboratory shall establish and maintain metrological traceability of its measurement results by means of a documented unbroken chain of calibrations, each contributing to the measurement uncertainty, linking them to an appropriate reference

  • 6.5.2 Measurement results traceable to SI units<br>• to be established through<br>a) calibration provided by a competent laboratory; or<br>b) certified values of CRMs from a competent producer with stated traceability to SI units; or<br>c) direct realisation of the SI units<br>ensured by comparison with national or international standards

  • 6.5.3 Traceability to SI not technically possible<br>• where this occurs, metrological traceability to an appropriate reference shall be demonstrated, for example<br>a) certified values of CRMs provided by a competent producer to non SI values<br>b) results of reference measurement procedures, specified methods or consensus standards that are accepted as providing measurement results fit for their intended use and ensured by suitable comparison


  • 6.6.1 Use of externally provided products and services<br>• Only suitable products and services are used when<br>a) incorporated into the laboratory’s own activities<br>b) provided directly to the customer by the laboratory as received from the external provider<br>c) used to support the operation of the laboratory

  • 6.6.2 Procedure and records for<br>a) defining, reviewing and approving the laboratory’s requirements for externally provided products and services<br>b) defining criteria for evaluation, selection, monitoring of performance and re- evaluation of external providers<br>c) ensuring that prior to laboratory use or supply to customers, the products and services conform to the laboratory’s requirements or where relevant to the Standard<br>d) actions to take arising from evaluations, monitoring or re-evaluations of external providers

  • 6.6.3 Communication of requirements to external providers<br>• These include<br>a) the products and services to be provided<br>b) the acceptance criteria<br>c) competence, including any required qualification of personnel<br>d) activities that the laboratory, or its customer, intends to perform at the external provider’s premises



  • 7.1.1 Procedure<br>Shall ensure<br>a) requirements are defined, documented and understood<br>b) laboratory has the capability and resources to meet the requirements<br>c) where external providers are used, the customer is advised and approves;<br>d) appropriate methods or procedures are selected

  • 7.1.2 Inappropriate method requested<br>• customer is informed, including if method is out-of-date

  • 7.1.3 Statement of conformity requested<br>• specification or standard and the decision rule are clearly defined<br>• unless inherent in the specification or standard, the decision rule is agreed with the customer

  • 7.1.4 Differences between requests and contract<br>• are resolved prior to laboratory activities commencing<br>• contract to be acceptable to both the laboratory and customer<br>• deviations requested do not impact on the laboratory’s integrity or the validity of results

  • 7.1.5 Deviations from the contract<br>• customer is informed

  • 7.1.6 Amendments to contracts<br>• contract review is repeated after work commences and amendments communicated to all affected personnel

  • 7.1.7 Cooperation with customers<br>• laboratory to clarify requests and to allow the customer to monitor its performance

  • 7.1.8 Records of reviews<br>• are retained, including changes to contracts and discussions had with the customer



  • Methods and procedures<br>• to be appropriate for all laboratory activities, including where necessary, for evaluation of measurement uncertainty and statistical techniques for data analysis

  • Currency of methods and procedures<br>• to be kept up-to-date and made available to personnel

  • Method version<br>• latest valid versions to be used unless it is not appropriate or possible<br>• where necessary, supplemented with additional details for consistent application

  • Method selection<br>• the laboratory to select an appropriate method and inform the customer when the customer has not specified the method

  • Method verification<br>• before introducing methods, the laboratory must verify that it can achieve the required performance<br>• records of verification must be kept<br>• verification to be repeated when changes to the methods are made by the issuing body/ies

  • Method development<br>• as proceeds, periodic review to occur to confirm the needs of the customer are still satisfied<br>• changes to the development plan to be approved and authorised

  • Deviations from methods<br>• shall only occur if the deviation is technically justified, documented, authorised and accepted by the customer


  • Validation<br>• non-standard methods, laboratory developed methods and standard methods used outside their scope or modified shall be validated

  • Changes made to validated method<br>• the influence of such changes shall be determined and if they affect the original validation, then the method must be revalidated

  • Method performance characteristics<br>• satisfy the customers needs and specified requirements

  • Validation records<br>a) the validation procedure used<br>b) specification of the requirements<br>c) performance characteristics of the method d) results obtained<br>e) a statement on the validity of the method, and its fitness for the intended use


  • 7.3.1 Sampling plan and method<br>• method addresses factors to be controlled to ensure validity of subsequent testing or calibration<br>• plan and method available at sampling site<br>• sampling plans based on statistical methods whenever reasonable

  • 7.3.2 Method<br>• describes<br>a) selection of samples or sites<br>b) sampling plan<br>c) preparation and treatment of samples from a substance, material or product

  • 7.3.3 Records of sampling data<br>• include<br>a) reference to the sampling method<br>b) date and time of sampling<br>c) data to identify and describe the sample<br>d) identification of the personnel<br>e) identification of the equipment used<br>f) environmental or transport conditions<br>g) diagrams or other means to identify the sampling location when appropriate<br>h) deviations, additions or exclusions from the method or sampling plan


  • 7.4.1 Procedure<br>• ensures the protection of integrity of the item and the interests of the laboratory and customer and covers<br>- transportation<br>- receipt<br>- handling<br>- protection<br>- storage<br>- retention and/or disposal<br>• precautions taken to avoid deterioration, contamination, loss or damage<br>• handling instructions provided with the item to be followed

  • 7.4.2 Identification<br>• system is in place for the unambiguous identification of items, including, if relevant, the subdivision and transfer of items

  • 7.4.3 Item deviations<br>• upon receipt, deviations from specified conditions are recorded<br>• if there is doubt about suitability of item, or<br>it does not conform to description provided, ensure that the customer is consulted and that the instructions are recorded<br>• when deviation is acknowledged and customer instructs to proceed with testing or calibration, the laboratory is to include a disclaimer in the report indicating that the results may be affected

  • 7.4.4 Storage conditions<br>• to be maintained, monitored and recorded


  • 7.5.1 Records<br>• for each laboratory activity include<br>- results<br>- report<br>- factors affecting the results and its measurement uncertainty<br>- date<br>- identify of personnel conducting the laboratory activity and checking data and results<br>• allow repetition of the laboratory activity<br>• original observations, data and calculations to be recorded at the time they made and be identifiable with the specific task

  • 7.5.2 Amendments<br>• can be traced to original observations or previous version of records<br>• original and amended data<br>- to be retained<br>- include the date<br>- an indication of the altered aspects<br>- the personnel responsible


  • 7.6.1 Contributions of MU<br>• shall be identified<br>• significant contributions taken into account when evaluating MU, including those from sampling

  • 7.6.2 Calibration<br>• MU for all calibrations performed shall be evaluated

  • 7.6.3 Testing<br>• where the test method precludes rigorous evaluation, an estimation shall be made based on an understanding of the theoretical principles or practical experience of the performance of the method


  • 7.7.1 Procedure<br>• for monitoring validity of results is in place<br>• data from monitoring activities are recorded in a manner which allows the detection of trends with statistical methods applied, where possible, for review of the results<br>• monitoring is to be planned and reviewed and include, where appropriate<br>a) use of reference materials or quality control materials<br>b) use of alternative calibrated instrumentation providing traceable results<br>c) functional checks of measuring and testing equipment;<br>d) use of check or working standards with control charts<br>e) intermediate checks on measuring equipment<br>f) replicate tests or calibrations<br>g) retesting or recalibration of retained items<br>h) correlation of results for different characteristics of an item<br>i) review of reported results<br>j) intra-laboratory comparisons<br>k) testing of blind sample(s)

  • 7.7.2 Comparison of results with other laboratories<br>• shall be used to monitor the laboratory’s performance<br>• monitoring shall be planned and reviewed and include participation in either or both<br>a) proficiency testing<br>b) inter-laboratory comparisons

  • 7.7.3 Analysis of monitoring data<br>• used to control and improve, where applicable, laboratory activities<br>• appropriate action is taken to prevent incorrect results from being reported when monitoring data is found to be outside of pre-defined criteria



  • Review and authorisation of results<br>• shall occur prior to release

  • Reports<br>• results are provided accurately, clearly, unambiguously and objectively<br>• include all the information agreed with the customer and necessary for the interpretation of the results<br>• issued reports are retained as technical records

  • Simplified reports<br>• when agreed with the customer<br>• all information not reported to customer and covered by 7.8.2 to 7.8.7 must be readily available


  • Report content<br>a) title<br>b) name and address of the laboratory<br>c) location where the laboratory activities were performed<br>d) unique identification that all components are recognised as a portion of a complete report and a clear identification of the end<br>e) name and contact information of the customer<br>f) method used<br>g) a description, unambiguous identification, and if necessary, the condition of the item<br>h) date of receipt of the item or date of sampling of the item where critical to the validity and application of the results<br>i) date(s) of the performance of the laboratory activity<br>j) date of the issue of the report<br>k) reference to the sampling plan and sampling method if relevant to the validity and application of the results<br>l) statement to the effect that results only relate to the item tested, calibrated or sampled<br>m) the results with the units of measurement, where appropriate<br>n) additions, deviations or exclusions from the method<br>o) identification of the person authorising the report<br>p) clear identification when the results are from external providers

  • Laboratory responsibility<br>• for all information provided in the report except when provided by the customer<br>- customer information to be clearly identified and a disclaimer included when information supplied can affect the<br>validity of results<br>• when customer is responsible for sampling, the report is to state that the results apply to the sample as received (also refer to 7.4.3)


  • Additional information<br>• for the interpretation of the test results, in addition to 7.8.2, reports to include where necessary<br>a) information on specific test conditions, such as environmental conditions<br>b) where relevant, a statement of conformity with requirements or specifications<br>c) where applicable, the MU in the same units as the measurand or in a term relative to the measurand when<br>- relevant to the validity or application of the results<br>- customer’s instruction<br>- MU affects conformity to a specification limit<br>d) where appropriate, opinions and interpretations;<br>e) additional information which may be required by specific methods, authorities, customers or groups of customers

  • Sampling<br>• when the laboratory is responsible for sampling, test reports shall meet the requirements of 7.8.5 where necessary


  • Additional information<br>• in addition to 7.8.2, calibration certificates to include<br>a) the MU of the measurement result presented in the same unit as that of the measurand or in a term relative to the measurand<br>b) the conditions under which the calibrations were made that have an influence on the measurement results<br>c) a statement to indicate how the measurements are metrologically traceable<br>d) results before and after any adjustments or repair<br>e) where relevant, a statement of conformity with requirements or specifications<br>f) where appropriate, opinions and interpretation

  • Sampling<br>• when the laboratory is responsible for sampling, calibration certificates shall meet the requirements of 7.8.5 where necessary

  • Calibration certificates or labels<br>• shall not include any recommendation on calibration intervals, unless agreed with the customer


  • 7.8.5 Additional information<br>• when the laboratory is responsible for the sampling, in addition to 7.8.2, reports to include<br>a) date of sampling<br>b) unique identification of the item or material sampled<br>c) location of sampling, including any diagrams, sketches or photographs<br>d) reference to the sampling plan and sampling method<br>e) details of any environmental conditions that affect the interpretation of the results<br>f) information required to evaluate MU for subsequent testing or calibration


  • Decision rule<br>• to be documented and applied, taking into account the associated risk, when a statement of conformity is provided to a customer

  • Statement of conformity<br>• includes<br>a) which results the statement of conformity applies to<br>b) which specifications, standards or parts thereof are met or not met<br>c) the decision rule applied (unless it is inherent in the requested specification or standard)


  • Authorised personnel<br>• opinions and interpretations are only made by authorised personnel and the basis upon which they have been made shall be documented

  • Based on results<br>• opinions and interpretations are based on the results obtained and clearly identified as such in reports

  • Direct verbal communication<br>• when opinions and interpretations are verbally communicated to the client, a record is retained


  • Amendments to reports<br>• are clearly identified

  • Amendments to reports<br>• where appropriate, the reason for the change is included in the report

  • Amendments to reports<br>• a further report is issued and referenced as amended, is uniquely identified and makes reference to the original report it replaces


  • 7.9.1 Documented process<br>• is available for receiving, evaluating and making decisions on complaints

  • 7.9.2 Availability of documented process and responsibility<br>• is available to any interested party<br>• when a complaint is received, the<br>laboratory is to confirm whether it relates to laboratory activities it is responsible for and action it<br>• laboratory is responsible for all decisions relating to complaints handling

  • 7.9.3 Content of complaints process<br>a) a description of the process for receiving, validating, investigating and deciding what actions are to be taken in response to it<br>b) tracking and recording complaints, including actions taken<br>c) ensuring that any appropriate action is taken

  • 7.9.4 Gathering and verifying information<br>• the laboratory is responsible in order to validate the complaint

  • 7.9.5 Acknowledging receipt<br>• whenever possible, the laboratory does this and provides the complainant with progress reports and the outcome

  • 7.9.6 Communication of outcomes<br>• to be made by, or reviewed and approved by, an individual(s) not involved in the original laboratory activities in question.

  • 7.9.7 Formal notice of end of complaint<br>• whenever possible, the laboratory to advise the complainant


  • 7.10.1 Procedure<br>• is available and implemented when any aspect of the laboratories activities does not conform to its own procedures or the agreed requirements of the customer<br>a) defines the responsibilities and authorisations for the management of non-conforming work<br>b) actions are based upon the risk levels established by the laboratory<br>c) an evaluation is made of the significance of the non-conforming work, including an impact analysis on previous results<br>d) a decision is taken on the acceptability of the non-conforming work<br>e) where necessary, the client is notified and work is recalled<br>f) defines the responsibility for authorising the resumption of work

  • 7.10.2 Records<br>• are retained of non-conforming work and the actions taken

  • 7.10.3 Implementation of corrective action<br>• shall be taken when the non-conforming work could recur, or there is doubt with the laboratory’s operations with its own management system


  • 7.11.1 Access to data and information<br>• data and information needed to perform laboratory activities is available

  • 7.11.2 Laboratory information management system<br>• the system for collecting, processing, recording, reporting, storing and retrieving data is validated, including interfacing with other laboratory systems before being used<br>• changes to the system are authorised, documented and validated before used

  • 7.11.3 Protection, safeguard and maintenance<br>• the information system<br>a) is protected from unauthorised access <br>b) is safeguarded against tampering and loss<br>c) is operated in an environment that complies with supplier or laboratory specifications or, for non-computerised systems, provides conditions which safeguard the accuracy of manual recording and transcription<br>d) is maintained in a manner which ensures the integrity of the data and information<br>e) includes the recording of system failures and the appropriate immediate and corrective actions

  • 7.11.4 Off-site systems<br>• laboratory ensures that the provider or operator complies with all applicable requirements of the Standard

  • 7.11.5 Instructions, manuals and reference data<br>• are readily available to personnel

  • 7.11.6 Calculations and data transfers<br>• are checked in an appropriate and systematic manner



  • 8.1.1 Management system<br>• supports and demonstrates the consistent achievement of the requirements of the Standard<br>• assures the quality of the laboratory results<br>• allows the requirements of clauses 4 to 7 to be met<br>• is in accordance with either Option A or Option B

  • 8.1.2 OPTION A, As a minimum, the laboratory management system shall address the clauses 8.2 to 8.9

  • 8.1.3 OPTION B, Laboratory that has established and maintains a management system, in accordance with the requirements of ISO9001 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 clauses 8.2 to 8.9


  • 8.2.1 Policies and objectives<br>• are established, documented for the fulfillment of the Standard<br>• are acknowledged and implemented at all levels of the laboratory

  • 8.2.2 Competence, impartiality consistent operations<br>• are addressed by the polices and objectives

  • 8.2.3 Laboratory management<br>• provides evidence of commitment to the development of the management system<br>• continually improves the management system’s effectiveness

  • 8.2.4 Reference to the management system<br>• of all documentation, processes, systems and records

  • 8.2.5 Access to parts of the management system<br>• is available to personnel


  • 8.3.1 Control of documents<br>• both internal and external documents relating to the fulfillment of the requirements of the Standard

  • 8.3.2 Document control process<br>a) documents are approved by authorised personnel prior to issue<br>b) documents are periodically reviewed and updated as necessary<br>c) changes and current revision status of documents are identified<br>d) relevant versions of documents are available and their distribution controlled as necessary<br>e) documents are uniquely identified<br>f) unintended use of obsolete documents is prevented


  • 8.3.1 Control of documents<br>• both internal and external documents relating to the fulfillment of the requirements of the Standard

  • 8.3.2 Document control process<br>a) documents are approved by authorised personnel prior to issue<br>b) documents are periodically reviewed and updated as necessary<br>c) changes and current revision status of documents are identified<br>d) relevant versions of documents are available and their distribution controlled as necessary<br>e) documents are uniquely identified<br>f) unintended use of obsolete documents is prevented


  • 8.4.1 Records retention<br>• to demonstrate fulfillment of the requirements of the Standard

  • 8.4.2 Controls<br>• are implemented for<br>- identification<br>- storage<br>- protection<br>- back-up<br>- archive<br>- retrieval<br>- retention times<br>- disposal<br>• are established for<br>- retention periods to satisfy contractual obligations<br>- confidentiality commitments<br>- access and availability


  • 8.5.1 Risks and opportunities are considered <br>a) to assure the management system achieves its intended goals<br>b) to achieve the laboratory objectives<br>c) to prevent (or minimise) undesired impacts and potential failures<br>d) to achieve improvement

  • 8.5.2 Plan<br>a) actions to address risks and opportunities<br>b) how to<br>- implement actions into the management system<br>- evaluate the effectiveness of actions

  • 8.5.3 Actions to address risks and opportunities<br>• are proportional to the potential impact on the validity of the laboratory results


  • 8.7.1 Nonconformities<br>• when occur, the laboratory shall<br>a) react and, as applicable, take action, correct the issue and address the consequences<br>b) evaluate the need for action to eliminate the cause so that it does not recur<br>c) implement any action necessary<br>d) review the effectiveness of any corrective action<br>e) update any risk and opportunities<br>f) makes any necessary changes to the management system

  • 8.7.2 Corrective action taken<br>• is appropriate to the effects of the nonconformity

  • 8.7.3 Records retained<br>a) of the nature of the nonconformity, cause(s) and any action(s) taken<br>b) of the outcomes of corrective action


  • 8.8.1 Conducted at planned intervals<br>• to establish whether the management system<br>a) conforms to<br>- the laboratory’s requirements, including laboratory activities<br>- the requirements of the Standard<br>b) is effectively implemented and<br>maintained

  • 8.8.2 Audit requirements<br>a) is planned and implemented, including frequency, defined responsibilities and reporting, taking into account<br>- the importance of the laboratory activities concerned<br>- changes affecting the laboratory<br>- the results of previous audits<br>b) audit criteria and the scope of each audit are defined<br>c) audit results are reported to relevant management<br>d) corrective actions, where necessary, are implemented promptly<br>e) records of the audit program, including outcomes, are retained


  • 8.9.1 Review of management system<br>• is conducted at planned intervals by laboratory management to ensure<br>- continued suitability, adequacy and effectiveness<br>- covers the stated policies and<br>objectives related to the fulfilment of the<br>Standard

  • 8.9.2 Records of inputs<br>• including information related to<br>a) changes in internal and external issues<br>b) fulfilment of objectives<br>c) suitability of policies and procedures<br>d) status of actions from previous reviews e) outcomes of recent internal audits<br>f) corrective actions<br>g) assessment by external bodies<br>h) changes in volume, type and range of laboratory activities<br>i) customer and personnel feedback j) complaints<br>k) effectiveness of any implemented improvements<br>l) adequacy of resources<br>m) results of risk identification<br>n) outcomes of the assurance of validity of results<br>o) any other relevant factors

  • 8.9.3 Records of outputs<br>• include all decisions and actions relating to<br>a) effectiveness of the management system<br>b) improvement of the laboratory activities relating to satisfying the requirements of the Standard<br>c) provision of required resources d) any need for change(s)


  • 1) evidence the management system is certified by a certification body (CB) accredited by JAS-ANZ, or by another signatory to the International Accreditation Forum (IAF) Multilateral Recognition Agreement (MLA).<br>2) evidence that the CB’s accreditation covers ISO/IEC 17021-3 i.e. the CB can certify management systems to ISO 9001.<br>3) copies of the most recent certification audit report(s) issued by the CB covering the laboratory’s management system in full.<br>4) confirmation from the CB of the close out of any non- conformities raised during certification audits.<br>5) evidence the certification of the management system covers the laboratory activities covered by its NATA scope of accreditation.<br>6) supports the facility fulfilling consistently the requirements of ISO/IEC 17025 to assure the quality of results.


  • Corrective Actions

  • Signature of Client

  • Signature of Auditor

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