Information
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Document No.
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Audit Title
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel
4. MANAGEMENT REQUIREMENTS
4.2 Management System
4.2.1 Policies and Procedures
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Has the laboratory documented its policies and procedures in a way that ensures the quality of tests/calibration and have they been communicated, made available, understood and implemented?
4.2.2 Quality Policy Statement
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Does the Quality Policy statement satisfy 17025 requirements?
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a statement of the laboratory’s standard of service
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commitment to comply with the Standard and continually improve the management system
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a requirement for all personnel to be familiar with and implement the quality documentation
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the purpose of the management system
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these overall objectives are to be reviewed as part of management review
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the laboratory management’s commitment to good professional practice and quality of its service
4.2.2, 4.2.5, 4.2.6 Quality Manual
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Does the quality manual include:
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defines management system policies and objectives
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defines the roles and responsibilities of technical management and the quality manager
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Top management commitment to good professional practice and quality of its service
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Does the Quality Manual include or make reference to the documented procedures?
4.2.3 Commitment to Management System
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Is there evidence that top management are committed to development, implementation and continual improve the management system?
4.2.4 Customer Requirements
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Is there evidence that top management have communicated the importance of meeting customer, statutory and regulatory requirements?
4.2.6 Quality Manager
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Are roles and responsibilities of the Quality Manager documented in the Quality Manual?
4.2.7 Changes to Management System
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Are procedures in place to ensure that integrity of the management system is maintained when changes are made?
4.3 Document Control
4.3.1 Procedures
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Have documented control procedures been established and maintained?
4.3.2.2 Obsolete Documents
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Are obsolete documents removed or suitably marked if retained for either legal or knowledge preservation purposes?
4.3.2.3 Identification
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Are all management system documents uniquely identified, marked with the date of issue and/or revision identification, page numbering, total number of pages or a mark to signify the end of the document, and the issuing authority(ies)
4.3.3.2 Altered or New Text
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Where practicable, is altered or new text identified in the document or the appropriate attachments?
4.3.3.3 Handwritten Amendments
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If hand written amendments are allowed, is there a defined procedures available which include authorities for such amendments and are they clearly marked initialled and dated?
4.3.3.4 Electronic Documents
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Does the document control procedures describe how changes to documents maintained electronically are made and controlled?
4.4 Review of Requests, Tenders, and Contracts
4.4.1, 4.4.3 Policies and Procedures
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Are policies and procedures related to review of requests, tenders and contracts are established and maintained?
4.4.2 Records of Review
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Are records of contract reviews, including any significant discussions and/or changes throughout the contract maintained?
4.4.5 Changes to Contracts
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Is the contract review process repeated if a contract has to be amended after work has commenced and are all affected staff advised of the amendment?
4.5 Subcontracting of Tests and Calibrations
4.5.2 Customer Approval
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Are customer is advised in writing and approval gained where tests/calibrations are subcontracted?
4.6 Purchasing
4.6.1 Policies and Procedures
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Are suitable policies and procedures available for selection, purchasing, reception and storage of relevant services and supplies?
4.6.2 Verification
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Do procedures prevent supplies affecting testing or calibration, being used until they have been verified as complying with defined specifications?
4.6.3 Purchasing Documents
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Are purchasing documents for items affecting the quality of work reviewed and approved for technical content prior to release?
4.6.4 Approves Suppliers
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Is there a list and a record of the evaluations for all approved suppliers and subcontractors?
4.7 Service to the Customer
4.7.1 Cooperation
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Does the laboratory have a policy or procedure for cooperating with customers requests and providing information on the laboratory's performance, whilst ensuring confidentiality to other customers?
4.7.2 Feedback
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Does the laboratory have a procedure for seeking customer feedback and is this information used to improve the laboratory’s activities?
4.8 Complaints
4.8 Policy, Procedure and Records
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Has the laboratory documented its policy and procedure for the resolution of complaints from customers or other parties and are records of the complaints, investigations and corrective actions (4.11) are maintained?
4.9 Control of Nonconforming Testing and/or Calibration Work
4.9.1 Policies and Procedures
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Is there a policy and procedure for recording and controlling work that does not conform to own procedures or customer requirements:
4.10 Improvement
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Is there evidence that laboratory is continually improving the effectiveness of the management system?
4.11 Corrective Action
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Are appropriate authorities documented for implementing corrective actions?
4.11 Policies and Procedures
4.12 Preventive Action
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Are preventive action procedures followed when improvements and potential sources of nonconformities are identified and are action plans developed, implemented and monitored for effectiveness?
4.13 Control of Records
4.13.2.1 Technical Records
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ensure laboratory retains records of:
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identity of personnel responsible for test/calibration
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identity of personnel responsible for checking results
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identify factors affecting the uncertainty
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enable the test or calibration to be repeated using original conditions
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4.13.2.2 Recording
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Are observations, data and calculations recorded at the time they are made and are they identifiable to the specific task?
4.13.2.3 Correction to Records
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ensure any changes to the original records (including electronic) are made so that:
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original record is not obscured
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correct value entered alongside
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alterations signed or initialled by the person making the correction
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equivalent measures must be taken for records stored electronically
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4.14 Internal Audits
4.14.1 Requirements
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Are internal audits conducted periodically and in accordance with a predetermined schedule?
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Do the internal audits cover all 17025 requirements?
4.14.2 Corrective Action and Notification of Customers
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Where audit nonconformities occur, is timely corrective action taken and are customers notified in writing if laboratory results have been affected?
4.14.3 Records
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Are records of internal audits and corrective actions maintained?
4.14.4 Follow-up Audits
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Are follow-up audits conducted to verify the effectiveness of corrective action taken?
4.15 Management Reviews
4.15 management review
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Does the agenda include;
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suitability of policies and procedures
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Reports from managerial and supervisory personnel
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outcome of recent internal audits
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corrective and preventive actions
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assessments by external bodies
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results of interlaboratory comparisons or proficiency tests
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changes in the volume and type of the work
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customer feedback
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complaints
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recommendations for improvement
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other relevant factors (eg quality control activities, resources and staff training)
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5. TECHNICAL REQUIREMENTS
5.2 Personnel
5.2.1 Competence
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Are personnel performing specific tasks qualified on the basis of education, training, experience?
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When staff are being trained is appropriate supervision provided?
5.2.2 Training Policy
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Does the laboratory have a policy and procedures for identifying training needs, providing training and evaluating its effectiveness?
5.2.3 Employees
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Are people employed by the laboratory competent and do they work in accordance with the documented management system?
5.2.4 Job Descriptions
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Does the laboratory maintain job descriptions for managerial, technical and key support staff?
5.3 Accommodation and Environmental Conditions
5.3.1 Facility
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Are policies and procedures in place to ensure that off-site facilities and environmental conditions do not compromise the quality of results?
5.3.2 Monitoring
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Do the procedures ensure that the laboratory monitors, controls and records environmental conditions, where applicable and that tests and/or calibrations are stopped when results are jeopardised by the environmental conditions?
5.3.3 Incompatible Activities
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Is there effective separation between areas of incompatible activities?
5.3.4 Access
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Are procedures in place to control the access to confidential office and laboratory areas, where appropriate?
5.3.5 Housekeeping
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Are laboratory housekeeping measures adequate?
5.4 Test and Calibration Methods and Method Validation
5.4.2 Method Selection
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Do laboratory test and/or calibration methods ensure that:
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meet the needs of the customer
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the customer has been informed of the method chosen (if not specified)
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where appropriate, are based on latest international, regional or national standards and where necessary the standard be supplemented with additional details to ensure consistent approach
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5.4.3, 5.4.4 Laboratory-developed and Non-standard Methods
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When the methods used that are not covered by a standard methods are:
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the purpose of the test and/or calibration identified
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the method developed is validated before use
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customer agreement is obtained
5.4.5.2 Method Validation
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Does records of method validation include:
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results obtained
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procedure used
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statement as to whether the method is fit for the intended use
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5.4.6.1, 5.4.6.2, 5.4.6.3 Uncertainty of Measurement
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Does the laboratory have procedures for estimating the uncertainty of measurement for all calibrations and tests?
5.4.7 Computers and Automated Equipment
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Has laboratory developed software been sufficiently documented and suitably validated
5.5 Equipment
5.5.8, 5.5.10 Equipment and Calibration Status
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Is equipment calibration status identified, where practicable and where intermediate checks are needed to maintain confidence in the calibration status are documented procedure followed?
5.5.9 Return to Service
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When equipment goes outside the direct control of the laboratory, is the function and calibration status checked before being returned to service?
5.5.12 Adjustments
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Is equipment, both hardware and software, safeguarded from adjustments which could invalidate the test/calibration results?
5.6 Measurement Uncertainty
5.6.1 Calibration Program
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Is equipment used in testing and/or calibration activities calibrated using defined procedure before being put into service?
5.6.3.1 Reference Standards
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Are programs and procedures for calibration of reference standards implemented and maintained?
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Do reference standard traceability procedures satisfy the requirements as described in 5.6.2.1
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Are reference standards must include traceability as described in 5.6.2.1
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Are reference standards only used for calibration?
5.7 Sampling
5.7.2 Deviations
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Are customer-requested deviations, additions or exclusions from the documented sampling procedures recorded and communicated to the appropriate personnel?
5.8 Handling of Test and Calibration Items
5.8.1 Procedures
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Do document procedures for test and/or calibration ensure protection of integrity of the items cover:
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Identification
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transportation
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receipt
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protection
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storage
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handling
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retention and/or disposal
5.9 Assuring the Quality of Test and Calibration Results
5.9.1 Quality Control
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Does the laboratory operate procedures for monitoring validity of tests and calibrations, and do they include:
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regular use of certified reference materials and/or secondary reference materials
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participation in interlaboratory comparison or proficiency-testing programs
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replicates using the same or different methods
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retesting or recalibration of retained items
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correlation of results for different characteristics of an item
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Is the resulting data. recorded so as trends are detectable and statistical techniques can be applied?
5.10 Reporting the Results
5.10.2, 5.10.3 Test Reports
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Do test report include the information listed in the Standard under 5.10.2 items (a) to (k)?
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unique identification of the test/calibration document, including on each page an identification to ensure the page is recognised as part of the document and a clear identification of the end of the document (c)
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name and address of the customer (d)
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identification of the method used (e)
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description, condition and identification of the item tested or calibrated (f)
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date of receipt of test/calibration item where applicable and the date the work was carried out (g)
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reference to the sampling plan and procedures used by the laboratory or other bodies where applicable (h)
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results with, where appropriate, the units of measurement (i)
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name, function and signature or equivalent identification of person authorising the test/calibration document (j)
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statement to the effect that the results relate only to the items tested or calibrated where applicable (k)
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name and address of the laboratory, and the location where the testing/calibrations were carried out, if different from the address of the location (b)
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title (a)
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Where necessary , are interpretation of the test results included in the reports, see 5.10.3 (a) to (e)?
5.10.7 Electronic Transmission of Results
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Where results are transmitted electronically are requirements set out in the Standard met?
5.10.9 Amendments to Test Reports and Calibration Certificates
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Does the laboratory ensure that amendments to a test report or calibration certificates after issue, are in the form of a further document or data transfer making reference to the original report?
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When a complete new test report or calibration certificate is required, is it uniquely identified (supplemental) and include a reference to the original it replaces?
