part - iii DETAILED checklist Clause No. Requirement (Doc. Ref./Clause No.) assessment COMPLIANCE Y/N/NA NOTES 4 MANAGEMENT REQUIREMENTS 4.1 ORGANIZATION 4.1.1 Legal responsibility 4.1.2 Requirements of ISO/IEC 17025, the needs of the client, regulatory authorities or organizations providing recognition met 4.1.3 Permanent facilities, sites away from its permanent facilities, temporary or mobile facilities 4.1.4 Responsibilities of key personnel 4.1.5 Laboratory requirements a) Managerial and technical personnel b) Undue internal and external pressures c) Confidential information and proprietary rights d) Policies and procedures to avoid involvement in inappropriate activities e) Organization and management structure f) Responsibility, authority and interrelationships of personnel g) Supervision of testing and calibration staff h) Technical management i) Quality manager QM access to the highest of management j) Deputies k) Relevance and importance of their activities 4.1.6 Appropriate communication process established by the top management
4.2 QUALITY SYSTEM 4.2.1 Appropriate quality system Documented system Documentation communicated, understood, available, and implemented 4.2.2 Quality manual Quality policy statement a) Laboratory management's commitment to good professional practice and to the quality of its testing and calibration in servicing its clients b) Management's statement of the laboratory's standard of service c) Objectives of quality system d) Personnel concerned with testing and calibration activities within the laboratory familiarize themselves with the quality documentation and implement the policies and procedures in their work e) Laboratory management's commitment to compliance with ISO/IEC 17025 4.2.3 Top management evidence of commitment to development and implementation of management system 4.2.4 Top management communication in meeting customer, statutory and regulatory requirements 4.2.5 Quality manual include or make references to supporting procedures including technical procedure 4.2.6 Roles and responsibilities of technical management and the quality manager 4.2.7 Top management shall ensure that integrity of management system is maintained. 4.3 DOCUMENT CONTROL 4.3.1 General Procedures to control all quality system documents 4.3.2 Document approval and issue 4.3.2.1 Reviewed and approval by authorized personnel
4.11.4 Monitoring of corrective actions 4.11.5 Additional audits 4.12 PREVENTIVE ACTION 4.12.1 Identification of improvements and potential sources of non-conformances Action plans 4.12.2 Procedures for preventive actions 4.13 CONTROL OF RECORDS 4.13.1 General 4.13.1.1 Procedures for quality and technical records 4.13.1.2 Record retention 4.13.1.3 Security and confidentiality of records 4.13.1.4 Procedures to protect and back-up electronic records 4.13.2 Technical records 4.13.2.1 Record content 4.13.2.2 Observations, data and calculations 4.13.2.3 Error correction 4.14 INTERNAL AUDITS 4.14.1 Periodic, in accordance with a predetermined schedule and procedure Scope of audit Quality manager responsibilities Trained, independent staff 4.14.2 Corrective action, client notification 4.14.3 Internal audit records 4.14.4 Follow-up audit activities 4.15 MANAGEMENT REVIEW 4.15.1 Predetermined schedule and procedure; covers: suitability of policies and procedures; reports from managerial and supervisory personnel; outcome of recent internal audits; corrective and preventive actions; assessments by external bodies; results of comparisons or proficiency tests; changes in the volume and type of the work; client feedback;
complaints; other relevant factors 4.15.2 Findings 5 TECHNICAL REQUIREMENTS 5.1 GENERAL 5.1.1 Factors determine the correctness and reliability 5.1.2 Consideration of factors contributing to total uncertainty 5.2 PERSONNEL 5.2.1 Competence of staff Staff undergoing training Personnel qualification 5.2.2 Goals for education, training and skills of personnel Policy and procedures for identifying training needs and providing training Relevance of training program 5.2.3 Employment status Supervision of contracted and additional personnel 5.2.4 Job descriptions 5.2.5 Authorization of personnel records 5.3 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS 5.3.1 Laboratory facilities Environmental conditions Documented technical requirements 5.3.2 Monitoring, controlling and recording environmental conditions Stopping testing 5.3.3 Effective separation between neighbouring
5.3.4 Access control 5.3.5 Housekeeping 5.4 TEST AND CALIBRATION METHODS AND METHOD VALIDATION 5.4.1 General Use of appropriate methods and procedures Instructions on use and operation of all relevant equipment, handling, preparation Documents, data up to date and available Deviation from test and calibration methods 5.4.2 Selection of methods Test and/or calibration methods meet client Use of latest valid edition of standards Method selection when not specified by client Laboratory-developed methods; client notification Confirmation of capability Client notification of inappropriate or out of date methods 5.4.3 Laboratory-developed methods Introduction of laboratory-developed methods Effective communication 5.4.4 Non-standard methods Agreement with the client Validation before use 5.4.5 Validation of methods 5.4.5.2 Fit for intended use Validation records
Calibration before being placed into service 5.5.3 Equipment operated by authorized personnel Up-to-date instructions on use and maintenance 5.5.4 Unique identification of equipment 5.5.5 Equipment records: a) identity of equipment and its software b) manufacturer's name, type identification, and serial number or other unique identification; c) initial checks (see 5.5.2); d) current location, where appropriate; e) manufacturer's instructions, if available, or reference to their location; f) dates, results and copies of reports and certificates of all calibrations, adjustments, acceptance criteria, due date of next calibration; g) maintenance plan, where appropriate; maintenance carried out to d ate; h) any damage, malfunction, modification or repair to the equipment. 5.5.6 Procedures for safe handling, transport, storage, use and planned maintenance 5.5.7 Overloaded, mishandling, suspect, or defective equipment Isolation of out-of-service equipment Effect of defect or departure from specified limits on previous results 5.5.8 Indication of calibration status 5.5.9 Checking equipment that goes outside the direct control of the laboratory
Traceability of reference standards Use for calibration only Calibration before and after adjustment 5.6.3.2 Reference materials Traceable to SI units of measurement, or to certified reference materials 5.6.3.3 Intermediate checks Defined procedures and schedules 5.6.3.4 Transport and storage Procedures for safe handling, transport, storage and use of reference standards and reference materials ACCAB Traceability Policy requirements 5.7 SAMPLING 5.7.1 Sampling plan and procedures for sampling Availability of sampling plan and procedure at sampling location Appropriate statistical basis 5.7.2 Deviations, additions or exclusions from sampling procedure 5.7.3 Procedures for recording sampling data and operations 5.8 HANDLING OF TEST AND CALIBRATION ITEMS 5.8.1 Procedures for the transportation, receipt, handling, protection, storage, retention and/or disposal of test and/or calibration items 5.8.2 System for identifying test and/or calibration items 5.8.3 Recording of abnormalities or departures from normal or specified conditions upon receipt Consultation with client on abnormal samples 5.8.4 Procedures and appropriate facilities for avoiding deterioration, loss or damage
a) deviations from, additions to, or exclusions from test method, and information on specific test conditions b) where relevant, statement of compliance/non-compliance with requirements and/or specifications; c) where applicable, statement on the estimated uncertainty of measurement d) where appropriate and needed, opinions and interpretations (see 5.10.5) e) additional information may be required by specific methods, clients or groups of clients 5.10.3.2 Test reports containing the results of sampling- additional requirements a) date of sampling; b) unambiguous identification of substance, material or product sampled (including the name of the manufacturer, the model or type of designation and serial numbers as appropriate); c) the location of sampling d) reference to sampling plan and procedures used; e) details of environmental conditions during sampling f) standard or other specification for the sampling method or procedure, and deviations, additions to or exclusions 5.10.4 Calibration certificates 5.10.4.1 Calibration certificates- additional requirements a) conditions (e.g. environmental) under which the calibrations were made b) uncertainty of measurement and/or a statement of compliance with an identified metrological specification c) evidence that measurements are traceable (see note 2 in 5.6.2.1.1). 5.10.4.2 Statements of compliance
5.10.4.3 Before and after results for adjustment or repair 5.10.4.4 Recommendation on calibration interval 5.10.5 Opinions and interpretations Basis documented, clearly identified 5.10.6 Testing and calibration results obtained from subcontractors Clearly identified Subcontractor results in writing or electronic Subcontractor certificate issued to contracting laboratory. 5.10.7 Electronic transmission of results 5.10.8 Format of reports and certificates 5.10.9 Amendments to test reports and calibration certificates Complete new test report or calibration certificate Name & Signature of Lead Assessor