TECHNICAL REQUIREMENTS OF ISO/IEC 17025:2005

Transcription

1 SADCAS Ref. No: TECHNICAL REQUIREMENTS OF ISO/IEC 17025:2005 Date/s of Evaluation: Assessor/s & Observers: Laboratory: Area / Field of Operation: Laboratory Representative: This report covers the following: Document Review only Implementation on Site Visit only Document Review And Site Visit Other Clause REQUIREMENTS & COMMENTS Compliance = C, Non-Compliance = NC, Not Applicable = NA Comment below on adequacy of how requirements have been addressed, documented and/or implemented. References to ISO/IEC are in italics & indicated as Std. The order of assessment need not follow the order of the checklist. Assessors are expected to know & have the standard, this worksheet is designed as guidance to prompt detailed recording of the process. REFER TO ISO/IEC FOR DETAIL AND FOR CLARIFICATION NOTES. 5 TECHNICAL REQUIREMENTS 5.1 General: Factors determining correctness, reliability of tests/calibrations performed Extent to which factors contributing to total uncertainty of measurement taken into account in: developing methods/procedures; training, qualification of staff; selection, calibration of equipment. C NC NA 5.2 Personnel: How are the following addressed/ implemented? Note Std Competence of all who operate specific equipment, perform tests/calibrations, evaluate results, sign reports/ certificates. Qualified on basis of appropriate education, training, experience and/or demonstrated skills. Appropriate supervision of trainees Goals education, training, skills. ID training needs, provide training. Evaluate effectiveness of training. Programme relevant to tasks Employed by/under contract. Supervised, competent, work in accordance with lab s management system Current job descriptions for managerial, technical, key support personnel involved in Note Std tests/calibrations Authorize specific personnel to: perform particular types of sampling, test, calibration; issue reports certificates; give opinions, interpretations; operate particular types of equipment. Records of authorization(s), competence, educational, professional qualifications, training, skills, experience of all technical personnel, including contracted personnel. Date, readily available. Issue No.: 1 Page 1 of 12 Date of Issue:

2 Additional / General Comments (This space may also be used to expand on comments in specific sections) 5.3 Accommodation and Environmental Conditions: How are the following addressed/ implemented? Issue No.: 1 Page 2 of 12 Date of Issue:

3 5.3.1 Not invalidate/adversely affect results. Permanent lab/other sites. Requirements documented Monitor, control, record where quality of results influenced. Stop work when results jeopardized Effective separations between incompatible activities. Measures to prevent cross contamination Access to areas affecting quality of tests/calibrations controlled based on particular circumstances Measures taken to ensure good housekeeping. Special procedures prepared where necessary. 5.4 Test &Calibration Methods &Method validation: How are the following addressed/ implemented? General: Appropriate for scope. Include sampling, handling, transport, storage, preparation, Note Std use/operation of equipment. Estimation of measurement uncertainty & statistic techniques for & See analysis of data, where their absence could jeopardize results. Up-to-date and readily available. 4.3 Deviations documented, technically justified, authorized, accepted by customer Selection of methods: How are the following addressed/ implemented? Meet needs of customer, appropriate for tests/calibrations. Prefer international, regional, national standards. Latest valid edition. Supplements to ensure consistency. By reputable technical organizations/in relevant scientific texts/journals or specified by the manufacturer of the equipment. Laboratory developed method/s appropriate for intended use and validated. Customer informed as to the method chosen. Confirm that it can properly operate standard methods before introducing the tests/calibrations. Confirmation repeated if standard method changes. Customer informed when method proposed by customer is considered to be inappropriate or out of date Laboratory developed methods: How are the following addressed/ implemented? Note Std Introduction of method planned, assigned to qualified persons equipped with adequate resources. Plans up-dated as development proceeds, effective communication amongst all persons involved. Non-standard methods: How are the following addressed/ implemented? Agreement with the customer, include clear specification of the customer s requirements and the purpose of the test and/or calibration. Validated appropriately before use Notes Std Notes Std Validation of methods: Confirmation by examination and provision of objective evidence that particular requirements for specific intended uses are fulfilled. Validate non-standard methods; laboratory-developed methods; standard methods used outside intended scope; amplifications/modifications of standard methods. As extensive as is necessary for application/field of application. Record results, procedure, statement of fitness for intended use. Range and accuracy as assessed for the intended use relevant to the customers needs. e.g. the uncertainty, detection limit, selectivity, linearity, repeatability, reproducibility, robustness) Issue No.: 1 Page 3 of 12 Date of Issue:

4 Additional / General Comments (This space may also be used to expand on comments in specific sections) Issue No.: 1 Page 4 of 12 Date of Issue:

5 5.4.6 Estimation of Uncertainty of Measurement: How are the following addressed/ implemented? Test &Calibration labs; uncertainty procedure for all calibrations and types of calibrations NB Notes std Notes Std Testing laboratories, identification of all the components of uncertainty & reasonable estimation is attempted. Reporting of results do not give wrong impression of uncertainty. Estimation based on knowledge of performance of method, measurement scope and validation data. All uncertainty components of importance in the given situation taken into account using appropriate methods of analysis Control of data: How are the following addressed/ implemented? Calculations and data transfers subject to appropriate checks in a systematic manner. (e.g. Scientific notation & rounding-off policy) Electronic equipment for acquisition, processing, recording, reporting, storage or retrieval of data. a) Software developed by user documented in sufficient detail, suitably validated as adequate for use. b) Procedures for integrity & confidentiality of data entry, collection, storage, transmission, processing. c) Notes Std Computers/automated equipment, proper functioning, conditions to maintain the integrity of data. 5.5 Equipment: How are the following addressed/ implemented? All required equipment & its software, including that outside its permanent control available Capable of achieving accuracy required, comply with relevant specifications. Calibration programmes See 5.6 for key quantities having significant effect on results. Calibrated/checked before use Operated by authorized personnel. Up-to-date instructions use, maintenance readily available Each item significant to the result, when practicable, uniquely identified Records maintained of each item significant to the tests and/or calibrations performed. a) The identity of the item of equipment and its software. b) The manufacture s name, type identification and serial number or other unique identification. c) Checks that equipment complies with the specification (see 5.5.2) d) The current location, where appropriate. e) The manufacturers instructions, if available, or reference to their location. f) Dates, results, reports/certificates, adjustments, acceptance criteria, due date of next calibration. g) The maintenance plan, where appropriate and maintenance carried out to date. h) Any damage, malfunction, modification or repair to the equipment. Issue No.: 1 Page 5 of 12 Date of Issue:

6 5.5.6 Notes Std Procedures for safe handling, transport, storage, use and planned maintenance of measuring equipment to ensure proper functioning and in order to prevent contamination or deterioration Defective equipment, prevented from use until shown by calibration or test to perform correctly. See 4.9 Examine effect of defect on previous tests/calibrations, control non-conforming work procedure When practicable identified to indicate calibration status, date last calibrated, re-calibration due Outside direct control, ensure function & calibration checked, satisfactory before returned to use Intermediate checks to maintain confidence in calibration status carried out to defined procedure Calibrations correction factors, procedures to ensure copies (e.g. in software) are correctly updated Equipment, hardware and software, safeguarded from adjustments, which would invalidate results. Additional / General Comments (This space may also be used to expand on comments in specific sections) Issue No.: 1 Page 6 of 12 Date of Issue:

7 5.6 Measurement Traceability: How are the following addressed/ implemented? Note Std General: All equipment including for subsidiary measurements having a significant effect on validity of results, calibrated before being put into service. Established programme and procedure for the calibration of its equipment Specific requirements Calibration: How are the following addressed/ implemented? Calibration laboratories, programme to ensure traceability to International System of Units (SI). Notes Std Stds & instruments to SI by unbroken chain of comparisons link to primary standards. See also Use laboratories demonstrating competence, measurement capability and traceability Certificates contain results, uncertainty/statement of compliance with identified metrological spec Calibration providing confidence in measurement by establishing traceability to standards such as: Certified reference materials provided by a competent supplier. Specified methods and/or consensus standards that are clearly described, agreed by all parties. Participation in a suitable programme of inter-laboratory comparisons where possible Testing: How are the following addressed/ implemented? Measuring & test equipment with measuring functions apply , unless calibration contributes Note Std little to total uncertainty of test result. Equipment providing uncertainty of measurement needed SI not possible, then certified reference materials, agreed methods, consensus standards, Reference standards and reference materials: How are the following addressed/ implemented? Reference standards: Programme & procedure for calibration, traceable. Used for calibration only unless not validated. Calibrated before and after any adjustment Reference materials: Traceable to SI units/to certified reference materials. Internal checked Intermediate checks: Checks to maintain confidence in calibration status of reference, primary, transfer/working standards, reference materials according to defined procedures and schedules Transport and storage: Procedures for safe handling, transport, storage and use in order to Note Std prevent contamination or deterioration and to protect their integrity. Issue No.: 1 Page 7 of 12 Date of Issue:

8 5.7 Sampling: How are the following addressed/ implemented? Notes Std Sampling plan & procedures available at the location where sampling is undertaken. Based on appropriate statistical methods, address factors to control to ensure validity of results Customer required deviations, recorded in detail with sampling data, results, communicated to all staff Records of data & operations, procedure, sampler, environmental conditions, location, statistics 5.8 Handling of test and calibration items: How are the following addressed/ implemented? Transport, receipt, handling, protection, storage, retention, disposal, protect integrity/interests Identify, for life of item, not confuse, accommodate sub-division and transfer of items Departures recorded on receipt. Where doubt consult customer before proceeding and record Notes Std Avoid deterioration, loss /damage storage, handling, preparation. Follow instruction. Environmental conditions maintained, monitored, recorded. Storage secure, protect condition and integrity. Additional / General Comments (This space may also be used to expand on comments in specific sections) Issue No.: 1 Page 8 of 12 Date of Issue:

9 5.9 Assuring the quality of test & calibration results: How are the following addressed/ implemented? QC procedures to monitor validity of results, data recorded, trends, statistics. Planned & reviewed: Note Std a) Regular use of certified reference materials and/or secondary reference materials. b) Participation in inter-laboratory comparison or proficiency testing programmes. c) Replicate tests or calibrations using the same or different methods. d) Re-testing or re-calibration of retained items. e) Correlation of results for different characteristics of an item QC data analysis. Action plan for incorrect results. Preventing the reporting of incorrect results. Issue No.: 1 Page 9 of 12 Date of Issue:

10 5.10 Reporting the results: How are the following addressed/ implemented? Notes Std Notes Std General Accurate, clear, unambiguous, objective, in accordance with specific instructions in methods. Information requested by client & for interpretation of results, refer and or Internal customers/written agreement, report simplified. Information 5,10.2 to readily available. Test reports and calibration certificates: How are the following addressed/ implemented? Report/certificate include at least following information unless the laboratory has valid reasons: a) A title (e.g. Test Report or Calibration Certificate ). b) Name and address of the laboratory and location of work, if different from address of laboratory c) Unique identification of report/certificate, on each page, clear identification of end. d) The name and address of the customer. e) Identification of the method used. f) Description of, the condition of, and unambiguous identification of the item(s) tested or calibrated. g) Date of receipt of item(s) where critical to validity and application of results, date(s) of performance. h) Reference to sampling plan and procedures used where relevant to validity or application of results. i) The test or calibration results with, where appropriate, the units of measurement. j) Name/s, function/s, signature/s or equivalent identification of person/s authorizing report certificate. k) Where relevant, a statement to the effect that the results relate only to the items tested/calibrated Tests reports In addition to , for test reports, where necessary for interpretation of test results, include; a) Deviations, additions, exclusions from test method, specific test conditions, such as environmental b) Where relevant, a statement of compliance/non compliance with requirements/specifications c) Estimated uncertainty of measurement; need when: -relevant to validity or application of results, -a customer requirement, -uncertainty affects compliance to specification limit d) Where appropriate and needed, opinions and interpretations (see ) e) Additional information, required by specific methods, customers or groups of customers In addition to and , results include the following, for interpretation of results: a) The date of sampling b) Unambiguous identification, manufacturer s name, model or type of designation, serial numbers c) The location of sampling, including any diagrams, sketches or photographs. d) A reference to the sampling plan and procedures used e) Environmental conditions during sampling that may affect the interpretation of the test results. f) Standard/other specification for sampling methods, deviations, additions, exclusions. Issue No.: 1 Page 10 of 12 Date of Issue:

11 Additional / General Comments (This space may also be used to expand on comments in specific sections) Issue No.: 1 Page 11 of 12 Date of Issue:

12 Calibration certificates In addition to , do certificates include the following, for interpretation of calibration results: a) Conditions (e.g. environmental) that have an influence on the measurement results. b) Measurement uncertainty/statement of compliance with metrological specification/clauses thereof. c) Evidence that the measurements are traceable? (see note 2 in ) Relate only to quantities and the results of functional tests. Statement of compliance with specification, identify which clauses of specification are met/not met Compliance statement omitting results & uncertainties, record maintain results for future reference Statements of compliance made, the uncertainty of measurement taken into account Adjusted or repaired, calibration results before and after adjustment/repair, if available, reported Not recommend calibration intervals unless agreed with customer, superseded by legal regulations Opinions and interpretations: Document basis upon which they have been made. Clearly marked Notes Std as such in a test report Testing and calibration results obtained from subcontractors Test results clearly identified. The sub-contractor reports the results in writing or electronically. Calibration laboratory performing work issues the calibration certificate to contracting laboratory Electronic transmission of results: Requirements of this international standard met (see also 5.4.7) Format of reports and certificates: Designed to accommodate each type of test or calibration Notes Std carried out and to minimize the possibility of misunderstanding or misuse Amendments to test reports & calibration certificates: Further document/data transfer include Supplement to Test Report/Calibration Certificate, identification, / equivalent form of wording Meet all the requirements of this international standard When complete new report/certificate, uniquely identified, contain reference to original replaced. General/additional comments and matters to follow up at next assessment Signed Lead/Technical Assessor: Date: Issue No.: 1 Page 12 of 12 Date of Issue: