ISO/IEC CHECKLIST

Transcription

1 ISO/IEC CHECKLIST WITH INTERPRETIVE COMMENTS October 2005 This document, based on the Laboratory Assessment Worksheet, includes only those clauses of ISO/IEC where clarification or interpretation has been sought. The interpretive comments are included in the 'Comments' column against the relevant clause(s). These comments are a result of discussions held by NATA staff and are provided as a guide only, as each facility's system is looked at in terms of its needs and situation. Issued: Oct 2005 Page 1 of 8

2 4 MANAGEMENT REQUIREMENTS 4.1 Organisation CLAUSE REQUIREMENT COMMENTS Undue pressure 4.1.5b ensure arrangements are in place so that management and personnel are free from internal and external commercial, financial and other pressures that might adversely affect the quality of their work emphasis is on arrangements not a policy or procedure. Operational integrity 4.1.5d ensure the facility has policies and procedures to avoid involvement in activities that compromise the confidence in its competence, impartiality, judgement or operational integrity facilities do need to consider this issue. intent and applicability of this clause will be dependent on both type of testing and size of facility and the policies and procedures should therefore reflect this. examples where this clause may need to be considered include staff who have responsibilities in production or marketing as well as testing; acceptance of sub-standard materials or services, e.g. training, calibrations. clause does require policies and procedures. may not always be examples of 'conflict of interest' evident. may be linked to 4.1.5b. 4.2 Management System Policies and procedures Quality policy statement document policies and procedures as a management system to ensure quality of all work and that they are communicated, available, understood and implemented ensure the quality policy statement is issued under the authority of top management and includes: the facility management s commitment to good professional practice and quality of its service a statement of the facility s standard of service the purpose of the management system a requirement for all personnel to be familiar with and implement the quality documentation the facility management s commitment to compliance with the Standard and to continually improve the management system these overall objectives are to be reviewed as part of management review. need to ensure requirements of the Standard are met in terms of facilities needs and activities. management system requirements should be there to support (and help improve) laboratories activities. if variable practices observed during an assessment, may be that documented procedures need improving. quality policy is the facility s document and should reflect that "personality". points need to be addressed to ensure intent has been met rather than literally, e.g. authority of top management. facilities should be encouraged to consider inclusion of reference to in next review of their quality policy. Issued: Oct 2005 Page 2 of 8

3 Quality manual 4.2.2, 4.2.5, maintain a quality manual that: defines management system policies and objectives includes or makes reference to supporting procedures, including technical procedures and outlines structure of the documentation in the management system defines the roles and responsibilities of technical management and the quality manager The quality manual needs to be uniquely identified to the facility. This does not however necessarily mean that it must include the name, phone number and address. 4.3 Document Control Approval and issue Identification Altered or new text ensure documents are reviewed and approved by authorised personnel prior to issue, and are included on a master list which identifies the revision status and distribution all management system documents must be uniquely identified and include 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) ensure where practical, the altered or new text is identified in the document or the appropriate attachments 4.4 Review of requests, tenders and contracts Policies and procedures 4.4.1, Records of review ensure policies and procedures related to review of requests, tenders and contracts are established, maintained and include: defining, documenting and understanding customer requirements before commencing work facility s capability and resources appropriate method selection work that is subcontracted by the facility maintain records of reviews, including any significant discussions and/or changes throughout the contract 4.5 Subcontracting of tests and calibrations Competency 4.5.1, ensure that subcontractors are competent (e.g. accredited facility) and records are maintained of subcontractors used and their competency (e.g. scope of accreditation) no requirement for amendment record per se. issuing authority doesn't necessarily have to be a "person", can be a "position". new or altered text does not necessarily have to be identified. important that facility is capable of doing the work that it commits to. important that facility and its customers agree on their requirements initially, i.e. at the time of contract review. evidence of contract review and changes to contracts will vary depending on the facility s needs, e.g. it may be part of sample receipt records, order requests or part of a larger project contract review being undertaken by the organisation. a better approach than requesting a copy of the scope of accreditation. Issued: Oct 2005 Page 3 of 8

4 4.6 Purchasing services and supplies Purchasing documents ensure purchasing documents for items affecting the quality of work are reviewed and approved for technical content prior to release facility must be able to demonstrate that it has established and approved what it is buying from its suppliers. 4.7 Service to the customer Cooperation cooperate with customers to clarify requests and monitor facility's performance whilst ensuring confidentiality to other customers no documented procedure required by Standard. looking for evidence. part of facility s good business practice. may be under 'contract review'. clause is applicable to small in-house testing facilities. 4.8 Complaints Policy, procedure and records 4.8 document policy and procedure for the resolution of complaints from customers or other parties and ensure records of the complaints, investigations and corrective actions (4.11) are maintained may be handled through corrective action procedure. 4.9 Control of nonconforming testing and/or calibration work Policies and procedures ensure policy and procedures are implemented when work or results do not conform to own procedures or customer requirements and include: defined responsibilities, authorities and actions an evaluation of the significance of the non conforming work corrective actions and decision about the acceptability of the nonconforming work to be taken immediately notification of the customer and work recall, if necessary defined responsibility for authorising the resumption of work. documentation is required by the Standard. may be found as part of corrective action, internal audits and/or preventive action. examples include QC results out of spec, calibration/check on a piece of equipment that is out of spec. defined responsibilities may be included in duty statements/organisation charts etc Improvement 4.11 Corrective action 4.12 Preventive action Identification and action 4.12 ensure needed improvements and potential sources of nonconformities are identified and action plans developed, implemented and monitored, using controls to ensure they are effective useful info provided in the 2 notes to the clause in the Standard. don't just look for a preventive action' section in the quality manual. look for examples, e.g. in management and contract reviews. not a reaction to "mistakes". Issued: Oct 2005 Page 4 of 8

5 4.13 Control of records Corrections to records ensure any changes to the original records (including electronic) are made so that: original record is not obscured correct value entered alongside alterations signed or initialled by the person making the correction equivalent measures must be taken for records stored electronically does not specifically require date of change to be recorded. This, however, continues to be good laboratory practice and has been included in the Standard Application Document Internal audits Requirements internal audits shall be conducted periodically and in accordance with a predetermined schedule and procedure to verify continuing compliance with the requirements of the management system and NATA Accreditation Criteria (NAC) quality manager is responsible for planning and organising audits to be carried out by trained and qualified personnel independent of activity being audited (where resources permit) training can be internal and/or experience based providing there are records available to demonstrate this training. records of qualifications of auditors may be part of staff member's training records. person carrying out internal audits is to be 'independent' where 'resources permit', therefore not always a requirement. if external person used to carry out internal audits then evidence of person's training and/or qualifications to carry out the audits must be available in the facility. facility needs to ensure management system meets requirements of the Standard, e.g. through management review records, authorisation of amendments to documents, etc Management reviews 5 TECHNICAL REQUIREMENTS 5.2 Personnel Authorised personnel ensure management has authorised specific personnel to: perform specific sampling, testing and/or calibration activities issue test reports and/or calibration certificates and that signatory approval has been taken into consideration give opinions and interpretations (in those fields of testing where permitted on test reports) operate particular types of equipment and that records for all technical personnel (including contracted personnel) are maintained for: relevant authorisation(s) including date on which authorisation and/or competence is confirmed competence educational and professional qualifications training, skills and experience training protocol/procedure (5.2.2) and/or job descriptions (5.2.4) may provide the detail and records for a facility to demonstrate authorisation and competence. how specific training records need to be is dependent on type of testing/calibration activity and how detailed the supporting documentation is. Issued: Oct 2005 Page 5 of 8

6 5.3 Accommodation and environmental conditions 5.4 Test and calibration methods and method validation Uncertainty of measurement calibration facilities or testing facilities performing their own calibrations must have and implement procedures for estimating the uncertainty of measurement for all calibrations must be raised and discussed with facility staff as per Standard Application Document. 5.5 Equipment 5.6 Measurement traceability 5.7 Sampling Procedures and plan ensure procedures for sampling are available at the sampling location and include: a sampling plan (based on appropriate statistical methods, wherever reasonable) factors to be controlled to ensure validity of the test/calibration results further discussions being held at field and AAC level, e.g. in relation to where and when it applies and whether or not accreditation will be available for the sampling plan aspect of this clause. 5.8 Handling of test and calibration items 5.9 Assuring the quality of test and calibration results 5.10 Reporting the results Test reports and calibration certificates , results of tests and calibrations must be reported accurately, clearly, unambiguously, objectively and in accordance with any specific instructions in the methods test reports and calibration certificates must include all information requested by the customer, required by the method and necessary for the interpretation of the test or calibration results results may be reported in a simplified way when performed for internal customers or in the case of a written agreement with customer, however, any information not reported to the customer, but is normally required to be, must be readily available in the facility test reports and calibration certificates must be designed to accommodate each type of test or calibration carried out and to minimise the possibility of misunderstanding or misuse for details on the use of the NATA endorsement refer to the Standard Application Document (SAD) and the NATA Rules. "simplified" reports are being considered by the Sector Managers (SM). If a facility makes such a request, it must be forwarded to the relevant SM and the General Manager, Operations and Technical. Issued: Oct 2005 Page 6 of 8

7 Test reports , test reports must include the information listed in the Standard under items (a) to (k) and the SAD a title (a) name and address of the facility, and the location where the testing/calibrations were carried out, if different from the address of the location (b) 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) name and address of the customer (d) identification of the method used (e) description, condition and identification of the item tested or calibrated (f) date of receipt of test/calibration item where applicable and the date the work was carried out (g) reference to the sampling plan and procedures used by the facility or other bodies where applicable (h) results with, where appropriate, the units of measurement (i) name, function and signature or equivalent identification of person authorising the test/calibration document (j) statement to the effect that the results relate only to the items tested or calibrated where applicable (k) may not be needed where facility carries out inhouse testing - use common sense approach. may also be met by inclusion of customer name and code, e.g. project or job number that is traceable within the facility s records. "function" can be approved signatory or job title. Issued: Oct 2005 Page 7 of 8

8 5.10.2, (continued) Opinions and interpretations where necessary for the interpretation of the test results the items included in (a) to (e) must also be included in the test report with the exception of (d) which is not permitted in all fields of testing (refer to relevant field specific Application Documents) deviations, additions or exclusions from the test method, and specific test conditions, e.g. environmental conditions (a) statement of compliance/noncompliance with requirements and/or specifications (b) statement on the estimated uncertainty of measurement where applicable (information on uncertainty is needed in test reports when it is relevant to the validity or application of the results, when a customer s instruction requires or when the uncertainty affects compliance to a specification limit) (c) opinions and interpretations where appropriate and needed (d) - additional information required by specific methods or customers (e) test reports containing the results of sampling must also include the additional requirements listed in (a) to (f) as necessary for the interpretation of the test results date of sampling (a) unambiguous identification of the material sampled (b) location of sampling including any diagrams, sketches or photographs (c) reference to the sampling plan and procedures used (d) details of environmental conditions during sampling (e) any standard or specification for the sampling method or procedure and deviations, additions or exclusions from the specification (f) in those fields of testing where not permitted written authority must be granted by NATA s Chief Executive statements of fact and compliance are not considered to be an opinion. currently extensive discussion at an international level regarding the inclusion of opinions on test reports. Issued: Oct 2005 Page 8 of 8