ORGANIZATION and MANAGEMENT REQUIREMENTS of ISO Guide 34: 2009

Transcription

1 SANAS Accr. No/s. ORGANIZATION and MANAGEMENT REQUIREMENTS of ISO Guide 34: 2009 Date/s of evaluation Assessor/s & Observers Facility Area / Facility Representative This report covers the following: Document Review only Implementation on Site Visit only field of operation Document Review Other and Site Visit 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 Guide 34 are in italics. The order of assessment need not follow the order of the checklist. Assessors are expected to know & have the Guide, this worksheet is designed as guidance to prompt detailed recording of the process. REFER TO ISO Guide 34:2009 FOR DETAIL AND FOR CLARIFICATION NOTES.. 4 ORGANIZATION AND MANAGEMENT REQUIREMENTS 4.1 Quality System Requirements: How are the following addressed/implemented? General Has a Quality System been established and implemented and is it maintained? Does the Quality System cover the type, range, and magnitude of RM production undertaken? Is the procedure for establishing the quality of materials described as a component of the quality system? Has the RM producer defined their scope of activity in terms of reference materials and matrices? (Including application, measurement methods used in the homogeneity, stability and characterization studies, and limitations due to material matrix) C NC NA Quality Policy Has the Quality policy been documented? Does the quality policy address Objectives and commitment to maintain the quality of all aspects of the production? Including: Material quality Homogeneity Stability Characterization Assignment of property values Material handling Storage Transport Does the policy include: A commitment to produce RM s which conform to the definitions of ISO Guide 30? Characterization according to ISO Guide 35? (Where appropriate) Certificates according to ISO Guide 31? To conduct testing and calibration according to ISO/IEC 17025? To require personnel to familialize themselves with the quality documentation? To continuously improve the system and commit to professional practice? SANAS Page 1 of 13

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3 4.1.3 Quality System: How are the following addressed/implemented? Has a quality system been established and implemented, and is it maintained? Are the policies, systems, programmes, procedures, instructions and findings documented? Is the quality system documentation communicated to, understood and available to all personnel? Does the quality system cover a) The choice of candidate reference materials? b) Preparation procedures? c) Homogeneity? d) Stability, including on-going stability where necessary? e) Procedures for characterization? f) Assessment of commutability (where applicable) g) Practical realization of metrological traceability? h) Assignment of property values (ISO Guide 31 where appropriate)? i) Arrangements for storage facilities? j) Identification, labelling, packaging facilities, packing, delivery and customer service? k) Compliance with Guides 30, and appropriate sections of 31 and 35? Does the Quality system indicate activities undertaken by subcontractors? Does the Quality system include policies and procedures to ensure that subcontractors, comply with the relevant clauses of Guide 34? Does the Quality system define the roles and responsibilities of the technical management? Does the Quality system define the roles and responsibilities of the quality manager? 4.2 Organization and Management: How are the following addressed/implemented? 4.2. Can the RM producer, or the organization of which it is part be held legally responsible? Does the RM producer operate in such a way that the requirements of ISO Guide 34 are complied with both at their permanent facilities, and sites away from the permanent facilities? Does the RM producer: a) have managerial/technical staff having authority and resources who can identify departures from the quality system, and actions to prevent or minimize such departures? b) have arrangements to ensure personnel are free from undue pressures? c) have policies and procedures to ensure customers confidentiality? d) have policies and procedures to avoid involvement is activities that may diminish confidence in its competence, impartiality, judgement, or operational integrity? e) define the organizational structure, with the aid of organizational charts? f) specify the responsibility, authority and inter-relationships of personnel? g) have the technical management, staff and resources to ensure quality of operations? h) have a quality manager, with access to the highest level of management? i) have appointed deputies (particularly quality and technical managers)? SANAS Page 3 of 13

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5 4.3 Document and Information Control: How are the following addressed/implemented? Notes in Std General Procedures to control all documents that form part of its quality system (internally generated/from external sources) e.g. standards, guides, test and/or calibration methods, specifications, instructions and manuals Document Approval and Issue Review and approval by authorized personnel Availability of a master list or equivalent, including revision status Adequate control to preclude use of invalid and/or obsolete documents Procedure(s) adopted shall also ensure: a) They are available where operations essential to the effective production of reference materials are performed b) Periodic review to ensure continuing suitability and compliance c) Invalid or obsolete documents are assured against unintended use d) Obsolete documents retained are suitably marked Document changes Review/approval by the same function who originally approved. Designated person has access to pertinent background info Where possible, changes identified in the document/the appropriate attachments where practicable Amendment by hand: procedure/authority, initialled, dated. Formal re-issue as soon as practicable Changes made and controlled in documents maintained in computerized systems. 4.4 Request, Tender and Contract Review: How are the following addressed/implemented? See Notes Policies and procedures for the review of requests, tenders and contracts. Ensure that: a) Requirements, including methods, adequately defined, documented and understood b) Capability and resources to meet the requirements c) Differences between tenders & contracts are resolved to the satisfaction of RMP and customer? Has the request tender and contract review been conducted in an efficient manner? Are the financial, legal and time schedule aspects taken into account? Records maintained of reviews, changes and pertinent discussions with customer Coverage of work contracted by the producer SANAS Page 5 of 13

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7 4.5 Use of subcontractors: How are the following addressed/implemented? Has the producer established procedures to select competent subcontractors and to ensure that tasks performed comply with specifications set by the producer? Are subcontractors required to comply with the relevant clauses of this guide? Are subcontractors selected on their ability to meet technical and quality assurance requirements? (the technical requirements are those in clause 5 of ISO Guide 34) Is work conducted by subcontractors according to specifications set by the producer? Does a protocol exist for the subcontractor to exercise their tasks? Are subcontractors accredited to ISO/IEC 17025, where applicable? Is subcontractor performance assessed? Is a register available of all subcontractors? Is a record of the assessments of the ability to carry out contracted tasks available? Do the records include any quality assurance approval that the subcontractor holds? 4.6 Procurement of Services and Supplies: How are the following addressed/implemented? Are policies and procedures available for the selection of services and supplies that can effect the quality of the RM s? Are only those services and supplies that comply with specifications used? When no formal approval of the services and supplies is available, has the producer procedures in place to ensure that purchased supplies and services comply with specified requirements? Are records of actions maintained? Are equipment & consumables affecting quality of results not used until inspected/calibrated/verified? Are records maintained of all suppliers and subcontractors? Do the records include quality assurance approval that the suppliers or subcontractors may hold? 4.7 Customer Service: How are the following addressed/implemented? Is the producer willing to cooperate with customers to clarify requests and questions? Does the producer seek feedback (positive and negative) and is this data analysed to improve the system? 4.8 Complaints Does the producer have policy and a procedure for the resolution of complaints from customers or other parties? Are records available of all complaints, the investigations, and corrective action taken? SANAS Page 7 of 13

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9 4.9 Control of Non-conforming work and or reference materials: How are the following addressed/implemented? Are policy and procedures in place to address any aspect of its production activities that do not conform to its own procedures? Does the procedure ensure that: a) Designated responsibilities/authorities for the management of non-conforming work are identified? b) The actions to be taken when NC work is identified are defined and effectively implemented? c) An evaluation of the significance of the NC work is made? d) Work is halted and certificates withheld? e) Remedial action is taken within a defined time frame? f) Customers are notified and non-conforming RM is recalled from customers? g) The responsibility for restarting work is identified? Is corrective action promptly followed, where evaluation indicates possible recurrence or doubt about compliance of the producers own policies and procedures? 4.10 Corrective Actions: How are the following addressed/implemented? General Has the producer policy and procedure for the management of corrective action? Are appropriate authorities designated for implementing corrective action when NC work or departures from policies/procedures in the management system/technical operations been identified? Cause analysis Does corrective action start with investigation to determine the root cause(s) of the problem? Corrective Actions Does the producer select the actions most likely to eliminate the problem, and prevent it recurring? Is the CA taken appropriate to the degree of magnitude of the problem, and risk? Are the required changes to operational procedures, as a result of investigations, documented? Monitoring of corrective actions Is the CA taken monitored to ensure that it has been effective? Additional Audits Are additional audits conducted in areas where there is doubt about the producer s compliance? 4.11 Preventive Actions: How are the following addressed/implemented? Are improvements or potential non-conformances identified, and preventative action taken? Does the producer monitor the results of the implementation of preventative actions? 4.12 Improvement: How are the following addressed/implemented? Does the producer continuously improve the effectiveness of the management system? (by using policy, objectives, audits, analysis of results, preventative actions and management review) SANAS Page 9 of 13

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11 4.13 Records: How are the following addressed/implemented? General Are procedures available for the identification, collection, indexing, access, storage, maintenance and disposal of quality and technical records? a) Do the quality records include internal audits, management reviews, corrective and preventative actions? b) Do the technical records include forms, contracts, work sheets, work books, check sheets, control charts and graphs, calibration reports/ certificates, papers, reports and certificates issued to customers and clients? Are records stored so that they are readily retrievable, and damage, deterioration and loss prevented? Are the retention times of records established and recorded? Are mistakes in records crossed out and not erased? Are alterations initialled? Are similar arrangements in place for amendments to electronic records? Are records held secure and in confidence? Are electronic records protected, backed-up, and unauthorized access prevented? Records and reports. Does the record system meet the requirements of the producer? Does the record system comply with any applicable regulations? Is the retention period of records of measurement observations, calculations, derived data including statistical and UoM longer than the period beyond which they may be referred to? Are the results or each calibration and measurement both by the producer and collaborators reported in accordance with ISO/IEC 17025? 4.14 Internal Audits: How are the following addressed/implemented? Are internal audits held periodically, to a predetermined schedule and procedure? Do the internal audits verify operations continue to comply with requirements? All elements of quality system, incl. technical and production addressed? Is the Quality manager responsible to plan, organize as scheduled as requested by management? Are internal audits conducted by trained and qualified personnel independent of the activities being audited where ever possible? Timely corrections when doubt on effectiveness of operations/correctness of results. Written notification of customers if results may have been affected Are all audit findings, and corrective actions that arise recorded? Does management ensure that actions are discharged within the agreed timescale? Do follow-up activities verify the implementation and effectiveness of corrective action? SANAS Page 11 of 13

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13 4.15 Management Reviews: How are the following addressed/implemented? Does top management according to predetermined schedule and procedure, periodically review its quality system and production activities to ensure their continuing suitability and effectiveness, and to introduce necessary changes/improvements? Does the review include: suitability of policies & procedures, reports from managerial & supervisory personnel; outcome of internal audits; corrective & preventive actions; assessments by external bodies; changes in volume of work, customer feedback; improvements, complaints; other relevant factors (resources, staff training, technical issues) Findings, actions that arise from them recorded, carried out within an appropriate/agreed timescale Signed : Lead/Technical Assessor Date SANAS Page 13 of 13