MANAGEMENT REQUIREMENTS of ISO/IEC 17025:2005 - Sanas

F 48 -05Additional / General Comments This space may also be used to expand on comments in specific sections2009-03-06 ©SANAS Page 2 of 11

F 48 -054.1.5 The laboratory cont. : How are the following addressed/implemented?g) Supervision by persons familiar with methods, procedures, purpose of test/cal.; assessment ofresults.h) Tech. management resp. for tech. operations, provide resources to ensure quality of lab operations.i) Quality manager: staff member, defined resp. & auth. ensuring quality system implemented,followed always. Direct access to highest management level where lab policy/resources decided on.j)Note StdAppointment of deputies for key managerial personnel.k) Ensuring awareness of relevance, importance, & contribution of staff’s activities to achievingobjectives of management system.4.1.6 Top management establish appropriate communication channels & that communication takes placeregarding effectiveness of the system.4.2 Management System: How are the following addressed/implemented?4.2.1 Appropriate to scope. Documented to extent to assure quality of results, communicated to,understood by, available to, implemented by appropriate personnel.4.2.2Notein StdManagement system policies & objectives defined in quality manual? (however named). Objectivesreviewed during management review. Objectives established. Quality policy statement issued underauthority of top management including at least:a) Management's commitment to good professional practice, quality of its work in servicing its customersb) Management's statement of the laboratory’s standard of servicec) The purpose of the management system related to qualityd) All personnel concerned with test/cal activities in lab familiar with/implement quality documentatione) Laboratory management's commitment to : comply with this International Standard & continuallyimprove the effectiveness of the management system4.2.3 Top management’s commitment to : development & implementation of management system &continual improvement of its effectiveness4.2.4 Communication by top management of importance of meeting customer, statutory & regulatoryrequirements4.2.5 Quality manual include/reference supporting & technical procedures. Outline documentation structure4.2.6 Defined roles/responsibilities of technical & quality manager, including ensuring compliance with Std.4.2.7 Top management ensure integrity of system when changes are implemented2009-03-06 ©SANAS Page 3 of 11

F 48 -05Additional / General Comments This space may also be used to expand on comments in specific sections2009-03-06 ©SANAS Page 4 of 11

4.3 Document Control: How are the following addressed/implemented?4.3.1Notes inStdF 48 -05General Procedures to control all documents that form part of its quality system (internallygenerated/from external sources) eg regulations, standards, other normative documents, test and/orcalibration methods, drawings, software, specifications, instructions, manuals4.3.2 Document Approval and Issue4.3.2.1 Review, approval by authorized personnel. Control to preclude use of invalid/obsolete documents.4.3.2.2 Procedure(s) adopted ensure:a) available where operations essential to the effective functioning of the laboratory are performedb) periodic review to ensure continuing suitability and compliancec) invalid or obsolete documents are assured against unintended used) obsolete documents retained suitably marked4.3.2.3 unique ID: issue date/revision, page no., total pgs./mark to signify end of document, issue authority4.3.3 Document changes4.3.3.1 Review/approval by original function. Designated person access to pertinent background info.4.3.3.2 Changes identified in the document/the appropriate attachments where practicable.4.3.3.3 Amendment by hand: procedure/authority, initialled, dated. Formal re-issue as soon as practicable4.3.3.4 Changes made and controlled in documents maintained in computerized systems.4.4 Review of Requests, Tenders & Contracts: How are the following addressed/implemented?4.4.1Note StdPolicies and procedures for the review of requests, tenders and contracts. Ensure that:a) see5.4.2Requirements, including methods, adequately defined, documented and understoodb) Capability and resources to meet the requirementsc) see5.4.2Selected method capable of customer’s requirements. Differences resolved before workcommences. Acceptable to laboratory and customer.4.4.2 Records maintained: reviews; significant changes; pertinent discussions with customer.4.4.3 Coverage of sub-contracted work.4.4.4 Deviation from the contract: customer informed.4.4.5 Amendment after work commenced, review repeated, communicated to affected personnel.2009-03-06 ©SANAS Page 5 of 11

F 48 -05Additional / General Comments This space may also be used to expand on comments in specific sections2009-03-06 ©SANAS Page 6 of 11

4.5 Sub-contracting of Tests and Calibrations: How are the following addressed/implemented?4.5.1 Work placed with a competent sub-contractor. Eg. Complies with this Std.4.5.2 Advise customer in writing, when appropriate, gain the approval of the customer, preferably in writing4.5.3 Responsible except where the customer or a regulatory authority specifies which to use.4.5.4 Register and a record of the evidence of compliance with this Std.F 48 -054.6 Purchasing Services and Supplies: How are the following addressed/implemented?4.6.1 Selection, purchasing of services/supplies affecting quality of results. Purchase, reception, storage4.6.2 Supplies/reagents/consumables affecting quality of results not used till verified. Records.4.6.3 Description of services/supplies ordered, reviewed, approved for technical content prior to release.4.6.4 Evaluate suppliers of critical consumables/supplies/services affecting quality results. Records.4.7 Service to the Customer: How are the following addressed/implemented?4.7.1NoteStd4.7.2NoteStdAfford customers/representatives opportunity to clarify request/s, monitor lab's performance in relationto the work performed, provided that the laboratory ensures confidentiality to other customers.Getting feedback from customers. Analysing and using feedback to improve the management system,testing and calibration services, & customer service.4.8 Complaints: How are the following addressed/implemented?See 4.10, Complaints from customers/other parties. Records complaints, investigations, corrective actions4.11&4.12taken2009-03-06 ©SANAS Page 7 of 11

F 48 -05Additional / General Comments This space may also be used to expand on comments in specific sections2009-03-06 ©SANAS Page 8 of 11

F 48 -054.9 Control of Non-conforming (NC) Testing and/or Calibration work: How are the followingaddressed/implemented?4.9.1 Policy and procedures when any aspect of its work, or results of this work, do not conform to itsNote Std own procedures or agreed requirements of the customer. Ensure that:a) Designated responsibilities/authorities. Defined actions incl. halting of work/withholding of resultsb) Evaluation of the significance of the NC workc) Correction is taken immediately with decision about acceptability of the NC workd) Customer is notified and work recalled, where necessarye) Defined responsibility for authorizing the resumption of work4.9.2see 4.10& 4.11Corrective action promptly followed, where evaluation indicates possible recurrence or doubt aboutcompliance of the laboratory’s operations with its own policies/procedures.4.10 Improvement: How is the following addressed/implemented?Continual improvement of the management system through the use of quality policy, objectives, auditresults, data analysis, corrective action, preventive actions & management review4.11 Corrective Action: How are the following addressed/implemented?4.11.1Note StdGeneral. Designate appropriate authorities for implementing corrective action when NC work ordepartures from policies/procedures in the management system/technical operations beenidentified4.11.2 Cause analysisNote Std Corrective action start with investigation to determine the root cause(s) of the problem4.11.3 Selection and implementation of corrective actions ID potential actions, select/implementaction most likely to remedy problem/prevent recurrence. Actions to degree appropriate tomagnitude/risk of problem. Document/implement changes.4.11.4 Monitoring of corrective actions to ensure that the corrective actions taken have been effective4.11.5Note StdSee 4.14Additional audits. Audit appropriate areas of activity where doubts were cast on the laboratory'scompliance with its own policies and procedures, or on its compliance with this Int. Std.4.12 Preventive Action: How are the following addressed/implemented?4.12.1 ID technical/quality improvements, potential sources of NCs. Develop, implement, monitor actionplans to reduce likelihood of NC occurring and to take advantage of opportunities for improvement.4.12.2Note StdProcedures include the initiation of preventive actions and application of controls to ensure thatthey are effective.2009-03-06 ©SANAS Page 9 of 11

F 48 -054.13 Control of Records: How are the following addressed/implemented?4.13.1 General. ID, collection, indexing, access, filing, storage, maintenance, disposal of quality and4.13.1.1 technical records. Reports of internal audits, management reviews, corrective & preventive action.4.13.1.2 Legible, readily, retrievable in facilities that provide a suitable environment to prevent damage orNote Std deterioration and loss. Established retention times.4.13.1.3 Held secure and in confidence.4.13.1.4 Protect, back-up, prevent unauthorized access to and amendment of electronic records4.13.2 Technical records. Retention period. Original observations, derived data, sufficient info for audit4.13.2.1 trail, staff, calibration, each result issued. Info to ID factors affecting uncertainty. Enable to beNotes Std repeated as close as possible to the original. ID person/s sampling, performing, checking results.see 5.4.74.13.2.2 Observations, data, calculations recorded at the time they are made, identifiable to specific tasks.4.13.2.3 Mistake crossed out/not deleted/correct value alongside, initialled. Avoid loss/change of electronicdata4.14 Internal Audits: How are the following addressed/implemented?4.14.1Note StdPeriodically, predetermined schedule/procedure. Verify operations continue to comply withrequirements. All elements of system, incl. testing/calibration. Quality manager plan, organize asscheduled/requested by management. Trained/qualified independent where possible4.14.2 Timely corrections when doubt on effectiveness of operations/correctness of results. Writtennotification of customers if results may have been affected.4.14.3 Records of the area of activity audited, audit findings and corrective actions.4.14.4 Follow-up to verify and record implementation and effectiveness of corrective action.4.15 Management Reviews: How are the following addressed/implemented?4.15.1 Top management according to predetermined schedule and procedure : periodically reviewNote Std laboratory’s management system and testing/calibration activities to ensure their continuingsuitability and effectiveness, and to introduce necessary changes/improvements.Review of : suitability of policies & procedures; reports from managerial & supervisory personnel;outcome of internal audits; corrective & preventive actions; assessments by external bodies;results of inter-laboratory comparisons/proficiency tests; changes in volume & type of work;customer feedback; complaints; recommendations for improvement ;other relevant factors, likequality control activities, resources & staff training.4.15.2 Findings, actions that arise from them recorded, carried out within an appropriate/agreed timescale2009-03-06 ©SANAS Page 10 of 11

Additional / General Comments This space may also be used to expand on comments in specific sectionsF 48 -05Signed :Lead/TechnicalAssessorDate2009-03-06 ©SANAS Page 11 of 11