SANAS Report. No 98, August/September PRESENTATION OF NEW LOGO s MPHO PHALOANE Senior Manager: Mechanical and Physical

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1 SANAS Report No 98, August/September 2008 PRESENTATION OF NEW LOGO s MPHO PHALOANE Senior Manager: Mechanical and Physical On 31 March 2008 the Council of Trade and Industry Institutions (COTII) Forum held a meeting at the dti Campus in Sunnyside, Pretoria. The forum is used to discuss matters of mutual interest among the institutions, as well as to inform all members about governments policies and feedback on the Cabinet Lekgotla s deliberations. At the end of the meeting Mpho Phaloane from SANAS and Shravan Singh from NMISA presented their new logos respectively to the Deputy Minister, Rob Davies indicating the similarity of their logos with respect to their relationship within the South African Technical Infrastructure. REMINDER ON THE USE OF SANAS LOGO OR REFERENCE TO ACCREDITATION MARLAN PILLAY Field Manager: Testing Laboratories As per SANAS R04 Clause 5.8.2, Laboratories are not allowed to use their SANAS logo or reference to accreditation on test reports that do not contain results from accredited tests. Misuse of accreditation is an offence (Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice, Act 19 of 2006).

2 VALIDITY OF TEST RESULTS FROM DEVIATING SAMPLES MARLAN PILLAY Field Manager: Testing Laboratories Whether a laboratory organizes the activity of sampling or the customer does the sampling and provides the sample to the laboratory, it is important that the test report captures the conditions under which a sample was taken or received. It will be difficult for labs to capture such conditions in a test report, but it is practical to have a system to keep records of such conditions and have a disclaimer contained in a test report, which will only appear in a case where there was any deviation noted. Deviating samples are unpreserved samples nearing its valid testing period or samples that have not been correctly preserved. When deviating samples are tested, it may be necessary to state the conditions of sample received (sample unique identification, sample preservation technique, sample storage & sampling date & time) on the test report. A remark on the test report that the results may have been compromised due to the sample condition should also be included. This may apply especially in the following cases: the maximum preservation time is exceeded the unpreserved sample condition is questionable where the date and time of sampling was not recorded the storage conditions of the sample is questionable or was not adhered to the sampling preservation is questionable or not enough information was provided that gives assurance that the sample was correctly preserved Remember that as per ISO/IEC regarding contract reviews with customers, the laboratory management shall obtain agreement with the customer whether a deviating sample should be tested. The laboratory management must also ensure that relevant remarks relating to the impact on the test results is contained in the test report. SANAS assessors may be assessing this during assessments so it is important to keep records of contract review available. (Adapted from ILAC News, Issue 33, April 2008 available on

3 PERSONNEL COMPETENCE JOHN PEART Accreditation Expert Accreditation is synonymous with competence. It was therefore concerning to hear that the most common reason for suspension recently has been due to a lack of competence of personnel. Accredited facility personnel must be deemed competent by their organisation. It is up to the facility to train and evaluate a person for their competency to fill a particular position and to declare such person competent to perform the specific task. It is the job of the Accreditation Body s (SANAS) assessment team during the assessment of a facility, to verify such evidence on which the competence declaration is based, and recommend to the Accreditation Body to grant or not, formal recognition of such. If it is widely believed that personnel competence is the most important, then records of a person s competence are vital information for the facility management. It is management, first and foremost, who must have the confidence that after a person is deemed competent that when they give that competent person a task that person will produce an accurate result. A full article on personnel competence will be published in the SANAS Communiqué. PRESSURE GAUGE CALIBRATION SOLOMON MAHLANGU Field Manager : Inspection Bodies The Standards SABS 0227 and ISO/IEC require calibration to be traceable to national or international standards. Measurement Traceability is defined as an unbroken chain of comparison to the national/ international standards. In South Africa, measurement traceability can only be provided by the National Metrology Institute of South Africa (NMISA) or a calibration laboratory appropriately accredited to ISO/ IEC Calibration certificates from these sources will include statements of uncertainty. However, equivalent calibration laboratories from other countries may also be used provided that they have an established traceability of measurement. Such traceability of measurement is provided by National Metrology Institutes participating in internationally recognised interinstitute comparisons and by laboratories accredited by bodies that are signatories to the ILAC multilateral agreement on calibration. Please note that the use of a calibrated reference standard (e.g. master gauge) does not transfer measurement traceability, but serves as a means to verify the accuracy of the instrument(s) for internal purposes only. When submitting your equipment for calibration (e.g. gauges) please ensure that the laboratory s scope of accreditation covers your required calibration to the accuracy you require. Should an inspection body use someone else equipment (e.g. client, lease), the inspection body remains responsible to ensure that the equipment is suitable for use and that traceability to national or international standards can be proven.

4 ADMINISTRATION UPDATE SUMÉ MURRAY Administrative Manager STAFF CHANGES CONGRATULATIONS to Tshenolo Molamu who has been appointed as SANAS Communications and Marketing Manager as of 1 September I would like to extend my sincere gratitude and appreciation to Tshenolo for her contributions to the administration department. Tshenolo managed the Post-Assessment activities which included Corrective Actions, Approval Committees and Certificates and Schedules of Accreditation. She has laid down an excellent foundation since May 2006 and assisted in various improvements. From the Administration Team, we wish her all the best and great success with her new position. FAREWELL to Mthokozisi Skosana who has been working in the Pre-Assessment activities team and was responsible for travel arrangements for SANAS assessments. A big thanks goes to him for his hard work and efforts in ensuring that assessors arrive at assessments, are taken care of with regards to accommodation. We know that he will achieve further excellence in his new challenging working environments and we wish him all the best. GOOD LUCK! ADMINISTRATION CONTACTS Senior Administrator: Praise Maja or praisem@sanas.co.za Chief Administrator: Cleon Andrews or cleona@sanas.co.za Administration Manager: Sumé Murray or sumem@sanas.co.za PROCESSES The draft, verification process and finalization of the Schedule of Accreditation is now a standard agenda item tabled on the opening and closing meeting forms, F01 and F02. It is imperative for accredited / applicant facility representatives and assessors to agree on and finalize this document after the assessment. The purpose for introducing this step as part of the assessment process is 1) for the Approval Committee and SANAS to have a confirmed scope of accredited activities that has been accepted by the facility and recommended by the assessment team and 2) to improve the turnaround time of issuing the final updated Schedule of Accreditation. It should be noted however, that changes to the previous scope of accreditation, especially additions / extensions / signatories / etc., will have to be ratified by the Approval Committee and SANAS prior to the Schedule of Accreditation being issued. For further information, please me at sumem@ sanas.co.za or contact me on CONGRATULATIONS TO OUR NEWLY QUALIFIED SANAS ASSESSORS! YOLANDA VINNICOMBE Quality Manager The following Assessors were qualified during March to August 2008: Technical Assessors: Jimmy Mbhele Inspection Bodies Trudy Machattie Medical Laboratories Betsie Beetge Testing Laboratories Nompumelelo Mthembu Testing Laboratories Lead Assessors: Mponeng Poo Medical Laboratories Nompumelelo Mthembu Testing Laboratories Thabo Chesalokile Verification and Testing Laboratories Your technical expertise is valuable to the country s technical infrastructure and growth. We re looking forward to a mutually beneficial working experience with you!

5 NOTIFICATION OF UPDATED FORMS/ DOCUMENTS YOLANDA VINNICOMBE Quality Manager The following new documents were approved and published during May and July 2008: F Proficiency Testing Requirements, ISO/IEC 17025:2005 Clause 5.9 and SANAS Requirements F Vertical Assessment: ISO/IEC 17024:2003. Certification of Persons 2008/05/ /07/09 The following forms and documents were revised/updated and published during July and August 2008: F 14B-03 Application for Accreditation of Blood Transfusion Service Laboratories F 14C-03 Application for Accreditation of Calibration Laboratories F 14CB-05 Application for Accreditation of Certification Bodies F 14GC-03 F 14GCPH-03 Application for Good Clinical Practice (GCP) Compliance Status Application for Good Clinical Laboratory Practice (GCPH) Compliance Status F 14GL-04 Application for GLP Compliance Status F 14IB-04 Application for Accreditation of Inspection Bodies F 14LM-03 Application for Accreditation of Legal Metrology/ Verification Laboratories F 14M-03 Application for Accreditation of Medical Laboratories F 14PH-03 Application for Accreditation of Pharmaceutical Laboratories F 14PT-04 Application for Accreditation of Proficiency Scheme Providers F 14T-04 Application for Accreditation of Testing Laboratories F 14V-03 Application for Accreditation of Veterinary Laboratories P SANAS Fees Medical Laboratories 2008/08/29 R DEPARTMENT OF HEALTH and SANAS' guidance on the application of SANS/ISO/IEC 17020: 1998 for Testing of Diagnostic X-Ray Imaging Systems by Inspection Bodies 2008/08/29

6 COMBINED MARKS YOLANDA VINNICOMBE Quality Manager As you are aware SANAS is a signatory to various Mutual Recognition Arrangements (MLAs) with the International Laboratory Accreditation Co-operation (ILAC) and the International Accreditation Forum (IAF). The use of the local SANAS Accreditation Symbol together with the ILAC or IAF mark is expected to dramatically improve recognition of SANAS accreditation as these marks are internationally known. Accredited facilities who wish to use the combined mark are required to sign the specific Sub-licence Agreements (F111 IAF Sub-Licence Agreement or F112 ILAC Sub-Licence Agreement ). No accredited facility may use the combined mark prior to SANAS informing them in writing that they may do so. Please contact me if you require any more information on the use of the combined mark, or for copies of the Sub-Licence Agreements, should you be interested in displaying the Combined Logo. SANAS Document R Use of Combined Marks is accessible on our website: Testing Laboratory EMS Certification Body ACCREDITED FACILITIES CONTRIBUTIONS FOR THE COMMUNIQUÉ TSHENOLO MOLAMU Manager: Communication and Marketing SANAS will be introducing a section in the Communiqué (from the next issue), where the accredited facilities can share their achievement or announcements. These contributions can be forwarded to the newly appointed Communications and Marketing manager, Ms Tshenolo Molamu on tshenolom@sanas.co.za or fax (012) SAGL ANNIVERSARY We have received contribution from The Southern African Grain Laboratory (SAGL) which recently celebrated their 10th anniversary, SANAS congratulates them, a full article will be published in the next SANAS Communiqué. SANAS 77 Meintjies Street, Building G, Sunnyside, Pretoria, 0002 Private Bag X23, Sunnyside, 0132 Tel: (012) Fax: (012)