WELCOME 2013 Communication Meeting September 2013 CEO Report 2013 Communication Meeting September 2013 Focus 2010 to 2015 Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006 (Act 19 of 2006) Functions: d) Promote the acceptance of its activities and those of all bodies accredited by SANAS or its international counterparts; e) Promote the recognition of accredited bodies by users of conformity assessment; f) Liaise with regional and international standard bodies and with technical regulatory and metrology organisations in respect of any matter related to accreditation; Content • • • • • • • Growth in accreditation & analysis; New areas and associate conformity assessment required; Acceptance of Conformity Assessment results in Africa; Support for Conformity Assessment Bodies; Preparing SANAS Feedback on Customer Experience measure; Upcoming events Accreditation Stats – June 2013 Total Number of Accredited Facilities: 1420 as at June 2013 350 302 300 292 250 211 181 200 149 148 150 100 50 0 65 34 17 6 2 7 2 4 Growth Statistics: March 2012 to March 2013 Growth increase by (58) 43 accredited facilities since 2012 20 18 20 15 12 10 3 3 5 0 0 0 0 1 0 1 0 0 -5 -7 -10 -8 Upcoming Extensions Owner Dept. of tourism Dept. Of Labour Status Responsible tourism Launched Occupational Health and Safety Partially rolled out Risk Based Inspection (RBI) Launched Energy Management ISO/IEC 5003 - February 2014 Carbon tax incentives Feb 2014 roll out - OHSAS 1800 Launched BUSA Greenhouse Gas ISO/IEC 14065 Validation and Verification , Water & Environment Air Quality Monitoring Waste Water Management Testing Calibration Certificatio n Othe r - - - X - X X X x x X Dept. of Energy & BUSA Dept. Environment al Affairs Inspection/ Verification X x x Launched X x X x new new Industrial Policy Action Plan (IPAP) Priority Sector needs Sector Green Economy: Energy savings Stack Emission Testing Testing Calibration X X Certification Inspection Certification of Buildings Nuclear x x Information Security Road transport Management X X X X X Truck owner compliance ?? ?? Supporting the acceptance of Conformity Assessment Bodies (CAB’s) results in Africa Pan African Accreditation Cooperation (AFRAC) The aim is to ensure the acceptance of our goods and service in Africa based on the acceptance of our testing, inspection and certification results. – South Africa through SANAS hold the Chair and Secretariat of AFRAC; – MoU signed between AFRAC, African Standards Organisation (ARSO), African Electro technical Standards Commission (AFSEC) and the African Metrology Institute (AFRIMETS); – The above cooperation known as the Pan African Quality Infrastructure (PAQI) approved by the African Union (AU) Council of Ministers of Trade (CAMI) and will be table at the upcoming Heads of AU States meeting early new year for endorsement Support for Conformity Assessment Bodies (CAB’s) • MCEP : a Department of Trade and Industry incentive, supporting CAB’s on a cost share basis: – Development& Implementation of Management system; – Equipment; – Extension of facilities; – Further incentive for job creation; – the dti website: www.thedti.gov.za SANAS’ Alignment Area Staff compliment ICT Customer Experience measure Finance (Under recovery on provision of services excluding government contribution) Status June 2013 Target (2015) 62 75 • • • Application process partially automated; Finance and procurement updated • 47.2 • - 6.78 Online registration and tracking of processes • Improve service delivery & communication • • Invoicing; Budgeting: Under recovering for services rendered; Efficiency improvement 60 0 • Customer Experience Measure 2012/13 Methodology & Sample Realisation • All interviews were done telephonically (CATI system) • Interviews were conducted 4 March to 4 April 2013 • Average duration of interviews: 11min 30secs Total Sample = 236 (5.29% margin of error at a confidence level of 93%) Target Sample: 170 Sample realised: 236 Available Contacts: 752 Modelled Score – Annual Change 2011 2011 2012 2012 Sample (n) = 171 Sample (n) = 144 Failure Delight Failure 2013 2013 Sample (n) = 236 Delight Failure Delight CSM 0 0.6% NPS 100 40.0 0 55.3% 20.6% NPS = Net Promoters Score; CSM = Customer Satisfaction Measure 2.8% 100 43.7 28.6% 0 60.4% 1.7% 100 47.2 35.1% 61.4% Modelled Index Score by Division by Year 2011 2011 2012 2012 Sample (n) = 171 Sample (n) = 144 2013 2013 Sample (n) = 236 Query 0 100 0 66.5 100 0 70.0 100 73.0 Assessment 0 100 0 77.1 100 0 80.3 100 82.5 Benefits 0 100 0 69.4 100 0 71.9 100 73.7 Certificates 0 100 67.7 Slide 15 0 100 71.3 0 100 74.7 Events Event Date Accreditation Day - Durban 9 June 2013 Annual Communication Meeting Gauteng Annual Communication Meeting Durban Annual Communication Meeting – Cape Town & PE AFRAC General Assembly (Kenya) 16 September 2013 18 September 2013 19 & 20 September 2013 24 to 27 September 2013 ILAC and IAF General Assembly (Korea) 16 to 25 October 2013 Thank You RE-ASSESSMENT AND ASSOCIATED DOCUMENTATION REVIEWS Linda Grundlingh Field Manager: Inspection 2013 Communication Meetings RE-ASSESSMENTS ISO/IEC 17011 clause 7.11.1: • Re-assessment is similar to an Initial assessment as described in clauses 7.5 to 7.9, except that experience gained during previous assessments shall be taken into account. • During the August 2011 peer evaluation, it was brought to our attention that we did not comply with clauses 7.5.10, 7.6 & 7.11.1 in that we did not conduct document reviews prior to Re-assessment. SANAS CORRECTIVE ACTION • Re-assessments are conducted at least 3-months (6-months in regulatory fields) prior to the start of each new accreditation cycle. • Re-assessment visits will involve a comprehensive re-examination of the facility’s accredited activities at the beginning of each new cycle, and will be similar to the Initial assessment. • This includes a full documentation review. RECENT CHANGES • The Re-assessment process has been revised to include a re-application process which is mandatory, followed by the review of facility documents prior to the Re-assessment. • This means that as of 01 April 2013, each facility is required to re-apply for accreditation at least 6-months prior to, and in the case of Inspection Bodies 9-months prior to the expiry of their Certificate and Schedule of Accreditation. WHAT HAS CHANGED? 1. On re-application, each facility will need to complete the relevant revised F14 application form and submit it to SANAS with the relevant documentation as prescribed in each application form. 2. This will include the facilities Management System Documentation (Quality manual), along with specific information or documents as specified in each application (Checklists etc.) WHAT HAS CHANGED? 3. On receipt of the application, SANAS will conduct a review of the information submitted. 4. SANAS will arrange for a Re-assessment approximately 3-months prior to, and in the case of Inspection Bodies 6-months prior to the expiry of the Certificate and Schedule of Accreditation. WHAT IF A FACILITY DOES NOT RE-APPY? 1. Where SANAS has not received the application for Re-assessment, the Reassessment will not be scheduled. 2. The facility’s accreditation will expire on the expiry of the Certificate and Schedule of accreditation. HOW CAN THIS BE PREVENTED? • To prevent any periods of non-accreditation, or to prevent losing your accreditation status, facilities must re-apply within the timelines stipulated by SANAS. These are: • At least 6-months prior to, and in the case of Inspection Bodies 9-months prior to the expiry date of their Certificate and Schedule of Accreditation). IMPLEMENTATION TIME LINE Facilities should have submitted their applications already for Certificates expiring in October and November 2013, however, if this has not yet been done, SANAS will allow a grace period and still accept the applications for Reassessment at this stage. WHAT ELSE HAS CHANGED? • Whilst reviewing the re-application process, SANAS also took the opportunity to review the current Accreditation Agreement. • Decrease the administrative burden of obtaining a signed accreditation agreement from each and every applicant. • Also decrease the risk of not having a contractual arrangement with our accredited facilities. WHAT ARE THE IMPLICATIONS • Once an applicant signs an application form, they will automatically accept the Terms and Conditions of Accreditation. • Very soon SANAS will implement an on-line system to accept the Terms and Conditions and submit the application. • F 147 - SANAS Terms and Conditions for Accreditation • F 199 - SANAS Terms and Conditions for GLP/GCP Compliance. DOCUMENTATION REVIEW FINDINGS • In the case of an Initial assessment, a maximum period of 6-months is allowed for applicant facilities to address the document review findings, after which the application will cease. • For Re-assessments, SANAS will not require evidence of corrective actions prior to the re-assessment, as these will be verified during the re-assessment. BRANCH FACILITIES • If branch facilities operate under the same management system as the Head Office: • The checklists submitted by the Head Office as well as the Lead Assessor’s document review report will be sent to any other Lead Assessor(s) appointed to conduct assessment(s) at branch facilities. PAYMENT CONDITIONS Thank you lindag@sanas.co.za REVISED / NEW SANAS ACCREDITATION REQUIREMENTS Sept. 2013 Yolanda Vinnicombe yolandav@sanas.co.za Terms and Conditions of Accreditation & GLP/GCP Compliance Stakeholder input • Terms and Conditions together with an example of the revised application form (ISO/IEC 17025) were published on the SANAS website for a period of 60 days. • 125 comments were received from 13 stakeholders • Each comment was reviewed, considered and where viable the Terms were amended • Published on 30 May ‘13: • F 147-01 Terms and Conditions of Accreditation • F 199-01 Terms and Conditions of GLP/GCP Compliance Terms and Conditions of Accreditation or GLP/GCP Compliance Replaces the following documents: • F57 Accreditation Agreement • R01 “Transfer of Accreditation / GLP Compliance and Franchising” • R05 “The Requirements, Obligations and Duties of an Accredited / GLP Compliant Facility Main Changes • List of definitions • The TOR becomes binding on signing the application form and remains in force for the period of validity of the Certificate of Accreditation • Conditions for objections to assessors • Full payment required before accreditation services conducted • Conditions for acceptance of an application • Specifies the validity period for applications Terms and Conditions of Accreditation or GLP/GCP Compliance Main Changes • Extraordinary assessments and the development of short-term methods of assessment • The period for which the CAB is required to maintain records for accreditation purposes • Conditions under which an assessment can be terminated • Conditions for the use of the combined mark • Conditions for renewal of accreditation • Information SANAS requires from a Certification Body on termination of accreditation • Publishing the accreditation status of CAB’s. Revised: Generic Procedures and Requirements 9 x SANAS Application Forms Main Changes F 14 • • • • • • Invoicing Information Information on key personnel and deputies – specific to standard Application for Approval of Personnel – replaces F18 17025: Detailed information on Proficiency Testing 2013/05/30 Standard specific checklist – indicates an overview of implementation of requirements. Specifies the minimum policies and procedures required. Signing of the application form binds the applicant to the Terms and Conditions Application for Medical Laboratory Accreditation to ISO 15189:2012 F14M-2012 New Document, to the new IOS 15189 standard Application for Testing and Calibration Laboratory Accreditation to ISO/IEC 17025 F 14TC-01 New, Combined all the ISO/IEC Application Forms, i.e. Testing, Calibration, Forensic, Pharmaceutical, Veterinary, Blood Transfusion 2013/05/30 2013/05/30 Stakeholder input Documents published for a comment period: • Draft R51-07 “Suspensions, Withdrawals and Re-Instatement of Accredited Organisations” – 30 day by 6 Sept’12 • Draft R03-07 “Nominated Representative and Signatories: Responsibilities, Qualifications and Approval”– 30 day by 15 Nov ’12 • Draft SANAS application form (F14:17025) – 60 day by 14 Sept Revised: Generic Procedures and Requirements Doc Title Date References, Acronyms and Definitions A 01-09 Refer to amendment form – aligns to TOR 2013/06/13 SANAS Fees P14-23 Applied 5.5% increase to fees as per National Treasury Requirements, Corrected amount for Certification Bodies: Additional assessor units per day. 2013-07-31 Transition to New Standards 2013/02/27 P 32-03 Minor changes regarding SANAS internal processes Revised: Generic Procedures and Requirements Doc R 03-07 Title Nominated Representative and Signatories: Responsibilities, Qualifications and Approval. Date 2013/06/13 Refer to amendment form – aligns to TOR Suspension and Re-instatement of Accredited / Compliant Organisations R 51-07 Entire document re-written to clarify requirements and align with TOR 2013/06/06 Calibration, Testing, Medical: Revised Requirements Doc R 50-03 Title Estimation of the Uncertainty of Measurement by Calibration Laboratories and Specification of Calibration and Measurement Capability on Schedules of Accreditation Date 2013-08-14 Revised to align with ILAC P14 “ILAC Policy for Uncertainty in Calibration” Requirements for the Issue of SANAS Calibration Certificates R 79-03 2013-07-31 Minor amendments Technical Guidelines for validation of methods used by chemical laboratories in the food, water and related industries TG 07-01 2012/10/10 New document Calibration of Installation and Appliance Testers TR 87-01 New document 2013/02/13 Inspection: Revised Technical Requirements (TR) & Forms (F) Transition to ISO/IEC 17020:2012 ends 1 March 2015 Doc TR 78-03 Title Department of Health (DoH) and SANAS Technical Requirements for the application of SANS/ISO/IEC 17020: 2012 for testing of Diagnostic X-Ray Imaging Systems by Inspection Bodies Date 2013/02/13 Minor amendment – 1 clause added SANAS Technical Requirements on the Application of SANS/ISO/IEC 17020:2012 TR 89-01 2013/03/14 New document Certification: NEW Requirements Doc Title Technical Requirements for Bodies providing Greenhouse Gas TR 88-01 Validation and Verification New document Date 2013/03/14 Documents made Obsolete Doc. CL Title 14 x SANAS Manual contents for the individual programmes Date Obsolete Reason 2013/06/06 The SANAS Website “Publications and Manuals” search function replaces the need for programme specific contents lists F 14C F 14F Application for Accreditation of Blood Transfusion Service Laboratories Application for Accreditation of Calibration Laboratories Application for Accreditation of Forensic Laboratories F 14PH Application for Accreditation of Pharmaceutical Laboratories 2013/05/30 F 14T 2013/05/30 F 14V Application for Accreditation of Testing Laboratories Application for Accreditation of Mechanical & Physical Testing Laboratories Application for Accreditation of Veterinary Laboratories F 14PH Application for Accreditation of Pharmaceutical Laboratories 2013/05/30 F 171 F 57 Organs of State Accreditation Agreement Accreditation Agreement 2013/05/30 2013/05/30 F 114 Accreditation Agreement - International Facilities 2013/05/30 F 18 Application for the Approval of Personnel 2013/05/30 F 14B F 14TP 2013/05/30 2013/05/30 2013/05/30 2013/05/30 Replaced by F14TC “Application for Testing and Calibration Laboratory Accreditation to ISO/IEC 17025” 2013/05/30 Replaced by F 147 “Terms and Conditions of Accreditation” and F 199 “Terms and Conditions of GLP/GCP Compliance” Included a section for approval of personnel in each F14 application form International Laboratory Accreditation Co-operation (ILAC) documents revised Doc Title Date ILAC Policy for Uncertainty in Calibration ILAC P1401/ 2013 Date of implementation: January 2014. 2013/02 ILAC Policy on the Traceability of Measurement Results ILAC P1001/2013 Date of implementation: January 2014. 2013/02 Thank You COMMUNICATION MEETING AAC PROCESS Christinah Leballo Senior Manager: Testing, Certification and BBBEE AAC PROCESS WHAT IS AAC PROCESS • It is a decision making process on the granting, denying, extending, suspending or withdrawal of accreditation • It is a requirement of ISO/IEC 17011. Clause 7.9. 2 states that the accreditation body shall, without undue delay, make the decision on whether to grant or extend accreditation on the basis of an evaluation of all information received (see 7.8.6) and any other relevant information. AAC PROCESS ISO/IEC 17011 also requires that the AB describes its accreditation decision-making process including effective separation of the assessment team and the decision makers SANAS DECISION-MAKING PROCESS METHODS (SANAS P20) ◙ For high risk decision making emanating from initial, re-assessments and extension of new scopes of accreditation, recommendations are made by an Approval Advisory Committee. ◙ For surveillance assessments, extension of existing scopes of accreditation and additional signatories of existing accredited facilities, decisions are made by SANAS Field Managers. AAC MEMBERS ◙ The AAC shall consist of not less than 2 members of which 1 shall be a permanent SANAS staff member. SELECTION CRITERIA Members are selected based on: ◙ their knowledge of the accreditation process; ◙ a general knowledge of the area of assessment to be evaluated; ◙ knowledge of SANAS requirements; and ◙ where applicable, regulatory requirements AAC MEMBERS TRAINING ◙ Induction ◙ Mentoring during at least one formal AAC proceeding; ◙ Monitoring: The competence of a “new” AAC member will be confirmed by an approved AAC member re-evaluating a pack reviewed by that member ON GOING MONITORING: IS AT LEAST ONCE IN EVERY 3 YEARS AAC PROCESS Information to be supplied to the AAC ◙ Assessment documentation, corrective actions and relevant supporting evidence Proceedings ◙ a review of the completeness of the documentation; ◙ evaluating whether the information submitted is adequate ◙ evaluation of the corrective actions and supporting evidence ◙ the coverage of the scope assessed; ◙ evidence that validation, verification of results and proficiency testing data had been assessed ◙ A review of the evidence submitted in support of granting signatory status ◙ Review of proposed schedule of accreditation recommended; TYPES OF DECISIONS ◙ Unconditional accreditation ◙ Deferral of decision(Initial) ◙ Rejection of accreditation ◙ Conditional accreditation ◙ Suspension of accreditation ◙ Withdrawal of accreditation Questions Thank You