1 / 54

WELCOME

WELCOME. 2013 C ommunication Meeting September 2013. CEO Report. 2013 C ommunication Meeting September 2013. Focus 2010 to 2015. Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006 (Act 19 of 2006 ) Functions:

heidi
Download Presentation

WELCOME

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. WELCOME 2013 Communication Meeting September 2013

  2. CEO Report 2013 Communication Meeting September 2013

  3. 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;

  4. 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

  5. Accreditation Stats – June 2013

  6. Growth Statistics: March 2012 to March 2013

  7. Upcoming Extensions

  8. Industrial Policy Action Plan (IPAP) Priority Sector needs

  9. 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

  10. 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

  11. SANAS’ Alignment

  12. Customer Experience Measure 2012/13

  13. Methodology & Sample Realisation • Total Sample = 236 • (5.29% margin of error at a confidence level of 93%) • All interviews were done telephonically (CATI system) • Interviews were conducted 4 March to 4 April 2013 • Average duration of interviews: 11min 30secs • Target Sample: 170 • Sample realised: 236 • Available Contacts: 752

  14. Modelled Score – Annual Change 2012 2011 2013 NPS = Net Promoters Score; CSM = Customer Satisfaction Measure

  15. Modelled Index Score by Division by Year 2011 2012 2013

  16. Events

  17. Thank You

  18. Re-assessment and Associated Documentation Reviews Linda Grundlingh Field Manager: Inspection 2013 Communication Meetings

  19. 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.

  20. 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.

  21. 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.

  22. WHAT HAS CHANGED? 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. This will include the facilities Management System Documentation (Quality manual), along with specific information or documents as specified in each application (Checklists etc.)

  23. WHAT HAS CHANGED? • On receipt of the application, SANAS will conduct a review of the information submitted. • 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.

  24. WHAT IF A FACILITY DOES NOT RE-APPY? Where SANAS has not received the application for Re-assessment, the Re-assessment will not be scheduled. The facility’s accreditation will expire on the expiry of the Certificate and Schedule of accreditation.

  25. 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).

  26. 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 Re-assessment at this stage.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. PAYMENT CONDITIONS

  32. Thank you lindag@sanas.co.za

  33. REVISED / NEW SANAS ACCREDITATION REQUIREMENTS Sept. 2013 Yolanda Vinnicombe yolandav@sanas.co.za

  34. 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

  35. 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

  36. 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.

  37. Revised: Generic Procedures and Requirements

  38. 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

  39. Revised: Generic Procedures and Requirements

  40. Revised: Generic Procedures and Requirements

  41. Calibration, Testing, Medical: Revised Requirements

  42. Inspection: Revised Technical Requirements (TR) & Forms (F) • Transition to ISO/IEC 17020:2012 ends 1 March 2015

  43. Certification: NEW Requirements

  44. Documents made Obsolete

  45. International Laboratory Accreditation Co-operation (ILAC) documents revised

  46. Thank You

  47. COMMUNICATION MEETING AAC PROCESS Christinah Leballo Senior Manager: Testing, Certification and BBBEE

  48. 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.

  49. 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 SANASDECISION-MAKINGPROCESS 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.

  50. 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

More Related