R RELATIONSHIP BETWEEN SANAS AND THE REGULATORS

Transcription

1 RELATIONSHIP BETWEEN SANAS AND THE REGULATORS Approved By: Chief Executive Officer: Ron Josias Executive Committee Revised By: Field Managers: Linda Grundlingh, Thabo Chesalokile, John Ndalamo Date of Approval: Date of Implementation: SANAS Page 1 of 5

2 CONTENTS: 1. Purpose and Scope Definitions and References General Responsibilities The Approval Process Complaints, Appeals and Disputes... 4 Addendum 1: Amendment Record... 5 SANAS Page 2 of 5

3 1. Purpose and Scope The purpose of this document is to describe the role of SANAS within the regulatory framework of South Africa. This document covers the relationship and responsibilities of SANAS and the regulator. It is applicable to all programmes dealing with a South African regulator. 2. Definitions and References SANAS PM SANAS Policy Manual SANAS A 01 References, Acronyms and Definitions SANAS P05 Assessment of Certification Bodies SANAS P 15 Accreditation of Inspection Bodies Regulatory and Voluntary Domain SANAS P 17 Accreditation of Verification Laboratories Act No. 19 of 2006: Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006 (The Accreditation Act) 3. General The formal recognition of a body s competence through accreditation is required by some of the regulators for bodies that wish to do work within the regulatory domain. SANAS, as the government endorsed national accreditation body, provides formal recognition of an organisation s competence, and provides a service to both the regulator and the applicant organisation. Where applicable, approval by the regulator of an organisation to do work within the regulatory domain is subjected to the organisation obtaining accreditation through SANAS. Should an approved organisation s accreditation be suspended or withdrawn by SANAS, it will automatically lose its regulatory approval status. The relationship of SANAS with accredited organisations is addressed in the SANAS Policy Manual (PM01) and programme specific SANAS documents (e.g. P05; P15, P17 etc.). 4. Responsibilities 4.1 Responsibilities of the Regulators The responsibilities of the regulators in their relationship with SANAS and the applicant organisations include the following: a) Granting of Approval to organisations who qualify to work in the regulatory domain; b) Participating in the relevant SANAS Specialist Technical and Approval Committees; c) Providing a contact person(s) between the Regulator and SANAS; d) Providing advice to SANAS on the relevant regulatory matters arising out of the assessment and accreditation process; e) Dealing with complaints and transgressions relating to the contravention of the relevant regulatory requirements; f) Notifying SANAS of any changes in an approved organisation s approval status; g) Meeting with SANAS on a quarterly basis to discuss issues of mutual interest and concerns; and h) Regulatory representatives who are qualified as SANAS assessors may be used as assessors provided there is no conflict of interest. SANAS Page 3 of 5

4 4.2 Responsibility of SANAS The responsibilities of SANAS include the following: a) Providing the Regulator with an accreditation system based on verifying an organisations competence at predetermined intervals; b) Maintaining a data base of all accredited organisations; c) Notifying the regulator of any changes in an organisation s accreditation status; d) Appointing a contact person(s) between SANAS and the regulator; e) Dealing with complaints and transgressions relating to the contravention of the relevant accreditation requirements; 5. The Approval Process (where applicable) 5.1 SANAS documents P05 Assessment of Certification Bodies ; P 15 Accreditation of Inspection Bodies Regulatory and Voluntary Domain and P 17 Accreditation of Verification Laboratories describes in detail the process for applying for and obtaining provisional approval from the relevant Government Department/Regulator, subsequent SANAS accreditation and formal approval by the relevant Government Department/Regulator. 5.2 Should an applicant, who has obtained provisional approval from the relevant Government Department/Regulator, not pursue their application for accreditation within the prescribed period as set out in the relevant P05 / P15 / P17 document, they will be obliged to return their letter of approval to the Regulator and make arrangements that completed work and work in progress at that time be redone by an Approved Body. The applicant would be liable for any costs incurred for the work to be redone. 6. Complaints and Appeals 6.1 All investigation and disputes arising from a contravention of the regulations will be the responsibility of the Regulator. 6.2 All investigations and disputes arising from the contravention of the accreditation requirement will be the responsibility of SANAS in accordance with its procedures P12 Handling of Complaints and Appeals. 6.3 Where investigations and disputes overlap the function of the Regulator and SANAS, both parties will cooperate to resolve the issue(s). SANAS Page 4 of 5

5 ADDENDUM 1: Amendment Record Proposed By: Section Change QM 2 Added reference to P05; P15 and P17 SM, FM Clause 3, 3 rd paragraph, last sentence Sentence replaced with: Should an approved organisation s accreditation be suspended or withdrawn by SANAS, it will automatically lose its regulatory approval status. Fm 4.1 (h) added. QM 5 Deleted this section, as this is detailed in P15 and P On receipt and review of a completed application for accreditation, SANAS will perform a document review on the applicant s quality manual and procedures and related documentation. 5.2 A report will be issued noting any deficiencies identified during the documentation review. The applicant must address and clear all the deficiencies identified on the documentation. 5.3 This will be followed by a Mandatory Pre-assessment visit to the applicant s office to determine the compliance of the documentation in the office to relevant technical regulation (e.g. SABS 0227, SANS 10378, etc). 5.4 On successful evaluation and clearance of all system corrective actions raised during the Mandatory Pre-assessment visit, SANAS will give the applicant a letter of acknowledgement (within ± 1 working week) stating that the documentation system at the applicant s office, complies with the relevant requirements. SANAS will emphasize that the applicant is not accredited until such time as SANAS can verify the technical competence of the organisation after performing some practical work. The letter will also require the organisation to notify SANAS of all work the organisation undertakes; 5.5 The applicant shall forward the letter from SANAS together with its application letter to the Regulator for their consideration to grant the applicant approval to operate as an Approved Body, subjected to the applicant becoming accredited within a specified period as agreed on by the Regulator and SANAS. (e.g. six (6) months for Vessels under Pressure); 5.6 SANAS will conduct its competence evaluation assessment within the agreed time period and will inform Regulator of the outcome of the SANAS Approval Committee s decision; 5.7 Accreditation will only be recommended once SANAS has had the opportunity to verify the applicant s competence on-site and/or through evaluating the documents produced by the applicant that gives objective evidence of the work the applicant has done within agreed on time period from the date of approval granted by the Regulator; QM 5.1 New sentence added QM 5.2 Added: who has obtained provisional approval from the relevant Government Department/Regulator Added: as set out in the relevant P15 / P17 document QM 6 Reference to Disputes deleted SANAS Page 5 of 5