R EXTRAORDINARY (UNSCHEDULED) ASSESSMENTS TO SANAS ACCREDITED FACILITIES.

Transcription

1 EXTRAORDINARY (UNSCHEDULED) ASSESSMENTS TO SANAS ACCREDITED FACILITIES. Approved By: Chief Executive Officer: Ron Josias Executive Committee Revised By: Quality Manager: Yolanda Vinnicombe Date of Approval: Date of Implementation: SANAS Page 1 of 5

2 CONTENTS: 1. Purpose Background References Process Reporting by the Assessor(s)... 4 ADDENDUM 1: Amendment Record... 5 SANAS Page 2 of 5

3 1. Purpose The purpose of this document is to define the requirements under which extraordinary or unscheduled assessments to accredited conformity assessment bodies (CABs) will be conducted by SANAS, and the responsibilities of accredited CABs during such visits and/or assessments. 2. Background In order to ensure the on-going compliance by accredited CABs it might be required from time to time to conduct unscheduled and/or unannounced extraordinary visits outside the planned visit cycle, at the premise(s) of the CAB. SANAS therefore reserves the right to conduct such extraordinary assessments over and above scheduled assessments at any time during an accreditation cycle under the following conditions. Extraordinary visits/assessments will be undertaken when SANAS needs to: follow up on the investigation and resolution of a complaint against a CAB; follow up on significant changes in relation to a CAB which may have an effect on the CAB s accreditation / compliance status; or For any other reason that SANAS may deem necessary to confirm on-going compliance to accreditation requirements. The extraordinary assessment will be at the cost of the CAB should SANAS confirm any transgression/contravention of the accreditation requirements. 3. References SANAS PM 01 SANAS P12 SANAS A 01 SANAS F147 SANAS F199 SANAS P 37 SANAS Policy Manual Handling of Complaints and Appeals References, Acronyms and Definitions Terms and Conditions of Accreditation Terms and Conditions of GLP/GCP Compliance Termination of Assessments 4. Process 4.1 Extraordinary assessments shall be conducted by an assessor(s) appointed by the applicable Field Manager (FM) or Senior Manager (SM), who, if deemed necessary, may be accompanied by a fulltime SANAS employee. The FM / SM shall ensure that no conflict of interest exists when appointing an assessor(s). 4.2 All extraordinary assessments shall be scheduled during the working hours of the CAB, at any of the accredited premises of the CAB, as required. 4.3 The FM/SM shall provide the assessor(s) with clear guidance as to the purpose and scope of the assessment. 4.4 Although SANAS reserves the right not to notify the CAB of the extraordinary assessment, SANAS will, at its discretion, notify the CAB at least one (1) hour prior to the assessment, informing the CAB of the purpose and scope of the assessment and the name of the assessor(s) allocated to perform the assessment. SANAS Page 3 of 5

4 4.5 Upon arrival at the CAB the assessor shall introduce him/herself as a representative from SANAS, and inform top management of the purpose and scope of the assessment. 4.6 Extraordinary assessments need only be as extensive as is required by the scope of the assessment. 4.7 The CAB shall comply with the Access and Cooperation requirements as specified in the Terms and Conditions of Accreditation (F147) or the Terms and Conditions of GLP/GCP Compliance (F199), as applicable. 5. Reporting by the Assessor(s) 5.1 The assessor shall prepare a short report on the purpose and extent of the assessment, and any findings or observations identified during the assessment. 5.2 Where necessary, additional supporting documentation shall be attached as evidence of noncompliance or otherwise. 5.3 In cases where the evidence collected or observed supports the purpose of the investigation, the assessor shall immediately notify the relevant Field Manager. 5.4 The report shall contain only factual observations related to the extraordinary assessment programme. The assessor shall ensure that the assessment team does not work outside of their scope assigned for the extraordinary assessment. 5.5 The report shall be sufficiently comprehensive as to allow for independent expert/s and/or the relevant Field or Senior Manager, as applicable, to peruse and evaluate the facts of the matter. 5.6 The relevant Field Manager and/or Senior Manager shall take the appropriate actions in accordance with SANAS procedures P12 Handling of Complaints and Appeals, or R 51 Suspensions, withdrawals and re-instatement of accredited or GLP/GCP Compliant organisations, as appropriate. SANAS Page 4 of 5

5 ADDENDUM 1: Amendment Record Proposed By: Section Change QM Page 1 Changed heading from Criteria for unscheduled visits or extraordinary assessments to accredited facilities by SANAS staff QM 1 Purpose changed from : The purpose of this document is to define the requirements under which unscheduled visits and/or extraordinary assessments to accredited facilities may be conducted, and the responsibilities of accredited facilities during such visits and/or assessments. QM 2, Par. 1 Replaced documents with Requirements or Technical Requirements (TR Documents) QM 2, Par 2 & 3 New paragraphs added QM 2 Deleted: SANAS has reserved the right to carry out additional or unscheduled extraordinary assessments for the purpose of verifying on going compliance, as it may reasonably require. QM 3 Deleted references to F57 and ILAC G10:1996 Included references to SANAS PM 01, P12, A01, F147, F199, P37 QM 4 Deleted section on definitions & removed definitions of Assessment and Conformity assessment body as these are available in A01. QM 4 Clause reworded to replace: 5.1 SANAS plans and schedules assessment activities to monitor the continued fulfilment of requirements for accreditation, by Conformity Assessment Bodies (CAB s). The CAB shall be informed of the date and assessment team members well in advance to allow the CAB an opportunity to accept/object to the appointed team members. 5.2 SANAS may also conduct unscheduled visits or extraordinary assessments as may be reasonably required to confirm ongoing compliance with accreditation requirements, over and above the scheduled assessments. 5.3 All unscheduled visits shall be conducted by the Field Manager (FM), or another SANAS employee appointed by the FM. 5.4 All unscheduled visits shall normally be scheduled during the normal working hours of the CAB, at any of the registered addresses of the CAB, including any satellite facility, or branch office. 5.5 The SANAS Senior Manager shall inform the organization s senior management at least 1 hour prior to the unscheduled visit or extraordinary assessment. 5.6 Upon arrival at the organization the SANAS employee shall identify him or herself using the SANAS identification card. 5.7 Unscheduled or extraordinary assessments or visits need only be as extensive as is necessary to confirm a particular aspect of the accreditation requirements, for example, compliance with a particular SANAS Regulatory document requirement, to follow up on the investigation and resolution of a complaint against the CAB, or to follow up on significant changes relevant to the accreditation of the CAB. QM 4.7 Replaced 6. CAB Requirements 6.1 The CAB shall provide SANAS with reasonable access and co-operation during any scheduled or extraordinary assessment to any of the CAB premises. 6.2 The CAB shall provide SANAS with reasonable access to all relevant information related to their accredited activities. This may include, but is not necessarily limited to, certificates, reports, raw data, records (technical, complaints, environment, internal audits, management reviews, contract reviews, personnel, method validation, proficiency testing results and equipment), Uncertainty of Measurement estimations, invoices and quotations etc, during any scheduled or extraordinary assessment or visit. QM 5 New clause added SANAS Page 5 of 5