CT 04 SAC CRITERIA FOR CERTIFICATION BODIES (GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES)

Transcription

1 ACCREDITATION SCHEME FOR MANAGEMENT SYSTEMS CERTIFICATION BODIES CT 04 SAC CRITERIA FOR CERTIFICATION BODIES (GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES) CT 04, April 2014 The SAC Accreditation Programme is managed by SPRING Singapore CT 04, April 2014 Page 1 of 8 All rights reserved

2 CONTENTS Page 1 Introduction 1 2 Qualification Criteria for GDPMDS Auditors 1 3 Requirements for Certification of GDPMDS Stage 1 audit Audit time Frequency of surveillance audits Surveillance activities Sampling of sites Sampling of outsourced third party logistics (3PLs) Report format 3 Annex 1 4

3 1 Introduction 1.1 This document specifies the supplementary SAC criteria for the certification of Good Distribution Practice for Medical Devices (GDPMDS), and is to be used with ISO/IEC Qualification Criteria for GDPMDS Auditors 2.1 A certification body shall appoint qualified QMS auditors to conduct GDPMDS audits. 2.2 In addition, all auditors shall have attended a briefing on the requirements of the certification standard on GDPMDS (HSA TS -01: Good Distribution Practice for Medical Devices) and other related HSA documents which includes GN-01: Guidance on the Application of Good Distribution Practice for Medical Devices and GN-03: Guidance on Preparation of a Site Master File For Licensing, by suitably qualified staff. 3 Requirements for Certification of GDPMDS 3.1 Stage 1 audit A full Stage 1 audit is not required. Only the management system documentation has to be reviewed. This can be done at the certification body s premises. 3.2 Audit time A minimum of 1 auditor day (8 hours) on-site is required for each initial certification, surveillance and recertification audits Additional auditor day(s) shall be required if a client has a wide range of medical devices, large number of staff, a large number of sites or complex operations. The certification body shall justify the time spent on the audits. CT 04, April 2014 Page 1 of 8

4 3.2.3 The audit time could be reduced as shown below: Type of clients % reduction Clients which are certified to ISO 9001 by a SAC 15% accredited certification body for QMS (Full GDPMDS scope is not accredited) Clients which are certified to ISO 9001 by a SAC accredited certification body for QMS with the full GDPMDS scope which covers other wholesale storage and warehousing other supporting land transport activities 25% 3.3 Frequency of surveillance audits The certification body shall conduct surveillance audits on certified clients at least once a year. 3.4 Surveillance activities The activities to be audited during each surveillance shall be the same as those activities for the quality management system certification. 3.5 Sampling of sites The sampling of sites for audits shall be based on IAF MD 1 IAF Mandatory Document for the Certification of Multiple Sites on Sampling 3.6 Sampling of outsourced third party logistics (3PLs) This situation applies to companies who use third party logistics (3PLs) that are not certified by SAC Accredited certification bodies for GDPMDS certification. This situation also applies to companies who use 3PLs that are not certified to ISO (Medical devices -- Quality management systems -- Requirements for regulatory purposes) for the full GDPMDS scope which covers other wholesale storage and warehousing other supporting land transport activities CT 04, April 2014 Page 2 of 8

5 3.6.2 For initial certification, all locations of the outsourced activities shall be audited During the 3-year certification cycle, all locations of the outsourced activities shall be audited at least once. The number of such locations shall be evenly distributed over the 3-year cycle After getting certified, new 3PLs or new / additional locations of existing 3PLs shall be audited before they can be included. Thereafter, these locations shall be audited as indicated in paragraph Note: 3PL activities in this context with reference to HSA TS-01 to cover storage and distribution (includes transportation) 3.7 Report Format Please see Annex 1 for sample report format. CT 04, April 2014 Page 3 of 8

6 Annex 1 logo GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMDS) AUDIT REPORT Form No.: MD-GDP-R2 Date of Revision: August 2011 Instructions 1. When making reference to attachments, please indicate the file name accordingly with respect to the actual documents name. 2. Attachments (support content of report):- Audit plans, Evidence available to support the minor nonconformities for closure of last audit, Non-conformity reports if issued separately for major corrective action and with evidence. 3. For legibility, the audit report should be computer-typed. SECTION A. AUDITEE INFORMATION (NOTE: Auditee refers to organisation subject to GDPMDS audit) Auditee Name & Address Tel No. Fax No. Address Management Representative/ Designation (e.g.qa,ra) Language(s) of operation SECTION B. PREVIOUS GDPMDS AUDIT INFORMATION Date of audit Type of audit Initial Surveillance Re-Certification Conditional Certification Others, please specify: Previous Audit Certification Body / Management Representative/ Designation Any Open CAPA? No Yes (specify CAPA and reason for non-closure) NOTE: If yes, specify CAPA and clarify reason for CAPA non-closure and ensure CAPA is closed as part of this audit. SECTION C. CURRENT GDPMDS AUDIT INFORMATION Type of Audit Initial Surveillance Re-Certification Conditional Certification Others, please specify: CT 04, April 2014 Page 4 of 8

7 Audit Scope Activities performed by auditee 1.Import 2.Storage 3.Distribution (incl. transportation) 4.Installation 5.Servicing (incl. repair/ maintenance) 6.Secondary Assembly 7.Special storage and handling conditions (specify:) Activities outsourced by auditee 1.Import 2.Storage 3.Distribution (incl. transportation) 4.Installation 5.Servicing (incl. repair/ maintenance) 6.Secondary Assembly 7.Special storage and handling conditions (specify: ) Medical Device Category: Medical Devices Covered under this Audit 1. Active implantable devices 2. Anaesthetic and respiratory devices 3. Dental devices 4. Diagnostic and therapeutic radiation devices 5. Electro mechanical medical devices 6. Technical aids for disabled persons 7. Non-active implantable devices 8. Ophthalmic and optical devices 9. Reusable instruments 10. Single use devices 11. Hospital Hardware 12. In vitro diagnostic devices Are any Manufacturing Activities not within the Purview of Secondary Assembly being performed by auditee? New activities and medical device categories not covered in previous audit Addresses of Sites Audited (specify activities performed at each site) For each outsourced activity, name and address of external provider GDPMDS standard applied during audit HSA TS 01 Revision 2.1 NOTE: List of medical devices should be documented and/or attached as an appendix to this report and retained by certification body. Yes, and auditee has been informed that a manufacturer s licence is required before they can continue to perform these activities. No, and auditee has declared that they do not perform any such manufacturing activities. NOTE: If any manufacturing activities not within purview of secondary assembly are performed, a manufacturer s licence is required. The QMS pre-requisite for the manufacturer s licence is conformity to ISO 13485, not GDPMDS. Refer to Annex 3 of TS-01 for more information on activities deemed to be secondary assembly. Start date of audit On-Site Audit Dates: Total audit time (auditor days) CT 04, April 2014 Page 5 of 8

8 SECTION D. AUDIT TRAIL (NOTE: For initial and re-certification audits, all fields to be completed. For other audits, nonapplicable fields can be left empty, provided a justification has been provided) Documentation E.g. Site Master File (SMF), Standard Operating Procedures (SOPs), Internal audit reports, etc List of Documents Reviewed, including Site Master File (document reference no.s) Resource Management Storage and Stock handling Traceability Complaints and Adverse Events Field Safety Corrective Actions Return of medical devices Disposal of medical devices Internal audits Management review Outsourced activities Activities and sites not audited & reasons for exclusion Was any requested information refused and/or obstacles encountered during audit? Deficiencies identified in list of documents reviewed, including Site Master File (SMF) List of Major Non- Conformities List of Minor Non- Conformities Observations for Improvement Secondary assembly Yes No NOTE: If yes, identify such information. NOTE: If none, indicate so. NOTE: If none, indicate so. NOTE: If none, indicate so. NOTE: If none, indicate so. CT 04, April 2014 Page 6 of 8

9 SECTION E. CONCLUSION Proposed corrective and preventative action (CAPA) to be performed by Auditee for each identified nonconformity Summary of Auditor s Verification for CAPA performed by Auditee to address each identified non-conformity Summary/Conclusions of Auditee s Conformance to GDPMDS Requirements E.g. Audit trail findings, summary of non-conformities, recommended corrective and preventative actions (CAPA), timeline for CAPA, etc. Auditor s Recommendation E.g. certification granted, continued, withheld, suspended until corrective action is completed, Audit Objectives have been met etc. SECTION F. AUDIT REPORT DETAILS Audit Report Reference Number Date of completion of audit report/ Total Days Audit team leader Audit team members Name Designation Lead Auditor List of Attachments I confirm that the information presented under Section A-F in this report is true and correct. Signature/Date Name of Audit team leader Company stamp CT 04, April 2014 Page 7 of 8

10 SECTION G. FOLLOW-UP ON CAPA BY AUDITEE (NOTE: This section to be completed if non-conformities have been identified. To be completed after CAPA has been completed by Auditee.) Summary of CAPA performed for each identified non-conformity Date of completion of CAPA/ Follow-Up Any follow-up items for next audit NOTE: If none, indicate so. I confirm that the information presented under Section G in this report is true and correct. Signature/Date Name of Auditee team leader Company stamp CT 04, April 2014 Page 8 of 8