Workshop_Quality_Systems_Auditing_-_The_Canadian_Experience

11th GHTF Conference Washington DC, October 3-4, 2007 Workshop Quality Systems Auditing - The Canadian Experience Egan Cobbold Chair SG3 outline overview of regulations and audit process… auditing projects with other regulators… experience… next steps… 11th GHTF Conference Washington DC, October 3-4, 2007 Overview of regulations Canadian Medical Devices Regulations • Promulgated in 1998. Calls for “manufacturer” to be certified to ISO 13485:2003. QMS sections enforced January 1, 2003 • Devices classified “Class I to IV”. Rules based classification system used (Class I low risk – Class IV highest risk) • Class II to IV Devices must be licensed before first sale • Depending on device class, licence applications contain an attestation, or evidence, that the device meets safety and effectiveness requirements. Existing licence must be amended before manufacturer makes “significant change” 11th GHTF Conference Washington DC, October 3-4, 2007 Overview of regulations Canadian Medical Devices Regulations • Licence applications must contain a valid (CMDCAS) ISO 13485:2003 certificate. Certificates are valid for no more than 3 years. • Third parties audit and certify quality management system (QMS) • Third parties called “CMDCAS recognized registrar” (Canadian Medical Device Conformity Assessment System). Fifteen organizations presently recognized by Health Canada • Manufacturer (as defined in regulations) must maintain a certified ISO 13485:2003 QMS as long as device(s) is(are) sold in Canada 11th GHTF Conference Washington DC, October 3-4, 2007 The numbers… 2,455 “manufacturers” holding 24,196 active licences 2,427 certificates in HC data base Devices imported from 45 countries Top 5 locations of licence holders (US, EU, Canada, Switzerland, Japan) 63 % (n=15388) of licences come from USA 51% (n=1275) manufacturers located in USA 900+ auditors trained by HC 40% of auditors give USA or Canada as mailing address 11th GHTF Conference Washington DC, October 3-4, 2007 Overview of audit process Audits performed in accordance with existing ISO standards augmented with Health Canada requirements, GHTF guidance and International Accreditation Forum (IAF) guidance : • ISO/IEC 17021 : Conformity assessment — Requirements for bodies providing audit and certification of management systems • IAF Guide 2 : IAF Guidance on the Application of ISO/IEC Guide 62:1996 (NOTE: only some of the Annexes of this document are used) • ISO 19011 : Guidelines for quality and/or environmental management systems auditing 11th GHTF Conference Washington DC, October 3-4, 2007 Overview of audit process Audits performed in accordance with existing ISO standards augmented with Health Canada requirements, GHTF guidance and International Accreditation Forum (IAF) guidance (contd.): • GHTF SG4(99) 28 Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements • GHTF SG4(00) 3 Training Requirements for Auditors (Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements - Supplement 2) • Health Canada / GD210: ISO 13485:2003 Quality Management System Audits Performed by Health Canada Recognized Registrars • Health Canada / GD207 : Guidance on the content of ISO 13485 quality management system certificates issued by CMDCAS recognized Registrars 11th GHTF Conference Washington DC, October 3-4, 2007 11th GHTF Conference Washington DC, October 3-4, 2007 Registrar ISO/IEC 17021 plus IAF GD2:2005 Audit process GHTF SG4(99) 28 Audit process HC GD210 Auditor Training GHTF SG4(00) 3 Certificates HC GD207 Audit process ISO 19011 Overview of audit process Objectives of all audits under CMDCAS must include: • A determination of the conformity of the manufacturer’s QMS to ISO 13485:2003, and • An assessment of the inclusion and effective implementation of the applicable provisions of the Canadian Medical Devices Regulations throughout the manufacturer’s QMS Under CMDCAS, third party auditors are not Government Inspectors! They do not have any regulatory powers. Auditors “…evaluate the capability of the management system to ensure compliance with statutory, regulatory and contractual requirements..” ( ISO 19011, para. 6.2.2 b) ) Nonconformities are always cited against a section of ISO 13485:2003 and are supported by objective evidence and links to regulatory requirements where appropriate. 11th GHTF Conference Washington DC, October 3-4, 2007 Link between audit and licence 11th GHTF Conference Washington DC, October 3-4, 2007 Annual Audit of Manufacturer Valid QMS Certificate Licence to sell device Renewal of QMS certificate at or before 3 yr anniversary Certificate Included with Licence Application (or Licence Amendment) QMS related arrangements with other regulators 11th GHTF Conference Washington DC, October 3-4, 2007 Health Canada involved in cooperative arrangements with the TGA (Australia), and FDA (USA). • TGA project is part of an MOU between Health Canada’s Health Products and Food Branch (HPFB) and Australia’s Therapeutic Products Administration (TGA). • FDA project is a “Pilot” program designed to “further regulatory cooperation” and “reduce regulatory burden on industry”. Cooperation with other regulators 11th GHTF Conference Washington DC, October 3-4, 2007 “Pilot Multipurpose Audit Program” (PMAP) jointly developed by HPFB and FDA. Relies on FDA Accredited Persons and CMDCAS Recognized Registrars to perform audits. Program developed because of increased regulatory cooperation that is being driven by a Memorandum of Understanding signed in 2003 between Canadian and US health departments and the more broader government level North American “Security and Prosperity Partnership” (SPP) signed in 2005. Pilot Multipurpose Audit 11th GHTF Conference Washington DC, October 3-4, 2007 Details • Audits performed under PMAP must satisfy both FDA and HC requirements. • Auditor prepares two reports. One in FDA format the other in Registrar’s standard format. Report intended for FDA must conform to Accredited Persons requirements. • Manufacturer must meet FDA and HC definition of manufacturer • No country of origin requirement Operational Cooperation with other regulators 11th GHTF Conference Washington DC, October 3-4, 2007 Memorandum of Understanding (MOU) underpins arrangement between Canada’s Health Products and Food Branch (HPFB) and Australia’s Therapeutics Goods Administration (TGA). • Audits performed under the MOU would encompass Canadian and Australian requirements and a single audit report would be produced • HPFB accepts ISO 13485:2003 QMS certificates issued by the TGA’s Manufacturers Assessment Branch (MAB) to Australian manufacturers. • TGA accepts ISO 13485:2003 QMS certificates issued by qualified CMDCAS registrars to Canadian manufacturer HPFB-TGA MOU 11th GHTF Conference Washington DC, October 3-4, 2007 Details • MOU contains a country of origin clause. Only organizations that meet Canadian and Australian definition of manufacturer and are located in Canada or Australia/New Zealand can participate • Device must meet Canadian and Australian definition of medical device and be authorized or eligible for authorization for sale in Canada and Australia • Health Canada in process of recognizing MAB as a registrar Under Development Mutual Recognition Agreements 11th GHTF Conference Washington DC, October 3-4, 2007 • Canada has signed multi-sectoral MRAs with the EU, EEA-EFTA and Switzerland • MRAs represent trade driven, legally binding international agreements negotiated between governments • One of the sectoral annexes deals with the conformity assessment of medical devices • To date, none of the MRAs are operational with respect to medical devices annex as confidence building phases have not taken place • However, many European Notified Bodies are also CMDCAS recognized or are affiliated with a registrar so they routinely perform “combined” audits for European and Canadian purposes reducing the need for these projects to be operational. • Third parties like to offer “one stop shopping” for manufacturers seeking CE mark as well as QMS certificate for Canada. 11th GHTF Conference Washington DC, October 3-4, 2007 Mutual Recognition Agreements Single audits that are intended to cover Canadian and European QMS requirements have presented some challenges, namely… • Auditor’s lack of understanding or misinterpretation of Canadian regulatory requirements (not widespread) Experience to date… 11th GHTF Conference Washington DC, October 3-4, 2007 • Assumption that European standards/guidance are equivalent to Canadian standards/guidance • Manufacturers submit European versions of QMS certificates or certificates of conformity to a European Directive. • Focus on European requirements with Canadian requirements treated as an “add on” • Auditors use a “check list” approach • Audit reports silent on Canadian requirements Experience to date… 11th GHTF Conference Washington DC, October 3-4, 2007 Projects with Australia and USA • Both projects are still in their infancy • A number of Canadian manufacturers have expressed some interest in participating Experience to date… 11th GHTF Conference Washington DC, October 3-4, 2007 • Advertise more to get wider acceptance of projects • Increase use of GHTF SG 3 and SG4 guidance documents in audit process • Educate stakeholders on value of joint audits • Improve present projects based on lessons learned and stakeholder feedback • Develop other projects ?? Next steps… 11th GHTF Conference Washington DC, October 3-4, 2007 • Sufficient engagement by manufacturers. • Possible revision to ISO 13485:2003 following upcoming changes to base ISO 9001. • Keeping third party auditors ( 900+) up to date on audit criteria and regulatory requirements. • Ensuring that auditors have sufficient time to: prepare for and perform audits; produce meaningful audit reports; and properly close nonconformities. Challenges… 11th GHTF Conference Washington DC, October 3-4, 2007 Quality Management Systems/CMDCAS/SCC http://hc-sc.gc.ca/dhp-mps/md- im/qualsys/index_e.html http://www.scc.ca/en/programs/iso_reg/medical.s html Projects http://hc-sc.gc.ca/dhp-mps/md- im/activit/int/index_e.html Contacts… 11th GHTF Conference Washington DC, October 3-4, 2007