ISO and UAV Audits Preparation and Client Rights

Transcription

1 1 ISO and UAV Audits Preparation and Client Rights Medical Devices Quality Management Systems Requirements for Regulatory Purposes Woodsage Dr. Bonita Springs, FL (239)

2 2 Audit Preparation ISO & Unannounced Audits Certified companies should be prepared at any time for audits by registrars and notified bodies! In anticipation of an audit and as standard practice, ensure key areas are maintained including: Internal audits Management review Complaints CAPA program Training Documentation and procedures Design documentation and changes Validations You, as the auditee, have the responsibility to demonstrate compliance at all times and you should use internal audits to assist in maintaining effectiveness of QMS

3 3 Objective and Scope of ISO Audits Auditee /Client Accredited Registrar Objectives Achieve and maintain certification to voluntary standard ISO 13485:2003 Facilitate global alignment based on ISO EIC 17021:2006. Provides confidence to all interested parties that the QMS fulfils the specified requirements. Accreditations through SCC, ANAB, IAF, UKAS, MHRA Scope & Role Organizations provide Medical devices and related services which demonstrates compliance to the standards and associated regulations The registrar is to audit with impartiality, competence, responsibility, openness, confidentiality and responsiveness to complaints. Registrars audit to ISO 19011:2011 standard requirements.

4 4 Registrar Requirements & Auditee Rights ISO Audits Auditors are to be certified to auditing per these requirements and have credentials Auditee has the right to ask for auditor credentials and training Have registrars certificates on file specific to Purchasing requirements Standard requires nonconformities to be clearly linked to relevant section of the standard or internal procedure. The relevant element from the standard must be referenced Clear evidence of nonconformity to the element is required auditor opinion of how the requirement should be applied is not appropriate The auditee has the right to appeal nonconformities issued Appeals are reviewed by the registrar and accrediting agencies many appeals are won Registrars provide terms and conditions of contract If they are not meeting the terms of contract regarding scheduling, auditor competency, etc. your QMS should dictate initiating a SCAR as an approved supplier The ISO IEC 17021:2006 standard requires that the registrar take action on such complaints in their QMS.

5 5 Objective and Scope of MDD Unannounced Audits Objectives Scope & Role Auditee Be prepared for UAV at any time Ensure subcontract agreements are in place for critical or crucial subcontractors. Accredited Notified Body & Registrar Perform one unannounced audit at least once every 3 rd year Increase frequency if high risk device, frequent non-conformities or suspect non-conformities Per Commission Recommendation 2013/473/EU 2 auditors for at least one day Can visit critical or crucial subcontractors Audit to include recently produced or in production product covered on CE certificate Traceability of critical components, tech file review linked to production process and testing of device Testing to be done per protocols set out in technical file Check in detail at least 2 critical processes (design, establishing material specs, purchasing, incoming, assembling, sterilization, release, packaging)

6 6 Notified Body Requirements & Auditee Rights Unannounced Audits Auditors are to be certified to auditing per these requirements and have credentials Ensure unannounced auditors have credentials verifying they are approved by the notified body The Audit is intended to be focused on witnessing product in manufacturing and tracing to technical file Refusal to allow audit to take place is cause for major nonconformity Industry has the right to contact Notified Body and provide information on effects of UAV on industry the regular 3 year audit cycle could have been changed to make one audit unannounced