ISO 13485 / 13488 Medical Industry (EN 46001/2)

(EN 46001/2) Internal Auditor

This ISO 13485/13488 CE Mark for Medical Industries Internal Auditor course is designed to provide the participants with the skills needed to understand the ISO 9000 standard, and to begin developing audit checklists. The student will be able to conduct an internal audit and obtain objective evidence of compliance of the quality system with the ISO standard and employee compliance with defined procedures and work instructions. This course is intended to build the observation and questioning skills needed to obtain objective information, and to follow audit trails to get the facts.

Who should attend?

Quality managers, supervisors, professionals, audit leaders/members, and anyone responsible for conducting, managing, or participating in internal audits should attend. This is a useful course for anyone who desires a fundamental knowledge of the audit process.

Key Topics

Introduction

• Purpose of internal audits
• ISO requirements for internal audits in relation to GMPs
• Workshop objectives

Review of the ISO standard

The audit process

• Initiating an audit
• Audit preparation (audit plan & checklists)
• Conducting the audit
• Evaluating findings (major and minor conformities)
• Corrective action follow-up
• The audit team
• Opening the audit
• The closing meeting
• Report preparation

Skills required by auditors

• Building rapport with auditees
• Questioning (open questions, probes, follow-up questions)
• Following an audit trail
• Working as an audit team

Case studies

• Review of policy manual segments
• Preparation of audit plan
• Role play; feedback of audit findings
• Review of procedures against the ISO standard
• Case studies; audit of job performance

Course Duration

This is a 2 day course and can be held at your site or at a venue close to your site. Please call us for a no-obligation, no-cost quote at 877-415-0191.

Thank you for your interest in BQPM Training!

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