A Comprehensive Exploration of the Medical Device Industry in South Africa
Learn more about SAHPRA, SANAS, and the importance of ISO 13485 Certification in South Africa.
ISO 13485 | Medical Device Quality Management (MDQMS) | Clause-by-Clause Internal Auditing Training
Enrol in this practical course designed for professionals aspiring to conduct internal and supplier audits within the medical device industry. Organised in a clause-by-clause format, it is designed to equip participants with a thorough comprehension of the ISO 13485 clauses and how to group them during an Audit. Start your journey today towards becoming a proficient Auditor in medical device quality management.
Pre-Requisites: Participants are required to be working with the ISO 13485 Standard within their organisations.
Duration: 5 Days
About The Course:
- Understand the principles of auditing a QMS.
- Understand the competence and evaluation of Auditors.
- Establish the audit programme.
- Implement the audit programme.
- Conduct the audit.
- Audit the clauses of the ISO 13485 Standard.
Learning Outcomes:
- Understand the seven principles of auditing.
- Evaluate auditor competence based on a pre-determined criterion.
- Establish an audit programme including objectives, risk and opportunities, scope, schedule, audit type, criteria and audit methods (Plan-Do-Check-Act).
- Establish audit programme objectives based on needs and expectations of interested parties, characteristics of and requirements for processes, products, services and projects and any changes to them, QMS requirements, need for evaluation of external providers, key performance indicators and the results of previous audits.
- Establish the extent of audit programme taking into account the management system standards and other applicable criteria, the number, importance, complexity and locations of the activities to be audited.
- Implement the audit programme by communicating to interested parties, defining objectives, scope and criteria of the audit and selecting audit methods.
- Manage audit programme results and maintaining audit programme records.
- Conduct the audit including opening and closing meetings, communicating during the audit, information availability and access, reviewing documented information, collecting and verifying information.
- Generate audit findings by evaluating audit evidence against the audit criteria.
- Prepare and distribute an audit report and conduct audit follow-up.
- Audit the different clauses of the ISO 13485 Standard.
Training Formats:
Online & Classroom (Hybrid)
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