Hey, I’m Adam - I’m a qualified lead auditor and I’ll be your instructor
Register your interest now for my ISO 13485 Internal Auditor Training Online Course for Small Businesses
Disclaimer: This is an upcoming course and is simply a registration of your interest, and does not tie you to any financial commitment.
What is ISO 13485?
ISO 13485 is a global standard that sets the bar for quality in the medical device industry. It's like a roadmap, guiding manufacturers to ensure their products are safe, effective, and meet the highest standards of care. By following ISO 13485, companies demonstrate their commitment to patient safety and regulatory compliance, building trust and confidence in their products.
It is recognised as a harmonised standard (European Union), designated standard (UK) or consensus recognised standard (FDA) and can be used by manufacturers as a way of presuming conformity with quality system elements of regulations.
Who is the ISO 13485 Auditor Course aimed towards?
This course is aimed at individuals who are being tasked with conducting audits to ISO 13485 in line with ISO 19011.
This can be undertaken by auditors who have experience in ISO 9001, but have not audited ISO 13485 specifically.
What is covered in our ISO 13485 Auditor Course?
In our 1 day e-learning course, you’ll cover the following - how to plan, perform and report on ISO 13485 audits appropriately.
We’ll cover the following:
Section 1: Quality Management Systems and ISO 13485
Overview: Explore the concept of quality management systems and their role in ensuring product safety and efficacy.
ISO 13485: Delve into the purpose, structure, and key requirements of this international standard specifically designed for medical devices.
Section 2: Internal Audits
Definition and Benefits: Explain the concept of internal audits and how they can help organizations identify non-conformities, improve processes, and demonstrate compliance.
ISO 13485 Requirements: Discuss the specific requirements for internal audits outlined in ISO 13485.
Section 3: Medical Devices
Overview: Provide a brief overview of medical devices and their regulatory landscape.
Section 4: Audit Planning and Preparation
Structured Approach: Outline a step-by-step process for planning and preparing for an audit, including setting objectives, selecting audit teams, and developing an audit plan.
Section 5: Auditing Skills
Essential Skills: Discuss key auditing skills such as:
Checklist and Sampling Plan: Preparing comprehensive checklists and sampling plans to ensure thoroughness.
Rapport Building: Establishing a positive and constructive environment for the audit.
Questioning, Listening, and Note Taking: Effectively gathering information and documenting findings.
Evidence Evaluation: Assessing audit evidence against defined criteria and requirements.
Report Writing: Creating clear and concise audit reports.
Section 6: Corrective Actions
Correction and Corrective Action Process: Explain the steps involved in addressing non-conformities, including corrective actions to prevent recurrence.
Follow-up and Closure: Discuss the importance of follow-up activities to ensure the effectiveness of corrective actions and the closure of non-conformances.
Section 7: Medical Device Regulations
Overview: Provide a comprehensive overview of medical device regulations, including:
MDR 2017/745 and MDR 2017/746: Discuss the key provisions of these EU regulations.
UK MDR: Explain how the UK has adapted the EU MDR to align with its regulatory framework.
EU Medical Device Regulations: Provide a general overview of the EU regulatory landscape for medical devices.
International Initiatives: Discuss the role of organizations like MD SAP, IMDRF, and MDCG in coordinating and harmonizing medical device regulations.
Section 8: Market Placement
CE Marking, UKCA Marking, and FDA Requirements: Explain the requirements for placing medical devices on the market in the EU, UK, and US, including the necessary certifications and markings.