Internal audits - Your pathway to become internal auditor
Within the medical device industries, the internal audits are a crucial tool to ensure the quality management system is in compliance and to determine the effectiveness of the quality system. Internal auditors must be appropriately trained to the underlying regulatory requirements, to the audit planning and execution as well as to the techniques generating meaningful audits.
Our training will guide you in 5 major steps along the pathway to become a qualified internal auditor. At the start of your journey we will introduce the key requirements for internal audits as per ISO 13485, (EU) 2017/745 (MDR) and MDSAP. The second step will lead us to the basics of ISO 19011, which is the standard for auditing management systems. We will discuss your role in audit programs, audit planning and audit reporting.
Within the third step we will enter the core of any auditor’s competence, i.e., the 6 audit principles of integrity, fair presentation, due professional care, confidentiality, independence, evidence-based approach and the risk based approach. As critical audit situations will surely arrive during your audits, we will dive into such situations and seek ways to handle them. Step 4 will encompass the myths of writing and grading nonconformities, which is actually the most difficult task for an internal auditor. Finally you will complete your qualification in step 5, when we will discuss your To-Do’s within the follow-up actions from internal audits to close out nonconformities and to communicate audit results.
Being an authorized lead auditor in medical devices, your trainer will ensure that your training will be pragmatic and accompanied by lots of real-life examples to ease your learning.
Contents
- Requirements from ISO 13485, (EU) 2017/745 (MDR) and MDSAP,
- Basics from ISO 19011,
- The 6 audit principles and ways to handle critical audit situations,
- Writing and grading nonconformities,
- Follow-up actions.
Your benefits
- You will get sufficient knowledge and practical competence to plan and execute internal audits.
- You will understand the difficulties of being an internal auditor while learning valuable tools to cope with critical audit situations.
- Real-life examples will enable you to increase the value of your company’s internal audit program.
Trainer
- Dipl.Ing.(FH) Michael Schaefer
Methods
Presentation, real-life examples, discussion, storytelling.
Participants
- Manufacturer of Medical Devices and in-vitro-Diagnostics
- Internal and supplier auditors
- Quality Management Representative, PPRC
- Consultants and freelancer
Sprache: Englisch
Durchführung: Remote
Dauer: 2 Tage
Kategorie: Englische Seminare
Anbieter: qtec services GmbH
Geeignet für: Manufacturer of Medical Devices and in-vitro-Diagnostics Internal and supplier auditors Quality Management Representative, PPRC Consultants and freelancer
Vorkenntnisse: not required
Referent
Prof. Dr. Michael Imhoff
Clinical Director
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Tags: Requirements from ISO 13485, (EU) 2017/745 (MDR) and MDSAP Basics from ISO 19011 The 6 audit principles and ways to handle critical audit situations Writing and grading nonconformities Follow-up actions
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Internal audits - Your pathway to become internal auditor
Within the medical device industries, the internal audits are a crucial tool to ensure the quality management system is in compliance and to determine the effectiveness of the quality system. Internal auditors must be appropriately trained to the underlying regulatory requirements, to the audit planning and execution as well as to the techniques generating meaningful audits.
Our training will guide you in 5 major steps along the pathway to become a qualified internal auditor. At the start of your journey we will introduce the key requirements for internal audits as per ISO 13485, (EU) 2017/745 (MDR) and MDSAP. The second step will lead us to the basics of ISO 19011, which is the standard for auditing management systems. We will discuss your role in audit prog
Referent
Prof. Dr. Michael Imhoff
Clinical Director
| Sprache: | Englisch |
| Durchführung: | Remote |
| Dauer: | 2 h |
| Kategorie: | Englische Seminare |
| Anbieter: | qtec services GmbH |
Geeignet für:
Manufacturer of Medical Devices and in-vitro-Diagnostics Internal and supplier auditors Quality Management Representative, PPRC Consultants and freelancer
890,00 EUR
Preis netto zzgl. Mwst. pro Teilnehmer
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