ISO 13485 Training Courses
Quality Management System Training – IRCA Certifed
ISO 13485 Lead Auditor Training & Internal Auditor Training
ISO 13485 Training
The Irish Quality Centre is the leading Irish training provider in ISO Standard, EU Regulations, and other Quality Training. Our practical, hands-on training creates long-lasting skills change in delegates and has helped us maintain over 87% client retention rate, all you need is to experience our training once.
Our internationally IRCA-approved Auditor Training courses (including ISO 9001 Auditor/Lead Auditor, ISO 13485 Auditor/Lead Auditor and Internal QMS Auditor) and these are delivered across Ireland and Europe both publicly and privately.
The International Standards Organisation (ISO) is the global leader in setting, maintaining and validating industry-based quality standards. The ISO standards developed quality management systems (QMS) that have become the accepted benchmark for deliverance of quality products and services.
ISO 13485:2016—Medical Device Quality Management Systems is specifically used by organisations associated with the full life-cycle of medical devices from design, production, usage, to even final decommissioning. And covers external suppliers and other associated services related to medical devices. The standards main intent is to bring consistency and uniformity to promote quality design, production, and usage of medical devices internationally.
The ISO standards require organisations to determine the effectiveness of their quality management systems on an annual basis through external auditors, with an ISO Certified Body led re-certification audit every 3 years to ensure compliance to ISO 13485 standards. The annual external audit is hugely important to organisations which makes it critical to develop an internal audit team to ensure the organisation is conforming to the requirements of the standard.
ISO standards also require organisations to conduct their own Internal audits with independent and competent auditors taking a Process and Risk Based approach. It is therefore essential that Internal Auditors are given the Education, Training, Knowledge, and Skills to conduct these audits effectively……
Internal Auditors have the responsibility of carrying out these audits, assessing remedial actions and ensuring the effectiveness of all core business processes.
Lead Auditors have similar responsibilities but with a greater emphasis on leading audits. The 5-day Lead Auditor training is designed with the specific objective of equipping participants with best-in-class audit practice to master the audit skills, managing and leading the entire ISO 13485 audit process from audit planning, resource allocation, team management and to final closing meeting where the audit results are presented to management. The Lead Auditor role is key to the efficient and effective audit process, with ultimate responsibility for the audit. This course is certified by the International Register of Certified Auditors (IRCA) and therefore certified auditors are expected to conduct audits in a professional thorough and fair manner against the regulatory or Quality Management Standards.
It is essential for Lead Auditors to be fully versed and understand the ISO 9001 Quality Standards to thoroughly manage the Quality Management Systems audit, and to be able to liaise appropriately with external bodies or auditors in an effective manner while also represent the organisation externally when auditing suppliers.
Book your Auditor Training below or click here to go to our other Medical Device Industry Training
ISO 13485 Foundation Training – Online
Great overall course. Learnt a lot and I am more confident to audit
Great teaching method to bring auditing to real life situations
Clear concise top quality course
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