ISO 13485 Certification Training Courses
There is probably no other industry where the importance of product conformity is as crucial as that in the design and manufacture of medical devices. Standards in any industry are an important way both to safeguard product conformity while simultaneously harmonizing requirements, not only nationally, but internationally as well.
An important step in safeguarding product conformity and ensuring that a manufacturing or design process can consistently produce product of the required standard, is a structured management system. With regards to medical devices, there is no standard that better represents the requirements for a comprehensive management system than ISO 13485. Compliance with ISO 13485 is often seen as the first step in achieving compliance with regulatory requirements.
Increasingly, certification to ISO 13485 is becoming the preferred method for medical device manufacturers and their sub tier suppliers/contractors to demonstrate the intent to comply with applicable regulatory and statutory requirements. Medical device manufacturers who are placing their products on the market within the European Union will need to address compliance with the requirements of the applicable Medical Device Directive and the CE marking process. ISO 13485 is recognized as an aid in supporting compliance with the MDD.
Our ISO 13485:2016 Training Courses
This course will provide each Learner with the knowledge and skills to effectively audit a complete QMS based on ISO 13485:2016 requirements - including internal, supplier and external audits (1st, 2nd & 3rd party).
Duration : 5 days Course Type : Lead Auditor Price : $ 2395.00 per person Course Ratings :
This course will enable the Learner to be able to effectively conduct an internal audit of a product, process or department/function of a QMS based on ISO 13485:2016 requirements.
Duration : 2 days Course Type : Internal Auditor Course Ratings :
This course will introduce Learners to Quality Management Systems and provide them with a highly insightful introduction to the purpose, intent and requirements of ISO 13485:2016.
Duration : 1 days Course Type : Fundamentals Course Ratings :
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The Kelmac Group® has developed a unique tradition of creating learning services that shape the future of conformity and compliance learning solutions for Executive Management, Practitioners and Auditors. Where others train followers, we train leaders™
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Virtual Instructor-Led Training for all ISO Courses Beginning 4/1
We are pleased to announce today, Wednesday 01st April 2020, CQI-IRCA approved the Kelmac Group® to start delivery of Virtual Instructor-Led Training [VILT] classes. The Kelmac Group® will immediately commence offering VILT classes for all ISO courses. We will shortly publish our VILT training schedule on our websites, plus we will also publish additional general information … Continue reading Virtual Instructor-Led Training for all ISO Courses Beginning 4/1Read More
Some Ways Your Business Can Benefit From ISO 9001:2015 Certification
The International Organization for Standardization (ISO) is the world’s largest developer of voluntary International Standards. ISO 9001 standards address various aspects of quality management. These standards provide guidance and tools for companies and organizations who want to ensure their products and services consistently meet their customers’ requirements. Why organizations pursue ISO 9001:2015 CertificationISO 9001:2015 is … Continue reading Some Ways Your Business Can Benefit From ISO 9001:2015 CertificationRead More
Evaluation of Process Performance in ISO 9001:2015
Every organization is made up of core, support and management processes which work together to ensure that the organization meets its business goals and objectives. If any process is not working effectively and efficiently, there can be a knock-on effect resulting in a negative impact on business performance.Consider an organization that has the following processes: … Continue reading Evaluation of Process Performance in ISO 9001:2015Read More