The aim of this course is to provide delegates with the knowledge and skills required to perform an audit of part of a quality management system based on ISO 13485 and report on the effective implementation and maintenance of the management system in accordance with ISO 19011.
Course aims.
The aim of this course is to provide delegates with the knowledge and skills required to perform an audit of part of a quality management system based on ISO 13485 and report on the effective implementation and maintenance of the management system in accordance with ISO 19011.
What will I learn?
Interpretative skills in understanding the requirements of ISO 13485:2016
Effective auditing techniques
Practical knowledge of the Management System Approach
Application of methods and techniques to conduct, and generate findings, on an ISO 13485:2016 audit.
Core concepts and background on medical devices – Quality management systems in the supply chain.
Review of common compliance problems and possible solutions.
Application of methods and techniques to gather, evaluate & triangulate satisfactory objective evidence during an audit to determine the conformance of a system.
Ability to generate accurate, appropriate, and comprehensive audit findings and conclusions.
This course will teach students the principles of ISO 13485:2016 and how to use tools as well as to teach students how to apply methods and techniques to plan and conduct an ISO 13485:2016 Audit.
Is this course right for me?
This course is aimed at:
3rd party ISO 9001 auditors converting to ISO 13485
Key personnel from organisations that are currently implementing a QMS
Managers and staff who are, or are about to become members of the organisation’s audit team
Quality Managers, Regulatory / Compliance Managers, Internal Auditors and Consultants.
About Us
International Associates (IA) are a leading provider of assessment, audit, verification, certification, and training services. Operating from our head office in Glasgow, UK, we have a Network of International Offices around the world with Regional Offices in Ireland, India ,Italy, China, Turkey and Thailand as well as a Network of Auditors around the world.
The organization was originally founded in 2016 and registered as a private company limited by shares in UK; however, all Senior Management working within IA have over 25 year's experience in the auditing, certification, regulatory and engineering areas.
We pride ourselves on our I.T. infrastructure, which has been designed to make things more accessible to our clients and to ensure that our Auditors are working as efficiently as possible in the field. Both of these activities ensure that we are competitive in the market place and do not have the burden of bureaucracy weighing us down.
Benefits of Using International Associates
Independent & Self Financing
International Associates Limited does not receive funding from the government or any other source. Our income comes from client fees alone. This dependence on the market ensures our fees are competitively priced and our service attractive.
Professionally Managed
All senior management are also qualified lead auditors who have extensive practical Quality Assurance experience from careers in industry. This gives an in-depth knowledge of the problems the industry faces and client assessment demands.
Modern & Progressive
We are forward thinking. Our approach to the market and client service is a modern one. Our on-line systems ensure that bureaucracy is kept to a minimum, thus reducing the possibility of mistakes and ensuring turnaround of certificates is efficient.
Understanding & Responsive
Being self-financing, depends on our clients. We understand their needs and feelings and welcome their comments. Client feedback is also integrated into our business planning systems and procedures.
Systems & Controls
Defining the manner in which audits are conducted. Audits are planned prior to arrival on-site and auditors briefed. The activities to be performed follow a scheduled timetable which is given to the client well in advance of the audit date.
Client Satisfaction
The entire audit is carried out in a manner to ensure client satisfaction with our service. Any complaints received are reviewed by our independent impartiality committee made up of industry experts.
Electronic Data Transfer
We use data synchronisation through our online portal throughout the entire certification process, which greatly improves efficiency and reduces time and costs.
Client Portal
We have an online portal for clients to access their records from any location, without the need to make data requests.
Professional Auditors
Our audit teams are not only well qualified to carry out the assessment; they also have industry experience and knowledge in the client’s business sector. They understand the problems people may have and can suggest possible solutions to help improve the system.
Fair Results
On completing the audit, a meeting is held with the client during which the results are explained. The client is asked to confirm the findings and is given the opportunity to clarify any misunderstandings affecting the result.
All clients have the right to make a complaint about our service or lodge an appeal regarding the findings. All complaints and appeals are reviewed by the IA impartiality committee.
Internationally Accepted Certification
Our certificates are recognized worldwide and accepted by the governments of all the major trading nations of the world.
Online Certification Check
We are currently developing a web-based certification verification system, which will allow the validity of certificates to be verified.
The ISO 13485:2016 Medical Devices Quality Management Systems Lead Implementer course empowers professionals with the knowledge and skills necessary to lead the implementation of ISO 13485 within their organizations.
This two day course explores the requirements of the ISO 13485:2016 Quality Management System standard, clause by clause, and provides a clear understanding of the key principles of the standards as well as the steps needed to implement ISO 13485:2016 within your organisation.
The ISO 13485 standard is developed to meet the vast requirements for a Quality management system. It provides a foundation for manufacturers to address the requirements pertaining to the EU Directives, regulations, responsibilities as well as the commitment to the safety and quality of related to ...
This ISO 13485 training is a one-day course for the introduction to medical device manufacturers. There is no such word as negotiable within the vocabulary of the medical device world and that is the sole purpose of the development of this course.
ISO 13485 quality management systems for medical devices and IVDs provide the framework to consistently produce safe and effective medical devices. The latest version has additions such as regulatory harmonisation and a greater emphasis on risk management. In addition, many countries have committed
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