ISO 13485 consultancy and training
ISO 13485 Certification and Training from Temple QMS
Temple QMS is a leading provider of ISO 13485 consultancy & training
Safety and quality are non-negotiable in the medical devices industry.
Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organisations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry.
ISO 13485 is designed to be used by organisations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
The ISO 13485 Services from Temple QMS
Training
With our range of ISO 13485 courses, you can enhance your knowledge of the standard at your own pace.
Evaluation
Our auditors assist you in identifying non-conformities or weak areas prior to your formal ISO 13485 audit.
Certified Accreditation
Clearly state your capabilities. You can win new business by earning accredited certification.
Integrated Audits
Our integrated auditing and surveillance service allows you to enhance your processes, ultimately leading to a more dependable, cost-effective management system such as ISO 13485.
Preparing for ISO 13485
Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organisations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. ISO does not perform certification.
Why was ISO 13485 revised and what are the main improvements?
All ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.
ISO 13485 Quality Management System Training
Maintain compliance
Improve in quality standards
Build confidence within your organisation with competent auditors
Motivate colleagues and ensure effective regulatory internal processes
Foundation Course
(1 Day)
The requirements of the ISO 13485:2016 standard, how the standard interacts with ISO 9001, the European Medical Device Directive and the US FDA’s Quality System Regulation.
Internal Auditor Course
(2 Days)
Intended for medical device quality professionals. Learn the practices of effective QMS process audits in accordance with the ISO 13485 and
ISO 19011.
EU Medical Device Regulation 2017/745 (1 Day)
This course aims to provide learners who have an existing, basic knowledge of, or experience in, quality management in the Medical Device Industry.
