What is the current version of ISO 13485?
What is the current version of ISO 13485?
ISO 13485:2016
The current version is ISO 13485:2016, which was published in March of 2016 (thus the: 2016). It is NOT a standard for products. It does not define product quality. This is a process-based standard: you use it to control your processes, then your end product should meet the desired results.
What is the difference between ISO 13485 2003 and ISO 13485 2016?
ISO 13485:2003 has no explicit criteria to describe requirements of transferring a product from design and development to production. ISO 13485:2016 corrects this and includes explicit requirements.
What is ISO 13485 2016?
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
What does ISO 13485 mean?
Medical devices — Quality management systems
ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical …
What are the requirements of Clause 8 of ISO 13485?
Clause 8 of ISO 13485:2016 gives the requirements for measurement analysis and improvements of these processes including: 8.1 General 8.2 Monitoring and Measurement 8.3 Control of nonconforming product
How to comply with section 8.2 monitoring and measurement in ISO 13485?
These areas are reflected in the six sub clauses in clause 8.2, namely: 8.2.1 Feedback, 8.2.2 Complaint handling, 8.2.3 Reporting to regulatory authorities, 8.2.4 Internal audit, 8.2.5 Monitoring and measurement of processes, and 8.2.6 Monitoring and measurement of product.
What are the applications of ISO 13485 for medical devices?
Applications of ISO 13485 ISO 13485 specifies quality management for medical device manufacturers and related organizations. This means a variety of companies in the medical device industry and pharmaceutical supply chain use ISO 13485 standards. Organizations that use this standard include:
What are the changes to ISO 13485 for 2016?
With the recent ISO 13485:2016 changes, both regulations now tightly define responsibility and authority, as well as management representation for regulatory and quality management system requirements. Training is addressed in ISO 13485: 2016 Clause 6.2 and addresses competency, training, and personnel awareness, as does the FDA’s 820.25.