Design and development validation and verification according to ISO 13485
Chany Runnels
Producing any part of a product includes validation and verification in its design and development. ISO 13485 requirements are a...
Producing any part of a product includes validation and verification in its design and development. ISO 13485 requirements are a great way to start, since it’s targeted specifically to medical device manufacturing. According to the...
Monitoring and measurement of processes in ISO 13485: How to comply with section 8.2
Verlene Law
Updated: October 4, 2023. Monitoring and measurement focus on the quality of the product or services, which reflects the effectiveness...
Updated: October 4, 2023. Monitoring and measurement focus on the quality of the product or services, which reflects the effectiveness of the Quality Management System. Simply put, it informs us about whether our products have...
How to comply with the latest changes in ISO 13485 clause 7.2.3 Communication
Communication is considered to be one of the crucial factors in compliance with ISO 13485. Poor communication practices, such as...
Communication is considered to be one of the crucial factors in compliance with ISO 13485. Poor communication practices, such as relying on verbal agreements and failing to document changes, could lead to high costs in...
How can ISO 13485 clause 7.4, Purchasing, enhance procurement?
We often cover four basic elements in sourcing a product for the company. These include the nature of the purchase,...
We often cover four basic elements in sourcing a product for the company. These include the nature of the purchase, the cost of the product, the quality of the product, and previous purchasing experience. This...
Common mistakes with ISO 13485:2016 documentation control and how to avoid them
Documentation control is the first task that most people would prepare for before an upcoming audit. Prior to an audit,...
Documentation control is the first task that most people would prepare for before an upcoming audit. Prior to an audit, we would ensure that any changes made to the work procedures are updated, review the...
Production and service provision process in ISO 13485
Strahinja Stojanovic
Clause 7.5 of ISO 13485, which deals with requirements for production and service provision, causes a lot of confusion. The...
Clause 7.5 of ISO 13485, which deals with requirements for production and service provision, causes a lot of confusion. The main reason for this is the fact that the standard aims to define requirements applicable...
