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Design and development validation and verification according to ISO 13485

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 American Society for Quality, the definition of validation in a quality environment is the act ...Read more

How to comply with section 8.2 Monitoring and measurement in ISO 13485:2018

Monitoring and measurement focus on the quality of the product or services, which reflect the effectiveness of the Quality Management System. Simply put, it informs us about whether our products have met the expectations in terms of quality, safety, and efficacy. The ISO 13485 standard defines the different areas in ...Read more

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 relying on verbal agreements and failing to document changes, could lead to high costs in terms of operational losses. A 2016 survey by the Society for Human Management (SHRM) asked ...Read more

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, the cost of the product, the quality of the product, and previous purchasing experience. This workflow is not always as smooth as we want it to be. Could it be ...Read more

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, we would ensure that any changes made to the work procedures are updated, review the Quality Manual and Quality Management System documents, and ensure that each process owner is aware ...Read more

Production and service provision process in ISO 13485

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 to a wide variety of manufacturing and service provision processes in the medical device industry. ...Read more



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