QMS…? ISO 13485 adds to the requirements of ISO 9001 by demonstrating responsibility for “maintaining the effectiveness of the quality...

What's the difference between ISO 13485 and ISO 9001? Do you need to adhere to both or just one of them? Electronic Quality Management...

The content below is a highly recommended article about specific information concerning how your QMS and EU-MDR/EU IVDR will impact your...

Non-conformance means that something went wrong with a process, service, or product, and the result doesn't match the initial specifications

Your Quality Management System can become overly complex over time due to excessive layers of unneeded documents, procedures, forms, etc..