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Setting good quality objectives for ISO 13485
In clause 4.2.1, ISO 13485 lists quality objectives as being mandatory for a Quality Management System (QMS) in the medical...
In clause 4.2.1, ISO 13485 lists quality objectives as being mandatory for a Quality Management System (QMS) in the medical device industry, which begs the questions: What are quality objectives, what is their purpose, and...
ISO 13485: How to write a short quality manual
Organizations sometimes go too far with their quality manual, creating a huge, unusable book that is pretty much just the...
Organizations sometimes go too far with their quality manual, creating a huge, unusable book that is pretty much just the ISO 13485 standard rewritten with all the “you shall” language changed to “we will.” I...
How to manage the Quality Manual according to ISO 13485:2016 requirements
Unlike the latest version of ISO 9001, which excluded the Quality Manual from requirements for documentation, the new ISO 13485 kept the requirement...
Unlike the latest version of ISO 9001, which excluded the Quality Manual from requirements for documentation, the new ISO 13485 kept the requirement for a Quality Manual partly because it is based on ISO 9001:2008. Considering the changes...
How to determine regulatory requirements according to ISO 13485:2016
It doesn’t matter if your organization has implemented ISO 13485 – or not – complying with regulatory requirements is critical to...
It doesn’t matter if your organization has implemented ISO 13485 – or not – complying with regulatory requirements is critical to production and service delivery in the medical device industry. That means, if you want your...
How to fulfill management responsibilities in ISO 13485:2016
There have always been requirements regarding management responsibilities in ISO 13485. After all, leadership from top management is part of...
There have always been requirements regarding management responsibilities in ISO 13485. After all, leadership from top management is part of the foundation of the standard, along with six other quality management principles. And, this is...