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Purpose ...................................................................................................................................................................... 3
Other useful resources .............................................................................................................................................. 3
Timing of the transition ............................................................................................................................................. 3
Twelve-step transition process .................................................................................................................................. 4
Sample documentation ............................................................................................................................................. 8
Special focus has been given to obligations to meet regulatory requirements in the Quality Management
System. Moreover, the differences in local regulations and their impact to the system have to be
addressed and incorporated. An organization can develop a procedure listing all applicable regulatory
concerns that apply to its activities; moreover, it can also state its roles to meet these requirements.
The organization can then define roles and responsibilities for meeting specific requirements under
these roles. Within this procedure, the organization should give reference to documents (for example,
procedures, work instructions, records) included in the Quality Management System in order to comply
with these regulatory requirements.
Read more here: How to determine regulatory requirements according to ISO 13485:2016.
The scope of the Quality Management System must be included in the Quality Manual.
Read more here: How to manage a Quality Manual according to ISO 13485:2016 requirements.
Read more at: How to meet ISO 13485:2016 requirements for medical device files.
5) Documentation Requirements
Along with medical device files, organizations are now required to define methods to protect
confidential health information. Moreover, the organizations are also required to prevent loss of
documentation and deterioration of any document. This requirement can be managed with the help of
a robust software application that protects the access of health information from unauthorized use, and
all records to be managed in the software. Backups of the information should be maintained according
to a defined frequency to prevent loss of documentation.
6) Addressing risks
According to the new version, the risks of medical products are only related to product safety or their
inability to meet regulatory requirements. All those risks must be addressed and managed. This
definition in ISO 13485:2016 is different from that of ISO 9001:2015. Therefore, product risk assessment
should be considered during the design and development phase, and it should be maintained in medical
device files. Any change in product design should constitute a new risk assessment request.
Read more at: Managing medical device infrastructure requirements according to ISO 13485:2016.
Read more at: Managing medical device infrastructure requirements according to ISO 13485:2016.
Read more at: ISO 13485:2016 nonconforming product – How to approach the post-delivery actions.
Read more at: How to manage the medical device sterilization process according to ISO 13485:2016.
Click here to see Conformio, an online software platform for managing ISO projects, through which you
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You can download the ISO 13485:2016 Documentation Toolkit. The free version of this toolkit will allow
you to see a sample of policies and procedures required by the ISO 13485:2016 standard.