ISO 13485: Document Numbers for records, record retention, compliance calendar

A clever tool for assigning record numbers is to incorporate a year or date into the control number. For example, 2022-097 could represent the 97th record for 2022. This built-in semi-intelligent system is simple and efficient, especially in companies that have been in business for several years. Having the year embedded in the number is a valuable tool for locating an older record. The biggest drawback however is when the new year starts, and one forgets to update the control number to the new year! To avoid missing this simple step, use the compliance calendar that I talk about later in this blog.

The end of the year is also a good time to start gathering up any paper records for scanning and archiving. Electronic records can also be assembled and electronically filed. Also, do any records need to be purged or destroyed? If yes, then make sure the destruction mechanism meets any regulatory compliance needs.

As part of a strategy for Regulatory Compliance (as required under the EU 2017/745 MDR), I suggest putting together a calendar for the upcoming year. Under each month, the list required activities such as paying annual registrations, conducting internal audits, performing a review of new and revised regulations, conducting a risk documentation review, etc. A simple compliance calendar can make sure that nothing falls through the cracks and everything is accounted for.

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