What are the primary, secondary and tertiary documents in the process of medical device certification?

The first-level document in certification refers to the quality management manual, which is programmatic.

Secondary documents refer to documented program documents required by standards, or program documents deemed necessary by other organizations.

Third-level documents refer to operational guidance documents within the scope of departments, such as work instructions.

Some people also refer to the records generated by the execution of the above-mentioned documents as four-level documents.