How to write the distribution number and controlled status in the medical device quality manual?

Distribution number should be pre-specified, generally consists of unit code + department code (2-4 English letters) + personnel serial number (2-3 Arabic numerals)

4.2 Controlled and uncontrolled documents

4.2.1 Documents can be divided into two categories: "controlled" and "uncontrolled". (a) "Controlled" documents are those that are under the control of the organization and can be changed, are change notification versions, can be traced back to all users when changes are made to the document, and are changed to ensure that they are current and valid;

4.2.1 Documents can be classified into "Controlled" and "Uncontrolled":
a) "Controlled" documents are those that are under the control of the organization and can be changed.

b) "Non-controlled" documents are foreign documents, the unit's system documents that do not require change control (including documents used for bidding, customer off-site use and other special issuance of documents, production schedules, quality monthly reports, and seasonal-related operational documents, etc., which have a statute of limitations that expires and is automatically invalidated), for the change of the non-notification version, the unit will notify all users when changes are made to the document, and will implement changes to the document to ensure that it is valid.

4.2.2 Controlled documents must be stamped "controlled" seal, distribution should be issued for registration, and note the distribution number. Non-controlled documents by the authorized personnel after the approval of the issuance, only for the issuance of registration, do not note the distribution number. The unit of controlled documents as non-controlled documents issued (such as bidding, customer off-site use), should be stamped "non-controlled" seal.

4.7 Identification of documents

4.7.1 Quality manual, program documents, annual quality objectives, departmental operating instructions, quality plans, various systems and other related documents using the distribution number and controlled status for identification. All internal use of the organization and the quality manual, procedure documents and other documents provided to the certification body, issued with a "controlled" seal, and issue number. Provided to other organizations to use quality manuals, procedural documents and other documents stamped with "non-controlled" seal, only for the issuance of registration, do not give the issuance number.

4.7.2 Records are identified by the name and number of the record.

4.7.3 Record forms can be identified by record number, department code (or department name), record date, or form number.

4.7.4 Technical standards, specifications, and other documents provided by the customer may be identified by name, number, list, or seal, as appropriate.

4.7.5 Where the documents under control, must ensure that it is currently effective; where the documents are not under control, the unit only to ensure that the issuance of its current validity, not tracking and maintenance.

4.7.6 There are four types of seals: "Controlled", "Uncontrolled", "Voided", and "Voided and Reserved". There are four types of seals: "Controlled", "Uncontrolled", "Voided" and "Voided and Retained", which are kept and used centrally by the document management.

And document identification needs to be pre-specified, i.e., the numbering rules for documents and records

Document modification needs to be identified, i.e., differentiating between different versions through document numbering