Document Control SOP

This procedure establishes the requirements for the creation, review, approval, distribution, revision, and obsolescence of all documents within the Quality Management System. It ensures that only current, approved versions of documents are available at points of use and that obsolete documents are promptly removed or clearly identified to prevent unintended use.

This procedure applies to all QMS documents including: - Quality Manual - Standard Operating Procedures (SOPs) - Work Instructions (WIs) - Forms and Templates - Specifications and Drawings - External documents of external origin (standards, regulations, customer specifications) This procedure does not apply to quality records, which are governed by the Record Control procedure.

Document Author: Responsible for drafting documents, incorporating review feedback, and ensuring technical accuracy. Document Reviewer(s): Subject matter experts responsible for reviewing documents for accuracy, completeness, and clarity. Document Approver: Quality Manager or designated authority responsible for final approval prior to release. At minimum, the Quality Manager must approve all SOPs. Document Control Coordinator: Responsible for maintaining the Document Master List, distributing approved documents, retrieving obsolete copies, and maintaining the document control system. All Employees: Responsible for using only current, approved documents and reporting any discrepancies to the Document Control Coordinator.

4.1 Document Identification & Numbering All QMS documents shall be assigned a unique document number following this convention: [Type]-[Module]-[Sequential Number] Example: SOP-DC-001 (SOP for Document Control, first document) Document types: QM (Quality Manual), SOP (Standard Operating Procedure), WI (Work Instruction), FRM (Form), SPEC (Specification) 4.2 Document Creation - Author drafts the document using the approved template (FRM-DC-001) - All documents must include: document number, title, revision level, effective date, page numbers, author, reviewer(s), and approver - Draft documents shall be watermarked "DRAFT" until final approval 4.3 Document Review & Approval - Documents shall be reviewed by at least one subject matter expert and approved by the Quality Manager (or delegate) - Review comments shall be documented and resolved prior to approval - Electronic signatures or wet-ink signatures are acceptable; electronic signatures must comply with FDA 21 CFR Part 11 where applicable - Target review cycle: 5 business days per reviewer 4.4 Document Distribution - Approved documents shall be distributed via the electronic document management system - Hard copy controlled documents (if any) shall be stamped "CONTROLLED COPY" with the distribution number - The Document Master List (FRM-DC-002) shall be updated to reflect the current revision and effective date 4.5 Document Revision - Revisions follow the same review and approval process as new documents - A Document Change Request (FRM-DC-003) shall be completed for all revisions - Changes shall be described in the revision history table within the document - Minor editorial changes (formatting, typos) may be processed as an administrative change with Quality Manager approval 4.6 Document Obsolescence - Obsolete documents shall be removed from all points of use within 1 business day of the new revision's effective date - One archived copy of each obsolete revision shall be retained and marked "OBSOLETE" - The Document Master List shall be updated accordingly 4.7 External Documents - External documents (ISO standards, regulatory guidance, supplier specifications) shall be logged on the External Document Register (FRM-DC-004) - The Document Control Coordinator shall monitor for updates to external documents at least annually

- Document Master List (FRM-DC-002) - Document Change Request forms (FRM-DC-003) - External Document Register (FRM-DC-004) - Document distribution records - Review and approval records (signatures/electronic approvals)

- ISO 13485:2016 Clauses 4.2.4, 4.2.5 - FDA 21 CFR 820.40 Document Controls - FDA 21 CFR Part 11 Electronic Records; Electronic Signatures (if applicable) - Quality Manual (QM-001)