Description:
This Document Control Procedure defines how we create, identify, review, approve, distribute, preserve, and monitor QMS documents to ensure only current controlled versions are used.

• Apply the QMS pyramidal structure (QM → QSP → SOP → FORM → LOG → TOOL → Records).

• Control QMS folders and enforce access control (read-only vs modify) per the RRM Matrix.

• Use a defined identification policy (e.g., QSP-XXXX-YYY rev.Z, SOP-XXXX-YYY rev.Z, FORM-XXXX-YYY rev.Z).

• Create documents using controlled templates and register status in the Document Master List (LOG-DOC-001).

• Manage updates using redline (tracked changes), and retain redlined and clean versions.

• Enforce independent reviewer and approver roles (not the same person) with signatures and dates.

• Define an effective date to allow replacement of obsolete copies and required documentary training.

• Control documents of external origin (standards, agreements, guidelines) and manage distribution and versioning.

Your needs:

• Document control procedure

• Document control procedure for MDR decision-making

• Reduce rework, prevent use of obsolete documents, and strengthen audit readiness.

This procedure is used whenever we create or revise QMS documentation, ensuring documents are uniquely identified, reviewed by qualified functions, approved with accountability, and made available in controlled locations.

It sets the rules for document lifecycle control. Document Master List is the register that defines status (draft/current/obsolete), distribution, and key metadata; it matters because it is the single point of control. Redline means traceable change marking; it matters because reviewers can verify what changed and why.

• Apply identification and revision conventions to every controlled document.

• Register new/revised documents and statuses in the Document Master List.

• Use controlled templates and standardized headers/footers.

• Perform reviewer and approver checks per RRM and keep them independent.

• Assign an effective date and complete required training before use.

• Replace and destroy obsolete controlled copies before the effective date.

• Preserve documents via secure storage and backup rules (per record control).

• Control external documents and track their versions and distribution.

At Lexqara, we implement document governance that prevents uncontrolled copies, improves cross-functional review efficiency, and supports internal audits and inspection readiness (QMS implementation, training, audit support). Resource Center [https://lexqara.com/resource-center] and QMS Implementation [https://lexqara.com/services/qms-implementation]. See EU MDR (Regulation (EU) 2017/745) [https://eur-lex.europa.eu/eli/reg/2017/745/oj]. Request a short gap assessment.