Document Control

The whole point of this section ‘Document Controls” are nobody can simply revise and approve any procedure and documents. All new revision of procedures, documents, protocol, manufacturing processes must be well thought of and be implemented effectively throughout the whole organization. 

Associates whom have been effectively trained on the documents can perform a task according to the procedure. Therefore, a new revision or a new document should have the approved status and effective status. Approved status is to show the document is only ready pending all the employees are trained effectively, then the document is changed to a status of ‘effective’ with a date. Then, the document is ready for the whole organization.

Each stage of a document must be indicated as either ‘DRAFT’, ‘Controlled’ or OBSOLETE’. Only approved documents can be used. Effective date of each document must be conspicuously shown on the document or the effective date is easily accessible. It is not uncommon for careless associate to work on the old revision of a procedure resulting in a messy deviation.  This obsolete document must be marked ‘OBSOLETE” and be removed promptly from being inadvertently used.

Any change to each document must be performed according to corporate procedure. It is critical to get all related departments managers involved to ensure the change can be reviewed, edit, approved and implemented.

A sponsor should have a document control department to ensure all new documents are initiated, edited and written properly and present documents revised accordingly. There should not be any obsolete document floating around.

Because there can be hundreds of documents in the organization from quality policy, procedures, work instructions, drawings, training record, verification and validation protocols and report, manufacturing processes, etc. It is important that medical device company to have a system to manage all the documents. There are many software out there to manage all the documents. Master Control is one of them.

Reference	Criteria
ISO 13485 4.2.1	Does the quality management system documentation include documents needed by the company to ensure the effective planning, operation, and control of its processes?
ISO 13485 4.2.3	Are the documents required by the quality management system controlled?
ISO 13485 4.2.3.a	Has a documented procedure been established to define the controls needed to approve documents for adequacy prior to issue?
ISO 13485 4.2.3.b	Has a documented procedure been established to define the controls needed to review, update as necessary and re-approve documents?
ISO 13485 4.2.3.c	Has a documented procedure shall be established to define the controls needed to ensure that changes and the current revision status of documents are identified?
ISO 13485 4.2.3.d	Has a documented procedure been established to define the controls needed to ensure that relevant versions of applicable documents are available at points of use?
ISO 13485 4.2.3.e	Has a documented procedure been established to define the controls needed to ensure that documents remain legible and readily identifiable?
ISO 13485 4.2.3.f	Has a documented procedure been established to define the controls needed to ensure that documents of external origin are identified and their distribution controlled?
ISO 13485 4.2.3.g	Has a documented procedure been established to define the controls needed to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.