Document Control in Healthcare — ISO 15189 and NABH Requirements

Document control is the system that ensures the right version of the right document is available at the point of use — and that outdated or obsolete documents are not used. It’s one of the first things NABL and NABH assessors check.

In healthcare, using an outdated procedure can harm patients. Document control is therefore not bureaucracy — it’s a patient safety measure. ISO 15189:2022 and NABH standards both have specific requirements for document control.

Core Elements of Document Control

• Unique identification: Every document has a document number, version, and effective date
• Approval process: Documents are reviewed and approved before use
• Master document list: A register of all current documents with their current versions
• Distribution control: Documents at point of use are current version
• Obsolete document management: Superseded versions are retrieved and marked “obsolete” or archived
• Revision control: Changes are tracked with revision history

Electronic vs Paper Document Systems

Both are acceptable for NABL/NABH accreditation. Electronic document management systems (EDMS) offer significant advantages:

• Automatic version control
• Audit trails for document changes
• Remote access for multi-site facilities
• Easier search and retrieval during assessments

If using paper, ensure controlled copies are clearly marked, uncontrolled copies are prohibited in point-of-use areas, and all staff have access to current versions.