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Document and Record Control

Best practices for managing documents and records in ISO management systems

Implementation 7 min read

Documents vs. Records

Documents

Controlled information that guides activities - policies, procedures, work instructions, forms. These can be changed through document control process.

Records

Evidence of activities performed - completed forms, test results, training records, audit reports. These cannot be changed after creation and must be retained.

Document Control Requirements

Creation and Approval

  • Document ownership assigned
  • Review and approval before issue
  • Version control implemented
  • Effective dates established

Distribution and Access

  • Controlled distribution to users
  • Availability at point of use
  • Prevention of unintended use
  • Access control where needed

Review and Update

  • Periodic review schedule
  • Updates based on changes
  • Re-approval after revision
  • Version history maintained

Identification

  • Unique document numbers
  • Revision/version numbers
  • Dates (issue, revision, review)
  • Status (draft, approved, obsolete)

Obsolete Documents

  • Removal from use
  • Retention if needed (archiving)
  • Clear identification as obsolete
  • Prevention of unintended use

Record Control Requirements

Creation

  • Records created as planned
  • Information is complete
  • Identifiable and traceable
  • Legible (even if electronic)

Storage

  • Protected from damage/loss
  • Retrievable when needed
  • Organized systematically
  • Secure from unauthorized access

Retention

  • Retention periods defined
  • Based on legal/regulatory/business needs
  • Consistently applied
  • Documented in retention schedule

Disposition

  • Disposal after retention period
  • Secure disposal for sensitive records
  • Documentation of disposal
  • Transfer to archives if needed

Documentation Structure

Tier 1: Policy Level

  • Quality/Environmental/Safety Policy
  • Management System Manual (optional)
  • High-level commitments

Tier 2: Process Level

  • Procedures (how processes work)
  • Process maps
  • Roles and responsibilities

Tier 3: Work Instructions

  • Detailed work instructions
  • Forms and templates
  • Checklists

Tier 4: Records

  • Completed forms
  • Test results
  • Meeting minutes
  • Audit reports

Electronic Document Management

Benefits

  • Easy access and distribution
  • Version control automated
  • Search capabilities
  • Reduced paper and storage
  • Improved collaboration
  • Audit trails

Considerations

  • System security and backups
  • User access controls
  • Training requirements
  • System validation
  • Migration and compatibility

Common Tools

  • SharePoint
  • Document management systems (DMS)
  • Quality management software
  • Cloud storage with controls
  • Wiki systems

Best Practices

Keep It Simple

  • Only document what's necessary
  • Use clear, simple language
  • Make documents user-friendly
  • Avoid over-documentation

Make It Accessible

  • Easy to find and retrieve
  • Available at point of use
  • Searchable
  • Mobile-accessible if needed

Engage Users

  • Involve end users in creation
  • Train on document use
  • Gather feedback regularly
  • Continuously improve

Automate Where Possible

  • Electronic approvals
  • Automated notifications
  • Version control
  • Retention management

Common Challenges

  • Over-documentation (too many, too complex)
  • Documents not kept current
  • Poor version control
  • Documents not accessible
  • Inadequate training on use
  • Records not consistently created
  • Retention not followed

Audit Focus Areas

  • Are documents current and approved?
  • Are obsolete documents removed?
  • Can employees access needed documents?
  • Are records complete and legible?
  • Is retention schedule defined and followed?
  • Are changes controlled?
  • Is training on documentation adequate?