ISO/IEC 17043 is the international standard that outlines the requirements for the competence of proficiency testing (PT) providers. One of the most critical components of this standard is the effective control of documents. Document control procedures ensure that all relevant information used within the PT provider’s operations is accurate, current, and accessible to authorized personnel.
Understanding the purpose, structure, and implementation of document control is essential for compliance with ISO 17043 requirements and for maintaining the integrity of a proficiency testing scheme.
Importance of Document Control in ISO 17043
Document control is vital in any quality management system. Under ISO 17043, proficiency testing providers must establish and maintain a system for controlling all quality-related documentation. This includes policies, procedures, forms, records, and technical documents that guide the planning, operation, and evaluation of PT activities.
Without a robust document control mechanism, organizations risk using outdated procedures, losing traceability, or failing to meet accreditation requirements.
Scope of Document Control Under ISO 17043
The document control process applies to all types of ISO 17043 documents, such as:
- Quality policies and manuals
- Operational procedures for PT planning and implementation
- Technical instructions for data handling and result evaluation
- Forms and templates used for participant communications
- Records of evaluations, internal audits, and corrective actions
Each of these must be appropriately controlled to ensure consistency, accuracy, and traceability throughout the proficiency testing process.
Key Elements of an ISO 17043 Document Control Procedure
To comply with ISO 17043, document control must follow a structured and systematic approach. A documented ISO 17043 procedure for document control typically includes the following key elements:
1. Document Identification
Every document must have a unique identifier, such as a title, reference number, version number, and date of issue or revision. This ensures that users can easily distinguish between current and obsolete versions.
2. Review and Approval
All ISO 17043 documents must be reviewed and approved by authorized personnel before being released for use. The review process ensures technical accuracy and compliance with the quality system.
3. Document Revision and Updating
Procedures must be in place for regularly reviewing and updating documents. When a document is revised, the change should be clearly documented in a revision history log. Obsolete documents must be withdrawn from use and either archived or clearly marked to prevent unintentional use.
4. Access and Distribution
Only the current, approved versions of documents should be available to staff involved in PT activities. Documents can be maintained electronically or in hard copy, but access should be restricted to authorized individuals.
5. Document Retention
Retention periods must be defined for different types of documents, including the ISO 17043 manual, technical records, and quality records. Retention policies should comply with regulatory, legal, and accreditation requirements.
6. Protection from Loss or Damage
Documents, whether electronic or physical, must be protected against unauthorized changes, loss, or deterioration. Backup systems and security measures should be part of the document control process.
Role of the ISO 17043 Manual in Document Control
The ISO 17043 manual serves as the foundation of the quality management system. It outlines the organization's commitment to quality, compliance policies, and a summary of procedures, including document control. It should reference the specific ISO 17043 procedure that governs how documents are created, approved, distributed, and archived.
During audits or assessments, accreditation bodies will review the manual to evaluate how well the document control system is integrated into the overall operations.
Conclusion
Document control is a cornerstone of ISO 17043 compliance. By establishing clear procedures for managing the lifecycle of quality and technical documentation, PT providers can ensure consistency, accountability, and continual improvement. A well-structured ISO 17043 manual supported by effective document control practices not only meets accreditation requirements but also strengthens the reliability of proficiency testing services.
