Glossary / Lexicon

Deutsch: Überprüfung der Dokumentation / Español: Revisión de la documentación / Português: Revisão da documentação / Français: Révision de la documentation / Italiano: Revisione della documentazione

Review of documentation in the quality management context refers to the systematic examination and evaluation of the documents that are part of or related to a quality management system (QMS). This process ensures that documentation is accurate, complete, up-to-date, and effectively supports the organization’s quality objectives. Documentation review is a critical activity for maintaining compliance with standards such as ISO 9001, as well as for ensuring that the documented processes align with actual practices and regulatory requirements.

Description

The review of documentation involves checking quality manuals, procedures, work instructions, quality records, and other related documents to verify their relevance, accuracy, and effectiveness in describing and guiding quality-related activities. The process includes evaluating the clarity of documents, their accessibility to relevant personnel, and their alignment with current operations and quality standards.

Application Areas

Documentation review is essential across all aspects of a QMS, including:

• Process Documentation: Ensuring that procedures and work instructions accurately reflect how processes are performed.
• Quality Policy and Objectives: Verifying that these documents remain relevant and aligned with the organization’s strategic direction.
• Compliance Documentation: Checking that all necessary records and documents meet regulatory and standard requirements.
• Continuous Improvement: Identifying opportunities for improving documentation and processes based on the review findings.

Well-Known Examples

• ISO 9001 Audits: Part of the audit process involves reviewing the organization’s quality documentation to ensure it meets the requirements of the ISO 9001 standard.
• Regulatory Inspections: For industries such as pharmaceuticals or aerospace, regulatory inspections include a thorough review of documentation to ensure compliance with industry-specific regulations.

Treatment and Risks

Inadequate or outdated documentation can lead to Miscommunication, non-conformances, and inefficiencies, potentially affecting product quality and compliance. To manage these risks, organizations should:

• Establish Regular Review Cycles: Schedule periodic reviews of documentation to ensure continuous accuracy and relevance.
• Engage Relevant Stakeholders: Include input from employees who use the documentation regularly, as well as from quality management and compliance specialists.
• Implement a Document Control System: Use document management software or systems to track revisions, approvals, and distribution of documents.

Examples of Sentences

• "A thorough review of documentation is indispensable for maintaining the integrity of the quality management system and ensuring operational excellence."
• "The review process helps identify gaps or discrepancies in documentation, providing an opportunity for continuous improvement and alignment with best practices."

Similar Terms or Synonyms

• Document audit
• Documentation evaluation

Summary

Review of documentation in the quality management context is a vital process that ensures all documents related to the QMS are current, accurate, and effective. This activity supports compliance with quality standards and regulations, facilitates efficient and correct execution of processes, and contributes to continuous improvement efforts within the organization. Regular and systematic documentation review is key to sustaining the efficacy of the QMS and achieving quality objectives.

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