Checklist of Mandatory Documentation Required by ISO 9001:2015

• ISO 9001:2015 requires certain mandatory documents and records, but the number of required procedures has been reduced compared to the 2008 standard version.
• Optional, non-mandatory documents, though not required, are often used by organizations to ensure processes are reliably implemented and consistently followed.
• Structuring documents, such as quality policies, risk assessments, and management reviews, helps companies ensure compliance, facilitate improvement, and maintain a functional quality management system (QMS).

Documentation for ISO 9001:2015 certification includes both mandatory and optional documents. ISO 9001:2015 is more flexible than its predecessor, reducing the number of mandatory procedures but still requiring specific documents and records, including those related to the scope of the QMS, quality policies, and calibration of measuring equipment. Additionally, mandatory records include management review results and records of nonconformities and corrective actions. These documents ensure that organizations maintain a reliable QMS and show compliance with the standard.

While not required by ISO 9001, organizations widely adopt optional documents for consistency and effectiveness in managing processes. Examples include procedures for internal audits, sales, risk management, and production controls. Even though the standard does not mandate documentation for every process, many companies document these processes to ensure they are followed correctly. It is recommended that procedures for managing risks, opportunities, and employee competence be documented as they support ongoing improvement.

How to structure and organize QMS-related documents includes recommending document templates and resources. Best practices emphasize that clear, well-maintained documentation is crucial for demonstrating compliance, improving performance, and achieving successful audits under ISO 9001:2015.

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