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Global Standards Assurance (GSA)

Checklist Of Mandatory Documentation Required By ISO 9001:2015

ISO 9001:2015 is a globally recognized standard that establishes the framework for an effective quality management system (QMS). To achieve compliance, organizations must maintain specific mandatory documents. While the latest version of the standard has reduced rigid documentation requirements, certain records and procedures remain essential. This guide provides a comprehensive checklist of mandatory documentation required by ISO 9001:2015, ensuring your organization meets all necessary compliance standards.

Understanding Documented Information In ISO 9001:2015

ISO 9001:2015 refers to documented information in two key categories:

  • Maintained Documented Information: These are controlled documents that define the processes an organization follows.
  • Retained Documented Information: These serve as records proving that processes have been followed and compliance has been met.

For organizations seeking certification, it is crucial to understand and maintain the necessary ISO 9001 mandatory documents to ensure smooth implementation and successful audits.

Mandatory Documents For ISO 9001:2015 Compliance

Below is a detailed checklist of mandatory documentation required by ISO 9001:2015 to help organizations comply with the standard:

A. Documents to be Maintained (Process & System Documentation)

  1. Scope Of The QMS (Clause 4.3): Defines the boundaries and applicability of the quality management system.
  2. Quality Policy (Clause 5.2): A statement outlining the organization’s commitment to quality.
  3. Quality Objectives (Clause 6.2): Clearly defined goals that align with quality improvement initiatives.
  4. Criteria For Evaluation And Selection Of Suppliers (Clause 8.4.1): A document outlining how external providers are selected and monitored.

B. Records To Be Retained (Proof Of Implementation & Compliance)

  1. Monitoring and Measuring Equipment Calibration Records (Clause 7.1.5.1)
  2. Records of Training, Skills, Experience, and Qualifications (Clause 7.2)
  3. Product/Service Requirements Review Records (Clause 8.2.3.2)
  4. Design and Development Outputs Review (Clause 8.3.2)
  5. Design and Development Inputs Records (Clause 8.3.3)
  6. Records of Design and Development Controls (Clause 8.3.4)
  7. Records of Design and Development Outputs (Clause 8.3.5)
  8. Design and Development Changes Records (Clause 8.3.6)
  9. Records of Characteristics of Products/Services (Clause 8.5.1)
  10. Records About Customer Property (Clause 8.5.3)
  11. Production/Service Provision Change Control Records (Clause 8.5.6)
  12. Record of Conformity of Product/Service with Acceptance Criteria (Clause 8.6)
  13. Record of Nonconforming Outputs (Clause 8.7.2)
  14. Monitoring and Measurement Results (Clause 9.1.1)
  15. Internal Audit Program and Results (Clause 9.2)
  16. Results of Management Review (Clause 9.3)
  17. Results of Corrective Actions (Clause 10.1)

These ISO 9001 mandatory documents must be properly controlled and readily available for audits to demonstrate compliance with the standard.

Non-Mandatory But Recommended Documentation

Although not explicitly required, the following documents help improve efficiency and facilitate compliance:

  • Procedure for Determining Context of the Organization (Clause 4.1 & 4.2)
  • Risk and Opportunity Management Procedure (Clause 6.1)
  • Competence, Training, and Awareness Procedure (Clause 7.2 & 7.3)
  • Procedure for Document and Record Control (Clause 7.5)
  • Internal Audit Procedure (Clause 9.2)
  • Customer Satisfaction Monitoring Procedure (Clause 9.1.2)

Maintaining these additional ISO 9001 mandatory procedures can enhance operational effectiveness and simplify compliance.

Controlling Documented Information

To ensure compliance with ISO 9001:2015, organizations must establish a robust document control process that includes:

  • Approval And Review Process: Ensuring documents are reviewed and approved before use.
  • Version Control: Preventing outdated or obsolete documents from being used.
  • Secure Storage And Accessibility: Maintaining documents in a way that ensures easy access and security.
  • Regular Audits And Updates: Periodically reviewing and updating documentation for relevance and accuracy.

Conclusion

Maintaining the mandatory documents for ISO 9001:2015 is crucial for certification and ongoing compliance. Organizations that effectively manage documented information not only meet certification requirements but also improve overall operational efficiency. By adhering to this checklist, businesses can confidently prepare for ISO 9001 audits and enhance their quality management practices.

For seamless implementation, organizations should also focus on maintaining well-documented procedures that support continual improvement and compliance with ISO 9001 mandatory procedures. Regular reviews and updates to these documents ensure sustained compliance and business excellence.

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