Essential Checklist of Mandatory Documentation Required by ISO 9001
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Navigating the maze of ISO 9001 requirements can be challenging. Especially for organizations new to the standards. Achieving ISO 9001 certification requires understanding which documents and records are mandatory. Proper documentation is more than compliance; it creates a robust Quality Management System (QMS). This enhances efficiency, improves customer satisfaction, and fosters continual improvement. This checklist simplifies the process. It highlights essential documents and records for compliance. Using this checklist ensures necessary documentation is in place. It streamlines ISO 9001 implementation and prepares effectively for audits.
Maintaining a structured set of mandatory records is crucial. It helps achieve and maintain ISO 9001 certification. This checklist ensures you cover all necessary quality management aspects. Regularly update and review these documents. Stay compliant with ISO standards. Improve your QMS. Deliver better products and services to your customers. A structured approach to documentation builds a culture of excellence and continual improvement. Use this checklist to streamline your ISO 9001 journey. Set your organization on a path to sustained success and quality enhancement.
Learn which documents to use and how to structure them
Mandatory Records
Here are the mandatory records you need to maintain for ISO 9001 compliance:
|
What must be documented
|
ISO 9001 Reference
|
|---|---|
|
Monitoring and measuring equipment calibration records*
|
Clause 7.1.5.1
|
|
Records of training, skills, experience, and qualifications
|
Clause 7.2
|
|
Product/service requirements review records
|
Clause 8.2.3.2
|
|
Record about design and development outputs review*
|
Clause 8.3.2
|
|
Records about design and development inputs*
|
Clause 8.3.3
|
|
Records of design and development controls*
|
Clause 8.3.4
|
|
Records of design and development outputs*
|
Clause 8.3.5
|
|
Design and development changes records*
|
Clause 8.3.6
|
|
Characteristics of product to be produced and service to be provided
|
Clause 8.5.1
|
|
Records about customer property
|
Clause 8.5.3
|
|
Production/service provision change control records
|
Clause 8.5.6
|
|
Record of conformity of product/service with acceptance criteria
|
Clause 8.6
|
|
Record of nonconforming outputs
|
Clause 8.7.2
|
|
Monitoring and measurement results
|
Clause 9.1.1
|
|
Internal audit program
|
Clause 9.2
|
|
Results of internal audits
|
Clause 9.2
|
|
Results of the management review
|
Clause 9.3
|
|
Results of corrective actions
|
Clause 10.2
|
Note: Records marked with an asterisk () are mandatory only when the relevant clause is not excluded.
Non-Mandatory Documents
These are commonly used non-mandatory documents for ISO 9001 implementation:
|
What must be documented
|
ISO 9001 Reference
|
|---|---|
|
Procedure for determining context of the organization and interested parties
|
Clauses 4.1 and 4.2
|
|
Procedure for addressing risks and opportunities
|
Clause 6.1
|
|
Procedure for competence, training, and awareness
|
Clauses 7.1.2, 7.2 and 7.3
|
|
Procedure for equipment maintenance and measuring equipment
|
Clause 7.1.5
|
|
Procedure for document and record control
|
Clause 7.5
|
|
Sales procedure
|
Clause 8.2
|
|
Procedure for design and development
|
Clause 8.3
|
|
Procedure for production and service provision
|
Clause 8.5
|
|
Warehousing procedure
|
Clause 8.5.4
|
|
Procedure for management of nonconformities and corrective actions
|
Clauses 8.7 and 10.2
|
|
Procedure for monitoring customer satisfaction
|
Clause 9.1.2
|
|
Procedure for internal audit
|
Clause 9.2
|
|
Procedure for management review
|
Clause 9.3
|
Common Questions About ISO 9001 Documentation Requirements
What are the six documents required by ISO 9001? ISO 9001:2015 does not mandate any specific procedures. Organizations must determine which procedures are necessary to prevent nonconformity.
What are the mandatory documents and records required by ISO 9001:2015? The four documents and 18 records listed above are mandatory. Each can be excluded if not applicable to your QMS scope.
What records must be kept to comply with ISO 9001? Keep the 18 records listed unless the specific requirement is excluded from your QMS scope.
How many mandatory procedures are there in ISO 9001:2015? There are no mandatory procedures, but organizations may include them to ensure processes occur as planned.
Does ISO 9001 require a quality manual? ISO 9001:2015 does not require a quality manual. However, many companies create one for customer requirements or to compile mandatory documents into one place.
Maintaining a structured set of mandatory records is crucial. It helps achieve and maintain ISO 9001 certification. This checklist ensures you cover all necessary quality management aspects. Regularly update and review these documents. Stay compliant with ISO standards. Improve your QMS. Deliver better products and services to your customers. A structured approach to documentation builds a culture of excellence and continual improvement. Use this checklist to streamline your ISO 9001 journey. Set your organization on a path to sustained success and quality enhancement.
Feel more confident about your ISO 9001 compliance? Remember, staying organized and proactive is key. For more resources and tips, visit our Resource Center. Keep striving for excellence! If you need more guidance or detailed information, just let me know.
