ISO 9001 Mandatory Procedures

What are the required or mandatory procedures for ISO 9001? The latest version of ISO 9001:2015 does not require mandatory procedures as such, but contains 7 clauses of requirements for documents and records.

The Seven ISO 9001 Clauses With Requirements

  • General Quality Management System Requirements
  • Leadership
  • Planning
  • Support
  • Operation
  • Performance Evaluation
  • Improvement

Learn more about the ISO 9001 Clauses.

mandatory procedures requirements

ISO 9001 Requirements - Documents and Records

  1. Monitoring and measuring equipment calibration records
  2. Records of training, skills, experience and qualifications
  3. Product/service requirements review records
  4. Record about design and development outputs review
  5. Record about design and development inputs
  6. Records of design and development controls
  7. Records of design and development outputs
  8. Design and development changes records
  9. Characteristics of product to be produced and service to be provided
  10. Records about customer property
  11. Production/service provision change control records
  12. Record of conformity of product/service with acceptance criteria
  13. Record of nonconforming outputs
  14. Monitoring measurement results
  15. Internal audit program
  16. Results of internal audits
  17. Results of the management review
  18. Results of corrective actions

Learn more about the ISO 9001 Requirements.

How Many Procedures Should I Document?

It is up to you how many procedures you document, there are no hard and fast rules for ISO 9001.

Some companies like to document all their operating procedures - we've seen documentation with more than 40 procedures - but beware, the more procedures you document the more work and internal audits you are creating for yourself and your company.

We recommend documenting the following procedures, which satisfies all the latest requirements:

  • Control of Documented Information
  • Control of Risks & Opportunities
  • Control of Competence & Awareness
  • Control of Calibrated Equipment
  • Control of Design & Development
  • Control of Purchasing & Procurement
  • Control of Non-conformity & Corrective Action
  • Control of Customer Satisfaction
  • Control of Internal Audits
  • Control of Management Reviews

Free download - Control of Calibrated Equipment procedure (ISO 9001)

The above free download will give you an idea of the current level of documentation required for an ISO 9001 procedure.

All the current ISO 9001 mandatory procedures are documented and explained in our Quality Manual Template.