ISO 9001 Requirements

 

What is the ISO 9001:2015 requirements? To become ISO certified, a company or organisation must submit documents that report its internal processes, procedures, and standards. These documents (or Quality Management System) determines that a company can provide quality products and services consistently


 
 
 
 
 
 
 

What is the ISO 9001 Requirements?


As with any standardisation or regulatory organisation that awards certifications, you can expect that there are a lot of requirements to comply with — especially since this is an international standard.

All the ISO 9001 requirements are set out by ISO in ten clauses.

Mandatory requirements need to be complied with, while non-mandatory requirements may be submitted for documentation purposes. To be certified compliant with ISO 9001:2015, the following documents must be submitted.


ISO 9001 Mandatory 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


Don’t Try to Manage It All Alone!


All the ISO 9001 requirements are fully documented and explained in our Quality Manual Template.

Non-Mandatory Requirements — But Often Included

  1. Procedure for determining context of the organization and interested parties
  2. Procedure for addressing risks and opportunities
  3. Procedure for competence, training, and awareness
  4. Procedure of equipment maintenance and measuring equipment
  5. Procedure for document and record control
  6. Sales procedure
  7. Procedure for design and development
  8. Procedure for production and service provision
  9. Warehousing procedure
  10. Procedure for management of nonconformities and corrective actions
  11. Procedure for monitoring customer satisfaction
  12. Procedure for internal audit
  13. Procedure for management review


After reading through the lists above, you might be thinking that his must include a lot of paperwork!

However, do note that because each company is unique and is run differently, having this certification lets other companies and people know that what your company does and produces passed an international standard of quality.


Not only does the ISO certificate benefit your consumers, but it also benefits your company itself.


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