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What are the requirements for iso 9001 certification?


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What do i need to do, to get my company iso 9001 certified?

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What are the requirements for iso 9001 certification?

  1. 1. What are the requirements for ISO 9001 certification? by: Wouter Rodrigues
  2. 2. ISO 9001 System Requirements: • For certification purposes you require a Quality Manual and Documented Procedures for the 6 main procedures:  Control of documents  Control of records  Internal audits  Control of non conforming product and/or service  Corrective action and  Preventive action
  3. 3. ISO 9001 System Requirements: • The other listed requirements do not have to have their own procedure, but should be addressed by your own internal procedures or proven by evidence of implementation like records, stats, forms etc. • If it suits you better you are also allowed to write a procedure for all requirements listed below. All the required procedures for the requirements below can be included in your quality manual or documented on their own, by only referring to the documented procedures in the quality manual. • Documenting them on their own and not part of the manual has the advantage that if you revise on procedure you do not have to revise the whole system.
  4. 4. ISO 9001 System Requirements: The requirements below are only the headings of all the clauses of an ISO 9001 system, if you require a full explanation on how adhere to each clause you would have to purchase an ISO 9001 standard from a certification body like SABS, or contract the services of a ISO consultant to get your system audit ready. If you have developed and implemented all the clauses below as per the standard, you will meet the requirements of an ISO 9001 system: 4. General Requirements 4.1 General 4.2 Document Requirements 4.2.1 General 4.2.2 QMS Manual 4.2.3 Control of Documents 4.2.4 Control of Records
  5. 5. ISO 9001 System Requirements: 5. Management Requirements: 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy Environmental Policy 5.4.1 Objectives, targets & programmes 5.4.2 Management System Planning 5.5.1 Responsibility & Authority 5.5.2 Management Representative 5.5.3 Communication, Participation & Consultation, Participation & Consultation 5.6 Management Review
  6. 6. ISO 9001 System Requirements: 6. Resource Management Requirements: 6.1 Provision of Resources 6.2 Human Resources 6.2 Planning Requirements: 6.2.1 General 6.2.2 Competence, Awareness & Training 6.3 Infrastructure Requirements 6.4 Work Environment
  7. 7. ISO 9001 System Requirements: 7. Product and/or service Realization Requirements: 7.1 Planning of Product/Service Realization 7.2 Customer-Related Processes Requirements: 7.2.1 Determination of Requirements Related to the Product/Service 7.2.2 Review of Requirements Related to the Product/Service 7.2.3 Customer Communication 7.3 Design and Development Requirements: 7.3.1 Design & Development Planning 7.3.2 Design & Development Inputs 7.3.3 Design & Development Outputs 7.3.4 Design & Development Review 7.3.5 Design & Development Verification 7.3.6 Design & Development Validation 7.3.7 Control of Design & Development Changes
  8. 8. ISO 9001 System Requirements: 7.4 Purchasing Requirements: 7.4.1 Purchasing Process 7.4.2 Purchasing Information 7.4.3 Verification of Purchased Product 7.5 Service and Service provision requirements: 7.5.1 Control of Production and Service Provision 7.5.2 Validation of Processes for Production & Service Provision 7.5.3 Identification & Traceability 7.5.4 Customer Property 7.5.5 Preservation of Product 7.6 Control of Monitoring & Measuring Devices
  9. 9. ISO 9001 System Requirements: 8. Measurement, Analysis and Improvement Requirements: 8.1 General 8.2 Monitoring and Measurement Requirements 8.2.1 Customer satisfaction 8.2.2 Internal Audits 8.2.3 Monitoring & Measurement of Processes 8.2.4 Monitoring & Measurement of Product 8.3 Control of non conforming product 8.4 Analysis of Data
  10. 10. ISO 9001 System Requirements: 8.5 Improvement 8.5.1 Continual Improvement 8.5.2 Corrective Action 8.5.3 Preventive Action Summary: If you have developed and implemented all the clauses above as per the standard, you will meet the requirements of an ISO 9001 system.
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