What are the requirements for Iso 9001 certification?

The requirements of the ISO 9001 system are listed below. For certification purposes they require the 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.) 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.

Quality AssuranceThe requirements below are only the headings of all the clauses of a ISO 9001 system, if you require a full explanation on how adhere to each clause you would have to purchase a ISO 9001 standard from a certification body like SABS, or contract the services of a ISO consultant to get your system audit ready.

General Requirements
  • General
Document Requirements
  • General
  • QMS Manual
  • Control of Documents
  • Control of Records
Management Requirements:
  • Management Commitment
  • Customer Focus
  • Quality Policy
Environmental Policy
  • Objectives, targets & programmes
  • Management System Planning
  • Responsibility & Authority
  • Management Representative
  • Communication, Participation & Consultation
  • Management Review
Resource Management Requirements:
  • Provision of Resources
  • Human Resources

What is the ISO 9001 quality management system and who should you trust to have it implemented?

What is ISO 9001 Quality Management System?

Planning Requirements:
  • General
  • Competence, Awareness & Training
Infrastructure Requirements Work Environment Product and/or service Realization Requirements:
  • Planning of Product/Service Realization
Customer-Related Processes Requirements:
  • Determination of Requirements Related to the Product/Service
  • Review of Requirements Related to the Product/Service
  • Customer Communication
Design and Development Requirements:
  • Design & Development Planning
  • Design & Development Inputs
  • Design & Development Outputs
  • Design & Development Review
  • Design & Development Verification
  • Design & Development Validation
  • Control of Design & Development Changes
Purchasing Requirements:
  • Purchasing Process
  • Purchasing Information
  • Verification of Purchased Product
Service and Service provision requirements:
  • Control of Production and Service Provision
  • Validation of Processes for Production & Service Provision
  • Identification & Traceability
  • Customer Property
  • Preservation of Product
Control of Monitoring & Measuring Devices Measurement, Analysis and Improvement Requirements:
  • General
Monitoring and Measurement Requirements
  • Customer satisfaction
  • Internal Audits
  • Monitoring & Measurement of Processes
  • Monitoring & Measurement of Product
Control of non conforming product Analysis of Data Improvement
  • Continual Improvement
  • Corrective Action
  • 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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