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.

Context Of The Organization
  • Understanding the organization and its context
  • Understanding the needs and expectations of interested parties
  • Determining the scope of the quality management system
  • Quality management system and its processes
  • Leadership and commitment
  • Leadership and commitment for the quality management system
  • Customer focus
  • Quality policy
  • Organizational roles, responsibilities and authorities
Planning For The Quality Management System
  • Actions to address risks and opportunities
  • Quality objectives and planning to achieve them
  • Planning of changes
  • Resources
  • General
  • People
  • Infrastructure
  • Environment for the operation of processes
  • Monitoring and measuring resources
  • Organizational knowledge
  • Competence
  • Awareness
  • Communication
  • Documented information
  • General
  • Creating and updating
  • Control of documented Information
  • Operational planning and control
  • Determination of requirements for products and services
    1. Customer communication
    2. Determination of requirements related to products and services
    3. Review of requirements related to the products and services
  • Design and development of products and services
    1. General
    2. Design and development planning
    3. Design and development Inputs
    4. Design and development controls
    5. Design and development outputs
    6. Design and development changes
  • Control of externally provided products and services
    1. General
    2. Type and extent of control of external provision
    3. Information for external providers
  • Production and service provision
    1. Control of production and service provision
    2. Identification and traceability
    3. Property belonging to customers or external providers
    4. Preservation
    5. Post-delivery activities
    6. Control of changes
  • Release of products and services
  • Control of nonconforming process outputs, products and services
Performance Evaluation
  • Monitoring, measurement, analysis and evaluation
    1. General
    2. Customer satisfaction
    3. Analysis and evaluation
  • Internal audit
  • Management review
  • General
  • Nonconformity and corrective action
  • Continual Improvement

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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What is ISO 9001 Quality Management System?

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