ISO 9001 Requirements

The latest version of ISO 9001:2015 has some substantial changes to the ISO 9001:2008 version:

Documentation requirements for ISO 9001:2015:

  • A scope;
  • A quality policy; and
  • Quality objectives.

(Much less requirements than ISO 9001:2008).

In addition, you could have documents that you deem necessary for the effectiveness of the organization.

Some of the requirements in ISO 9001:2015 include:

  • Determining the context of the organization (issues and needs of interested parties)
    • Identifying associated risks and opportunities
    • Planning actions to address the identified risks and opportunities;
  • Allocating roles and responsibilities;
  • Setting objectives and plans;
  • Determining and providing resources;
  • Calibrating monitoring and measuring devices if relevant;
  • Keeping adequate records and controlling documents;
  • Ensuring key product / service aspects of the business meet the requirements of ISO 9001 and customers. Where appropriate, documenting these;
  • Recording non-conformances, determining cause, and considering corrective action where necessary;
  • Monitoring processes;
  • Regularly reviewing compliance with the management system through internal audits;
  • Regularly reviewing the effectiveness of the management system; and
  • Facilitating continual improvement.

To be ready for the certification audit, an organization must:

  • Have documents, required by ISO 9001;
  • Have procedures that are needed by your organization;
  • Operate in accordance with the procedures / documents;
  • Provide evidence that the organization is operating according to the procedures and documents.

phone supportFor further information about meeting ISO 9001 requirements call Compliancehelp on free call 1800 503 401. We’ll happily answer your questions.


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