The Stage 1 shall provide an indication to the healthcare organisation whether relevant aspects of the ISO 9001:2015 standard have been addressed. Stage 1 is a service offered to customers prior to commencement of the certification process.

The Stage 1 consists of a document review and site visit (can be done in parallel). Not all areas of the healthcare organisation that provide complex care need to be visited during the Stage 1.

The Document Review and Initial Visit shall be performed:

  1. To audit and determine the customers readiness for Initial audit (stage 2);
  2. Evaluating the level of conformance of the customers management system processes and documentation with the standard(s);
  3. Evaluating the  understanding and implementation of key requirements of the standard(s);
  4. To gain sufficient understanding related to the organization and their management system, services, processes, customers for proper planning of the stage 2 audit;
  5. To review the allocation of resources for stage 2 and agree with the customer on details of the stage 2 audit.

The Initial Visit shall also be used to:

  1. Ensure that the customer understands the Certification concept;
  2. Agree on the certification scope and possible exclusions;
  3. Identify if there are outsourced process relevant to the certification scope and determine how this affect the certification audit;
  4. Verify the correctness of key company info forming the basis for the project setup (e,g. Application Form, including confirmation of site specific information like location, processes, no. of employees, shifts etc.)