ISO/DIS 17021 Requires an Onsite Readiness Review

ISO/DIS 17021 is titled, “Conformity assessment – Requirements for bodies providing audit and certification of management systems.” This draft standard states initial registration audits are to be conducted in two stages: Stage 1 – Readiness Review, and Stage 2 – Site Audit.

Offsite readiness reviews have been common in the past and may have only required the submission of the quality manual for review. In the near future, when ISO 17021 becomes a requirement for registrars, that will no longer be the case. Onsite stage 1 readiness reviews will be necessary to determine if an organization is prepared for the stage 2 audit.

Stage 1 audits will be performed onsite to:

  • Evaluate the location and site-specific conditions, and to undertake discussions with personnel to determine the preparedness for the stage 2 audit
  • Review the status and understanding of requirements, especially identification of key performance objectives, processes, and operation of the system
  • Collect necessary information on the system scope, processes, and locations, as well as, related quality, legal, and environmental aspects and risks
  • Review the allocation of resources for the stage 2 audit and agree with the organization on the details for the stage 2 audit
  • Provide a focus for planning the stage 2 audit by gaining a sufficient understanding of the system and site operations
  • Evaluate if internal audits and management review are being planned and performed effectively, and that the organization is ready for the stage 2 audit

Stage 1 audits are to be onsite audits. Only in exceptional cases could a stage 1 audit be carried out without a visit. The decision to perform a remote stage 1 audit should be justified and documented, and the organization should be informed that the planning for the stage 2 audit might not be accurate.