Contact Your Registrar

Have you made any changes that might affect the capability of your quality management system? Did you inform your certification body in advance of their next surveillance audit?

In clause 8.6.3 of ISO 17021, the requirements standard for registrars, it states a certification body must have legally enforceable arrangements to ensure certified clients inform them, without delay, of any matters that may affect the capability of the management system to continue to meet the requirements of the standard used for certification.

Using examples from ISO 17021, you are to contact your certification body for any changes related to:

  • legal, commercial, or organizational status or ownership
  • organization and management, e.g., key managerial, decision-making, or technical staff
  • contact address and sites, e.g., any relocations or new locations
  • scope of operations under the certified management system
  • management system and its processes, e.g. loss or addition of a process

Why notify the registrar? Audits are carried out based on sampling, which introduces an element of uncertainty in the audit results. The sampling should be increased in the areas of greatest change. The certification body must be told about the changes so their audit plan can be adjusted.

In clause 5.2.1.h of ISO 19011, the auditing guidelines standard, it states the audit objectives should consider risks to the organization. Clause 5.2.2.i says that audit programs should take into account any significant changes to an organization and its operation.

More examples could be changes related to:

  • employee counts and shift work
  • new products and requirements
  • loss or addition of key suppliers
  • customer sanctions or special status conditions
  • new statutory or regulatory requirements
  • work quantity from customers
  • major new customers
  • newly outsourced processes

ISO 9001, 5.4.2, requires top management to maintain the integrity of the system when changes to the quality management system are planned and implemented. One way of doing that is to ensure the need for changes is assessed at management review meetings per ISO 9001, 5.6.1. And, clause 5.6.2.f states changes that might affect the quality management system must be included as an input at management review.

When planning and reviewing these changes, remember to alert the certification body and your own audit program so the appropriate adjustments can be made to the external and internal audit plans.