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More Updates on ISO 9001:2015

The working draft is not yet complete. Once all of the comments receive are dispositioned, the Draft International Standard (DIS) will be released. This is expected in June or July of this year. Comments from the public will be requested in order to finalize the standard.
Several new requirements are currently in the draft, including

  1. “Products and Services” will replace “Products”.
  2. While the concept of exclusions will still apply, though the term “exclusions” will not be used.
  3. The terms “document” and “records” are being replaced by a single term “documented information”. Control for documented information will be the same as the 2008 standard.
  4. An expanded planning section will be titled “Context of the Organization” and will require companies to consider the needs of all interested parties in the design of the QMS.
  5. Much more emphasis will be placed on requirements for managing the organizations processes using the process approach and will require process owners, process inputs, process outputs and process measures.
  6. While the title of “management representative” will be dropped, the requirement for top management to appoint one or more individuals to be responsible for monitoring and reporting on the QMS will still be included.
  7. Formal “preventive action” process will be dropped, and be replace with the addition of “risk based thinking” in the planning of the QMS and new product design and development.

The intention is still to release the FDIS (final draft international standard) early next year and the published standard by the end of the year.
Regarding the Transition Period –

  1. While the transition period is expected to be 3-years, final approval on that has not been completed. That said, companies can simply transition to the new standard during their normal re-certification audit.
  2. Certification Bodies (CBs, or registrars) may start their training next year, after the FDIS is released. Because of the huge changes to the standard, the details around “what is expected by a 3rd-party auditor will take some time. Starting in 2016, CBs may start auditing to the new standard, but a lot of details will be being worked out during this first year, so there will likely be inconsistencies in these audits as everyone gets used to the new standard.
  3. Because of the big changes, most experts advise that companies retain their ISO 9001:2015 Consultants before the end of next year, thus avoiding the expected turmoil during audits to the new standard in 2016.

That’s all for now, more when information becomes available.