Here’s What You Need to Know about ISO 9001:2015

efield | March 7, 2018

Author: Joe Mansour

The ISO 9001:2015 standard was first announced in September of 2015, leaving a three-year window to update ISO 9001, but with less than six months left in that window, more and more organizations are gearing up to make the necessary enhancements, and the task of upgrading for some is becoming rather urgent.

Our transition plan is available on the DQS website and we offer a two-part upgrade process. Stage 1 is to determine the organization’s readiness, and Stage 2 is the actual upgrade audit to assess the effectiveness of the ISO 9001:2015 requirements.

Identification of Processes

ISO 9000:2015, defines “Process” as a “set of interrelated or interacting activities that use inputs to deliver an intended result.”

It may be challenging to justify the inclusion of Purchasing and Warehousing under a more extensive process, say “Fulfillment.”  In most organizations, both Purchasing and Warehousing have well-defined inputs and expected outputs, with very little in common.  Therefore, having both under the same umbrella may not be adequate.

However, if justification could be made that, say for a Distributor,  Purchasing and Warehousing are related activities to ensure adequate stock levels at all times, then that may make it perfectly fine for the two “distinctly different” activities to be merged into one.

Based on what has been seen so far, for smaller organizations, ten or so processes may be sufficient to meet the intent of the requirements.  Mid-size companies may have a bit more – perhaps 15 or so.  For more substantial organizations 20-25 may be the right subscribed number.  Anything more or less will have to be evaluated for adequacy.

Identification of Risks

For the identified processes, clause 4.4.1 requires that the risks be identified and managed.  “Risks” should include factors that may prevent the organization from achieving its intended targets in meeting their Interested Parties’ expectations and objectives.  Most organizations find the use of FMEAs suitable in addressing this requirement, but its use is not mandatory.

Establishing Goals and Objectives for all Processes

Also in 4.4.1, the need to monitor the process by use of process indicators is included as well.  Please note that this requirement is not just related to the “Key Processes,” but all processes of the organization.

Our webinar webpage offers several webinars on various sections of the standard that are still available for you to access. If you have any questions about the ISO 9001:2015 update or you would like to learn more about DQS’s two-stage upgrade process, feel free to email us at [email protected] or call us at 800-285-4476.