The Draft International Standard (DIS) has been released for comment and includes significant change:
o The "Quality Manual" is gone
o 6 “mandatory” documented procedures are gone.
o A separate clause or sub-clause titled 'Preventive action’ is gone, replaced by Risk based approach (this proactive approach is easier to understand than preventive action).
o Products are now referred to as "Goods & Services"
o Continual Improvement is now referred to as "Improvement"
o Documents and Records is now referred to as "Documented Information"
o Work environment is now referred to as "Environment for the operation of processes"
o “Purchased product” is now referred to as “Externally provided products and services”
o “Supplier” is now referred to as “External provider”
o No longer requires specific reference to 'EXCLUSIONS' when determining the applicability of its requirements.
o The definition of “Customer” has a broader sense.
o Some terms and definitions added such as “interested party”, “statutory requirement”, “regulatory requirement”, “service” etc.
o The standards were based on the seven quality management principles, not the eight as before (principle “System approach to management” is gone)
o Changes to structure:
The new standard will follow the ten section structure defined in Annex SL (previously ISO Guide 83):
o Draft International Standard (DIS) - published in June 2014
o Final Draft International Standard (FDIS) - expected January 2015
o ISO Standard - expected September 2015