Monday, January 26, 2015

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):

  1.      Scope
  2.      Normative References
  3.      Terms and Definitions
  4.      Context of the Organization
  5.      Leadership
  6.      Planning
  7.      Support
  8.      Operation
  9.      Performance Evaluation
  10.   Improvement

ISO 9001:2015 TIMELINE

o   Draft International Standard (DIS) - published in June 2014

o   Final Draft International Standard (FDIS) - expected January 2015

o   ISO Standard - expected September 2015