ISO Element

ISO 9001:2008 Change

Rationale/Impact

1. Scope

Added “statutory” to regulatory requirements

Makes language consistent with 7.2.1; not a new requirement.
Statutes are laws; regulations are typically specific guidelines published & enforced by regulatory bodies.

Note 1 modified on “product” definition: term product applies to product intended for, or required by a customer.
Includes purchased products and products resulting from internal stages of the product realization process.

Expands definition of product covered by the Standard.

4.1.a

Determine processes needed as opposed to identify.
Outsourced processes: controls to be applied shall be defined within the QMS

Expands definition to outsourced processes

4.2.1.e

Documented procedures and records are included in the quality management system (QMS)

Emphasis is on organization determining what needs to be documented

4.2.3.f

Covers ensuring that documents of external origin “necessary for planning and operation of the QMS are identified and their distribution controlled”

Clarifies external documents’ content

5.1.a

Added statutory to regulatory

This implies organizations must keep on top of both laws & regulations & document those applicable.

5.5.2

Management representative (MR) must be a member of the organization’s management. 3 Key responsibilities:
-Ensure processes of QMS are established, implemented, maintained
-Report to top management about the effectiveness of the management system (through management review)
-help promote customer focus throughout the organization

MR must be an employee & have the responsibility & authority to make decisions, assign resources and get things done; customer focus point person.

6.2.1

Competence requires
a) determining the necessary competence – job requirements b)provide training or take other actions to achieve necessary competence

Clarifies previous requirement of training effectiveness