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Our clients have been asking questions on the changes to
ISO 9001,
and the
impact to their Quality Management System. To answer these questions
Quality Consulting Group (QCG) Management has reviewed the draft
changes to the (ISO 9001:2008), QCG management have prepared the
following information.
The following summary provides an indication that their is no
significant changes expected from the current
ISO 9001.
This
amendments is primarily for clarification purposes. It is expected
that the transition to the new standard, will not require any major
changes. It is also expected that certified clients will have a
period of up to 3 years to make the transition to the new ISO 9001:2008
Standard.
Note: The summary is based on the ISO/DIS (Draft International
Standard) version. Clarification of all changes are detailed
in the official released version of ISO 9001:2008 Standard.
The changes are summarised as follows:
Clause 0.2 (Process approach)
Text added
to emphasize the importance of processes being capable of achieving
desired outputs.
Clause 1.1 (Scope - General)
Clarification
that product also includes intermediate product.
Explanation
regarding statutory, regulatory and legal requirements.
Clause 4.1 (General requirements)
Addition
of a note to clarify outsourced processes as well as the
types of control that may be applied to such processes.
Clause 4.2.1 (Documentation requirements - General)
Clarification that QMS documentation also includes records.
Clarification that one document may include the requirements
of one or more procedures, and that the requirements of one procedure
may be covered by more than one document.
Clause 4.2.3 (Control of documents)
Clarification
regarding the documents of external origin that need to be controlled.
Clause 5.5.2 (Management representative)
Clarifies that this person must be a member of the organization's
own management.
Clause 6.2.2 (Competence, training and awareness)
Now requires the organization to ensure that necessary competence
has been achieved.
Clause 6.4 (Work environment)
A note has
been added to clarify the term work environment.
Clause 7.2.1 (Determination of requirements related to
the product)
Clarifies that post-delivery activities
may include actions under warranty provisions, contractual obligations
such as maintenance services and supplementary services such as
recycling or final disposal.
Clause 7.3.1 (Design & development planning)
Clarifies that design and development review, verification, and
validation have distinct purposes but may be conducted and recorded
separately or in any combination as suitable for the product and
the organization.
Clause 7.3.3 (Design & development outputs)
Clarifies that information needed for production and service
provision may include preservation of the product.
Clause 7.5.4 (Customer property)
A note has
been added to specify that personal data should be considered customer
property.
Clause 7.5.5 (Preservation of product)
Clarification
that preservation of the product relates to the maintenance of conformity
to requirements.
Clause 7.6 (Now retitled Control of monitoring and measuring
equipment)
Addition of a note related to the
confirmation of computer software used as monitoring and measuring
equipment.
Clause 8.2.1 (Customer satisfaction)
Note
added to provide examples of how customer satisfaction data could
be collected.
Clause 8.2.2 (Internal audit)
Editorial changes
to clarify this requirement of the standard.
Clause 8.2.3 (Monitoring and measurement of processes)
Note added to clarify that when deciding on appropriate methods,
the organization should consider impact on the conformity to product
requirements and on the effectiveness of the quality management
system.
Clause 8.2.4 (Monitoring and measurement of product)
Clarification that the release of the product relates to the delivery
to the customer.
