1. ISO 9001:2008 Documents
Compared Against ISO 9001:1994

2. The new ISO 9000:2008 standard is complete, the
deadline is set for implementation, and conversion to
the new standard is causing some degree of
uneasiness in many companies. The process of
becoming certified in the first place was difficult
enough, but to change what has already been
implemented already is daunting, to say the least. In
order to ease some of your doubts, we have gone
through the new standard and compared it to the old
version. The following is a detailed and technical
evaluation of new requirements. This will allow you
to understand how your system will have to change
to achieve compliance in the future.

3. Section 4: Quality Management Systems
4.1 (General requirements) requires that the
organization continually improve the effectiveness of
the quality management system; 4.1 b) requires that
the sequence and interaction of quality management
system processes be determined; e) requires that the
organization measure, monitor, and analyze quality
management system processes; and f) requires the
organization to implement action necessary to
achieve planned results and continual improvement of
those processes. 4.1 also requires that the
organization control and identify within the quality
management system any outsourced processes that
affect product quality.

4. 4.2.2 (Quality Manual) a) requires that the quality
manual include not only the scope of the quality
management system, but also details of and
justification for any exclusions; c) requires the
manual to include a description of the interaction
between the processes of the quality management
system.

5. Section 5: Management responsibility
5.1 (Management Commitment) requires that the
evidence provided by top management to
demonstrate commitment to the quality management
system includes evidence of continually improving its
effectiveness; a) requires that top management
communicates to the organization the importance of
meeting customer as well as statutory and regulatory
requirements.
5.2 (Customer Focus) requires that top management
ensure that customer requirements are determined
and fulfilled with the aim of enhancing customer
satisfaction.

6. 5.3 (Quality Policy) b) requires that the quality policy
include a commitment to comply with requirements
and continually improve the effectiveness of the
quality management system; c) requires that the
quality policy provides a framework for establishing
and reviewing quality objectives.
5.4.1 (Quality Objectives) requires that quality
objectives br established at relevant functions and
levels within the organization. (Quality objectives
must include those needed to meet requirements for
product.) Such objectives must be measurable and
consistent with the quality policy.

7. 5.5.2 (Management Representative) c) requires that the
Management Representative ensure the promotion of
awareness of customer requirements throughout the
organization.
5.5.3 (Internal Communication) requires that top
management ensures appropriate communication
processes are established within the organization and
that communication takes place regarding the
effectiveness of the quality management system.

8. 5.6.2 (Review Input) requires that management review include
current performance and improvement opportunities related
to: a) results of audits, b) customer feedback, c) process
performance and product conformance, d) status of
preventive and corrective actions, e) follow-up actions from
earlier management reviews, f) changes that could affect the
quality system and g) recommendations for improvement.
5.6.3 (Review Output) requires that management review outputs
include:
a) improvement of the effectiveness of the quality management
system and its processes,
b) improvement of product related to customer requirements,
and c) resource needs.

9. Section 6: Resource management
6.1 (Provision of Resources) requires that the organization
determine and provide the resources needed to a) implement
and maintain the quality management system and continually
improve its effectiveness, and b) enhance customer
satisfaction by meeting customer requirements.
6.2.2 (Competence, Awareness and Training) c) requires that
the effectiveness of any training provided is evaluated and d)
requires ensurance that personnel are aware of the relevance
and importance of their activities and how they contribute to
the achievement of the quality objectives.

10. 6.3 (Infrastructure) requires that the organization determine,
provide, and maintain the infrastructure needed to achieve
the conformity of product to requirements (including, for
example, buildings, work space, process equipment, and
supporting services).
6.4 (Work Environment) requires that the organization
determine and manage the work environment needed to
achieve conformity of product.

11. Sources:
http://www.iso9001help.co.uk/422.html
http://ezinearticles.com/?ISO-9001:2008-Documents-Compared-AgainstISO-9001:1994&id=5162039