Document Review: FDIS ISO 9001:2000 against ISO 9001:1994
By Dan Nelson
The new ISO 9000:2000 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.
If you have any more questions, we would be happy to answer
them. If you need a little more help, we can upgrade your system to meet
the new requirements for a nominal, fixed fee.
Section 4: Quality Management Systems
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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.
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5.2 (Customer Focus) requires that top management ensure
that customer requirements are determined and fulfilled with the aim of
enhancing customer satisfaction.
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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.
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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.
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5.5.2 (Management Representative) c) requires that the
Management Representative ensure the promotion of awareness of customer
requirements throughout the organization.
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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.
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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.
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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.
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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.
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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.
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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).
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6.4 (Work Environment) requires that the organization
determine and manage the work environment needed to achieve conformity
of product.
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8.1 (General) requires that the organization plan and
implement the monitoring, measurement, analysis and improvement processes
needed to: a) demonstrate conformity of the product, b) ensure conformity
of the quality management system, and c) continually improve the effectiveness
of the quality management system. This must include the determination
of applicable methods, including statistical techniques, and the extent
of their use.
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8.2.1 (Customer Satisfaction) requires that, as one of
the measurements of the performance of the quality management system,
the organization must monitor information relating to customer perception
as to whether the organization has fulfilled customer requirements. The
methods for obtaining and using this information must be determined.
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8.2.3 (Monitoring and Measurement of Process) requires
that the organization apply suitable methods for monitoring, and where
applicable, measuring of the quality management system processes. These
methods must demonstrate the ability of the process to achieve planned
results. When planned results are not achieved, correction and corrective
action must be taken, as appropriate, to ensure conformity of the product.
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8.4 (Analysis of Data) requires the organization to determine,
collect, and analyze appropriate data to demonstrate the suitability and
effectiveness of the quality management system and to evaluate where continual
improvement can be made. This must include data generated as a result
of monitoring and measurement and other relevant sources. This analysis
of data must provide information relating to: a) customer satisfaction,
b) conformance to product requirements, c) characteristics and trends
of processes and products including preventive action, and d) suppliers.
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8.5.1 (Continual Improvement) requires that the organization
must continually improve the effectiveness of the quality management system
through the use of the quality policy, quality objectives, audit results,
analysis of data, corrective and preventive actions, and management review.
