The document discusses the changes between the new ISO 9001:2008 standard and the old version. It provides a detailed evaluation of new requirements in sections such as quality management systems, management responsibility, resource management, product realization, measurement/analysis/improvement. Key changes include greater emphasis on continual improvement, meeting customer requirements, monitoring processes, and data analysis. The document recommends a website for free ISO 9001 ebooks to help understand the standard.

1. Iso 9001 documents
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.
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.
4.2.2 (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.
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.
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

2. needed to meet requirements for product.) Such objectives must be measurable and
consistent with the quality policy.
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.
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.
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.
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.
Section 7: Product Realization
7.2.1 (Identification of Customer Requirements) requires that the organization
determine: a) requirements specified by the customer including delivery and post-
delivery requirements, b) product requirements not specified by the customer but
necessary for intended or specified use, c) statutory and regulatory requirements related
to the product, and d) any additional requirements determined by the organization.
7.2.3 (Customer Communication) requires that the organization determine and
implement effective arrangements for communicating with customers in relation to a)

3. product information, b) enquiries, contracts, or order handling, including amendments,
and c) customer feedback, including complaints.
7.4.1 (Purchasing Control) requires that the criteria for selection, evaluation, and re-
evaluation of suppliers be established. Records of the results of evaluations and any
necessary actions arising from the evaluation must be maintained.
Section 8: Measurement, Analysis and Improvement
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.
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.
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.
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.
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.
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