4. Overview of Systemic Requirements

Section 4 of the ISO 9001:2000 standard asks you to establish a quality
management system. Of course, the entire standard expects you to develop and
document a quality management system. Consequently, you may wish to think of
Section 4 as a general introduction to Sections 5, 6, 7, and 8 since these four
Sections discuss the development of a quality system in greater detail.

According to Section 4, your organization must establish a quality management
system that complies with ISO 9001:2000. More precisely, you must develop and
implement the processes that make up your quality management system, and you
must continually improve the effectiveness of your system.

Section 4 also expects your organization to document your quality management
system. It expects you to develop documents that you can use to implement,
maintain, and control your quality management system. Specifically, Section 4
expects your organization to prepare a quality manual, to control quality documents,
and to maintain quality records. In general, your manuals, documents, and records
must respect and reflect what you do and how you do it.

5. Overview of Management Requirements

Section 5 of the ISO 9001:2000 standard speaks directly to your top management.
It asks your top managers to meet six sets of management requirements. It asks
them to support quality, satisfy customers, establish a quality policy, carry out
quality planning, control your quality system, and perform management reviews.

Your top managers must emphasize the importance of quality; and they
must support the development, implementation, and improvement of your quality
management system. In part, this means that they must ensure that customers are
satisfied. It means that your top managers must expect your organization to identify
and meet customer requirements and to enhance customer satisfaction.

Your top managers are also expected to develop and implement your
organization's quality policy and to carry out quality planning. They must ensure
that quality objectives are formulated and that quality management system
planning is performed.

Section 5 also asks your top managers to control your quality system. In order to
do so, they must define and communicate responsibilities and authorities; they
must appoint a member of management to manage your quality system; and
they must facilitate communication throughout your organization.

Finally, Section 5 expects top managers to perform management reviews. It
expects your top managers to plan and perform regular reviews of your quality
management system. Specifically, Section 5 expects top managers to examine
information about your quality system and to generate remedial decisions and
actions.

6. Overview of Resource Requirements

Section 6 of the ISO 9001:2000 standard expects your organization to
identify and provide quality resources. It asks your organization to provide
quality personnel, a quality infrastructure, and a quality work environment.

Specifically, you must ensure that the people who influence product quality are
competent. In addition, you must identify, provide, and maintain the infrastructure
that your organization needs in order to ensure that its products meet requirements.
And, you must identify and manage the work environment that your organization
needs in order to assure the quality of its products.

7. Overview of Realization Requirements

Section 7 of the ISO 9001:2000 standard expects your organization to meet
product realization requirements. As we indicated earlier, product realization
is a process. More precisely, the term product realization refers to a set of
interconnected processes that are used to bring products into being. As you
may recall, we also said that you may exclude or ignore Section 7 requirements
if you cannot apply them in your situation. However, please remember that you
may only exclude or ignore a Section 7 requirement if doing so does not
impair your ability or willingness to provide products that meet the
requirements set by customers and regulators.

In general, Section 7 expects your organization to control product realization.
In particular, ISO wants you to control product realization planning. ISO wants you
to plan product realization and to develop your product realization processes.
Section 7 also expects you to control customer processes.

ISO wants you to identify product oriented requirements and obligations,
and to review them before you agree to supply products to your customers.
In addition, ISO wants you to develop a process that you can use to control
communications with your customers.

According to Section 7, you must also control product design and development.
Section 7 expects you to plan the design and development of your products. You
must define product design and development inputs and generate product design
and development outputs. You must approve design and development outputs
before you release them, and you must use these outputs to control product
quality. In addition, you must perform design and development reviews,
verifications, and validations. And, finally, you must manage changes
in product design and development.

In addition, Section 7 expects you to control your purchasing function.
Specifically, ISO wants you to make sure that purchased products and
services meet requirements, and that your suppliers and subcontractors
meet requirements as well.

Section 7 also wants your organization to control production and service
provision. You must plan how production and service delivery should be
controlled, and then you must control these processes. ISO also expects
you to pay special attention whenever process outputs cannot be measured,
monitored, or verified. In such cases, you must document that these special
processes can, in fact, produce planned results.

Section 7 also expects you to control the identity of your products throughout
the product realization process. This Section also expects you to protect
property supplied to you by your customers, and to preserve your own
products and components.

Finally, Section 7 expects your organization to control its monitoring and
measuring devices. ISO expects you to identify your monitoring and measuring
needs, to select devices that will meet those needs, and then to use those devices
to ensure that your products meet requirements. Furthermore, you must calibrate
your monitoring and measuring devices, and then you must protect them in order
to prevent unauthorized changes.

8. Overview of Remedial Requirements

Section 8 of the ISO 9001:2000 standard expects your organization to carry out
remedial activities. Specifically, ISO expects you to plan your remedial activities.
ISO expects you to plan how monitoring, measuring, and analytical processes will
be used to demonstrate conformance and to improve your quality management
system; and then ISO expects you to use these processes.

In particular, ISO wants you to monitor and measure customer satisfaction,
and to plan and perform internal audits. In addition, ISO wants you to monitor and
measure the processes that make up your quality management system, and to
take corrective actions whenever quality processes fail to achieve planned results
Similarly, ISO wants you to monitor and measure product characteristics, and to
do something about it whenever products fail to meet requirements.

Section 8 also expects your organization to control nonconforming products.
Furthermore, ISO expects you to re-verify products that have been corrected,
to control nonconforming products after delivery or use, and to maintain the
associated records.

According to Section 8, your organization must also identify what kind of
information it needs to have about its quality management system, and then
it must collect and analyze that information.

Finally, Section 8 expects you to make quality improvements. It expects you
to continually improve the effectiveness of your quality management system;
and it expects you to correct actual nonconformities and prevent potential
nonconformities.