4. Systemic requirements and guidelines

Section 4 provides a general overview of the entire ISO IEC 90003 standard. The
rest of the standard discusses this material in greater detail. It starts by asking you to
establish, implement, and maintain a quality management system (QMS). It then asks
you to identify and support the processes that your QMS needs, to specify how they
are interconnected, and to monitor and control process performance. It then asks
you to establish a quality policy, quality objectives, quality procedures, quality
documents, quality records, and a quality manual.

5. Management requirements and guidelines

Section 5 starts by asking top management to demonstrate a commitment to
quality management, to develop a quality policy, to set quality objectives, and to
plan the establishment of a QMS. It then asks them to define QMS responsibilities
and authorities, to appoint a management representative, and to perform
management reviews at planned intervals.

6. Resource requirements and guidelines

Section 6 asks you to provide the resources that your QMS needs. It asks you to
identify the people and the work that could affect product quality and then to make
sure that these people are competent. It also asks you to provide the infrastructure
and work environment that you need in order to meet product requirements.

7. Realization requirements and guidelines

Section 7 is by far the largest section. It asks you to develop product realization
processes and to plan how software products are realized by setting product
quality objectives, by identifying product requirements, and by establishing
arrangements for communicating with customers and regulators. It also
asks you to carry out design and development review, verification,
and validation activities, and to control changes.

Section 7 also discusses purchasing, production, and service provision. It asks
you to write purchase procedures, to control the selection of suppliers, to monitor
supplier performance, to plan product purchases, and to verify purchased products.
It then asks you to plan, monitor, and control software production, build, release,
replication, delivery, installation, support, and maintenance activities and to
facilitate traceability.

And finally, it asks you to determine your monitoring and measuring requirements,
to select suitable monitoring and measuring equipment, to establish monitoring
and measurement processes, to prepare calibration and verification plans,
and to protect your monitoring and measurement equipment.

8. Remedial requirements and guidelines

Section 8 starts by asking you to plan how your organization’s monitoring,
measurement, and analytical processes will be used to demonstrate conformity and
make improvements.  It then asks you to monitor and measure customer satisfaction
and to perform internal audits at planned intervals. It also asks you to find out whether
processes are achieving planned results, to verify that quality requirements are being
met, to control nonconforming products, and to prevent the unintended delivery or
use of nonconforming software products.  Then it asks you to analyze data about
your QMS in order to evaluate its suitability and effectiveness. And lastly, it asks
you to take corrective and preventive action and to make any changes that
must be made in order to maintain QMS suitability and effectiveness.