Quality System Requirements

The new ISO 9001:2000 quality management system requirements focus management on customer
satisfaction, quality objectives and the continual improvement of business management systems. The
new standard provides a clear link between customer requirements, processes and improvements that
was not present in prior standards.
The ISO 9001 standards specify requirements for a quality management system that is applicable across
diverse business segments and may be used for internal application by an organization, certification by
an independent third party (registrar) or for contractual purposes with a customer. The ISO 9000 series of
standards has been adopted as a national quality system standard by most developed countries through
the International Organization of Standardization (ISO) since its implementation in 1987. The year 2000
update is process-based, which is a change from the element-based 1994 version.
Semiconductor Industry
Establishing quality management system standards for the semiconductor supply chain began with
inspection-focused military standards, coupled with numerous customer special requirements. To
complicate matters, many suppliers service a diverse customer base, each with its own commodity-
specific quality management system requirements.
To effectively manage customer's requirements for quality management systems, organizations must
adopt strategies for working smarter, and use their limited resources effectively. Creating commodity-
specific standards by the automotive and telecommunications OEMs is a step in the right direction and
will enhance the implementation of the ISO 9001:2000 requirements throughout their supply chains. The
effect of the proliferation of these sector-specific standards is that a supplier may be required to maintain
multiple certifications to please their diverse customer base.
ISO 9001:2000 Principles

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The ISO 9001:2000 standards are based on eight quality management principles (Table 1). The
principles provide a basis for performance improvement and organizational excellence. Organizations will
take different paths to implementing these due to the complexity of their processes and supplier/customer
relationships. It is senior management's responsibility to effectively manage and implement these
principles.
The ISO 9000 series of standards is applicable to all product categories, sectors and sizes of
organizations. The new revision is easier to use than the 1994 element-based revision and links the
quality management system to the organizational processes. The process focus provides clear audit trails
and requires measurable results to meet quality objectives. The revision departs from the previous
specific 20-element structure to a generic process-based structure, adopting a process management
approach generally used in today's businesses. This simple process-based structure is consistent with
the plan-do-check-act improvement cycle. Also, the standard is more compatible with ISO 14001:1996,
the environmental management system requirements.
ISO 9001:2000 Requirements
The ISO 9001:2000 standard contains five major processes or clauses: quality management system,
management responsibility, resource management, product realization, and measurement analysis and
improvement. A summary of the highlights and changes to these clauses follows:
Quality Management System. The Quality Management System must be an integral part of the business
management system. A new requirement is to measure, monitor and analyze processes, then implement
actions to achieve planned results and continual process improvement.
The standard allows flexibility in how the system is structured and documented. A quality manual, quality
policy, quality objectives and six procedures are required by the standard (control of documents, control
of records, training, internal audits, control of nonconforming product, and corrective and preventive
action) and must be documented. A process map is required to describe the interaction between
processes of the quality management system.
Documents are needed by the organization to ensure effective planning, operation and control of its
processes. The nature and extent of the documentation must satisfy contractual, statutory and regulatory
requirements.
Management Responsibility. Top management must visibly define and communicate an overall strategy
for the quality management system and delegate authority for action. They must be involved in
establishing policies and objectives, as well as system design, implementation, maintenance, review and
improvement. Customers' needs and expectations must be determined, translated into requirements for
processes within the organizations system and met. A quality policy statement must be communicated
throughout the organization and reflect management's focus on quality requirements, objectives and
goals.
A key new requirement is for quality objectives to be defined by the organization with a focus to direct the
organization and drive continual improvement efforts. The quality management system focus is expanded
to reflect a broader business management system view. Establishing appropriate communication
processes and communication about the effectiveness of the system are new requirements.
The requirements for the management review process have been greatly enhanced, requiring review of
audit results, customer feedback, process performance, product conformance, status of preventive and
corrective actions, follow-up actions from prior management reviews, changes that may affect the quality
management system, and improvement opportunity identification.
Resource Management. The new requirement is for resources to be determined and provided to
implement and maintain the quality management system and improve its effectiveness. The human
resource requirements have been enhanced to include the requirement that employee competency be
based on appropriate education, training, skills and experience. Employees must be aware of the
relevance and importance of what they do and how they contribute to the achievement of quality
objectives. The new standard contains requirements for maintaining infrastructure such as the facilities,
process equipment, hardware and software.
Product Realization. This clause includes requirements for contract review, design, purchasing,
production/service process controls, product/process validation, identification, traceability, control of
customer property, product preservation and calibration. Organizations must plan the process for product
realization, determine resource needs, and define appropriate processes and documentation
requirements. There are two types of fundamental processes: realization processes that result in products
of the organization, and support processes, which include management processes. A new requirement is
for the organization to determine and implement effective arrangements for communicating with
customers on product information, inquiries, order or contract handling and changes, and customer
feedback, including complaints.
Measurement, Analysis and Improvement. Organizations must plan and implement measurements, and
monitor and analyze activities that ensure conformity and achieve improvements in their quality
management system and the products/ services it provides. Key to continual improvement efforts is the
measurement system, the determination of appropriate methodologies for monitoring and the appropriate
use of statistical techniques.
A new requirement is for management to monitor and manage customer satisfaction. Sources of
information may include customer complaints, surveys, scorecards, direct communications and media
reports. Also, monitoring and measuring of processes is required. Appropriate data shall be collected and
analyzed to demonstrate suitability and effectiveness of the quality management system, and to monitor
continual improvements.