ISO 9000 - A Primer

Introduction

Organizations - industrial, commercial, or governmental - supply products intended to satisfy customers' needs and/or requirements. Increased global competition has led to increasingly more stringent customer expectations with regard to quality. To be competitive and to maintain good economic performance, organizations/suppliers need to employ increasingly effective and efficient systems. Such systems should result in continual improvements in quality and increased satisfaction of the organization's customers and other stakeholders (employees, owners, subsuppliers, society).

Customer requirements often are incorporated in "specifications". However, specifications may not in themselves guarantee that a customer's requirements will be met consistently, if there are any deficiencies in the organizational system to supply and support the product. Consequently, these concerns have led to the development of quality-system standards and guidelines that complement relevant product requirements given in the technical specifications. The International Standards in the ISO 9000 family are intended to provide a generic core of quality -system standards applicable to a broad range of industry and economic sectors.

The management system of the organization is influenced by the objectives of the organization, by it's products, and by the practices specific to the organization and, therefore, quality systems also vary from one organization to another. A major purpose of quality management is to improve the systems and processes so that continual improvement of quality can be achieved.

The ISO 9000 Family of Quality System Standards

The ISO 9000 family of quality system standards specify quality system requirements. for use where a supplier's capability to design and supply conforming product needs to be demonstrated.

The requirements specified are aimed primarily at achieving customer satisfaction by preventing nonconformity at all stages from design through to servicing.

The family of ISO 9000 standards includes:

• ISO 9000 - Quality Management and Quality Assurance Standards - Guidelines for Selection and Use
• ISO 9001 - Quality Systems - Model for Quality Assurance in Design, Development, Production, Installation and Servicing
• ISO 9002 - Quality Systems - Model for Quality Assurance in Production, Installation and Servicing
• ISO 9003 - Quality Systems - Model for Quality Assurance in Final Inspection and Test
• ISO 9004 - Quality Management and Quality System Elements - Guidelines

ISO 9001, 9002 and 9003 are the standards which specify the requirements. ISO 9000 provides the organization with guidance to selecting the appropriate standard (9001, 9002 or 9003) and ISO 9004 is a guideline to the implementation of a quality system.

The Quality System

A primary concern of any organization should be the quality of it's products. However, quality also encompasses the ability of an organization to provide support and maintenance of the product and the quality system in a consistent manner.

In order to be successful, an organization should offer products that:

a) meet a well defined need, use, or purpose;
b) satisfy customers' expectations;
c) comply with applicable standards and specifications
d) comply with the requirements of society;
e) reflect environmental needs;
f) are made available at competitive prices;
g) are provided economically.

In order to meet its objectives, the organization should ensure that the technical, administrative, and human factors affecting the quality of its products will be under control, whether hardware, software, processed materials, or services. All such control should be oriented towards the reduction, elimination, and, most importantly, prevention of quality nonconformities.

A quality system should be developed and implemented for the purpose of accomplishing the objectives set out in the organization's quality policy.

In order to achieve maximum effectiveness and to satisfy customer expectations, it is essential that the quality system be appropriate to the type of activity and to the product being offered.

A quality system has two interrelated aspects, as follows.

a) For the customer, there is a need for confidence in the ability of the organization to deliver the desired quality as well as the consistent maintenance of that quality.

b) For the organization, there is a business need to attain and to maintain the desired quality at an optimum cost; the fulfillment of this aspect is related to the planned and efficient utilization of the technological, human, and material resources available to the organization.

Elements of a Quality System

The ISO 9000 standards describe the elements that a quality system should encompass, but not how a specific organization should implement these elements. Because the needs of organizations vary, it is not the purpose of the standards to enforce uniformity of quality systems. The design and implementation of a quality system will be influenced by the particular objectives, products, processes, and individual practices of the organization.

A quality system as specified by a standard such as ISO 9001 covers the following elements:

• Quality System - Documented Policies and Procedures
• Management Responsibilities
• Contract Review
• Design Control
• Document Control
• Procurement Control (includes Supplier Control)
• Purchaser Supplied Product
• Identification and Control of Items
• Control of Processes
• Inspection
• Control of Measuring and Test Equipment
• Inspection, Test and Operating Status
• Control of Nonconforming Items
• Corrective Action
• Preventive Action
• Handling, Storage and Shipping
• Quality Assurance Records
• Internal Audits
• Training and Personnel Qualifications
• Statistical Techniques

All elements must be adequately documented and controlled. Documentation includes a written quality policy, a quality policy manual, which specifies the basic methods as to how the company will meet the requiremnts, and supplemental documents such as written procedures, guidelines and work instructions which document exactly how the policies are implemented and controlled.

The standards do not specify any product requirements, but they are designed to cover a four generic product categories that fit nearly any organization:

• Hardware
• Software
• Processed Materials
• Services

These product categories encompass all the kinds of product supplied by organizations, and the ISO 9000 family are applicable to organizations supplying one or more of the generic categories.

Application of ISO 9001

ISO 9001 is applicable when:

a) design is required and the product requirements are stated principally in performance terms, or they need to be established, and

b) confidence in product conformance can be attained by adequate demonstration of a supplier's capabilities in design, development, production, installation, and servicing.

Once an organization decides to implement a quality standard such as ISO 9001, its must also choose whether or not to have the quality system "certified" (the terms "registered" and "accredited" are also used). This choice is largely market driven. The adoption of such a standard to build a quality system has many internal benefits. External benefits are largely a customer requirements.

An independent (third party) evaluation of the quality system provides the most benefit to both the customer and the organization. An independent third party auditor provides an evaluation of the quality system, which provides customers and the organization with confidence that product conformance can be attained because the supplier's capabilities in design, development, production, installation, and servicing have been adequately demonstrated to the third party auditor. Once such adequate demonstration has been provided, the third party auditor "certifies" that the organizations quality system is effective and meets all of the requirements of the specified quality system standard.

Quality system certification is not to be confused with product certifications. Product certifications work with the resultant product directly and provide confidence that the product meets all of its published specifications, and most likely, other industry standard and accepted safety standards. In the US., such certifications can be obtained from such testing laboratories as UL, CSA, MET Labs and ETL. Such labs are known as "nationally recognized testing labs", and are specifically in the business of providing product certifications.

Once quality system certification is obtained, the organization must undergo surveillance audits every six months to provide evidence that the system continues to be effective and remain in compliance with the selected quality system standard. If the organization does not maintain the system adequately, it could be in jeopardy of loosing its certification.

CANBERRA's Implementation of ISO 9001

The process of implementing and certifying the quality system varies by the organization, but all organizations will follow the same general preparation:

• Select the Standard which best fits the organizations activities
• Review the requirements
• Plan the implementation
• Assign responsibilities
• Document the system
• Train employees
• Select a registrar
• Undergo the audit
• Maintain the system

For many years, CANBERRA had complied with basic inspection and quality control requirements. In the early 1980's, CANBERRA adopted ASME NQA-1, Quality Assurance Standard for Nuclear Facilities, due to domestic (US) customer demands. NQA-1 requires documented procedures in certain system elements, but is not as rigorous as the ISO 9000 family of standards. In addition, compliance to NQA -1 is measured by performance (the output of activities meet the requirements), whereas ISO 9001 compliance is measured by the process (if the process is controlled, the output will be consistent).

When CANBERRA decided to implement an ISO 9001 program, the majority of work was in the documentation arena. Policies needed to updated to reflect ISO requirements, and procedures, guidelines and work instructions needed to be developed in those areas not previously developed for NQA-1. Because CANBERRA had a well defined and well documented quality system before adopting ISO 9001, the implementation effort was much less than an organization who was implementing a formal quality system for the first time.

The Results

The result of the ISO 9001 compliance is a quality system which fosters an environment of teamwork, trust and respect. The organization is committed to quality, and bases the system on it's people - the best and the brightest, working within a framework of communication, cooperation, commitment and leadership.

Team-based activities are encouraged at each level and department of the organization. The quality system places the responsibility for quality of work on each employee, and does not rely on a traditional system of quality control. An objective of the quality system is to minimize all non-value added operations, such as inspection, repair, and rework. All employees are empowered to stop work or processes when, in their belief, quality is affected. Each employee has the right (and are encouraged) to report quality problems to the president, should they feel it necessary.

The quality system elicits the involvement of every employee at every level in an effective Corrective Action Program. A corrective action system is in place for customer complaints and process related problems requiring the involvement of the Quality Assurance organization. Other systems exist to handle product design discrepancies. Each system is available for use by any employee of the company.

The goal of this approach is 100% Customer Satisfaction. By focusing on our quality system, continuously improving our products and processes, and constantly innovating, we believe we create the most value for our customers.