Overview of the ISO 9000 Series

Quality Management Systems Standards

Background
The challenges to develop and manufacture products of quality and to meet related customer needs began
during the Industrial Revolution, when a shift occurred from one-of-a-kind goods produced by artisans to
products manufactured in quantity by factory or other workers. In the manufacturing sector, quality
assurance mechanisms for design, production, and distribution, ranging from raw materials to packaging,
have evolved substantially since the mid-19th century. Rapid growth of the service industry sector over
the past 30 years has led to greater efforts to achieve quality in this arena as well.
Since the 1980s, the nations of the European Union have attempted to establish a universal approach to
quality in the manufacturing sector to facilitate trade and free passage of goods among and between
Union members. First expressed in the 1987 ISO 9000 series of documents, this originally European
approach has been applied worldwide as other nations, industries, and manufacturing companies have
exerted strenuous efforts to compete internationally. ISO 9001:2000 has been adopted in place of existing
quality standards in many areas. For example, the European Union and the United States have adopted
these ISO standards verbatim in EN (European Norm) ISO 9001:2000 and the American National
Standards Institute/American Society for Quality (ANSI/ISO/ASQ) 9001-2000, respectively.1,2
There is little question that rethinking processes, developing systematic procedures, and codifying
improved methods can have a beneficial effect for many organizations. However, an organization can
easily expend more than 12 man-months of effort over a period of one to three years developing Quality
Management Systems (Quality Systems) documentation and providing training to ensure adherence to
procedures before certification. The actual time expended will depend on the level and organization of
existing documentation and the time it takes to achieve internal agreement on processes. Of course, in
addition to the time spent and fees paid to obtain certification, an organization will incur ongoing costs to
maintain its quality system and for periodic audits.

For information on EN ISO 9001:2008, contact the European Committee for Standardization, Rue de Stassart, 36,
B-1050 Brussels, Belgium; www.cenorm.be; telephone (32) 2-550-0811; or fax (32) 2-550-0819. ANSI is the
primary source for ISO standards in the United States: 25 W 43rd Street, New York, NY 10036; www.ansi.org;
telephone (212) 642-4900; or fax (212) 398-0023. ISO headquarters: 1 rue de Varembe, Case postale 56, CH 1211,
Geneva 20, Switzerland; www.iso.ch; telephone (41) 022-749-0111; or fax (41) 022-733-3430. ISO standards are
also available from the British Standards Institution (http://www.bsi-global.com/), Standards Australia
(http://www.standards.org.au/), and other comparable standards bodies.
2
In November 2008, IS0 9001 was reissued with very minor changes. Organizations previously certified to the 2000
version of the standard should have little difficulty revising their quality system to satisfy the changes and will have
two years to do so. More significant changes are expected in the 2009 update of ISO 9004:2000 Quality
Management Systems Guidelines for Performance Improvement.

Overview of the ISO 9000 Series

Quality Management Systems Standards

Who Is ISO? What Is 9001?

The International Organization for Standardization (ISO) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing international standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and nongovernmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
ISO 9001 is a voluntary international standard that can be applied to Quality Systems in all types of
organizations, including those performing design, manufacturing, distribution, testing, and service
functions. The main purpose of this standard is to help ensure that the stated and implied needs of
customers are satisfied by requiring organizations that request registration to implement Quality Systems
through formal organizational policies, processes, and procedures.
The ISO 9001 standard also stipulates that all aspects of Quality Systems be documented, monitored, and
controlled so that continuous improvements can be made. When an organization successfully
demonstrates to an accredited registrar (a third-party organization) full compliance with the standards
requirements, the organizations Quality System, not the organization itself, is certified (registered) to
the ISO 9001 standard.

How Do ISO 9000 Series Standards

Apply to Equipment Service?
A medical equipment management program serves as a good example of how a Quality System can be
implemented. In considering how ISO 9000 series standards can be applied to such a service operation, an
organization must (1) understand the concepts and goals of the standards and select those that are most
appropriate to its Quality System and (2) apply specific aspects of the standards to the Quality System.
The ISO 9000 Series Quality Management Systems Standards fall into one of two categories:
requirements standards and guidance standards. Any organization seeking ISO 9001 certification should
purchase and become familiar with all three:

1.

Requirements:3 The ISO 9001 standard divides the Quality System requirements into five areas,
listed in the table below (a detailed outline of the standard appears in the Appendix of this
document; also see the Correspondence Charts below). ISO 9001:2008 contains eight clauses; the
standards requirements are contained in the last five (4, 5, 6, 7, and 8see below for how they
can be applied to a medical equipment program):
Clause Title
Scope
Normative Reference

Clause No.
1
2

International Organization for Standardization (ISO). Quality management systemsRequirements. ISO 9001.
ISO, Geneva, Switzerland.

Overview of the ISO 9000 Series

Quality Management Systems Standards
Definitions
Quality Management System
Management Responsibility
Resource Management
Product Realization
Measurement Analysis and Improvement

2.

3
4
5
6
7
8

Fundamentals and Vocabulary:4 This guidance standard includes a discussion of quality

management principles, the role of top management within the Quality System, and the types of
documents used. It supports a better understanding of the requirements and goals of ISO 9001.
For example:
Quality: The degree to which a set of inherent characteristics fulfills requirements.
Management System: A set of interrelated or interacting elements that establish policy and
objectives and achieve those objectives.
Quality Management System: A management system for directing and controlling an
organization with regard to quality.

3.

Guidelines for Performance Improvements:5 The implementation of this guidance standard

will help make an organizations Quality System more effective in achieving the organizations
business goals.

Concepts and Goals of the Standards

Major Requirements
The major requirements of the ISO 9000 series standards call for developing a Quality System,
maintaining documentation, defining customers and customer requirements, and monitoring and
improving processes. The standards are addressed to suppliers of a product, which is defined as the result
of activities or processes. Product can be tangible or intangible and further categorized as hardware,
software, processed material, or service. A service is a result generated by activities at the interface
between the supplier and the customer, and by supplier internal activities to meet the customer needs. 3
At the interface, the supplier or the customer may be represented by personnel or equipment.

Developing a Quality System

In healthcare facilities, medical equipment service could be covered under a facilitywide or departmental
(e.g., medical physics, clinical or biomedical engineering, medical electronics) Quality System. Service
organizations, too, may fall under the umbrella of a parent organizations Quality System or have their
4

International Organization for Standardization (ISO). Quality management systemsFundamentals and

vocabulary. ISO 9000:2005. ISO, Geneva, Switzerland.
5
International Organization for Standardization (ISO). Quality management systemsGuidelines for performance
improvements. ISO 9004:2000 (will be reissued in 2009). ISO, Geneva, Switzerland.

Overview of the ISO 9000 Series

Quality Management Systems Standards
own comprehensive Quality System. However, additional documentation specific to performing
inspection and preventive maintenance (IPM), repair, and other maintenance activities will be needed.

Quality System Documentation

Quality System documentation is generally tiered, and all documents are subordinate in content to the
policies contained in the organizations Quality System Manual. These tiers and their relation to one
another are illustrated in Figure 1. The Quality System Manual (tier 1general requirements) and a
Quality System Procedures Manual (tier 2standard operating procedures) provide broad concepts and
methods for achieving quality for the applicable department or function. A Quality System Work
Instructions Manual (tier 3work instructions) provides specific guidelines for performing tasks and
should be configured to the experience and capabilities of the people performing those tasks. In applying
the ISO 9001 standard to medical equipment service, one set of work instructions, for example, should
describe how to perform appropriate IPM activities for the equipment that an organization has contracted
to service. The organization must also be able to demonstrate the basis for IPM intervals or why some
devices do not require scheduled IPM. Other work instructions should address procedures used for
entering devices into the equipment inventory and tracking their status. The final level of documentation
(tier 4) is the data that documents the output of system procedures and work instructions. This includes
Quality System forms, equipment inventories, and IPM and repair records.

Overview of the ISO 9000 Series

Quality Management Systems Standards
Defining Customers and Their Requirements
As noted, the ISO 9000 series standards originated in the manufacturing sector, where products are
produced for a specified customer or type of customer. When these standards are applied to an entity that
provides medical equipment service, the customer(s) must be identified, and stated and implied customer
needs must be carefully defined.
Although patient safety and clinical outcome are primary reasons for having medical equipment service,
patients are typically unaware of service needs, and service personnel do not interact with patients.
Medical equipment service supports the needs of clinicians and healthcare administrators. Nursing staff
and others require reliable equipment to perform their patient care tasks, as well as education and training
in the correct use of that equipment. Administrators require information for decision making, such as
equipment status and service costs.
Within the framework of ISO 9001, an entity that provides medical equipment service contracts with an
entity that purchases the service. The purchaser of service is the customer. A few examples follow:

A healthcare-facility-based equipment service department contracts with an office of its

administration.

A healthcare-facility-based equipment service department can also contract with other healthcare
facilities to service equipment at other locations.

Independent and original equipment manufacturer (OEM) service organizations, as well as equipment
distributors, contract with healthcare facilities, clinics, and doctors offices. (Note: The supplying
entity must also typically purchase goods and/or services from subcontractors or other suppliers to
fulfill the requirements of a customer contract.)

Monitoring and Improving Processes

ISO 9001 requires that performance be monitored, but does not dictate a specific type of quality program
(e.g., total quality management [TQM], continuous quality improvement [CQI]) or a particular method of
monitoring and improving quality. For example, Quality System procedures must be developed for
control of nonconforming product, corrective/preventive action, and internal quality audits. Customer
satisfaction must also be monitored and responded to.

Applying Specific Aspects of the

Standards to the Quality System
Examples of how the five primary clauses might be applied to a medical equipment program follow:

4. Quality management system: Requires a defined and documented quality policy, including
objectives consistent with organizational goals and each customers needs. As explained above, the
customer and its needs must be clearly defined. The system must be reviewed periodically, such
reviews must be documented, and a mechanism for change and improvement must exist.

Overview of the ISO 9000 Series

Quality Management Systems Standards

5. Management responsibility: Requires that top management provide evidence of its commitment to
the development and implementation of the Quality System. Management must ensure that system
documentation adequately addresses the requirements of the standard and that the service is delivered
in a manner consistent with the documentation.

6. Resource management: Requires a clear definition of the customers needs that is understood by
both the customer and the provider of service. These needs must be agreed to, be consistent with the
department budget, and be documented. For example, a significant increase in equipment inventory
would indicate a need for greater resources.

7. Product realization: Requires that IPM and repair activities be carried out under controlled
conditions, including documentation of the steps required and criteria for workmanship. (This could
be interpreted to include, for example, consistency of performed inspections with the written
procedures.) Personnel should be appropriately qualified and/or the process monitored to ensure that
requirements are met. Examples of specific, interconnected processes include monitoring service
bulletins/problem reports, receiving and logging work, decontaminating equipment, assessing
equipment for scheduled support requirements, and reporting defective or hazardous equipment.

8. Measurement analysis and improvement: Requires data to be collected and analyzed to determine
optimal scheduled equipment service intervals and/or to assess equipment reliability and service
costs. Customer satisfaction must be periodically surveyed, and corrective/preventive actions must be
implemented as warranted by data and survey analysis.

How Do These Standards Affect Medical Equipment Service?

The requirements of the ISO 9000 series standards stress the need for Quality Systems that encompass the
definition of the customers needs, methods of monitoring whether those needs are met,
corrective/preventive action with verification of success, and documentation. Quality planning guided by
the standard can help meet the conflicting demands of providing customers with better equipment support
while maintaining or decreasing costs. General recommendations include the following:

Clearly define customers and their needs. Discuss with nursing and healthcare facility administration
how the program can be of greatest benefit to them:
Can IPM activities be scheduled more conveniently for nursing?
Can nurses be provided with reports that clearly explain the status of their equipment and deal
with problems they may be encountering?
Would positive comments on their proficiency in using the equipment be appreciated and
beneficial in encouraging continued and, where needed, improved proficiency by all users?

Decide on meaningful performance indicators to monitor. These could include IPM failure rates, the
number (or percentage) of scheduled IPM procedures that are not completed on schedule, equipment
availability, safety indicators, and customer satisfaction.

Document and review performance indicators and customers needs at least annually:
Is all equipment covered?
Are tasks being performed that will have the greatest impact on customers and their patients?

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Quality Management Systems Standards

Follow documented procedures. If they do not work or cannot be done, investigate why, search for
solutions, and implement changes.

When problems are discovered, fix them. Do not fall back on excuses such as insufficient personnel
or user fault. Instead, gather together those involved and develop appropriate solutions. Then follow
through with implementation and monitoring to verify that the solution works. Document all steps in
the process.

Overview of the ISO 9000 Series

Quality Management Systems Standards

Appendix
Outline of ISO 9001:2008
1. Scope
1.1. General
1.2. Application
2. Normative Reference
3. Terms and Definitions
4. Quality Management System
4.1. General Requirements
4.2. Documentation Requirements
4.2.1. General
4.2.2. Quality Manual
4.2.3. Control of Documents
4.2.4. Control of Quality Records
5. Management Responsibility
5.1. Management Commitment
5.2. Customer Focus
5.3. Quality Policy
5.4. Planning
5.4.1. Quality Objectives
5.4.2. Quality Management System Planning
5.5. Responsibility, Authority, and Communication
5.5.1. Responsibility and Authority
5.5.2. Management Representative
5.5.3. Internal Communication
5.6. Management Review
5.6.1. General
5.6.2. Review Input
5.6.3. Review Output
6. Resource Management
6.1. Provision of Resources
6.2. Human Resources
6.2.1. General
6.2.2. Competence, Awareness, and Training
6.3. Infrastructure
6.4. Work Environment
7. Product Realization
7.1. Planning of Product Realization
7.2. Customer Related Processes
7.2.1. Determination of Requirements Related to the Product

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Quality Management Systems Standards
7.2.2. Review of Requirements Related to the Product
7.2.3. Customer Communication
7.3. Design and Development
7.3.1. Design and Development Planning
7.3.2. Design and Development Inputs
7.3.3. Design and Development Outputs
7.3.4. Design and Development Review
7.3.5. Design and Development Verification
7.3.6. Design and Development Validation
7.3.7. Control of Design and Development Changes
7.4. Purchasing
7.4.1. Purchasing Process
7.4.2. Purchasing Information
7.4.3. Verification of Purchased Product
7.5. Product and Service Provision
7.5.1. Control of Product and Service Provision
7.5.2. Validation of Processes for Production and Service Provision
7.5.3. Identification and Traceability
7.5.4. Customer Property
7.5.5. Preservation of Product
7.5.6. Control of Monitoring and Measuring Devices
8. Measurement, Analysis, and Improvement
8.1. General
8.2. Monitoring and Measurement
8.2.1. Customer Satisfaction
8.2.2. Internal Audit
8.2.3. Monitoring and Measurement of Processes
8.2.4. Monitoring and Measurement of Product
8.3. Control of Nonconforming Product
8.4. Analysis of Data
8.5. Improvement
8.5.1. Continual Improvement
8.5.2. Corrective Action
8.5.3. Preventive Action