QMS Standards
1.1 The Relevance of Standards
International standards bring technological, economic and societal benefits. They help to harmonize technical
specifications of products and services, making industry more efficient and breaking down barriers to
international trade. International standards also contribute effectively to sustainability, by providing good
practices on the use of technologies and the management of processes affecting economic, social and
environmental aspects.
International standards ensure that products and services are safe, reliable and of good quality. For business,
they are strategic tools that reduce costs by minimizing waste and errors and increasing productivity. They help
companies to access new markets, level the playing field for developing countries and facilitate free and fair
global trade.
The existence of different national or regional standards can create technical barriers to trade and increase the
cost of doing business. International standards provide the technical basis on which political trade agreements
can be put into practice, whether they are at the regional or international level.
For business
International standards are strategic tools and guidelines to help companies tackle some of the most
demanding challenges of modern business. They ensure that business operations are as efficient as possible,
increase productivity and help companies access new markets.
Benefits include:
Cost savings - International standards help optimise operations and therefore improve the bottom line
Enhanced customer satisfaction - International standards help improve quality, enhance customer
satisfaction and increase sales
Access to new markets - International standards help prevent trade barriers and open up global markets
Increased market share - International standards help increase productivity and competitive advantage
Environmental benefits - International standards help reduce negative impacts on the environment
For Society
ISO has over 19 500 standards touching almost all aspects of daily life.
When products and services conform to International Standards consumers can have confidence that they are
safe, reliable and of good quality. For example, ISO's standards on road safety, toy safety and secure medical
packaging are just a selection of those that help make the world a safer place.
International Standards on air, water and soil quality, on emissions of gases and radiation and environmental
aspects of products contribute to efforts to preserve the environment and the health of citizens.
For government
ISO standards draw on international expertise and experience and are therefore a vital resource for
governments when developing regulations.
National governments can make ISO standards a regulatory requirement (remember ISO standards themselves
are voluntary). This has a number of benefits:
Expert opinion - ISO standards are developed by experts. By integrating an ISO standard into national
regulation, governments can benefit from the opinion of experts without having to call on their services
directly.
Opening up world trade - ISO standards are international and adopted by many governments. By
integrating ISO standards into national regulation, governments help to ensure that requirements for
imports and exports are the same the world over, therefore facilitating the movement of goods, services
and technologies from country to country.
A standard is a document that provides requirements, specifications, guidelines or characteristics that can be
used consistently to ensure that materials, products, processes and services are fit for their purpose. By a
standard, we mean a document published by either a national or international organization that has achieved a
relatively high level of industry recognition and credibility in its specific area of expertise. There are of course ad
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hoc standards that are created and distributed within specific technical fields. Such ad hoc standards are
extremely useful but are generally not recognized at so high a national or international level.
Examples of widely recognized national and international standards include QS-9000 for the automotive
industry; AS9100 and IAQS 9100:2000 for aerospace; the Baldrige National Quality Program for total quality
management; TL 9000 for telecommunications; and the FDA/CGMP 820, EN46001, and ISO 13485 standards
for medical devices.
Popular standards
ISO 14000 - Environmental management
ISO 22000 - Food safety management - Inspire confidence in your food products
ISO 26000 - Social responsibility - Helps your organization to operate in a socially responsible way
ISO 50001 - Energy management - makes energy savings and organizations more energy efficient
ISO 31000 - Risk management - manage risks that could be negative for the company’s performance
ISO 4217 - Currency codes - Avoid confusion when referring to world currencies
ISO 3166 - Country codes - Avoid confusion when referring to countries and their subdivisions
ISO 639 - Language codes - Describe languages in an internationally accepted way
In many cases, a specific standard is complemented by a series of additional mandatory standards. For medical
companies that wish to deliver product into countries that require a product certification (CE mark), it is
necessary to comply with the Medical Device Directive 93/43/EEC. Health Canada provides its own Medical
Devices Regulations that require specific licensing. In addition, the ISO 14000 standard is used for
environmental management systems.
QMS mastery is a journey not a destination. There are literally thousands of standards and supplemental
guidelines in use throughout the world. However, no matter how complex the set of standards, the underlying
process to create an effective QMS is the [Link] mastery of this process is no different than the mastery of
any technical regimen.
Selection of a QMS Baseline
A number of quality management baselines exist that can result in an effective QMS. They consist
primarily of custom designed total quality management (TQM) programs, and programs built upon a nationally
or internationally recognized standard. Three specific types of systems for evaluation: a typical TQM example, a
system based on ISO 9001 and a system based on the Baldrige standard.
We note that all three systems can be designed to encompass all of the organization’s core
competencies. In addition, all three can employ action teams to measure cost of quality and to provide top
management with a corrective and preventive action protocol. The key difference between the three lies in the
ability of the ISO 9001 approach to attain certification, either nationally, internationally, or both.
Although the Baldrige award is a nationally recognized certification, of the three concepts, only the ISO
9001 QMS provides for both accredited international and national recognition. In addition, the standard is used
as the foundation for a number of sector-specific applications that include the automotive, medical, aerospace,
and telecommunications industries.
Custom total TQM ISO 9001 QMS Baldrige National Quality Program
Requires development of a Based on an international standard Based on a national standard with
customized standard. with a potential for accredited potential for accredited certification at
international andnational certification. the national
Usually based on action team
formation Action team formation is optional. level.
with top management oversight. Covers all core competencies. Usually based on action team
formation with top management
Covers all core competencies. Worldwide application. oversight.
Worldwide application. Covers core competencies.
National application.
Based on a national standard
The process to produce an effective QMS requires the following:
The analysis of the standard’s requirements;
The introduction of an interpretive scheme based on the author’s experience and technical background;
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The top management decision on the total effort to be expended to produce the QMS (i.e., the degree of
responsiveness);
The integration of business strategy with strategic quality management goals;
The clear presentation of the strategic organizational policies documented in a quality manual (manual);
The aggressive implementation of the designed QMS;
The demonstration that the QMS is effective through the analysis of data that tracks QMS performance
against quality objectives.
Management system standards
Some of ISO’s most well-known standards are management system standards. They provide a model to follow
when setting up and operating a management system. Like all ISO standards, they are the result of
international, expert consensus. Therefore, by implementing a management system standard, organizations
can benefit from global management experience and good practice.
These standards can be applied to any organisation, large or small, whatever its product or service and
regardless of its sector of activity.
An effective management system has many benefits including:
more efficient resource use
improved risk management, and
increased customer satisfaction as services and products consistently deliver what they promise.