Page 47 - Facility Piping Systems Handbook for Industrial, Commercial, and Healthcare Facilities

CODES AND STANDARDS

CODES AND STANDARDS 1.5

FOOD AND DRUG ADMINISTRATION (FDA)

The FDA is a government agency originally created by the Federal Food, Drug, and
Cosmetic Act and charged with the responsibility to see that all drugs are safe, effective,
and properly labeled. The regulation implementing its authority is 21 CFR 211.

ISO 9000

ISO is the abbreviation of the International Organization for Standardization based in Geneva,
Switzerland. ISO consists of national standards organizations from approximately 100 coun-
tries throughout the world. The United States is represented by ANSI. Internationally recog-
nized and accepted standards are required to establish a minimum level of consistency and
standard of quality (quality assurance) for any product to be sold internationally. These are
called ISO 9000 standards. Conformance with these standards is ensured by audit, inspec-
tion, and review from third-party organizations, called registrars, which receive their accredi-
tation through individual countries’ accreditation bodies, approved by the ISO.
ISO standards are voluntary between members and are not a legal requirement. They
ensure that a manufacturer has a quality assurance system in place and that the procedures
are written, documented, and observed by all employees. The ISO 9000 series consists of
five quality standards:
1. ISO 9000, ANSI/ASQC Q90 defines the terms and presents principal quality management
and quality assurance practices used in the ISO 9000 series of standards and establishes
guidelines for their selection and use. This standard is applicable to all industries.
2. ISO 9001, ANSI/ASQC Q91 establishes models for quality assurance in the design,
development, production, manufacture, installation, and service sectors of an organi-
zation. This standard, which is the most comprehensive of the three external quality
assurance standards, is applicable to organizations that develop and produce their own
products. This also applies to construction and engineering services.
3. ISO 9002, ANSI/ASQC Q92 establishes models for quality assurance in production and
installation. This standard is applicable to service industries and manufacturers that
produce designs and specifications for other organizations.
4. ISO 9003, ANSI/ASQC Q93 establishes models for quality assurance during final inspec-
tions and testing. This standard is applicable to testing laboratories, small shops, divisions
within a firm, and equipment distributors that inspect and test supplied products.
5. ISO 9004, ANSI/ASQC Q94 establishes internal organization management guidelines
for design and implementation of quality systems; it is applicable to all industries.

OCCUPATIONAL SAFETY AND HEALTH
ADMINISTRATION (OSHA)

The purpose of OSHA, a division of the Department of Labor, is to establish regulations
that control and promote safety in the workplace. These regulations primarily concern
the manufacturing, construction, transportation, and agricultural industries. OSHA also
determines permissible exposure limits for chemicals and establishes norms for safety and
monitoring procedures where workers are exposed to hazardous and toxic chemicals. These
regulations require that all chemicals and hazardous materials be labeled and defined by
material safety data sheets (MSDS).

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