El Comite de Tecnologia de la Camara Americana organiza un seminario para el público en general sobre las normas de calidad ISO 9000. Dichas normas sirvenMessage 1 of 1 , Apr 8, 2002View SourceEl Comite de Tecnologia de la Camara Americana
organiza un seminario para el público en general sobre
las normas de calidad ISO 9000. Dichas normas sirven
para verificar la calidad en empresas de servicios -
incluyendo firmas de abogados.
Para cualquier pregunta pueden contactar al suscrito
Alvaro Aguilar 263-5333 o al organizador Rodrigo
Fabrega Barsallo Molino & Mulino
P.O. Box 4493
Panama 5, Panama
personal email: aguilara_5389@...
web site: http://www.fabamm.com
To: (Recipient list suppressed)
From: "AmCham CW" <amcham@...>
Subject: ISO FORUM
LA CAMARA AMERICANA DE COMERCIO
E INDUSTRIA DE PANAMA (AMCHAM)
Invita a sus miembros y a todo el público en general
al Foro denominado:
Las normas ISO 9000:
Control de calidad en las empresas
Sus competidores lo usan
Sus clientes se lo exigen
(Y le reducen los gastos)
Ing. Halil Musa
Gerente de Servicios de Asesoría, KPMG
(Asesor de ISO)
Ing. Roy Williams
SGS Panamá Control Services, Inc.
Tres expertos de ISO estarán conformando un panel para
preguntas y respuestas.
17 de abril del 2002 - 4:30 p.m. a 6:30 p.m.
Hotel Marriott Panamá, Salón Campo Alegre "A"
Miembros: $10.00 No Miembros: $15.00
Cancelaciones sólo serán aceptadas
24 horas antes del evento.
Do You Yahoo!? -- Une adresse @... gratuite et en français !
Yahoo! Mail : http://fr.mail.yahoo.com
ISO 9000: What is the Significance for Law Firms & Paralegal
by james W. Kolka, Ph.D., J.D.
The ISO 9000 series of standards first appeared in 1987. While it was
assumed to be British or European, the series could be traced back to
1963 when the U.S. Department of Defense (DoD) published its "MIL-Q-
9858A Quality Program Requirements." In 1979, the Geneva-based
International Organization for Standardization (ISO) created
Technical Committee (TC) 176, an international committee that
includes U.S. representation, to bring about "standardization in the
field of generic quality management, including quality systems,
quality assurance and generic supporting technologies, including
standards which provide guidance on the selection and use of
standards." (Source: International Organization for Standardization,
ISO Momento 1989, Geneva, Switzerland)
The translation of a U.S. military quality standard for non-military
use occurred in the United Kingdom and became British Standard (BS)
5750, which in turn became the precursor for ISO 9001 and the ISO
9000 series of standards published in 1987. In its simplest and most
basic form, an ISO 9001/2/3-based quality management system contains
a series of documents that require a company to:
document what it does;
perform to that documentation;
ensure the process is effective; and
record the results of the work.
For attorneys, it is important to know that ISO 9000 quality
management programs contain specified elements set forth in clauses
that are documented and evaluated on a periodic basis. For better or
worse, this process creates a paper trail.
While there are more than 20 standards within the ISO 9000 quality
management series, there are five key standards that concern most
companies. Two are guidance standards, and three are conformance
standards. Registration, the act of having a quality system verified
as being in conformance with a set of requirements by an approved
third party, occurs only in one of the three conformance standards.
ISO 9000-1: Quality Management and Quality Assurance Standards--
Guidelines for Selection and Use
This standard should be reviewed first by companies contemplating
registration. It provides a basic explanation of the ISO 9000 series,
definitions of key terms and guidance on the selection and use of the
three conformance standards.
ISO 9004-1: Quality Management and Quality System Elements--Guidelines
While this guidance standard should be reviewed before applying a
quality management system to a conformance standard such as ISO 9001
or ISO 9002, most often it is ignored. This is unfortunate, because
it is a part of the ISO 9000 series designed to offer guidance on
implementing the conformance standards. In particular, it discusses
system controls and issues that relate to liability issues and
liability exposures that deserve serious attention. As a "duty of
care," every company should review ISO 9004-1 in conjunction with
developing its quality management system.
ISO 9001: Quality Systems--Model for Quality Assurance in Design,
Development, Production, Installation and Servicing
This is the most comprehensive of the three conformance standards. It
includes everything from design through production (or for services,
delivery of such services) to storage, delivery and servicing (in the
field). It contains 20 clauses.
ISO 9002: Quality Systems--Model for Quality Assurance in Production,
Installation and Servicing
This conformance standard is identical to ISO 9001 except that it
does not contain the design function. It applies to a wide range of
facilities that manufacture to external design specifications and
facilities that make product lines for end users, such as sheet steel
and sheet aluminum. It contains 19 clauses.
ISO 9003: Quality Systems--Model for Quality Assurance in Final
Inspection and Test
ISO 9003 is the least comprehensive and least used of the three
conformance standards, since it does not include design or
production. It contains 16 clauses and focuses on final inspection
The Future of the ISO 9000 Series
All ISO standards, whether they address film speed, printing
machinery or quality management, are revisited approximately every
five years to consider whether the standard should be retained,
revised or deleted. The first revision of the ISO 9000 series was
completed and published in 1994. The second revision presently is in
process and due to be published late in the year 2000. While the
second revision was modest, ISO 9001:2000 promises to be more
To begin, there will be a single conformance standard, which will be
paired consistently with its guidance standard ISO 9004. Provision
will be made to omit those requirements that do not apply to an
organization. For example, if a company does not design products, the
design clause will be omitted. (Previously, this would have been
handled by ISO 9002.) As with ISO 14001, the Environmental Management
Systems Standard (which is paired with its guidance standard ISO
14004), ISO 9001 requirements will include a demonstration of
continuous improvement and the prevention of nonconformity.
The revised ISO 9001 and ISO 9004 standards are being developed using
a simple process-based structure comprised of eight inclusive
elements: scope, normative reference, terms and definitions, quality
management systems requirements, management responsibility, resource
management, process management and measurement, analysis and
The Significance of ISO 9000
Globally, over 180,000 sites (some companies have multiple sites) are
registered to an ISO 9000 conformance standard, with the number
increasing annually. Over 50,000 are registered in the United
Kingdom, 55,000 on the European continent and 30,000 in the United
States. While the initial growth in ISO 9000 registrations was market-
driven (i.e., customers purchasing a company's products or services
if they are registered to ISO 9000 to assure consistent quality),
more recently an increasing number of registrations are being driven
by procurement, contract or regulatory requirements. This is
especially true in the United States.
For example, in 1994 the big three U.S. automobile companies
(Chrysler, Ford and General Motors) issued their own standard, QS
9000, and stipulated that all parts suppliers (approximately 9,000
companies), as well as their own divisions, must be certified to QS
9000 in order even to bid on a contract. This requirement has been
expanded to vendors in the semi-conductor industry, the
transportation industry (e.g., trucking firms that transport GM parts
and automobiles) and tooling and equipment manufacturers with TE
9000. Presently, versions similar to QS 9000 are being adopted by
German automobile manufacturers (VDA-6.1), French automobile
manufacturers (EAQF) and Italian automobile manufacturers (ASQV).
In addition to the automotive industry, a related standard, AS 9000,
has been adopted by the aerospace industry. TL 9000 has just been
adopted by the telecommunications industry, and the maritime industry
has adopted a standard that must be met by ships in order to operate
at sea and obtain insurance. (International Maritime Organizations
(IMO) Marine Management and Ship Operation Guideline ISO 9002/ISM
Code). For the manufacture of medical devices, the European Union
(EU) has incorporated ISO 9000 into its three medical devices
directives. The FDA harmonized its new medical device regulation with
the EU's approach with its new FDA Quality System Regulation (QSR).
What makes these later applications different from the basic ISO 9000
model that was and is market-driven? It is the addition of
requirements to ISO 9000 to apply it to a specific industry, from the
manufacture of medical devices to the manufacture of automobiles,
aircraft, telecommunication equipment or sailing ships at sea.
Similar industry specific applications can be expected in the future,
from the manufacture of pharmaceuticals to the management of
What Are the Implications of ISO 9000?
As noted earlier, the number of ISO 9000 registrations is growing, as
well as applications to specific product sectors, such as
automobiles, aerospace and medical devices. As with any standard with
widespread applications, ISO 9000 raises a number of legal issues. To
begin, ISO 9000 is a process management standard designed to improve
the consistency and quality of processes for companies that
manufacture products or deliver services.
To understand how well this was accomplished, or if it was
accomplished effectively, it is necessary to understand ISO clauses
such as process control (4.9), product identification and
traceability (4.8), inspection and test status (4.12), control of non-
conforming products (4.13), and corrective and preventive action
(4.14). Further, it is necessary to understand the third-party
registration process to determine if the third-party registration
process was effective and what would constitute evidence of an ISO
9000 system breakdown.
For example, to understand how improper training might produce a
defective product, it would be necessary to understand the relevant
process management clauses and clause 4.18, which applies to training.
As a standard that focuses on managing process quality, product
safety is not addressed unless a company makes product safety a
priority in addressing design control (4.4); or a regulatory agency
such as the FDA mandates product safety as an aspect of design
control (CFR 820.30) in its ISO 9000-based Quality System Regulation
QSR; or the EU requires it as a part of its product safety technical
file. Even then, it may be important to examine the design documents
or technical file to see if product safety and safety standards for
risk analysis were addressed effectively.
What Does ISO 9000 Mean for Paralegal Professionals?
In order to provide effective legal representation to clients with
ISO 9000 quality management systems or to challenge the effectiveness
of those systems, it is necessary to have knowledge of their
operation vis-a-vis a company. All products pass through pre-
production, production and post-production phases of development and
potential liability exposure. Each phase has generated liability
Pre-production includes product design, risk analysis, hazards
analysis, foreseeable use and misuse, human factors analysis,
instructions and warnings, packaging (a specific requirement of the
FDA and the EU for medical devices), product liability insurance
considerations and record retention.
Production includes all phases of manufacturing from quality
management procedures to materials, component parts, subcontracting,
supplier management, manufacturing processes and packing, handling,
storage and delivery.
Post-production includes servicing, customer relations (including
feedback and complaints), promotional materials, product warranties
and contracts, accident reporting, failure analysis and product
The phases are not discrete and, in fact, overlap. The phases
parallel the clauses of ISO 9001, and they also describe phases where
lawsuits have occurred. To provide effective legal counsel, law firms
will have to master the operation of Quality Management Systems such
as ISO 9001 in relationship to potential areas of liability exposure.
It is an area where law firms can turn to paralegal professionals to
provide that expertise.
James W. Kolka, Ph.D., J.D., is a senior consultant with Excel
Partnership, Inc. He has been a member of the Wisconsin Bar for 35
years. His most recent book, ISO 9000: A Legal Perspective, was
published earlier this year by INFORM and ASQ Quality Press. For
information, call INFORM at (703) 680-1436.