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Our newsletters provide guidance on ISO 9001,
AS9100, ISO 13485, ISO/TS 16949, TL 9000, ISO
14001,
ISO 27001, ISO 20000, and related ISO
standards, as well as, Six Sigma.
If you have any questions about the articles
appearing in this issue, or you want to suggest
topics for future issues, please let us
know.
Web Archiving
A Web page that is here today, may not be
around tomorrow. A new standard, ISO
28500:2009, Information and Documentation -
WARC File Format, will ensure that the vast
and often valuable information posted on the
Web is not lost when a page changes or
disappears.
ISO 28500 provides a file format known as
WARC (Web ARChive), which offers a convention
for concatenating multiple data objects into
one long file. The format can be used to
build applications for harvesting, managing,
accessing, and exchanging content.
For a long time, keeping track of the
staggering number of Web sites and pages
posed a difficult challenge for digital
curators and archivists, and resulted in
countless lost data. With WARC, ISO 28500
takes Internet archiving to the next level by
enabling the effective management, structure,
and storage of billions of resources
collected from the Web and elsewhere.
Standardization on the WARC format offers a
guarantee of durability, and will help Web
archiving become part of the mainstream
activities of heritage institutions, by for
example, fostering the development of new
tools and ensuring interoperability between
collections.
The WARC format is an extension of the ARC
file format, which has been used by the
Internet Archive since 1996, and by numerous
heritage institutions to store "Web crawls" -
which represent extracts of entire Web pages
and their links.
The motivation to extend the ARC arose from
the discussions and experiences of the
organizations within the International
Internet Preservation Consortium (IIPC) -
whose core mission is to acquire, preserve,
and make accessible knowledge and information
from the Internet for future generations.
IIPC members were finding it increasingly
difficult to store and manage the growing
volume of information coming from the
Internet.
According to the ISO technical committee that
developed ISO 28500, several applications are
already WARC compliant, such as the Heritrix
crawler for harvesting, the WARC tools for
data management and exchange, the Wayback
Machine, and NutchWAX. And, I noticed that
the Library of Congress is already using the
WARC format to harvest web sites.
You can order ISO 28500:2009 at the ANSI
Standards Store at this web
page.
On-time Delivery
The QuEST Forum is a unique collaboration of
service providers and suppliers dedicated to
improving quality and performance in the
telecommunications supply chain. The QuEST
Forum has helped unify the global telecom
community through the implementation of TL
9000, a telecom-specific quality standard
that builds on ISO 9001.
TL 9000
The performance data requirement of TL 9000
sets it apart from other quality management
standards. TL 9000 certified organizations
must submit TL 9000 measurement data using
predefined counting rules to the QuEST
Forum's partner, the University of Texas at
Dallas. Security and anonymity are maintained
during the submittal, storage, and reporting
of all TL 9000 measurement data.
Through the compilation of industry
statistics, such as industry average,
best-in-class, and worst-in-class, the
measurement data enables QuEST Forum members
to identify opportunities for improvement, as
well as, compare themselves to their
competitors and set meaningful
improvement goals. Furthermore, an
organization's quality management system
based on TL 9000 serves as a platform to
support the continual improvement of these
measurements.
Study
The QuEST Forum commissioned the publication
of a study to ascertain the state of telecom
quality as evidenced by the TL 9000
measurement data. Since the amount of TL 9000
data covers 47 TL 9000 measurements, 126
product categories, and 869 registrations, as
a starting point, the study focused on a
single TL 9000 measurement, On-Time Delivery,
across a
sample of representative product categories
for the two-year period, 2007-2008.
Summary
Over the study period, the average on-time
delivery improved from 75% to 81%. The range
of results improved from (31% to 98%) to (72%
to 99%). The Worst-In-Class average improved
from 30% to 54%. To see the full report, go
to this TL
9000 web page.
Conclusion
A major premise behind QuEST Forum's
inception was that as organizations used TL
9000 data to drive improvement, the net
effect over time would be an overall
improvement in the quality of the telecom
industry. Based on the study results, it
appears the founding intent of the QuEST
Forum and TL 9000 - to improve telecom
quality - is being realized.
The study also vividly illustrates the
importance of the TL 9000 measurements and
the valuable insight they can provide.
Without a common measurement system the study
would not have been possible. The TL 9000
measurements provided for the secure
collection of anonymous data both derived
using accepted definitions and reported in a
common format.
While many certified organizations that
faithfully use TL 9000 attest to the
improvements in quality derived from
utilizing TL 9000, this study confirms these
statements. The benchmark
data derived from the TL 9000 measurement
data will hopefully be used to drive
meaningful improvement targets for certified
organizations and the industry as a whole.
Revised 14 CFR 21
The Federal Aviation Administration (FAA)
recently published significant revisions to
14 CFR 21, the regulations that govern the
design, production, and continued
airworthiness of U.S. civil aircraft. These
changes become effective April 14, 2010.
The FAA is amending its certification
procedures and identification requirements
for aeronautical products and articles. The
amendments will update and standardize those
requirements for Production Approval Holders
(PAHs), revise export airworthiness approval
requirements to facilitate global
manufacturing, move all part marking
requirements from part 21 to part 45, and
amend the identification requirements for
products and articles.
The changes also standardize the quality
system requirements for PAHs so that all PAHs
comply with the same set of quality system
requirements, regardless of the product or
article produced.
Quality System Requirement
This final rule prescribes a PAH's
requirements for controlling the quality of
the product or article it manufactures. The
FAA has imposed additional PAH quality system
requirements designed to achieve overall
improvement of the PAH's quality system.
The quality system consists of fourteen
specific quality system requirements. As
described below, it is important to note that
those fourteen quality system requirements
are scalable, depending on the size and
complexity of the PAH and of the product or
article produced. Some of these requirements
were already mandatory prior to this
rulemaking and have been retained. The
remaining requirements also have already been
incorporated by industry for years and used
voluntarily as ''best practices.''
Prior to this rulemaking, holders of
different production approvals complied with,
and were audited to, differing sets of
requirements. For instance, if a manufacturer
produced a Parts Manufacturing Approval (PMA)
part and a Technical Standard Order (TSO)
article, the manufacturer was subject to
different quality and marking standards for
each part it produced.
Today's requirements are now applicable to
Production Certificate (PC) and PMA holders
and TSO authorizations alike. This final rule
relieves PAHs from having to maintain, and
the FAA from having to oversee, multiple PAH
systems and procedures. Hence, this final
rule will increase regulatory efficiency.
Two of the sections in 14 CFR 21 relating to
the quality system are included below.
21.137 Quality System
Each applicant for, or holder of, a
production certificate must establish and
describe in writing a quality system that
ensures that each product and article
conforms to its approved design and is in a
condition for safe operation. This quality
system must include:
(a) Design data control. Procedures
for controlling design data and subsequent
changes to ensure that only current, correct,
and approved data is used.
(b) Document control. Procedures for
controlling quality system documents and
data, and subsequent changes, to ensure that
only current, correct, and approved documents
and data are used.
(c) Supplier control. Procedures that:
(1) Ensure that each supplier-furnished
product or article conforms to its approved
design; and
(2) Require each supplier to report to
the production approval holder if a product
or article has been released from that
supplier and subsequently found not to
conform to the applicable design data.
(d) Manufacturing process control. Procedures for controlling manufacturing
processes to ensure that each product and
article conforms to its approved design.
(e) Inspecting and testing. Procedures
for inspections and tests used to ensure that
each product and article conforms to its
approved design. These procedures must
include the following, as applicable:
(1) A flight test of each aircraft
produced unless that aircraft will be
exported as an unassembled aircraft.
(2) A functional test of each aircraft
engine and each propeller produced.
(f) Inspection, measuring, and test
equipment control. Procedures to ensure
calibration and control of all inspection,
measuring, and test equipment used in
determining conformity of each product and
article to its approved design. Each
calibration standard must be traceable to a
standard acceptable to the FAA.
(g) Inspection and test status. Procedures for documenting the inspection and
test status of products and articles supplied
or manufactured to the approved design.
(h) Nonconforming product and article
control. Procedures to ensure that:
(1) Only products or articles that
conform to their approved design are
installed on a type-certificated product.
These procedures must provide for the
identification, documentation, evaluation,
segregation, and disposition of nonconforming
products and articles. Only authorized
individuals may make disposition
determinations.
(2) Discarded articles are rendered
unusable.
(i) Corrective and preventive actions. Procedures for implementing corrective and
preventive actions to eliminate the causes of
an actual or potential nonconformity to the
approved design or noncompliance with the
approved quality system.
(j) Handling and storage. Procedures
to prevent damage and deterioration of each
product and article during handling, storage,
preservation, and packaging.
(k) Control of quality records. Procedures for identifying, storing,
protecting, retrieving, and retaining quality
records. A production approval holder must
retain these records for at least 5 years for
the products and articles manufactured under
the approval and at least 10 years for
critical components identified under §
45.15(c) of this chapter.
(l) Internal audits. Procedures for
planning, conducting, and documenting
internal audits to ensure compliance with the
approved quality system. The procedures must
include reporting results of internal audits
to the manager responsible for implementing
corrective and preventive actions.
(m) In-service feedback. Procedures
for receiving and processing feedback on
in-service failures, malfunctions, and
defects. These procedures must include a
process for assisting the design approval
holder to:
(1) Address any in-service problem
involving design changes; and
(2) Determine if any changes to the
Instructions for Continued Airworthiness are
necessary.
(n) Quality escapes. Procedures for
identifying, analyzing, and initiating
appropriate corrective action for products or
articles that have been released from the
quality system and that do not conform to the
applicable design data or quality system
requirements.
21.138 Quality Manual
Each applicant for, or holder of, a
production certificate must provide a manual
describing its quality system to the FAA for
approval. The manual must be in the English
language and retrievable in a form acceptable
to the FAA.
To see the full FAA Final Rule for 14 CFR 21,
view this PDF
document.
http://edocket.access.gpo.gov/2009/pdf/E9-24821.pdf
ISO 9004:2009
ISO 9004:2009
The just-published new edition of ISO 9004
provides organizations with a model for
"sustained success" in today's complex,
demanding, and ever-changing environment.
ISO 9004:2009, Managing for the sustained
success of an organization - A quality
management approach, is the third edition
of the standard first published in 1987. It
is intended to support the achievement of
sustained success by any organization
(regardless of size, type, or activity)
through a quality management approach.
While the initial goal is to ensure the
production of quality products and services
that will lead to the achievement of customer
satisfaction, the longer-term purpose is to
ensure the economic survival of the
organization. The new edition of ISO 9004
gives guidance on how an organization should
adopt a systematic approach to achieve this
sustained success.
ISO 9004:2009 provides guidance for the
continual improvement of an organization's
overall performance, efficiency, and
effectiveness based on a process-based
approach. It focuses on meeting the needs and
expectations of customers and other relevant
parties, over the long term, and in a
balanced way.
Compared to ISO 9001:2008, ISO 9004:2009
provides a broader perspective of quality
management, particularly for performance
improvement. It will prove useful to
organizations whose top management wishes to
move beyond ISO 9001, in pursuit of ongoing
improvement, measured through the
satisfaction of customers and other
stakeholders.
ISO 9004:2009 allows organizations to enhance
the quality of product and service delivery
to their customers by promoting
self-assessment as an important tool to
enable organizations to:
benchmark their level of maturity,
covering leadership, strategy, management
system, resources, and processes
identify their strengths and weaknesses
identify opportunities for either
improvements or innovation, or both.
The self-assessment tool may become a key
element during the strategic planning
processes in any organization.
The objectives of customer satisfaction and
product quality are extended in ISO 9004:2009
to include the satisfaction of interested
parties and the performance of the
organization. The combination of ISO 9001 and
ISO 9004 will allow you to get the most of
your quality system.
ISO 9004:2009 replaces ISO 9004:2000 by
making substantial changes to its structure
and contents based on eight years' experience
of implementing the standard worldwide, and
introduces changes intended to improve
consistency with ISO 9001 and other
management system standards. An example of an
important change in the structure of ISO 9004
is that the "body" of the standard starts
with the chapter giving guidance on how to
manage an organization aiming for sustained
success and not how to build a quality
management system.
Although ISO 9004:2009 complements ISO
9001:2008 (and vice versa), it can also be
used independently. It is not intended for
third-party certification, regulatory, or
contractual use, nor as a guide to the
implementation of ISO 9001:2008. To help
users get the best out of the standard, an
annex gives a clause-by-clause correspondence
between ISO 9001:2008 and ISO 9004:2009.
Medical Labs
Medical laboratories accredited to ISO
15189:2007 are recognized as meeting the
management system principles of ISO 9001:2008
according to a joint communiqué by ISO (the
International Organization for
Standardization), ILAC (the International
Laboratory Accreditation Cooperation), and
the IAF (the International Accreditation
Forum).
The ISO-IAF-ILAC communiqué was issued to
address the misconception that medical
laboratories accredited to ISO 15189:2007 do
not operate a recognized management system.
Until now, accredited medical laboratories
were often requested by their customers to
undertake the additional step of
certification to ISO 9001:2008 to demonstrate
that they were in full control of their
processes.
This recognition will reduce redundant,
costly, and time-consuming audits and, at the
same time, enable medical laboratories to
better meet their customers' needs.
Note: ISO 15189:2007 specifies requirements
for quality and competence particular to
medical laboratories. The standard is for use
by medical laboratories in developing their
quality management systems and assessing
their own competence, and for use by
accreditation bodies in confirming or
recognizing the competence of medical
laboratories.
While ISO is the developer and publisher of
ISO 15189 and ISO 9001, it does not carry out
auditing and certification. These services
are performed independently by accreditation
and certification bodies. ISO does not
control such bodies, but does develop
voluntary International Standards to
encourage good practice in their activities
on a worldwide basis.
ILAC is the world's principal international
forum for the development of laboratory
accreditation practices and procedures and
the promotion of calibration and testing
laboratory and inspection accreditation. This
accreditation ensures that decisions on
international trade, public health, and
environmental issues are based on reliable,
reproducible, and accurate data. As well as
working in other fields, national
accreditation bodies that are members of ILAC
assess and declare the competence of medical
laboratories against the requirements of ISO
15189.
IAF is the world association of accreditation
bodies and other bodies interested in the
accreditation of conformity assessment bodies
providing certification and inspection
services. Its primary function is to develop
worldwide programs of accreditation that
promote the elimination of non-tariff
barriers to trade. Accreditation bodies
declare the competence of certification
bodies in the fields of management systems,
products, services, personnel, and other
similar programs of conformity assessment.
Critical Safety Items
AS9017:2009, Control of Aviation Critical
Safety Items, is now available. It is
intended to prescribe consistent requirements
for CSI management for organizations and
suppliers who perform work for prime
contractors receiving direct contracts from
U.S. government agencies.
The contractor, which receives the initial
government contract, will receive their CSI
requirements directly from the U.S.
government agency and be required to maintain
a CSI management system that ensures
compliance to all requirements.
The flow down of this standard is in addition
to any specific contract clauses, e.g.,
Federal Acquisition Regulations, Defense
Federal Acquisition Regulations, required by
the government to be flowed to sub-tier
sources.
The standard will be auditable with the
expectation that the prime contractor will
flow CSI requirements to the supply chain and
periodically assess, audit, validate, and
recognize compliance to AS9017 per their own
processes. All manufacturers of CSIs must
comply with the requirements of AS9100 or a
technically equivalent quality management
system standard.
Special process suppliers may meet this
quality management system requirement through
their Nadcap certification. Any operation,
process, or other action associated with the
new manufacture of any CSI must only be
performed by sources meeting the applicable
requirements of AS9017.
The International Aerospace Quality Group
(IAQG) has announced a new timeline for the
transition to the aerospace standards
published in 2009:
AS9100:2009, Requirements for Aviation,
Space, and Defense Organizations
AS9110:2009, Requirements for Aviation
Maintenance Organizations
AS9120:2009, Requirements for Aviation,
Space, and Defense Distributors
Transition Schedule
The IAQP sanctioned auditor training is
expected to be available by April 30, 2010.
The following 14 month period, ending July 1,
2011, is to provide time for trainers and
auditors to be trained, and for certification
bodies to be accredited to the AS9104-1
standard.
Certification of organizations to the new
standards (AS9100, AS9110, or AS9120) can
start any time after the accreditation of a
certification body to AS9104-1. After July 1,
2011, all audits must be against the
applicable new standard. AS9100:2004 will be
canceled on July 1, 2012. The transition plan
and related guidance materials are to be
published by December 31, 2009.
Supporting Standards
AS9101:2009, Audit Requirements for
Aviation, Space, and Defense
Organizations, is expected to be
published before the end of this year. It
will replace the current audit checklists,
AS9101, AS911, and AS9121. All certification
audits must be conducted in compliance with
this standard.
AS9104-1, Requirements for Oversight of
Aerospace Quality Management System
Certification Programs, is expected to be
published by April 2010. All certifications
of organizations to the 2009 versions of the
aerospace standards must be completed in
compliance with this updated standard.
Upgrade Audits
AS9104-1 will include revised audit day
tables. An upgrade to one of the new
standards during a scheduled surveillance
audit will use the "recertification" audit
day table. A certification upgrade during a
recertification audit will use the "initial"
audit day table.
Auditor Training
IAQG sanctioned training for all AA and AEA
auditors will be required prior to those
auditors conducting a certification audit to
the 2009 versions of the aerospace standards.
This sanctioned training will be developed by
a training firm selected by IAQG.
The training materials, exam, and training
for trainers will be made available to other
training providers and organizations.
However, the training providers and other
organizations wanting to train aerospace
auditors for authentication must be approved.
The sanctioned training will be the only
training accepted for re-authentication of
auditors for the 2009 aerospace standards.
AS9100:2009 Differences
You can download a PDF file from this AS9100
page at our web site to see the detailed
differences in AS9100:2009 compared to
AS9100:2004:
Whittington & Associates provides training, consulting and auditing services for
management systems based on
ISO 9001, ISO/TS16949, ISO/TS 29001, TL 9000, AS9100, ASS9110, AS9120, ISO 13485,
ISO 27001, ISO 20000, and ISO 14001.