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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
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know.
ISO 9001 Corrections
ISO 9001:2008 Technical Corrigendum 1 was
published on July 15, 2009 with corrections
to Annex A and Annex B of the ISO 9001:2008
standard published on November 15, 2008.
The corrections were limited to Tables A.1
and A.2, the ISO 9001:2008 and ISO 14001:2004
cross-reference tables, and Table B.1, the
ISO 9001:2000 to ISO 9001:2008 changes table.
Annex A, Table A.1, Correspondence between
ISO 9001:2008 and ISO 14001:2004
The correction says to replace the entire A.1
table with the new A.1 table. Rather than
repeat the table in this article, I have
listed the changes by page and ISO 9001 table
entry:
Page 15
5.1: Add clause 4.6, Management review, under
the ISO 14001 column.
5.2: Remove the 4.6 entry under the ISO 14001
column.
5.5.1: Remove the 4.1 entry under the ISO
14001 column.
Page 17
8.4: Add clause 4.5.3, Nonconformity,
corrective action, and preventive action
under ISO 14001 column.
Annex A, Table A.2, Correspondence between
ISO 14001:2004 and ISO 9001:2008
The correction says to replace the entire A.2
table with the new A.2 table. Rather than
repeat the table in this article, I have
listed the actual changes by page and ISO
14001 table entry:
Page 18
4.1: Remove the entries for clauses 5.5 and
5.5.1 under the ISO 9001 column.
Page 19
4.4.6: Remove the clause 7.5 entry under the
ISO 9001 column.
Annex B, Table B.1, Changes between ISO
9001:2000 and ISO 9001:2008
These corrections are complete row
replacements in Table B.1. Rather than show
the full old and new rows, I have described
the changes below:
Page 20, Annex B, Table B.1, seventh row: The
entire sentence should be shown as a
strike-through. In other words, include
"Annexes A" as part of the deleted sentence.
Page 21, Annex B, Table B.1, second row: The
word "are" at the end of the first sentence
should have been underlined to indicate it
was an addition.
Page 25, Annex B, Table B.1, first row: The
second sentence should not have been shown as
a strike-through. It replaced the prior
deleted sentence and should have been
underlined as an addition.
Free Download
You can download a free PDF file of the
Technical Corrigendum at this Techstreet Web Page.
Recycling Standards
As industry embraces opportunities to lessen
their environmental footprint through various
recycling programs, the recycling industry
finds itself facing new initiatives designed
to ensure wastes are handled appropriately.
There are currently three such accredited
programs - RIOS, R2, and E-Stewards, all
designed to deal with electronic waste.
RIOS (Recycling Industry Operating Standard)
was developed by the Institute of Scrap
Recycling Industries (ISRI). RIOS is an
integrated management system standard that
combines the management of quality,
environmental, and occupational health and
safety into a single unified system.
Developed specifically by and for the scrap
recycling industry, RIOS provides a
systematic framework for recycling facilities
to achieve measurable improvement in their
management system performance.
R2 (Responsible Recycling) is an independent
set of voluntary operational practices
specific to electronics recycling. The
practices were developed by the EPA with
industry input. At the foundation of R2 is
the requirement to develop an Environmental,
Health, and Safety Management System (EHSMS)
to plan and monitor its environmental,
health, and safety practices, including the
activities it undertakes to conform to R2
Practices. ISRI has adopted R2 into the RIOS
certification program to provide a voluntary
path for electronics recyclers to improve
their facility operations and use RIOS as the
tool to meet the EHSMS requirement in R2.
For more information on R2, go to this EPA
webpage.
The final standard is the e-Steward program
developed by the Basel Action Network (BAN).
The focus of this program is to ensure
exports of electronic hazardous waste to
developing countries are eliminated and
replaced with producer responsibility and
green design programs. BAN initially had
worked with both the RIOS and the EPA groups, but
chose to develop their own standard based on
the principles of the Basel Convention.
The ANSI-ASQ National Accreditation Board
(ANAB) offers accreditation for the RIOS, R2,
and e-Steward programs. See the ANAB website for more information.
For organizations that have already developed
management systems that conform to ISO 9001,
14001, and 18001, meeting the requirements of
any of these three initiatives should not be
an overwhelming task.
Note: This article was based on an article
written by Larry Tibert, EHS Business Unit
Manager, for the NQA Update Newsletter.
ISO 10018 Draft
With key elements of ISO 9001 focused on
people, ISO 10018 is under development to
explain the human element in successful
management systems.
ISO 10018, "Quality management - Guidelines
on people involvement and competences", is at
the Committee Draft stage, with publication
targeted for February 2012.
According to Paul Simpson, IRCA Technical
Manager and Member of the ISO 10018 Working
Group, most auditors are aware of the need to
consider the people aspects when auditing a
management system. He says systems are not
simply documents describing processes to be
followed, nor records evaluated for evidence
that processes are effectively implemented.
A system is the sum of behaviors and
the values of individuals from top to bottom.
ISO 10018 will give much needed guidance on
people involvement and competence in quality
management systems. Although being developed
by ISO/TC 176, the technical committee
responsible for publishing the ISO 9000
series and supporting standards, the
principles apply equally to other management
systems.
What is Covered?
At the heart of ISO 10018 are four key areas:
1. the eight quality management principles
2. human factors that can affect quality
3. competence acquisition and people
involvement
4. specific guidance against ISO 9001
clauses
When ISO 9001 was reissued in 2000, it was
based on eight quality management principles
as outlined in ISO 9000. Four of these
principles are about people, but ISO 9001
does not develop these principles to any
extent. This was the main reason why ISO set
up a working group to create a standard
providing guidance on how people affect the
principles and how more effective use of
people can improve an organization.
The standard will give specific guidance as
to where an improved use of human factors can
help with satisfying each clause of ISO 9001.
ISO 10018 will also include two outline
processes covering competence acquisition and
people involvement.
The Human Factor
ISO 10018 will provide a brief overview of
how human factors that affect quality can be
effectively used within a management system.
Human factors are broken down into three
groups in the document: 1) leadership, 2)
people involvement, and 3) competence.
Recommendations over the years for effective
quality management have included the first
two groups. The third, competence, is a
particularly hot topic at the moment with
the issue of ISO 17021 for certification
bodies.
1) Leadership Factors:
leadership - the role of a leader within
an organization
culture and values - how leaders are
involved in establishing an organizational
culture through their behavior and values
change management - the leader role in
managing change, including culture change and
involving people
knowledge management - the role of
leaders in ensuring knowledge is shared
within the organization and used effectively
2) People Involvement Factors:
communication - a key area within most
organizations (and so easy to get wrong); the
guidance looks at targeting messages and the
use of various media
teamwork - the ability to work with
others to achieve company goals is
fundamental to ensuring work gets done
networking and collaboration - an area
related to teamwork and communication. Many
professionals build networks of contacts and
interested partners to enable them to use
resources not contained within the organization
discipline - both self and external
discipline are required to ensure most tasks
are completed to plan
empowerment and responsibility - the
other side of the coin to discipline.
Empowerment enables employees to work with
little supervision in areas of their
responsibility
exploration - the process for taking
calculated and reasonable risks and to learn
through experience
recognition and rewards - providing
feedback to employees on a job well done and
ensuring rewards are aligned with achievement
3) Competence Factors:
recruitment - the process for bringing
people into the organization
education and learning - processes for
developing knowledge and skills
awareness - how to make people aware of
all the key aspects of processes they are
working in
creativity and innovation - in these
changing times, the ability to apply creative
solutions to challenges and to quickly
innovate are becoming core competences
competence itself - the sum of all the
parts above
If any organization carries out its
activities with all of these people aspects
in mind, then the key benefit will be
improved performance through engaged
employees with a clear understanding of where
the organization is going and how each person
can help it to get there.
Auditing and ISO 10018
Auditors that assess against ISO 9001 will
not have to worry about the need to raise
additional nonconformities against ISO 10018.
The draft standard does not add any
requirements to ISO 9001, it merely provides
guidance to understand the people aspects in
effective implementation for those involved
in developing management systems.
Users of the standard are expected to be an
organization's leaders and those with
responsibility for developing and
implementing systems. However, auditors
familiar with ISO 10018 could use it to point
an auditee to areas of best practice.
Note: This article is an edited version of an
article written by Paul Simpson for the
IRCA Quarterly e-zine. If you want to
participate in the IRCA forum
discussion on ISO 10018, go to this IRCA
forum webpage.
AS9110 and AS9120
The AS9100, Revision C, aerospace standard
was published early this year. You can read
about the changes introduced by the new
edition in this AS9100C
PDF file at my web site.
Tailored versions of AS9100C for maintenance
organizations (AS9110A) and distributors
(AS9120A) are now available.
AS9110, Revision A, is for organizations that
provide maintenance, repair, and overhaul
services for commercial and military aviation
products. It is also for original equipment
manufacturers with maintenance, repair, and
overhaul operations that operate
autonomously, or that are substantially
different from their manufacturing and
production operations.
AS9120, Revision A, is for organizations that
procure parts, materials, and assemblies, and
then resell these products to customers in
the aviation, space, and defense industries.
This includes organizations that procure
products and split them into smaller
quantities for resale.
Certification to AS9100C, AS9110A, and
AS9120A will not begin until after their
AS9101D checklist becomes available, which
may not be until early next year.
In the past, the AS9101 checklist was only
for use with AS9100. The AS9110 maintenance
standard had its own checklist (AS9111), as
did the AS9120 distribution standard
(AS9121). A major change in the AS9101D
checklist is that it will apply to AS9100C,
AS9110A, and AS9120A. Therefore, AS9101D will
replace the related checklists AS9101C,
AS9111, and AS9121.
The current audit checklists support an
elemental approach to assessing quality
management systems. They also focus the
auditor on completing the checklist and end
up taking valuable time away from actual
auditing.
The AS9101D update is expected to help
transition auditing practices to align with
ISO 17021 (the Stage 1 and Stage 2
certification approach), as well as, promote
methods that support process-based management
audits.
Some of expected changes in the new AS9101
checklist are:
One checklist supporting AS9100, AS9110,
and AS9120
Elimination of the scoring and key
requirements designations
Including determination of effectiveness
in addition to conformity
More emphasis on performance measurements
Introduction of the objective evidence
record
Additional AS9100:2009 standard guidance and
deployment support material is available at
this IAQG
web page.
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.
