ISO9001:2008 (final con.)

Classified as “medium” impact are:

• Minor additional or reduced requirements for some users.
• Possible impact on understanding by many users.
• Need for limited changes of an organization’s QMS documentation.
• Need for eventual revision of other QMS standards but potential compatibility problems would be tolerable in the interim.
• No significant need for additional education or training for users.
• Creates a minimal requirement for recertification.

Categorized as “low” impact criteria are:

• No increased or reduced requirement.
• No change in intent of requirement.
• No impact on most users.
• No need for additional education or training for users.
• Only need for minimal or marginal changes of an organization’s QMS documentation. In the benefit category, the document lists the following activities as “high” benefit to users:
• Addresses a widely expressed specific user need by improving clarity and eliminating confusion.
• Corrects an error in the existing standard.
• Eliminates inconsistencies within ISO 9001.
• Eliminates inconsistencies within the ISO 9000 family.
• Eliminates major problems of translation.
  

Ranked as “medium” benefits are:

• Improves clarity in regard to a widely expressed user need but may not eliminate confusion and/or translation difficulty.
• Improves clarity in response to needs identified by some users.
• Increases compatibility with ISO 14001.
• Demonstrates willingness to respond to the wish to see improvement in compatibility between ISO 9001 and ISO 14001 even though alignment is not a priority for this amendment.
• Reduces problems of translation.
  

Ranked as “low” benefit are the following:

• Improves clarity only in response to a very low number of requests for improvement.
• Marginal improvement in clarity where benefit may be offset by risk of unintended consequences, e.g. with respect to translation, interpretation.
• Changes not addressing a clear user need.

by QSU Publishing Company (www.qsuonline.com)

Update ISO9001:2008 (con.)

Moreover, the document instructs standards writers to consider general comments from TC 176 member bodies made during the so-called systematic review of ISO 9001 prior to commencing the revision, to include specific comments that do not deviate significantly from the current scope and purpose of the revision, but to avoid comments that go beyond the current scope and purpose of ISO 9001.

Finally, the document lists the criteria for assessing the potential impact and benefits of proposed changes to the document.

“One of the major requirements in drafting this amendment is the need to limit the impact on users. The writers of the amendment will therefore need to assess proposed changes and evaluate impact and benefits in making any amendments to the standard,” the document states.
Under the “high” impact category, standards writers are instructed to include:

• Additional or reduced requirements significantly affecting many users or particular categories of users, e.g. purchasers, those using related management system standards, small businesses.
• Change in intent of requirement.
• Need for urgent revision of related QMS standards.
• Need for extensive changes of an organization’s QMS documentation.
• Decreased compatibility with ISO 14001.
• Inconsistency within the ISO 9000 family.
• Need for recertification or significant transition period.
• Need for extensive user education or training.

Update ISO9001:2008

Trevor Smith of Canada, international chair of TC 176 says ISO requires a periodic review of every standard for continuedrelevance. “Driven by ISO to start the revision process we wanted to do a full and thorough analysis of changes that may be needed so that we
can argue on the basis of real data instead of just people’s feelings,” he says. “People can get emotional about changes to the standard just for the sake of it, as opposed to doing a proper impact analysis as to why changes should be done,” says Smith. “I think what came out of this meeting was a mechanism that the group will be using to take the requests for update
and then sort of determine what is the impact of those changes for the benefit of users.”
The design specification had not been released publicly as of press time; however, a copy obtained by QSU reveals that standards writers intend to keep the quality management system standard generic and applicable to all sizes and types of organizations in any sector. “The current scope and purpose of the standard, the title and the field of application shall be unchanged from ISO 9001:2000,” the document states.

According to the document, standards writers intend to retain the model and process approach from the current edition. “The changes shall be restricted so that the impact of the amendment
on the users is limited,” the document emphasizes, noting that compatibility with the recently revised ISO 14001 standard must be maintained.

The document also states that the “concept of ISO 9001 and ISO 9004” shall continue to be perceived as a “consistent pair.” Some experts, however, privately say that the tie between the two standards is still under review.

With respect to compatibility with ISO 14001, the document states that there are two main areas to be addressed: terminology and common requirements.
“Noting that ISO 14001:2004 has been published and is highly compatible with ISO 9001:2000, the proposed amendment to ISO 9001:2000 should aim to maintain or enhance this compatibility,” according to the document.

Nevertheless, the document states that the following areas do not necessarily represent potential compatibility issues:

• Different text in common elements or terminology.
• Different numbering of the clauses.
• Different models and structure.
• Inclusion of guidance, notes or annexes.

In addition to maintaining compatibility with the environmental standard, the document also states that the current level of compatibility with sector specific and other management system standards (MSS) should be maintained.

“A number of other of MSS are based on ISO 9001:2000 and have made use of its structure and text. The writers of the amendment need to be aware of the impact of changes upon the compatibility of these standards with ISO 9001,” according to the document. “The current level of compatibility with the other ISO or non-ISO MSS, not based on ISO 9001:2000, should not be reduced.”

While maintaining a “significantly unchanged” overall structure of the standard, the document advises that some changes may be made provided “the intent of the standard is not changed, the impact on users is limited and it contributes to clearer understanding for users.”

Work Begins on ISO9001:2008 (Con.)

In the case of the companion guidance document, ISO 9004, the term, “revision”
is being used to convey the committee’s intent to introduce substantive
changes. Despite the fact that the committee’s recent survey of 941
users indicated little dissatisfaction with ISO 9004, the relatively low
international sales of the standard have been interpreted as a silent call to
improve the usefulness of the document,
which is intended to help companies move beyond the base requirements of ISO 9001 to a higher performing quality management system.
At the outset of the week-long series of meetings of ISO Technical
Committee (TC) 176 — the committee responsible for the ISO 9000 family
of international standards — experts debated a proposal to further
limit the scope of the revision of ISO 9001 through a formal resolution,
but later agreed to proceed without such a resolution at least for the time
being.

Sandy Sutherland, convener of the task group charged with developing
the design specification for the future ISO 9001, told QSU that such a
resolution would have resulted in an unnecessary layer of bureaucracy and
the potential to do more harm than good.

Experts, however, agreed to limit the scope of the ISO 9001 design
specification based on the expected impact of a particular change on the
user community. “For instance, do people require additional training and
education, extensive training and education, minimum or none,” says
Sutherland of the United Kingdom. Anything deemed to have a high
impact would be held for a future revision.

Sutherland says that a surprising degree of consensus emerged from
the meetings here though he declined to comment on specific language
contained in the design specification, which will be used as a kind of outline
for standards writers as they begin considering actual text changes to
the standard later this year.

“Our challenge was how to express that consensus effectively and
how to set the framework within the design specification in a way that
everybody got the assurances out of it the way they want,” says Sutherland,
adding that the potential impact of each change was assessed in a special
matrix.

“The matrix looks at what the impact of the change would be and
what the benefit of the change would be … Irrespective of the benefits, if
it’s high impact it’s not for this amendment … We have a little bit of flexibility
if it’s medium impact.We’ve done an analysis and produced examples
in each of those categories.”

Sutherland says that the task group considered the results of ISO’s
mandatory justification study on the need for a revision, the extensive
data collected as a result of the Internet survey, which drew respondents
from 63 countries or economies and the committee’s official interpretations
to the current standard.

“The justification study made it quite clear that the effect of the
changes on a large number of users should be limited,” explains Charles
Corrie, secretary of TC 176’s Subcommittee 2, which has responsibility
over drafting matters related to ISO 9001 and ISO 9004. “We’ve identified
impacts in terms of performance, outcome or effect on things like need for
training, effect on certification, transition.

“We’ve done something similar for benefits to users. Then we put a
decision logic into that matrix, whereby if the impact is high we then considered
that the change being reviewed should be deferred for consideration
to a future revision to ISO 9001 and not be considered. If it’s low
impact and low benefit, likewise it should be deferred,” he explains.
Trevor Smith of Canada, international chair of TC 176, tells QSU that
the introduction of the impact matrix should go a long way in assuring
that only necessary changes will be made to the standard during this revision,
which is expected to result in publication sometime around the third
quarter of 2008.

Work Begins on ISO9001:2008

KUALA LUMPUR — With the impact of ISO 9001:2000 felt
even in this emerging economy, standards writers from
around the world gathered here recently to begin developing the
blue print for the next iteration of the world’s best-known
quality management standard, planned for 2008.
Some 300 delegates from 50 countries and economies
descended upon this bustling, diverse Muslim capital
famed for its glistening twin towers — 88 stories of glass
and steel — that rank among the world’s tallest and
most magnificent structures.While a few delegates lobbied
for new requirements to the international standard,
most seemed determined to limit the scope of
the revision to only those changes necessary to
clarify the existing document.
The International Organization for Standardization
(ISO) makes no formal distinction
between a revision or amendment in its
technical parlance, but standards experts
have carefully chosen to describe this revision
of ISO 9001 as an “amendment” in
the hope of sending a message to the estimated
half million certificate holders
that they will make only those changes
necessary for clarification of the document
or for achieving greater alignment
with ISO 14001 on environmental management.

Introduction (Continue1)

Process approach

This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requireme For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach“ An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction When used within a quality management system, such an approach emphasizes the importance of a) understanding and meeting requirements, b) the need to consider processes in terms of added value, c) obtaining results of process performance and effectiveness, and d) continual improvement of processes based on objective measurement. The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level. NOTE In addition, the methodology known as “Plan-Do-Check-Act“ (PDCA) can be applied to all processes. PDCA can be briefly described as follows. Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization‘s policies. Do: implement the processes. Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results. Act: take actions to continually improve process performance.

INTRODUCTION

General
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization‘s quality management system is influenced by: its business environment, changes in that environment, or risks associated with that environment; its varying needs; its particular objectives; the products it provides; the processes it employs; its size and organizational structure. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.

The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked "NOTE" is for guidance in understanding or clarifying the associated requirement.

This International Standard can be used by internal and external parties, including certification bodies, to assess the organization‘s ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization‘s own requirements.

The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.

ps. Next Step is a Process approach.

DRAFT INTERNATIONAL STANDARD ISO/DIS 9001 (ISO9001:2008)

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 9001 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems.
This fourth edition cancels and replaces the third edition which has been technically revised. Annex A of this International Standard is for information only.

ps. Next content will be Introduction of Draft International Standard (ISO9001update to Version 2008).....SOON....

Draft ISO9001:2008 / ISO DIS 9001

Dear all,





I have met the draft of ISO 9001:2008 or ISO/DIS 9001 in Internet.


You can see in this link:


http://www.isoclubthailand.com/images/1196105513/ISO_DIS_9001__E_[1].pdf



Steven Lee

ISO 9001:2000 Lead Auditor Training

ISO 9001:2000 Lead Auditor Training (RABQSA Certified)
To become a lead auditor: If you satisfactorily achieve the required pass points for the written examination and the required minimum grading for the continuous assessment, you will receive a "Successful Completion" certificate to demonstrate that you have met the training requirement for individual QMS auditor certification by the RABQSA. Before becoming a Lead Auditor, there are also professional requirements that must be met, including conducting a number of verifiable audits, educational requirements, workplace experience, and sponsorship.

This RABQSA certified course meets the training requirements for RABQSA Quality Management Systems Lead Auditors, Auditors and Provisional Auditors. This course makes extensive use of student activities and case studies to help students fully understand the requirements of auditing to the ISO 9001:2000 standard. Lecture time is held to a minimum providing students time to learn and then practice their newly acquired skills in real-life audit situations that assure that students are prepared to conduct effective audits.

ISO 9001:2008 - What’s new and what will stay the same?

Just recived this email from DQS german auditing company.The current revision of ISO 9001 is making strong progress. It is already scheduled to be published in October 2008, according to the responsible ISO committee ISO/TC 176/SC 2.What do organizations have to expect from the new ISO 9001:2008? Basically no major changes at all. There is one important message to remember: There won’t be any new requirements. Compared to the current version, the only difference will be minor editorial changes.One example:ISO 9001:2000If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4).ISO 9001:2008 (Draft)If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer and maintain records (see 4.2.4).A draft ISO/DIS 9001 is scheduled to be published in September 2007.
From http://elsmar.com/Forums/member.php?u=33547

I believe Piney has combined information
on ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000.

ISO 9000:200X is already at the FDIS (Final Draft Interantional
Standard) stage. This means that ISO 9000:200X could be published as an
International Standard by the end of 2005.

The plan is to Amend ISO 9001:2000 and to Revise ISO 9004:2000. Amend means to
clarify content to improve useability of the
standard. There should be no changes to requirements. Revise means to clarify
and to change requirmeents. Keep in mind that ISO
9004 is a non-normative standard. There really are no requirements within ISO
9004 from a certification standpoint. There are requiremtns

within ISO 9004 if an organization chooses to implement it for improvement
purposes.


Both the amendment to ISO 9001 and the revision to ISO 9004 are expected to be
completed by 2008 based on how long the amendment / revision process has taken
in the past. If there are lots of arguemnts and
disagreement amongst member bodies, it may take even longer.


Regards, Dirk

from http://elsmar.com/

Contents of ISO 9001
ISO 9001:2000 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. Outline contents are as follows:
Page iv: Foreword
Pages v to vii: Section 0 Introduction
Pages 1 to 14: Requirements
Section 1: Scope
Section 2: Normative Reference
Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)'
Pages 2 to 14 ** Section 4: General Requirements
Section 5: Management Responsibility
Section 6: Resource Management
Section 7: Product Realization
Section 8: Measurement, analysis and improvement
In effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS.
Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards
Page 23: Bibliography
The standard specifies six compulsory documents:
Control of Documents (4.2.3)
Control of Records (4.2.4)
Internal Audits (8.2.2)
Control of Nonconforming Product / Service (8.3)
Corrective Action (8.5.2)
Preventive Action (8.5.3)
In addition to these, ISO 9001:2000 requires a Quality Policy and Quality Manual (which may or may not include the above documents).

ISO 9000 Series

ISO 9000 includes the following standards:

* ISO 9000:2005, Quality management systems - Fundamentals and vocabulary. Covers the basics of what quality management systems are and also contains the core language of the ISO 9000 series of standards. A guidance document, not used for certification purposes.
* ISO 9001:2000 Quality management systems - Requirements is intended for use in any organization which designs, develops, manufactures, installs and/or services any product or provides any form of service. It provides a number of requirements which an organization needs to fulfill if it is to achieve customer satisfaction through consistent products and services which meet customer expectations. It includes a requirement for the continual (i.e. planned) improvement of the Quality Management System, for which ISO 9004:2000 provides many hints.

This is the only implementation for which third-party auditors may grant certification. It should be noted that certification is not described as any of the 'needs' of an organization as a driver for using ISO 9001 (see ISO 9001:2000 section 1 'Scope') but does recognise that it may be used for such a purpose (see ISO 9001:2000 section 0.1 'Introduction').

* ISO 9004:2000 Quality management systems - Guidelines for performance improvements. covers continual improvement. This gives you advice on what you could do to enhance a mature system. This standard very specifically states that it is not intended as a guide to implementation.

There are many more standards in the ISO 9001 family (see "List of ISO 9000 standards" from ISO), many of them not even carrying "ISO 900x" numbers. For example, some standards in the 10,000 range are considered part of the 9000 family: ISO 10007:1995 discusses Configuration management, which for most organizations is just one element of a complete management system. ISO notes: "The emphasis on certification tends to overshadow the fact that there is an entire family of ISO 9000 standards ... Organizations stand to obtain the greatest value when the standards in the new core series are used in an integrated manner, both with each other and with the other standards making up the ISO 9000 family as a whole".

Note that the previous members of the ISO 9000 family, 9001, 9002 and 9003, have all been integrated into 9001. In most cases, an organization claiming to be "ISO 9000 registered" is referring to ISO 9001.