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9001 was founded in 1987 as an internationally-accepted quality management
certification system to define, identify, and confirm quality benchmarks
within organizations. But since then it has become much more. Today, ISO
9001 is helping thousands of companies worldwide manage their processes
to become more efficient and cost-effective. Progressive companies
are finding the ISO 9001 process can offer real strategic value, especially
if it is aligned with corporate goals and objectives. For these companies,
the ISO 9001 auditing process is more than running down a checklist—it
is a true business asset. To apply this model successfully, you need to
work with a certifying organization that understands your business and
mirrors your commitment to quality and continual improvement.
TÜV SÜD America's Insight
As the ISO 9001 auditing process has evolved over the years, so has TÜV SÜD America.
We've taken the process to new heights with Insight Auditing. It's more
than a process, it's an attitude. Our auditors are experienced, well-trained
and insightful. But above all, they're passionate about their work. They
come to your facility with a fresh eye and out-of-the-box thinking. They
take the time to listen to you and understand your business-so they can
add value beyond the auditing process. TÜV SÜD auditors strive to work
as business partners with you. At each engagement we "read between
the lines" of the audit to uncover observations that can lead to
increased efficiency, reduced costs and increased speed to market.
of ISO 9001
The International Organization for Standardization (ISO) was founded 1946.
Based in Geneva, Switzerland, it created the first international standards
for manufacturing, trade and communications. ISO 9001 was initially published
in 1987 and specifies, in broad terms, the
necessary components of a quality management system and, in detail, the
basic requirements of the quality function for all industries.Today, more than
90 countries are members, with the U.S. representative being the American
National Standards Institute (ANSI). There are over 700,000 ISO 9001 certified
companies around the world (including more than 50,000 in North America),
all demonstrating a commitment to continual improvement in quality.
The most recent change
to the ISO 9001 standard is ISO 9001:2008. This new standard is now in
place and includes improvements in these key areas:
- Provides greater clarity, consistency and ease of use.
- Incorporates 37 sanctioned interpretations requested through the official interpretations process.
- Improves usability for "service" organizations.
- Improves compatibility with ISO 14001:2004.
ISO 9001 will continue
to evolve to meet the needs of an ever-changing marketplace and to ensure
adherence to quality standards. In fact, TÜV SÜD experts are part of
the ISO Technical Subcommittee working on the development of the next
Partnerships Through ISO 9001
Compliance with ISO 9001 demonstrates to other companies that you take
quality and customer satisfaction seriously. Companies with a similar
philosophy will know you share their commitment. Many companies, both
in the US and abroad, insist suppliers have a certified quality system
in place as a condition of doing business. This requires suppliers to
use sub-suppliers to comply with quality standards to ensure quality throughout
the supply chain. A company with ISO
9001 certification has a competitive edge over nonqualified companies.
Any company can make claims about quality; ISO 9001 certified companies
have proof of their commitment to quality and continuous improvement.
Who would you rather build a business partnership with?
Increases The Many Benefits of ISO 9001 Certification
The difference in ISO auditing
is found when the chemistry between your ISO auditors and staff creates
a bond that becomes more than the sum of its parts. Not only are problems
solved and opportunities uncovered, there is added value extending to
areas you may not expect.
Implementing our Insight Auditing process within
the context of an ISO 9001 certification can also verify your organization's
quality process is aligned with your business strategy. This alignment
is critical to ensure your organization functions smoothly and processes
complement the company's overall mission and vision.The initiation of
ISO certification may have started because of troubles conducting business
internationally or from certification demands from a customer. Once the
spirit of quality management and continual improvement is embraced, organizations
experience a wide range of unexpected benefits beyond certification and
extending throughout their organizations.
- Improved customer
- Increased profits.
- Enhanced marketplace
- Break down of
internal organizational boundaries as staff from different functions
and levels work together.
- Increased productivity
as the correct data, equipment, tools and documentation are integrated
into the total process.
- Decreased operating
costs due to fewer problems and reduced rework
not to mention fewer
returns and lower after-sales support costs.
- Increased employee
responsiveness to customer needs and requirements
focus on driving
- Elevated confidence
among sales force as quality improves.
- Improved employee
understanding of how ISO efforts, quality management systems and your
business strategy are aligned for organizational improvement.
Value From ISO 9001 With TÜV SÜD America
Implementing ISO 9001 focuses on establishing the quality mission, policies
and procedures that form the foundation of an effective and quantifiable
quality management system.Achieving certification
can seem a bit overwhelming. Like most larger-scale initiatives, there
are a number of steps to take prior to the certification to minimize cost,
reduce risk of failure and maximize value.
STEP 1 - MANAGEMENT
A commitment from senior-level management must be a driving force in this
critical initiative. Again, this is not simply running down a checklist,
this is a commitment to the culture of quality. Employees must understand
and embrace the corporate vision. Management must reinforce and demonstrate
their commitment by providing necessary resources and on-going support
for the process.Now is the time to
make sure the ISO 9001 initiative is aligned with corporate goals and
strategy. Establishing clear and quantifiable business objectives will
help keep the process on track and people focused on the appropriate goals.
As part of our Insight Auditing approach, we also audit how your business
strategy is integrated into your operational processes.Commitment also involves
assigning responsibility and authority for quality initiatives, planning,
problem identification, solution implementation and control. One person
should have ultimate responsibility for the project. The ISO 9001 "management
representative" must report directly to top management.
STEP 2 - PLANNING
(NO ONE PLANS TO FAIL, BUT SOMETIMES WE FAIL TO PLAN)
Planning is the second step to certification. In addition to selecting
an ISO 9001 management representative, you need to appoint a task force
to champion the development and implementation process. The members should
have knowledge of ISO 9001 and program management experience. Senior management
should either be a part of this task force or provide very visible support.
Not only does this help from an operational level, it also ensures the
process stays on track with the strategic business goals of your company.The task force is
responsible for creating the implementation plan. This includes roles,
responsibilities, deliverables, time lines and budget. The implementation
time line should include:
- Building a project
support team that includes all applicable departments.
- Documenting the
initial tactics to help reach quality process goals.
- Creating a general
training program to educate all workers about the new quality initiative.
- Establishing internal
- Reviewing and
implementing new process documentation.
- Scheduling internal
about change can be disturbing to uninformed employees. Keep the lines
of communication open about your ISO 9001 activities. You need to help
employees understand the value of this effort. They need to hear this
from all levels of your organization.
STEP 3 - DOCUMENTATION
If you've been in business for a long time, you probably have a lot of
documentation. Chances are much of it is uncontrolled, inadequate or even
obsolete. If you're a start-up you probably don't have much documentation.
In either case, ISO 9001 documentation standards are very clear. This
is an area that requires attention to detail, commitment to effective
implementation and to maintenance.One good way to start
this process is to separate your documentation into tiers, with each tier
representing a different level of detail.
One: Quality Manual.
Required by ISO 9001, this manual identifies the strategies and policies
of your organization and relates, on a macro-level scale, how your organization
will address the requirements of the standard, and answers the question, "Why does your business do what it does?"
Two: Processes and Procedures.
Next, your organization will need to identify the processes under which
your company operates. Often, these processes can be separated into two
groups: "key" processes (sometimes referred to as "customer-oriented" processes) and, support processes (e.g., organizational processes supporting
key processes such as human resources, training, preventive maintenance,
document and data control, etc.). Some processes, depending upon their
criticality to your organization or whether they are addressing specific
requirements of ISO 9001:2008, may have to be documented in a formal procedure.
Other processes simply may be described in the Quality Manual with sufficient
detail to ensure the process is capable of being understood and effectively
implemented. Either way, processes and procedures should detail such aspects
as what should be done, when and where it will be done and who will do
Three: Work Instructions.
Work instructions provide details on how specific tasks or operations,
as identified in Tier 2 Processes and Procedures, are to be performed.
The need for work instructions can be based upon the complexity and /
or criticality of the task at hand and the qualification and competency
of the workforce.
Four: Quality Records.
To some extent, your organization will have to add a fourth tier to include
forms, charts, illustrations or checklists used on a daily basis. These
documents are generically referred to as Quality Records as they demonstrate
evidence of activities performed or results achieved.Organizational processes
and documented procedures are a critical part of an ISO 9001 quality management
system. They define the correct and proper operation of a company from
a quality perspective and are applicable to all operations within your
organization, to include product development, service provision, production
and delivery systems. An independent ISO 9001 Certification Body (quality auditing
organization) verifies that processes and procedures are followed and,
that the quality management system is effective in achieving your organizations'
may appear that ISO 9001 generates a huge amount of documentation, however,
many companies find that it actually reduces their dependence on paper.
As not all processes are required to be documented in procedure form,
and the determination of the need for documented procedures and work instructions
is based upon many different factors, processes may also be "documented" in the form of flowcharts, visual aids, data bases, and other media forms.
Help For Your ISO 9001 Audit
If you're ready to start the process, there is plenty of support available
to you. ISO 9001 seminars are available from TÜV SÜD America and other
organizations. These will give you a better appreciation of the ISO 9001
process and how it can help your company.There is a tremendous
difference between reading the ISO 9001 requirements and knowing how to
establish and implement the systems that meet the requirements.
can offer a variety of assistance on ISO 9001 quality awareness training,
system evaluation, documentation writing/review and internal auditor training.One sign of an experienced
consultant is someone who actively engages all appropriate levels of personnel
in the process. Experience within your marketplace, specific international
knowledge and the right "chemistry" are other considerations. Using a consultant
will increase your cost. However, the guidance and experience of the consultant
may reduce the time it takes for you to achieve your ISO 9001 certification.
Certification Bodies (like
TÜV SÜD America and TÜV SÜD Canada) are not allowed to consult. We cannot
advise you on how to solve a problem. We do highlight where problems exist.
The strict separation of auditing and consulting is a fundamental ethical
requirement of all ISO 9001 Certification Bodies. Selecting the right
Certification Body for your situation is critical. Cutting corners at this stage
could jeopardize your entire quality initiative. You need to find a Certification Body
that will work with you as a partner, take the time to learn your organization's
needs within the context of your ISO 9001 effort and reflect your passion
from TÜV SÜD America
is strict and exacting. It should be more than a checklist of what is
done or not done to requirements. Used properly, it can be empowering
and dynamic, providing information that can help drive organizational
improvements. Over the years, TÜV SÜD America has refined its approach helping
companies maximize the value of ISO 9001 certification. Our auditors are
trained to think outside-the-box to maximize the value of the ISO 9001
certification process. We call this the IDEAL Process.
The four phases
of this process include:PHASE 1 - INFORMATION
The process begins with an informational meeting between your company
and the TÜV SÜD team. We summarize our role and explain the auditing
we listen. We listen to understand your business goals and strategies
so we can help you develop a quality initiative that can best support
your organization now and into the future. During this meeting
we'll answer any questions about our services and explore how we should
work together as a team. You will also have the opportunity to talk with
Team chemistry is an important part of any audit. We want
to set the foundation for a lasting relationship. During our initial series
of information meetings we will identify any specific issues that need
to be resolved prior to the actual audit.
One important consideration
in the information phase is the opportunity for a pre-audit. It is not
a formal requirement for certification. A pre-audit is a high level evaluation
indicating where your company currently stands in compliance with ISO
9001. If you are new to ISO 9001, this will help educate your management
and staff on what is about to occur.
You'll become more familiar with
our auditors and our Insight Auditing approach and we'll learn more about
the processes within your company. Your auditor will point out any areas
of concern. Addressing issues at this point reduces risk of nonconformance
during the actual audit. This early observation can be immediately implemented
into your management system, so you can benefit from our insights before
the actual audit even starts.
PHASE 2 - DISCOVERY
Most Certification Bodies call this phase "documentation review," performing
a quality manual review prior to the audit. At TÜV SÜD America, we conduct
a more thorough "discovery evaluation" of your documentation.
Over the years we've found many audit nonconformances result from documentation
problems and the procedures relating to documentation. So we've added
a process to help your team at this stage.
We review the quality manual
and the supporting procedures. Most auditors only review the quality manual.
We can discover a significant amount of documentation-related problems
at this stage. In some cases we make 10-20 observations during this review.
You can use the supplied report to make any necessary changes before the
audit. This saves time, money and reduces the stress surrounding the audit.In addition, TÜV
SÜD reviews your organizational profile, which is an outline of your organization's
operating environment. This profile includes a description of your organization,
customer and market requirements, supplier and partnering relationships,
competitive situation and strategic context of your operations. This review
allows our audit team to better understand your business before we come
to your site, so our Insight Auditing can begin long before we
audit your facility.
During the entire
discovery evaluation process the audit plan is being developed. Our auditors
gather all pre-audit and relevant data and construct more than a checklist.
The Insight Auditing approach to creating the audit plan is designed to
reflect your company's audit priorities and help align your overall business
goals/objectives with the quality initiative.
PHASE 3 - AUDIT
After all the planning and preparation comes the actual audit.The length of the
audit depends on the size of the business. A small business may be audited
by a single auditor in one day. A large organization may require a team
of auditors working over several days. If a number of facilities perform
identical tasks, we use sampling techniques to minimize the number of
locations visited. Audits are typically performed by:
- Touring your
facility and observing ongoing operations.
- Interviewing employees
working at various levels in your organization.
- Reviewing documentation
and evaluating quality records.
The audit team collects
evidence that your company has implemented a quality management system
in compliance with the ISO 9001 standard and that your practices match
the descriptions captured in your quality documentation.TÜV SÜD America's Insight
Auditing process then takes it one step further. The quality management
system is then evaluated against your business objectives, strategies
and vision statement. All must be aligned to ensure overall success and
During the auditing
process our auditors will probably ask a number of intriguing questions.
During the closing meeting you'll see the value of these questions and
Insight Auditing. Our auditors are sensitive to the needs of your business
and the integrity of the ISO 9001 process. In addition to the ISO requirements,
we'll also present a series of observations. We can't consult but we can
point out areas for improvement. Our auditors are trained to look beyond
the numbers and uncover findings you can use to increase efficiency, process
effectiveness and quality. This is what Insight Auditing is all about.
A closing meeting
is conducted at the audit's completion and all identified problems are
reviewed. The audit team will also share its recommendation regarding
your certification. If all goes well, your company will be recommended
for certification and issued an ISO 9001 certificate. If nonconformances
are identified, the audit team will confer with you and agree upon the
required follow-up actions. Certification is not a "pass/fail" activity. It is an eventual certainty unless you decide not to proceed
or can't correct the nonconformance.
PHASE 4 - LEARNING
Following the certification audit, an auditor will return periodically
(once or twice a year) for routine surveillance visits. This ensures that
your management system continues to comply with ISO requirements and continuously
improves.The audit team will
evaluate portions of your quality system for evidence that the system's
original baselines are still being followed.
A quality system
is dynamic. The audit team also looks for evidence of continual improvement.
If processes or procedures change and the changes are beneficial in meeting
organizational objectives that indicates your system is working well.While this seems
like the end, this is a phase that never ends.TÜV SÜD America's Insight
Auditing® approach, including the IDEAL Process, is a unique
combination of longer-term business strategy and shorter-term operational
We don't simply monitor procedures. Using the IDEAL Process,
we strive to bring findings to your attention that may directly improve
your quality program. At the same time our Insight Auditing discipline
continues to align your business strategy and corporate vision with your
organization's operational process. We constantly keep an eye on your
business so you can use your quality system to improve today and set the
stage for future growth tomorrow.
on Your ISO 9001 Certification
ISO 9001 certification is the first step in a never-ending journey toward
continuous improvement. Now you have the foundation to integrate your
quality process into your company's overall business plan. You can also
use this certification as springboard toward more advanced high-performance
business models such as Six Sigma or the Malcolm Baldrige National Quality
Program Criteria.So where do you begin?
Contact TÜV SÜD America today. We'll show you how to get started on the road
to ISO 9001 certification and how our Insight Auditing approach can bring
your quality management system to a new level of effectiveness.
For more information, contact us.