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12602-BSI-ISO-PRODUCT-GUIDE-XDOC-220711:Guide 22/7/11 11:26 Page 1
What is ISO 9001?
ISO 9001 is the world’s most popular quality management
system standard. It covers how organizations should
manage their activities to be as efficient as possible, and it
concentrates on what organizations should do to make
sure that their customers’ requirements are met
Why use this standard?
ISO 9001 saves and makes you money. There is a great deal
of evidence to show that ISO 9001 helps organizations
improve customer satisfaction, reduce costs and operate
more efficiently with more involved and motivated staff.
Also companies can attract new business because a lot of
organizations look for ISO 9001 certification as evidence
that their suppliers are well-run companies.
Additionally, most organizations are interested in growing.
ISO 9001 puts robust structures in place to manage how
everything is done, and strip out wasted effort. This
gives managers more time to invest in making
2Profit from more satisfied customers with BSI
BSI Quality ROI Calculator –
showing the financial benefits
of ISO 9001 certification
ISO 9001 can help you save and make money and BSI’s
new, unique and free Return on Investment (ROI)
calculator can show you how.
The tool is based on the findings of independent
academic researchL which shows that organizations with
ISO 9001 certification financially outperform those
without. Such financial benefits are supported by the
experiences of thousands of BSI’s customers. The tool
enables you to compare the cost of certification with the
financial benefits you could expect from it.
Support your business case for investing in ISO 9001.
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Call 0845 080 9000 now.
12602-BSI-ISO-PRODUCT-GUIDE-XDOC-220711:Guide 22/7/11 11:26 Page 2
ISO 9001 has been designed so that it can be used by any
organization, large or small, whatever its products or
services. Here we explain some of the basics.
A management system is simply the way an organization
manages it processes, people and other resources so that
its products or services meet organizational objectives and
For example, your objective may be to satisfy your
customers’ quality requirements; or to comply with
statutory regulations; or to achieve specific turnover or
A management system is usually a combination of policies,
processes, procedures, training, forms and records that
enable your business to operate effectively to meet its
The ISO 9001 standard
ISO 9001 provides a set of requirements to be met when
you set-up and operate a quality management system.
These requirements constitute international best
practice for managing quality.
The requirements are a distillation of all
the best ideas from hundreds of
experts and users for more than 30
years. The standard is very well tried
and tested and regularly updated.
How organizations meet the
requirements is entirely up to them,
depending on what works best for
the individual company.
The Plan-Do-Check-Act (PDCA) cycle is the operating
principle of all ISO management system standards. By
following this cycle, you can manage and continually
improve your organization’s effectiveness.
Plan – establish objectives and make plans (analyse your
organization’s situation, establish overall objectives, set
interim targets and develop plans to achieve them).
Do – implement your plans.
Check – measure/monitor your actual results against
Act – correct and improve your plans to get better results.
Whether you are the managing director setting the
direction of the business, or an individual carrying out a
specific task, the PDCA cycle is very useful in achieving
Understanding the basics
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System approach to management
When you identify, understand and manage interrelated
processes as a system, it contributes to the organization's
effectiveness and efficiency in achieving its objectives.
Continually improving your organization's overall
performance should be a permanent objective.
Factual approach to decision making
Effective decisions are based on the analysis of data and
Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and a
mutually beneficial relationship enhances the ability of both
to create value.
The principles behind ISO 9001
ISO 9001 is built around eight management principles that
guide and inform everything in it. They are:
You need to understand current and future customer
needs. You should meet customer requirements and strive
to exceed customer expectations.
Leaders establish unity of purpose and the direction of the
organization. Leaders should create and maintain an
environment where people can become fully involved in
achieving the organization's objectives.
Involvement of people
People at all levels are the essence of an organization and
their full involvement enables their abilities to be used for
the organization's benefit.
Your desired result is achieved more efficiently when
activities and related resources are managed as a process.
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Plan – management responsibility
This part of ISO 9001 gives management a powerful
planning tool. The starting point is for managers to show
commitment to the successful operation of the
management system through being involved.
The individual requirements take managers through the
following sequence of activities:
Customer focus. Find out what the customer’s current and
future needs and expectations are at a strategic level. How
you do this is up to you.
Quality policy. Use the information gathered from the
customer to write a quality policy that is relevant to the
purpose of your organization.
Objectives. Establish measurable objectives for the
organization to help you achieve the aims of the quality
Plan the system. Allocate responsibilities and establish
effective processes to achieve your objectives.
Review the operation of the system at regular
intervals. Improve it where necessary. Ensure appropriate
resources are provided.
ISO 9001 in more detail
Quality Management System Model reproduced with permission from ISO
OF THE QUALITY MANAGEMENT SYSTEM
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This involves the facilities and equipment you need to
perform effectively. Start by determining and providing
what is needed. Review this regularly.
Here you look at the conditions under which work is
performed and ensure that this is appropriate for meeting
customer’s requirements. Again, review this regularly.
Plan – resource management
The resource management part of the standard makes sure
that you review and provide the resources needed to
implement and improve the system.
Resources are looked at in three ways: people,
infrastructure and work environment.
• Decide the competencies and skills needed within the
• Then look at the people that you have and identify gaps
in existing competencies.
• Fill those gaps by providing training and coaching or
• Review how effective the actions taken have been in
helping you achieve the required competancies for the
• Through these techniques you always know whether the
training you provide is actually adding value to the
organization and contributing to results.
ISO 9001 in more detail
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Don’t worry if some of the topics here do not relate to you.
Remember, ISO 9001 is designed to be used by all types of
organizations. You simply concentrate on the areas relevant
Make sure at each stage that people understand their role
and are competent to carry out tasks in line with business
policies, procedures and objectives.
ISO 9001 in more detail
Do – product or service realization
You now have the commitment and direction from
management and the necessary resources to do the job.
ISO 9001 goes on to give you a set of requirements for
managing the work you do. Start with planning. Plan the
journey from the point where the customer asks for
something, right through to delivery (and beyond if
necessary). Typically this involves defining the processes for:
• Design and development
• Production / operational / service activities
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Check and act – measurement analysis and
Don’t stop once you deliver to the customer. Go on to find
out whether the customer is satisfied. Take other
measurements of the system’s performance, analyse these
and identify the areas for improvement. Again, the
standard provides you with a set of requirements for
achieving this using tried and tested techniques.
This involves the monitoring of customer perception. It
does not mean that you have to send questionnaires to
your customers. There are many different ways of
monitoring perception. You can use methods relevant to
Conduct reviews of your system to make sure that things
are going to plan.
Monitoring and measurement of products
Individual processes drive the system and it’s important
that they are operating effectively and efficiently. Products
should also be measured and monitored to ensure that you
are meeting the customer’s requirements.
Control of non-conforming products
If something goes wrong, procedures should be in place
to ensure that the problem is controlled and dealt with
Analysis of data
Using the standard effectively will produce data on how
effective your systems are. Use the data to find
One of the key objectives of ISO 9001is to make sure that
your organization improves. Using the results of the
analysis will help you to determine where those
improvements can be made.
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ISO 9001 in more detail
12602-BSI-ISO-PRODUCT-GUIDE-XDOC-220711:Guide 22/7/11 11:26 Page 8
1 Top management commitment is vital if the
system is to be implemented successfully. Make
sure senior managers are actively involved,
approve resources and agree the key processes in
2 Look at what systems, policies, procedures and
processes you have in place at the moment.
Then compare those with what ISO 9001 asks for.
You may be surprised at how much you already
do. ISO 9001 will allow you to keep the things
that work for you while refining those that don’t.
3 Make sure you have good internal
communication channels and processes within
the organization. Staff need to be involved and
kept informed of what’s going on.
4 Give some thought to how departments work
together. It’s important that the people within
your organization don’t work in isolation but
work as a team for the benefit of the customers
and the organization.
5 Don’t ignore the impact that introducing these
systems will have on your customers and
suppliers. Speak to them to gain insight as to
how they view your service and how they feel
improvements could be made.
6 Clearly lay out a well-communicated plan of
activities and timescales. Make sure everybody
understands them and their role in achieving
7 The nature and complexity of your documentation
will depend on the nature and complexity of your
organization. ISO 9001 only defines the need for
six procedures. What you have in addition to this
is up to you. Consider using your IT systems or
software such as BSI’s Entropy® Software to
manage your system and documentation more
8 Make the achievement of ISO 9001 engaging
and fun. Use competitions, such as for the first
completed process. These will increase
9 Train your staff to carry out audits of the system.
Auditing can help with an individual’s
development and understanding as well as
providing valuable feedback on potential
problems and opportunities for improvement.
10 And finally, if you feel that you are doing
something just for the sake of ISO 9001 and it
doesn’t add any value to you as a business,
question whether it’s necessary. Nine times out
of ten it won’t be needed.
Ten tips on making ISO 9001 effective for you
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1. Make contact
Get in touch and tell us what you need, so that we can
sort out the best services for you. We’ll then give you a
proposal detailing the cost and time involved.
2. Complete BSI’s application form
We’ll assign you a Client Manager, who will be your point
of contact through the process – and beyond. They’ll have
an excellent understanding of your business area and will
support you as you move forward to the assessment and
certification of your quality management system.
3. Consider training
Whether you’re seeking to implement a quality management
system or would like to increase your general awareness of
ISO 9001, there are a range of workshops, seminars and
training courses available.
4. Gap analysis
We can carry out an optional gap analysis, also called a
Pre-Assessment, of your existing management system
against the requirements of the standard and identify any
omissions or weaknesses that need resolving before formal
5. Formal assessment
We’ll do a two-stage assessment. First a desktop review of
your management system against ISO 9001 identifying any
omissions or weaknesses that need resolving before Stage 2
when we’ll conduct a full on-site assessment.
6. Certification and beyond
Once the assessment has been successfully completed,
we’ll issue a certificate of registration, clearly explaining the
scope of your management system. The certificate is valid
for three years, and your assessor will visit you regularly to
help you make sure that you remain compliant, and
support you in the continual improvement of your systems.
The key steps in getting certified to ISO 9001
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BSI keeps you informed
BSI’s publications draw on a wealth of expert knowledge
from across industry. They are particularly useful when you
are getting started. Standards and publications can be
purchased individually, as a kit, or as part of an annual
Key ISO 9000 standards and publications are:
ISO 9000 – describes the fundamentals of quality
management and defines terms used in the ISO 9000
quality management ‘family’ of standards.
ISO 9001 – is the core document. It specifies the
requirements for a quality management system.
ISO 9004 – provides guidance to organizations to support
achieving sustained success with a quality management
BIP 2013 – understanding ISO 9001 and process-based
BIP 2014 – creating a process-based management system
for ISO 9001
These standards and publications are available from our
online shop at www.bsigroup.com/shop.
Fast forward with BSI training
BSI has a comprehensive range of ISO 9001 training
courses. Our introductory courses broaden general
awareness of customer-focused business practice, and our
implementation and auditing courses take that knowledge
further to drive change within your organization.
Our training comes in a number of formats including open
schedule courses, in-company training, eLearning modules
and distance learning qualifications. Visit
or call 0845 086 9000 for details.
Manage information with Entropy® Software
BSI’s Entropy® Software system is used by leading
companies at over 14,000 sites around the world to
improve their business performance and manage their risks.
For further information please visit
www.bsigroup.co.uk/entropy, call 0845 080 9000 or
Show you meet the standard with certification
Independent assessment by BSI will assure you and your
key stakeholders that your quality management system
meets the requirements of ISO 9001.
Before the formal certification assessments, BSI can perform
a gap-analysis (a review of what you do compared with the
standard’s requirements) to help identify the areas that need
to be tackled to achieve certification smoothly. You can also
use our online Self-Assessment Tool.
When your certification has been awarded by BSI you have
a market differentiator that is recognized worldwide. BSI
also works with you to promote your achievement. For
more information visit www.bsigroup.com/certification
or call 0845 080 9000 now to start your journey to be a
more successful business.
BSI supporting you every step of the way
- ROI Calculator
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From beginners through to advanced users, BSI has a broad range of Quality solutions
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