ISO 9000 In Healthcare:
A Guide To Its Implementation
Quality and customer satisfaction are key priorities
for today’s most successful organizations. Where the
market place is competitive, there are significant
efficiency pressures, and consumer’s demands are
increasing, success does not just happen. Attaining
it requires commitment, buy-in, and the appropriate
management system. While commitment starts with
management, and depends upon the organization,
several frameworks exist to assist in developing the
management system. One such framework is the
globally recognized ISO 9001:2000.
ISO 9001:2000 is a standard, which provides
organizations with a guide to achieving the goals of
quality, and customer satisfaction. It has been
successfully implemented by hundreds of thousands
of organizations, in a wide variety of industries, with
healthcare being no exception. BSI Management
Systems itself has customers from a wide range of
healthcare industries, including hospitals, medical
practices, nursing homes, dentistry, oncology,
ambulance services, and support services.
This guide provides an overview of the application of
ISO 9001:2000 to healthcare. The guide highlights
significant opportunities to implement ISO
9001:2000, and subsequently become registered to
the standard by a registrar like BSI Management
THE USE OF QMS IN HEALTHCARE
In recent years, quality and QMS have gained
significant support in the healthcare industry in North
America. While this has not always been the case,
governments, regulators, industry bodies, healthcare
providers, and support service organizations, are
realizing that through implementing frameworks like
ISO 9001:2000, they can improve quality and
reliability, and increase efficiencies. This can mean
an improved service, a reduction in adverse events,
and ultimately a lower cost of provision.
Organizations such as the JCAHO, Health Canada
Accreditation, the American Society for Quality, the
Institute of Medicine, the Canadian Council on
Health Services, the Automotive Industry Action
Group, the National Association of Manufacturers,
and the Baldrige National Quality Program (National
Institute of Science and Technology), have all
identified quality, and customer service as important
areas for improvement in healthcare.
BENEFITS OF USING A QMS
ISO 9001:2000, derives a number of benefits for
healthcare organizations, including:
• Potential for efficiency gains and cost
reduction: ISO 9001:2000 can create significant
efficiency gains because of its process
orientation. The standard focuses organizations
upon areas where costs can be reduced, both
internally, and in relation to its customers.
• Potential for quality and reliability
improvements: The process orientation, and
the need to be customer focussed and
continually improve, provide significant
opportunities to increase the reliability, and
quality of healthcare. ISO 9001:2000 provides
opportunities to standardize the service
throughout organizations, and the healthcare
industry as a whole.
• Potential for regulatory support and funding:
Increasingly, regulators and legislators are
regarding quality as vital to improving
healthcare. Bodies such as the JCAHO, Health
Canada, and Institute of Medicine have
emphasized this. Registration may therefore
lead to greater funding and support.
• Potential to simplify the implementation of
other quality systems: ISO 9001:2000 has the
potential to make accreditation and conformity to
other requirements much simpler. It has been
regarded as a building block to JCAHO
accreditation, and the Baldrige awards.
• Potential for an improved care process: ISO
9001:2000 focuses organizations on the
processes involved. In healthcare it can improve
the organization’s understanding of the
complexities of the industry, including the
relationships between organizations such as
hospitals and medical practices.
• Potential for Differentiation:
Registration differentiates an organization from
its competition. It shows customers that the
organization is committed both to their needs,
and improving the quality of the service they
• Potential for continuous improvement: ISO
9001 stipulates the importance of review, and
continual improvement. In healthcare, where
these are paramount, registration can be
ISO 9001:2000 VERSUS ISO 9001/2/3:1994
Many people may be familiar with the 1994
version of ISO 9000, the forerunner to ISO
9001:2000. At the time however, they may have
deemed it inappropriate for their organization.
The successor, ISO 9001:2000, however
contains a number of significant changes that
should encourage a reassessment of the
standard’s applicability. Two of the most
significant changes are:
A Process Approach: One of most significant
principles (and most different from ISO
9001:1994) is the process approach. It is based
on the idea that organizations should understand
what they do, and the processes that affect this,
that is the processes that result in the provision
of a product or service. The standard focuses
upon these processes and the interactions
between them. Examples of this include the
importance placed on supplier/customer
relationships, the importance of input and
outputs, and the likelihood that one output is an
input for another process.
Measurement, Analysis & Improvement:
Since 1994, the importance of measurement,
analysis, and improvement has been upgraded.
It focuses organizations on the outcome and
success of the management system. This helps
your organization improve and conform to
requirements within the industry.
THE CONCEPT ISO 9001:2000
The ISO 9001:2000 standard is a generic document,
allowing for interpretation and implementation by
both the manufacturing and service sectors. It
focuses upon specific principles, which should be
adhered to. The standard however affords a
significant degree of freedom to develop a QMS,
which suits the organization, as long as it conforms
to these key tenets.
ISO 9001:2000 PRINCIPLES
• Customer focused organization
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationship
One of most significant principles is the process
approach (see box below). This focuses the
organization on what it does. The process approach
links business objectives and results more closely.
The standard is based around the core concept of
Plan-Do-Check-Act, and focuses the organization on
the processes, which are key to its operation. It also
builds in the ideas of planning, and reviewing, and
the fact that organizations should strive to
Source: BS EN ISO 9001:2000
ISO 9001:2000 & HEALTHCARE
The principles and structure of ISO 9001:2000 mean
it can be applied to healthcare, as easily as it has
been applied to the manufacturing industries in the
past. More specifically it can be implemented by any
organization in any sub-segment, regardless of their
size. It is applicable to hospitals, and medical care
facilities, as well as support services, such as
laundry and cleaning.
THE HEALTHCARE PROCESS
Generically, healthcare is based around the care of
the patient, with an organization’s typical goal being
to ensure the effective passage from the patient’s
enquiry through to their discharge, and their
APPLICATION OF THE ISO 9001:2000 CONCEPT
ISO 9001:2000 promotes a focus on the customer,
and their satisfaction from the service provided. In
healthcare, this is often regarded as the patient.
However, there are several other stakeholders that
are customers. This includes the automotive
manufacturers and other organizations that pay for
health insurance, the health insurance companies
themselves, families, and other healthcare
Taking the approach that the patient is the primary
customer, the Plan-Do-Check-Act principle can be
applied as follows:
At a generic level, the diagram highlights some of
the processes involved in healthcare. More
specifically, these might include:
While this highlights some of the processes that may
occur, there are many more organizationally specific
processes, which should be considered.
Source: The Process Practice Ltd
Source: The Process Practice Ltd
ISO 9001:2000 SPECIFIC CLAUSES
The following gives an overview of how specific
clauses in ISO 9001:2000 can be applied to
healthcare. It concentrates on specific issues, which
are of relevance, and provides examples.
CLAUSE 4 – QUALITY MANAGEMENT SYSTEM
A core requirement of the standard and
subsequently of importance to healthcare
organizations is the need to develop (and
implement) a QMS, which defines the processes in
the organization, and how these relate. The clause
also requires that the organization has
documentation (which you must control). Within
healthcare, much of this may already exist in the
form of externally generated literature, such as
standard laboratory operating procedures, and
regulatory requirements. When looking at relevant
processes, the organization must consider
outsourced processes, such as cleaning and laundry
The documentation, which might need to be
• Quality Manual
• Patient/Health Records
CLAUSE 5 – MANAGEMENT RESPONSIBILITY
As with other organizations and industries, the QMS
must have the support and commitment of top
management. They should be involved in setting the
quality policy, and measurable objectives, and
should consider the requirements of stakeholders
(customer focus) including any social needs.
To achieve the above, planning is vital. Plans may
already exist for example concerning patient care,
emergency and disaster management, and security.
ISO 9001:2000 requires that management review
the QMS. Information might include:
• Patient feedback and complaints
• Results of Audits
• Reports from other stakeholders, such as
insurance companies, and doctors
CLAUSE 6 – RESOURCE MANAGEMENT
To satisfy patient requirements, and continually
improve the organization, identification, and the
provision of the necessary resources is essential.
This should cover people, infrastructure and the
environment. This may involve, training staff,
maintaining buildings and equipment, and ensuring
a safe working environment.
DOCUMENTS OF INTEREST:
• HB 10202:2002 – A Guide for the
Adoption of ISO 9001:2000 in Healthcare:
A guidance document sold by BSI Business
Information for implementing ISO 9001:2000
in healthcare organizations. Available
Information relating to the application of ISO
9001:2000 in healthcare has been adapted
from this document. It was written by The
Process Practice Ltd.
• ISO 17799: Information Security is an
important aspect of healthcare, for example
the secure storage and use of patient
records being paramount. ISO 17799 is a
management system standard, which
focuses upon Information Security.
• ISO 14000: The environment and how you
treat it, as an organization is important in
healthcare. ISO 14000 is an Environmental
Management System, set out in a similar
way to ISO 9001:2000 which can provide a
framework to implement effective
Environmental Management Systems. BSI
can provide registration to this.
CLAUSE 7 – PRODUCT REALIZATION
This concerns the process of providing healthcare to
the patient. For some segments, such as optometry
and dentistry the life cycle can be lifelong, for others
it may be much shorter.
Some of the aspects that should be considered
within healthcare include:
• Planning enables the development of
processes for serving patients and other
customers. Plans may include those for the
fitting of implants and prosthetics.
• Customer Related Process; in healthcare, it
might be that the customer (patient) is unable
specify their needs, or respond. The provider
may therefore have responsibility for
• Design is important. Patients, and therefore
their needs are often different. A process is
required to determine a generic method of care
and/or treatment parameters.
• The actual provision of healthcare requires
controls. These require the use of best practice
and equipment, and competent personnel.
Areas of control include patient/health records,
patient needs, and admissions.
• Related to controls, is the need for
identification and traceability. This includes
the need for patient records to be maintained,
supplies such as implants to be traced, and the
correct area of the body for surgery identified.
• Any monitoring devices used for control, such
as scales, and blood pressure,
electrocardiogram, and therapeutic equipment
need to be kept accurate.
CLAUSE 8 – MEASUREMENT, ANALYSIS &
Measurement, analysis and improvement are key
aspects for ISO 9001:2000. They also enable a
healthcare organization to avoid and learn from
mistakes and failings in the process, and focus it
upon serving the patient or customer more
Aspects that should be considered include:
• The organization should have a plan for all
measures, covering for example clinical
measurements, and equipment checks. Often
measuring is useful for statistical analysis.
• The level of patient (customer) satisfaction is
a good place to start measuring and analyzing.
• As well as measuring the clinical elements of
healthcare, there should be other measures,
including non-clinical suppliers and services
(support processes), and administrative
processes taking place.
• Non-conformity, which includes the wrong
procedure or diagnosis, failing to keep
appointments with patients, mistaken identity,
and mislabeled drugs, can have severe
consequences within healthcare.
• Is not necessarily the case that an apparent
non-conformance is a failing of the care plan.
There is no guarantee of success in healthcare
provision; it could be a non-conformance on the
part of the patient, which the organization has no
• In healthcare, corrective and preventative
actions, and continual improvements are
vital. Corrective actions should provide a means
to stop a non-conformance happening again.
Preventative actions should provide a means to
stop the non-conformance before it occurs, and
continual improvements looks for ways to
improve the system. All involve measurement
THE BENEFITS OF REGISTERING WITH
BSI MANAGEMENT SYSTEMS
Choosing BSI means partnering with an organization
that has a reputation for excellence and integrity. We
are the largest and most respected global
management systems registrar, with offices in over
90 countries around the world.
Other reasons to choose BSI:
• We pride ourselves on the quality of our
assessment staff. We have more full time
assessors than any other registration body. We
also follow some of the strictest criteria when we
match assessors with your organization's
activities. This ensures they understand the
needs and requirements of you industry
• BSI is accredited by independent accreditation
services, ensuring our integrity.
• Use of the highly regarded BSI Registered Logo,
and an association with the world’s first and
largest national standards body
In addition to our management systems registration
services, we offer a wide range of complementary
services, which add value to our customers, and
their management system. These include training
courses, product testing, and product certification
FREE GUIDANCE DOCUMENTS:
• What is ISO 9001:2000
• Glossary of ISO 9000 Terms
• 10 Tips of the Selection and Use of a
Management System Consultant
• 10 Tips for the Transition to ISO 9001:2000
These and more can be downloaded free of
IWA 1: QUALITY MANAGEMENT SYSTEMS –
GUIDELINES FOR PROCESS
IMPROVEMENTS IN HEALTH SERVICE
Because of the complexity of healthcare, and in
order to address issues of quality and safety,
ISO (International Organization for
Standardization) has published IWA 1. This
document which was prepared by the
Automotive Industry Action Group, and American
Society for Quality (Healthcare Division), with
input from a number of other individuals and
organizations, is a guidance document to ISO
9004:2000 (“Quality Management Systems –
Guidelines for performance improvements”) in
The document takes the form of ISO 9004:2000,
including much of the text from it, however it also
includes guidance specifically for healthcare
organizations. Throughout the document, there
are examples, which relate to healthcare,
including those covering; terms and conditions,
the control of documents, needs and
expectations, planning, training, design,
purchasing, and measuring and improving.
IWA 1 is a guidance document, which cannot be
IWA 1 can be purchased from www.aiag.org
IMPLEMENTATION AND REGISTRATION PROCESS
There are nine steps to implementing ISO 9001:2000 in the healthcare sector:
Before you can begin preparing for your application, you will require a copy of
the standard. You should read this and make yourself familiar with it. Copies
can be purchased from www.bsiamericas.com
There are a large number of tools that can be very helpful at every stage of the
process of implementing any ISO 9001:2000 based QMS. We recommend “The
Route to Registration” published by BSI, and available at
You should begin the entire implementation process by preparing your
implementation team. Responsibility for a QMS lies with Senior Management;
therefore it is vital that Senior Management is involved from the beginning of
There are a wide range of training courses available to assist, at every level of
understanding, see www.bsiamericas.com/training.
Using a consultant to help you through the process can be very helpful, but
consider the cost/benefits. Download BSI’s 10 Tips for the Selection and Use of
a Quality Management Systems consultant from www.bsiamericas.com for
You don’t just write the documents or develop processes; you’ve got to get staff
to use them through training and awareness.
The registrar is a third-party, like BSI Management Systems, who assesses the
effectiveness of your quality management system, and issue a certificate if it
meets the requirements of the standard. Factors to consider when choosing a
registrar include industry experience, geographic coverage, price and service
The key step in the process is a registration assessment, at which your quality
management system will be assessed.
REGISTRATION WITH BSI MANAGEMENT SYSTEMS
There are seven steps to gaining registration to ISO 9001:2000 with BSI Management Systems
Your registrar will periodically visit you to ensure your system continues to
meet the requirements of the standard.
The organization will be asked to complete of a company profile. BSI
professionals will do everything they can to help you do this.
BSI forwards a proposal for delivery of assessment services.
Submission of a formal application to BSI Management Systems
BSI will appoint a client manager who will be the principal point of contact
throughout the registration process, and beyond. Client Managers have
knowledge concerning the nature of the client’s business, and will offer support
throughout the development of the QMS.
BSI can provide pre-assessment services, which review the QMS and
establish readiness for the initial assessment.
The formal assessment is entirely objective, checking that the organization
does what it says it does, and that it meets the requirements of the standard.
The client will be informed of BSI’s recommendation before the assessment
team leaves the premises.
The initial report is independently reviewed, the formal registration decision
taken and if the assessment proved successful, a certificate of registration is
issued. Once this has occurred, the organization can advertise its success,
and promote registration to ISO 9001:2000.
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