INTERNATIONAL

PRINCIPLES
FOR HEALTHCARE
STANDARDS
Third Edition

A FRAMEWORK OF REQUIREMENTS FOR STANDARDS

Published by The International Society for Quality in Health Care December 2007
3rd Floor, Joyce House, 8-11 Lombard Street East, Dublin 2, Ireland

ISQuas International Principles for Healthcare Standards Third Edition

A FRAMEWORK OF REQUIREMENTS FOR STANDARDS

INTRODUCTION
The process of ISQua standards assessment and international accreditation is a way for external evaluation
and standards setting organisations to assure themselves that their standards meet international best practice
requirements and to demonstrate this to their clients, funders and other stakeholders.
It is now ten years since ISQuas first edition of the international principles for healthcare standards
were developed as a guide for standards development and revision. The 2nd edition of the Principles was
implemented in August 2004 and has been used by ISQua to accredit over 30 sets of standards covering
acute, primary and community services and specialist service areas.
Review Process
The ISQua Accreditation Council has now reviewed and revised the 2nd edition Principles to ensure:
they are based on current evidence, research and sound practice
they reflect the current patient safety emphasis of the WHO World Alliance for Patient Safety initiative
they are user friendly, understandable, valid, relevant, can be interpreted consistently and facilitate quality
improvement and duplication within the Principles is minimised.
The review process involved an initial request for comments and suggestions for improvement to
organisations that had used or were using the Principles and to ISQua standards assessors. Using this
feedback, a working group produced a first draft revision for consideration by the Accreditation Council. A
second draft was prepared and circulated to users for comment. It was also posted on the ISQua website and
was pilot tested through a self-assessment process by two organisations. The feedback from these processes
was used to develop the third draft which was approved with minor changes by the Accreditation Council.
3rd edition Principles
The 3rd edition contains six Principles compared with the five Principles in the 2 nd edition. The dimensions
of quality are no longer grouped within one Principle as in the 2nd edition but are now addressed in four of
the Principles. The increased emphasis on safety is reflected by a Principle devoted to that dimension. The
revised Principles are:
Quality Improvement:
Standards are designed to encourage healthcare organisations to improve quality and performance within
their own organisations and the wider healthcare system
Patient/Service User Focus:
Standards are designed with a focus on patients/service users and reflect the patient/service user continuum
of care or service

Copyright 2000 - 2011, ISQua The International Society for Quality in Health Care. All rights reserved.

ISQuas International Principles for Healthcare Standards Third Edition

Organisational Planning and Performance:

Standards assess the capacity and efficiency of healthcare organisations
Safety:
Standards include measures to protect and improve the safety of patients/service users, staff and visitors to
the organisation
Standards Development:
Standards are planned, formulated and evaluated through a defined and rigorous process
Standards Measurement:
Standards enable consistent and transparent rating and measurement of achievement.
Changes to 3rd edition from 2nd edition
New requirements for standards include:
the definition of organisations values, ethics and strategic objectives
evaluation and analysis of performance data and its use for improvement
staff planning
training of staff on equipment
clinical risk assessments
infection control
patient safety issues
patient/service user records
clear standards framework and
clear standards wording.
Other changes include:
provision of more guidance to assist interpretation and application of the Principles
change of numbering to delete sub-criteria
amalgamation of some criteria
more logical grouping resulting in criteria relating to different dimensions of quality from previous
Principle 3 being incorporated in Principles 1, 2, 3 and 4.
The attached table identifies the extent to which criteria from the 2nd edition Principles have been
incorporated into the 3rd edition.

ISQuas International Principles for Healthcare Standards Third Edition

ISQua Standards Assessment Process

On application to ISQua, organisations will be provided with an assessment tool and guidance documents.
The assessment process includes a standards preview, self-assessment and independent standards assessment
by an ISQua standards assessment team.
The guidance information is not part of the assessment process. It is intended to provide information to
assist in applying the Principles to a particular environment or country without reducing the intent of the
Principles and criteria.
The criteria and Principles will continue to be rated on a three point scale of Met, Partially Met and Not Met
and assessors will provide comments on the standards, recommendations and other identified opportunities
for improvement. Standards may be ISQua Accredited for up to four years with a requirement to submit an
action plan and two progress reports within that period.
Implementation
Following Accreditation Council and ISQua Board approval, the Principles will be introduced in January
2008 and be applicable to organisations having standards assessed after 30 June 2008.
Those organisations having standards assessed before 30 June 2008 may elect to be assessed against either
the 2nd or 3rd edition of the Principles.
Criteria
Principle
1

Revised Principles
QUALITY IMPROVEMENT

1.1

The standards require healthcare

organisations to define, as
appropriate to their size and scope,
their:
mission or purpose
values
ethics or code of behaviour and
strategic objectives.

1.2

The standards define responsibilities

for quality and performance
improvement at different levels of the
organisation.

Guidance

Standards are designed

to encourage healthcare
organisations to improve quality
and performance within their
own organisations and the wider
healthcare system.

Responsibilities may be defined for

governance, management, clinicians,
other staff and, where applicable,
volunteers.

ISQuas International Principles for Healthcare Standards Third Edition

Criteria
1.3

Revised Principles
The standards define the
responsibilities of a healthcare
organisation for:
governance and
organisational management.

1.4

The standards require healthcare

organisations to inform the public of:
the services they provide and
the quality and performance of
the services.

1.5

The standards require that policies,

procedures or processes and
plans for all key functions in the
organisation are
documented
authorised
kept current and
implemented.

1.6

The standards require an approach

to quality improvement that:
is systematic
is continuous
is organisation-wide
covers all aspects of performance
supports innovation
incorporates monitoring, including
of all high risk processes and
procedures, and evaluation.

Guidance
a) Governance responsibilities
may relate to determining the
organisations direction, setting
objectives and developing policy to
guide the organisation in achieving
its mission, and monitoring the
achievement of those objectives
and the implementation of policy.
b) Organisational management
responsibilities may relate to
setting targets or goals for the
future through planning and
budgeting for the organisations
range of services, establishing
processes for achieving those
targets, allocating resources
to accomplish those plans and
ensuring that plans are achieved
by organizing, staffing, controlling
and problem-solving.

Authorisation may be demonstrated

by the signature of a person with
authority to approve policies and
plans, or the recorded decision of a
governing body.

ISQuas International Principles for Healthcare Standards Third Edition

Criteria
1.7

Revised Principles
Guidance
The standards require that key care
Requirements could include:
and service processes and outcomes a) the use of these methods to
be measured through the use of:
measure functions such as human
performance indicators
resources, infection control, risk
patient/service user satisfaction
management and patient/service
surveys/assessments and
user care and services;
other performance measures.
b) encouragement of the use of
indicators expressed as ratios
with defined numerators and
denominators;
c) use of other performance
measures such as surveys, audits
and feedback;
d) the referencing of clinical
performance indicators to evidence
based medicine;
e) encouragement for healthcare
organisations to develop,
implement or enrol in a quality
indicators program.

1.8

The standards require the

evaluation and analysis of data from
performance measurement and its
use to improve performance and
services.

Data sources may include:

a) indicators, patient/service user
satisfaction assessments and other
performance measures;
b) complaints; and
c) near misses, incidents and
adverse events.

1.9

Law, regulations and health policy

are recognised and integrated into
the standards.

a) Common legal and regulatory

requirements that may be
referenced relate to employment,
health and safety, building,
environmental protection,
reportable diseases, waste
management, food and hygiene,
health professional registration,
health information, medicines and
technical standards.
b) Health policy may relate to new
public health initiatives based on
latest research or evidence that
have been issued as guidelines but
not incorporated into law.

ISQuas International Principles for Healthcare Standards Third Edition

Criteria
Principle
2

2.1

Revised Principles
PATIENT/SERVICE USER FOCUS

Standards are designed with a

focus on patients/service users
and reflect the patient/service user
continuum of care or service.
The standards cover the rights of
patients/service users to:
dignity and respect
privacy
confidentiality and
safety and security.

2.2

The standards require a system for

receiving, investigating and resolving
patient/service user complaints and
concerns in a fair and timely way.

2.3

The standards require staff to involve

patients/service users in their own
care and services by:
respecting their preferences and
choices;
informing them about their options
for care and treatment; and
obtaining their informed consent.

Guidance

Requirements could include

organisations:
a) documenting patient/service user
rights and responsibilities;
b) implementing training activities on
them for staff.

Choices may include whether or not

to be treated, the type of treatment,
who they want involved in their care or
service and end of life wishes.
Preferences may relate to
a) how they are addressed
b) personal effects
c) clothing and self care routines
d) food, drink and meals
e) activities, interests, privacy,
visitors.
Written consent is obtained for such
activities as:
a) participation in research or
experimental procedures
b) all operative and invasive
procedures, anaesthesia and
moderate/deep sedation and
c) where there is a significant risk of
adverse effects.

ISQuas International Principles for Healthcare Standards Third Edition

Criteria
2.4

Revised Principles
The standards require the cultural
and spiritual sensitivities of patients/
service users and their communities
to be recognised.

2.5

The standards cover access to

services for patients/service users,
including:
a range of services based on
the needs of the community
and the scope of the organisation

Guidance
This may include requirements to:
a) provide access to spiritual care or
advice that meets patients /service
users needs;
b) train staff on the cultural beliefs,
needs and activities of different
groups served;
c) provide separate facilities and
services for women and men
where appropriate for the culture.

access for individuals with

disabilities and special needs

2.6

2.7

coordinated admission or entry

processes.
The standards require that the
Assessments may cover:
assessments of patients/service
a) patient/service user needs and
users:
risks appropriate to the type of
are comprehensive
service and patient/service user;
involve relevant disciplines
b) elements such as:
are completed and documented in
- medical
a timely manner.
- physical
- mental, behavioural and
emotional
- nutritional
- functional
- pain
- abuse and neglect.
The standards require that individual
care/service plans are prepared and
documented:
based on the assessment of
patient/service user needs,
including the results of diagnostic
tests where relevant
involving the patients/service
users and their families
including the goals or desired
results of the treatment, care or
service.

ISQuas International Principles for Healthcare Standards Third Edition

Criteria
2.8

Revised Principles
The standards require that health
professionals:
follow the care/service plans
monitor the progress of patients/
service users in achieving the
goals or desired results of
treatment, care or service
reassess patients/service users
needs when indicated
revise the care/service plan
according to results.

Guidance

2.9

The standards require that referral,

transfer of care, discharge or end of
service is planned.

Requirements could include:

a) planning commencing at first
contact with the organisation and
being ongoing;
b) planning including patients/service
users and their families;
c) planning involving making links
with referral agencies, other
levels of health service and other
organisations;
d) if death is the expected outcome of
the service, planning including the
preparation of patients and their
families for death, the management
of pain and symptoms, linkage with
support groups, counselling, and
addressing spiritual and cultural
needs.

Principle
3

ORGANISATIONAL PLANNING
AND PERFORMANCE
Standards assess the capacity
and efficiency of healthcare
organisations.

3.1

The standards require that

Requirements could include:
organisations use a planning process a) the plan considering the number of
to determine the level of staffing and
staff and independent practitioners
skill mix required to meet the needs
needed, the levels of seniority
of the services provided.
and experience required, and the
different disciplines and roles to
match the needs of services to be
provided;
b) the planning process being
documented and able to be
evidenced.
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ISQuas International Principles for Healthcare Standards Third Edition

Criteria
3.2

Revised Principles
The standards require that, for
the positions they hold, staff,
independent practitioners and
volunteers where applicable, have
relevant and current:
orientation and training
education
knowledge
skills and
experience.

Guidance

3.3

The standards require that

those permitted by law and by
the organisation to practice are
credentialed and have their scope of
practice defined.

Requirements could include:

a) procedures for assessing or
accepting healthcare professional
training;
b) credentials and scopes of practice
being documented and regularly
reviewed.

3.4

The standards require that staff,

independent practitioners and
volunteers where applicable:
a) have their performance and
competency evaluated on a
regular basis
b) receive relevant ongoing
education and skill training and
c) are provided with internal
and external development
opportunities.

Requirements could include

competency assessments and
performance evaluations being
documented and shared with the staff
member (or practitioner or volunteer)
involved.

3.5

The standards require staff to

follow current accepted standards,
protocols and evidence based clinical
practice guidelines.

3.6

The standards require healthcare

organisations to involve patients/
service users, their families, staff and
where possible the wider community
in planning for the provision of
services.

Requirements could include the

documentation of the planning
process and those involved in it.

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ISQuas International Principles for Healthcare Standards Third Edition

Criteria
3.7

Revised Principles
The standards require organisational
planning to identify desired or
expected service and organisational
results and measure progress in
achieving them.

3.8

The standards require service

planning to be based on the
organisations strategic direction
and to consider environmental and
financial factors.

3.9

The standards require the planning

of functions, activities and the
development of departments and
services to include provisions for
coordination with each other and
with relevant external services.

3.10

The standards require that the

efficient use of resources is regularly
reviewed and is evaluated against
organisational plans and budgets.

Guidance
Requirements could include:
a) strategic and operational plans
including longer term and short
term goals and objectives for the
organisation and its services;
b) progress in achieving these goals
and objectives through defined
activities being measured and
reported on a regular basis.

Reviews may include the utilisation of

staff, equipment, supplies and space.

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ISQuas International Principles for Healthcare Standards Third Edition

Criteria
Principle
4

Revised Principles
SAFETY

Guidance

4.1

The standards require a planned

and structured approach to risk
management that addresses
all significant risks faced by the
organisation and its services.

A risk management plan may include

elements such as:
a) policy
b) context
c) scope and objectives and criteria
for assessing risk
d) risk management responsibilities
and functions
e) staff training
f) a list of identified risks strategic,
operational, financial and hazard
g) a risk register or similar with an
analysis of the risks and their level
h) summary of risk treatment plans
for major risks
i) processes for communicating with
stakeholders.

4.2

The standards require the risk

management plan to be monitored
and reviewed for effectiveness and
results communicated within the
organisation.

Requirements could include the

organisation:
a) undertaking routine surveillance of
actual performance compared with
required performance;
b) investigating the current situation
and specific issues periodically;
c) using results from the monitoring
and review processes to make
improvements.

4.3

The standards require healthcare

organisations to have processes for
reporting and investigating safety
incidents, adverse events and near
misses affecting patients/service
users, staff or visitors and for using
findings to improve services.

The system may include:

a) training for staff
b) means for documenting and
reporting incidents/events
c) root cause analysis
d) processes for informing patients/
service users of adverse events.

Standards include measures to

protect and improve the safety of
patients/service users, staff and
visitors to the organisation.

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ISQuas International Principles for Healthcare Standards Third Edition

Criteria
4.4

Revised Principles
Guidance
The standards require the
The health and safety program for
organisation to protect the health and staff needs to be appropriate to the
safety of staff.
risks in the particular care sector and
may include:
a) protective clothing and equipment
for staff
b) workplace assessments
c) workload monitoring and stress
management
d) staff vaccination
e) prevention from needlestick or
manual handling injuries
f) protection from occupational
hazards.

4.5

The standards require healthcare

organisations to
train staff on the safe operation
of equipment, including medical
devices, and
ensure only trained and
competent people handle
specialised equipment.

4.6

Standards require healthcare

organisations to ensure that:
relevant safety law and
regulations are met
the buildings, space, equipment
and supplies necessary for the
stated services are provided and
facilities and equipment are
inspected, tested, maintained and
updated or replaced in a planned
and systematic way.

4.7

The standards require healthcare

organisations to undertake clinical
risk assessments to safeguard
patients/service users from
unintended consequences of care/
treatment.

Risk assessments could be required

to include:
a) medication management, covering
issues such as patient/service user
allergies and antibiotic resistance;
b) equipment risks, e.g. fire/injury
risks from use of lasers;
c) risks resulting from long term
conditions.

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ISQuas International Principles for Healthcare Standards Third Edition

Criteria
4.8

Revised Principles
The standards require healthcare
organisations to have a planned and
systematic program for preventing
and controlling infections which
includes at least handwashing and
cleaning requirements.

Guidance
Other requirements may include, as
appropriate to the care or services
provided:
a) structures and resources
b) use of isolation and precaution
techniques
c) use of antibiotics
d) sterilisation activities
e) monitoring
f) collection, analysis and use of
infection event data
g) reporting
h) staff education.

4.9

The standards provide guidance

to assist organisations to manage
issues of patient/service user safety
relevant to the care sector, including
any appropriate safety priority areas
from the WHO Global Patient Safety
initiative.

For acute services and others where

applicable, this will include standards
covering processes for:
a) the safe management and use of
blood and blood products
b) right patient/right side/right site
interventions
c) safe practices before, during
and after surgery, anaesthesia,
moderate/deep sedation and
invasive procedures
d) safe medication management,
including:
- prescribing/ordering
- transporting, storing and
disposing
- preventing, monitoring and
documenting
- responding promptly to adverse
effects and medication errors.

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ISQuas International Principles for Healthcare Standards Third Edition

Criteria
4.10

Revised Principles
The standards require patient/service
user records to be current, complete,
accurate and secure to assist the
safety and continuity of care and
treatment.

Principle
5

STANDARDS DEVELOPMENT

Guidance
In the case of both electronic and
hard copy records, requirements may
include, as relevant to the service
being provided:
a) legible, dated, timely and signed
entries
b) alert notations
c) progress notes, observations,
consultation reports, diagnostic
results
d) all significant events such as
alteration to patients/service
users condition and responses to
treatment and care
e) any near misses, incidents or
adverse events
f) procedures for confidentiality,
security and storage
g) use of only recognised
abbreviations
h) procedures for retaining and
destroying records.

Standards are planned, formulated

and evaluated through a defined
and rigorous process.

5.1

The need for new or revised

standards and priorities are
established by seeking the views
of potential users, professional,
purchaser, provider and patient/
service user groups and
governments and other stakeholders
and using evaluation data from the
use of previous standards.

5.2

Relationships with the standards of

other organisations and professional
and regulatory requirements are
considered.

5.3

Standards are developed or revised

in accordance with a plan that
includes objectives, resources and
timeframes.

Links or overlap with other

standards may be identified to aid
implementation of the standards and
avoid duplication where possible.

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ISQuas International Principles for Healthcare Standards Third Edition

Criteria
5.4

Revised Principles
Standards are based on:
current available research,
evidence and experience
internationally recognised
guidelines
recommendations from WHO and
national/international professional
organisations and
input from technical experts and
legal requirements.

Guidance
Standards based on those of other
organisations/countries could be
adapted to local culture and health
service requirements.

5.5

Government, professional,
purchaser, provider and service user
interests have adequate opportunity
for input into the standards
development and revision process
through direct representation and
formal consultation.

Opportunities for other interested

parties to participate may include
publication of draft standards for
comment, such as posting on the
internet.

5.6

The scope and purpose of the

standards are clear in terms of:
the type of healthcare
organisation to which they apply;
whether they are designed for use
by a whole organisation;
what range of services they
cover;
the reason the standards are
needed and used.

The purpose or reason for the

standards may be:
a) to set a minimal level of acceptable
performance
b) to facilitate quality improvement
c) for accreditation or certification
d) for licensing or
e) for insurance eligibility.

5.7

There is a clear framework for the

standards that makes them easy for
organisations and assessors to use.

The framework may include:

a) standards being grouped logically,
e.g. by function or system;
b) standards being labelled so
that their content can be easily
identified;
c) the numbering system for the
standards and their criteria or
elements enabling them to be
easily identified;
d) A clear description of the standards
framework in the documentation
provided to users.

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ISQuas International Principles for Healthcare Standards Third Edition

Criteria
5.8

Revised Principles
The wording of the standards is clear
and unambiguous.

Guidance
Clear wording may be achieved by:
a) sentences having clear subjects
and objects so it is clear what is
required or who is responsible;
b) words that may have more than
one meaning or interpretation
being clearly defined, e.g. good,
well or sufficient;
c) a formal review process to
identify and clarify wording that is
ambiguous or not clear;
d) material being available to assist
users in the interpretation of the
standards.

5.9

Standards are tested/piloted

and evaluated by providers and
assessors prior to approval to
ensure they are understandable,
measurable, relevant and achievable.

5.10

New and revised standards are

approved by the standards setting
body or appropriate authority before
general implementation in the sector.

5.11

There is a process to determine the

Requirements may include:
conditions under which the standards a) the process being documented;
could be used by an independent
b) expectations being defined and
assessment organisation, other
agreed, e.g. that the standards
than the body that developed the
are used as intended and that the
standards.
independent organisation provides
feedback on the standards and the
results of using them.

5.12

Information and education are

provided to users and assessors
of the new and revised standards
to enable interpretation and
implementation.

5.13

Parameters, timeframes and any

transitional arrangement for the
implementation of revised standards
are clearly identified and followed.

Requirements could include revisions

of standards being publicised and
distributed to users and assessors in
sufficient time for them to develop an
understanding of the standards before
the date of implementation.

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ISQuas International Principles for Healthcare Standards Third Edition

Criteria
5.14

Revised Principles
Guidance
The views on standards and the
Processes could include:
satisfaction of users, assessors and
a) feedback on the standards being
stakeholder groups with them are
sought from the organisation
obtained, documented and monitored
assessed and the assessors after
and the analysed data is evaluated to
assessments;
assist with improving standards.
b) periodic surveys of stakeholders
being used to obtain their feedback
on the standards;
c) analysing feedback data on a
regular basis, e.g. annually;
d) using the data in the standards
revision process in a way that can
be demonstrated.

Principle
6

STANDARDS MEASUREMENT
Standards enable consistent
and transparent rating and
measurement of achievement.

6.1

There is a transparent system for

rating an organisations performance
on each standard, criterion or
element.

6.2

Guidelines or other information

are provided to assist assessors
to rate consistently and healthcare
organisations to assess their own
performance on the standards.

Guidance may be provided on how

criteria or standards are weighted or
how ratings are to be applied where
there are identified risks or safety
issues.

6.3

There is a defined methodology for

measuring overall achievement of a
set of standards in a consistent way.

a) Examples of how the methodology

may define achievement include
achievement on all compulsory
standards, or all standards being
achieved at a defined level, or no
standards being rated at below a
defined level.
b) The methodology may be used
by organisations to assess
their overall achievement of
the standards as part of a selfassessment process.
c) Overall performance on the
standards may be used for
the purposes of certification or
accreditation, but these processes
may use additional criteria that are
not relevant here.
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ISQuas International Principles for Healthcare Standards Third Edition

Criteria
6.4

Revised Principles
The satisfaction of healthcare
organisations and assessors with the
measurement and rating system is
evaluated and results used to make
improvements.

Guidance
Processes could include:
a) feedback on the rating system
obtained after the assessment
from the organisation assessed
and the assessors, e.g. its
usefulness and ease of use;
b) analysis of feedback data on a
regular basis, e.g. annually;
c) using the data to improve the
rating system in a way that can be
demonstrated.

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ISQuas International Principles for Healthcare Standards Third Edition

Attachment
The extent to which criteria from the 2nd edition Principles have been incorporated into the 3rd edition.
Criterion/Topic
3rd edition
Quality Improvement

Defined mission, values, ethics, strategic objectives

Defined responsibilities for quality improvement

3rd edition
reference
1
1.1
1.2

2nd edition
reference
1

3.1.5 + New
1.1

Defined responsibilities for governance, management

1.3

2.4

Key policies, procedures plans

1.5

3.2.4

Information to public on services, quality

Quality improvement system
Key indicators/measures

Data evaluation, analysis, use for improvement

Integration of law, health policy
Patient/Service User Focus

1.4
1.6

1.2

1.3, 3.9.5

1.7

3.5.1, 3.5.2

1.9

1.4

1.8
2

New
2

Patient/Service user rights

2.1

3.7.1

Patient/Service user involvement in own care/services

2.3

3.2.3, 3.7.1,
3.7.2

Complaint system

2.2

Cultural and spiritual sensitivity

2.4

Patient/Service user assessment

2.6

Monitoring progress, revising care/service plans

2.8

Access to services

Patient/Service user care/service planning

2.5

2.7

3.7.4

3.1.4

3.1.1, 3.1.2,
3.1.3, 3.4.1
3.2.1

2.2, 3.5.1

2.2, 3.5.1,
3.6.2,

End of service planning

2.9

Staff planning

3.1

Credentialling, defined scope of practice

3.3

3.3.1 + New

3.5

3.2.2, 3.9.5

Organisational Planning and Performance

Orientation, skills and experience

Performance/competency evaluation, ongoing training

Following standards, evidence based guidelines

Involvement of patients/service users and staff in planning

3.2
3.4
3.6

Measurement of identified desired results

3.7

Coordinated planning of activities and development

3.9

Service planning based on strategic direction

Efficient use of resources evaluated, plans and budgets

3.8
3.10

2.2, 3.4.3
3

New

3.3.1, 3.3.2
3.3.2, 3.9.3

3.7.3, 3.9.1
3.5.1
3.9.2
3.4.2

3.6.3
20

ISQuas International Principles for Healthcare Standards Third Edition

Safety

Criterion/Topic
3rd edition

Planned risk management

Risk management plan monitoring

Incident/Adverse event reporting/investigation system

Staff health and safety protection
Staff training on equipment

Safety law, building and equipment safety

Clinical risk assessment

Infection control program

Patient safety issues/priority safety areas

3rd edition
reference
4
4.1
4.2
4.3
4.4
4.5

2nd edition
reference
3
3.8.2
3.8.3
3.8.4
3.8.5
New

4.6

3.8.1, 3.8.3

4.8

New

4.7
4.9

New
New

Patient/Service user records

4.10

Establishing need for new standards, priorities

5.1

4.1.1

Standards development plan

5.3

4.1.2

Standards Development

Relationships with other standards considered

Standards based on research, guidelines, technical input

5.2

New
4

4.1.3

5.4

3.9.5, 4.1.4

Clear scope and purpose of standards

5.6

2.1 + New

Clear wording of standards

5.8

New

Involvement of interested parties in development process

Clear standards framework

Testing/Piloting of standards

5.5

5.7

New

5.9

4.2.3

5.11

4.3.1

Approval of standards by standards setting body

5.10

Timeframes, transitional arrangements for implementation

5.12

Information and education to users and assessors

4.2.1

4.2.4
4.3.2

Satisfaction with standards monitored, data evaluated

5.13

4.4.1, 4.4.2

Transparent rating system for standards, criteria

6.1

5.1.1

Defined methodology for measuring overall achievement

6.3

5.2.1

Standards Measurement

Guidelines for users for consistent rating

Satisfaction of users with rating system evaluated

6.2
6.4

5.1.2
5.3.1

21