The 3rd GCC Laboratory Proficiency Conference is organized as part of the strategic orientations of the GCC Standardization Organization (GSO) for the development of the standardization and quality infrastructure, thereby contributing to the development of commerce and industry and to the support of national economy in the GCC member states. Since the field of proficiency testing is newly introduced in the GCC member states and as the infrastructure of laboratories has not yet taken the shape of national or regional organizations representing the laboratories and reflecting their requirements, GSO is in need of meeting with a considerable group of laboratories to explore and prioritize GCC member states’ requirements in terms of the fields which must top the list of the fields to be developed and upgraded. Based on the study conducted by GSO during 2011 on the status of proficiency testing activities in the member states which shown that the laboratories operating in the member states are in need of a unified data center on proficiency testing activities, GSO organized two conferences in 2013 and 2014 on the subject. The conferences scored high rates of success in terms of the selected scientific material, quality of speakers and the targeted audience. Accordingly, GSO conceptualization of the method of coordinating and upgrading the activity of proficiency tests in the GCC member states included a recommendation on the organization of annual training courses and awareness symposia by the GSO on the fields of proficiency tests. This year’s Conference will be held in Dubai during two days the 24th and 25th of March 2015, and will coincide with the annual Analytical Industry exhibition ARABLAB which will be held in Dubai during the period 23 – 26 March 2015.

1. Accreditation of Inspection health and social care in the UK
Paul Stennett, Chief Executive Officer, UKAS

2. World Accreditation Day 2015

3. Introduction to UKAS
• UKAS established in 1995 as a non-profit distributing
private company limited by guarantee
• Originated in 1966; 49 years of accreditation experience
• The UK’s national accreditation body; European Union
Regulation gives a legal framework and requirement for
accreditation throughout Europe
• The performance of UKAS is monitored by the UK
Government and peer-assessed internationally

4. “Procedure by which an authoritative body gives
formal recognition that an organisation is competent to
carry out specific tasks”
• Independent & impartial assessment by competent
authoritative third party – an accreditation body
• Demonstration of technical competence, integrity &
impartiality
• Gives confidence to all users and reduces risk
What is accreditation?

5. UKAS and Healthcare accreditation
• The first accreditation scheme for medical (pathology)
laboratories in the UK, was launched in 1992 by
Clinical Pathology Accreditation (“CPA”).
• CPA was established by the medical and clinical
professionals in the UK who developed the CPA
standard.
• The CPA standard provided much of the basis for ISO
15189.
• CPA merged with UKAS in 2009.

6. UKAS accreditation for Diagnostics
and Scientific Services
• Medical Laboratories ISO 15189
• Point of care testing ISO 15189 and 22870
• EQA Providers ISO 17043
• Physiological diagnostics
• Imaging Services Accreditation Scheme
• Medical Devices ISO 13485
• Hospital QM schemes (ISO 9000)
• Public Health laboratories(ISO15189 & 17025)
• Medical Physics and engineering (ISO 15189)
( under development)

7. UKAS Accreditation – essential ingredients
• Delivered in accordance with international
standards that are mutually recognised
• Defined requirements for competence of bodies
seeking/gaining accreditation
• Rigorous independent, impartial assessment
process conducted by competent peer assessors
• Independent decision making
• Access to stakeholder expertise and input

8. UKAS Accreditation – recent developments
• In the UK, UKAS is accrediting most of the major
“diagnostics areas” to ISO15189
• UKAS also accredits EQA (“Proficiency Testing”)
schemes and general hospital quality
management schemes ( based on ISO9000)
• Recent requests have been received for Adult
residential care homes and caring for the dying
schemes

9. Accreditation underpinning healthcare services
UKAS
Accreditation
ISO/IEC 17011
Organisations that conduct Evaluations or ‘Conformity
Assessment’
Certification or Inspection
(ISO/IEC 17065 or 17020)
Testing/Diagnostic and measurement services
(ISO 15189, 17025 or equivalent e.g. ISAS/IQIPS)
Service that includes taking
and testing of samples
e.g. Blood/biopsies
Service that includes the
identification of a disease
or characteristic Process or service
e.g. care pathway,
dental service
Defined Clinical Service
standard
The Patient

10. • Consider the activity - is the clinical service, or a
significant component, considered to be conformity
assessment?
• Consider the criteria for competence - does existing
criteria exist? Does this identify the type of recognition?
• Consider the status of the assessing body - what is
their function, what recognition do they provide? What
standards do they work to? Independent and impartial?
• Consider the assessment process – type of
assessment, competence of assessors, framework within
which it is delivered, level of rigour, frequency
there may be more than one option!
Accreditation, Certification or Inspection?

11. Accreditation Certification Inspection
 Relevant international standard (or
mapped equivalent) used as criteria
used for accreditation e.g. ISO/IEC
15189, ISAS standard
 Used for attesting the competence of
evaluation or ‘conformity assessment’
bodies
 Assessment conducted in accordance
with EU Regulation and ISO/IEC 17011
 Delivered by the national accreditation
body (UKAS)
 Assessment of scope of activities using
trained competent peer assessors
 On site Initial assessment followed by
annual surveillance activity and full
reassessment every 4 years
 Cannot rely on self-assessment
 Recognised internationally where
mutual recognition arrangements exist
 Recognised by UK Government as the
highest level of control in the
conformity assessment chain
 Audit of system, process or service by
an independent third party
 Certification standard can be an
international standard or stakeholder
developed standard/scheme
 ‘Certification Body’ can have
competence recognised to perform
audits by accreditation (ISO/IEC 17065)
 Certification will be awarded on an on-
going basis and certified service will
require periodic
surveillance/recertification audits
 Trained and authorised auditors used
with defined competence – may not
need to be full peer assessment as
required by the scheme
 Objectives of certification must be
defined and compliance demonstrated
before certification awarded
 Multiple certification bodies can be
used, or a single body – accreditation
can be used to ensure consistency
 UKAS accredited certification is
recognised by UK government and also
internationally where relevant mutual
recognition arrangements exist
 Inspection of a system, process or
service by an impartial body (differing
levels of independence are defined)
 Inspection standard needs to be
defined and accepted by relevant
stakeholders
 ‘Inspection Body’ can have
competence recognised to perform
inspections by accreditation (ISO/IEC
17020
 Can be used for one-off, ad-hoc
evaluation as well as on-going
scheduled regime
 Trained and authorised inspectors used
with defined competence – may not
need to be full peer assessment as
required by the scheme
 Objectives of inspection process must
be defined
 Can be used where an incremental
quality improvement is needed
 Multiple inspection bodies can be
used, or a single body – accreditation
can be used to ensure consistency
 UKAS accredited inspection is
recognised by UK government and also
internationally where relevant mutual
recognition arrangements exist

12. Standards of competence for bodies conducting
assessments of Clinical Services
• Currently a variety of approaches – direct accreditation
and certification/inspection
• No need to develop criteria for these bodies – there are
existing international standards
• Guidance could be developed to support the international
standards
• Specific requirements could be identified to apply to UKAS
and other assessment bodies e.g. use of lay assessors to
assess clinical service
Developing accreditation and standards

13. How accreditation works
Requirements
of accreditation
Impartiality, integrity,
independence
Competence
Appropriate resources and
facilities
Performance demonstrated to
be to required standard
Capable of sustaining the
required level of performance

14. Who conducts the assessment?
• Competence criteria defined for assessors
• Competent Peer Assessor(s) used to cover
repertoire/scope of service
• Lead Assessor – UKAS Assessment Manager
• Lay assessors
• All assessors trained and authorised by UKAS
• All assessors monitored and evaluated to ensure
competence is maintained

15. UKAS – Inspection & Social Care
UKAS is developing accreditation for inspection of health and social
care services using the accreditation standard ISO / IEC 17020:2012.
 ISO 17020 states that inspection can be to “provide information with
no determination of conformity”
Three separate pilot assessment programmes are currently underway
for,
 Accreditation of inspection of care providers by independent
inspection bodies.
 Accreditation of reviews of healthcare services provided by the UK
National Health Service (“NHS”) healthcare providers.
 Accreditation of inspection of caring for the dying ( in the last hours
and days).

16. Accreditation of inspection of care homes by
independent inspection bodies
• There are around 30,000 care homes as well as other types
of care providers in the UK and these are inspected by
regulatory bodies in England, Scotland, Wales and Northern
Ireland for regulatory compliance.
• There are also a number of private inspection bodies
operating in the UK that provide inspection services to care
homes and care providers.
• The private inspection bodies assist care homes to improve
the quality of care, to prepare for regulatory compliance
where applicable, and in some cases for awarding star
ratings to recognise achievement of inspection standards.

17. Accreditation of inspection of care homes
by independent inspection bodies cont..
• UKAS has considered that the accreditation of inspection of
care homes by private inspection bodies is in the public
interest and in 2014 announced the initiation of a pilot
assessment programme.
• Following a process of consultation with interested applicants
and stakeholders, 3 applicants were selected for piloting the
UKAS assessment process for accrediting inspection of adult
social care using the standard ISO/ IEC 17020:2012
(Conformity assessment – Requirements for operation of
various types of inspection bodies).

18. Accreditation of Inspection etc – some issues
• These observations are based on early experience
of assessing in our pilot scheme – later this year
UKAS will publish a “Lessons Learned” review.
• At this stage there is no national standard only
“proprietary standards” – however UKAS aims
ensure the outcomes are similar and comparable
and meet the purpose of the inspection.
• Our purpose: “To assure and improve the quality of
care provided by residential care homes and other
care providers in the UK.

19. Accreditation of Inspection etc – some issues
• UKAS also hopes to use the requirements of the
Government Regulatory Body (“Care Quality
Commission”) to further inform the standards.
• Traditionally ISO 17020 is used for the inspection
of products, but in this pilot study we are working
with a “personal service” and UKAS had to be
sensitive to the special circumstances of providing
a service to elderly people.

20. Accreditation of Inspection etc – some issues
• Therefore, much work was required to
understand how to apply the standard to an
inspection of a service, with observations on
the:
- Patients
- Elderly people
- Relatives of the patients
- Interviewing persons using and providing the
service

21. Accreditation of Inspection etc – some issues
• This was quite a challenging process both for
the “cared for” persons and difficult for us to
observe.
• UKAS needed to ensure that the
underpinning systems and processes were
inspected in order to deliver a sustainable
service. (“It all continues to work when we are
not there”)

22. How accreditation works
Requirements
of accreditation
Impartiality, integrity,
independence
Competence
Appropriate resources and
facilities
Performance demonstrated to
be to required standard
Capable of sustaining the
required level of performance

23. The first accreditation “RDB”
• RDB – is now accredited for residential care homes
(but not yet dementia or learning difficulties persons)
• Therefore as yet there is no accreditation awarded for
specialist care – UKAS may extend scope as and
when more experience has been gained
• The RDB Scheme gives ‘star ratings’ – as this was
our first assessment, this was also a challenge of how
to assess this.
• As we move to the surveillance process, one area of
focus will be to compare outputs of the IB’s inspectors
for consistency.

24. The assessment team for RDB
• Assessment team – always more then one
person including witnesses.
• Complete competence criteria developed and
provided for Technical Assessors
• Qualified nurses with experience in care
homes are trained as the Technical
Assessors.
• Further steps:- possibility of a British standard
being developed by BSI for the inspection of
care homes in the coming year.

26. Accreditation of inspection of care homes by
independent inspection bodies cont..
• The pilot programme is now underway and is expected to be
completed by end of 2015.
• On completion of the programme and accreditation of
successful pilot applicants, UKAS will open applications to
others who wish to apply for UKAS accreditation for
inspection of adult social care providers.
• UKAS has just awarded accreditation to ISO/IEC17020:2012
to the first inspection body in the pilot scheme
• It is hoped that the UK Government Regulator for care
homes will be able to recognise adult residential care homes
which have been inspected by a UKAS accredited inspection
body and take this into account in their programme of audits.

27. Conclusions
• In the UK there is a growing awareness of the positive
role that accredited certification and inspection bodies
can play in helping raise quality standards in care
homes and other “patient pathways”.
• This helps adult residential care homes provide
improve high quality care for the users of their
services and assurance for Government, Regulators
and the families of those persons in residential care
homes.

28. Conclusions 2
• These are early days for UKAS in this area and we
have much to learn.
• Progress so far is positive and it is hoped that the
application of accreditation in this will deliver positive
benefits for the users of these services.
• Sharing of experience.
• More information: jon.murthy@ukas.com or
info@ukas.com

29. World Accreditation Day 2015

30. Thank you