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Update United Kingdom Accreditation Service Newsletter September 2010 Issue 58 EA enters into a formal partnership with the Commission page 04 First accreditation for certification of alternative test kits page 05 CQC – new system of registration for medical laboratories page 11 First accreditation for Digital Terrestrial Television Receiver testing Page 02
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Page 1: Update - UKAS 58.pdf · Update September 2010 05 Campden Certification is the first certification body in the UK to be granted accreditation to BS EN 45011: 1998 (General requirements

UpdateUnited Kingdom Accreditation Service Newsletter Se

ptember 2010

Issue 58

EA enters into a formal partnershipwith the Commission

page 04

First accreditationfor certification ofalternative test kits

page 05

CQC – new system ofregistration for medicallaboratories

page 11

First accreditation for Digital Terrestrial TelevisionReceiver testingPage 02

Page 2: Update - UKAS 58.pdf · Update September 2010 05 Campden Certification is the first certification body in the UK to be granted accreditation to BS EN 45011: 1998 (General requirements

02 Update September 2010 www.ukas.com

DTG Testing was founded bythe Digital Television Group,the industry association fordigital television in the UK,which represents broadcasters,consumer groups and manufacturers. The DigitalTelevision Group is responsiblefor controlling and maintainingthe specification for inter-operability requirements fordigital terrestrial television(DTT) within the UK, known asthe D-Book.

DTG Testing is the sole test service for

manufacturers of broadcast receivers

wishing to apply the Digital Tick and

Freeview marks to their equipment. The

Digital Tick mark was developed by the

UK government as part of the rollout of

the new DTT service in the UK and is

being implemented by Digital UK, the

body tasked with publicising and handling

the digital switchover across the country.

By proving the interoperability and

performance of receivers, manufacturers

are able to use the marks to show that

their products are capable of handling

the services provided by the new

broadcasts.

The laboratory provides testing on all

types of set top boxes and televisions,

with their current scope of accreditation

covering the requirements for receivers

using Digital Video Broadcasting-

Terrestrial (DVB-T) technology. The

schedule covers six major areas of testing

as detailed in the D Book: Service

information, Multimedia and Hypermedia

Experts Group (MHEG) interactivity,

Subtitling, Active Format Descriptions,

Time Exclusive Services and Receiver

Radio Frequency Performance testing

covering sensitivity, performance with

the presence of Additive White Gaussian

Noise, Co-channel interference, adjacent

and non-adjacent channel interference

from both Phase Alternate Line (PAL)

and DVB-T signals, and echoes due to

multipath signals. Requirements cover

both the 64 and 16 Quadrature

Amplitude Modulation (QAM) systems

First accreditation for Digital Terrestrial Television Receiver testingThe first accreditation to ISO/IEC 17025: 2005 for conformance testing ofdigital terrestrial television receivers has been granted to DTG Testing Ltd.

currently used and cover 2k and 8k

modes of Coded Orthogonal Frequency

Division Multiplexing (COFDM).

The laboratory set itself the goal of

gaining accreditation in the 2009-2010

financial year, which it achieved in spite

of the best efforts of one of the worst

winters in recent memory trying to

disrupt the initial assessment.

With the Digital Switchover well under

way, the Digital Tick and Freeview Marks

are now very much in the public eye.

For the providers of equipment and

services ensuring that receivers have all

the services and features that are

expected by the end user is key to the

success of the process.

The accreditation of DTG Testing

demonstrates its commitment to

provide an independent resource for

the testing of digital terrestrial television

receivers to the industry.

Page 3: Update - UKAS 58.pdf · Update September 2010 05 Campden Certification is the first certification body in the UK to be granted accreditation to BS EN 45011: 1998 (General requirements

Health information standard

www.ukas.com Update September 2010 03

New Chair for Policy AdvisoryCommittee

UKAS has developed accreditation for certification to the new Department of HealthInformation Standard. The standard setsdown criteria for organisations providingwritten or scripted medical based patient information. Many different kinds of organisations produce health and social careinformation, for a wide range of communities.This standard has been developed to providereassurance that the health and social careinformation they access comes from a reliablesource. It has also been designed to raisethe general standard of information provided.

Once an organisation has been assessed andcertified against the Information Standard bya UKAS accredited certification body, the organisation will be able to display the Information Standard Quality Mark on theirinformation materials so people searchingfor health and social care information caneasily identify it as coming from a reliable,trustworthy source.

UKAS granted accreditation to five certification bodies under EN 45011: 1998for the Information Standard; EMQC Limited,G4S Assessment Services (UK) Ltd, KnightInternational Inspectorate, the Royal Societyfor Public Health and SGS United KingdomLimited.

The June meeting of the UKAS Policy Advisory Committee (PAC) saw the appointment of Dr Martin Jones as Chairfor the next three years. The appointment ofDr Jones, who has been CBI’s representativeon PAC for over twelve years, to serve a second term of office in this importantrole, was unanimously endorsed by theother PAC members.

The PAC is UKAS’ main stakeholder advisorygroup and is made up of a balanced representation of organisations with an interest in accreditation, including directcustomers, users of accredited services andgovernment departments and agencies.With the expansion of accreditation intonew areas of business, such as the healthsector, the PAC also agreed proposals toreplace the PAC from next year with a new,enlarged Policy Advisory Forum (PAF), inorder to ensure that UKAS receives stake-holder advice from across all aspects of itsbusiness. In accepting the appointment asChair, Dr Jones recognised the importanceUKAS places on the advice provided byPAC and the need to ensure the effectiveestablishment of the new PAF in order tomaximise stakeholder input for the future.

At the same meeting, Paul Stennett,UKAS Chief Executive, paid tribute to thewise and helpful guidance of the outgoingChair, Dr Seton Bennett of the NationalPhysical Laboratory (NPL), both at themeetings and beyond. Dr Bennett willcontinue to represent NPL on the UKASPAC until the end of the year.

Environmental Technologies Verification Scheme

Dr Martin Jones, Paul Stennett and Dr Seton Bennett

Innovative environmental technologies

are urgently needed to provide

solutions to the major environmental

challenges faced by Europe and the

world, to deliver the transition to a low

carbon, resource efficient economy.

The European Commission is exploring the

development of a voluntary scheme for

Environmental Technology Verification (ETV).

This is intended to generate independent and

credible information on new environmental

technologies by verifying that performance

claims put forward by technology developers

and vendors are complete, fair and based on

reliable test results.

The claims will be evaluated by Verification

Centres independent of the developers and

vendors. The Centres will critically review the

information provided and will need to ensure

that the testing that supports the claims is

reliable.

Before the Europe-wide ETV scheme is put in

place, a pre-programme is planned to pilot the

scheme and help shape the characteristics of

the final scheme.

The UK has agreed to participate in the ETV

pre-programme, and UKAS will be working

with DEFRA on this project.

UKAS will be involved in the accreditation of

any Verification Centres based in the UK and

the test laboratories that may be involved in

the testing activities. The criteria for the

assessment of the Centres will be developed

at a European level, with the participation of

the European cooperation for Accreditation,

to ensure a consistent approach in all

Member States.

The technology areas that are currently being

proposed by the UK for the pre-programme

are water treatment and monitoring, soil and

groundwater monitoring, and remediation

and energy technologies.

Page 4: Update - UKAS 58.pdf · Update September 2010 05 Campden Certification is the first certification body in the UK to be granted accreditation to BS EN 45011: 1998 (General requirements

04 Update September 2010 www.ukas.com

The European Accreditation Co-operation (EA) and the European Commission signed aFramework Partnership Agreement in Brussels on June 30, 2010. The signing ceremony wasattended by Graham Talbot, EA Chairman and Ms Liliana Brykman, Director on behalfof Mr Heinz Zourek, Director General Enterprise and Industry.

The partnership agreement sets out the

terms and conditions of the relationship,

with a view to achieving the common

policy aims and objectives stated in the

Cooperation Guidelines. It covers a

period of four years commencing on

1 January 2010.

EA also signed a Specific Agreement on

an Operating Grant for 2010, which

details financial contributions from the

Commission in the form of operating

grants for EA to carry out elements of

its work as the official accreditation

infrastructure in Europe. A similar

agreement should be signed with the

EFTA countries by the end of the year.

There is still work to be completed,

notably establishing the processes and

procedures necessary to administer the

Specific Agreement on the Operating

Grant. The EA Executive Committee will

therefore pursue its planned work

programme and update stakeholders in

due course.

EA enters into a formal partnership with the Commission

The agreement formalises the relationship

between the two organisations that

started with the adoption of the new

European legislative package, in particular

Regulation (EC) 765/2008 of the

European Parliament and of the Council

of 9 July 2008, and the recognition of

EA as the official European accreditation

infrastructure. Further progress was

made with the signing of the “General

Guidelines for the Cooperation between

the European co-operation for

Accreditation and the European

Commission, the European Free Trade

Association and the competent National

Authorities” on 1 April 2009 in Brussels.

On signing the agreements GrahamTalbot commented:

This is a significant

achievement for EA and I would

like to thank those within EA and

the Commission who contributed

to reaching this important

milestone. EA will strive to carry

out its new role with diligence,

impartiality, independence and

professionalism to ensure that the

trust that has been placed in EA

is well-founded.

Ms Liliana Brykman and Graham Talbot

Page 5: Update - UKAS 58.pdf · Update September 2010 05 Campden Certification is the first certification body in the UK to be granted accreditation to BS EN 45011: 1998 (General requirements

www.ukas.com Update September 2010 05

Campden Certification is the firstcertification body in the UK to begranted accreditation to BS EN45011: 1998 (General requirementsfor bodies operating product certification systems) for certificationof the validation and on-going conformity of alternative micro-biological test kits. The accreditationwas granted on the 27 July 2010and covers the certification of kitswhere Campden Certification is itself responsible for the validationand where validation is the responsibility of other organisations,in accordance with the ISO 16140protocol.

Microbiology testing for quality assurancepurposes in the food industry involves detecting and, where appropriate, enumerating both pathogenic bacteria andspoilage organisms, and is part of the armoury of food manufacturers to assessand ensure food safety and to maintainproduct quality and shelf life. Statutory requirements and industry codes of practicehave been developed over many years; theirprimary role is to protect public health andthey often stipulate specific tests, includingthose for certain food-borne pathogenicbacteria of concern and for specific indicatororganisms. Generally, these requirementsspecify the use of published standard testmethods e.g. International Organisation forStandardisation (ISO) methods or a validatedequivalent method to be followed.

Food testing laboratories accredited againstthe requirements of ISO/IEC 17025 (Generalrequirements for testing and calibration laboratories) will generally favour selecting ISOtest methods because of the ISO 17025: 2005requirement to, where appropriate, selectcurrent published international test standards.If not, extensive validation is required. Fullvalidation of a food microbiology testmethod as described in ISO 16140: 2003(Microbiology of food and animal feedingstuffs – Protocol for the validation of alternativemethods) is out of reach of most organisations;

it involves appointing an expert laboratoryand a number of collaborating organisationsall of whom are required to test for the organism of concern using both the methodto be validated and the current published ISOmethod for that bacterium for comparisonpurposes. ISO 16140 specifies minimumnumbers of participants and replicates to betested along with food types that should beconsidered and of course suitable statisticalcomputations to assess the performance ofthe method against the recognised reference method.

The complexity of conducting full validationin accordance with ISO 16140 for methodswhich are not based on accepted ISO reference publications means that to a largeextent, official recognised methods in foodmicrobiology have not evolved significantlyover the past couple of decades. Detectionmethods in particular continue to take, depending on the organism, several days toarrive at a confirmed result. This is particularlytrue for conventional culture-based methodsavailable for the detection of Salmonella infoods. The fast pace of the food industryfed by a public demand for 24 hour, seven-days-a-week grocery shopping often meansthat food manufacturers face challengeswhen it comes to awaiting laboratory testresults and meeting supply requirementsfrom retailers. This is particularly so for shortshelf life fresh products.

To respond to the needs of food industrytesting requirements, businesses supplyingmicrobiology laboratories with test materialsspend significant R&D budgets developingrapid methods to reduce the time taken forlaboratory tests and in some cases have successfully brought to market test kits thatcan cut by more than half the time todemonstrate a negative result for organismslike Salmonella and Listeria. However theneed to validate and therefore show paritywith established ISO conventional proceduresremains and is still seen to be a barrier to uptake within the food microbiology testingindustry.

In 2008 UKAS were approached by CampdenBRI (formerly Campden & Chorleywood Food

Research Association) with a view to accrediting the process of validating ISO 16140) for food microbiology testing tofacilitate easier take up of alternative methodsby testing laboratories while, importantly allowing those laboratories to meet the expectation that alternative methods specified in legislation or industry codes ofpractice could be seen to be equivalent. To meet the requirements of ISO/IEC 17025,testing labs would then simply need todemonstrate competence with the alternative method and that the applicationof the alternative method in the testing laboratory was covered by the scope of theISO 16140 validation protocol. Campden BRIsubsequently set up an independent company limited by guarantee and appliedto UKAS for accreditation to BS EN 4011.

Pat Eycott, Systems Manager at CampdenCertification Limited said "The services provided by Campden Certification Limitedoffer kit manufacturers the exciting opportunity of being able to obtain both validation and certification of their test kitsin accordance with ISO 16140: 2003 byworking with a single organisation. This provides a more efficient and straight forwardapproach to kit validation and certification.Where existing validation data is available, orwhen it has been generated under anotherscheme, Campden Certification Limited isalso able to offer certification. CampdenCertification Limited is accredited to BS EN45011: 1998 to undertake its certification activity giving users of these methods confidence in the performance of thesemethods and independent data on theequivalence of these alternative methods to the relevant standard method."

First accreditation for certification of alternative test kits

Page 6: Update - UKAS 58.pdf · Update September 2010 05 Campden Certification is the first certification body in the UK to be granted accreditation to BS EN 45011: 1998 (General requirements

Stationary Source Emissions Quality Assurance of Measuring Systems underISO/IEC 17025 accreditation

UKAS and the EnvironmentAgency have been workingin partnership under theMCERTS scheme for stackemissions to define accreditation criteria fortesting laboratories that perform work on industrialautomated instrumental systems monitoring emissionsto air to the requirements ofBS EN 14181– stationarysource emissions – qualityassurance of automatedmeasuring systems undertheir ISO/IEC 17025 accreditation.

This type of work has been performed

outside the scope of accreditation for a

number of years and following many

instances of variability and significant

examples of general misunderstanding

of the key requirements, both industry

and the Environment Agency looked for

mechanisms to increase the confidence

in those performing this work.

It was decided that accreditation was

the obvious step to secure this confi-

dence; however, as this was a new area

to UKAS, the route to accreditation

would be developed as a pilot project

scheme. This has now been running

successfully with a group of participants

for the past year to fully develop the

accreditation process.

The key areas UKAS has focused onare:l Verification that the emissions

monitoring system is fit for purpose

and functioning correctly.l Agreement in advance with all

parties of both the protocols and

objectives of the exercise.l Performance of the individual testing

activities under accreditation.l Production of a comprehensive

report meeting all the requirements

of BS EN 14181 and the Environment

Agency guidance.

The assessment stage is now complete

and it is envisaged that all participant

testing laboratories will be granted

UKAS accreditation to BS EN 14181

under ISO/IEC 17025 and MCERTS for

stack emissions in January 2011. From

this date, it will become a mandatory

requirement of the Environment Agency

that all industrial process operators

operating with a permit from the

Environment Agency under the

Environmental Permitting Regulations

procuring this type of work will have to

ensure their chosen supplier holds the

correct accreditation. For further

information please contact

Rohit Chirodian, Assessment Manager

([email protected]).

06 Update September 2010 www.ukas.com

Page 7: Update - UKAS 58.pdf · Update September 2010 05 Campden Certification is the first certification body in the UK to be granted accreditation to BS EN 45011: 1998 (General requirements

Project Evolution has a key aim tofurther enhance UKAS’ service toour customers and stakeholdersthrough the implementation of anERP system and through the simplification and improvement ofUKAS processes and procedures.

Hitachi Consulting UK is a recognisedleader in delivering proven business andIT strategies and solutions to Global2000 companies across many industries,including 25 percent of the Global 100companies.

Microsoft Dynamics AX is an establishedbusiness management solution, whichwill provide UKAS with a fully integratedbusiness platform which consolidatesand standardises processes, allowing thedelivery of key business information, improved productivity and visibilityacross the business and has a defineddevelopment road map through to2020.

A dedicated project team at UKAS willwork on Project Evolution with HitachiConsulting UK over the coming yearwith planned delivery in 2011. UKAS hasalready, and will continue to, involverepresentatives from our customers andstakeholders at key stages throughoutthe project.

Key deliverables for customers and stakeholders:

The implementation of this ERP solutionwill result in dramatic changes to theUKAS working practices, by simplifyingprocesses and developing tools to enhance services to our customers andstakeholders. Key deliverables include,but are not limited to:

– ‘Enhanced Communications’ –The ability to better track the progressof ongoing work and improved transparency of customer communications. This means that any UKAS staff member will be able to provide customers with up-to-date information regarding their account with UKAS.

– ‘Improved Tracking and Monitoring of Service Levels’ – Improvements to the way UKAS tracksand monitors the many tasks and deadlines that make up the accreditation process. This allows UKAS to be more proactive, further reducing the possibility of any delays.

– ‘Customer Web-Portals’ –Customers will have 24/7 access to up-to-date information regarding theiraccount with UKAS including the ability to, track ongoing work, post improvement action evidence and submit applications online.

Evolution at UKASFollowing a robust and in-depth review of a number of leading ERP (Enterprise Resource andPlanning) vendors, UKAS is pleased to announce that Hitachi Consulting UK has been selected as the implementation partner for Project Evolution which will deliver an ERP systembuilt on a Microsoft Dynamics® AX platform.

Support for customers and stakeholders:

UKAS recognises the need to supportcustomers and stakeholders duringthese changes to systems and processesso that UKAS can continue to deliver accreditation services to a high standard.

Whilst the implementation of an ERPsystem on this scale will undoubtedlycause some disruption, UKAS is planningto minimise this through providing in-depth and comprehensive training toall UKAS staff and by having a phasedimplementation of some aspects of thefunctionality.

Customers and stakeholders shouldbegin to see changes during 2011 including the introduction of web-portalsshortly after the implementation of themain system. UKAS will support customers and stakeholders in the useof these new tools through the provisionof user guides, fully trained contacts atUKAS and potentially, demonstrations atcustomer days.

UKAS will continue to keep customersand stakeholders informed of theprogress of Project Evolution, however if you have any specific queries or needmore information please contact theproject team on [email protected]

www.ukas.com Update September 2010 07

Page 8: Update - UKAS 58.pdf · Update September 2010 05 Campden Certification is the first certification body in the UK to be granted accreditation to BS EN 45011: 1998 (General requirements

Agri-Food and Biosciences (AFB)

Construction, Mechanical & Materials

Section (CMM)

Certification

Engineering

Electrical/Physical/ Thermal (EPT)

Environment

Industrial Chemistry

Measurement Audit

Divisional Director, Operations

Jeff Ruddle

Chief Ex

Paul St

08 Update September 2010 www.ukas.com

Finance

Alan

Commercial Operations and Business Information

Development and ISAS

Corporate Services

UKAS Organisation Chart

Accreditation Director

Jane Beaumont

Page 9: Update - UKAS 58.pdf · Update September 2010 05 Campden Certification is the first certification body in the UK to be granted accreditation to BS EN 45011: 1998 (General requirements

Human ResourcesManager

Debbie Bartlett

Divisional Director, Technical

Lorraine Turner

Director Technical and External Affairs

Graham Talbot

xecutive

tennett

www.ukas.com Update September 2010 09

Director

n Hill

Finance Marketing and communications

Technical

UKAS Contact Details

General Enquiries 020 8917 8400Fax 020 8917 8499Website www.ukas.com

Useful emailsAFB [email protected] [email protected] [email protected] [email protected] Communications [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] Chemistry [email protected] Desk [email protected] [email protected] Audit [email protected] [email protected]

HumanResources

Page 10: Update - UKAS 58.pdf · Update September 2010 05 Campden Certification is the first certification body in the UK to be granted accreditation to BS EN 45011: 1998 (General requirements

Changing the CPA decisionmaking process

In order to be compliant with ISO/IEC 17011CPA will be changing its decision makingprocess and this needs to be done to meetthe requirements of the standard for accrediting bodies. Turnaround times havealready improved significantly over the pastthree years and further improvements arepossible. The present system provides for ajoint decision between the office-based Accreditation Managers and the relevantmember of the Professional Advisory Committee (PAC). This process follows theassessment visit that is carried out by theRegional and Peer Assessors. Although thisis a very thorough system, it impacts on thetime taken for a laboratory to be aware ofthe final decision.

In the new proposals the Assessment Teamwill make a recommendation on site duringthe de-brief session with the laboratorymanagement, so that the laboratory canmake a start on addressing any findings thathave been raised. Where decisions arestraightforward, these will be made by the Regional Assessors, whilst the more complexones will be passed on to the relevant professional lead on the PAC. The majorityof the work will be completed by telephoneconference, only occasionally requiring a fullmeeting of the PAC. The timescale forthese changes to the decision-makingprocess will be six-eight months.

Developing a new Professional CommitteeStructure

A new professional committee structure isbeing considered to take on some of theduties of the old CPA Board. By extendingthe term of office for the committee members will provide continuity and indoing so will help to ‘bed-in’ the new decision making process. The new CPA

CPA/UKAS DevelopmentsIn April 2009, Clinical Pathology Accreditation (CPA) was acquired by UKAS. Since this acquisitionthere have been a number of initiatives in progress to develop CPA and deliver CPA processes effectively and safely into UKAS. The main initiatives are: changing the CPA decision makingprocess, developing a new Professional Committee Structure and Specific Standard Changes.

structure will consist of 4 tiers; the UKASBoard, the Clinical Advisory Committee(CAC), the Professional Advisory Committee,and Discipline and Specific Committeeswhen required.

The CAC will consist of members who havebeen invited by CPA, and appointed by theCEO. It is highly probable that the memberswill have been involved with CPA as PAC andex-PAC members. CAC will advise the UKASBoard on accreditation strategy, deal withappeals and meet three-four times a year.

The PAC will continue to participate in thedecision making process utilising “tele-conference” meetings once a fortnight instead of face-to-face meetings every sixweeks.

Specific Standard Changes

At present, CPA assesses to standards thathave been developed over a number of yearsby the organisation, taking into account therequirements of international standards.The intention now is to migrate to international standards through a series oftransition phases. It is expected that thistransition will take 2 to 3 years.

The objective is to ensure that UKAS andCPA are working in harmony. It is intendedthat, at some point, CPA will become an integral part of UKAS in order that its activities can be covered under the Europeancooperation for Accreditation (EA) multilateral agreement (MLA).

Although not an activity yet covered underthe EA MLA, CPA and UKAS are working together on the introduction of the newstandard for EQA/PT providers. ISO/IEC 17043was published earlier this year and as thestandard is new to both UKAS and CPA itprovides an ideal opportunity to develop ajoint approach to training and accreditationprocesses.

ISO 15189 is the standard for competency inmedical laboratories and the new revision isexpected to be published in 2012. CPA willnot undertake any gap analysis to updatethe current CPA standard, there will be aphased transition to the international standard. The project has started, and pilotsites will be selected. This transition will ensure that accreditation for medical laboratories in the UK is consistent with accreditation internationally.

One element of CPA which will not change is that peer assessment will remain at theheart of the process. Maintenance of thepeer assessment approach is vital and theCPA model has recently been adopted byUKAS for its Imaging Services Accreditation.Peer assessment will remain a key part ofUKAS’ strategy for CPA ensuring not onlythat the most appropriate individuals carryout assessments but also that CPA can keepfees as low as possible for all medical laboratories.

CPA Office Closure

The lease on CPA Sheffield office expires atend of March 2011. In March this year, CPAstarted consultation with employees on thefuture location of the office. The consultationended in early June and it was announcedthat CPA will move all activities to the UKASoffice in Feltham. After careful consideration,it has been decided that the long term interests of the business will be best servedby proceeding with the plan to close theSheffield office and transfer the supportfunctions on a phased basis.

The transfer will start in October and it is expected to be completed by the end of theyear. CPA is in the process of communicatingthis decision to all customers and peer assessors.

10 Update September 2010 www.ukas.com

Page 11: Update - UKAS 58.pdf · Update September 2010 05 Campden Certification is the first certification body in the UK to be granted accreditation to BS EN 45011: 1998 (General requirements

CQC – new system of registrationfor medical laboratoriesWhat is registration? The Care Quality Commission (CQC) is

introducing a new system of registration,

which brings the NHS, independent health-

care and adult social care under a single set

of essential standards of quality and safety.

This brings with it significant changes for

independent medical laboratories, as they

will for the first time need to register with

the CQC in order to legally practice from

1 October 2010.

The new registration system makes sure

that essential standards of quality and safety

apply across the whole care sector. It means

that people can expect services to meet the

same essential standards that protect their

safety, and respect their dignity and rights.

The Health and Social Care Act 2008 outlines

the scope of registration. The Department

of Health has set out the new regulations in

the Health and Social Care Act 2008

(Regulated Activities) Regulations 2010 and

Care Quality Commission (Registration)

Regulations 2009.

After initial registration, CQC will continuously

monitor whether providers are meeting the

essential standards of quality and safety.

However, CQC is working with UKAS to set

out an agreement on sharing information to

assist this monitoring process. The aim of

the agreement is to prevent unnecessary

duplication of gathering information on

performance. In this connection UKAS and

CQC are in discussions that will enable the

UKAS owned body, Clinical Pathology

Accreditation (CPA) to share its expertise and

knowledge about medical laboratory services

with CQC to establish systems that will help

avoid any additional assessments falling on

medical laboratories if they are accredited

by CPA.

CQC has a wider range of strong new

powers including imposing conditions on

registration, fines, and in extreme cases,

cancellation of registration. Where there are

concerns about compliance, CQC will identify

them quickly and work with providers to

improve, taking proportionate enforcement

action where necessary.

Laboratories that needto registerNHS Trusts that directly provide laboratory

services were registered with CQC on 1 April

2010. Independent stand-alone or private

medical laboratories now need to register

with CQC if they examine tissue, cells or

fluids from the body for the purpose of

discovering the presence, cause or extent of

disease, disorder or injury.

However, there are some exemptions.

Laboratories that only carry out analysis for

genetic purposes, or research and analysis

associated with a national cancer screening

programme, will not need to register.

What action laboratoriesneed to take nowThe application process is now open and

independent laboratories are advised to

submit an application on or before 1 August

2010. If CQC receives the application by this

date, the laboratories will be able to continue

to operate legally after 1 October 2010 even

if CQC has not yet processed its application.

To prepare for registration, providers can

begin to familiarise themselves with the

guidance about compliance documents,

which make clear the outcomes CQC can

expect people to experience if a provider is

compliant with the regulations and how

compliance is determined.

There is also an online interactive version

which enables providers to collect and print

out the guidance that applies to particular

types of service. This is available at www.

cqcguidanceaboutcompliance.org.uk

CQC has also made available an e-learning

module, which guides providers step-by-step

through the application process, as well as a

guidance document on ‘How to complete

the application form’. Both of these are

available on the CQC website –

www.cqc.org.uk/registration

CQC encourage all providers to visit the CQC

website for the most up to date information

on the entire registration process, timescales

and the action they need to take.

If providers have any further queries, they

can email: [email protected]

If any laboratories have any enquiries relating

to CQC registration and their accreditation

with CPA, then they should contact Cheryl

Blair at [email protected]

www.ukas.com Update September 2010 11

Page 12: Update - UKAS 58.pdf · Update September 2010 05 Campden Certification is the first certification body in the UK to be granted accreditation to BS EN 45011: 1998 (General requirements

In 1997, UKAS established a Development Group that would be dedicated to developing assessment and accreditation services for new areas, schemes and fieldsof activity in response to the needs of stakeholders and users of accreditation.Development projects and enquiries may originate from the public or private sectors and are managed by Accreditation Managers (Development), supported asrequired by Assessment Managers and Customer Liaison staff. Any potential newaccreditation activities have first to meet defined eligibility criteria and are subject to resource availability and current priorities.

Section Profile

Development Group

A major project is being undertakenon behalf of the Royal College of Radiologists and the College of Radiographers to provide accreditationfor the Imaging Services AccreditationScheme, ISAS. A dedicated team hasbeen developing our assessment andaccreditation processes and the firstaccreditation for ISAS is expectedwithin the next few months.

We are also working with a number ofproject owners including the ForestryCommission, the Department ofHealth, the Forensic Science Regulator,UK National Technical Authority for Information Assurance (CESG) and theDepartment for Energy and ClimateChange (DECC) to provide assessmentand accreditation for a wide range ofnew areas of activity ranging from examination of scenes of crime topoint of care testing in the communityand carbon sequestration projects.

Flexibility of approach is essential fordevelopment work, whilst at the sametime ensuring that any assessmentand accreditation activity is performedto the same standard and using thesame processes as for establishedwork in Operations. If we develop orneed to make use of different assessment tools and techniques inDevelopment, such as the web-basedassessment tool currently being pioneered by the Imaging ServicesTeam, we will also consider whetherthe use of these tools and techniquescan be extended into establishedfields of accreditation.

DEVELOPMENT TEAM

Jane BeaumontAccreditation Director

David HaywardAccreditation Manager (Development)

Ian RonksleyAccreditation Manager (Development)

Dorota PitmanCustomer Liaison Officer (Development)

Imaging Services Team

Ethna Glean Accreditation Manager (Development)

Deborah LoveAssessment Manager

Lynette Blackhurst Assessment Manager

David HalfpennyAssessment Manager

Kayleigh GregoryCustomer Account Coordinator

12 Update September 2010 www.ukas.com

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www.ukas.com Update September 2010 13

A particular highlight on the UKAS/ISAS

stand was the new additional function

of the web-based tool, called TrafficLight Ready. Traffic Light Ready is

being made available as a free resource

to all UK imaging services. This new

function will enable the organisation to

use a traffic light scoring system to

assess its current performance against

the ISAS Standard. Radiology Managers

or equivalent can request an immediate

login by emailing the ISAS customer

service team at UKAS. A new brochure

on ISAS was also available for delegates.

UKAS also presented an early rise session

entitled ‘ISAS one year on’. Ethna

Glean, ISAS Accreditation Manager, gave

an overview of progress with ISAS whilst

Jane Beaumont, UKAS Accreditation

Director, looked at how accreditation

could support imaging services and also

other diagnostic disciplines to deliver the

current healthcare service improvement

agenda. The majority of the session was

then handed over to ISAS participants.

Dr. Melanie Hiorns, Consultant Radiologist,

Great Ormond Street Hospital for Children

NHS Trust, drew on her personal

experience as an ISAS assessor and as an

Early Implementer to give an enthusiastic

and highly positive account of ISAS. She

said: ‘I never knew there were so many

ways to get a job done, and all have

their strengths and weaknesses, but

training as an ISAS assessor has shown

me the different aspects’. Melanie

concluded that the assessor role has

provided her with a great insight into her

own Service’s strengths and weaknesses

which can only serve to support their

own preparations for accreditation.

Deborah Southon, Project Lead for ISAS,

Plymouth Hospitals NHS Trust, gave a

very considered account of her Service’s

participation in ISAS. She commented:

‘There is a lot of work involved, but the

benefits of participating in ISAS far

outweigh the effort’. Although the

Service had found the process very

demanding in terms of time to do the

work, Deborah was keen to highlight

that the UKAS ISAS team was extremely

supportive and that valuable learning

had been gained by all Plymouth staff

involved in the assessment and

accreditation process. She reinforced

this with a recent quote from a colleague:

“We are moving away from seeing it

[ISAS] as a quality badge or benchmark

against similar Trusts and more as a tool

to drive continuous quality improvement.”

The session was moderated by ZenaMitton, former President of The Society

and College of Radiographers.

For further information about ISAS, the

ISAS assessor role and or to apply for a

login to Traffic Light Ready and a copy

of the ISAS brochure please email

[email protected]

UKRC 2010 –ISAS one year on! A dedicated UKAS team has recently returned from showcasing ISAS (Imaging Services Accreditation Scheme) at the annual radiology and oncology congress, UKRC 2010. This year’scongress was held at the International Convention Centre, Birmingham with the associatedexhibition housed at the nearby National Indoor Arena. The UKAS/ISAS stand at the exhibitionwas the focus of much interest from radiographers and radiologists seeking informationabout the progress of this new UKAS venture during its first year.

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14 Update September 2010 www.ukas.com

Events

TAF Awards DinnerThe Trade Association Forum (TAF) encourages the development and

sharing of best practice among UK trade associations. UKAS is the

headline sponsor for the TAF Best Practice Awards and Paul Stennett,

UKAS Chief Executive was delighted to present the Awards at the

TAF Best Practice Awards and Networking Dinner on the 1 July at the

Russell Hotel in London.

UKAS continues to work with TAF to raise awareness of accredited

services. The TAF events are also great opportunities for UKAS to

emphasise the importance of using a UKAS accredited organisation

and the value of UKAS accreditation.

UKAS and BSI highlight Government-wide role for

Against a backdrop of unprecedented challenges to the public purse

and a desire to challenge all aspects of public sector activity, UKAS

and BSI held their annual House of Lords reception to raise the

prospect of standards and accreditation playing a greater part in

delivering Government policy. A large audience of around 150 senior

representatives from across the public sector gathered to hear how

standards and accreditation can provide practical, business-focussed

solutions to address key areas of Government policy.

In introducing the event, Lord Lindsay, UKAS Chairman commented

“There is growing recognition that standards and accreditation can

make a major contribution to the delivery of public services,

especially at this time when departments and agencies are having to

find savings in their budgets and are looking for more cost effective

ways of delivering services. With every penny of public spending

being scrutinized, the ability of standards and accreditation to

deliver fast, market-focussed answers to help governments find

quick-win solutions has never been more important.”

UKAS recently published a new brochure regarding the Imaging Services Accreditation

Scheme (ISAS). The brochure is a great starting point for anyone who would like to

learn more about the patient focused imaging scheme, which is available to public

and private imaging services across the UK. The brochure includes the benefits of

participating in the scheme, details of the assessment and accreditation process, and

support available to imaging services. To request hardcopies of the brochure email:

[email protected] or visit: www.isas-uk.org to download a

copy, and to find further information about ISAS.

Mike Low, Director Standards, BSI added “BSI works across a wide

range of areas and provides off-the-shelf, cost effective, practical/

solutions to the issues that governments are addressing, not just in

the UK. Many countries have seen the benefit of using standards

and accreditation as a major enabler to more efficient public

procurement and we would encourage more of this in the UK.”

New promotional material

New ISAS brochure now available

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Events

www.ukas.com Update September 2010 15

standards and accreditation

Forensic Awareness WorkshopThe Forensic Science Regulator Andrew Rennison recommended

in 2009 that all providers of forensic science services, in both police

and private sectors, become accredited by UKAS to demonstrate

their technical competence. UKAS recently held a series of Forensic

Awareness Workshops to raise awareness of the Forensic Science

Regulator’s policy regarding accreditation in the forensic sector. The

workshops, which were kindly supported by the Regulator, provided

Police Forces and commercial forensic providers with an introduction

to UKAS as the Government appointed National Accreditation Body, an

insight into the principles of the Standards, the route to achieving

accreditation, and an overview of the basic requirements.

The series of workshops has now been completed and all the

presentations from the workshops can be downloaded from

http://www.ukas.com/media-centre/events/awareness/

UKAS_Forensic_Awareness_Workshops.asp

The Health and Social Care sector is a priority sector for UKAS. The recent acquisition of Clinical Pathology Accreditation (CPA), in addition to other activitiessuch as the Imaging Services Accreditation Scheme, Point of Care Testing, and thedevelopment of a Healthcare Information Accreditation Scheme, is evidence thataccreditation is becoming a preferred strategy in delivering high quality services fitfor the 21st Century.

To support Commissioners of Healthcare services, UKAS has produced a promotionalbriefing brochure that sets out how accreditation can support consistency in theprovision of care, provide a mechanism for measuring quality improvement, andtherefore ultimately inform investment decisions.

The briefing will be distributed widely to Commissioners, as well as being availablefor download from the UKAS website.

Lord James of Blackheath. speaking at the House of Lords reception

Guest speaker at this year’s reception was Lord James of Blackheath.

Drawing on his wide experience of senior roles in the City, as Chairman

of the Millennium Dome and author of the 2005 James Review of

Tax-Payer Value, Lord James gave warning of the need for sensible

decision making to ensure more can be delivered with less. Lord

James commented “There is the need for creative Government

initiatives, not least for kick-starting a great many businesses that

have fallen into distress in the recession. Standards and accreditation

provide a very positive means of delivering a confident solution to

many issues Government has to address, such as assisting struggling

businesses. They are a great illustration of how some different thinking

could provide real benefit in public service delivery and business

support.”

The annual House of Lords receptions continue to provide valuable

opportunities for UKAS staff to make and renew contacts within the

public sector and are a key component of the campaign to raise

awareness and knowledge of accreditation in government circles.

The success of this year’s event, with the largest ever attendance, is an

indication of the growing interest in standards and accreditation as an

effective tool for the delivery of Government policy.

New promotional material

Informing Commissioners of Healthcare services

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16 Update September 2010

Diary dates

The diary lists forthcoming national and international accreditation-related events of interestto our readers, as well as upcoming UKAS training courses.

Update is published quarterly by the United Kingdom Accreditation Service (UKAS). Articles in Updatemay be reproduced on receipt ofpermission from the Editor. Update is also published on the UKAS website atwww.ukas.com

UKAS is a non-profit-distributing company limited by guarantee. It is the sole national accreditation body recognised by the UKGovernment for the assessment (against international standards) of the technical competence of organisations offering evaluationservices such as testing, inspection, calibration and certification.

Information Desk

Tel: +44 (0)20 8917 8400Fax: +44 (0)20 8917 [email protected]

United Kingdom Accreditation Service

21–47 High Street, Tel: +44 (0)20 8917 8400Feltham, Fax: +44 (0)20 8917 8500Middlesex www.ukas.comTW13 4UN www.ukas.org

Editor

Aneet GoomerTel: +44 (0)20 8917 8467Fax: +44 (0)20 8917 [email protected]

Sanctions

Sanctions data is provided in Update on a quarterly

basis. Full statistics from January 2008 are available

on the UKAS website www.ukas.com

For the period April to June 2010:

Imposed total suspensions:

7 organisations –

(3 laboratories and 3 inspection bodies and

1 certification body)

Imposed total withdrawals

0 organisation

The data does not include suspensions and

terminations that have been imposed for

non-payment of fees.

September

6-8 Training CourseAssessor Training ISO/IEC 17025 [email protected]

9-10Training CourseLead Assessor Course [email protected]

14 EA Laboratory CommitteeManagement [email protected]

15-16EA Laboratory [email protected]

15-17Committee Conformity Assessment Working Group31 – Revision to ISO/[email protected]

21-22EA [email protected]

21-22Training CourseLaboratory Internal Audit [email protected]

28-29EA Horizontal Harmonisation [email protected]

29ISO Technical [email protected]

29-30EA Certification [email protected]

November

2Training CourseISO 15189 Transition Course [email protected]

2-3 Training CourseISO/IEC 17020 AwarenessCourse [email protected]

3-5 Training CourseAssessor Training ISO 15189 [email protected]

10European cooperation forAccreditation Advisory [email protected]

11 PAC [email protected]

15-18 Training CourseCombined Laboratory [email protected]

23EA [email protected]

23-24 Training CourseUncertainty of Measurement – [email protected]

24ISAS Preparatory Workshop [email protected]

24-25 EA General [email protected]

30Training CourseTraceability and Uncertaintyfor Managers [email protected]

October

1EA Inspection [email protected]

6Training CoursePreparation for [email protected]

6ISAS Preparatory Workshop [email protected]

6-7EA Communications & Publications [email protected]

6-7EA Multilateral [email protected]

12-14Training Course Forensic Laboratory Management – Implementation of ISO [email protected]

19-20Training Course Uncertainty of Measurement– Calibration [email protected]

19-21Training Course Laboratory ManagementCourse [email protected]

20-29IAF ILAC Annual [email protected]

Nuclear New Build –Inspection Opportunities

UKAS is now receiving enquiries from inspection bodies for accreditation of inspection of manufactureof nuclear components for the planned PWR powerstations in the UK. Further to this, UKAS is now considering developing a pilot programme for assessment and accreditation of potential applicants.Once the terms and conditions of the pilot programme are established, further information willbe published on the UKAS website www.ukas.comAny applications received for accreditation of inspection of nuclear components will be progressedonce a pilot programme has been established. Pleaseforward any enquiries by e-mail to [email protected]


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