PUBLIC REPORT 2012 TRUST IN THE FUTURE - RVA
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public report 2012 Trust in the future Dutch Accreditation Council (RvA)
2 3
I am interested in the future
more than the past because I intend
to live in it.
(Albert Einstein)
Vision, mission and core values FOREWORD Dear reader, confidence consumers and others
can have in the quality of the
Vision Whether it is with regard to the work on the basis of accreditation
The Dutch Accreditation Council (RvA) wants to be the national accreditation body which: economy, our safety in all kinds of by the accredited establishments
• forms or the accessibility of good is justified, where this is often
performs accreditations transparently in all the required sectors, both private and public; care: consumer confidence is often experienced unconsciously as
• linked to the future and in this obvious.
increases the confidence of society in services and products by the certificates of conformity issued to its clients; connection someone else must
• ensure that everything will be all As the RvA we try to create bridges
provides the quality image of the organisations assessed by the RvA; right. That other must provide between users, the public sector
• confidence but without anyone and accredited establishments. All
contributes to removing trade barriers; indicating what the measure for of us must bear in mind that we
• confidence is. This is a difficult task, can influence today the confidence
is a strong link in the global accreditation network; is seen internationally as a leading accreditation organisation; we will not deny it. in the future by making standards
• more explicit and learning together
offers its staff challenging work. So long as everything is going well, from what often goes wrong.
nobody says anything. As soon as This report is about building
things go wrong, it often appears confidence in the future. In it you
Mission that an unexpressed expectation has can also find the story of the work
The Dutch Accreditation Council (RvA) ensures that the confidence interested not been fulfilled. That unexpressed we are doing today on building
parties have in all the certificates of conformity and assessment reports issued under its expectation is often that it must be confidence.
supervision is justified. ‘impossible’ for ‘it’ to happen.
We hope you enjoy reading it and
On the other hand in some cases it that it gives you a challenging
Core values is indeed accepted that things can perspective on a future with
Our organisation has the following core values as its starting points in everything it does: go wrong. Think of near-disasters confidence.
• involving aircraft, unintended
competence, consequences of operations,
• building site accidents and so much
impartiality and independence, more. To this the response in many
• cases is not: how can we exclude
market-orientation, them, but how can we reduce them,
• what can we learn from this, so that Jan van der Poel
people-orientation, the chances of this happening again Chief Executive
• become smaller?
integrity, The work of the RvA fits in with
• the latter because we establish in
transparency. advance whether the organisations
we assess are independent and
In Dutch the first letters of these words read as the acronym ‘commit’, expert and have their own culture
this indicates ‘commitment’. It is particularly this commitment based on our core values which offers clients for improvement.
an actual guarantee of trust, now and in the future.
Accreditation provides confidence
assurance that these organisations,
which are testing, measuring,
inspecting and certifying will do
well in the future. This is not a
guarantee that things will never go
wrong in the same way as holding
a driving license doesn’t guarantee
that a driver would never cause
a traffic accident. But that the5
CONTENTS
Part 1 Part 2
trust in the future: connection leads to confidence:
the contribution by the Dutch personal visions of trust in the future
Accreditation council (rvA)
VOC: Quo Vadis?
By way of introduction 7 Column by Kees Pasmooij 36
Accreditation as a bridge of People want safety.
confidence between a cohesive A plea for clarity and continuity
public sector and society. by Paul Schnabel 37
Vision and practice 9
Justified confidence in the future.
Supervision and advice: Column by Paul Hesselink 40
guaranteeing confidence 11
Provide clear quality mechanisms.
International cooperation 13 A conversation with
Louise Gunning-Schepers 41
The internal organisation 15
Accreditation of medical
Quality leads to confidence laboratories 2.0: quality now even
in the future 18 more recognisable.
Column by Marc Thelen 43
Medical laboratories: in the lead
with transparent quality 20 Confidence in the future?
Realise the connection!
A group discussion with
Annexes Ed Nijpels, André Knottnerus
and Frits Spangenberg 44
The primary process of the RvA 22
Confidence in the future?
Administrative bodies and Make sure there are clear rules
advisory committees 23 and supervision!
Column by Albert Jan Maat 49
Brief financial overview 24
Our work in figures 25
Accepted scheme managers 28
Quality marks of the RvA 31
List of abbreviations 336 7
“Never be intimidated by the future.
The weapons of reason by which you
defend yourself now will also be of use to
you then when it is necessary”
(Marcus Aurelius)
BY WAY OF INTRODUCTION The core task of the Dutch
Accreditation Council (RvA) is to
The year 2012 is coming to an end. guarantee the confidence of the
As Christmas approaches, Marcia people, the public sector, companies
Luyten has a talk in the Buitenhof and bodies. In the first part of this
television programme with two report you will not only find an
‘éminences grises’ of Dutch politics, account of the manner in which
Hans Wiegel and Ruub Lubbers, our organisation contributed as
and two younger people who are an autonomous administrative
also involved in the future of our authority in 2012 to cementing
society: Dennis Wiersma, chairman trust but also our contribution to
of FNV Jong, and IJmert Muilwijk, confidence in the future. In the
chairman of CNV Jongeren. It was second part you can read the positive
a debate between two generations, views of several people with regard
quite confrontational but highly to confidence in the future. We do
respectful. Generations meet each this in the form of a representation
other in the truest sense of the of two personal interviews with Paul
words. Schnabel, director of the Social and
Cultural Planning Office, and Louise
Several subjects were reviewed such Gunning-Schepers, chairman of the
TRUST IN THE FUTURE as the gap that has arisen with Executive Board of the University
Contribution by the Dutch Accreditation Council (RvA) regard to pensions between the baby- of Amsterdam and Hogeschool
boom generation and the younger [Polytechnic] of Amsterdam. We
people. The central subject is the also had a very fascinating group
confidence in the future. Obviously, discussion on this topic with Ed
some statements will not make you Nijpels, whose role includes being
cheerful. Both older gentlemen chairman of our Supervisory Board,
indicated that a fundamental lack André Knottnerus, chairman of
of trust on all fronts has crept up on the Netherlands Scientific Council
our society. But nevertheless, one of for Government Policy, and Frits
the last statements by Ruud Lubbers Spangenberg, founder of the market
was: “Let’s look at the future of the research company Motivaction.
Netherlands and restore confidence
in the society.” These are authentic opinions which
you perhaps might not always
Several days later on 25 December, share. However: they are a source
Queen Beatrix gave her traditional for reflection. Reflection fits into
Christmas address. She calls for the a report such as this one. It is a
people to trust our constitutional line we started as autonomous
State. This is the basis of a just administrative body with the public
society. But according to Queen report for 2010.
Beatrix this trust must be earned. A
quotation: “Openness and tolerance What remains, is the question: “In
forms a major basis of trust. what way will the market cement
Throughout the ages our society trust in the future?” We put this
drew strength from the presence of question to four organisations that
people with different cultural and play a major role in the certification
ideological backgrounds. Tolerance of the service provision and
made our country strong.” products. You can find their opinion
in several columns which are also
included in the second part of this
report.8 9
The national government will start to work more cheaply, more flexibly and more efficiently,
with less administrative and official fuss and regulatory pressure. This should contribute
to improvement of the service provision to the people and to businesses. Policy and
implementation will be simplified, supervisory duties and advisory roles will be joined, duties
terminated or decentralised to other authorities and deregulation will be forcefully continued.
This will lead to lower compliance costs.
(Coalition agreement 29 October 2012)
ACCREDITATION AS A BRIDGE bodies and certifiers. The risk The Accreditation Council considers
The authors are the following: A report such as this should OF CONFIDENCE BETWEEN A assessments formulated by the that the Dutch public sector
• Kees Pasmooij, until recently obviously also include the more COHESIVE PUBLIC SECTOR AND official inspectorates can help authorities notifying the bodies
chairman of the Vereniging ‘solid’ details. Therefore following on SOCIETY. VISION AND PRACTICE. address any problems jointly. It is should better use accreditation
Overleg Certificatie-instellingen from this you will find information a joint approach for a common as as an alternative way of assessing
association, a vital organisation about the organisation of our Society assumes that the reports well as a social interest for all the the notified bodies - often called
which because of its role primary process, the composition and certificates issued by the respective parties. NoBos, an abbreviation for ‘Notified
supervises the reliability of the of the executive committees and assessment bodies are reliable and Bodies’ - which these authorities
products and services which we advisory bodies providing an offer security for our health, safety In this way we aim on the one hand are still currently conducting
want to trust. essential contribution to the duties and the environment. We often for a proper division of roles and themselves. This encourages the
• Paul Hesselink, until recently of the RvA, a brief overview of rely on this blindly and as a result type of work and on the other hand European harmonisation of the
chairman of Fenelab, the the financial results for the year great disappointment is expressed for good communication in order notified bodies. The work method in
trade association of accredited 2012, the information of our work with regard to setbacks. This is to establish jointly what are the connection with accreditation can
laboratories and calibration and in figures, the accepted scheme understandable. But much is being most important possibilities for then be coordinated between the
inspection bodies and also General managers, the marks of the RvA and done to prevent faults. However, improvement and how they can be ministries, the bodies and the RvA.
Director of Kiwa. a glossary of the abbreviations used. the exclusion of faults would not realised. This would create accreditations
• Marc Thelen, attached as be 100% achieved, however much In 2011 the RvA indicated to the which comply with the expectations
medical manager to the clinical And finally, let us return to the we say that we want this. It would ministries which possibilities it was of the national authority as well
chemistry and molecular biology overture of this introduction. In it yield an unliveable and unaffordable contemplating. In 2012 we explained as the international standards. In
department of Amphia Hospital we refer to a special meeting in the society. this in many discussions and addition, accreditation contributes
in Breda. In addition, as an Buitenhof television programme presentations at the ministries. In to transparency, regular and
initiator he provides guidance to and the Christmas address of In this connection the RvA fulfils the meantime this has contributed structured supervision and
the transition of the laboratory our monarch. And then there a sort of bridging role. The core to several concrete projects. A part European support.
specialisms to the ISO-standard was the statement of our queen activities of the RvA are aimed of this has already been realised,
15189. in her abdication address: “The at determining in advance others will be implemented in 2013. From 1 July 2013 onwards in
• Albert Jan Maat, chairman of LTO responsibility for our country the expertise, independence, We will review them below on the connection with the Construction
Nederland, the entrepreneurs’ must be in the hands of a new impartiality and the ‘self-purifying basis of the three variants which we Products Regulation the Ministry
organisation for the agricultural generation.” In short: new, inspiring operation’ of the management proposed last year: of the Interior, Construction
sector in the Netherlands. challenges are facing us. system of bodies assessing the and Housing decided to re-notify
quality, safety and trustworthiness 1. Notification and Designation the inspection agencies for
In the core text of this report The answer is in all cases of products and services. In order to issue certificates of building products on the basis of
we offer you our account of the unequivocally positive. This is conformity for CE marking, bodies accreditation. The Ministry also
activities undertaken by the RvA in apparent not only from the contents The Accreditation Council takes are often notified by or on behalf authorises the RvA to make these
the year 2012 in realising its social of this public report but certainly the responsibilities of the market of ministers. Brussels considers notifications in the database of
role of guaranteeing confidence. also from the talks we had and the parties and supervising authorities accreditation for the respective NoBos, called NANDO.
After this introduction you will columns from the market. With as a starting point. This means area of operation sufficient
subsequently read more about dedication and involvement the RvA that the suppliers of products and proof of expertise. Other forms The Ministry of Social Affairs and
the contribution which we can will also continue in the coming services are primarily responsible for of demonstrating expertise are Employment (Sociale Zaken en
and will continue to make to the years to contribute to cementing the safety of the consumers. In our discouraged and made unattractive. Werkgelegenheid: ‘SZW’) takes
formation of a more cohesive trust in the future. opinion the effectiveness of the work The statements of notified bodies are care of European notification and
public sector, the organisation of official inspectorates would be recognised throughout Europe in national designation of certification
of supervision and advice, the increased if they focussed more on connection with free movement of and inspection bodies on the
international developments in the detection and enforcement and less goods and services. basis of the designation criteria
area of accreditation, the internal on indirect forms of control, as this proposed by the field of activity.
developments and quality care is already happening by certificates The assessment of the bodies on
and the transition of medical and accreditation. The outcomes of the basis of these criteria, strongly
laboratories from a national to an their work could then more often resembling accreditation, has been
international standard. form an input for improving the outsourced to the RvA. In 2012 the
controls carried out by the market first assessments were carried out,
parties themselves, and of the as much as possible by overlapping
systems of external supervision by already existing accreditations in
accredited laboratories, inspection order not to increase the burden10 11
What wise rulers are obliged to do:
not solely and exclusively take into account the wrongs that exist
at certain times but also those which can arise in future
and this should be countered by all possible means.
(Machiavelli)
for the bodies. In this way trust expectations, that the parties In 2012 a discussion was held with SUPERVISION AND ADVICE: It is preferable for the following Supervisory Board will be heard. The
can be built up between the parties acknowledge and use each other’s the Ministry of Safety and Justice GUARANTEEING CONFIDENCE competence areas to be represented Accreditation Committee reports
and within a few years they can criteria and that they do not each about accreditation of laboratories on the Supervisory Board: annually on its activities to the
probably be incorporated into the apply their own yardstick. engaged in DNA tests and The Dutch Accreditation Council • commercial sector, Supervisory Board.
accreditation protocols. The SZW accreditation of forensic research. (RvA) is allowed to operate with a • public sector,
Inspectorate can keep its finger on The RvA considers this to be a very high degree of independence but • research/technology, objection chairmen committee
the pulse via its market supervision feasible option, an option which is There were discussions with the forms of supervising the work of the • healthcare/medical, It is possible that there may be an
and feed its findings back to the also in line with previous positions Ministry of Social Affairs and RvA and advice in the accreditation • food and goods, objection to a decision by the RvA.
RvA in order to improve the system of the cabinet with regard to the use Employment regarding a quality decision-making process are of major • quality. If that is the case, the Chairmen
where necessary. of accreditation and certification. mark scheme for temping agencies. importance in this connection. They Committee for Objection will be
In 2012 the Ministry of SZW guarantee independence, expertise When selecting the Members the engaged. This Committee consists of
Since 2012 the Ministry of announced that it will be deploying At European level the employees and provide a critical evaluation of major personal qualities are: at least one and not more than five
Infrastructure and the Environment the Labour Inspectorate less with of the RvA contributed to our activities. • wide knowledge and experience legally trained Members. If a notice
has been notifying in Brussels regard to companies that voluntarily harmonisation of accreditation of professional organisations; of objection has been received,
inspection agencies for inland have an OHSAS certificate criterions via schemes for food Supervision and advice contribute • being able to advise and the Executive Board will appoint a
vessels on the basis of an according to the SCCM scheme. safety, a current theme with to a major extent to the trust of encourage properly; Member of the Chairmen Committee
accreditation. Specific methods have Along comparable lines in the interfaces to the Dutch Food and the public sector, society and • objective, detached approach; to form an advisory committee for
been jointly determined by the RvA domain of the Ministry of Health, Consumer Product Safety Authority. our customers in performing • integrity and sense of that objection. The Members of this
and the Human Environment and Welfare and Sport (Ministerie van our activities. Various bodies and responsibility; Committee are strictly independent.
Transport Inspectorate (Inspectie Volksgezondheid, Welzijn en Sport: In 2013 the RvA will also committees are active in the RvA • independent and critical attitude; They will never be Members of the
Leefomgeving en Transport: ‘ILT’) ‘VWS’) the HKZ certification in communicate intensively with the to this end. In the organisational • formulation of a balanced opinion. Executive Board of the RvA and do
and have been laid down by the RvA mental healthcare is incorporated ministries with regard to the above chart in Appendix 2 you can see the not carry out any activities under
in a Specific Accreditation Protocol. as a risk-mitigating factor. We are three themes. We are convinced relation they have to each other and The Members of the Supervisory the responsibility of the Executive
In this connection the ILT can keep looking forward to the evaluation: that thereby we can contribute to their composition. In this text we Board are appointed for a period of Board. They are appointed by the
its finger on the pulse and feed its will this approach mean there will achieving a more cohesive public will outline the role and activities of three years and can be reappointed Supervisory Board. This guarantees
findings back to the RvA in order soon be as many, fewer or more sector, which in future will also the different bodies and committees. twice for the same period. impartial treatment of objections.
to improve this system too where problems than with the traditional enjoy society’s trust that important
necessary. inspection approach? matters such as health, safety Minister of economic Affairs Accreditation committee eA Multilateral Agreement committee
and the environment are being Pursuant to EU Regulation 765, the The Accreditation Committee In order to remain a signatory of
Via the Dutch Emissions Authority We are in talks with the Dutch guaranteed at a good level. Dutch National Accreditation Body consists of four members. They are the MLA the RvA must satisfy the
the same ministry is going to use Food and Consumer Product Appointment Act (Wet aanwijzing appointed by the Supervisory Board requirements of the European
accreditation for the notification of Safety Authority about the way in nationale accreditatie-instantie) and on the basis of their expertise in Regulation 765/2008 and the ISO
verification agencies in connection which defects in compliance they the Dutch Independent Executive accreditation, their integrity and 17011. Every four years the RvA
with the Emission Trading Scheme. have established can be improved Agencies Framework Act (Kaderwet independence. The Accreditation is assessed by a team of about
In this scheme a small error of by companies certified under ZBO), the Minister supervises the Committee meets once a month. eight ‘peers’ in the form of a Peer
measurement can save or cost accreditation and what is to be RvA via regular communications Its duty is to advise the Director/ evaluation. Representatives on
millions. applied as a detection threshold. as laid down in the protocol dated Chief Executive about granting behalf of the Ministry of Economic
After all, not all defects constitute a 18 November 2010, by approval of accreditations. In addition, the Affairs (Ministerie van Economische
2. Reduction of inspection pressure risk to food safety. rates, budgets, annual accounts, Committee has the power to advise Zaken: ‘EZ’) are invited as a standard
Since the previous cabinet period amendments to the Articles, on the suspension or withdrawal in this connection.
sound ways are already being sought 3. Self-regulation appointment of Director and by of accreditations of bodies that
in order to reduce the pressure Policy departments of the various attending the EA Peer Review. have been granted accreditation. executive board
of inspection on companies with ministries can focus on self- It receives information from The Director/Chief Executive is
a good track record. For instance regulation via the so-called ‘Integral Supervisory board the Executive Board and the responsible for the realisation of the
inspections could be carried out Balancing Framework’. This means The Supervisory Board of the RvA is management about measures and Accreditation Council’s objectives,
less often if there was proper self- that the ministries have to formulate comparable to the Supervisory Board sanctions against bodies. its strategy and policy, and the
regulation. Inspectorates could the expectations of and the criteria of a commercial organisation. This The Accreditation Committee developments resulting from
then deploy their manpower in less for the result to be achieved. A Board ensures that the Executive does not take decisions. The these. He accounts for this to the
properly regulated and higher-risk system can then be designed in Board realises the objectives of the decision-making is entrusted to the Supervisory Board.
sectors. To this end it is important consultation with the scheme RvA. Selection of the Members takes Executive Board. If the Executive
that the public sector and the managers and the RvA which meets place on the basis of expertise and Board has a different view from
market are aware of each other’s the expectations and the required competencies. the advice of this Committee, the
results.12 13
The only limit to our realisation
of tomorrow will be our doubts of today.
(Franklin D. Roosevelt)
user council INTERNATIONAL COOPERATION In its turn the RvA also contributes In 2011 the ISO 14065 standard for
The User Council is an advisory to Peer Reviews in other countries by the accreditation of the validation
panel laid down in the Articles. This Accreditations are mutually sending lead assessors and assessors and certification of greenhouse gases
Council consists of representatives recognised internationally (Mutual for such Reviews. In connection was added to the area of operations
of the direct RvA clients. The Recognition/Acceptance). To this with European cooperation for of the RvA. This is important for the
Supervisory Board receives the end accreditation bodies enter accreditation assistance was trust that society should have that
minutes of the meetings, so that it into agreements within the global rendered in 2012 to the evaluations the emission rights of greenhouse
can include the opinions of users in umbrellas of IAF and ILAC and the of the National Accreditation Bodies gases are being determined in the
its deliberations. regional umbrella for Europe: the of Turkey, Poland and Norway. In proper way.
EA. connection with the International
Management Accreditation Forum (IAF) the europe
The management of the RvA consists What is good enough for one RvA provided the lead assessor The EA was put on a formal basis
of the Director/Chief Executive country, is good enough for the for the assessment of the Pacific via European Regulation EU
and the Operational Director. They other country. Certificates of Accreditation Cooperation (PAC) 765/2008. The Peer Review is a
take care of the proper policy and conformity operate as a passport in the Asia-Pacific region. The RvA process acknowledged throughout
management of the organisation in the free trade of products and provides a major contribution to Europe. Accreditation of a European
and they report on this to the services with the result that trust is the training of and the continuous establishment is legally effective for
Supervisory Board. created amongst buyers and users. refresher courses for these peer harmonised standards throughout
Accreditation should justify this reviewers. Europe.
The forms of supervision and advice trust. In order to promote harmonisation
outlined in this chapter are a major international normalisation is the when standards appear (again)
contribution towards the RvA having peer review basis of harmonisation at European level, trainers will
confidence in the future. This is In order to support mutual The assessments of the RvA take be trained who can pass on the
confidence that not only applies to recognition, the accreditation place on the basis of accreditation European interpretation locally
our organisation, but also to our bodies assess each other. This takes standards. In order to harmonise to colleague assessors. In 2012 too
clients and the civilians. Therefore place in a so-called Peer Review, these assessments internationally, the RvA provided many European
this is the place to thank all these in which a team of assessors a standards framework is required trainers.
members for their input in the year from other accreditation bodies which has international force.
2012. verify whether the organisation For laboratory and inspection In the areas of health, safety and
being assessed complies with the activities these are currently the ISO the environment there are many
agreed international ISO/IEC 17011 standards, which enjoy worldwide European guidelines. In order to
standard. This is a guarantee of the support. This movement got into enhance compliance with them,
expertise and independence of the its stride later with regard to the inspection bodies are being notified
accreditation body. certification activities. In this at national level to Brussels, the
In Europe, apart from this, there respect the European EN standard so-called ‘Notified Bodies’. Although
are also evaluations with regard and the international IAF Guidelines these bodies are only accredited
to the additional requirements were effective side by side. In the nationally they are considered to
for national accreditation bodies meantime there are ISO standards have the expertise to be able to
on accreditation and market for certification of management carry out their activities throughout
supervision laid down in Regulation systems and people. Europe. So their results must be
765/2008. recognised throughout Europe.
In 2012, after many years of work, According to Regulation 765
The Accreditation Council will again the ISO accreditation standard for accreditation is the obvious route
be subjected to a Peer Review at the product certification, the ISO/IEC for the Member States to determine
end of 2013. The complete report 17065, appeared. Moreover, renewed the expertise of inspection bodies.
will, after it has been determined, be versions of the standards for the In order to allow this to take place
published on the website of the RvA, accreditation of inspection bodies unequivocally in Europe, the EA
www.rva.nl. and medical laboratories have come has drawn up a guideline (EA -2/17)
into effect. An ample transitional specifically for use at Notified Bodies.
period has been determined for all
these standards in order the save
the extra costs for the accredited
establishments which would result
from a faster implementation.14 15
If you dedicate yourself completely to the present
it indicates a general
short-sightedness with regard to the future
(Albert Camus)
The RvA applied this guideline to Within the global accreditation THE INTERNAL ORGANISATION In addition, two new positions Absenteeism policy and employee
its assessments for the first time in community more regions are were created in the RvA in 2012: a satisfaction
2011. In 2012 in the Netherlands the increasingly arising such as EA. It is As of 1 January 2010 the RvA went functional manager and a part-time In 2012 extra attention was paid to
experiences were evaluated with the often quicker to harmonise within for a fundamental change in its lawyer. The functional manager has cutting back absenteeism due to
bodies and the notifying authorities. these regions. How the regions management structure. In 2010 an important role in streamlining illness. The management followed
We are inputting these experiences which actually form the basis of and 2011 this structure had to the increasingly further expanding a workshop to improve skills in
into the discussions on this subject the global, mutual recognitions are gain shape, be embedded into the ICT provisions and in addition acting dealing with absenteeism due
in the EA. related to individual countries in organisation and find support as an intermediary between ICT to illness and to make uniform
the membership of ILAC and IAF, amongst its personnel. At the same and the operational work process. arrangements about procedures in
Globally still has to crystallise in the coming time our personnel had to get used The lawyer was appointed because this area. The result was that in 2012
The autonomous organisations of years. Not all EA MLA signatories are to the consequences for our work the RvA with its ZBO status is absenteeism due to illness reduced
ILAC (Laboratories and Inspection) also a member of IAF/ILAC. of the autonomous administrative increasingly more involved in legal by 0.7% to 4%.
and IAF (Certification) co-operate agency (‘ZBO’) status becoming cases pertaining to administrative
intensively in several areas. This The status of the participation in effective in 2010. In 2012 the process law. In May/June 2012 the RvA had
applies to the organisation and the mutual recognition as of April 2012 in this respect has become clear. an employee satisfaction survey
completion of the Peer Reviews, was: We specifically chose not to start The details referred to above only carried out by an external agency.
for communication and for the EA: any new time-consuming internal relate to the employees directly For the proper operation of the
assistance to countries just starting 35 signatories in 35 countries projects but to follow the routes employed by the RvA. In addition, organisation it is important to
accreditation. IAF: already taken and to finish what had we work together with roughly 750 know where there are any problems
54 signatories in 51 economies been started in the previous years. external professionals and assessors preventing efficient and practical
In 2012 the ILAC formulated ILAC: This created a calm atmosphere who are deployed on call for specific work. This survey showed points for
standpoints in the area of the 80 signatories in 66 economies in the organisation and space to assessments. All together this is the improvement which were already
traceability of measurement values dedicate ourselves optimally to equivalent of about 25 FTE work. partly addressed in 2012 and which
to international standards. The Of establishments accredited by the quality of our services. This In order to guarantee the quality are partly included in the annual
Inspection Committee established the RvA 32 laboratories and 32 was obviously with the objective of the assessments, with the future plan for 2013. Overall, the score of
in 2011 held its first meeting in certification bodies have taken out of also continuing to guarantee in mind, the assessor management the RvA employees was an ample 7.
2012 and was busy introducing the a license to be able to carry the ILAC confidence in future in the way the department is working continuously
renewed accreditation standard for mark or the IAF mark respectively Accreditation Council expects and on maintaining and where necessary training and education
inspection bodies. on their statements. which we ourselves certainly expect. expanding this pool of specialists. In order to guarantee quality, now
In anticipation of the expected and in the future, it is essential to
In 2012 the IAF unequivocally laid personnel retirements of experts and the pay continuous attention and time
down the minimum requirements The total number of employees need for new experts in certain to training and education. The world
for time spent by certification remained almost level in 2012. On fields, an assessor management of accreditation and accreditation
bodies in a document that is 31 December 2012 93 employees workgroup started at RvA in 2012. standards is constantly in flux. In
compulsory for all accredited were permanently employed by the This workgroup is mapping the order to provide good and reliable
certification bodies. A start was RvA and six employees had a flexible capacity need for the coming years services personnel must be aware
made on determining the minimum employment contract. All together and developing an action plan to of the latest developments in the
requirements for the drafting of this is a work force of 86.9 FTE be able to fulfil this need. Moreover, area of accreditation but must
reports on certification assessments. with an average age of 48.3 and an the workgroup is focussing on the also develop their other skills or
In the IAF community a lot of average of 8 service years. cooperation between the assessor keep them at the required level. In
attention is being paid to the management department and the addition, it is important to let the
reliable certification of management But several shifts took place in the operational departments. assessors carry out their work with
systems. Additional methods work force in 2012 because seven the least possible mutual differences
are being worked out in order to employees resigned from the RvA (harmonised). A lot of energy and
determine whether certificates have and eight new employees started time is put into this as well.
been granted with good reason. this year. One of the employees
Control audits, unannounced who resigned was the Operational In 2012 over 250 days were spent on
inspections and shadow audits are Director. At the beginning of education and training by employees
solutions being reviewed. 2013 we conducted a successful of the RvA. Part of this training was
recruitment to fill this vacancy. The given internally by our own trainer;
new Operational Director, mr. J.A.W. part of the training was outsourced
de Haas, started on 4 March 2013. to external agencies.16 17
A lot of attention was paid to which processes are dealt with and the future
training in the area of skills and the quality of the service. In 2013 the streamlining of internal
communication. Communication Moreover, in 2012 a start was made processes continues in full. The aim
training is relevant to all RvA on a fixed structure for evaluations is to improve our own quality and executive boArD
employees. Skill training is detailed and the follow-up of the findings efficiency.
according to personal need, for arising from this. The effects of this In addition, a lot of attention will
instance training in the area of will become noticeable from 2013 be paid to the continuity of our
often-used software, in order to onwards. knowledge base built up over past
improve efficiency and output. years. During the course of the year
Basic accreditation training and The quality project started up lead assessors in particular will be
training with regard to assessing in 2012 is - apart from better recruited and settled in, in order
according to accreditation guaranteeing our PDCA cycle for to anticipate several lead assessors
standards in connection with the continuous improvement - also resigning due to retirement later unit
unit heAlth cAre ASSeSSorS unit A unit b
process of settling-in employees are aimed at achieving even more in 2013 and 2014. The internal lead
often given internally. These are clearly defined processes and at assessors form the lion’s share of our
hardly available in the market. In including benchmarks in this, for knowledge base.
connection with harmonisation and instance for the completion time.
professionalisation of assessment, Finally, in 2013 three other matters
almost 500 assessors in total Annual plan according to the A3 will also keep our organisation busy
gathered together on 18 days to method again: the internal quality project
achieve uniform opinions according In 2012 the RvA worked for the first of the RvA, the Transition Project
to an accreditation standard time with an annual plan according in which over 250 medical labs
relevant to them. The outcomes of to the A3 method. will move in a time frame of four
the scheme for settling different This is an annual plan with a lot years from a nationally recognised
interpretations were for instance of cohesion in which objectives to an internationally recognised quAlity AnD
FinAnce, StrAteGy & GenerAl
hrM proceSS
used as case subjects. and points for action are directly accreditation standard and three itc & FAcilitieS
MAnAGeMent
DevelopMent Support
related to mission, vision and processes in which accredited
ict and Facility Management success-determining factors, all this establishments move to a new
As mentioned earlier, the resources compiled in A3 format in an orderly standard version. You will read more
in ICT have increasingly expanded and digital manner. The initial about this elsewhere in this report.
at RvA. experiences with this method have
In 2012 new software was purchased been very positive. The big lines can
in order to manage (non-primary) be easier adhered to throughout
processes and software for Facility the year and the focus on objectives
Management. Personnel have been is better. For 2013 this method has
trained to work with this software so therefore again been used for the
that it can be optimally deployed. formulation of an annual plan.
Points of action or objectives that
cooperation and efficiency were not completely finished in
At RvA the consultation structure 2012 are included in the annual
reached its definitive form in 2012. plan for 2013 so that a meticulous
The cooperation and distribution completion is guaranteed and
of work between the various certain points are not lost.
departments have profited from this.
The lines are short and clear and
that aids efficiency. The divisions of
duties in the management team are
also better synchronised and this has
a positive effect on the speed with18 19
Only the watchfulness of public opinion
ensures the future of a society.
(Noam Chomsky)
QUALITY LEADS TO CONFIDENCE handling complaints about the rvA complaints being dealt with There was one session of an recorded reports about the perfor-
IN THE FUTURE According to the provisions in the concerning the performance of the objections committee. In two cases mance of accredited establishments
Dutch General Administrative Law rvA per category the parties lodging objections by category
internal quality care and handling Act (Algemene bestuurswet: ‘Awb’) withdrew the objection after
complaints and reports the RvA has a complaints scheme in Accreditation additional communication and Accreditation
The Accreditation Council has its place for any complaints about its category 2012 2011 2010 arrangements. category 2012 2011 2010
own quality care system in order management. This scheme has been Laboratories 4 1 3 In one case the decision on the Laboratories 7 0 0
to guarantee the execution of its published as the Policy Directive Inspection 8 1 1 objection was appealed from. Inspection 12 10 7
mission and objectives. To monitor BR-008 and is directly accessible on Certification 6 5 17 An appeal brought in 2010 was Certification 15 6 13
and optimise the proper operation www.rva.nl. CCKL withdrawn in 2012. CCKL
of the system we for instance use In 2012, in most cases the Code of Practice 1 0 0 Code of Practice 0 0 0
observations during internal audits, organisation did not yet achieve Other 7 7 5 reports and signs of dissatisfaction Other 0 4 3
complaints and feedback we have the processing period of six weeks Total 26 14 26 with accredited establishments Total 34 20 23
received from users of accredited but the number of complaints Reports on the conduct of accredited
services. where this was indeed reached has In 2012 all complaints about the establishments should first be made
doubled. The objective for 2013 is performance of the RvA were known to that establishment. If
Each year a management assessment to improve this processing period declared admissible. the establishment complained of
will determine whether the further and to have dealt with all Of the complaints dealt with does not deal with the complaint
quality care system meets our own the complaints at least within 3 from 2012, 15% were found to be properly, the complainant can turn
wishes, the requirements of ISO/ months. justified, 35% partly justified and to the RvA.
IEC 17011, the European Regulation 50% not justified. One complainant
EU 765/2008, the Dutch National From the complaints about the turned to the National Ombudsman In 2012 a relatively large number
Accreditation Body Appointment RvA in the year 2012 the following because of the way his complaint of reports and signs were
Act and the Dutch Independent particular aspects emerged: was dealt with. In this connection received about certification and
Executive Agencies Framework Act • the communication between RvA the Ombudsman advised to inspection bodies. In particular
(Kaderwet ZBO). and the accredited organisation; make a clearer distinction in the the subject matter was the quality
• the (project) management of communication between complaints or the conduct of the auditors
In 2012 the accent of the internal assessments. about the RvA and reports or signs and inspectors. With regard to
audits was on the implementation about accredited establishments. laboratories the use of the right
and effectiveness of the preventative The complaints partly led to a This recommendation has been methods and the reference to
and corrective measures. In addition, project to improve the planning adopted and implemented. accreditation require particular
we concentrated on following the process. In addition, the quality attention. Attention by authorities
internal procedures and work rules project mentioned above must processing notices of objection in the course of enforcement
in the organisation. contribute to improvement on these In 2012 objections to a decision of resulted in extra complaints about
We have established that we want to points. the RvA were lodged four times. The the correctness of the final audits
improve ourselves on both points. decisions against which objections of asbestos removal and soil quality
A quality project was started to More than half of the complaints were lodged related to: for instance. Signs such as these,
improve the effectiveness of our originated from the sector of • accreditation extension restricted but also those in connection with
system and the embedding of this in certification bodies and inspection to one year, the public debate, gave the RvA
the organisation and this continues agencies. Interpretation of standard • tougher control, reason in many cases to conduct
into 2013. texts at these bodies tends to lead • the formulation of the decision, extra investigation by itself. If the
The management assessment was to an almost legal discussion. • Request for information under the complaint - and thereby the extra
discussed with the Supervisory Sometimes the assessor is blamed Dutch Government Information investigation of the RvA - appears
Board. The processing of complaints for this and a complaint then (Public Access) Act (Wet to be unjustified, the establishment
is a permanent agenda item in the results. In order not to obfuscate the openbaarheid van bestuur: ‘Wob’). complained of without grounds will
meetings of the Supervisory Board complaints scheme unnecessarily, not pay for the investigation. The
and in the management meetings. a so-called dispute settlement RvA will then bear the costs.
scheme has been set up. Should
there be an important specific
difference of opinion about the
interpretation of the standard, the
assessed establishments can submit
this to the RvA by reporting an
interpretation dispute.20 21
I found that patients receive sparse information about quality and that it is unclear how reliable this information is.
There is no fixed point where you can find that up-to-date information.
Many people have worked hard on quality improvement and the development of standards, guidelines and protocols.
My compliments for this but it is going too slowly and is insufficiently systematic.
Pooling knowledge and power is the motto.
(Edith Schippers, Minister of VWS)
MEDICAL LABORATORIES: IN transition to the iSo 15189:2012 Future-proof trust
THE LEAD WITH TRANSPARENT standard In an era in which mergers and
QUALITY The appearance of the 2012 version other forms of economy of scale
of this standard was the immediate of medical laboratories are taking
In the world of healthcare there reason for the scientific associations place, the fact that these laboratories
is much ado about providing, and the RvA to consider how CCKL are again raising the bar somewhat
buying and transparency of quality. accredited establishments could higher for themselves demonstrates
What for many specialisms is still move with due care and under a sense of responsibility. During a
a rather young field, has already control from accreditation on the meeting for interested parties in
been standard for over 10 years for basis of the Code of Practice to January 2013 the health insurers
medical laboratory specialisms. accreditation on the basis of the present expressed their appreciation
More than 70% of the Dutch international ISO 15189 standard. of this step. Their major argument
laboratories have been accredited on In this connection the starting was: they could very well make a
the basis of the CCKL (Foundation point is to retain as much as procurement criterion of it.
for the Promotion of the Quality possible the involvement of the
of Laboratory Testing and for the sector that launched the CCKL To conclude this contribution we
Accreditation of Laboratories in system so successfully. In order return to the quotation by Minister
Healthcare) Code of Practice (‘PRL’). to be able to comply with the Edith Schippers with which we
internationally recognised standard, opened. This included a mention
laboratory accreditation work is carried out in particular of the ‘pooling of knowledge and
The CCKL accreditation is being used on training and qualification of power’ motto. The Dutch medical THE FACTS BEHIND TRUST IN THE FUTURE
by over 250 medical laboratories assessors, the assessment regime laboratories are certainly aiming for Annexes
to demonstrate their expertise and and defining the accredited areas of this, also in international context. It
quality in the area of regulation operation. Moreover, it is important is an extraordinary challenge with
as well as the contribution to that the CCKL guideline is of an much perspective for confidence in
the diagnosis and treatment of outlining nature and that the ISO the future!
patients. This system originates standard leaves more space to self-
from scientific associations of the demonstrate that the criterions have
respective specialisms such as been complied with.
clinical chemistry and medical
microbiology and has been extended In order to assess these important
into fields such as pathology, major adjustments for the
embryology, hospital pharmacy laboratories, with the smallest
and job tests. The Dutch Code of possible extra burden on them, a
Practice played a major role in the transitional period of four years
formation of the ISO 15189 standard has been determined, commencing
for medical laboratories which has on 1 January 2015. Prior to this
in the meantime been accepted the transition plan formulated in
internationally. By complying with cooperation between the scientific
this standard the results of the associations of the laboratory
Dutch medical laboratories are disciplines and the RvA will be
qualified for use in international tested in several pilots.
research. Working for clients in
other countries is also facilitated
by this. Via this standard health
insurers have an independent
benchmark making the quality to be
bought objective.22 23
Annex 1 Annex 2
THE PRIMARY PROCESS OF THE ADMINISTRATIVE BODIES AND
DUTCH ACCREDITATION COUNCIL (RVA) ADVISORY COMMITTEES
This overview contains the
composition of the administrative
bodies and advisory committees as
of 1 March 2013. In addition, we
regularly engage advisory panels
the composition of which can vary.
Hence you will not see any names
of the members of these advisory
panels in this summary.
SuperviSory
ApplicAtion plAnninG Supervisory board boArD
- drs. E.H.T.M. Nijpels (Chairman)
2nd session period until 22 June 2013
- dr. A.G.M. Buiting
2nd session period until 1 January 2014 Accreditation Objection Chairmen
- dr. S.A. Hertzberger committee Committee
ASSeSSMent Report 3rd session period until 22 June 2015
- ing. J. Visser
2nd session period until 27 March 2014
Negative
result ASSeSSMent Extension - ir. L. Visser
1st session period until 26 October 2014 User council Director/chieF Advisory panels
executive
Positive result executive board and Management
SubSequent
ASSeSSMent
Yes ir. J.C. van der Poel
(Director/Chief Executive)
mr. J.A.W.M. de Haas
Yearly cycle No
(Operational Director)
preliMinAry Positive
inveStiGAtion result Accreditation committee
AccreDitAtion
ir. M.N.D. de Vries (Chairman) oFFice
DeciSion dr. W. Huisman
Negative result
K.J. van Schalm
Prof. dr. ir. O.A.M. Fisscher
Positive Negative
result result
objection chairmen committee
End of SuSpenSion/ mr. L.A.F.M. Kerklaan
accreditation AccreDitAtion
process withDrAwAl mr. M.N. van Zijl
user council
ir. J.C. van der Poel (RvA, Chairman)
mr. J.A.W.M. de Haas (Operational
Director RvA)
P. Cornelissen (VOC)
B. Meekma (VOC)
H. Tolman (Fenelab )
ing. R.P. Veerman (VEROCOG)
J.H.F. van der Wart (Fenelab)
Vacancy 2x (Medical labs)24 25
Annex 3 Balance sheet as at 31 December 2012 Results for 2012 (x € 1,000) Annex 4
(x € 1,000)
BRIEF FINANCIAL OVERVIEW 2012 2011 OUR WORK IN FIGURES
Assets 2012 2011 Net turnover 12,422 11,241
As an independent foundation VFixed assets 224 360 Costs of turnover 3,958 3,314 Confidence in the future also requires
and ZBO the Dutch Accreditation Receivables and Gross margin 8,464 7,927 the possibility of audits. A summary
Council (RvA) is a non-profit Transitory Assets 3,271 2,886 in figures of our activities in 2012
organisation. Our independence is Liquid resources 2,729 2,552 Personnel costs 6,034 5,543 will be found in this Annex. As a
guaranteed via the Dutch National Total 6,224 5,798 Miscellaneous comparison we also added previous
Accreditation Body Appointment expenditures 2,221 2,243 figures in several cases.
Act (Wet aanwijzing nationale Liabilities 2012 2011 Sum total of costs 8,255 7,786
accreditatie-instantie: ‘Wanai’) and Equity capital 3,010 2,737
by a modern governance structure Short-term debts and Operational result 209 141 Accreditations granted as at 31 December
with the Supervisory Board, the transitory liabilities 3,214 3,061 Interest income 63 59
Accreditation Committee and the Total 6,224 5,798 Result 272 200 Standard Explanation NL. 2012 Abroad 2012 Total 2012 NL. 2011 Abroad 2011 Total 2011
Objection Committees. Certification
We also guarantee our independence profit and loss account for 2012 rates EN 45011 Products & Services 45 7 52 43 7 50
by a healthy but limited amount (x €1,000) The starting point - subject to special ISO/IEC 17021 Management systems 48 38 86 50 42 92
of equity capital. This prevents us The income of the RvA is generated circumstances - is to increase the ISO/IEC 17024 Persons 6 1 7 8 1 9
from taking too great financial risks particularly from activities carried rates by not more than the index Subtotal certification 99 46 145 101 50 151
when conformity issuing bodies out on the basis of rates. We of Statistics Netherlands (CBS) for Inspection
decide to discontinue accreditation determine these rates on the basis business services. The rates have ISO/IEC 17020 Inspection 125 5 130 122 6 128
if the RvA takes a decision which of a discussion of the budget with been adjusted as follows: ISO/IEC 14065 Inspection 5 0 5 0 0 0
is disagreeable to them. That also the User Council and after approval Subtotal inspection 130 5 135 122 6 128
provides confidence in the future. by the Supervisory Board and the 2012 2011 Laboratories RvA mark
Minister of Economic Affairs. Index applied 1.8% 1.1% ISO/IEC 17025 Calibration 56 3 59 54 3 57
The figures have been taken as a The activities level was approx. 5% Rate (lead) assessor +1.0% +1.1% ISO/IEC 17025 Testing 230 16 246 225 17 242
summary from the adopted annual higher than estimated. This was Rate specialists +1.0% +1.1% ISO/IEC 17043 Proficiency testing 13 2 15 12 1 13
accounts for 2012. No rights can be particularly caused by: Other rates +1.0% +1% to ISO Guide 34 Reference materials 2 0 2 2 0 2
derived from them. The full annual • extra assessments in connection +1.1% ISO15189 Medical laboratories in
accounts as prepared and adopted with the transition to the new Multilateral Agreement 9 2 11 10 1 11
after approval by the Supervisory version of the 17021 standard The rates for the activities in Subtotal laboratories 310 23 333 303 22 325
Board and the Minister of Economic which appeared in 2011; connection with the CCKL Code of Regulation (EG)
Affairs and provided with an • a larger number of extension Practice were also increased in 2012 Nr. 1221/2009 (EMAS) EMAS verification 1 0 1 1 0 1
unqualified report, can be viewed assessments than anticipated; by 1.0% (in 2011 by 1.1%). These rates Total RvA mark 540 74 614 527 78 605
on www.rva.nl. If you type the •the SZW project. are not covered by the Ministerial Laboratories healthcare
search word “jaarrekening” (annual approval but for the rest are formed CCKL Code of Practice Medical
accounts), you will have access to the Although this involved having to in the same manner as the other laboratories 246 0 246 246 0 246
annual accounts for 2012. Obviously hire an extra number of external rates.
we will be pleased to send you a copy assessors, nevertheless a higher Total number of accreditations granted 786 74 860 773 78 851
at your request. You can contact us positive result was able to be
via telephone number +31 (0)30 23 achieved. The result is added to the
94 500. reserves. Recommendations given by Accreditations Committee per report
Norm RvA mark 2012 Healthcare 2012 Total 2012 RvA mark 2011 Healthcare 2011 Total 2011
Initial assessment
positive recommendation 23% 20% 22% 28% 30% 29%
Re-assessment of
positive recommendation 72% 69% 70% 67% 60% 64%
Postponed reports 1% 6% 4% 3% 8% 5%
Negative recommendation 4% 5% 4% 2% 2% 2%
Total 100% 100% 100% 100% 100% 100%You can also read
