Bulletin 3 2004
An essential element of the nature of accreditation is that once a laboratory has been assessed, it is assigned a scope of accreditation. When defining the scope of accreditation, FINAS follows international practices presented in the document EA-2/05 (rev.02) "The Scope of Accreditation and Consideration of Methods and Criteria for the Assessment of the Scope in Testing". This document is available on the Web site of the European co-operation for Accreditation (EA) (www.european-accreditation.org).
As a rule, the scope is fixed. It includes a fairly detailed definition of the material/product or quantity to be tested, the test type or measured range, the testing method or the best measurement capability, depending on whether the body is a testing laboratory or a calibration laboratory. For instance, the scope of a testing laboratory may include the determination of aluminium from tap water by means of atomic absorption spectrometry as per the relevant SFS Standard. If a laboratory wants to have its scope of accreditation amended (for instance, a new method is added or an existing method is updated), a written application is submitted to the accreditation body. The new methods or modifications are assessed and entered into the scope of accreditation.
The procedures associated with the fixed scope may be rigid for a laboratory that engages in research and/or development and that cannot always predict the properties of the object to be tested (e.g. investigation of new chemical compounds or testing of varying materials). For such a laboratory, a flexible scope may be a more practical alternative. When the scope is flexible, not all modifications pertaining to testing need always be assessed in advance, but the laboratory can still refer to accreditation. The modifications made are assessed during the next assessment visit. Besides the material/product to be tested, flexibility may be associated with the test type, the measured range or the best measurement capability. However, flexibility does not allow the laboratory to change the testing or calibration principle. For instance, a method entered in the scope of accreditation cannot be replaced by a completely different method.
The principles of a flexible scope have been under much discussion in the international co-operation organisations of accreditation bodies. When using flexible scope in accreditation, FINAS follows the same procedures as accreditation bodies in other countries. When applying for a flexible scope, a laboratory must have the following:
- A well functioning quality system.
- A clear systematic approach.
- Readiness to modify its methods according to needs. The laboratory can thus show that it has a good understanding of its methods and their uncertainty of measurement or other factors causing uncertainty, it can validate methods in an expert and comprehensive manner and it can ensure the correctness of results by means of quality assurance.
- Applicable and sufficient resources. The laboratory shows that it has the necessary equipment, preparedness and competence. During the assessment, special attention is paid to the training and experience of personnel and to the updating of methods.
- Thorough documentation. Besides comprehensive guidelines and validation reports, this also covers the methods used, the materials studied and the changes made.
- National/international contacts that guarantee that the laboratory keeps up with current trends.
When assessing the flexible scope for the first time, assessors ensure that the laboratory has the necessary prerequisites and procedures as well as the proper documentation for the flexible scope. During the next visits, how the laboratory has complied with the principles of the flexible scope, and how the relevant procedures have been applied in the laboratory’s activities, are assessed. Special attention is paid to validation and quality assurance practices and to documentation.
Many countries have had experiences of flexible scope accreditation. A flexible scope is deemed to apply to both testing and calibration laboratories. A laboratory that has a flexible scope may also have a fixed scope at the same time. Many accreditation bodies have therefore decided to record the scopes of accreditation so that they clearly distinguish between fixed and flexible scopes. FINAS has not yet emphasized flexibility in any of its own scopes of accreditation. When determining the scope of accreditation, it should also be noted that the laboratory may have clients (e.g. the authorities) for whom the scope should be as fixed as possible, even in cases where the laboratory’s activities meet the requirements of a flexible scope.
Changes in FINAS’s invoicing practices
In 2005 FINAS will adopt a new practice in invoicing for the annual basic fee. The basic fee, which has generally been charged in connection with the assessment, will be charged separately once per calendar year. The invoicing principles (www.finas.fi) and the annual costs of accreditation will remain the same as before.
At present, the basic fee for periodic assessments and re-assessments is usually charged at the same time as the fee for the assessment. This practice has worked well when periodic assessments have been done once a year. In practice, however, assessment times may have varied within a span of a few months, shifting between the end of the previous year and the start of a new year; this has caused irregularities in collection of the basic fee.
To ensure equal treatment of all accredited bodies, the present invoicing practice is being clarified by separating invoicing for the basic fee from invoicing for periodic assessments and re-assessments. In principle, the basic fee for accreditation is charged once per calendar year irrespective of when or how frequently periodic assessments and re-assessments are carried out. The invoice is sent in April and the fee is determined according to the category specified in the accreditation decision in force on 1 April. As before, the fee for periodic assessments and re-assessments and for other related costs is charged when the assessment reports and decision documents are sent.
The new practice will be adopted in 2005. A separate notice describing this change will be sent to our clients by the end of 2004.
New VANK-P appointed
The Advisory Committee for Conformity Assessment Matters (VANK) acts as an advisory organ in co-operation matters concerning accreditation, product inspections and in-use inspections. The Committee is appointed by the Government of Finland, and its members represent various authorities, industry, consumer and environmental organizations, standardization associations, and bodies subject to accreditation. The Committee monitors accreditation and other activities used for assessing and verifying competence, as referred to in the relevant Decree (1568/1991), makes proposals for the development of operations, gives opinions on the requirements set for operations and, upon request, on other matters concerning accreditation, and makes proposals for the promotion of domestic and international co-operation and for the provision of training and information services. The Committee is divided into two subcommittees. Matters concerning accreditation and the assessment of competence are discussed in subcommittee P, which has the following composition (term extending from 5 April 2004 to 4 April 2007):
Pekka Järvinen, Finnish Standards Association SFS
Leena Eranti, Confederation of Finnish Industry and Employers
Kimmo Haarala, DNV Certification Oy/Ab
Eeva Liisa Hartikainen, Finnish Environment Institute
Seppo Heiskanen, Confederation of Finnish Industry and Employers
Jaakko-Juhani Himberg, Helsinki and Uusimaa Hospital District
Ulla Kankaanpää, Ministry of the Environment
Marja Leena Kantanen, National Public Health Institute
Sanna-Mari Karjalainen, Safety Technology Authority
Kaija Kivinen, Ministry of Social Affairs and Health
Matti Lanu, Technical Research Centre of Finland
Anja Liukko, Ministry of Trade and Industry
Tomi Lounema, National Consumer Administration
Mika Mustonen, SGS Fimko Ltd
Kirsti Nuotio, Finnish Customs Laboratory
Tuula Pirhonen, Veterinary Medicine and Food Standards Research Institute
Katariina Rautalahti, Product Control Agency for Welfare and Health
Liisa Rautiainen, Technical Research Centre of Finland
Jouko Roine, Inspecta Oy
Salme Sundqvist, Association of Finnish Local and Regional Authorities
Leena Tikkanen, Centre for Metrology and Accreditation
Veijo Turunen, Confederation of Finnish Industry and Employers
Katri Valli, Finnish Standards Association SFS
Tuija Sinervo and Eivor Koskinen
A new publication series on assessment policy
FINAS has started a new publication series "Arviointiperiaatteet" (Policy Documents), which explains the principles that are followed in assessments on the basis of accreditation requirements. The documents are compiled by the Advisory Committee for Conformity Assessment Matters, Subcommittee for Accreditation Matters, together with Finnish specialists. They follow the assessment policies agreed within the international co-operation organizations of accreditation bodies (European co-operation for Accreditation and International Laboratory Accreditation Cooperation). The Finnish-language publications are available in electronic form on the FINAS Web site:www.finas.fi(under "julkaisut"). The first publications are: Periaatteet standardin SFS-EN ISO/IEC 17025 mukaisen näytteenottotoiminnan arvioimiseksi (The principles for the assessment of sampling according to Standard SFS-EN ISO/IEC 17025) and FINASin vertailumittauspolitiikka (The FINAS policy for proficiency testing).
The EA database on accredited bodies
In order to increase the usability and recognition of accreditation, the EA (European co-operation for Accreditation) has compiled an Internet database on bodies and scopes of competence that European accreditation bodies have accredited. The database was launched on 15 June 2004. At present, the database contains information about calibration laboratories accredited by the accreditation bodies in Finland (FINAS), Denmark (DANAK), France (COFRAC) and Germany (DAR-DKD). In addition, information on testing laboratories accredited by COFRAC are in test use in the database. The database will be extended gradually to cover other accreditation bodies and other accredited sectors. The database is available on the EA Web site: http://db.european-accreditation.org/.
Information from FINAS
Lead assessor Raimo Lewing and assistant Anne Naumanen have left FINAS for new employment elsewhere.
The FINAS Day of 2005 will be held on Thursday, 27 January, at the Fair Centre in Helsinki.
EA-8/01 (rev.01) IAF/EA Guidance on the Application of ISO/IEC 17024:2003
ILAC G22:2004 Use of Proficiency Testing as a Tool for Accreditation in Testing
New accreditation decisions
K047 Ahltronix Varkaus Oy; Low-frequency electrical quantities; electrical energy, 12 May 2004.
S023 Qualisan Oy; Certification of quality systems against Standard ISO 9001:2000 in the fields of health care and social services, 21 June 2004.
T215 Botnia Hightech Oy, Test Laboratory; Type testing of mobile phones and validation of type tests for mobile phones, 27 May 2004.
T216 Plancenter Ltd, Environmental Research; Chemical and microbiological testing of water, 21 June 2004.
Amendments to accreditation decisions
I001 Electrical Inspection Fimtekno Ltd; The scope of accreditation has been extended to include extensive measurements of earthing systems as of 9 August 2004.
T043 Centre for Laboratory Medicine, Tampere University Hospital; The name of the laboratory has changed; the new name is Pirkanmaa Hospital District, Centre for Laboratory Medicine as of 23 June 2004.
T066 Haapajärvi Food and Environmental Laboratory; The laboratory has given up accreditation.
T075 Central Laboratory of Residue Analysis of Pesticides and Heavy Metals in Food; The accreditation of the laboratory has been suspended as of 23 August 2004.
T117 TCC Salo; The scope of accreditation has been extended to include the TCC Copenhagen Laboratory as of 30 June 2004.
T131 Lapland Water Research Ltd; The accreditation of the laboratory has been suspended temporarily as of 31 May 2004.
T166 JK Juusto Kaira Ltd, Producer Laboratory; The scope of accreditation has been extended to include microbiological testing of milk as of 30 June 2004.
T183 TCC Tampere; The scope of accreditation has been extended to include Bluetooth and WLAN equipment and the field of FCC requirements as of 21 May 2004.
T191 Consulting Engineers Paavo Ristola Ltd, Environmental laboratory; The scope of accreditation has been extended to include microbiological testing as of 10 June 2004.
T202 Central Hospital of Kymenlaakso, Laboratory of Nuclear Medicine; The name of the laboratory has changed; the new name is Kymenlaakso Hospital District, Kymenlaakso Laboratories, Laboratory of Clinical Chemistry, Laboratory of Nuclear Medicine as of 19 May 2004.
T212 Turku University Central Hospital, TUCH laboratories, Department of Clinical Neurophysiology ; The name of the laboratory has changed; the new name is Turku University Central Hospital, Department of Physiology and Nuclear Medicine, Department of Clinical Neurophysiology as of 16 June 2004.
K040 VTT Industrial Systems; Calibration of speed measuring radars (Doppler).
S005 SFS-Inspecta Certification; Certification of plastic pipes, steels and units for concrete reinforcements and certification of the welding process of metallic materials according to SFS-EN 729-2, 3 or 4. Certification of food safety according to British Retail Consortium (BRC) technical standards. Certification of the chain of custody of wood-based raw material management.
S007 DNV Certification Oy/Ab; Certification of environmental management systems against SFS-EN ISO 14001
S009 SGS Fimko Ltd; Certification of quality systems against SFS-EN ISO 9001:2000.
S019 SGS Fimko Ltd; Certification of environmental management systems against SFS-EN ISO 14001
T057 Rautaruukki Oyj, Hämeenlinna Works, Process Laboratory; Chemical testing of water.
T058 City of Helsinki Environment Centre, Environmental Laboratory; Chemical and microbiological testing of food, water and environmental samples.
T060 Rovaniemi City Food Laboratory; Chemical and microbiological testing of food and water.
T061 Stora Enso Oyj, Research Centre, Water and Trace Element Analyses; Chemical testing of water.
T062 Electrowatt-Ekono Oy, Imatra Measurement Group and Espoo Measurement Group; Emission measurements.
T063 Municipal Joint Union for Public Health in the Hämeenlinna Region, Environmental and Food Research Laboratory; Chemical and microbiological testing of food and water.
T064 Water Protection Association of the River Kokemäenjoki, Laboratory; Chemical testing of water and environmental samples, microbiological testing of water samples.
T065 Lappeenranta Town Food and Environmental Laboratory; Chemical and microbiological testing of food and water.
T067 Äänekoski Municipal Testing Laboratory; Chemical and microbiological testing of food and water.
T070 Medix Laboratories Ltd; Clinical chemistry, haematology, cytology, histopathology, clinical microbiology, clinical immunology and genetics.
T071 Novalab Oy; Chemical testing of food, food supplements, plant material, compost, wood (impregnated), soil, feed and water, and microbiological testing of food, feed, herbal medicinal products and food supplements and water.
T179 DOSECO Ltd; Personal dosimetry.
Bodies assessed for notification procedures
SFS-Inspecta Certification; Directive on construction products (89/106/EEC), bricks, mortars, wooden stairs, 25 May 2004; Metal chimneys, 13 August 2004.
Electrical Inspection FIMTEKNO Ltd; Directive on cableway installations (2000/9/EC), 24 June 2004.
DNV Certification Oy/Ab; Directive on construction products (89/106/EEC), Log houses, 11 May 2004.
Nordic Accredited Testing Laboratories Oy; EMC Directive 89/336/EEC), 9 June 2004.
INNOVA Adult Education Centre; Directive on pressure equipment 97/23/EC), 8 June 2004.