9 June 2015 marks World Accreditation Day (WAD) as a global initiative, jointly established by the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC), to raise awareness of the importance of accreditation. This year’s theme focuses on how accreditation can support the delivery of health and social care.
Whether caused by expanding global population or increased life expectancy, the need to provide reassuring, consistent and cost-effective health and social care has been growing in its magnitude and complexity. Accreditation within the health and social care sector supports this assurance: it provides an essential tool for healthcare providers to demonstrate that they have undergone a rigorous process to ensure that their patients consistently receive high quality services delivered by competent staff working in safe environments.
The major conformity assessment standards that are covered by accreditation in this sector are:
– ISO 13485 for medical device certification, which ensures excellence in the provision of medical devices; accredited ISO 13485 certification is used to assess conformity of medical devices against this standard;
– ISO 15189 for medical laboratory accreditation, which allows medical laboratories to demonstrate their technical competence for providing care providers with diagnostic results, and ensuring that patients receive the most pertinent treatment and care;
– ISO 15195 used to demonstrate the accuracy and traceability of some measurements in medical laboratories;
– ISO/IEC 17020 for residential care home inspection; accredited inspection allows residential care home to demonstrate their competence, impartiality and performance capability to assure patients and their families of the high quality of their services;
– ISO 9001 and ISO/IEC 27001 for management system certification of medical facilities; accredited certification bodies may certify healthcare providers to ISO 9001 to continuously support quality or to ISO/IEC 27001, which is an information security management system that gives patients confidence in those organisations handling their personal data and includes people, processes and IT systems by applying a risk management process.
Accreditation of medical laboratories is spreading in Europe
Since 2003 when ISO 15189 was established to be progressively made mandatory by an increasing number of European national authorities throughout the following years, the number of medical laboratories accredited by EA-Member accreditation bodies has been constantly increasing every year, except for 2010. It even rocketed by more than 80% and 115% in 2008 and 2011, respectively.
In 2014, the number of accredited medical laboratories in EU countries still rose by 13.5% to reach more than 2,600 accredited medical laboratories by end of the year. In 2014, more than 100 quality management systems in Europe were specifically accredited under ISO 13485 for medical device certification.
Heath care issues at the heart of EA’s discussions
One of the working groups (WGs) of the EA Laboratory Committee (LC) is focused on health care issues. Convened by Rolf Straub from SAS, the Swiss NAB, this EA LC WG is continuing its discussions on how to implement the 2012 version of ISO 15189 in a harmonised way in Europe. For this purpose, two 2-day assessor training workshops were held by the EA LC in June 2014 in Espoo, Finland; about 50 assessors from EA-Member NABs attended the workshops.
Another issue being discussed in the EA LC WG is how accreditation bodies are using “flexible scopes” of accreditation in medical testing.
EA cooperating with the EC to ensure optimal quality of healthcare services
On 11 July 2014, EA signed a 26-month services contract with the European Commission (EC) to contribute to the development of a quality assurance (QA) scheme for breast cancer services (BCS). All aspects of BCS including diagnosis, surgery, treatment, nursing care and palliative care will be covered by the QA scheme, with a main focus on the quality of care and experience of the patient.
EA’s mission is to provide comprehensive guidance for the scheme’s different stakeholders, i.e. national authorities, professional bodies, national accreditation bodies (NABs) and conformity assessment bodies (CABs). Managing a well-established process for the production and publication of application, technical advisory and guidance documents, EA will provide generic publications describing the accreditation framework, toolkit, processes and procedures for accreditation.
An RvA-led steering group specific for the BCS project was set up within the EA Executive Committee. The working group dedicated to the project is led by an expert from ACCREDIA (Italian NAB); the membership includes experts from ENAC (Spanish NAB), DANAK (Danish NAB), IARM (Macedonian NAB) and FINAS (Finnish NAB). By the fall of 2016, a pilot project will be implemented in order for EA-member ABs to test in practice the BCS accreditation scheme by performing accreditation activities in accordance with the scheme’s requirements.
EA participating in the 2015 International Congress of Metrology focused on health and biology
EA is actively contributing to the 17th International Congress of Metrology (CIM) to be held on 21-24 September 2015 in Paris – see our Homepage News published on 28 May 2015 at:
http://www.european-accreditation.org/information/ea-contributingto-the-paris-congress-of-international-metrology
The CIM is the meeting-point for technical exchanges between all the actors of measurement: industrial users of equipment, technical experts, public and private laboratories, manufacturers and service providers. These topics in the health and biology fields are major concerns during this edition, which will notably include a round-table session on “Best practice in healthcare: contribution of metrology” with the intervention of COFRAC, the French NAB. Other thematic sessions will deal with metrology of medical laboratories, especially metrology requirements for medical laboratories in the framework of ISO 15189 accreditation, metrology for radiotherapy and MRI, certified reference materials in biology, as well as comparison in the field of disinfectants and antiseptics.
Further information about how CIM 2015 tackle measurement, analysis and innovation in the health field is given on a specific press release available on the CIM website at:
http://www.metrologie2015.com/files/communiques/1432907449_CP-CIM2015-10Avril2015-GB-HealthTopics.pdf
To find out what is happening for WAD 2015 in your country, please contact your local NAB.
To get further information about WAD 2015, please consult the EA/IAF/ILAC brochure at:
http://www.european-accreditation.org/brochure/wad-2015-brochure