Accreditation and Air Quality
Accreditation and air quality
Put simply, accreditation is an assurance that a person, facility or organisation conforms to a recognised scientific standard and it often goes hand-in-hand with some kind of government or official recognition. Products or systems used within the above will obviously contribute their bid for accreditation. Air quality, and the means used to purify air, can be important in acquiring accreditation, particularly in the laboratory environment, including the clinical pathology lab. To clarify some of the key issues around accreditation, Allergy Cosmos spoke to Ben Courtney, the Accreditation Manager for the Clinical Pathology Accreditation (CPA) area of the United Kingdom Accreditation Service (UKAS)
What does the United Kingdom Accreditation Service (UKAS) do? What are its powers?
The United Kingdom Accreditation Service is the sole national accreditation body that is recognised by government to assess, against internationally agreed standards, organisations that provide certification, testing, inspection and calibration services. UKAS now also includes Clinical Pathology Accreditation (CPA) which is the area of UKAS that assesses medical laboratories.
Accreditation by UKAS/CPA demonstrates the competence, impartiality and performance capability of these evaluators. UKAS is a non-profit-distributing private company, limited by guarantee. It is independent of government but is appointed as the national accreditation body byAccreditation Regulations 2009 (SI No 3155/2009) and the EU Regulation (EC) 765/2008 and operates under a Memorandum of Understanding with the government through the Secretary of State for Business, Innovation and Skills (BIS).
The Service is licensed by BIS to use and confer the national accreditation symbols (formerly national accreditation marks) which symbolise government recognition of the accreditation process. In short, UKAS/CPA accreditation provides an assurance of the competence, impartiality and integrity of conformity assessment bodies. Having a UKAS accredited certification, testing and calibration and inspection reduces the need for suppliers to be assessed by each of their customers. Furthermore, the involvement of UKAS in international groups provides for mutual recognition which further reduces the need for multiple assessments of suppliers and, as a consequence, helps to reduce barriers to trade. It is therefore BIS policy to recommend the use of UKAS accredited conformity assessment services whenever this is an option.
Accreditation is optional but the organisations that UKAS accredit are assessed regularly and must demonstrate conformity with the relevant Standard. Where nonconformity is detected by UKAS assessors, this needs to be corrected within an agreed timescale. While UKAS cannot close organisations down, not meeting accreditation requirements means organisations can risk losing their status and, in many sectors, accreditation is required by stakeholders or commissioners for the organisation to be used as a supplier. Loss of accreditation can therefore have a detrimental effect on an organisation’s business because the confidence accreditation provides, and on which customers rely, has been lost.
In which sectors (eg hospitals, research labs) is air quality an issue where accreditation is important?
This very much depends upon the business. For instance, for accredited testing laboratories, there are specific environmental requirements and the laboratory needs to demonstrate that the environment is fit for purpose for that test. It may be that air quality comes into this, particularly in microbiology work, such as that in pathology departments, media performance testing laboratories or pharmaceutical testing laboratories. If testing laboratories contaminated their testing due to poor air quality this would be an issue that the organisation would need to address in order to meet the requirements of accreditation.
Can systems such as air purifiers/air cleaners acquire accreditation – if so, how?
Accreditation is defined as an authoritative body providing recognition that another body or person is competent to carry out specific tasks. As such, pieces of equipment cannot directly be accredited. However potentially, any kind of evaluation could become an accredited activity if there was an identified need (eg, market/safety/political etc) and suitable drivers. Products such as air purifiers/air cleaners could be evaluated against standards (ISO/EN/BS, if they exist), or other ‘normative’ documents (so long as they contain requirements) resulting in attestation of conformity against those standards/normative documents by a conformity assessment body. Potentially, this could be done using accredited product certification (EN45011 or ISO/IEC 17065). Accredited product certification is a process by which an impartial and competent conformity assessment body, such as a certification body in this case, operates certification schemes to provide assurance that the product complies with specified requirements.
Can organisations such as Allergy Cosmos, which sell products for improving air quality, acquire some kind of accreditation for their work? What is required?
Potentially, any legal entity can become an accredited conformity assessment body providing that they undertake evaluations and can demonstrate full compliance with the relevant international standard (eg, ISO/IEC 17065:2012). However, the standard may specify activities that the legal entity cannot undertake eg, consultancy, which in the case of ISO/IEC 17065 includes the “distributing of a certified product or a product to be certified” and, as a result, would disqualify Allergy Cosmos from becoming an accredited organisation. They could however, if a suitable product certification scheme was in existence, have their products certified by a certification body, that would be accredited for such an activity using standards/normative documents as described above.
Once organisations such as Allergy Cosmos are clear on what accreditation they need, they would apply for accreditation to UKAS. Any application received by UKAS would be processed and an Assessment Manager assigned who would discuss the application with the applicant. Normally we would conduct a Pre-assessment visit at the applicant’s head office to establish whether all relevant components of the management system are in place prior to formal assessment. Once the organisation has had the opportunity to address any identified gaps, a formal assessment would take place and UKAS would establish the organisation’s level of conformity with the relevant Standard. Where nonconformity is identified, a timescale is agreed to send evidence to UKAS to demonstrate that the nonconformity has been corrected. Once all nonconformities are cleared, the organisation can be accredited. As described above, it may be that it may be more relevant for Allergy Cosmos to apply for certification on a product from a certification body who would turn be accredited by UKAS rather than be directly accredited themselves.
Ben joined UKAS in 2008 and became the Accreditation Manager for the Clinical Pathology Accreditation (CPA) area of UKAS in 2012. He manages a team of assessors within CPA who assess medical laboratories such as pathology departments in NHS Trusts. Prior to Ben’s move into CPA, he was an Assessment Manager in the Agri-Food & Biosciences section for four years assessing medical laboratories to ISO 15189, proficiency testing providers to ISO 17043 and a wide range of testing laboratories to ISO 17025 including clinical trial, veterinary, poultry and tobacco laboratories.
Prior to joining UKAS, Ben worked for almost 10 years in an NHS pathology department specialising in microbiology, serology and Chlamydia PCR testing before taking on management responsibilities. Ben is a member of the Institute of Biomedical Science and has a BSc and MSc in Medical Microbiology.