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The Irish National Accreditation Board

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The Irish National Accreditation Board (INAB) the state organization with the responsibility for the accreditation of laboratories, certification bodies, and inspection bodies. It provides accreditation in conjunction with the International Organisation for Standardisation ISO 17000 series of standards and guidelines. It is the statutory organization in charge of Good Laboratory Practice (GLP). INAB was established in 1985 and is a Committee of the Health and Safety Authority under the Industrial Development (Dissolution of Forfas) Act 2014. In January 2010, the European Commission was notified by the Department of Enterprise, Trade, and Employment (now the DJEI) that INAB is the sole accreditation body for Ireland in line with regulation EC/765/2008. One of its many functions is the Accreditation of Testing and Calibration Laboratories ISO 17025, ISO 15189 INAB has provided laboratory accreditation for medical labs to ISO 15189 since its publication in 2003. For the medical laboratory agenda, INAB uses a mixture of technical experts and medically qualified assessors from other EA Accreditation Organisations who have considerable knowledge in medical laboratory accreditation.

INAB has also trained a number of Irish technical experts in ISO 15189. Legislation (SI No 360 of 2005) published in 2005 obliges blood bank laboratories to operate to ISO 15189 by November 2008. These laboratories have to also meet these terms with additional requirements relating to blood traceability and haemovigilance (notification of serious adverse reactions and events). The general accreditation process involves a documentation evaluation of an applicant laboratory’s quality system and processes, an on-site pre-assessment visit to recognize possible issues to be addressed before the assessment, and an on-site appraisal visit with the full INAB evaluation team to validate the technical capability of the lab and its fulfillment of ISO 15189 and INAB criteria. Once all problems have been adequately addressed a thorough report with the supporting proposal is presented to the Board of INAB for judgment on the award of accreditation.

Accreditation is awarded for a 5 year period and is reevaluated through annual on-site inspection visits. Why is Accreditation so important? The single European market allows for free movement of goods, services and people within the European Union. This free trade assumes confidence in the product or service being presented and can only be used upon removal of technical hurdles to trade. Members of the EU have established a system of national accreditation bodies, which guarantee that the aptitude of all labs, inspection, and qualification bodies are assessed to the same values. Accreditation is frequently required to display conformance with the necessities of laws, EU Directives, and official regulations. The European Commission recognizes accreditation as the preferred method for the abolition of technical barriers to trade and has declared that “Accreditation is essential for the correct operation of a transparent and quality-oriented market.”

Accreditation can give a competitive advantage and smooth the progress of access to export markets, as well as acting as a vehicle to raise standards and introduce improved work practices. Benefits of accreditation Government Accreditation is the preferred method for securing public confidence in the reliability of activities that have an effect on health, welfare, security and the environment. Therefore, accreditation is used, to identify bodies competent for the implementation of government regulations and policies. Consumer Accreditation gives consumers assurance through ensuring consistently high standards in the quality and safety of products or services purchased. Industry Accreditation is an essential instrument for decision making and risk management.

Organisations can save time and money by using an accredited contractor. Precise measurements and experiments carried out in conformity with best practices restrict product failure, control manufacturing costs and encourage innovation. Accredited Members Accreditation is selected by an organization because of the competitive advantages it presents, through admittance to a given market via independent evaluation and exhibition of compliance with international requirements. Accreditation is objective evidence that organizations have the competence to abide by best practice. It is the internationally recognized method that is used to develop and maintain high standards of performance. It is often a requirement for eligibility to apply for international projects.

Accreditation process Inquiry Stage Before applying for accreditation – a copy of the relevant standard is needed for the application. Standards can be purchased from the Standards Website Must be familiar with the INAB R1 Regulations and INAB terms and condition Application Stage Only online applications can be submitted. Contact INAB to be provided with a link to enter the INAB CRM online system. Log on and complete the application upload signed the statement and other important documents (Quality Manual). An accreditation officer, chosen by the INAB Manager, will get in touch with you once your application has been received and reviewed. Other supporting documentation may be requested. Pre-Assessment Stage A pre-assessment is designed to evaluate your organization’s readiness for full assessment. The INAB accreditation officer will gather a peer assessment team suitable to the scope applied for. Notification of the proposed team will be given before the visit. Usually, a pre-assessment visit takes about a day. A report will be sent after the visit outlining the findings of the team. Assessment Stage Following the pre-assessment, the organization has the chance to address the result of the pre-assessment. An assessment visit is arranged. The length of the visit and the type of the peer assessment team is reliant on the range of accreditation requested. The assessment determines an organizations compliance with the applicable standard(s), INAB requirements and other obligatory documents. This includes quality systems and technical ability.

After the visit, the team makes a recommendation on accreditation. Clearance of Non-Compliances A usual end result of an assessment visit is non-compliances are observed. The organization is then required to give in evidence of corrective actions to address any noncompliances raised within 3 months of the assessment. When all corrective actions have been acknowledged and all non-compliances have been cleared, the peer assessment team’s suggestion is presented to the IAB Board. The INAB Board meet around 6 times a year.

The INAB Accreditation Officer presents a report containing the proposal to the Board to make the decision on accreditation. If successful, accreditation is awarded for a specified scope. Award of Accreditation The organization will be given a certificate of accreditation and a scope of accreditation. The certificate is valid for 5 years reliant on successful observation visits. The organization will receive a unique registration number and symbol. The scope of accreditation will be publically available on the INAB Directory of Accredited Bodies on the INAB website. The Assessment Team The Irish National Accreditation Board contracts peer experts to evaluate organizations on INAB’s behalf to guarantee compliance with the applicable standards and requirements. These experts are also qualified in the assessment of quality assurance principles and jointly with the accreditation officer form the team that assesses each organization.

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