Saolta University Health Care Group Galway University Hospital
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1 Saolta University Health Care Group Galway University Hospital Medical Microbiology Dept, University Hospital Galway, Newcastle Road, Galway Testing Laboratory Registration number: 097T is accredited by the Irish National Board (INAB) to undertake testing as detailed in the Schedule bearing the Registration Number detailed above, in compliance with the International Standard ISO/IEC 17025: nd Edition General Requirements for the Competence of Testing and Calibration Laboratories (This Certificate must be read in conjunction with the Annexed Schedule of ) Date of award of accreditation: 17:12:2001 Date of last renewal of accreditation: 14:07:2016 Expiry date of this certificate of accreditation: 14:07:2021 This shall remain in force until further notice subject to continuing compliance with INAB accreditation criteria, ISO/IEC and any further requirements specified by the Irish National Board. Manager: Dr Adrienne Duff Chairperson: Mr Tom O Neill Issued on 14 July 2016 Organisations are subject to annual surveillance and are re-assessed every five years. The renewal date on this Certificate confirms the latest date of renewal of accreditation. To confirm the validity of this Certificate, please contact the Irish National Board. INAB is a signatory of the European co-operation for (EA) Multilateral Agreement (MLA) and the International Laboratory Cooperation (ILAC) Mutual Recognition Arrangement, for Testing. Edition 31, 14/07/ T Page 1 of 14
2 Schedule of (Annex to Certificate) PUBLIC HEALTH MICROBIOLOGY LABORATORY Initial Registration Date : 23-September-1998 Postal Address: Medical Microbiology Department University Hospital Galway Newcastle Road Galway Telephone: +353 (0) Fax: +353 (0) enda.burke@hse.ie Contact Name: Mr Enda Burke Facilities: Conditionally available for public testing Edition 31, 14/07/ T Page 2 of 14
3 Schedule of THE IRISH NATIONAL ACCREDITATION BOARD (INAB) is the Irish body for the accreditation of organisations including laboratories. Laboratory accreditation is available to testing and calibration facilities operated by manufacturing organisations, government departments, educational institutions and commercial testing/calibration services. Indeed, any organisation involved in testing, measurement or calibration in any area of technology can seek accreditation for the work it is undertaking. Each accredited laboratory has been assessed by skilled specialist assessors and found to meet criteria which are in compliance with ISO/IEC or ISO/IEC (medical laboratories). Frequent audits, together with periodic inter-laboratory test programmes, ensure that these standards of operation are maintained. Testing and Calibration Categories: : Permanent laboratory calibration and testing where the laboratory is erected on a fixed location for a period expected to be greater than three years. Category B: Category C: Category D: Site calibration and testing that is performed by staff sent out on site by a permanent laboratory that is accredited by the Irish National Board. Site calibration and testing that is performed in a site/mobile laboratory or by staff sent out by such a laboratory, the operation of which is the responsibility of a permanent laboratory accredited by the Irish National Board. Site calibration and testing that is performed on site by individuals and organisations that do not have a permanent calibration/testing laboratory. Testing may be performed using (a) (b) (c) (d) portable test equipment a site laboratory a mobile laboratory or equipment from a mobile or site laboratory Standard Specification or Test Procedure Used: The standard specification or test procedure that is accredited is the issue that is current on the date of the most recent visit, unless otherwise stated. Glossary of Terms Facilities: Public calibration/testing service: Conditionally available for public calibration/testing: Normally not available for public calibration/testing: Commercial operations which actively seek work from others. Established for another primary purpose but, more commonly than not, is available for outside work. Unavailable for public calibration/testing more often than not. Laboratory users wishing to obtain assurance that calibration or test results are reliable and carried out to the Irish National Board criteria should insist on receiving an accredited calibration certificate or test report. Users should contact the laboratory directly to ensure that this scope of accreditation is current. INAB will, on request, verify the status and scope. Edition 31, 14/07/ T Page 3 of 14
4 Type of test/properties measured 811 Microbiology tests on Documented in-house method No x foods based on ( ).01 Dairy Products Enumeration of micro-organisms at 30 C No 11 ( ISO 4833:2013).02 Egg and Egg Products.03 Meat and Meat Enumeration of micro-organisms by spiral plating at No 11a ( ISO :2013) products, game and 30ºC poultry.04 Fish, Shellfish and Enumeration of coagulase positve Staphylococci No 13 ( ISO :1999) Molluscs.06 Soups, Broths and Enumeration of E. coli at 44ºC using membranes No 8 ( ISO :2001) Sauces.07 Cereals and Bakery Enumeration of Bacillus cereus No 4 (ISO 7932:2004) using Bacillus Products cereus select agar..13 Ices and Desserts.15 Confectionary Enumeration of Enterobacteriaceae No 9 (ISO :2004).17 Prepared dishes Enumeration of Clostridium perfringens No 6 ( ISO 7937:2004) Detection of Salmonella species No 12 ( ISO 6579:2002+A1:2007) Detection of Listeria monocytogenes No 22a ( ISO : A1: 2004) Enumeration of Listeria No 22b ( ISO : A1: 2004) monocytogenes and Listeria species Detection of thermotolerant Campylobacter No 5 ( ISO :2006) species Edition 31, 14/07/ T Page 4 of 14
5 Type of test/properties measured 811 Microbiology tests on Documented in-house method No x foods based on ( ).01 Dairy Products Detection and enumeration of No 25 ( ISO :2004) Enterobacteriaceae by MPN.04 Fish Shellfish and Molluscs Enumeration of E.coli in shellfish using the MPN technique No 20 (Based on DD ISO/TS :2005 Part 3 Enumeration of E.coli in raw molluscs by the Multiple Tube Technique).08 Fruit and vegetables Enumeration of micro-organisms at 30 C No 11 ( ISO 4833:2013) Enumeration of micro-organisms by spiral plating at 30ºC No 11a (ISO :2013) Enumeration of coagulase positive Staphylococci No 13 ( ISO :1999) Enumeration of E.coli at 44ºC using membranes No 8 ( ISO :2001) Enumeration of Bacillus cereus No 4 ( ISO 7932:2004) using Bacillus cereus select agar Detection of Salmonella species No 12 ( ISO 6579:2002+A1:2007) Detection of Listeria monocytogenes Enumeration of Listeria monocytogenes & Listeria species No 22a ( ISO : A1: 2004) No 22b ( ISO : A1: 2004) Edition 31, 14/07/ T Page 5 of 14
6 Type of test/properties measured 811 Microbiological tests Documented in-house method No on foods x based on ( ).09 Herbs and Spices Enumeration of micro-organisms at No 11 ( ISO 4833:2013).16 Nuts and Nut products 30 C and Snacks Enumeration of micro-organisms by No 11a (ISO :2013) spiral plating at 30ºC Enumeration of coagulase positive No 13 ( ISO :1999) Staphylococci Enumeration of E. coli at 44ºC using No 8 (ISO :2001) membranes Enumeration of Clostridium No 6 ( ISO 7937:2004) perfringens Enumeration of Bacillus cereus No 4 ( ISO 7932:2004) Enumeration of Enterobacteriaceae No 9 ( ISO :2004) Detection of Salmonella species No 12 ( ISO 6579:2002+A1:2007) Detection of Listeria No 22a ( ISO : A1: 2004) monocytogenes Enumeration of Listeria No 22b ( ISO : A1: 2004) monocytogenes and Listeria species Edition 31, 14/07/ T Page 6 of 14
7 INAB Classification number (P9) Microbiological tests on foods Non-alcoholic beverages Bottled waters Type of test/properties measured Enumeration of micro-organisms at 30 C Enumeration of micro-organisms by spiral plating at 30ºC Documented in-house method No x based on ( ) No 11 (ISO 4833:2013) No 11a (ISO :2013) Enumeration of E. coli at 44ºC using membranes No 8 ( ISO :2001) Enumeration of coagulase positive Staphylococci No 13 ( ISO :1999) Detection of Salmonella species No 12 ( ISO 6579:2002+A1:2007) Enumeration of Coliforms and E.coli by membrane filtration with in-house confirmation using chromogenic agar No W2 - (based on MDW 2009) part 4-section A Enumeration of Enterococci by membrane filtration No W3 - (ISO :2000) Colony Count by Pour Plate method No W4 - (based on MDW (2012) part 7- section A Enumeration of Clostridium perfringens by Membrane filtration No W5 - (based on MDW (2010) part 6-section B) Enumeration of Coliforms and E.coli by IDEXX (Colilert 18) No W18 - MDW (2009) part 4-section D) Enumeration of Pseudomonas aeruginosa by membrane filtration No W6- MDW (2010) part 8-section B Edition 31, 14/07/ T Page 7 of 14
8 INAB Classification number (P9) Microbiological tests on foods Foodstuffs intended for Special Nutritional uses Type of test/properties measured Enumeration of micro-organisms at 30 C Enumeration of micro-organisms by spiral plating technique at 30ºC Documented in-house method No x based on ( ) No 11 ( ISO 4833:2013) No 11a (ISO :2013) Enumeration of coagulase positive Staphylococci No 13 ( ISO :1999) Enumeration of E. coli at 44ºC using membranes No 8 ( ISO :2001) Enumeration of Bacillus cereus No 4 ( ISO 7932:2004) Detection of Salmonella species No 12 ( ISO 6579:2002+A1:2007) Detection of Listeria monocytogenes No 22a ( ISO :1996+A1:2004) Enumeration of Listeria monocytogenes and Listeria species No 22b ( ISO :1998+A1:2004) Detection of thermotolerant Campylobacter species No 5 (ISO :2006) Detection and Enumeration of Enterobacteriaceae by MPN No 25 ( ISO :2004) Edition 31, 14/07/ T Page 8 of 14
9 Microbiological tests for Factory Hygiene purposes Surfaces Type of test/properties measured Enumeration of microorganisms at 30 C Documented in-house method No x based on ( ) and using FLMM 23 No 11 ( ISO 4833:2013) Enumeration of microorganisms by spiral plating technique at 30ºC No 11a (ISO :2013) Enumeration of coagulase positive Staphylococci No 13 ( ISO :1999) Enumeration of E. coli at 44ºC using membranes No 8 ( ISO :2001) Enumeration of Enterobacteriaceae No 9 ( ISO :2004) Edition 31, 14/07/ T Page 9 of 14
10 Microbiological tests for Factory Hygiene purposes Surfaces Type of test/properties measured Detection of Listeria monocytogenes Documented in-house method No x based on ( ) and using FLMM 23 No 22a ( ISO : A1: 2004) Enumeration of Listeria monocytogenes and Listeria species No 22b ( ISO : A1: 2004) Detection of Salmonella species No 12 (ISO:6579:2002+A1:2007) Enumeration of Clostridium perfringens No 6 ( ISO 7937:2004) Detection of thermotolerant Campylobacter species No 5 (ISO : 2006) Edition 31, 14/07/ T Page 10 of 14
11 Microbiological tests on foods Others Ice Cubes Type of test/properties measured Enumeration of Coliforms and E. coli by membrane filtration with in-house confirmation using chromogenic agar Documented in -house method No x based on ( ) No. W2 - based on MDW (2012) part 4-section A Enumeration of Enterococci by membrane filtration No. W3- (ISO :2000) Colony Count by Pour Plate method No. W4-based on MDW (2012) part 7-section A Enumeration of Coliforms and E. coli by IDEXX (Colilert 18) No. W18-based on MDW (2009) part 4-section D Enumeration of Pseudomonas aeruginosa by membrane filtration No. W6-based on MDW (2010) part 8-section B Edition 31, 14/07/ T Page 11 of 14
12 Waters, including effluents Bacteriological condition of potable waters Type of test/properties measured Enumeration of Coliforms and E.coli by membrane filtration with in-house confirmation using chromogenic agar Documented in -house method No x based on ( ) No. W2 - based on MDW (2009) part 4-section A Enumeration of Enterococci by membrane filtration No. W3 - (ISO :2000) Colony Count by Pour Plate method No. W4 -based on MDW (2012) part 7-section A Enumeration of Clostridium perfringens by membrane filtration No. W5 -based on MDW (2010) part 6-section B Enumeration of Coliforms and E. coli by IDEXX (Colilert 18) No. W18-based on MDW (2009) part 4-section D Enumeration of Pseudomonas aeruginosa by membrane filtration No. W6 -based on MDW (2010) part 8-section B Detection & enumeration of Legionella spp and Legionella pneumophilia No.W22 - ISO 11731:1998 with in house modifications. Edition 31, 14/07/ T Page 12 of 14
13 Waters, including effluents Bacteriological condition of Environmental waters Type of test/properties measured Enumeration of Coliforms and E. coli by membrane filtration with in-house confirmation using chromogenic agar Documented in -house method No x based on ( ) No. W2 - based on MDW (2012) part 7-section A Enumeration of Enterococci by membrane filtration No. W3 - (ISO :2000) Colony Count by Pour Plate method No. W4 - based on MDW (2012) part 7-section A Enumeration of Clostridium perfringens by membrane filtration No. W5 - based on MDW (2010) part 6-section B Enumeration of Coliforms and E. coli by IDEXX (Colilert 18) No. W18 -based on MDW (2009) part 4-section D Edition 31, 14/07/ T Page 13 of 14
14 Waters, including effluents Bacteriological condition of swimming pools and spas Type of test/properties measured Enumeration of Coliforms and E. coli by membrane filtration with in-house confirmation using chromogenic agar Enumeration of Pseudomonas aeruginosa by membrane filtration No. W2 - based on MDW (2009) part 4-section A No. W6-based on MDW (2010) part 8-section B Enumeration of hetertropic bacteria by pour plate method W4-based on MDW (2012) part 7- section A Edition 31, 14/07/ T Page 14 of 14
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