EUROLAB
en-iso-22117-quality-assurance-for-microbiological-testing-labs
Microbiological Testing AOAC 2000.14 Aerobic Plate Count in Dairy ProductsAOAC 2001.02 Surface Swab Testing in Kitchen EquipmentAOAC 2003.01 Campylobacter Detection in Poultry ProductsAOAC 2003.07 Detection of Campylobacter spp. in Food and Environmental SamplesAOAC 2004.02 Yeast and Mold Count in Fruit JuiceAOAC 2004.05 Mold Count in Nuts and SeedsAOAC 2005.03 Detection of Enterotoxins in Canned VegetablesAOAC 2007.01 Listeria Detection in Processed MeatsAOAC 2008.06 Norovirus Detection in Leafy GreensAOAC 2011.02 E. coli O157:H7 Testing in SproutsAOAC 2011.03 Detection of Cronobacter spp. in Infant FormulaAOAC 2013.09 Vibrio Detection in SeafoodAOAC 2015.01 Enumeration of Thermophilic Spores in MilkAOAC 2016.03 Total Aerobic Bacteria in Raw VegetablesAOAC 2017.09 Yeast Detection in BeveragesAOAC 2020.01 Cronobacter Enumeration in Infant CerealsAOAC 978.18 Standard Plate Count in Dairy ProductsAOAC 978.18 Total Coliform Test in ShellfishAOAC 978.24 Total Coliform Count in Food SamplesAOAC 983.19 Coliforms in Ice Cream ProductsAOAC 986.33 Staphylococcus aureus Count in SandwichesAOAC 990.12 Coagulase-Positive Staphylococci in FoodAOAC 990.12 Lactic Acid Bacteria in Fermented FoodsAOAC 991.14 Bacillus cereus Detection in Cooked RiceAOAC 991.14 Salmonella Detection Using ELISA MethodAOAC 991.15 Detection of Bacillus cereus in FoodsAOAC 996.08 Listeria monocytogenes Screening in Ready-to-Eat FoodsAOAC 996.08 Salmonella Detection in Dried FoodsAOAC 998.08 Detection of Escherichia coli O157:H7 in FoodsAOAC 998.08 Yeast and Mold Count in Fruit JuicesASTM D4783 Rapid Enumeration of Aerobic Microorganisms in Food PackagingASTM E1428 Evaluation of Antifungal Properties on Food Contact SurfacesASTM E2617 Detection of Mycotoxins-Producing Fungi by PCRASTM E2754 Standard Guide for Sampling of Microbial Contamination on SurfacesASTM E2876 Determination of Bacterial Endotoxins in Water Used in Food ProcessingASTM E2881 Rapid Detection of Pathogens in Food Using BiosensorEN 13697 Quantitative Surface Testing for Microbial ReductionEN 13704 Sporocidal Activity Testing of Disinfectants in Food AreasEN 1650 Quantitative Suspension Test for the Evaluation of Fungicidal ActivityEN ISO 10272-1 Detection of Campylobacter in Raw ChickenEN ISO 10272-2 Enumeration of Campylobacter in MeatEN ISO 11290-1 Detection of Listeria in Vacuum-Packaged FishEN ISO 11290-2 Enumeration of Listeria monocytogenes in Soft CheeseEN ISO 11731 Detection of Legionella in Cooling Tower WaterEN ISO 11731 Legionella Detection in Hot Water SystemsEN ISO 11731-2 Legionella Detection in Low Nutrient EnvironmentsEN ISO 13720 Pseudomonas spp. in Refrigerated ProductsEN ISO 13720 Spoilage Bacteria Testing in Vacuum-Packaged MeatEN ISO 14189 Enumeration of Sulfite-Reducing Bacteria in FoodEN ISO 14189 Sulfite-Reducing Anaerobes in Food Water SystemsEN ISO 15213 Enumeration of Anaerobic Bacteria in Canned FoodsEN ISO 15216-1 Detection of Norovirus and HAV in ShellfishEN ISO 15216-2 Quantitative Detection of Norovirus in BerriesEN ISO 16212 Detection of Fungi in Plant-Based FoodEN ISO 16266 Detection of Pseudomonas in Drinking WaterEN ISO 16649 Enumeration of Beta-Glucuronidase-Positive E. coliEN ISO 16649-1 Enumeration of Beta-Glucuronidase-Positive E. coliEN ISO 16654 Detection of E. coli O157 in Leafy GreensEN ISO 17410 Counting of Psychrotrophs in Refrigerated Ready MealsEN ISO 17604 Swab Sampling Techniques in Meat IndustryEN ISO 17604-2 Sampling for Bacterial Analysis in PoultryEN ISO 18465 Detection of Human Norovirus in OystersEN ISO 18465 Norovirus Detection in Frozen ShellfishEN ISO 19036 Statistical Uncertainty in Microbiological ResultsEN ISO 21149 Microbial Limits in Cosmetic Food-Based IngredientsEN ISO 21527-1 Enumeration of Yeast in Acidified Canned ProductsEN ISO 21527-2 Enumeration of Yeasts and Moulds in Acidic FoodEN ISO 21528-1 Total Enterobacteriaceae Count in SpicesEN ISO 21528-2 Enumeration of Enterobacteriaceae in ConfectioneryEN ISO 21528-2 Enumeration of Enterobacteriaceae in FoodEN ISO 22118 Quantification of Listeria monocytogenes in FoodEN ISO 22964 Detection of Cronobacter in Dairy-Based DessertsEN ISO 22964 Detection of Enterobacteriaceae in Powdered MilkEN ISO 29201 Quantification of Virus Particles in Food WastewaterEN ISO 4832 Coliform Count in Processed FoodEN ISO 6222 Enumeration of Aerobic Bacteria in Bottled WaterEN ISO 6579 Detection of Salmonella spp. in SpicesEN ISO 6579-3 Salmonella Serotyping MethodsEN ISO 6887 Preparation of Test Samples and Dilutions for Microbiological TestingEN ISO 6887-1 Preparation of Test Samples from Raw Food MaterialsEN ISO 6887-3 Sample Preparation for Fishery ProductsEN ISO 6887-4 Preparation of Test Samples from Frozen ProductsEN ISO 6887-5 Preparation of Samples from Prepared MealsEN ISO 6887-6 Sample Prep for Dry Foods and PowdersEN ISO 6888-2 Enumeration of Staphylococcus aureus in Egg ProductsEN ISO 6888-3 Detection of Staphylococcus in Ready-to-Eat MealsEN ISO 6888-3 Enumeration of Coagulase-Positive StaphylococciEN ISO 7218 Guidelines for Expression of Results in CFUEN ISO 7218 Guidelines for Plate Count Method in Microbiological LabsEN ISO 7218 Procedures for Colony Counting in MicrobiologyEN ISO 7932 Enumeration of Bacillus cereus in Dehydrated FoodsEN ISO 7937 Enumeration of Clostridium perfringens in GravyEN ISO 8199 General Requirements for Microbiological Methods in WaterEN ISO 8199 Method Validation for Microbiological Water TestingEN ISO 9308-1 Detection of E. coli in Treated WastewaterEN ISO 9308-2 Membrane Filtration for Coliform Bacteria in BeveragesISO 10272-1 Campylobacter Detection in PoultryISO 11290-1 Detection and Enumeration of Listeria monocytogenes in FoodsISO 11290-1 Listeria monocytogenes Detection in Dairy ProductsISO 11290-2 Listeria Count in Cold-Stored FoodsISO 11731 Legionella Detection in Bottled WaterISO 13136 VTEC Detection in Dairy ProductsISO 13720 Pseudomonas spp. Enumeration in Chilled FoodsISO 14189 Enumeration of Sulfite-Reducing Bacteria in WaterISO 15213 Anaerobic Bacteria Testing in Canned FoodISO 15213 Enumeration of Sulfite-Reducing BacteriaISO 15214 Lactic Acid Bacteria Enumeration in Fermented FoodISO 15216-1 Hepatitis A Virus Detection in Frozen BerriesISO 15216-2 Norovirus Detection in Processed VegetablesISO 16211 Anaerobic Sulfite-Reducing Bacteria TestingISO 16212 Fungi Testing in Cosmetic Food IngredientsISO 16266 Pseudomonas aeruginosa in Bottled WaterISO 16649-2 E. coli Enumeration in Raw MeatISO 16649-2 Enumeration of Escherichia coli by Colony-count TechniqueISO 16649-3 Beta-Glucuronidase E. coli DetectionISO 16654 E. coli O157 Detection in Ground BeefISO 17410 Detection of Psychrotrophic Microorganisms in Meat ProductsISO 17410 Psychrotrophic Microorganism Testing in Chilled FoodsISO 17604 Carcass Surface Microbial Sampling in SlaughterhousesISO 17604 Microbiological Swabbing of Animal CarcassesISO 17994 Comparative Testing for Microbiological Water AnalysisISO 18465 Norovirus Testing in ShellfishISO 18593 Surface Swab Microbiological Analysis in Food FacilitiesISO 19020 Food Processing Surface Hygiene MonitoringISO 19036 Uncertainty Estimation in Microbiological CountsISO 21149 Microbiological Examination in Cosmetic Raw Food MaterialsISO 21527-1 Enumeration of Yeasts and Molds in Dried Food ProductsISO 21527-1 Yeast and Mould Count in Low Water Activity FoodsISO 21528-2 Enterobacteriaceae Detection in Food ProductsISO 22964 Cronobacter spp. Testing in Infant FormulaISO 29201 Enteric Virus Quantification in WastewaterISO 4833 Total Viable Count Testing in Food SamplesISO 4833-1 Aerobic Plate Count in Food ProductsISO 6222 Heterotrophic Plate Count in WaterISO 6579 Detection of Salmonella spp. in Food SamplesISO 6579-1 Salmonella spp. Testing in Ready-to-Eat FoodsISO 6887-1 Sample Preparation for Microbiological Examination of FoodISO 6887-2 Microbiological Sample Prep for Dairy ProductsISO 6888-1 Enumeration of Coagulase-Positive Staphylococci (Staphylococcus aureus)ISO 6888-1 Staphylococcus aureus Enumeration in Bakery ProductsISO 6888-2 Staphylococcus aureus in Processed MeatISO 7218 General Requirements for Microbiological ExaminationsISO 7218 Microbiological Counting Methods in Food TestingISO 7218 Standardized Colony Count TechniquesISO 7251 Coliform Bacteria Detection in Drinking WaterISO 7932 Bacillus cereus Enumeration in CerealsISO 7937 Clostridium perfringens Testing in Cooked MeatsISO 7937 Detection and Enumeration of Clostridium perfringens in FoodsISO 8199 Microbiological Analysis of Water QualityISO 9308-1 Coliform and E. coli in Treated Water

Complete Guide to EN ISO 22117 Quality Assurance for Microbiological Testing Labs: Laboratory Testing Service Provided by Eurolab

EN ISO 22117 is a widely recognized international standard that governs the quality assurance of microbiological testing laboratories. This comprehensive guide will provide an in-depth look at the relevant standards, legal and regulatory framework, and international/national standards applicable to this specific laboratory test.

1.1 Overview of Relevant Standards

The EN ISO 22117 standard is a harmonized standard that combines the requirements of ISO 15189:2012 (Medical laboratories Requirements for quality and competence) and ISO 17025:2005 (General requirements for the competence of testing and calibration laboratories). This standard applies to microbiological testing laboratories, including those involved in the analysis of microorganisms, antimicrobial resistance, and biotoxin detection.

1.2 Legal and Regulatory Framework

EN ISO 22117 is a mandatory standard that must be complied with by all microbiological testing laboratories operating within the European Union (EU) member states. Compliance with this standard ensures that laboratories meet the essential requirements for quality and competence in providing accurate and reliable test results.

1.3 International/National Standards

The following international and national standards apply to EN ISO 22117:

  • ISO 15189:2012 Medical laboratories Requirements for quality and competence

  • ISO 17025:2005 General requirements for the competence of testing and calibration laboratories

  • EU Regulation No. 536/2013 on clinical trials (art. 34, 35)

  • EU Directive 98/79/EC on in vitro diagnostic medical devices (IVDMD)

    • 1.4 Standard Development Organizations

    The following standard development organizations play a crucial role in the development and maintenance of EN ISO 22117:

  • International Organization for Standardization (ISO)

  • European Committee for Standardization (CEN)

  • Technical Specification (TS) committee

    • 1.5 Evolution of Standards

    Standards evolve over time to reflect changes in technology, methodology, and regulatory requirements. EN ISO 22117 is no exception, with regular updates and revisions ensuring that the standard remains relevant and effective.

    This section will provide a detailed explanation of why this specific test is needed and required, including business and technical reasons for conducting EN ISO 22117 Quality Assurance for Microbiological Testing Labs testing.

    2.1 Why This Test Is Needed

    The testing service provided by Eurolab ensures that microbiological testing laboratories meet the essential requirements for quality and competence in providing accurate and reliable test results. The consequences of not performing this test can be severe, including loss of reputation, fines, and even closure of the laboratory.

    2.2 Business and Technical Reasons

    Conducting EN ISO 22117 Quality Assurance for Microbiological Testing Labs testing is essential for several reasons:

  • Ensures compliance with regulatory requirements

  • Provides accurate and reliable test results

  • Enhances quality assurance and control measures

  • Supports innovation and research development

  • Contributes to environmental sustainability

    • 2.3 Industries and Sectors

    The following industries and sectors require EN ISO 22117 Quality Assurance for Microbiological Testing Labs testing:

  • Healthcare (hospitals, clinics, medical devices)

  • Pharmaceutical industry

  • Food safety (food processing, production)

  • Environment (water quality monitoring)

    • This section will provide a detailed explanation of how the test is conducted, including testing equipment and instruments used, testing environment requirements, sample preparation procedures, and measurement and analysis methods.

    3.1 Step-by-Step Explanation

    The EN ISO 22117 Quality Assurance for Microbiological Testing Labs testing service provided by Eurolab involves the following steps:

  • Sample collection

  • Sample transportation

  • Sample storage

  • Sample preparation

  • Testing equipment and instruments used (e.g., microscopes, spectrophotometers)

  • Testing environment requirements (temperature, humidity, pressure)

    • 3.2 Equipment and Instruments Used

    Eurolab uses state-of-the-art equipment and instruments to ensure accurate and reliable test results.

  • Microscopes (light microscopy, electron microscopy)

  • Spectrophotometers

  • Thermocyclers

  • Automated systems for data analysis

    • This section will explain how test results are documented and reported, including the report format and structure, interpretation of test results, certification and accreditation aspects, and traceability and documentation requirements.

    4.1 Report Format and Structure

    Eurolab provides comprehensive test reports that include:

  • Test results

  • Quality control measures

  • Sample information (ID, date, time)

  • Environmental conditions during testing

    • 4.2 Interpretation of Test Results

    The interpretation of test results is crucial for ensuring accuracy and reliability.

  • Reporting limits (critical values)

  • Statistical analysis (mean, standard deviation)

    • Section 5: Conclusion

    In conclusion, EN ISO 22117 Quality Assurance for Microbiological Testing Labs testing is a critical component in ensuring the quality and competence of microbiological testing laboratories. The comprehensive guide provided above highlights the importance of compliance with this standard and the role that Eurolab plays in supporting laboratories in meeting these requirements.

    Section 6: References

    The following references are cited throughout this comprehensive guide:

  • EN ISO 22117

  • ISO 15189:2012

  • ISO 17025:2005

  • EU Regulation No. 536/2013

  • EU Directive 98/79/EC

    • This concludes the complete guide to EN ISO 22117 Quality Assurance for Microbiological Testing Labs: Laboratory Testing Service Provided by Eurolab.

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