Nelac v1m5 microbiology 2012-0717 checklist

Template Information

Aqs audit template (www.aqsnet.com)

Category: general

Template Questions

  • Audit Type
  • 1240) V1M5 1.1: This Standard applies to laboratories undertaking microbiological analysis of environ
  • 1242) V1M5 1.2: The essential quality control procedures applicable to microbiological analysis are i
  • 1244) V1M5 1.3: The relevant definitions from TNI, Volume 1, Module 2, Section 3.0 apply. Definitions
  • 1245) V1M5 1.3.1: Additional Terms and Definitions
  • 1246) V1M5 1.3.1: Reserved
  • 1247) V1M5 1.3.2: Exclusions and Exceptions
  • 1248) V1M5 1.3.2: Reserved
  • 1250) V1M5 1.4: A reference method is a method issued by an organization generally recognized as comp
  • 1251) V1M5 1.4: When a laboratory is required to analyze a parameter by a specified method due to a r
  • 1252) V1M5 1.4: If there is not a regulatory requirement for the parameter/method combination, the pa
  • 1249) V1M5 1.4: Method Selection
  • 1256) V1M5 1.5: Validation is the confirmation by examination and the objective evidence that the par
  • 1255) V1M5 1.5: Method Validation
  • 1267) V1M5 1.6.1: General
  • 1268) V1M5 1.6.1: Prior to acceptance and institution of any method for data reporting, satisfactory
  • 1266) V1M5 1.6: Demonstration of Capability (DOC)
  • 1272) V1M5 1.6.1: For the initial DOC, appropriate records as discussed in Section 1.6.2 shall be com
  • 1273) V1M5 1.6.1: An initial DOC shall be completed each time there is a change in instrument type, p
  • 1276) V1M5 1.6.2: Initial DOC
  • 1300) V1M5 1.6.3: Ongoing DOC
  • 1304) V1M5 1.6.3.2: This ongoing demonstration may include one of the following or by performing anot
  • 1311) V1M5 1.7: Technical Requirements
  • 1312) V1M5 1.7.1: Calibration
  • 1315) V1M5 1.7.1 b): For instruments that are continuous monitors, such as in-line specific conductan
  • 1320) V1M5 1.7.2: Reserved for specific procedures.
  • 1322) V1M5 1.7.3.1: Sterility Checks and Method Blanks
  • 1323) V1M5 1.7.3.1 a): Method Blanks
  • 1321) V1M5 1.7.3: Quality Control
  • 1332) V1M5 1.7.3.1 b): Sterility Checks
  • 1345) V1M5 1.7.3.2: Test Variability/Reproducibility
  • 1347) V1M5 1.7.3.3: Sample Specific Controls (where applicable)
  • 1350) V1M5 1.7.3.4: Data Reduction
  • 1352) V1M5 1.7.3.5: Quality of Standards, Reagents and Media
  • 1354) V1M5 1.7.3.5 a): Media – Culture media may be prepared from commercial dehydrated powders or ma
  • 1355) V1M5 1.7.3.5 a) i.: Laboratory-prepared media
  • 1359) V1M5 1.7.3.5 a) ii.: Ready-to-use media
  • 1363) V1M5 1.7.3.5 c): Reagent Water
  • 1370) V1M5 1.7.3.6: Selectivity
  • 1377) V1M5 1.7.3.6 d): Culture Controls
  • 1378) V1M5 1.7.3.6 d) i.: Negative Culture Controls
  • 1379) V1M5 1.7.3.6 d) i. 1: Negative culture controls demonstrate that the medium does not support th
  • 1381) V1M5 1.7.3.6 d) ii.: Positive Culture Controls
  • 1382) V1M5 1.7.3.6 d) ii. 1: Positive culture controls demonstrate that the medium can support the gr
  • 1384) V1M5 1.7.3.7: Constant and Consistent Test Conditions
  • 1385) V1M5 1.7.3.7 a): Laboratory Facilities
  • 1389) V1M5 1.7.3.7 b): Laboratory Equipment
  • 1390) V1M5 1.7.3.7 b) i.: Temperature Measuring Devices
  • 1394) V1M5 1.7.3.7 b) ii.: Autoclaves
  • 1405) V1M5 1.7.3.7 b) iii.: Volumetric Equipment
  • 1406) V1M5 1.7.3.7 b) iii.: Volumetric equipment shall be verified as follows:
  • 1410) V1M5 1.7.3.7 b) iv.: UV Instruments
  • 1413) V1M5 1.7.3.7 b) v.: Incubators, Water Baths, Ovens
  • 1416) V1M5 1.7.3.7 b) vi.: Labware (Glassware and Plasticware)
  • 1421) V1M5 1.7.4: Data Acceptance/Rejection Criteria
  • 1423) V1M5 1.7.5: Sample Handling
  • 1429) V1M5 1.7.5 b): Laboratories that receive samples from potable water sources (including source w