Chapter 45. Certification for Noncommercial Environmental LaboratoriesRead Chapter
- Part I.Read allGeneral Provisions
- Section 10
- Purpose
- Section 20
- Establishment of certification program
- Section 30
- Applicability
- Section 40
- Definitions
- Section 50
- Scope of certification
- Section 60
- General: certification requirements
- Section 70
- Process to apply and obtain certification
- Section 80
- Maintaining certification
- Section 90
- Notifications and changes to certification elements and status
- Section 95
- Suspension of certification
- Section 100
- Decertification
- Section 110
- Procedures to deny certification or decertify a laboratory; appeal procedures
- Section 120
- Exemptions
- Section 130
- Fees
- Section 140
- Petitioning for a variance
- Section 150
- (Reserved)
- Section 160
- (Reserved)
- Section 170
- (Reserved)
- Section 180
- (Reserved)
- Section 190
- (Reserved)
- Part II.Read allStandards
- Article 1.Read allPersonnel
- Section 200
- Laboratory manager
- Section 210
- Quality assurance officer
- Section 220
- Laboratory personnel requirements and management responsibilities
- Section 230
- Absence of laboratory manager
- Section 240
- (Reserved)
- Section 250
- (Reserved)
- Section 260
- (Reserved)
- Section 270
- (Reserved)
- Section 280
- (Reserved)
- Section 290
- (Reserved)
- Article 2.Read allOn-Site Assessment
- Section 300
- Frequency of on-site assessment
- Section 310
- Announced and unannounced on-site assessments
- Section 320
- Request for records
- Section 330
- Areas to be assessed
- Section 340
- National security considerations
- Section 350
- Arrival, admittance, and opening conference
- Section 360
- On-site laboratory records review and collection
- Section 370
- Observations of and interviews with laboratory personnel
- Section 380
- Closing conference
- Section 390
- Follow-up and reporting procedures.
- Section 400
- Documentation of on-site assessment
- Section 410
- (Reserved)
- Section 420
- (Reserved)
- Section 430
- (Reserved)
- Section 440
- (Reserved)
- Section 450
- (Reserved)
- Section 460
- (Reserved)
- Section 470
- (Reserved)
- Section 480
- (Reserved)
- Section 490
- (Reserved)
- Article 3.Read allProficiency Testing
- Section 500
- Laboratory enrollment in proficiency testing program
- Section 510
- Requirements for laboratory testing of PT study samples
- Section 520
- PT criteria for laboratory certification
- Section 530
- [Repealed]
- Section 540
- (Reserved)
- Section 550
- (Reserved)
- Section 560
- (Reserved)
- Section 570
- (Reserved)
- Section 580
- (Reserved)
- Section 590
- (Reserved)
- Article 4.Read allQuality System
- Section 600
- Quality system
- Section 610
- Quality manual
- Section 620
- Organization
- Section 630
- Records
- Section 640
- Recordkeeping system and design
- Section 650
- Records management and storage
- Section 660
- Required records
- Section 670
- Audits
- Section 680
- Subcontracting analytical samples
- Section 690
- Outside support services and supplies
- Section 700
- Complaints
- Section 710
- Environment and work areas
- Section 720
- Equipment and reference materials
- Section 730
- Test methods and standard operating procedures
- Section 740
- Measurement traceability and calibration
- Section 750
- Quality assurance
- Section 760
- Quality control requirements
- Section 770
- Chemical testing: positive and negative controls
- Section 771
- Chemical testing: limit of detection and limit of quantitation
- Section 772
- Chemical testing: data reduction
- Section 773
- Chemical testing: quality of standards and reagents
- Section 774
- Chemical testing: selectivity
- Section 775
- Chemical testing: constant and consistent test conditions
- Section 780
- [Repealed]
- Section 781
- [Repealed]
- Section 782
- [Repealed]
- Section 783
- [Repealed]
- Section 784
- [Repealed]
- Section 785
- [Repealed]
- Section 786
- [Repealed]
- Section 787
- [Repealed]
- Section 788
- [Repealed]
- Section 789
- (Reserved)
- Section 790
- Microbiology testing: general
- Section 791
- Microbiology testing: sterility checks and blanks, positive and negative controls
- Section 792
- Microbiology testing: test variability and reproducibility
- Section 793
- Microbiology testing: method evaluation
- Section 794
- Microbiology testing: test performance
- Section 795
- Microbiology testing: data reduction
- Section 796
- Microbiology testing: quality of standards, reagents, and media
- Section 797
- Microbiology testing: selectivity
- Section 798
- Microbiology testing: constant and consistent test conditions
- Section 800
- [Repealed]
- Section 801
- [Repealed]
- Section 802
- [Repealed]
- Section 803
- [Repealed]
- Section 804
- [Repealed]
- Section 805
- [Repealed]
- Section 806
- [Repealed]
- Section 807
- [Repealed]
- Section 808
- [Repealed]
- Section 809
- (Reserved)
- Section 810
- Air testing: general
- Section 811
- Air testing: negative and positive controls
- Section 812
- Air testing: analytical variability/reproducibility
- Section 813
- Air testing: method evaluation
- Section 814
- Air testing: limit of detection
- Section 815
- Air testing: data reduction
- Section 816
- Air testing: quality of standards and reagents
- Section 817
- Air testing: selectivity
- Section 818
- Air testing: constant and consistent test conditions
- Section 819
- (Reserved)
- Section 820
- [Repealed]
- Section 821
- [Repealed]
- Section 822
- [Repealed]
- Section 823
- [Repealed]
- Section 824
- [Repealed]
- Section 825
- [Repealed]
- Section 826
- [Repealed]
- Section 827
- [Repealed]
- Section 828
- [Repealed]
- Section 829
- [Repealed]
- Section 830
- (Reserved)
- Section 840
- (Reserved)
- Section 850
- Sample handling, sample acceptance policy, and sample receipt
- Section 860
- Laboratory report format and contents