Quality Documents: Reference Guide 03
Quality Implementation and Management Commitment
Section 1.4.2.1 (ASCLD/LAB© criteria)
Defines the components of the laboratory quality system to include implementation and commitment by management.
Quality Manual – Implementation - Section 1.4.2.1
Laboratory Operational Policies - Quality 002
Laboratory Operational Policies - Quality 003
Client Quality Survey
Quality Management Structure and Responsibilities
Section 1.4.2.2 (ASCLD/LAB© criteria)
Defining the management structure and responsibilities within the quality system.
Quality Manual – Infrastructure - Section 1.4.2.2
Annual Laboratory Audit
Section 1.4.2.3 (ASCLD/LAB© criteria)
Describes the laboratory program for conducting annual audits.
Quality Manual – Audit – Section 1.4.2.3
Laboratory Operational Policies – Quality 001
Laboratory Operational Policies - Operations 009
Document Control Ledger
Acknowledgement of Document Revisions or Change
Quality System Review
Quality System Review
Section 1.4.2.4 (ASCLD/LAB© criteria)
Describes the laboratory program for review of the quality system.
Quality Manual – Audit - Section 1.4.2.3
Laboratory Operational Policies - Quality 001
Laboratory Operational Policies - Operations 009
Document Control Ledger
Acknowledgement of Document Revisions or Change
Quality System Review
Evidence Analysis Procedures and Protocols
Section 1.4.2.5 (ASCLD/LAB© criteria)
Defines the procedures and protocols for the analysis of evidence to include method selection, approval and conditions for departure from accepted methods.
Quality Manual – Methods - Section 1.4.2.5
Laboratory Operational Policies - Operations 002
Examination Guidelines Template
Scientific Method Validation
Section 1.4.2.6 (ASCLD/LAB© criteria)
Describes the laboratory program for validation of new scientific methods.
Quality Manual – New - Section 1.4.2.6
Laboratory Operational Policies - Operations 004
Validation Study
Scientific Method Validation Documentation and Dissemination
Section 1.4.2.7 (ASCLD/LAB© criteria)
Describes the laboratory program for insuring the validity of all scientific methods, their documentation and dissemination to personnel.
Quality Manual – Scientific - Section 1.4.2.7
Laboratory Operational Policies - Operations 002
Validation Study
Controls, Standards, and/or Reagents
Section 1.4.2.8,1.4.2.9, 1.4.2.10 (ASCLD/LAB© criteria)
Describes the laboratory program for insuring the reliability and utilization of controls, standards and/or reagents.
Quality Manual – Controls - Section 1.4.2.8
Laboratory Operational Policies - Operations 006
Instrumentation Utilization
Section 1.4.2.11 (ASCLD/LAB© criteria)
Describes the laboratory program for the utilization of appropriate instrumentation.
Quality Manual – Equipment - Section 1.4.2.11
Laboratory Operational Policies - Operations 005
Laboratory Inventory Report
Laboratory Inventory Form
Instrument / Equipment Maintenance Log
Instrumentation Calibration
Section 1.4.2.12, 1.4.2.13 (ASCLD/LAB© criteria)
Describes the laboratory program for identifying, maintaining and, where appropriate, the calibrating of laboratory instrumentation. Demonstrates how compliance with established instrument performance standards are met.
Quality Manual – Maintenance - Section 1.4.2.12
Laboratory Operational Policies - Operations 005
Laboratory Inventory Report
Laboratory Inventory Form
Instrument / Equipment Maintenance Log
