ORA LABORATORY MANUAL OF QUALITY POLICIES
This document is uncontrolled when printed: 2/11/2010For the most current and official copy, check the Internet athttp://
This Office of Regulatory Affairs (ORA) Laboratory Manual of Quality Policies (hereafterreferred to as Volume I) has been prepared to meet the requirements for laboratory accreditationof the International Organization for Standardization/International Electrotechnical Commission(ISO/IEC) 17025 (2005). It has been formatted using clause numbers from ISO/IEC 17025 toprovide ease in review.
2.0 Controlled Distribution of the Quality Manual
The Division of Field Science (DFS) is responsible for maintaining the official master copy of the ORA Laboratory Manual which contains the ORA Quality Manual. The ORA QualityManual consists of Volume I, ORA Laboratory Manual of Quality Policies and Volume II, ISO17025 ORA Laboratory Procedures. General distribution of this manual is accomplished using acomputer network. Annual review is coordinated by the Division of Field Science.
3.0 Quality Policy Statement
ORA laboratories are committed to laboratory accreditation according to the requirements of ISO/IEC 17025. This commitment is evidenced by the approval signatures for this manual.The quality policy statement is stated in Volume I, Subsection 4.2.2
4.0 Management Requirements4.1
The Associate Commissioner for Regulatory Affairs (ACRA) is responsible for establishing theorganization’s commitment to the management system, implementing it, and delegatingresponsibility for its accomplishment.The Director of the Division of Field Science is responsible for issuing policy and procedures forthe ORA laboratories and monitoring their implementation.Laboratory management, including supervisory analysts and quality managers, is responsible forensuring that analytical activities meet the requirements of the agency, its customers, and