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1.1.1 This Standard addresses quality assurance requirements for software used in design, safety analysis, and supporting activities. 1.1.2 This Standard specifies the requirements for the quality assurance program applicable to the design, development, maintenance, modification, acquisition, and use of analytical, scientific, and design computer programs that are used in high energy reactor…

Scope 1.1 This Standard specifies essential elements in implementing a program for using chemicals to sterilize medical devices in health care facilities. Such chemicals can be vapour, gaseous, or liquid and are delivered in validated concentrations and quantities in defined sterilizers. The body of this Standard contains requirements that are common to all chemical sterilization processes,…

1. Scope 1.1 General 1.1.1 This Standard specifies minimum requirements for a suppli er's quality assurance program - Category 1. The supplier is responsible for planning and developing a program which assures that each management, design, and technical responsibility for quality is integrated and executed effectively. The program is aimed primarily at being preventive by…

1. Scope 1.1 General 1.1.1 This Standard specifies minimum requirements for a s upplier's quality assurance program - Category 2. The supplier is responsible for planning and developing a program aimed primarily at controlling production processes as well as inspection and test verifications and corrective action which (a) assure that products or services conform to specified…

1. Scope 1.1 General 1.1.1 This Standard specifies minimum requirements for a supplier's Quality Assurance Program - Category 3. The supplier is responsible for planning and developing a program aimed primarily at controlling inspection and test verifications which (a) assure that products or services conform to specified requirements; and (b) readily detect and control the…

1. Scope 1.1 General 1.1.1 This Standard specifies minimum requirements for a supplier's quality assurance program - Category 4. The supplier is responsible for planning and developing a program which provides objective evidence that contract requirements are met and which detects and dispositions nonconforming products or services. 1.1.2 This Standard may be applied to…