Quality Policy and Objectives
Sam Lazzara Resume LinkedIn Profile Documents Services Schedule Call +1 510 397 9739 sam@lazzara.net Does your organization's Quality Policy inspire you, or tire you? First, let's review US FDA and ISO 13485 requirements and ISO 14969 guidance. After that, I am sharing my current "state of the art" model for a Quality Policy and corresponding Quality Objectives. Quality Policy Definitions ISO 9000:2005 - Overall intentions and direction of an organization related to quality as formally expressed by top management. US FDA 21 CFR 820 - Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility. US FDA 21 CFR 820.20 Management responsibility (a) Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality p...