Significance and Use
5.1 Effective decision-making in a quality systems-controlled environment comes from an informed understanding of quality issues and associated risks. As such, management should monitor and review the performance of the QMS at pre-planned and regular intervals to ensure the system’s effectiveness and identify opportunities for improvement of the QMS itself. Management should also provide oversight of the QMS by an independent quality practitioner(s) to assure its effectiveness.
5.2 Moreover, risk-based decision-making encompasses all elements of the QMS and should be at the forefront of each decision. Consumer safety is the top priority, regardless of other considerations.
5.3 Aspects of risk should be considered relative to intended (or unintended) uses of a product to ensure consumer safety. Management should assign priorities and adequate resources to activities or actions based on assessing the risk, including the probability of harm and the potential severity of that harm. It is essential to engage appropriate parties in evaluating the risk. Such parties may include:
5.3.2 Manufacturing personnel;
5.3.3 Marketing personnel; and
5.3.4 Other stakeholders, as needed.
5.4 Implementation of risk management includes assessing the risks, implementing risk management controls commensurate with the level of risk, and evaluating the risk management efforts’ results. Risk management assessment is an iterative process and continues when additional information emerges that changes the potential risk’s nature.
5.5 Risk management works in conjunction with process understanding to manage and control change and helps drive continuous improvement.
1.1 This guide focuses on the core elements of an effective quality management system (QMS) necessary to optimize consumer and product safety, product quality, and conformance with requirements from industry, governmental agencies, and other authorities having jurisdiction. This guide incorporates basic quality principles, guidelines, and industry best practices necessary to establish a QMS adaptable to all organizations.
1.2 Laws and regulations from authorities having jurisdiction supersede recommendations within this guide.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.