ISO 9001: 2015 Quality System Manual Development and Implementation for Business and Commerce with Expanded Emphasis on Risk Management

Abstract

ISO 9001: 2015 is the latest edition of the Quality Management System from the International Standard Organization. One of the most noticeable changes about the new edition is the emphasis on risk-based thinking. This study introduces a template for developing a Quality Manual and a systematic approach to Risk Assessment using a risk-based decision-making framework embedded in the Quality Management System. An extensive discussion on decision-making, risk and opportunity analysis is provided with the aim of developing a seamless integration between QMS, risk analysis, and decision-making. This study proposes a decision-making framework that aligns ISO 9001 requirements with the decision-making process. The proposed decision-making methodology is aimed specifically at product and service selection. A case study is used to demonstrate the methodology.