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30 MoldMaking Technology —— JANUARY 2016 KEEPING UP WITH Moving to ISO 9001:2015 Requires a Top-Down Approach By Lewis Yasenchak A quality management system (QMS) is the framework of policies, processes and procedures used to ensure that a company can fulfill all tasks required to achieve its objec- tives. The International Organization for Standardization (ISO) 9001 quality management system places greater emphasis on building this system to suit each company's particular needs and strives to give companies a high-level understanding of the important issues that can affect these systems. A revision to this standard was released in September 2015, and all companies currently certified to ISO 9001:2008 will be required to update or transition to the new requirements within three years (by September 2018). This new column is intended to help guide moldmakers and molders to ISO compliance, linking their day-to-day work metrics to financial metrics. The purpose of ISO 9001 is to help organizations provide products and services that meet all relevant customer needs and expectations, and comply with all relevant regulatory and statutory requirements. Any organization can achieve these objectives if it establishes a QMS and continually works to improve its suitability, adequacy and effectiveness. The requirements of ISO 9001:2015 include both manufac- turing and administration pro- cesses, such as document control, records management, corrective action, customer surveys, sup- plier report cards, apprenticeship training and internal audits. These provide objective evidence that a company is operating with the proper controls, policies, procedures and practices to help ensure customer require- ments are met. Such evidence is obtained in booking customer orders, purchasing raw materials, fulfilling orders, and han- dling customer returns and complaints. These same operational controls are also the foundation for much of a company's financial data, including, for example, inventory, revenue, and customer credits and/or allowances. Even ISO 9001's requirements related to job duties, respon- sibilities and communications throughout the company con- tribute to the control environment that's so important for the credibility of financial information. Five key aspects of internal control are the control environ- ment, risk assessment, control activities, information and communications, and monitoring. These align with various operational controls in an ISO 9001 system, such as compli- ance with the Sarbanes-Oxley (SOx) Act, financial transactions and accounts, internal audits, financial controls, and "walk- through" methodology for integrated audits. All of these activities must start at the top. Therefore the biggest change in the standard requires that the CEO/owner take ownership of the compliance process, replacing the quality manager, which was a position typically held by small mold- makers and molders with limited resources. Top management is now required to demonstrate leadership and commitment, and ensure the integration of QMS requirements into the company's business processes, maintaining quality objectives to support the achievement of the organization's business goals. The CEO/owner is responsible for the strategic leadership of the organization to ensure its future relevance, credibility and viability. Now, establishing ISO organizational objectives and priorities, reviewing and evaluating the progress, and working for attainment of these ISO objectives and performance goals falls to this senior position as well. The CEO also maintains staff focus on the company's mission and vision, and balances organizational priorities through an inclusive strategic planning and management system. He or she seeks out opportunities to improve orga- nizational operations and shifts organizational philosophy to integrate departments and programs to function as a strong, cohesive operation. Another duty is developing policies and Implementing ISO guiding principles to govern every activity within a moldmaking or molding facility is essential to properly managing the supply chain. This new column will share knowledge, highlight opportunities and spotlight rewards of the ISO 9001: 2015 revision. ISO 9001:2015 can also bring growth and fnancial benefts to a company by helping to increase productivity and effciency.