Quality Progress - July 2016 - 54

STANDARDS OUTLOOK BY BILL ASTON Leaders of Change A case for risk-based thinking and organizational transformation ISO 9001:2015 INCLUDED several Leadership and commitment for change wasn't explained or com- changes after last year's revision, but the Top management's responsibility to municated from C-level management mandate for top management to demon- demonstrate leadership and commitment to the individuals who will be affected strate leadership and commitment to the can't be delegated to a management rep- by a change or expected to implement quality management system (QMS)-as resentative because ISO 9001:2015 no lon- it. The establishment, implementation described in subclauses 5.1.1 and 5.1.2- ger requires the appointment of one such and maintenance of a QMS are not is an important one. person. Yes, ISO 9001:2015 subclause 5.3 one-person activities. They require the does require top management to assign involvement of all management, process responsibility and authority to relevant owners and employees, as well as top persons to ensure QMS requirements are management's involvement, leadership communicated and understood. But it's and commitment. For example, top management must: * Take responsibility for the effectiveness of the QMS. * Incorporate QMS requirements into the organization's business processes. * Encourage the use of the process approach and risk-based thinking (RBT). * Directly engage persons (employees) to contribute to the effectiveness of the QMS and support this. * Ensure risks and opportunities that 2 important to know the primary responsibilities-to champion the effectiveness Retooling your RBT of the QMS, and encourage the use of the Using the process approach and RBT are process approach and RBT-remain with hot topics for organizations implement- top management. ing ISO 9001 for the first time and others The requirement for C-level manage- transitioning to its revised requirements. ment to demonstrate its commitment to There's nothing new about RBT. In fact, may affect the QMS are identified and the QMS's continual improvement also is ISO 19011:2011-Guidelines for audit- addressed. identified in subclause 5.2.1D.3 ing management systems highlighted * Ensure the enhancement of customer satisfaction.1 Most people don't like change. This can be particularly true if the need the need for organizations to identify risk as associated with QMSs, environmental management systems, and occupational health and safety management. ISO 19011:2011 also included a reference to using risk-based auditing (RBA). RBT is ingrained in product and service planning processes for a majority of organizations. Although it may not be recognized as such, RBT is a natural part of the planning process. It includes the identification of resources such as personnel qualifications, equipment, facilities, manufacturing processes, material suppliers and control of outsourced services needed to meet specified requirements. RBT is integral to the standardization of processes and activities to minimize variation, which lower the risk of nonconformance. In this case, RBT would 54 QP * www.qualityprogress.com http://www.qualityprogress.com

Table of Contents for the Digital Edition of Quality Progress - July 2016

Up Front
LogOn
Expert Answers
Keeping Current
Mr. Pareto Head
A Quick Study
Clear Pathway
Pulling It All Together
Dead or Alive
Innovation Imperative
Measure for Measure
Quality in the First Person
Career Corner
Standards Outlook
ASQ's Continuing Education and Profesional Development Directory
QP Toolbox
QP Reviews
One Good Idea
Back to Basics

Quality Progress - July 2016

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