BY: JAVELIN F. ESPINAS MPA STUDENT-PSU ISO 9001:2015 Potential benefits to an organization of implementing a Quality Management System based on this Standard:
1.Ability to provide products and services that meet customer and
applicable statutory and regulatory requirements 2.Facilitating opportunities to enhance customer satisfaction 3. Addressing risks and opportunities associated with its context and objectives 4.Ability to demonstrate conformity to specified QMS requirements Major differences •New structure: High Level Structure •Easier for organizations with multiple management systems •Risk-based thinking •Improved applicability for services •Increased emphasis on organizational context •Increased leadership requirements •Less emphasis on documents •Greater emphasis on achievingdesired outcomes to improve customer satisfaction ISO 9001:2015 •QMP 1 – Customer Focus •QMP 2 – Leadership •QMP 3 – Engagement of People •QMP 4 – Process Approach •QMP 5 – Improvement •QMP 6 – Evidence-based Decision Making •QMP 7 – Relationship Management PDCA is a tool to manage processes and systems. PDCA enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on. PROCESS APPROACH Define the context of the organization Define the scope, objectives and policies Determine the processes Determine the sequence of processes Define ownership and accountability Define need for documented information Define interfaces, risks and activities within process Define monitoring and measuring requirements Define the resources needed Implement verify the process against its planned objectives Improvement RISK-BASED THINKING
enables an organization to determine the factors that could cause
its processes and its QMS to deviate from planned results, to put preventive controls to minimize negative effects and to make maximum use of opportunities as they arise.
Concept of Preventive Action is expressed through the use of Risk
Based Thinking. The whole QMS - A preventive tool.