ISO 9001:2015-Quality Management System Implementation&Audit

Explore the ISO 9000 family’s fundamentals and vocabulary for quality management systems, introducing the seven principles: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, relationship management.

Lead with a clear strategy and inspiring vision by committing, communicating mission and policies, building shared values, and fostering trust to empower every level to pursue quality.

Embrace the ISO 9001:2015 process approach by treating activities as inputs to outputs, guided by resources and the PDCA cycle, with risk based thinking improving customer satisfaction.

Drive continuous improvement by identifying opportunities, planning and implementing actions to achieve desired results and enhance customer satisfaction, while using quality tools and root-cause analysis.

Lead with relationship management as the final ISO 9001:2015 principle, building trust-based, long-term partnerships with suppliers, customers, and other interested parties through information sharing, collaboration, and resource-aware performance feedback.

Define the scope of the quality management system under ISO 9001:2015 by identifying goals, customer requirements, and regulatory obligations, and applying the standard's requirements to any organization.

Explore normative references and terms and definitions in ISO 9001:2015, reference ISO 9000, and understand concepts as defined in ISO 9000, noting that purchasing the 9000 document is not mandatory.

Define the scope of the quality management system by identifying sites, products and services, external/internal issues, interested parties, and applicable versus justified non-applicable requirements; document and justify exclusions for audit.

Identify, maintain, and provide organizational knowledge to support process operation and conforming products, while addressing changing needs. Auditors verify how knowledge is collected and shared from internal and external sources.

Organizations determine competence of personnel performing work affecting quality, based on education, training, and experience, and maintain documented information as evidence; auditors assess training, mentoring, reassignment, and outsourcing of personnel.

Explain how staff read and understand the quality policy and objectives, contribute to the quality management system, and recognize consequences of nonconformity, with auditors reviewing records and interviewing personnel.

Identify, create, update, and control documented information for the quality management system. Ensure clear identification, version control, approval, retention, and availability to the right people, with proper storage and protection.

Implement extent controls for externally provided processes, products, and services to ensure supplier conformance and delivery of specified outputs, guided by risk-based thinking and supplier audits.

Measure and analyze customer satisfaction to monitor perceptions of product and service fulfillment, using surveys, inquiries, and complaints data to drive improvement in the quality management system.

Identify opportunities for improvement to meet customer requirements and boost satisfaction, using audits, process data, and feedback to improve products, reliability, and on-time delivery.