
Explore why a quality management system (QMS) is essential for any organization, detailing how defining, controlling, and improving processes boosts efficiency, reduces waste, and ensures consistent, customer-focused results.
Learn to implement ISO 9001:2015 quality management systems by designing and building processes, deploying, controlling, measuring, and continually improving, with emphasis on internal audits and aligning with customer needs.
Compare ISO 9001:2008 and 2015, noting the new context of the organization, split leadership and planning, expanded resource support, and a ten-clause structure spanning product and service operations.
Define a process as interrelated activities that convert inputs into outputs using resources and monitor effectiveness and efficiency. Adopt the process approach to identify, implement, manage, and continually improve processes.
Explore the pdca cycle in iso 9001, outlining the plan, do, check, and act phases across clauses 4–7 planning, 8 operation, 9 performance evaluation, and 10 improvement.
Explore how iso 9001:2015 shifts from process approach to risk based thinking across the product life cycle, and quantify and mitigate risks using pdca and the six ms.
Explore terminology differences from ISO 9001:2008 to ISO 9001:2015, including products and services, documented information, environment for operation, monitoring resources, and externally provided products and services.
Compare eight ISO 9001 quality management principles with the seven in 2015, noting shifts to customer focus, leadership, engagement of people, process approach, evidence-based decisions, continual improvement, and relationship management.
Define the boundary of the quality management system under ISO 9001:2015 and show how it applies to organizations, with automotive supplements in 16949 covering design, production, and supply chain.
Explore normative references in ISO 9001:2015, including fundamentals and vocabulary from nine thousand two thousand fifteen, and examine automotive industry supplements and control plan references.
Identify organization's context by evaluating internal and external issues and interested parties, define scope of the quality management system, and outline its processes with inputs and outputs.
Top management demonstrates leadership and commitment, taking accountability for the quality management system and aligning policy and objectives with the organization’s context and strategic direction through integration into business processes.
Top management establishes the quality policy aligned with purpose and direction. It provides a framework for objectives and continual improvement, and ensures roles and responsibilities are documented and communicated.
Explore ISO 9001 clause 6 planning: address risks and opportunities, set aligned quality objectives, and plan changes to the quality management system.
This lecture explains clause 7.0 on support, covering resources, competency, awareness, communication, and document information. It emphasizes infrastructure, environment, and organization knowledge for consistent quality and production continuity.
Explore ISO 9001 clause 8 on operational planning and control, covering production and service provision, outsourced processes, process criteria, resources, changes, and nonconforming output.
Explore planning design and development under ISO 9001 clause 8.3-8.4, including design inputs, functional and performance requirements, verification, validation, and external provider controls.
Ensure preservation of product quality along the value chain by identifying customer requirements, packaging and handling, and choosing suitable transport; manage changes, control releases, and address nonconformities with documented actions.
Explore ISO 9001:2015 clause 9.0 performance evaluation, detailing monitoring, measurement, analysis and evaluation, internal audits, and management review to ensure effective quality management and continuous improvement.
Explore clause 10 on continual improvement in ISO 9001, covering general improvement, nonconformities and corrective actions, preventive actions, and strategies to enhance product quality, delivery, and customer satisfaction.
Learn core terms and definitions from ISO 9001:2015 and IATF16949 Part 1, including top management, stakeholders, customers, processes, quality assurance and control, and continual improvement.
Explore ISO9001:2015 terms and definitions, including obligatory and statutory requirements, nonconformity and conformity, output, product and service, data, information, documents, quality manual, and audits, with preventive and corrective actions.
Identify and assess internal and external risks to manufacturing processes and infrastructure; establish an ISO 9001:2015 contingency plan with stakeholder notification, periodic testing, and annual management reviews.
Explore a real-world contingency plan case study from an automotive setting, detailing action plans, responsibilities, and backups for abnormal conditions across general, transport, manpower, machine, customer, and computer system contingencies.
Explore how manufacturing process audits ensure compliance with the control plan and SOPs, assess risk-based thinking, and verify corrective and preventive actions under ISO 9001 and 16949.
Explore ISO 9001:2015 exclusions and applicability via annexure eight point five, showing how size, complexity, and risk influence exclusions, with emphasis on documented information and externally provided products and services.
Learn to build an annual ISO 9001:2015 process audit plan, detailing parts and models, monthly planning vs actuals, with qualified auditors and approval workflow.
Explore a practical process audit checklist case study that guides auditors through a 21-point evaluation of process control standards, parameters, records, calibration, maintenance, identification, traceability, customer complaints, and continuous improvement.
The turtle diagram is a flexible tool in quality management that maps inputs, outputs, process steps, resources, personnel, and performance indicators to define and improve processes under ISO 9001:2015.
Explore how ISO 9001:2015 guides document control through a case study of a document control matrix, detailing master copy, control copy, uncontrolled copy, reference copy, retention, and disposal.
Differentiate repair from rework in ISO 9001:2015 quality management by applying risk analysis to decide when to rework non-conforming products versus repair, with drilling and patching examples.
What is Quality Management System?
A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
ISO 9001:2015, the international standard specifying requirements for quality management systems, is the most prominent approach to quality management systems. While some use the term "QMS" to describe the ISO 9001 standard or the group of documents detailing the QMS, it actually refers to the entirety of the system. The documents only serve to describe the system.
Course Objectives
To provide students with the knowledge and skills to understand, implement and maintain the latest quality management system standard ISO 9001:2015
Prerequisites
There is no prerequisite for this program.
Who Should Attend?
This course is ideal for those who are directly and indirectly involved either in the implementation or maintenance of the system or part of the system., including department managers, supervisors, quality representatives, engineers, and administrative staff who have a focus on business improvement, performance and profitability.
Benefits of Implementing QMS
· Defining, improving, and controlling processes
· Reducing waste in the system
· Preventing errors and defects
· Reduction in costs
· Facilitating and identifying training opportunities
· Motivation of people at all levels
· Setting organization-wide direction
· Communicating a readiness to produce consistent results