This training is the basis for quality management system specialists (QMS). During the training the requirements of the standard ISO 9001:2015 and examples of requirements implementation are discussed in detail. At the end of each part follow practical exercises for achieving requirements understanding, creation of quality management system draft documents, development of solutions. In order to implement a risk-oriented approach and achieve results in the internal audit process, the training examines the risks and management measures in areas of the audit execution program, as well as the risks of unrealized improvements resulting from the audit. QMS training in addition to theoretical and practical material considers issues of psychology of QMS implementation. The most frequent questions: how to motivate a team, how to find the time, how to convince TOP management. At the end of the training, participants understand the purpose of the internal audit, are able not only to plan, carry out, evaluate the results of audit but also to motivate, convince the audited to the necessary improvements.
The training is led by the leading expert auditor TÜV SÜD ISO 9001.
- Training duration: 2-5 days.
- Price: upon the request, depending on training duration
- Language: Russian, English.
- employees of organizations implementing the quality management system, as well as new employees with responsibility in the quality management system;
- the staff of the organizations with the certified quality management system, persons interested to improve/increase QMS effectiveness;
- internal auditors.
The course is suitable for all economic activities of organizations: both productions manufactures and services providers.
- What do we need QMS for? Norms and normative documents in the field of quality management. Changes in the norms of QMS in accordance with the trends of modern management. ISO 9001:2015 logic and structure.
- Principles of quality management. A series of ISO 9000 norms. Scope of the quality management system. Terminology in the field of quality and quality management systems: basics of work with the terminology, changes in the terminology;
- Management based on the process approach: requirements on the QMS processes (specific customers’ requirements, consideration of legislative and normative requirements, internal needs of the organization), structure and correlation of processes, monitoring and measurement methods. Documentation of QMS processes, evaluation, and analysis of processes; description methods. Determination of indices on the processes;
- Organizational context. Interested parties – their needs and expectations. Balance of the interested parties’ needs. Strategic orientation of the organization.
- Management and leadership. Quality policy based on the context. Determination of roles, responsibility, and authority;
- Risk-based planning: determination of quality risks and opportunities, risk-related actions, integration of action into processes; Preventive actions. Ensuring readiness to face emergency situations. Development of quality aims. Determination of aims with consideration of non-standard risks and opportunities;
- Management of organizational changes: strategic types of changes, changes components, models and risks of organizational changes;
- Requirements on supportive means and resources: personnel, infrastructure, production conditions, monitoring, and measurement means, knowledge. Development of human resources: resources planning, determination of aims for the personnel and competency profile, development of mechanisms of evaluation and competence maintenance. Knowledge management, the culture of preserving the company’s intellectual potential. QMS documentation: documentation structure, documented information. Requirements on the documentation. Documentation structure, management levels. Documentation registration. Management of internal and external documentation.
- Planning in ISO 9001;
- Customers as one of the interested parties, customers related processes. Identification, analysis, and assessment of the customers’ requirements;
- Management of the collaboration with external providers. Key providers from the point of view of ISO 9001:2015. Election of providers: a primary and periodic evaluation. Creating of a value chain. Monitoring of the effectiveness of work with providers;
- Requirements on design and development of the products, services, and processes;
- Management of the processes of production and service rendering. Ensuring production safety. Production output; After-sales maintenance. Work with non-conformities of the product;
- Requirements on the organization of control and monitoring of the system, processes, products, and production. Peculiarities of management of non-conformities in the system of qualitative management: objects, processes, improvement.
- The notion of constant improvement: reactive and proactive improvement.
- Data analysis and building of an information field for theAnalysis of the management system;
- What do we need audits for? Place and meaning of the internal audit in the quality management system
- Norms of the internal quality audit:ISO 19011, ISO 9001. Which documented information is needed for the internal audit? Audit principles;
- Audit types: production audit, process audit, procedure audit, system audit. Selection of the audit type for measurement if the quality management system;
- Management of the audit programs. Requirements on the auditors’ qualification;
- Process-oriented audit. Planning and preparation of the audit. Preparation of question lists;
- Audit conducting: audit stages on site. Principles of conducting an opening meeting. Investigation methods during the audit. Audit closing. Evaluation of the audit results. Preparation of the audit report;
- Tracing of further actions in the result of the internal audit. Correction and corrective actions: what needs to be done in the result of the internal audit? Preventive actions;
- Communication theory. First impression. Distance selection;
- The technology of question formulation: how to ask in order to “listen”;
- Management of objections;
- Analysis of typical problems occurring when preparing and conducting an internal audit of the quality management system;
Business Games (the contents may vary):
- Application of PDCA cycle;
- Explanation of inapplicability of the requirements and reasons hindering the realization of the norm requirements;
- Definition of the contents of the processes, the process model, its optimization; description of QMS processes, determination of criteria of the process effectiveness, monitoring and measurement of processes; analysis of the context, composing a Quality Policy;
- The building of a risk system, risk assessment, priority setting in work with risks;
- Identification of risks and opportunities, assignment of actions, integration of actions into the documented information on standard and non-standard risks and opportunities;
- Development of aims in the field of quality
- Implementation and management of organizational changes;
- Formation of a competence profile, mechanisms of competence upgrading, identification of key knowledge and their holders, determination of a program of knowledge sharing;
- Identification of requirements and assessment of the compliance of the infrastructure and production conditions;
- Business game “New products development“;
- Management of collaboration with external providers;
- Customers’ satisfaction;
- Management of changes and improvement;
- Management review of the system;
- Formation and optimization of management of the documented information in the quality management system;
- Preparation of the year audit program;
- Preparation of the question list of the internal audit;
- Audit situation assessment based on interview results
- Audit situation assessment based on a photographic material;
- How not to start a war with the audited person?
Work with terminology; creating an assessment of processes in the QMS, choosing the right approach to the process documentation; assessment of the context (working environment) of the organization, building up a quality strategy of the organization; decomposition and aims development; creating a well-balanced strategy of work with interested parties; identification, assessment and management of risks in the field of quality; management of supportive means for the quality management system; preparation of reports for management review; development of internal audit program; development of internal audit check-list; organization of correct team of internal auditors; communication skills and code of ethics for internal auditors; methods for effectively achievement of QMS results.