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Quality Management S ystems – Requirements

This document outlines the requirements and processes involved in the organization's quality management system, including customer communication, design and development, purchasing, production and service provision, control of nonconforming outputs, infrastructure, and management of interested parties.

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Quality Management S ystems – Requirements

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  1. Quality Management Systems – Requirements The scope of the organization's quality management system shall be available and bemaintained as documented information. • Described in terms of: • Products and services • Main processes involved • Sites where processes are operated

  2. 4.4 QMS and Processes First we shall define the processes needed to meetthe requirements for the provision of productsand services.Requirements for these processes are given in clause 8 The policy of our organization is to create value for the customers at competitive price. Customers Customers requirements

  3. 4.4 QMS and Processes 8.2 Requirements for products and services 8.2.1 Customer communication 8.2.3 Review of requirements related to products and services 8.2.4 Changes to requirements for products and services A sales process is a set of activities for selling a product or service:  planning the sale, initial contact, need assessment, presentation, meeting objections, follow-up … Customers Customers requirements Sales

  4. 4.4 QMS and Processes 8.3 Design and development of products and services 8.3.2 Design and development planning, 8.3.3 Design and development inputs, 8.3.4 Design and development controls, 8.3.5 Design and development outputs, 8.3.6 Design and development changes Design and development is the process of creating a new product and services to be sold by an organization to its customers. Customers Customers requirements Sales Design

  5. 4.4 QMS and Processes Purchasing is engaged in buying anything you can not produce within the organization, and out-sourcing is something you could produce yourself, but choose not to due to capacity or commercial considerations. 8.4 Control of externally provided processes, products and services 8.4.1 General 8.4.2 Type and extent of control 8.4.3 Information for external providers Customers Customers requirements Sales Design Purchasing Suppliers Sub-contractors

  6. 4.4 QMS and Processes 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes An organization must carry out the activities to provide products or services under controlled conditions. These include work instructions, suitable equipment, activities controlling product release, delivery and post-delivery... Customers Customers requirements Production & service provision Sales Design Purchasing Maintenance Suppliers Sub-contractors

  7. 4.4 QMS and Processes The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, or approved by a relevant authority or by the customer. Customers 8.6 Release of products and services Customers requirements Production & service provision Sales Design Purchasing Maintenance Suppliers Sub-contractors

  8. 4.4 QMS and Processes The organization shall ensure thatoutputs that do not conform to theirrequirements are identified and controlled toprevent their unintended use or delivery. Customers Customers requirements 8.7 Control of nonconforming outputs Production & service provision Sales ? Design Purchasing Maintenance Suppliers Sub-contractors

  9. 4.4 QMS and Processes The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes to achieve conformity of products and services. Customers Customers requirements 7 Support 7.1.3 Infrastructure Production & service provision Sales ? Design Purchasing Maintenance Suppliers Sub-contractors

  10. 4.4 QMS and Processes Interested parties The process of management of the company 4.2 Understanding the needs and expectations of interested parties 5.1.2 Customer focus Customers Customers requirements Production & service provision Sales ? Design Purchasing Maintenance Suppliers Sub-contractors

  11. 4.4 QMS and Processes Interested parties The process of management of the company 9.1.2 Customer satisfaction The organization shall monitor customers' perceptions of the degree to which their needsand expectations have been fulfilled. Customers Customers requirements Production & service provision Sales ? Design Purchasing Maintenance Suppliers Sub-contractors

  12. 4.4 QMS and Processes Interested parties 5.2 Policy 6 Planning The process of management of the company Customers Customers requirements Production & service provision Sales ? Design Purchasing Maintenance Suppliers Sub-contractors

  13. 4.4 QMS and Processes Interested parties 7.1 Resources: The organization shall determine and providethe resources needed for the QMS The process of management of the company 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment 7.1.5 Monitoring and measuring 7.1. 6 Organizational knowledge Customers Customers requirements Production & service provision Sales ? Design Purchasing Maintenance Suppliers Sub-contractors

  14. 4.4 QMS and Processes Interested parties Monitoring of the operating costs of the system. The process of management of the company 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment 7.1.5 Monitoring and measuring 7.1. 6 Organizational knowledge Accounting Customers Customers requirements Not ISO 9001:2015 requirement Production & service provision Sales ? Design Purchasing Maintenance Suppliers Sub-contractors

  15. 4.4 QMS and Processes Interested parties The process of management of the company 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment 7.1.5 Monitoring and measuring 7.1. 6 Organizational knowledge Accounting Customers QA Customers requirements Production & service provision Sales ? Design Purchasing Maintenance 9.1 Monitoring, measurement, analysis and evaluation 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation 9.2 Internal audit 9.3 Management review 10 Improvement Suppliers Sub-contractors

  16. 4.4 QMS and Processes Interested parties The process of management of the company Resources 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment 7.1.5 Monitoring and measuring 7.1. 6 Organizational knowledge Accounting Customers QA Customers requirements Production & service provision Sales ? Design Purchasing Maintenance Legend: Suppliers Value adding processes Supporting processes Sub-contractors External parties Monitoring, inspection, maesuring

  17. Leadership and management Customer (requirements, needs and expectations) 1 Customer (satisfaction) 2 17 Project manage-ment 16 15 11 Human resources 12 Quality management 10 Finance resources 13 14 Accounting(outsourced) IT management C B A 3.2 5 Product planning, sales and marketing Design & development, purchasing 3 Production, inspection and testing 4 6 9 8 7 3.1 Suppliers QMS Interaction Chart Sequence and interaction of processes

  18. 4.4 QMS Examplecont.

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