Quality systems management system

Guidelines for auditing quality systems - management of audit programs... 

Employee previously rewarded for deviating from the procedure, due to a culture of rewarding speed over quality, resulting from and reflecting a defective quality-assurance management system... 

Under a quality system, managers are expected to establish training programs that include the following ... 

The revised and adopted module ISO 9001 2000 makes the quality system management requirements extremely clear. The review of Tables 1 and 2, under the heading Correspondence between ISO 9001 (1994) and ISO 9001 2000, reveals that the same processes are specified in both standards, even though they have different names and subheadings. The quality system requirements in ISO 9001 2000 are comprehensively grouped under clause 7 with additional emphasis on customer satisfaction and internal communication. Where exclusions are made, claims of conformity to this international standard are not acceptable unless these exclusions are limited to the requirements within clause 7. Such exclusions do not affect the organization s ability or responsibility to provide products that fulfill customer and applicable regulatory requirements. 

An audit organization is an organization that regularly conducts quality assurance management system audits to a required standard. 

Every production plant will be controlled by a Process Control System (PCS). A PCS not only controls set-points but also delivers data which define the product quality. Process management systems allow the direct access of the production management to the production line. 

ISO 14000 is the International Organization for Standardization s standard for developing and maintaining quality environmental management systems. ISO 14000 describes in considerable detail what a company must do without prescribing how it... 

A formal quality policy should be established and implemented company-wide by excipient manufacturers. Management should be committed to this policy and should appoint appropriate company personnel to be responsible for coordination and implementation of the quality system. Management should participate in the development of the company s quality policy and provide the resources necessary for development, maintenance and periodic review of such a policy and quality system. 

The ISO 9001 standard was originally based on BS 5750. A primary objective of this standard is to ensure the commitment of management to quality with respect to the business as well as to customer needs. The Quality Systems Management standard recognizes that employees require measurable objectives. In addition to a detailed record system that shows the origin of raw materials and how the products were processed, it includes auditing (both internal and external, in the form of certification) at defined intervals to check and ensure conformity and effectiveness. 

DOE G 414.1-2A, Quality Assurance Management System Guide for Use with 10 CFR 830, Subpart A, Quality Assurance Requirements. Document is available from Department of Energy, AD-631/ FORS, Washington, DC. 

Hence effective quality systems management will greatly enhance the management of health and safety, and will lead to an overall improvement in the level of safety performance. 

The ISO 14001 EMS was designed to be compatible with ISO 9000 Quality System. Both systems share many common management principles, techniques and procedures. However, the main distinctions between the systems are described in the policies of both management systems. 

The UK government enquiry into the Piper Alpha disaster in the North Sea in 1988 has had a significant impact on working practices and equipment and has helped to improve offshore safety around the world. One result has been the development of a Safety Management System (SMS) which is a method of integrating work practices, and is a form of quality management system. Major oil companies have each developed their own specific SMS, to suit local environments and modes of operation, but the SMS typically addresses the following areas (recommended by the Cullen Enquiry into the Piper Alpha disaster) ... 

The second approach - creation of systems for non-destructive testing quality assurance in compliance with ISO standards 9000 series - considers the quality system as an assembly of organisational strueture, procedures, processes and resources necessary for overall quality management at the laboratory. This approach requires methodieal development. 

Quality. The plant operated by Synthetic Chemicals Ltd. operates within a quaUty management system, which complies with British Standard (BS) 5750 and ISO 9001, Part 1. 

Introduction Review and audit processes are used in the chemical process industry to evaluate, examine, and verify the design of process equipment, operating procedures, and management systems. These processes assure compliance with company standards and guidelines as well as government regulations. Reviews and audits can encompass the areas of process and personnel safety, environmental and industrial hygiene protection, quality assurance, maintenance procedures, and so on. 

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