Quality manual meaning

Are the means used to ensure that product conforms to specified requirements documented in the form of a quality manual and quality system procedures ... 

The quality manual shall be a written document including the scope of the Quality System. Information about the construction organization, such as name, location, and means of communication, shall be included, as well as additional information, such as its line of business and a brief description of its background, history, and size. 

The quality manual shall provide a description of the structure of the construction organization. Responsibility, authority, and interrelation may be indicated by such means as organization charts, flowcharts, and/or job descriptions. These shall be included in the quality manual. 

It has to be shown by means of internal audits, that the operation (i.e. the daily work in the laboratory) is in compliance with the quality system. This must be stated in the quality manual A schedule has to be defined and a standard procedure for internal audits has to be prescribed. 

The ISO 9000 series of standards (1994) was based on the process approach. The management organizations that have adopted the 1994 edition of the standards had to describe their business processes and develop quality manuals and procedures needed to support them. The revised ISO 9001 2000 international standard model is very clear it encourages the adoption of the process approach as a means of readily identifying and managing opportunities for improvement. The present family of 21 standards in the ISO 9000 series is reduced to five. 

ISO/DIS 13485 The supplier shall establish, document, and maintain a quality system as a means of ensuring that product conforms to specified requirement. The supplier shall prepare a quality manual covering the requirements of ISO 9001. The quality manual shall include or make reference to the quality system procedures and outline the structure of the documentation used in the quality system. 

If computer-integrated resin handling systems are considered, one must compare their operating procedures with one s process requirements. These process requirements describe the flow of resin and product through the system, which determines the system s electronic architecture. Pertinent considerations include batch vs. continuous operations, the type and number of conveying lines, resin storage and distribution, quality control means and procedures, inventory control, the type and quantity of process parameter sensors, the type and quantity of controlled devices, modes (automatic, semiautomatic, manual, and/or shutdown modes), process information, process management controls, and centralized vs. local operation (Fig. 9-1). 

Assembly techniques by dowel insertion, with or without the use of adhesives, are common in joining solid wood in furniture and wood joinery industries. The traditional way to insert dowels in good quality solid timber furniture is by percussion, pneumatic or manual means. 

Use labels of red Lamicoid with white lettering or of equivalent quality, secured in place by screws or rivets. Where practical, the remote sources of power shall be interlocked with the disconnect means. If not, a manual means shall be provided to quickly disconnect these sources. 

Throughout the text of this quality system manual and applicable procedure, the term product also means service. ... 

The requirements of this manual are aimed at the prevention of quality failures and the maintenance of a system that provides the most effective and efficient means of achieving the documented objectives. 

It is clear that the manual preparation and continual updating of the charts shown in Fig. 2 for a multilevel, multi-analyte quality control system involves a great deal of work. However, it is possible in a multilevel control system to represent all individual values at different levels on one chart which is a variant of the Shewhart mean plot. The difference of an individual value (e.g. from the target mean (x ) is divided by the target standard deviation (sQ and thus the position of the individual value is represented relative to the target mean in standard deviation intervals 1), see Fig. 1. The bias of each value, irrespective of its analyte concentration, is therefore represented on the same standard deviation scale. This is very convenient for manual and computer plotting as complex scaling is avoided. Fig. 4 shows an example of this... 

The process industry comprises mainly continuous but batch processes also. The industries involved are chemical, petrochemical, pharmaceuticals, refineries, etc. These are usually very large and complex facilities. The main goal of any process plant is to get the maximum benefit (which means the demanded amount with the specified quality using the less resources) assuring safety and stability of the plant. In order to achieve this goal, control strategies have been applied and evolved over the years as new capabilities were available. From the initial manual control to the current digital distributed control system (DCS). 

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