Management system quality manual

The quality system must be described in written documents approved by management (policies, quality manual, etc). 

Is there a quality manual clearly describing the management system, i.e. as per ISO 9000 series or other ... 

List the work instructions and standard procedures used in your laboratory that you think contribute to your laboratory s quality management system and should therefore appear in a Quality Manual. 

The initial resource requirement will therefore be the effort required to agree the quality management system structure and content and compile the information as a Quality Manual. This process often takes several months to complete and, according to the size of the laboratory concerned, may involve a number of staff allocating a significant proportion of their time to this work. It must be remembered that the quality management system must be tailored to the work - not the work tailored to the quality management system. 

A laboratory must have a defined quality management system, which is described in the Quality Manual. The procedures for auditing and reviewing... 

All members of staff of a laboratory are responsible for ensuring that they are familiar with the quality management system, as set out in the Quality Manual and any supporting documentation. They are expected to follow the... 

Chapter 4.2 demands that the laboratory must have a quality management system appropriate to the scope of its activities. This must be documented in a quality manual which is written in an imderstandable form and available to all persoimel (see chapter 7 in this book). 

In the quahty manual the laboratory s management system policies and objectives shall be defined. The quality policy statement shall be issued imder the authority of the top management. For more details on quality manuals see chapter 7. 

The laboratorys management system policies and objectives shall be defined in a quality manual (hovirever named)... 

The laboratoiy quality manual is a document addressing the quality management system requirements and shall... 

The quality manual is the heart of eveiy management system related to quality. Quality assurance in analytical laboratories is most frequently linked with ISO/IEC 17025, which lists the standard requirements for a quality manual. In this chapter examples are used to demonstrate, how these requirements can be met. But, certainly, there are many other ways to do this. 

Clause 4.2.2 of ISO/IEC 17025 requires that a quality policy statement be issued by the top management and that the quality system policy and objectives are defined and documented in the quality manual. 

The laboratory s management system policies related to quality, including a quality policy statement, shall be detned in a quality manual (however named). 

The quality manual also has to include or has to make reference to all supporting and technical procedures. The quality manual therefore is the central document of the quality management system. 

As mentioned above the quality policy is one of the most important parts of the quality manual. The whole system should only reflect and realize the quality statements and requirements in the daily work. The policy shall be authorized by the top management, because this statement has to reflect clearly, how cracial quality aspects are in the work of the laboratory. 

Regular management reviews are required by ISO/IEC 17025. They can show that the management system and the testing activities are suitable and effective. They have to be planned. The schedule and the procedure have to be documented in the quality manual. 

If the quality manual is written and used in electronic form, first of all the same requirements have to be met. There must be a system for managing the access rights on the files, a system to ensure that no unauthorized documents is placed on the system, that all withdrawn documents are stored for later information and that all documents are securely backed up. 

The quality manuals and procedures provide users and frontline managers with all the information they need to make a successful documented quality system based on the international standard ISO 9001 2000 series of standards. 

The ISO 9001 2000 international standard adopted by (company name) specifies requirements for a quality management system to demonstrate the ability to consistently provide products that meet customer satisfaction and applicable regulatory requirements. The objective is to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system. In this quality system manual, the term product applies only to the product intended for, or required by, a customer. It should be noted that no exclusion is permitted in the adopted model. 

Company name) has established and maintained a quality system manual to describe the scope of its quality management system, including details of and justification for any exclusions (see 1.2). The documented procedures established for the quality management system, or reference to them, and a description of the interaction between the processes of the quality management system are included. 

The quality management system documentation includes quality policy, a quality manual, and documented procedures required by this international standard and quality standards. 

The quality manual describes in detail the scope and justification for any exclusions made and the reference to the documented procedures established and maintained. The quality manual and procedures further describe the interactions between the elements of the quality management system. 

This manual provides reference to the organizational quality management system to ensure consistency, reproduceability, and continuous improvement in the company s operations with a particular reference to customer satisfaction and to meet regulatory requirements as appropriate. The manual refers to the elements of international standard ISO 9001 2000 incorporated in the already existing ISO 9003 (1994) quality manual. 

The quality manual outlines the structure of the quality management system and reference procedures. 

Don t reinvent the wheel when applying for your ISO 9001 registration or updating to the new 2000 standards. ISO 9001 2000 Document Development Compliance Manual A Complete Guide and CD-ROM shows you how to develop ond implement a documented quality management system based on the ISO 9001 2000 standards. 

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