Management system policy document

TQM involves all the organizations, all the functions, the external suppliers, the external customers and involves the quality policy. Similarly, TQM cannot be achieved without good Quality Management Systems (QMS) which bring together all functions relevant to the product, providing policies, procedures and documentation. The elements of a quality organization consist of these three mutually dependent items (Field and Swift, 1996) ... 

An inventory management system should be established - meaning set up on a permanent basis to meet defined inventory policies and objectives approved by executive management. It should be documented - meaning that there should be a description of the system, how it works, the assignment of responsibilities, the codification of best practice, procedures, and instructions. The system should be planned, organized, and controlled in order that it achieves its purpose. A person should therefore be appointed with responsibility for the inventory management system and the responsibilities of those who work the system should be defined and documented. Records should be created and maintained that show how order quantities have been calculated in order that the calculations can be verified and repeated if necessary with new data. The records should also provide adequate data for continual improvement initiatives to be effective. 

In terms of documentation, the requirements of ISO/IEC 17025, ISO 9001 and ISO 15189 are very similar and so will be dealt with together. For a quality management system to be effective, all of the components (policies, systems, programmes, procedures, instructions, etc.) must be clearly documented so that everyone in the organization knows what is expected of them. Figure 9.1 shows... 

This section provides a summary description of what this management system document contains. Some organizations choose to place their incident investigation policy statement here. 

In chapter 4.2.1 of ISO/IEC 17025 the necessity for a management system and for documentation of policies, systems, procedures etc. is stated. It is important that the system is appropriate for the laboratories activities (fit for the purpose ). The system and documentation only make sense, if they provide feedback to the persoimel. 

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 must have policy and procedures for all purchasing requirements, whether laboratory consumables, equipment, or calibration services. Records must be kept and any checks to ensure the products are fit for purpose documented. Records of purchases should be sufficiently detailed to identify what was purchased, when it was purchased, and any other relevant information, and the management system standard under which they were made should be identified. 

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

Documentation plays an important role in the effective control and implementation of quality management system requirements. The quality policy, objective, and applicable procedures ensure to meet ... 

While the previously described tasks can be considered as rather straightforward, the issue of the suitability determination of apparatus, equipment and computerised systems may involve complex investigations, inquiries at the manufacturer or vendor, extensive acceptance testing and validations and/or vendor audits in order to render these systems GLP compliant. Most certainly the amount of work involved in these aspects will necessitate the prioritisation of the various systems in use at the test facility. In the assumed case of a test facility having been in operation for some time already, albeit not under GLP, these apparatus and systems may be credited to a certain extent with the assumption of suitability for their purposes. In a first round, therefore, only the relevant documentation already available on their performance need be collected, while a formal retrospective evaluation and acceptance testing may be deferred to a later time point. The policy document of test facility management dealing with the time plan for the introduction of GLP should include therefore also a timetable for such further activities to be performed after the successful implementation of GLP. 

The environmental report is a concise document, which starts with a purpose statement and overall summary, introduces strategy, policy and management systems, then goes on to discuss environmental protection initiatives and product stewardship. It concludes by discussing environmental impact data and costs. Figures are presented in tabular form, and also as graphs at the bottom of each page. 

B.3. Use of documented Quality Management System (QMS), e.g., policy, manual, procedures, standards (see Section 8)... 

Federal U.S. EMS guidelines and information are documented in (Department of Energy 1998). International standards for EMS will be discussed in Section 4.5.3. Environmental management systems (EMS) include environmental policies, goals, and standards, which are discussed in the next three subsections. 

Well documented and soundly thought out compliance management systems and policies indicate a thorough TSCA compliance approach. 

The policy document defines the aims of the accreditation relative to the company the rest of the quality management system will be based on this documentation. 

With respect to guidehnes and standards that include provisions applicable to the prevention of accidents resulting in severe injuries or fatalities, it is my view that the Europeans are the world s leaders. Very little safety literature applies specifically to preventing serious injuries. But, at http //mahbsrv.jrc.it/NewProducts-SafetyManagementSystems.html, you will find Guidelines on a Major Accident Prevention Policy and Safety Management System as Required by Council Directive 96/82/EC (Seveso II). This document was issued by the European Commission—Joint Research Centre, Institute for Systems Information and Safety, Major Accident Hazards Bureau in Luxemburg. 

The two main efforts in conducting an audit are (1) Review and understanding of the policy and procedure documents for the management sys-tem(s) and (2) Assessment of expected system outcomes through reviews of records, through interviews, and by observations. The baseline audit assesses both Numbers 1 and 2 but typically directs most of its attention to Number 1. In contrasL the full management systems audit also assesses both Numbers 1 and 2 but typically directs most of its time and effort to Number 2. 

The leading document in the safety system is the official safety and health policy issued by the executive management. This policy forms the commitment to implement a structured safety management system, which in turn will bring about a change in the safety culture. The policy should be prominently displayed in the office foyer, on the company website, in the employees safety handbook, and on safety notice boards. 

Input requirements for MORT analysis, like those for any other detailed, comprehensive analysis, are extensive. Detailed information about the hardware and facilities, environment, procedures, and personnel directly involved is required for full evaluation of the specific control factors, and additional information about the management system is required to evaluate the policies, procedures, implementation plans, risk assessment program, and other upstream factors. Normally, a combination of interviews, physical inspections, and reviews of many procedures and project documents is required. The MORT chart and/or mini-MORT chart can serve as a planning and organizational tool for the collection of evidence and other relevant information. 

Set up a system that documents and manages any changes to the written policies and procedures. 

To a great extent, use of audits stems from quality management practices that began with ISO 9000 and related standards. The concept requires companies seeking to achieve ISO 9000 certification to thoroughly document their management systems to ensure quality defined by the standard. Then independent auditors visit the company and its operations to verify that it conforms to the standard and to internal policies and procedures. Later, international standards applied the overall process to other areas, including safety and health. 

Establishing the requirements for a company s quality management systems, the ISO 9000 series provides a set of world-wide standards. Listing the features and characteristics required in the documented policies, manuals, and procedures of an organisation, its aim is to support a process of systematic quality assurance and control. However, rather than outlining the specific methods by which to achieve control, these standards represent a codification of the principles of control, enabling alternate interpretation and application across a wide range of environments. The series encompasses five individual standards ... 

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