Standard operating procedure manual

R. Ira in Bacteriology Standard Operative Procedure Manual for Microbiology Laboratories, National Institute of Biologicals, New Delhi, India, 1995, p.73. 

A standard operating procedure manual should definitely be prepared for systems as potentially dangerous as open beam analytical systems, and all persons must be made familiar with the procedures applicable to safe use ofthe equipment. The person in charge of the facility is responsible for ensuring that all personnel are informed of safe procedures and that it is required that all personnel must comply with the written safety policies. This should be done not... 

The second aspect of quahty documentation is to detail how the work processes referred to in the manual are performed. The QA unit is often the organization responsible for issuing a set of procedures designed to assure conformance to the appropriate standards or to company poHcy. The procedures, often called standard operation procedures (SOP) or quahty operating procedures (QOP), should include such topics as customer complaints, audit protocols, stabihty testing, preparation of COAs, test method vahdation, etc. 

US Environmental Protection Agency, Region 4, Environmental Investigations Standard Operating Procedures and Quality Assurance Manual, Sections 1-18, EPA, Athens GA (1996 with 1997 revisions). 

All operations that are done regularly in the laboratory, especially the analyses, have to be described in standard operation procedures (SOP). It is useful to describe the standard operations in separate documents and to include only a list of all SOP s in the qnality manual. 

To meet the requirement for standard operating procedures, the laboratory is advised to develop a system to ensure that aU working copies of the SOPs are identical. When SOP revisions are distributed, aU holders of the manual should be instructed at a minimum to destroy the outdated version of the procedure. A better approach is to require the outdated version to be returned to and accoiuited for at a central location. FoUow-up should then be provided to ensure the return of all copies of the outdated procedure. Ideally each distrib-... 

The manufacturer should verify the operation of these critical components during the installation according to their standard procedures for evaluating the proper operation of these components. Additional IQ checks will verify that the necessary documentation is available for proper operation of the chamber. These checks should confirm that standard operating procedures and equipment manuals are available. In addition, all calibrated instruments associated with the chamber should be documented in current calibration and placed on a calibration program. 

Check the documentation for completeness (operating manuals, maintenance instructions, standard operating procedures for testing, safety, and validation certificates). 

This manual is written in general terms so that it can be used as a procedural guideline by the individual responsible for writing quality manuals and applicable standard operating procedures and programs. The format of this manual, these procedures, and the numbering system can easily be used by small to large companies and are acceptable to ISO certification bodies. 

The CD-ROM consists of manuals and procedures that should be useful to all companies. As the ISO 9000 series of quality standards becomes more widely adopted by organizations, both in the United States and elsewhere in the world, it is essential for compliant companies to create quality systems manuals and applicable standard operating procedures (SOPs) for their employees. These SOPs enable both new and experienced staff to understand the requirements of the ISO 9000 series of standards, along with the principles and practices of the company, and comply with these regulations to build the elements of quality into their products and services with a particular reference to customer satisfaction. 

The contents of the manual are divided into three major sections objectives, quality manuals, and standard operating procedures. The first section addresses the definition of quality, basic changes, correspondence between international standard ISO 9001 (1994) and ISO 9001 2000, and the process of documentation development and application for registration and certification. 

The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed in the quality system manual and applicable standard operating procedure to reflect the vocabulary currently used. 

The distribution of the quality manual and standard operating procedures is controlled. 

The CD contains Quality Systems Manuals with samples of policy stotements that can be customized to fit your organization. It provides you with 20 Standard Operating Procedures that you con edit to your specifications and print when you need them. Written in a global format applicable to any process-related industry, ISO 9001 2000 Document Development Compliance Manual A Complete Guide and CD-ROM gives you everything you need to document the ISO 9001 process quickly, effortlessly, and cost-effectively. 

The ISO 9001 2000 Document Development Compliance Manual A Complete Guide and CD-ROM provides guidelines to those involved in the development of quality system manuals and applicable standard operating procedures (SOPs) to comply with the requirements of international standard ISO 9001 2000 and proceed with the registration/certihcation process. The quality manuals (models) and SOPs provided in the CD-ROM are also a valuable tool for the companies to transform their existing ISO 9001, ISO 9002, and ISO 9003 quality manuals and SOPs to meet the requirements of revised standards. 

ISO 9001 2000 quality manuals, together with 20 standard operating procedures, provide explicit instruction,s on how to achieve the standard for anyone responsible for writing and executing quality manuals and applicable procedures. Included herein is the ready-to-use template on a CD-ROM that one can immediately use as his own without reinventing the wheel, thus saving time and money without missing any critical quality elements. 

This manual provides instant answers for quality professionals, quality assurance managers, auditors, and protocol writers regarding what should be made part of quality manual standards and ISO 9000 standard operating procedures to enhance productivity. 

Standard operating procedures will be required as written instruction to operating personnel on how to operate the manufacturing process. These will cover operation in conjunction with the computer system and also any tasks that are independent of the computer system. Where there is a requirement for quality-critical data to be manually entered on the computer system, there should be an additional check on the accuracy of the entry. If the computer system is not designed to carry out and record this check, then the relevant SOP must include this check by a second operative. 

Every analytical laboratory, governmental, private, or university, has a standard set of procedures that provide both general and specific information to laboratory members. These fall into certain categories, including the laboratory s standard operating procedures (SOPs), quality assurance/quality control manuals (QA/QC manuals), procedural manuals, analytical method files, and laboratory information management systems... 

Center for Biologies Evaluation and Research (CBER). Manual of Standard Operating Procedures and Policies, SOPP 8001.2. Accessing the FDA Lists of Disqualified and Restricted Clinical Investigators, Debarred Individuals, and Firms Under the FDA Application Integrity Policy, April 1, 1998. 

Center for Biologies Evaluation and Research. Manual of Standard Operating Procedures and Policies, SOPP 8404. Refusal to File Guidance for... 

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