Quality manual operating procedures

Does ISO 9001 require the other types of policies to be defined and documented There is no requirement in clause 4.1.1 but in clause 4.2.2 there is a requirement to prepare a quality manual covering the requirements of the standard and this is where you should document your operational policies. While the quality manual could simply contain the quality system procedures, the guidelines given in ISO 10013 clearly indicate that whether or not this is the case, the manual should describe the organization s policies for meeting the requirements of the standard. These aspects are addressed in Part 2 Chapter 2. 

For a quality manual to be a manual it should contain the procedures and instructions, as does a computer manual or a car maintenance manual, so whether one volume of the manual contains or refers to other documents does not prevent the collection of documents being referred to as the quality manual. Manuals tend to include operating instructions, hence the word manual. The quality manual should therefore contain all the policies and practices but not necessarily in one volume. 

Some organizations divide their quality system documentation into three levels a quality manual, a set of operating procedures, and the support documentation. 

The 1987 version of ISO 9001 required the quality policy and the quality system procedures and instructions to be documented, clearly identifying three levels of documents in practice, organizations produced an intermediate level between the quality policy statement and the procedures which addressed the requirements of the standard and cross-referenced the associated procedures. This intermediate level together with the quality policy statement was often referred to as the quality manual. However, some manuals merely paraphrased the requirements of the standard, some described the quality system, and others confined the manual to the organization s operational policies. The guidance given in clause 5.3.1 of ISO 9004-1 suggests that the quality system documentation consists of policies and procedures. Clearly these policies are of a somewhat lower level than the corporate quality policy addressed in Part 2 Chapter 1. 

Appropriate documents are those which are needed to carry out work and a list of 11 such documents is provided in the standard as examples. However, it may not be appropriate to place the quality manual at all locations if it does not contain any operational policies or procedures. The work instructions should specify the documents that are required for the task so that it is then clear that any not specified are not essential. It should not be left to the individual to determine which documents are essential and which are not. 

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). 

An organized document filing system must be maintained. This could be a paper file, an electronic document file, or a mixture of both. The equipment inventory system contains key information on the components of each system, their performance criteria and maintenance and calibration status. All documents including installation and performance documentation, as with other documents necessary to demonstrate the quality of the data, include SOPs for the qualification procedures, calibration, maintenance, personnel training, etc. If the manufacturer s operating, service, or maintenance manuals are used or cited in the operating procedures, copies of these manuals should be maintained. To facilitate retrieval, documentation should be stored in a central location and be indexed for easy retrieval. 

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. 

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 responsibilities, authorities, and interrelationships of personnel are fully described (provide your company organization chart) for all quality activities in the quality manual as well as in the applicable procedures described in the quality manual appendix and other procedures applicable to your company s operations. 

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... 

Organizational measures are based on human action for their performance. In the fine chemicals and pharmaceutical industries, reactor-charging operations are often manual operations and the product identification relies on the operator. In this context, quality systems act as support to safety, since they require a high degree of traceability and reliability. Examples of such measures are labeling, double visual checks, response to acoustic or optical alarms, in process control, and so on. The efficiency of theses measures is entirely based on the discipline and instruction of the operators. Therefore, they must be accompanied by programs of instructions, where the adequate procedures are learned in training. 

Quality assurance QA) awareness The CSO s established procedures ensure both quality work and that current regulations are followed. A review of the CSO s standard operating procedure (SOP) manual and discussions with the QA manager will provide this information. Also, results from recently conducted regulatory agency audits should be reviewed. 

The standard operating procedure (SOP) manual contains the procedures validated by the laboratory it is a complete set of instructions for pre-analytical, analytical and post-analytical methodology and also procedures for quality assurance/control, chain-of-custody and security. Each step in the handling of the specimen should be evaluated, optimized where possible and documented in the SOP. Important steps in the analytical process include collection, transport and accessioning of the specimen, sample preparation, isolation and detection of the analytes, production of the report and disposal of the specimen. This chapter focuses on the quality assurance and control issues for analytical method development and validation as well as statistical representation of the data. 

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