Quality systems procedures manual

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

The standard requires the supplier to prepare a quality manual covering the requirements of the standard and also requires the quality manual to include or make reference to the quality system procedures and outline the structure of the documentation used in the system. 

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. 

The audit plan should be consistent with written quality auditing procedures included in the quality manual or other quality system documentation. The plan should include or refer to the objective criteria to be used to evaluate conformance to requirements. The plan should include or refer to other documents that will be used during the audit, including previous audit reports. If the audit is to include the review of batch or production records, such review should be conducted in accordance with a specified sampling plan or other appropriate statistical rationale as specified in a firm s quality system procedures. 

If we look at ISO 10013, which is referenced for guidance in preparing a quality manual, we will see that it shows that the quality manual is a top-level document containing the stated quality policy, the quality objectives, and a description of the quality system (see Figure 2.2). The definition in ISO 8402 supports this concept and the requirement aligns with this definition. However, ISO 8402, ISO 10013, and the above requirement from ISO 9001 provide a choice as to whether the manual contains or refers to procedures. 

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

Create a system manual that describes your quality system and how it works and references all the procedures, standards, etc. that implement your quality policies. 

In the bibliography to ISO/TS 16949 there is only one customer reference manual mentioned the QS-9000 Measurement Systems Analysis Manual. This provides excellent guidelines for selecting procedures to assess the quality of a measurement system. It includes an introduction to measurement systems, explains the factors that cause variation in a measurement system, has guidance for preparing for a measurement system study, and includes step-by-step procedures for determining the degree of each type of variation present in a measurement system. 

The impact of this requirement depends upon what constitutes the specified requirements. The standard does not require you to demonstrate conformance with every requirement of ISO 9001. However, if your customer has invoked ISO 9001 in the contract, this clause requires that you maintain sufficient records to demonstrate compliance. As stated elsewhere in this book, there is no definition clarifying what specified requirements are. If specified requirements are a//the requirements that you have specified in your quality system, your plans, procedures, specifications, etc., this requirement may well be viewed as the most onerous in the standard. A pragmatic approach to take is to declare in your quality manual that the specified requirements are specified customer requirements . 

Each construction organization shall be responsible for developing a QSP. The Quality System shall include a quality manual, quality policy and objective, structure of organization, documented procedures, work instructions, a quality plan, and document and data control. 

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 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 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 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. 

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

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 system manual provides descriptions of management efforts and initiatives to ensure customer requirements are met with continuous improvement in the hnal product inspection and testing activities. The quality system manual and procedures ... 

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. 

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... 

Sets of instructions that detail the procedures designed to reduce errors occurring during analytical procedures and ensure accurate quantitations are found in the quality assurance (QA) and quality control (QC) manuals. Quality assurance procedures are used by the laboratory to detect and correct problems in analytical processes. As newer methods and instrumentation are added to the laboratory, older procedures must be modified or changed completely. Quality control procedures are used to maintain a measurement system (i.e., a gas chromatograph) in a statistically satisfactory state to ensure the production of accurate and reliable data. 

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. 

The general process of sample transformation into data is the same at every environmental laboratory. The differences are primarily in the manner various tasks are performed by laboratory personnel. To assure the quality of produced data, every laboratory must develop, implement, and maintain a quality system that is documented in the Laboratory QA Manual. The implementation of specific tasks related to sample management, analysis, and quality system, which may be different at different laboratories, is addressed through a set of laboratory s own SOPs. A full service laboratory has dozens of SOPs, describing every laboratory procedure and task from sample receiving to invoicing. The SOPs are updated as necessary and undergo internal review and approval. 

T.A. Ratliff, The Laboratory Quality Assurance System A Manual of Quality Procedures and Forms, Van Nostrand Reinhold, New York, 1993. 

A quality manual has to document those procedures and policies that are carried out in the laboratory that can affect an analysis. In addition details of the organisational relationships, responsibilities and authorities of all of the more senior staff and the internal auditors are described. The manual will probably include descriptions of the resources of the laboratory, examples of records used, calibration and audit schedules, and routines such as the periodic review of the quality system. 

The quality system should be documented in a QA program manual that outlines all the quality policies and procedures for the laboratory. This manual should be considered the handbook for all employees. New employees should become familiar with the document so that they can use it to answer questions that may arise in their work. New or retrained employees should sign a form documenting that they have read and understood the manual. This form should be kept in the personnel files. 

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