ISO 9001 Quality Manual

12 Key excerpts on "ISO 9001 Quality Manual"

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  eBook - ePub

  Process Improvement with CMMI v1.2 and ISO Standards

  • Boris Mutafelija, Harvey Stromberg(Authors)
  • 2008(Publication Date)
  • Auerbach Publications

    (Publisher)

  Chapter 4

  ISO Standards

  Introduction

  In this chapter we will summarize the content and structure of the following ISO standards for quality management, software engineering processes, systems engineering processes, and information technology service delivery:

  ■  ISO 9001:2000,Quality management systems – Requirements (ISO 2000b)

  ■  ISO 90003:2004,Guidelines for the application of ISO 9001:2000 to computer software (ISO 2004a)

  ■  ISO 15288:2008,Systems and software engineering – System life cycle processes (ISO 2008a)

  ■  ISO 12207:2008,Systems and software engineering – Software life cycle processes (ISO 2008b)

  ■  ISO 20000:2005,Information technology – Service management (ISO 2005a)

  ISO, the International Organization for Standardization, was formed in the mid-1940s with the goal of unifying international industrial standards. ISO has published more than 16,000 standards, most of which are narrowly focused on specific technical criteria. In contrast to the bulk of ISO standards, ISO 9000:2000, Quality management systems – Fundamentals and vocabulary (ISO 2000a), probably the best known ISO standard, is a generalized standard for quality management systems. A quality management system defines the activities an organization performs to ensure that its products and services meet the needs and expectations of its customers. As such, ISO 9000 is intended to be applicable to organizations of all sizes and types, no matter what types of products and services those organizations provide.

  ISO 9000, shown in Figure 4.1

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  Iso 9001

  2000 Document Development Compliance Manual: A Complete Guide and CD-ROM

  • Syed Imtiaz Haider(Author)
  • 2001(Publication Date)
  • CRC Press

    (Publisher)

  130 ISO 9001:2000 Document Development Compliance Manual 200.20.2 YOUR COMPANY NAME HERE Quality Quality refers to all properties and characteristics of a service that make it capable of satisfying a client’s expressed or specified needs. Quality Audit A quality audit is a methodical and independent examination in order to determine if quality-related activities and results satisfy predetermined requirements, and if these requirements are implemented efficiently and are capable of achieving the objectives. Quality Assurance Quality assurance refers to all predetermined and systematic actions nec-essary to give appropriate confidence that a product or a service satisfies given quality requirements. Quality Control Quality control is that part of good manufacturing practice which is concerned with sampling, specifications, and testing. Organization, docu-mentation, and release procedures ensure that the necessary and relevant tests are actually carried out, and that materials are not released for use, and that products are not released for sale or supply, until their quality has been judged to be satisfactory. Quality Manual The quality manual is a document describing general measures taken by the company to ensure that quality of its products or services. QUALITY SYSTEMS MANUAL DEFINITIONS Clause — 3.0, ISO 9001:1994 Revision 0 Correspondence clause of ISO 9001:2000 3.0 Written by: Checked by: Approved by: Date Supersedes mm/dd/yyyy Date Issue mm/dd/yyyy Page 4 of 7 200.20.2 ISO 9001:2000 Document Development Compliance Manual 131 YOUR COMPANY NAME HERE Quality Planning A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project, or contract can be referred to as quality plan. Quality Policy The overall quality intentions and direction of an organization formally expressed by top management is called the quality policy.

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  ISO 9001: 2000 In Brief

  • Bruce Sherring-Lucas(Author)
  • 2005(Publication Date)
  • Routledge

    (Publisher)

  With an effective QMS in place, the organisation will achieve increased profitability and market share and the purchaser can expect reduced costs, improved product fitness for role, increased satisfaction and, above all, growth in confidence. But … without an effective QMS, organisations will definitely suffer.

  In the following sections we will look at each element that makes up a Quality Management System and how they combine to clearly define how a business achieves its goals. 2.4 What is a Quality Manual?

  ‘a document specifying the quality management system of an organisation’ (ISO 9000:2000)

  A Quality Manual is a document setting out the general quality policies, procedures and practices of an organisation. Or, put another way, it is an organisation’s written record of what they say and do to produce a quality product or deliver a quality service.

  An organisation’s Quality Manual is the formal record of its QMS. It is: •  a rule book by which their organisation performs its business; •  a source of information from which customers may derive confidence; •  a means of defining the responsibilities and inter-related activities of every member of the organisation; •  a medium for defining the level of quality that an organisation wishes to consistently deliver; •  a vehicle for auditing, reviewing and evaluating the organisation’s QMS.

  Figure 2.18 A Quality Manual is vital for success

  A Quality Manual is the single point of reference required to run all aspects of an organisation to consistent quality levels. It is the heart of a QMS and is essential for anyone considering applying for ISO 9001:2000 certification.

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  Total Quality Management

  Text, Cases, and Readings, Third Edition

  • Joel E. Ross, Susan Perry(Authors)
  • 2017(Publication Date)
  • CRC Press

    (Publisher)

  The series is produced in five parts: ISO 9000, 9001, 9002, 9003, and 9004. ISO 9000 and 9004 are guidelines, whereas ISO 9001, 9002, and 9003 are the categories for which companies may apply for certification.

  ISO 9000, “Quality Management and Quality Assurance Standards—Guidelines for Selection and Use,” is an advisory document. It explains how the overall standard is divided, gives guidelines to use in determining which of the three classifications (9001, 9002, 9003) is applicable to a business, and gives guidelines on how the systems may be implemented.

  The three components of ISO 9000 and the 20 subclauses of the quality requirements for ISO 9001 to 9004 are shown in Figure 12-1 , arranged in three major blocks. The central block of nine clauses is considered the core requirements because these relate to what happens in the operating process itself. Very broadly, this term covers input, what is done with the input (i.e., the process), and the output (i.e., what goes out to the customer). The sections in the left and right blocks have a supporting rather than a core role but are just as essential as those in the central operating process block. To meet the standard, a quality system must be shown to fulfill the requirements under Quality System Control and support activities as fully as those included under Operating Process.

  The requirements of the three components of ISO 9000 (Figure 12-1 )20 are outlined below.

  Operating Process The requirements included under Operating Process are described briefly here. Any reader who intends to design a quality system to meet ISO 9001, however, should obtain and read the actual standard. Contract Review

  One of the fundamental aspects of quality is meeting the customer’s requirements. Clearly, to meet these requirements a supplier must know what they are. Contract review is concerned with adequately defining and documenting these requirements and establishing that the resources needed to meet them are available. What should be covered in such a record of requirements and how it should be documented will vary from business to business.

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  Standards And Quality

  • Anwar El-Tawil(Author)
  • 2014(Publication Date)
  • WSPC

    (Publisher)

  A fourth situation also exists, where an organization or a corporation decides to use the principles of ISO 9000 standards to improve the quality of its products and services, but is not interested in certification. In this case, the organization should implement the approaches and techniques provided in the ISO 9004 standard, which gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly in managing for the long-term success of an organization. ISO 9004 is recommended as a guide for organizations whose top management wishes to extend the benefits of ISO 9001 in pursuit of systematic and continual improvement of the organization’s overall performance. However, ISO 9004 is not intended for certification or contractual purposes.

  It is worthwhile reminding the reader that, ISO 9001 prescribes Quality System Requirements, which are distinct from the Technical Requirements of Product and Technical Requirements of Processes. The three sets of requirements are complimentary, but neither can replace the others.

  7.5  IMPLEMENTATION OF ISO 9000 IN THE WORLD

  Since the first ISO 9000 standards were published in 1987, a spectacular increase in the number of organizations implementing them and obtaining certification was witnessed. By the end of 2013, over 1.1 million organizations have been certified to ISO 9001 in 170 countries (Figure 11

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  The Quality Audit for ISO 9001:2000

  A Practical Guide

  • David Wealleans(Author)
  • 2017(Publication Date)
  • Gower

    (Publisher)

  For management auditing, it is probably best to avoid the discussion as to whether we are auditing functions, but ensure that we are looking at areas which are not too narrow, which are coherent and which have clearly defined interfaces. This is not to say that process management has no use in the field of quality management. There are many process management initiatives which have brought great benefit to their respective organizations. Just do not become too worried about whether it is a process or not when conducting quality audits.

  QUALITY MANAGEMENT SYSTEMS

  Just as we have said that quality management is about coordinating all the activities that go towards achieving customer satisfaction, so a quality management system is a defined set of rules and disciplines which cover how we are going to manage quality. Since the word ‘system’ is used, this implies that it has been consciously designed and forms an integrated whole. Thus while organizations who have gradually grown up with a range of individual disciplines and standard approaches can achieve ISO 9001 certification, this would still not be classed as a quality management system by purists.

  In practice, a quality management system is usually what organizations create when they are seeking ISO 9001 certification. The typical process is to pool together what we already have and fill in any gaps by documenting a few more standard disciplines such as an audit programme. A quality manual is then produced, ostensibly to pull everything together and provide a central focus, but normally it is a boring document to read and attended to by nobody other than the certification assessor and the occasional quality manager of large customers (who must have copious quantities of time to spare to want to read these documents).

  From an auditor’s point of view, this ‘getting by’ approach to defining the system for certification purposes is not necessarily a problem. This is because what is thought of as the quality management system in an organization does not necessarily reflect the real and complete system. For a start, managers often think of the quality system as comprising only elements which have an impact on their ISO 9000 certification. This is clearly not true; there are other factors which impact upon the customer which tend to lie outside the scope of the standard (image, speed of response, advertising, cost, payment terms and procedures and so on).

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  Iso 9001

  2000 for Small Business: Implementing Process-Approach Quality Management

  • Arpad Gaal(Author)
  • 2001(Publication Date)
  • CRC Press

    (Publisher)

  provide and maintain adequate and suitable work environment within the in-frastructure, ensuring equipment and service to meet product conformity; 3. manage the work environment in order to maintain product conformity, customer satisfaction, and continuous improvement. 6.4 6.3 6.2.2 6.1 6.2.1 8/23 5.5.2 ISO 9001:2000 for SMALL BUSINESSES 275 Issued Rev Date Pg No MINFOR INCORPORATED 1/1/ 99 4/30/2000 Signed Rev No QUALITY SYSTEM MANUAL AG 2 4.1.2.3 Management representative The management representative shall have the authority, regardless of other re-sponsibilities, to establish, implement, and maintain the processes of the quality management system as stated above under “Responsibility and Authority.” 4.1.2.4 SAE AS9000 AS9000 requirements have been incorporated throughout the product’s pro-cessing cycle by the application of Quality Operating Procedures. 4.1.3 Management review Management review shall be planned in order to evaluate the suitability, adequacy, and effectiveness of the quality management system. The review input shall be based on assessed results of internal audits carried out to the specified quality ob-jective procedures. The measured audit results, when reviewed and evaluated by upper management, will demonstrate whether any corrective action is required to improve the quality management system to achieve organizational objectives. Management reviews shall be conducted and documented as stated in QOP 011 (pg 235 or 428). 4.2 QUALITY SYSTEM 4.2.1 General This Quality System Manual outlines the requirements of ISO 9001/2000 as to how the product quality objectives are identified, documented, and maintained in line with organizational commitments, including permissible exclusions. The Manual references the QOPs, which outline the specific process instructions relating to specified tasks, sequences and interactions. In certain cases, the Manual itself states the applicable process instructions.

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  GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)

  Regulations, Standards, and Guidelines

  • Leonard Steinborn(Author)
  • 2004(Publication Date)
  • CRC Press

    (Publisher)

  282 GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers It identifies the issues which need to be addressed and is independent of the technology, life cycle models, development processes, sequence of activities, or organization structure used by a supplier. Where the scope of an organization’s activities includes areas other than computer software development, the relationship between the computer software elements of that organization’s quality system and the remaining aspects should be clearly documented within the quality system as a whole. This part of ISO 9000 provides guidelines for the application of ISO 9001:1994. Where text has been quoted from ISO 9001:1994, that text is enclosed in a box, for ease of identification. Throughout this part of ISO 9000, “shall” is used to express a provision that is binding between two or more parties; “will” to express a declaration of purpose, or intent, of one party; “should” to express a recommendation among possibilities; and “may” to indicate a course of action permissible within the limits of this parts of ISO 9000. QUALITY MANAGEMENT AND QUALITY ASSURANCE STANDARDS — PART 3: GUIDELINES FOR THE APPLICATION OF ISO 9001:1994 TO THE DEVELOPMENT, SUPPLY, INSTALLATION AND MAINTENANCE OF COMPUTER SOFTWARE 1 S COPE This part of ISO 9000 sets out guidelines to facilitate the application of ISO 9001:1994 for organi-zations developing, supplying, installing and maintaining computer software. It does not add to, or otherwise change, the requirements of ISO 9001. This part of ISO 9000 is not intended to be used as assessment criteria in quality system registration/certification. 2 N ORMATIVE REFERENCES The following standards contain provisions which, through reference in this text, constitute provi-sions of this part of ISO 9000. At the time of publication, the editions indicated were valid.

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  Exporting Automotive Components

  An Answer Book for Small and Medium-sized Enterprises

  • International Trade Centre(Author)
  • 2004(Publication Date)
  • United Nations Publications

    (Publisher)

  For a company the development, manufacture and delivery of high-quality products along with first-class service have to be declared goals for continuous success. The quality management system (QMS) should be documented in a number of quality manuals and process statements. Production facilities are certified according to ISO 9000. The ISO 9000 standards are based on eight quality principles, which provide quality management systems fundamentals, vocabulary and guidelines for performance improvements. • Customer focus. Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements, and should strive to exceed customer expectations. • Leadership. Leaders establish unity of purpose and the direction of the organization. They should create and maintain an internal environment in which people can become fully involved in achieving the organization’s objectives. • Involvement of people. People at all levels are the essence of an organization. Their full involvement enables their abilities to be used for the organization’s benefit. • Process approach. A desired result is achieved more efficiently when activities and related resources are managed as a process. • System approach to management. Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives. • Continual improvement. Continual improvement of the organization’s overall performance should be a permanent objective of the organization. • Factual approach to decision making. Effective decisions are based on the analysis of data and information. • Mutually beneficial supplier relationships. An organization and its suppliers are interdependent. A mutually beneficial relationship enhances the ability of both to create value.

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  Quality Management in Construction Projects

  • Abdul Razzak Rumane(Author)
  • 2017(Publication Date)
  • CRC Press

    (Publisher)

  (Source : Feigenbaum, A.V. (1991), Total Quality Control, Reprinted with permission of The McGraw-Hill Education.) Quality engineering becomes the field, or apex, of the triangle. The technical work area of the discipline—quality systems implementation—is shown in the first tier. The second tier then shows the principal techniques of quality engineering technology. Quality engineering relates the particular requirements of the plant and companies to the available quality technology—including both hardware equipment and planning and control actions—to put in place much of the ongoing operating detail of the quality systems framework for the firm. Quality engineering technology thus provides the technical areas to deal with such questions as the following: What are the specific details of the control activities to take place during the development and production and service cycles? Will these quality activities best be accomplished through the use of quality information equipment or by the use of people guided by procedures? What information and material inputs will be needed? What type of information data is required? How should it be analyzed, and what sort of feedback should be used? Depending upon the differences in the product-quality levels encountered, what criteria are there for alternative courses of corrective action? Feigenbaum (1991) has further elaborated the entire range of techniques used in quality engineering technology by grouping them under three major headings: Formulating of quality policy. Included here are techniques for identifying the quality objectives and quality policy of a particular company as a foundation for quality analysis and systems implementation. Product-quality analysis. Techniques for analyzing include those for isolating and identifying the principal actors that relate to the quality of the product in its served market

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  Quality Management in Plastics Processing

  • Robin Kent(Author)
  • 2016(Publication Date)
  • William Andrew

    (Publisher)

  Tip - Existing systems can be adapted to ISO 9001. The best method is to document the existing processes and systems. These can then be considered against the ISO 9001 requirements and new elements introduced only where the existing processes do not meet the requirements. This is more work for the consultant but less disruptive for the company.

  ISO 9001 requires documented information but does not specify how this should be set out, written or stored. This can be on paper (text or flow charts) or on computers (text or flow charts). This is an operational decision for the company.

  Maintained Documents (5) ■  Scope of the QMS (4.3). ■  Operation of processes (4.4.2). ■  Quality policy (5.2.2). ■  Quality objectives (6.2.1). ■  Control of production and service provision (8.5.1).

  Retained Records (23) ■  Operation of processes (4.4.2). ■  Monitoring and measurement Resources (7.1.5.1). ■  Measurement traceability (7.1.5.2). ■  Competence (7.2). ■  Operational planning and control (8.1). ■  Requirements review (8.2.3). ■  Design and development: •  Planning (8.3.2). •  Inputs (8.3.3). •  Controls (8.3.4). •  Outputs (8.3.5). •  Changes (8.3.6). ■  Externally provided products and services (8.4.1). ■  Control of production and service provision (8.5.1). ■  Traceability (8.5.2). ■  Property belonging to customers/external providers (8.5.3). ■  Control of changes (8.5.6). ■  Release of products and services (8.6). ■  Control of nonconforming outputs (8.7.2). ■  Monitoring, measurement, analysis and evaluation 9.1.1). ■  Internal audit (9.2.2). ■  Management review (9.3.3). ■  Nonconformity and corrective action (10.2.2).

  The documented information required by ISO 9001 The documented information required for ISO 9001 should be either maintained, e.g. process and procedure information, or retained, e.g. records of processes and procedure operation.

  Maintained documents

  Several sets of documented information are required to be ‘maintained’ by ISO 9001 and these are listed on the left.

  This documented information can be maintained via a ‘company quality brochure’ (see Section 4.8

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  ISO 9001:2015 for Small Businesses

  • Ray Tricker(Author)
  • 2016(Publication Date)
  • Routledge

    (Publisher)

  The organisation needs to identify the processes required to realise products and services that satisfy the requirements of customers and a plan has to be defined to manage these processes, especially their input and output stages. The documentation that describes how the QMS processes are applied for a specific product, service, project or contract is usually contained in a separate Quality Plan.

  In ISO 9001:2015 the organisation is recommended to identify and plan all of the production, installation and servicing processes that directly affect quality. Procedures should be available to ensure that these processes are completed under controlled conditions especially with respect to special processes such as those for defining work to be carried out where no previous procedure exists.

  Process planning

  Special equipment or environmental conditions; compliance with relevant standards (national, European and international); criteria for workmanship (e.g. written standards, representative samples or illustrations) need to be planned. Procedures have to be available to ensure that there is an appropriate system for the maintenance of equipment to ensure a continuing process capability. Records of all these procedures and processes must be maintained, controlled and fully documented.

  Indeed, all productive work should be planned and undertaken in accordance with the organisation’s procedures and any specific documents that have been detailed for that particular contract (e.g. contract specifications).

  8.2 Requirements for products and services

  8.2.1

  Customer communication

  Lines of communication between the customer and the organisation with regard to product information, enquiries and contract amendments, feedback including complaints, etc. must be clearly defined.

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