ISO 9000:2005

QUALITY MANAGEMENT SYSTEMS

- Fundamentals and vocabulary
19 pages
(32 pages with applications)

The family of International Standards for Quality Management

Series ISO 9000 ISO 9000:2005 Quality management systems. Fundamentals and vocabulary ISO 9001:2008 Quality management systems. Requirements ISO 9004:2009 Managing for the sustained success of an organization.
A quality management approach

ISO 19011:2011 Guidelines for auditing management systems Other standards

ISO 10001:2007 Quality management. Customer satisfaction.
Guidelines for codes of conduct for organizations

ISO 10002:2004 Quality management. Customer satisfaction.

Guidelines for complaints handling in organizations

ISO 10003:2007 Quality management. Customer satisfaction.

Guidelines for dispute resolution external to organizations ISO 10005:2005 Quality management systems. Guidelines for quality plans ISO 10006:2003 Quality management systems. Guidelines for quality management in projects ISO 10007:2003 Quality management systems. Guidelines for configuration management

ISO 10012:2003 Measurement management systems.

Requirements for measurement processes and measuring equipment

ISO/TR 10013:2001 Guidelines for quality management system documentation ISO 10015:1999 Quality management. Guidelines for training ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000

ISO 9000 Principle stages in the development of series ISO 9000 and allied standards for Quality Management Systems

1987: ISO 9000 Quality Management Systems, First series (ISO) 1994: ISO 9000 Quality Management Systems, Second series
ISO 9000, ISO 9001, ISO 9002, ISO 9003

1996: ISO 14001 Environmental management systems.

Requirements with guidance for use

2000: ISO 9000 Quality Management Systems, Third series (ISO)

ISO 9000, ISO 9001

2005: ISO/IEC 27001 Information security management systems requirements 2005: ISO 22000 Food Safety Management System.
Requirements for any organization in the food chain

2008: ISO 9001:2008 Quality Management Systems, Fourth series (ISO) 2009: ISO 9004:2009 Managing for the sustained success of an organization.
A quality management approach. Fourth series (ISO) 3

ISO 9000:2005 8 QUALITY MANAGEMENT PRINCIPLES

The successful direction of organization requires systematic and transparent management. A profitable management system should be addressed to the needs of all interested parties and should assure continually improve performance.

1. CUSTOMER FOCUS
Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

2. LEADERSHIP
Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.

3. INVOLVEMENT OF PEOPLE
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit.
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ISO 9000:2005 8 QUALITY MANAGEMENT PRINCIPLES

4. PROCESS APPROACH A desired result is achieved more efficiently when activities and related resources are managed as a process.

5. 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.

6. CONTINUAL IMPROVEMENT
Continual improvement of the organization's overall performance should be a permanent objective of the organization.

7. FACTUAL APPROACH TO DECISION MAKING

Effective decisions are based on the analysis of data and information.

8. MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS

An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
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ISO 9000:2005
MODEL of a PROCESS-BASED QUALITY MANAGEMENT SYSTEM (QMS)

ISO 9000:2005 and ISO 9001:2008

PROCESS APPROACH (4th principle) represents the application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome. The MODEL of QUALITY MANAGEMENT SYSTEM (QMS) demonstrates

I. Two general parties of QMS

ORGANIZATION CUSTOMERS, what are in >> input of QMS by requirements to the product; >> output of QMS by monitoring of their satisfaction. So, the CUSTOMER in the FOCUS of QMS (1st principle).

ISO 9000:2005 and ISO 9001:2008

II. Implementation of methodology Plan-Do-Check-Act (PDCA) by
PLANning the objectives, processes and resources for reaching requirements of customers and for realization of the policy of organization. This demonstrates the LEADERSHIP of top management (2nd principle) and management responsibility. DOing and implying the processes by >> RESOURSE MANAGMENT >> PRODUCT REALIZATION CHECKing by >> MONITORING, MEASUREMENT and ANALYSIS of processes and product. This is the realization of 7th principle FACTUAL APPROACH TO DECISION MAKING. ACTing by CONTINUAL IMPROVEMENT of QMS and processes (6th principle).

ISO 9000:2005 3.1. Basic TERMS relating to QUALITY

QUALITY - degree to which a set of inherent/innate characteristics fulfils requirements. This term can be used with adjectives such as poor, good or excellent. REQUIREMENT - need or expectation that is stated, generally implied or obligatory.

3.2 Basic TERMS relating to MANAGEMENT

MANAGEMENT - coordinated activities to direct and control an organization. QUALITY MANAGEMENT - coordinated activities to direct and control an organization with regard to quality.

QUALITY PLANNING - part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfil the quality objectives.
QUALITY CONTROL - part of quality management focused on fulfilling quality requirements.
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ISO 9000:2005

3.2 Basic TERMS relating to MANAGEMENT

SYSTEM - set of interrelated or interacting elements.

MANAGEMENT SYSTEM - system to establish policy and objectives and to achieve those objectives.
QUALITY MANAGEMENT SYSTEM (QMS) - management system to direct and control an organization with regard to quality.

QUALITY POLICY - overall intentions and direction of an organization related to quality as formally expressed by top management. QUALITY OBJECTIVE (goal) - something sought, or aimed for, related to quality. These objectives are generally based on the organization's quality policy. They are generally specified for relevant functions and levels in the organization. They should be quantitative for basic levels.

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ISO 9000:2005 3.3 Basic TERMS relating to ORGANIZATION

ORGANIZATION - group of people and facilities with an arrangement of responsibilities, authorities and relationships.
public - institution, charity, municipality, university private - sole trader, company, firm, enterprise, corporation

ORGANIZATIONAL STRUCTURE - arrangement of responsibilities, authorities and relationships between people.

INFRASTRUCTURE - organization system of facilities, equipment and services needed for the operation of an organization.
WORK ENVIRONMENT - set of conditions under which work is performed. environmental factors: temperature, ergonomics and atmospheric composition
social, psychological factors

CUSTOMER - organization or person that RECEIVES a product. Consumer, client, end-user, retailer, beneficiary and purchaser SUPPLIER - organization or person that PROVIDES a product. Producer, distributor, retailer of a product, or provider of a service or information.
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ISO 9000:2005

3.4 Basic TERMS relating to PROCESS AND PRODUCT

PROCESS a set of interrelated or interacting activities which transforms inputs into outputs.
Processes in an organization are generally planned and carried out under controlled conditions to add value. Each input to a process can be an output of other process.

PRODUCT - result of a process.

product categories: hardware (e.g. machine, engine mechanical part); software (e.g. computer program); services (e.g. transport); processed materials (e.g. lubricant).

PROJECT - unique process, consisting of a set of coordinated and controlled activities with start and finish dates, undertaken to achieve an objective conforming to specific requirements, including the constraints of time, cost and resources.

PROCEDURE - specified way to carry out an activity or a process.

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ISO 9000:2005

3.8 Basic TERMS relating to EXAMINATION

OBJECTIVE EVIDENCE - data supporting the existence or verity of something. It can be obtained through observation, measurement, test or other means. INSPECTION - conformity evaluation by observation and judgement accompanied as appropriate by measurement, testing or gauging. TEST - determination of one or more characteristics according to a procedure. VERIFICATION - confirmation, through the provision of objective evidence, that SPECIFIED REQUIREMENTS have been fulfilled.

VALIDATION - confirmation, through the provision of objective evidence, that the REQUIREMENTS FOR A SPECIFIC INTENDED USE OR APPLICATION have been fulfilled.
REVIEW - activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives. Examples: Management review, review of customer requirements and nonconformity review.
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ISO 9000:2005

3.5 Basic TERMS relating to CHARACTERISTICS

CHARACTERISTIC - distinguishing feature.
A characteristic can be inherent or assigned; qualitative or quantitative; physical (e.g. mechanical, electrical, chemical or biological characteristics), sensory, behavioral, temporal (e.g. reliability, availability), ergonomic and others.

QUALITY CHARACTERISTIC - inherent characteristic of a product, process or system related to a requirement. DEPENDABILITY (reliability) - collective term used to describe the availability performance and its influencing factors (reliability performance, maintainability performance and maintenance support performance)

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ISO 9000:2005

3.6 Basic TERMS relating to CONFORMITY

CONFORMITY - fulfilment of a requirement. DEFECT - non-fulfilment of a requirement related to an intended or specified use. PREVENTIVE ACTION - action to eliminate the cause of a POTENTIAL nonconformity or other undesirable POTENTIAL situation. CORRECTIVE ACTION - action to eliminate the cause of a DETECTED nonconformity or other undesirable situation.

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ISO 9000:2005 3.7 Basic TERMS relating to DOCUMENTATION

INFORMATION meaningful/significant data.

DOCUMENT - information and its supporting medium. The medium can be paper, magnetic, electronic or optical disc, photograph etc
DOCUMENTATION - A set of documents such as specifications and records. SPECIFICATION - document stating requirements.

QUALITY MANUAL - document specifying the quality management system of an organization.

QUALITY PLAN - document specifying which PROCEDURES and associated RESOURCES shall be applied by WHOM and WHEN to a specific project, product, process or contract. A quality plan often makes reference to parts of the quality manual or to procedure documents. It is generally one of the results of quality planning. RECORD - document stating results achieved or providing evidence of activities performed.
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ISO 9000:2005 3.9 Basic TERMS relating to AUDIT

AUDIT - systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
INTERNAL AUDITS (first-party) are conducted by ORGANIZATION ITSELF, or on behalf of organization the for management review and other internal purposes, and may form the basis for an organizations declaration of conformity.

EXTERNAL AUDITS (second-party) are conducted by parties having an interest in the organization, such as CUSTOMERS, or by other persons on their behalf.
EXTERNAL AUDITS (third-party) are conducted by EXTERNAL, INDEPENDENT AUDITING ORGANIZATIONS, such as those providing certification/registration of conformity to ISO 9001 or ISO 14001.

AUDITOR - person with the demonstrated personal attributes and competence to conduct an audit.
TECHNICAL EXPERT a person who provides specific knowledge or expertise to the audit team. AUDIT TEAM - one or more auditors conducting an audit, supported if needed by technical experts.

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ISO 9000:2005 3.9 Basic TERMS relating to AUDIT

AUDIT PROGRAMME - set of one or more audits planned for a specific time frame and directed towards a specific purpose. An audit programme includes all activities necessary for planning, organizing and conducting the audits. AUDIT PLAN - description of the ACTIVITIES AND ARRANGEMENTS for an audit. AUDIT SCOPE - EXTENT AND BOUNDARIES of an audit. AUDIT CRITERIA - set of POLICIES, PROCEDURES OR REQUIREMENTS. AUDIT EVIDENCE - RECORDS, STATEMENTS OF FACT or other information which are relevant to the audit criteria and verifiable.

AUDIT FINDINGS - RESULTS OF THE EVALUATION of the collected audit evidence against audit criteria.
AUDIT CONCLUSION - OUTCOME of an audit provided by the audit team after consideration of the audit objectives and all audit findings.
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ISO 9000:2005

3.10 Basic TERMS relating to quality management for MEASUREMENT PROCESSES

MEASURING EQUIPMENT - measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process.
MEASUREMENT PROCESS - set of operations to determine the value of a quantity. MEASUREMENT MANAGEMENT SYSTEM - set of interrelated and interacting elements necessary to achieve metrological confirmation and continual control of measurement processes. METROLOGICAL CONFIRMATION - set of operations required to ensure that measuring equipment conforms to the requirements for its intended use.
It generally includes calibration or verification, any necessary adjustment or repair, comparison with the metrological requirements, as well as any required sealing and labelling.
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