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RH ANDERSEN's

ISO/QMS GLOSSARY

For your convenience we have offered this brief glossary of ISO and quality-related terminology. While not comprehensive, it should serve to qualify commonly used terms and acronyms.

 
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A2LA - See below.

 

Adequacy - In QS-9000, a term used to indicate that the intent of the standard has been met appropriate to the scope of the operation.

 

Aerospace standards - See AS9100 

 

American Association for Laboratory Accreditation (A2LA) - a nonprofit, non-governmental, public service, membership society. The mission of A2LA is to provide comprehensive services inn laboratory accreditation and training. The organization also certified accrediting bodies.  

 

American Society for Quality - Measurement Quality Division (ASQ-MQD)

 

Analysis of data - Data analysis is necessary to demonstrate the effectiveness of your quality management system. In ANSI/ISO/ASQ Q90001-2000, analysis of data is one of the most important elements (8.4).

 

 

ANSI - American National Standards Institute (ANSI.Org)

 

 

AS9100 - SAE AS9100 is the standard for aerospace manufacturers. It includes ISO 9000 plus additional requirements by the industry.

 

 

ASQ - American Society for Quality (ASQ.Org).

 

 

Audit - A systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which requirements are being fulfilled. 

 

Auditee - Organization being audited.

 

Auditor - Person(s) performing an audit.

 

Automotive Standards - Standards for quality used by automotive industry    such as QS-9000 and ISO TS/16949. See also IATF. 

 

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Baldridge Award (Malcolm Baldridge National Quality Award ) - Annual award given to U.S. company that excels in quality management/achievement (also known as MBNA)

 

Benchmark Data - The results of an investigation to determine how competitors and/or best-in-class companies achieve their level of performance.

 

BSI - British Standards Institution.

 

 

 

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Capability- The ability of an organization, system or process to realize/produce a product that will fulfill its requirements.

 

 

Cause and Effect Diagram - A graphical statistical technique used to tie multiple possible causes to a significant effect that is generally causing a problem.

 

 

Characteristic - A distinguishing feature of an item.

 

 

CIM - Computer Integrated Manufacturing.

 

 

Competence - A demonstrated ability; evidence of applied knowledge or skill.

 

 

Compliance - An affirmative indication or judgment that the supplier of a product or service has met the requirements of the relevant specifications, contract, or regulation; also the state of meeting the requirements.

 

Component -   Any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of a finished product.

 

 

Conform - To meet (or conform to) stated requirements.

 

 

Conformance - The ability of a product or service to meet (or conform to) stated requirements.

 

 

Conformity - The ability of a product or service to meet (or conform to) stated requirements. In 9000-2000 the term conformity has replaced the term conformance, although both are interchangeable regarding definition and acceptable as description.

 

 

Continuous Improvement - Action taken to find ways in improve processes, decrease variation, decrease costs, and improve effectiveness of the organization. A requirement under 9000-2000.

 

 

Contract review - A contract review is a set of activities carried out to ensure that all customer orders, purchase orders or contracts specify all the quality requirements and to ensure that the organization can meet these requirements before committing to do so.  

 

Control Plan - Written description of the system for controlling parts and processes. Sometimes called a quality plan.

 

 

Correction - Action taken to eliminate a detected nonconformity

 

 

Corrective action - Action taken to remove the cause of a detected nonconformity or other undesirable situation. Action(s) designed to identify and eliminate root causes of nonconformities (nonconformances). See ISO 9001-2000 clause 8.5.2.

 

 

Customers - A customer is anyone who receives products or services from the organization.

 

 

Customer Satisfaction - Customer's perception of the degree to which the customer's requirements have been fulfilled.

 

 

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Data - facts, especially numerical facts, collected together for reference or information.

 

 

Data analysis - Analysis of data is necessary to demonstrate the effectiveness of your quality management system. In ANSI/ISO/ASQ Q90001-2000, analysis of data is one of the most important elements. See ISO 9001-2000 clause 8.4

 

 

Defect- Nonfullfillment of a requirement related to intended or specified use.

 

 

Deficiency - (the amount of a) shortfall - something lacking.

 

 

Descriptive statistics - Statistical techniques used to summarize numerical or quantitative data. Pie charts, bar charts, histograms and scatter plots are some of the simple graphical methods used to display descriptive statistics.

 

 

Design of experiments - Designed experiments are used to carry out tests or investigations in a planned manner. Statistical techniques are then used to evaluate the data so that conclusions may be reached with certain levels of confidence. Design of experiments finds its greatest use in investigating complex system where outcomes may be influenced by a larger number of factors.

 

 

Design review - A design review is a set of activities whose purpose is to evaluate how well a potential product (a design) meets all quality requirements. During the course of this review, problems must be identified and solutions must be developed.

 

 

Design validation - Design validation is a process whose purpose is to examine products and to use objective evidence to confirm that these products meet user needs.

 

 

Design verification - Design verification is a process whose purpose is to examine design outputs and to use objective evidence to confirm that outputs meet input requirements.

 

 

Disposition - action of getting rid of or making over, to arrange, a putting in order.

 

 

Document - Information and its supporting medium. Document control in ISO 9001-2000 is described in clause 4.2.3.

 

 

Documentation - Objective evidence committed to writing. Also, supporting medium for compliance such as Manual, SOPs, Work Instructions, Quality Records, NCMRs, CARs, etc.

 

 

Dominant Element - that element that is most influential or prominent.

 

 

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Element(s) - Elements include responsibilities, authorities, relationships, functions, policies, procedures, practices, processes, and resources. Quality system elements combine to form a quality system.

 

 

Entity - An entity could be a product, process, person, activity, machine, service, system, department, company, institution, or organization.

 

 

Evaluate -To determine the amount or value of something. To appraise or assess.

 

 

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Fishbone Diagram - A problem-solving tool (statistical technique) that uses a graphic description of the various process elements to analyze potential sources of variation, or problems. Sometimes called Cause and Effect Diagrams.

 

 

FMEA (Failure Mode Effects Analysis) - An analytical technique used to assure that potential failure modes and associated causes have been considered and addressed.

 

 

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Grade - A category or rank given to different quality requirements for products, processes or systems having the same functional use.

 

 

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HACCP - Hazard Assessment and Critical Control Point application for food safety. See also ISO 22000

 

Histogram - A simple graphical statistical technique used to measure central tendencies and dispersion.

 

 

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IATF - The IATF is an ad hoc group of OEM's and automotive trade associations with a common goal is to improve the quality of automotive products worldwide. IATF members include the Big 3 (Ford, Chrysler and GM), along with Fiat, Citroen, VW, Renault and national automotive trade associations from the US, Germany, UK, Italy and France. Additionally, the Japanese vehicle association, JAMA, has been involved with the IATF's efforts to develop TS 16949.

 

Identify - To establish who or what a given person or thing is; to recognize.

 

IEC -  International Electro-technical Commission.

IEEE  - Institute of Electrical and Electronic Engineers.

  

Improvement - The action or process of making or becoming greater; an increase, growth, development or intensification. Also see continuous improvement and quality improvement.

 

 

Infrastructure - System of facilities, equipment and services needed for the operation of an organization.

 

Inspection - Measuring, monitoring and testing a product; Observing and evaluating for conformity.

 

Interested party - A person or group having an interest in the performance or success of an organization.

 

Internal quality audit - Internal audits are audits carried out by the organization's personnel. Internal quality audits examine the elements of a quality system in order to evaluate how well these elements comply with quality system requirements.

 

International Organization for Standardization - Developers of the ISO quality management system standards (ISO.ORG)

 

Ishikawa Diagram - A problem-solving tool (statistical technique) that uses a graphic description of the various process elements to analyze potential sources of variation, or problems. [Sometimes called Cause and Effect Diagram or Fishbone Diagram]

  

 

ISO - A group of global standards maintained by the International Organization for Standardization. ISO is from the Greek Isos, meaning equal. The purpose of ISO originally was to "equalize" the standard for quality between the various countries of Europe. 

 

 

ISO 8402 - ISO standard that standardizes quality management and quality assurance vocabulary.

 

 

ISO 9000 - A family of ISO standards that apply to quality management and quality assurance . Specifically, quality systems.Superceded by ISO/TS 16949

 

ISO Q9000 - Q9000 is the American version of ISO 9000. The content is the same, the grammar has been Americanized to enhance understanding. Superceded by ISO/TS 16949.  

 

ISO 9001 - Quality Management System. The worlds most popular QMS Standard applies to both product and service oriented companies.

 

ISO 9004 - The companion document to the ISO 9001 Standard. Provides Guidance to understanding and implementing (and self-auditing) the Standard.

 

ISO 10011 - A family of ISO standards that apply to quality audits and auditors.

 

ISO 10303 - Standard for the Exchange of Product data (See STEP, below),

 

ISO 14000 - Series of standards for Environmental Management 

 

ISO 14001 - Primary standard for Environmental Management

 

ISO 15161:2001 - Guidelines on the application of ISO 9001:2000 for the food and drink industry (replaced by: ISO 22001).

ISO 22000 is a "hybrid" of the Quality Management Standard ISO 9001 and HACCP. The ISO 22000 series of Standards applies ISO 9001 and HACCP methodologies to specific food safety applications.  

ISO 22000 - Food safety management systems - Requirements for any organization in the food chain.

ISO 22001 - Guidelines on the application of ISO 9001:2000 for the food and drink industry (replaces: ISO 15161:2001).

ISO TS 22003 - Food safety management systems for auditing bodies (providing audit and certification of food safety management systems).

ISO TS 22004 - Food safety management systems - Guidance on the application of ISO 22000:2005.

ISO 22005 - Traceability in the feed and food chain - General principles and basic requirements for system design and implementation.

ISO 22006 - Quality management systems - Guidance on the application of ISO 9002:2000 for crop production.

ISO 26000 - The Standard for Social Responsibility. A guidance document for sustainable business practices. See Social Responsibility

 

ISO/TS 16949:1999 - Automotive standard that uses ISO 9000:1994 as a base, but improves upon QS 9000. The standard was developed by the IATF.

 

ISO TS/16949:2002 - Automotive standard that supercedes QS-9000 and includes ISO 9001:2000's process approach. The standard was developed by the IATF

 

ISO/IEC 17025 - Standard for Calibration and Laboratory Accreditation. With 2005 release added many elements of ISO 9001:2000, while maintaining layout of 1999 Standard..

 

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JIS - Japan Industrial Standards.

JUSE - Japanese Union of Scientists and Engineers.

 

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Major - In auditing, a nonconformity which is indicative of a system deficiency that poses immediate hazard to the product quality. Any nonconformity has to be corrected prior to obtaining certification.

 

Malcolm Baldridge National Quality Award (MBNA) - Annual award given to U.S. company that excels in quality management/achievement (same as Baldridge Award)

Management Review - A periodic review, by management, of the quality management system as required by the standard.

  

Management System - A set of interactive elements (system) to establish a policy and objectives and to achieve them.

 

MBNA - See Baldridge Award 

 

Minor - In auditing, a finding of nonconformity which is indicative of a system deficiency, but poses no immediate hazard to product quality. Nonconformities have to be rectified within a certain time limit. Note, a number of minor discrepancies listed against the same requirement can represent a total breakdown of the system and thus be considered a Major.

 

 

Monitor - To observe, supervise, keep under review; To measure or test at intervals, especially for the purpose of regulation or control.

 

MRB - Material review board.

 

 

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NIST - National Institute of Science and Technology.

 

Nonconformance - Product or material which does not conform to the customer specifications and/or requirements. Sometimes used interchangeably with non-conformity.

 

 

Nonconforming product - Product which does not conform to the customer specifications and/or requirements. Same as NonConformance/Nonconformity.

 

 

Nonconformity - When a product, process, procedure, system, or structure deviates from the ISO requirements; the nonfullfillment of a requirement.

 

 

Nonfulfillment - Failure to fulfill a specified requirement. Sometimes used interchangeably with nonconformance/nonconformity.

 

 

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Objective Evidence - Used in quality audits, objective evidence is information which can be proven true, based on facts obtained through observation, measurement, test or other means.

 

 

Organization -  The term organization (in the 2000 standard) refers to you, the unit to which the standard applies, replacing supplier (in the 1994) standard. The terms used in ANSI/ISO/ASQ Q9000-2000 to define the supply chain are as follows:  supplier --> organization --> customer. Where supplier replaces what was called the subcontractor in the 1994 standard.

 

 

Organizational structure - The pattern of responsibilities, authorities, and relationships that control how people perform their functions and govern how they interact with one another.

 

 

Outsource - In ISO 9000-2000, the terms subcontract and outsource are interchangeable and have the same meaning.

 

 

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Pareto Charts - a graphical statistical technique used to tally data in descending or ascending frequency order. They are used to identify significant areas for investigation.

 

Parts Per Million - See PPM

 

 

PPM -  PPM is a way of stating the performance of a process in terms of actual or projected defective material.

 

 

PFMEA - Process Failure Mode Effects Analysis- An analytical technique used to assure that potential process failure modes and associated causes have been considered and addressed. [See FMEA]

 

 

Pie Chart - a simple graphical technique used to show percentages of a whole, and represent percentages at a set point in time

 

 

Policy - A course of action or principle adopted or proposed by a government, party, individual, etc.; any course of action adopted as advantageous or expedient.

 

 

Preservation - An action or an act of preserving or protecting something; the fact of being preserved.

 

 

Prevention - The action of stopping something from happening or making impossible an anticipated event or intended act.

 

 

Preventive action - An action taken to eliminate the cause of a potential nonconformity or other undesirable potential situation; Action(s) designed to prevent the occurrence of nonconformities. See ISO 9001-2000 clause 8.5.3

 

 

Procedure - Specified way to carry out an activity or a process. Quality procedures are used to control how work should be done, who should do it, and under what circumstances. Procedures are also used to define responsibility and authority, which supplies and materials should be used and which documents and records must be used to carry out the work. 

 

 

Process - A set of interrelated or interacting activities, which transforms inputs into outputs. Processes can be social, industrial, agricultural, governmental, chemical, mechanical, electrical, and so on. In every case, inputs are turned into outputs because some kind of work, activity, or function is carried out. 

 

 

Process approach - The systematic identification and management of the processes employed within an organization, with emphasis on the interactions between such processes.

 

 

Process capability analysis - Analyses used to examine variability of a process so that an estimate can be made of its ability to produce product that conforms to requirements.

 

 

Process Map - A flowchart used to show the sequence of processes and how they tie together.

 

 

Product - A product is the result of a process. Products can be tangible or intangible, a thing or an idea, a service or function, a concept or creation, etc.  

 

Product Realization - Product realization refers to the layers of processes that are used to bring products into being.  It is the process of creating a product, from conceptualization through development. ISO 9001-2000's use of the term product realization, underscores an important change in philosophy from a product-centric to process-centric approach.

 

 

Product inspection - An activity that compares one or more characteristics of a product with specified requirements in order to determine if the product conforms to these requirements.

 

Product nonconformity - When one or more characteristics of a product fail to meet specified requirements they are referred to as product nonconformities.

 

 

Property - That which one owns; a thing or things belonging to a person, persons or organization; possessions collectively; a characteristic possessed by something.

 

 

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QMS - See Quality Management System

 

 

QS-9000 - A set of quality requirements based on ISO 9000, used by the American domestic automobile manufacturers to register their suppliers. Superceded by ISO TS/16949.

 

 

Qualification - Demonstrating the ability to fulfill specified requirements.

 

 

Quality - The degree to which a set of inherent characteristics fulfills a requirement

 

 

Quality assurance - The part of quality management that is focused on providing confidence that quality requirements will be fulfilled;  planned and systematic activities implemented within the quality system to provide adequate confidence that requirements for quality will be met.

 

 

Quality audits- Quality audits examine the elements of a quality system in order to evaluate how well these elements comply with quality system requirements. Elements include responsibilities, authorities, relationships, functions, procedures, processes, and resources. Elements combine to form a quality system. A systematic and independent examination to determine quality related activities are implemented effectively and comply with the quality systems and/or quality standards

 

 

Quality Circle - A group of individuals who share job responsibilities, that work together to solve quality problems.

 

 

Quality control - That part of quality management that is focused on fulfilling quality requirements; a set of activities or techniques whose purpose is to ensure that all quality requirements are being met and to eliminate any nonconformities.

 

 

Quality improvement- A set of activities whose purpose is to enhance the efficiency and effectiveness of the organization for the benefit of both the organization and its customers. ISO 9001-2000 defines quality improvement as part of quality management  focused on increasing the ability to fulfill quality requirements. Note: The requirements can be related to any aspect such as effectiveness, efficiency or traceability.

 

 

Quality management - Quality management includes all the activities that managers carry out in an effort to implement their quality policy. These activities include quality planning, quality control, quality assurance, and quality improvement.  

 

Quality Management System  (QMS) - System used to direct or control an