ISO is a non-governmental organization established in 1947, headquartered in Geneva – Switzerland, officially called The International Organization for Standard, abbreviated ISO. Why is it not abbreviated as IOS but abbreviated as ISO, there are 2 explanations as follows: One is that the letter I and O are two vowels that follow it is a consonant so it cannot be pronounced, so people reverse the position. between the O and the letter S to ISO for ease of pronunciation; The second is that ISO is derived from the Greek word ISOS meaning equality. This means that all member states of this organization are equal.
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But in fact the second explanation is correct.
Currently, ISO has 163 member countries. The ISO organization operates in all fields, except for the electronics sector, which belongs to the International Electronical Committee (IEC). Therefore, electrical industry standards have the word IEC, for example, ISO/IEC 27001 – Information security management (standard cooperation between ISO organization and IEC Organization).
The precursor to ISO 90001956, the NATO Quality Assurance Committee, has issued regulation 10CFR 50 Annex B – Quality Assurance Standard for Nuclear Power Plants and Recycling Fuel Plants (US NRC). 1959 issue Mil-Q-9858, US Department of Defense Quality Program Requirements1968 NATO issues AQAP 1 (Allied Quality Assurance Procedures), NATO Industrial Quality Control Requirements.1972 Institute British standards issued BS 4891, Guidelines for quality assurance (BSI)1974 The British Standards Institute publishes standard BS 5179, Guidelines for the operation and evaluation of quality assurance systems (BSI). 1979 The British Standards Institute publishes BS 5750, Quality Systems (BSI). This is the precursor to the ISO 9000 series of standards in 1987.
The formation and development of the ISO 9000 series of standards
The ISO 9000 series of standards was developed by the ISO/TC 176 Standard Technical Committee – Quality management and quality assurance, and SC2 Technical Subcommittee – quality systems is responsible for drafting.
In 1987, the ISO organization accepted most of the requirements in the BS 5750 standard, and based on that to issue the ISO 9000 series of standards, the ISO 9000 series of standards includes 3 standards:
ISO 9001:1987 with the name: Model for quality assurance in design/development, production, installation and service. ISO 9002 :1987 with the name: Model for quality assurance in production, installation and service. ISO 9003:1987 with the name: Model for quality assurance in final inspection and test (Model for quality assurance in final inspection and test).
In 1994, before the development of the quality management industry, the 9000:1987 set of standards proved to be inappropriate and needed to be updated and revised. Therefore, the standards ISO 9001, ISO 9002, ISO 9003 are revised by ISO. In this revision the emphasis is on ensuring quality through preventive action, rather than just testing the end product and continuing to require proof of compliance with documents. The term “quality system” is also included in the name of the standard to emphasize the idea of quality assurance. The ISO 9000:1994 series of standards includes the following standards:
ISO 9001:1994 with the title: Quality systems – Model for quality assurance in design/implementation, production, installation and service. , installation and servicing).ISO 9002:1994 with the title: Quality systems – Model for quality assurance in production, installation and servicing. ).ISO 9003:1987 with the title: Quality systems – Model for quality assurance in final inspection and test.
In 2000, ISO organization merged 3 standards ISO 9001:1994, ISO 9002:1994, ISO 9003:1994 into one ISO 9001:2000 standard. Enterprises only apply design and development procedures when in fact they participate in designing new products. The version of ISO 9001:2000 has fundamentally changed thinking by introducing the concept of “process management” and making this concept at the heart of the standard. ISO 9001:2000 uses process control to monitor, measure and optimize your tasks and activities instead of testing the end product. The 2000 version of ISO 9001 also requires the involvement of Top Management, through which Top Management will integrate the quality management system into existing business systems, avoiding the case of multiple overlapping systems. cross-exist in an enterprise. In addition, the ISO 9000:2000 series of standards adds two new standards, ISO 9004 and ISO 19011:2002.
ISO 9000:2000 – Basis and terminologyISO 9001:2000 – Quality management systems – Requirements; ISO 9004:2000 – Management systems quality – Guide to continual improvement; ISO 19011:2002 – Guide to quality management system auditing.
In 2005, the ISO 9000: 2000 standard was revised and updated to the ISO 9000: 2005 standard – Quality management systems – bases and terms.
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In 2008, the ISO 9001:2000 standard was revised for the third time, in this revision no new requirements were added. ISO 9001:2008 Quality management systems – Requirements.
In 2009, Standard 9004:2000 was revised to ISO 9004:2009 Management for sustained success – Quality management approach.
In 2011, the ISO 19011:2002 standard was changed to ISO 19011:2011 – Management system assessment guidelines.
In 2015, the ISO 9000 series of standards was greatly changed, mainly ISO 9001 and 9000. The ISO 9001:2015 standard added many new requirements and changed the high-level structure for easy integration with other standards such as ISO 14001, ISO 13485… This is the latest version and allows businesses 3 years to convert from the system 9001:2008 to ISO 9001:2015.
In 2016, ISO Organization issued a new standard ISO 9002:2016 guiding the application of ISO 9001: 2015.
In April 2018, the ISO 9004 standard was revised and re-issued to ISO 9004:2018.
Diagram of core ideas in ISO 9001 through changes
The intended use of the standards in the ISO 9000 family of standards
Other quality management related standardsISO 10001:2007Quality management – customer satisfaction – Guidelines for codes of practice for organizationsISO 10002: 2014Quality management – customer satisfaction – Guidelines Guidelines for handling complaints in organizationsISO 10003:2007Quality management – customer satisfaction – Guidelines for dispute resolution outside of organizationsISO/TS 10004:2012Quality management – customer satisfaction – Guidelines for monitoring and measuringISO 10005:2005 Quality management systems – Guide to quality planningISO 10006:2003 Quality management systems – Guidelines for project quality managementISO 10007:2003 Quality management systems – Guidelines Configuration management guidanceISO 10012:2003Measurement management systems – Requirements for measuring processes and measuring equipmentISO/TR 10013:2001Guide to quality management documentationISO 10014:2006/Cor 1:2007Management quality – A guide to achieving economic and financial benefitsISO 10015: 1999Quality management g – Training Guide ISO/TR 10017:2003Guide to the use of statistical techniques in ISO 9001:2000ISO 10018:1012Quality management – Guide to people participation and competence;ISO 10019:2005 Selection guide selection and use of a quality management system consultant.ISO 13485:2016 Medical instruments – Quality management systems – Requirements for regulatory purposes;
4. Common abbreviations in standard notation
Official ISO management system standards are usually denoted by letters and numbers, and have the following format: “ISO nnnnn ”, where:
ISO stands for standard issued by ISO organization; sometimes it doesn’t, usually it’s an association that develops the standard, eg ISO/IEC 10177:1993 or a special symbol such as ISO/TS 16949:2009;nnnnn is the symbol number of the standard standard or set of standards, for example: ISO 9000;yyyy is the year of publication of that standard.
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The following are some abbreviations commonly found in standards: Table 1.2
Table 1.2 – Common abbreviations in standard notation Symbols Etymology – meaning Example WD Working Draft ISO / IEC 27032 Working Draft WD CD Committee Draft Initial Draft ISO CD 9001 FCD Final Committee Draft Final Draft ISO/IEC FCD 23000-12 DIS Draft International Standard Official Draft International Standard ISO/DIS 9001 FDIS Final Draft International Standard Final Draft International Standard ISO/FDIS 9001 TR Technical Report Technical Report Technical Specification ISO/TR 10017: 2003 DTR Draft Technical Report Draft Technical Report ISO/IEC 19791 DTR TS Technical Specification ISO/TS Technical Specification ISO/TS 16949: 2009 PAS Publicly Available Specification Specification publicly available PAS 99 Integrated Management System Cor Technical Corrigendum Technical Correction ISO 14001:2004/Cor1:2009 Guide Technical Committee Guidelines for the Implementation of Standards
The process of drafting the new ISO Standard is as follows:
The first is the table WD -> CD -> FCD -> DIS -> FDIS -> Standard.