iso 9000 the iso 9000 family of quality management systems standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service thirdparty certification bodies provide independent confirmation that organizations meet the requirements of iso 9001 over one million organizations worldwide background iso 9000 was first published in 1987 by iso international organization for standardization reasons for use the global adoption of iso 9001 may be attributable to a number of factors in the early days the iso 9001 9002 and 9003 requirements were intended to be used by procuring organizations as the basis of contractual arrangements with their suppliers this helped reduce the need for supplier development by establishing basic requirements for a supplier to assure product quality the iso 9001 requirements could be tailored to meet specific contractual situations depending on the complexity of product business type design responsibility manufacture only distribution servicing etc and risk to the procurer if a chosen supplier was weak on the controls of their measurement equipment calibration and hence qcinspection results that specific requirement would be invoked in the contract the adoption of a single quality assurance requirement also lead to cost savings throughout the supply chain by reducing the administrative burden of maintaining multiple sets of quality manuals and procedures a few years later the uk government took steps to improve national competitiveness following publication of cmd 8621 and third party certification of quality management systems was born under the auspices of the national accreditation council of certification bodies naccb which has become the united kingdom accreditation service ukas in addition to several stakeholders benefits a number of studies have identified significant financial benefits for organizations certified to iso 9001 with a 2011 survey from the british assessment bureau showing 44 of their certified clients had won new business while the connection between superior financial performance and iso 9001 may be seen from the examples cited there remains no proof of direct causation though longitudinal studies such as those of corbett et al 2005 have suggested that while there is some evidence of this the improvement is partly driven by the fact that there is a tendency for better performing companies to seek iso 9001 certification the mechanism for improving results has also been the subject of much research lo et al 2007 identified operational improvements eg cycle time reduction inventory reductions as following from certification global adoption the increase in iso 9001 certification is shown in the tables below worldwide total of iso 9001 certificates end of each year 2000 2001 2002 2003 2004 2005 2006 2007 409421 510616 561747 567985 660132 773867 896929 951486 2008 2009 2010 2011 2012 2013 2014 982832 1064785 1118510 1111698 1096987 1126460 1138155 top 10 countries for iso 9001 certificates 2014 rank country no of certificates 1 china 342800 2 italy 168960 3 germany 55363 4 japan 45785 5 india 41016 6 united kingdom 40200 7 spain 36005 8 united states 33008 9 france 29122 10 australia 19731 top 10 countries for iso 9001 certificates 2010 rank country no of certificates 1 china 297037 2 italy 138892 3 russian federation 62265 4 spain 59854 5 japan 59287 6 germany 50583 7 united kingdom 44849 8 india 33250 9 united states 25101 10 korea republic of 24778 top 10 countries for iso 9001 certificates 2009 rank country no of certificates 1 china 257076 2 italy 130066 3 japan 68484 4 spain 59576 5 russian federation 53152 6 germany 47156 7 united kingdom 41193 8 india 37493 9 united states 28935 10 korea republic of 23400 iso 9000 series quality management principles the iso 9000 series are based on seven quality management principles qmp the seven quality management principles are qmp 1 customer focus qmp 2 leadership qmp 3 engagement of people qmp 4 process approach qmp 5 improvement qmp 6 evidencebased decision making qmp 7 relationship management principle 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 principle 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 organizations objectives principle 3 engagement of people people at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit principle 4 process approach a desired result is achieved more efficiently when activities and related resources are managed as a process principle 5 improvement improvement of the organizations overall performance should be a permanent objective of the organization principle 6 evidencebased decision making effective decisions are based on the analysis of data and information principle 7 relationship management an organization and its external providers suppliers contractors service providers are interdependent and a mutually beneficial relationship enhances the ability of both to create value contents of iso 90012015 a fish wholesaler in tsukiji japan advertising its iso 9001 certification iso 90012015 quality management systems requirements is a document of approximately 30 pages which is available from the national standards organization in each country only iso 9001 is directly audited against for third party assessment purposes contents of iso 90012015 are as follows section 1 scope section 2 normative references section 3 terms and definitions section 4 context of the organization section 5 leadership section 6 planning section 7 support section 8 operation section 9 performance evaluation section 10 continual improvement essentially the layout of the standard is similar to the previous iso 90012008 standard in that it follows the plan do check act cycle in a processbased approach but is now further encouraging this to have riskbased thinking section 033 of the introduction the purpose of the quality objectives is to determine the conformity of the requirements customers and organizations facilitate effective deployment and improve the quality management system before the certification body can issue or renew a certificate the auditor must be satisfied that the company being assessed has implemented the requirements of sections 4 to 10 sections 1 to 3 are not directly audited against but because they provide context and definitions for the rest of the standard not that of the organization their contents must be taken into account the standard no longer specifies that the organization shall issue and maintain documented procedures however iso 90012015 requires the organization to document any other procedures required for its effective operation the standard also requires the organization to issue and communicate a documented quality policy a quality management system scope and quality objectives the standard no longer requires compliant organizations to issue a formal quality manual the standard does require retention of numerous records as specified throughout the standard new for the 2015 release is a requirement for an organization to assess risks and opportunities section 61 and to determine internal and external issues relevant to its purpose and strategic direction section 41 the organization must demonstrate how the standards requirements are being met while the external auditors role is to determine the quality management systems effectiveness more detailed interpretation and implementation examples are often sought by organizations seeking more information in what can be a very technical area certification international organization for standardization iso does not certify organizations itself numerous certification bodies exist which audit organizations and upon success issue iso 9001 compliance certificates although commonly referred to as iso 9000 certification the actual standard to which an organizations quality management system can be certified is iso 90012015 iso 90012008 will expire by around september 2018 many countries have formed accreditation bodies to authorize accredit the certification bodies both the accreditation bodies and the certification bodies charge fees for their services the various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the accredited certification bodies cb are accepted worldwide certification bodies themselves operate under another quality standard isoiec 17021 an organization applying for iso 9001 certification is audited based on an extensive sample of its sites functions products services and processes the auditor presents a list of problems defined as nonconformities observations or opportunities for improvement to management if there are no major nonconformities the certification body will issue a certificate where major nonconformities are identified the organization will present an improvement plan to the certification body eg corrective action reports showing how the problems will be resolved once the certification body is satisfied that the organization has carried out sufficient corrective action it will issue a certificate the certificate is limited by a certain scope eg production of golf balls and will display the addresses to which the certificate refers an iso 9001 certificate is not a onceandforall award but must be renewed at regular intervals recommended by the certification body usually once every three years there are no grades of competence within iso 9001 either a company is certified meaning that it is committed to the method and model of quality management described in the standard or it is not in this respect iso 9001 certification contrasts with measurementbased quality systems evolution of iso 9000 standards the iso 9000 standard is continually being revised by standing technical committees and advisory groups who receive feedback from those professionals who are implementing the standard 1987 version iso 90001987 had the same structure as the uk standard bs 5750 with three models for quality management systems the selection of which was based on the scope of activities of the organization iso 90011987 model for quality assurance in design development production installation and servicing was for companies and organizations whose activities included the creation of new products iso 90021987 model for quality assurance in production installation and servicing had basically the same material as iso 9001 but without covering the creation of new products iso 90031987 model for quality assurance in final inspection and test covered only the final inspection of finished product with no concern for how the product was produced iso 90001987 was also influenced by existing us and other defense standards mil specs and so was wellsuited to manufacturing the emphasis tended to be placed on conformance with procedures rather than the overall process of management which was likely the actual intent 1994 version iso 90001994 emphasized quality assurance via preventive actions instead of just checking final product and continued to require evidence of compliance with documented procedures as with the first edition the downside was that companies tended to implement its requirements by creating shelfloads of procedure manuals and becoming burdened with an iso bureaucracy in some companies adapting and improving processes could actually be impeded by the quality system 2000 version iso 90012000 replaced all three former standards of 1994 issue iso 9001 iso 9002 and iso 9003 design and development procedures were required only if a company does in fact engage in the creation of new products the 2000 version sought to make a radical change in thinking by actually placing front and centre the concept of process management the monitoring and optimisation of a companys tasks and activities instead of just inspection of the final product the 2000 version also demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators another goal was to improve effectiveness via process performance metrics numerical measurement of the effectiveness of tasks and activities expectations of continual process improvement and tracking customer satisfaction were made explicit iso 9000 requirements include approve documents before distribution provide correct version of documents at points of use use your records to prove that requirements have been met and develop a procedure to control your records 2008 version iso 90012008 in essence renarrates iso 90012000 the 2008 version only introduced clarifications to the existing requirements of iso 90012000 and some changes intended to improve consistency with iso 140012004 there were no new requirements for example in iso 90012008 a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version iso 9001 is supplemented directly by two other standards of the family iso 90002005 quality management systems fundamentals and vocabulary iso 90042009 managing for the sustained success of an organization a quality management approach other standards like iso 19011 and the iso 10000 series may also be used for specific parts of the quality system 2015 version in 2012 iso tc 176 responsible for iso 9001 development celebrated 25 years of implementing iso 9001 the 2015 version is also less prescriptive than its predecessors and focuses on performance this was achieved by combining the process approach with riskbased thinking and employing the plandocheckact cycle at all levels in the organization some of the key changes include highlevel structure of 10 clauses is implemented now all new standards released by iso will have this highlevel structure greater emphasis on building a management system suited to each organizations particular needs a requirement that those at the top of an organization be involved and accountable aligning quality with wider business strategy riskbased thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement less prescriptive requirements for documentation the organization can now decide what documented information it needs and what format it should be in alignment with other key management system standards through the use of a common structure and core text inclusion of knowledge management principles quality manual management representative mr are no longer mandatory auditing two types of auditing are required to become registered to the standard auditing by an external certification body external audit and audits by internal staff trained for this process internal audits the aim is a continual process of review and assessment to verify that the system is working as it is supposed to to find out where it can improve and to correct or prevent identified problems it is considered healthier for internal auditors to audit outside their usual management line so as to bring a degree of independence to their judgements industryspecific interpretations the iso 9001 standard is generic its parts must be carefully interpreted to make sense within a particular organization developing software is not like making cheese or offering counseling services yet the iso 9001 guidelines because they are business management guidelines can be applied to each of these diverse organizationspolice departments united states professional soccer teams mexico and city councils ukhave successfully implemented iso 90012000 systems over time various industry sectors have wanted to standardize their interpretations of the guidelines within their own marketplace this is partly to ensure that their versions of iso 9000 have their specific requirements but also to try and ensure that more appropriately trained and experienced auditors are sent to assess them the tickit guidelines are an interpretation of iso 9000 produced by the uk board of trade to suit the processes of the information technology industry especially software development as9000 is the aerospace basic quality system standard an interpretation developed by major aerospace manufacturers those major manufacturers include alliedsignal allison engine boeing general electric aircraft engines lockheedmartin mcdonnell douglas northrop grumman pratt whitney rockwellcollins sikorsky aircraft and sundstrand the current version is as9100d ps 9000 qs 9000 is an interpretation agreed upon by major automotive manufacturers gm ford chrysler it includes techniques such as fmea and apqp qs 9000 is now replaced by isots 16949 isots 169492009 is an interpretation agreed upon by major automotive manufacturers american and european manufacturers the latest version is based on iso 90012008 the emphasis on a process approach is stronger than in iso 90012008 isots 169492009 contains the full text of iso 90012008 and automotive industryspecific requirements tl 9000 is the telecom quality management and measurement system standard an interpretation developed by the telecom consortium quest forum in 1998 quest forum developed the tl 9000 quality management system to meet the supply chain quality requirements of the worldwide telecommunications industry the tl 9000 standard is made up of two handbooks the qms requirements handbook and the qms measurement handbook the current versions of the requirements and measurements handbooks are 50 unlike iso 9001 or other sectorspecific standards tl 9000 includes standardized product and process measurements that must be reported into a central repository which allows organizations to benchmark their performance in key process areas against peer organizations it is important to note that tl 9000 r50 contains the full text of iso 90012008 iso 134852016 is the medical industrys equivalent of iso 9001 iso 134852016 is a standalone standard because iso 13485 is relevant to medical devices manufacturers unlike iso 9001 which is applicable to any industry and because of the differences between the two standards relating to continual improvement compliance with iso 13485 does not necessarily mean compliance with iso 9001 and vice versa isoiec 900032014 provides guidelines for the application of iso 9001 to computer software isots 29001 is quality management system requirements for the design development production installation and service of products for the petroleum petrochemical and natural gas industries it is equivalent to api spec q1 without the monogram annex iso 22000 food safety management systems effectiveness this section possibly contains original research please improve it by verifying the claims made and adding inline citations statements consisting only of original research should be removed may 2013 learn how and when to remove this template message the debate on the effectiveness of iso 9000 commonly centres on the following questions are the quality principles in iso 9001 of value does it help to implement an iso 9001compliant quality management system does it help to obtain iso 9001 certification the effectiveness of the iso system being implemented depends on a number of factors the most significant of which are commitment of senior management to monitor control and improve quality organizations that implement an iso system without this desire and commitment often take the cheapest road to get a certificate on the wall and ignore problem areas uncovered in the audits how well the iso system integrates into current business practices many organizations that implement iso try to make their system fit into a cookiecutter quality manual instead of creating a manual that documents existing practices and only adds new processes to meet the iso standard when necessary how well the iso system focuses on improving the customer experience the broadest definition of quality is whatever the customer perceives good quality to be this means that a company doesnt necessarily have to make a product that never fails some customers will have a higher tolerance for product failures if they always receive shipments ontime or have a positive experience in some other dimension of customer service an iso system should take into account all areas of the customer experience and the industry expectations and seek to improve them on a continual basis this means taking into account all processes that deal with the three stakeholders customers suppliers and organization only then will a company be able to sustain improvements in the customers experience how well the auditor finds and communicates areas of improvement while iso auditors may not provide consulting to the clients they audit there is the potential for auditors to point out areas of improvement many auditors simply rely on submitting reports that indicate compliance or noncompliance with the appropriate section of the standard however to most executives this is like speaking a foreign language auditors that can clearly identify and communicate areas for improvement in language and terms executive management understands facilitate action on improvement initiatives by the companies they audit when management doesnt understand why they were noncompliant and the business implications associated with noncompliance they simply ignore the reports and focus on what they do understand advantages proper quality management can improve business often having a positive effect on investment market share sales growth sales margins competitive advantage and avoidance of litigation the 2015 version of the standard brings the following benefits by assessing their context organizations can define who is affected by their work and what they expect this enables clearly stated business objectives and the identification of new business opportunities organizations can identify and address the risks associated with their organization by putting customers first organizations can make sure they consistently meet customer needs and enhance customer satisfaction this can lead to more repeat customers new clients and increased business for the organization organizations work in a more efficient way as all their processes are aligned and understood by everyone this increases productivity and efficiency bringing internal costs down organizations will meet necessary statutory and regulatory requirements organizations can expand into new markets as some sectors and clients require iso 9001 before doing business criticisms of iso 9001 certification a common criticism of iso 9000 and 9001 is the amount of money time and paperwork required for a complete implementation and later when needed iso 9001 certification the level of minimum documentation for a minimum scope organization has been greatly reduced going from iso 90012000 through iso 90012008 and lastly iso 90012015 according to barnes opponents claim that it is only for documentation proponents believe that if a company has documented its quality systems then most of the paperwork has already been completed one study showing reasons for not adopting this standard include the risks and uncertainty of not knowing if there are direct relationships to improved quality and what kind and how many resources will be needed additional risks include how much certification will cost increased bureaucratic processes and risk of poor company image if the certification process fails in short wade argues that reliance on the specifications of iso 9001 does not guarantee a successful quality system the standard is seen as especially prone to failure when a company is interested in certification before quality dalgleish argues that while quality has a positive effect on return on investment market share sales growth better sales margins and competitive advantage taking a quality approach is unrelated to iso 9000 registration abrahamson argues that fashionable management discourse such as quality circles tends to follow a lifecycle in the form of a bell curve possibly indicating a management fad pickrell argues that iso systems merely gauge whether the processes are being followed it does not gauge how good the processes are or whether the correct parameters are being measured and controlled to ensure quality furthermore when unique technical solutions are involved in the creation of a new part iso does not validate the robustness of the technical solution which is a key part of advanced quality planning it is not unheard of for an isocertified plant to display poor quality performance due to poor process selection andor poor technical solutions conformity assessmentcontaining iso published standards iso 10006quality managementguidelines to quality management in projects iso 13485medical devicesquality management systemsrequirements for regulatory purposes iso 14001environmental management standards iso 19011guidelines for quality management systems auditing and environmental management systems auditing isots 16949quality management system requirements for automotiverelated products suppliers isoiec 27001information security management iso 39001road traffic safety management iso 50001energy audit as 9100aerospace industry implementation of iso 90001 list of iso standards isotc 176 quality management system test management verification and validation international organization for standardization annex sl bamford robert deibler william 2003 iso 9001 2000 for software and systems providers an engineering approach 1st ed crcpress isbn0849320631 isbn9780849320637 naveh e marcus a 2004 when does the iso 9000 quality assurance standard lead to performance improvement assimilation and going beyond ieee transactions on engineering management 51 3 352 doi101109tem2004830864 naveh e 1999 iso 9000 survey99 an analytical tool to assess the costs benefits and savings of iso 9000 registration qsu publishing company an abstract of the 2007s iso survey of certificates an abstract of the 2008s iso survey of certificates bacivarov ioan coordinating editor 2015 special issue iso90012015 asigurarea calitatii quality assurance 21 83 issn12245410 official website isotc 176 sc 2 iso committee responsible for developing iso 9000 standards vteiso standards by standard numberlist of iso standards iso romanizations iec standards19999 1 2 3 4 5 6 7 9 16 17 31 0 1 2 3 4 5 6 7 8 9 10 11 12 13 128 216 217 226 228 233 259 269 302 306 361 428 500 518 519 639 1 2 3 5 6 646 657 668 690 704 732 764 838 843 860 898 965 999 1000 1004 1007 10731 1155 1413 1538 1629 1745 1989 2014 2015 2022 2033 2047 2108 2145 2146 2240 2281 2533 2709 2711 2720 2788 2848 2852 3029 3103 3166 1 2 3 3297 3307 3601 3602 3864 3901 3950 3977 4031 4157 4165 4217 4909 5218 5426 5427 5428 5725 5775 5776 5800 5964 6166 6344 6346 6385 6425 6429 6438 6523 6709 6943 7001 7002 7010 7027 7064 7098 7185 7200 7498 1 7637 7736 7810 7811 7812 7813 7816 7942 8000 8093 8178 8217 8373 85011 8571 8583 8601 8613 8632 8651 8652 8691 88058806 8807 88205 8859 1 2 3 4 5 6 7 8 8i 9 10 11 12 13 14 15 16 8879 90009001 9036 9075 9126 9141 9227 9241 9293 9314 9362 9407 9506 9529 9564 95929593 9594 9660 97971 9897 9899 9945 9984 9985 9995 1000019999 10005 10006 10007 10116 101183 10160 10161 10165 10179 10206 10218 10303 11 21 22 28 238 10383 10487 10585 10589 10646 10664 10746 10861 10957 10962 10967 11073 11170 11179 11404 11544 11783 11784 11785 11801 11898 11940 2 11941 11941 tr 11992 12006 12182 12207 122342 13211 1 2 13216 13250 13399 134062 13450 13485 13490 13567 13568 13584 13616 14000 14031 14224 14289 14396 14443 14496 2 3 6 10 11 12 14 17 20 14644 14649 14651 14698 14750 14764 14882 14971 15022 15189 15288 15291 15292 15398 15408 15444 3 15445 15438 15504 15511 15686 15693 15706 2 15707 15897 15919 15924 15926 15926 wip 15930 16023 16262 166122 16750 16949 ts 17024 17025 17100 17203 17369 17442 17799 18000 18004 18014 18245 18629 18916 19005 19011 19092 1 2 19114 19115 19125 19136 19407 19439 19500 19501 19502 19503 19505 19506 19507 19508 19509 19510 19600 19752 19757 19770 197751 197945 19831 20000 20000 20022 20121 20400 21000 21047 21500 218272002 22000 23270 23271 23360 24517 24613 24617 24707 25178 25964 26000 26300 26324 27000 series 27000 27001 27002 27006 27729 28000 29110 29148 291992 29500 30170 31000 32000 38500 40500 42010 55000 80000 1 2 3 category 