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Quality Certifications & Quality Management Standards Reference - BillDoll
Reference Section @ BillDoll.com – The Billion Dollar Site
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Quality Certifications - Quality Management Standards, Certificates
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Main Sections @ The Billion Dollar Site
Content derived from Wikipedia article on ISO Standards
List of ISO Standards – see content on each topic from Wikipedia
List of ISO standards # ISO 3 ISO 4 ISO 9 ISO 31 ISO 31-0 ISO 31-1 ISO 31-11 ISO 31-2 ISO 31-3 ISO 31-4 ISO 31-5 ISO 31-6 ISO 31-7 ISO 31-8 ISO 216 ISO 228 ISO 233 ISO 259 ISO 269 ISO 428 ISO 639 ISO 639-1 ISO 639-2 ISO 639-3 ISO/IEC 646 ISO 690 ISO 843 ISO 1000 ISO 1007 ISO 2014 ISO 2015 ISO/IEC 2022 ISO 2145 ISO 2281 ISO 2709 ISO 2711 ISO 2788 ISO 3029 ISO 3103 ISO 3166 ISO 3307 ISO 3602 ISO 3864 ISO 3977 ISO 4031 ISO 4157 ISO 4217 ISO 5218 ISO 5775 ISO 5776 ISO 6166 ISO 6425 ISO 6438 ISO 6523 ISO 6709 ISO 7001 ISO 7098 ISO 7736 ISO 7810 ISO 7811 ISO 7812 ISO 7816 ISO 8583 # cont. ISO 8601 ISO/IEC 8632 ISO 8652 ISO/IEC 8820-5 ISO 9000 ISO 9126 ISO 9241 ISO 9362 ISO 9506 ISO 9529 ISO 9660 ISO 9984 ISO 9985 ISO/IEC 9995 ISO 10006 ISO/IEC 10118-3 ISO 10160 ISO 10161 ISO/IEC 10165 ISO 10303 ISO 10303-11 ISO 10303-21 ISO 10303-22 ISO 10303-28 ISO 10383 ISO 10589 ISO 10646 ISO 10664 ISO 10962 ISO/IEC 10967 ISO 11170 ISO/IEC 11179 ISO/IEC 11544 ISO 11783 ISO/IEC 11801 ISO 12006 ISO 12207 ISO 12234-2 ISO/IEC 13211-1 ISO/IEC 13250 ISO 13450 ISO 13485 ISO 13490 ISO 13567 ISO 13584 ISO 13616 ISO 14000 ISO 14443 ISO/IEC 14496-10 ISO 14750 ISO/IEC 14882 ISO 15022 ISO 15189 ISO 15288 ISO/IEC 15291 ISO/IEC 15444 ISO/IEC 15445 ISO 15504 ISO 15686 ISO 15693 ISO 15897 ISO 15919 ISO 15924 ISO 15926 ISO 15930 # cont. ISO/IEC 16262 ISO 17025 ISO/IEC 17025 ISO/IEC 17799 ISO 18245 ISO 18629 ISO 19005 ISO 19011 ISO 19092-1 ISO 19092-2 ISO 19114 ISO/IEC 19757 ISO/IEC 19775-1 ISO 20000 ISO 20022 ISO 22000 ISO/IEC 23270 ISO/IEC 26300 ISO/IEC 27001 ISO/IEC 80000
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A ANSI escape code Ada (programming language) Ada Conformity Assessment Test Suite Ada Semantic Interface Specification D Directory Access Protocol Document Schema Definition Languages Document Style Semantics and Specification Language E ECMAScript Elementary Time Unit Encoded Archival Description F FTAM 110 film 120 film 126 film 135 film Fortran H H.264/MPEG-4 AVC HTML High-Level Data Link Control I ICER IS-IS ISO metric screw thread ISO 10303 Application Modules International Bank Account Number International Standard Audiovisual Number International Standard Book Number International Standard Music Number International Standard Musical Work Code International Standard Party Identifier International Standard Recording Code International Standard Serial Number International Standard Text Code J JBIG JPEG 2000 K Kunrei-shiki Rōmaji L List of ISO transliterations List of devices that support H.264/MPEG-4 AVC M MHEG-5 MPEG-4 Part 3 Manufacturing Message Specification Message Oriented Text Interchange Systems Meta-Object Facility N Namespace Routing Language National Voluntary Laboratory Accreditation Program O OSI model OpenDocument P PDF/A PDF/X PHIGS PNG POSIX Pinyin P cont. Preferred number Prolog R RELAX NG RM-ODP Regular Language description for XML S Smart card Standard Generalized Markup Language T Tag Image File Format / Electronic Photography Topic map U Unified Modeling Language U cont. Universal Character Set Universal Disk Format V VRML W Web3D Consortium WiMedia Alliance X X.400 X.500 X3D XML Metadata Interchange XML Schema Language Comparison
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Content derived from Wikipedia article on ISO 9000
ISO 9000
ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. For a manufacturer, some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) would include:
a set of procedures that cover all key processes in the business; monitoring manufacturing processes to ensure they are producing quality product; keeping proper records; checking outgoing product for defects, with appropriate corrective action where necessary; and regularly reviewing individual processes and the quality system itself for effectiveness. A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered." Certification to an ISO 9000 standard does not guarantee the compliance (and therefore the quality) of end products and services; rather, it certifies that consistent business processes are being applied.
Although the standards originated in manufacturing, they are now employed across a wide range of other types of organizations. A "product", in ISO vocabulary, can mean a physical object, or services, or software. In fact, according to ISO in 2004, "service sectors now account by far for the highest number of ISO 9001:2000 certificates - about 31% of the total" - source: the ISO Survey 2004
Quality Management Principles The ISO 9000 standard is built around 8 principles of sound management:
Customer Focus Leadership Involvement of People Process Approach System Approach to Management Continual Improvement Factual Approach to Decision Making Mutually Beneficial Supplier Relationships.
ISO 9000 family ISO 9000 includes the following standards:
ISO 9000:2005, Quality management systems - Fundamentals and vocabulary. covers the basics of what quality management systems are and also contains the core language of the ISO 9000 series of standards. ISO 9001:2000 Quality management systems - Requirements is intended for use in any organization which designs, develops, manufactures, installs and/or services any product or provides any form of service. It provides a number of requirements which an organization needs to fulfill if it is to achieve customer satisfaction through consistent products and services which meet customer expectations. This is the only implementation for which third-party auditors may grant certifications. ISO 9004:2000 Quality management systems - Guidelines for performance improvements. covers continual improvement. This gives you advice on what you could do to enhance a mature system. This standard very specifically states that it is not intended as a guide to implementation. There are many more standards in the ISO 9001 family (see "List of ISO 9000 standards" from ISO), many of them not even carryng "ISO 900x" numbers. For example, some standards in the 10,000 range are considered part of the 9000 family: ISO 10007:1995 discusses Configuration management, which for most organizations is just one element of a complete management system. ISO notes: "The emphasis on certification tends to overshadow the fact that there is an entire family of ISO 9000 standards ... Organizations stand to obtain the greatest value when the standards in the new core series are used in an integrated manner, both with each other and with the other standards making up the ISO 9000 family as a whole".
Note that the previous members of the ISO 9000 family, 9001, 9002and 9003, have all been integrated into 9001. In most cases, an organization claiming to be "ISO 9000 registered" is referring to ISO 9001.
Contents of ISO 9001 Like all properly-written Standards (see BS 0:2005 A standard for standards.), ISO 9001 seeks to set criteria which achieve a goal and is not prescriptive as to methods.
The requirements come in Sections 4 to 8.
Section 4 is entitled General Requirements Section 5 is entitled Management Responsibility Section 6 is entitled Resource Management Section 7 is entitled Product Realization Section 8 is entitled Measurement, analysis and improvement In each of these areas, ISO 9001:2000 seeks to set out key requirements, which if met will ensure consistency.
The standard specifies six compulsory documents:
Control of Documents (4.2.3) Control of Records (4.2.4) Internal Audits (8.2.2) Control of Nonconforming Product / Service (8.3) Corrective Action (8.5.2) Preventive Action (8.5.3) In addition to these, ISO 9001:2000 requires a Quality Policy and Quality Manual (which may or may not include the above documents).
Summary of ISO 9001:2000 in informal language
The quality manual is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality manual is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards.
Decisions about the quality system are made based on recorded dataand the system is regularly audited and evaluated for conformance and effectiveness.
You need a documented procedure to control quality documents in your company. Everyone must have access to up-to-date documents and be aware of how to use them.
To maintain the quality system and produce conforming product, you need to provide suitable infrastructure, resources, information, equipment, measuring and monitoring devices, and environmental conditions.
You need to map out all key processes in your company; control them by monitoring, measurementand analysis; and ensure that product quality objectives are met. If you can’t monitor a process by measurement, then make sure the process is well enough defined that you can make adjustments if the product does not meet user needs.
For each product your company makes, you need to establish quality objectives; plan processes; and document and measure results to use as a tool for improvement. For each process, determine what kind of procedural documentation is required. (Note: a “product” is hardware, software, services, processed materials, or a combination of these.)
You need to determine key points where each process requires monitoring and measurement, and ensure that all monitoring and measuring devices are properly maintained and calibrated.
You need to have clear requirements for purchased product. Select suppliers appropriately and check that incoming product meets requirements.
You need to determine the skills required for each job in your company, suitably train employees and evaluate the effectiveness of the training.
You need to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints.
When developing new products, you need to plan the stages of development, with appropriate testing at each stage. You need to test and document whether the product meets design requirements, regulatory requirementsand user needs. You need to regularly review performance through internal audits and meetings. Determine whether the quality system is working and what improvements can be made. Deal with past problems and potential problems. Keep records of these activities and the resulting decisions, and monitor their effectiveness. (Note: you need a documented procedure for internal audits.)
You need documented procedures for dealing with actual and potential nonconformances (problems involving suppliers or customers, or internal problems). Make sure no one uses bad product, determine what to do with bad product, deal with the root cause of the problem and keep records to use as a tool to improve the system.
Revisions
The standard has evolved over several revisions.
The initial 1987 version, ISO 9000:1987, 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. This initial document, while structured like the British Standard, drew heavily from numerous documents then in use around the world. Although the Standard has gone through two more iterations which have resulted in some radically changed language, all the core, prevention oriented quality assurance requirements were present in the 1987 document. Contrary to many claims, the Standard did not focus on quality control via retroactive checking and corrective actions. The language of this first version of the Standard was influenced by existing US and other Defence Military Standards ("MIL SPECS"), so was more accessible to manufacturing and was well-suited to the demands of a rigorous, stable, factory-floor manufacturing process. With its structure of twenty 'elements' of requirements, the emphasis tended to be overly placed on conformance with procedures rather than the overall process of management - which was the actual intent.
The 1994 version, ISO 9000:1994, was an attempt to break from the practices which had somewhat corrupted the use of the 1987 standard. It also emphasized quality assurance via preventive actionsand continued to require evidence of compliance with documented procedures. Unfortunately, as with the first edition, companies tended to implement its requirements by creating shelf-loads of procedure manualsand becoming burdened with an ISO bureaucracy. Adapting and improving processes could be particularly difficult in this kind of environment.
The 2000 version, ISO 9000:2000, sought to make a radical change in thinking by actually placing the concept of process management front and centre in the Standard. Documents produced by the ISO Technical Committee which drafted the third edition make it clear that they didn't see any change in the essential goals of the standard, which had always been about 'a documented system' not a 'system of documents'. The goal was always to have management system effectiveness via process performance metrics. The third edition makes this more visible and so reduced the emphasis on having documented procedures if clear evidence could be presented to show that the process was working well. Expectations of continual process improvement and tracking customer satisfaction were made explicit at this revision. Unfortunately too many organizations continue to produce reams of unnecessary documents and to write quality systems around the paragraph structures of ISO 9001 rather than analysing their business processes and building systems around the process flow of the organization.
Certification
ISO does not itself certify organizations. Many countries have formed accreditation bodies to authorize certification bodies, which audit organizations applying for ISO 9001 compliance certification. It is important to note that it is not possible to be certified to ISO 9000. Although commonly referred to as ISO 9000:2000 certification, the actual standard to which an organization's quality management can be certified is ISO 9001:2000. 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 world-wide.
The applying organization is assessed based on an extensive sample of its sites, functions, products, services and processes; a list of problems ("action requests" or "non-compliances") is made known to the management. If there are no major problems on this list, the certification body will issue an ISO 9001 certificate for each geographical site it has visited, once it receives a satisfactory improvement plan from the management showing how any problems will be resolved.
An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body, usually around three years. In contrast to the Capability Maturity Model there are no grades of competence within ISO 9001.
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's supposed to, find out where it can improve and to correct or prevent problems identified. 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.
Under the 1994 standard, the auditing process could be adequately addressed by performing "compliance auditing":
Tell me what you do (describe the business process) Show me where it says that (reference the procedure manuals) Prove that that is what happened (exhibit evidence in documented records) How this led to preventive actions was not clear.
The 2000 standard uses the process approach. While auditors perform similar functions, they are expected to go beyond mere auditing for rote "compliance" by focusing on risk, status and importance. This means they are expected to make more judgements on what is effective, rather than merely adhering to what is formally prescribed. The difference from the previous standard can be explained thus:
Under the 1994 version, the question was broadly "Are you doing what the manual says you should be doing?", whereas under the 2000 version, the question is more "Will this process help you achieve your stated objectives? Is it a good process or is there a way to do it better?". The ISO 19011 standard for auditing applies to ISO 9000.
Industry-specific interpretations
The ISO 9001 standard is generalized and abstract. 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 organizations—police departments (US), professional soccer teams (Mexico) and city councils (UK)—have successfully implemented ISO 9001:2000 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. AS 9000 is the Aerospace Basic Quality System Standard, an interpretation developed by major aerospace manufacturers. The current version is AS 9100. PS 9000 is an application of the standard for Pharmaceutical Packaging Materials. 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 ISO/TS 16949. ISO/TS 16949:2002 is an interpretation agreed upon by major automotive manufacturers (American and European manufacturers); the latest version is based on ISO 9001:2000. The emphasis on a process approach is stronger than in ISO 9001:2000. ISO/TS 16949:2002 contains the full text of ISO 9001:2000 and automotive industry-specific requirements. TL 9000 is the Telecom Quality Management and Measurement System Standard, an interpretation developed by the telecom consortium, QuEST Forum. The current version is 4.0 and unlike ISO 9001 or the above sector standards, TL 9000 includes standardized product measurements that can be benchmarked. ISO 13485:2003 is the medical industry's equivalent of ISO 9001:2000. Whereas the standards it replaces were interpretations of how to apply ISO 9001 and ISO 9002 to medical devices, ISO 13485:2003 is a stand-alone standard. Compliance with ISO 13485 does not necessarily mean compliance with IS0 9001:2000.
Criticisms of ISO 9000
Please help improve this article by introducing appropriate citations. (help, get involved!) This article has been tagged since February 2007.
Many companies have found the transition to conforming to ISO 9000 difficult. This, along with doubts about the fundamental value of the standard, has spawned many criticisms, including:
Quality programmes are notoriously difficult to quantify as Crosby warned in Quality is Free back in 1979, long before the first of these standards emerged. When an organization is measuring nothing, the only "quality costs" it knows are the basics of scrap and rework, and often even these are not being tracked effectively. Once a formal system is introduced, much more accurate data starts to emerge and initial costs of quality often appear to increase.
Toyota abandoned the standard in 2000, moving back to their in-house Toyota Production System.
One of the most concise and well-regarded statements of how to achieve quality is Deming's 14 points. A comparison of the principles of even ISO 9001:2000 against the 14 points still shows a considerable mismatch.
Quality consultants
A rarely examined aspect of ISO 9000 is the consultant. In the UK the government initiated a programme called the "Quality Initiative" with a TV advert showing paperwork being blown out of the window by the consultant. There were very few qualification requirements for the early consultants and the Quality Initiative rapidly became a paperwork-producing exercise using the recently-invented word processor. Success in the Quality Initiative was based on completion of the project rather than certification, quality improvement or bottom-line improvements for the customer.
For quality consultants to be effective, they need to have a good understanding both of ISO 9001 and the sector or company they are seeking to apply it to. Effective ISO 9001 implementation is supposed to lead to improved productivity, efficiency, consistency and client service. If ISO 9001 is not delivering this, then it has not been effectively implemented and the fault may very well lie with the consultant.
Dr. Jack E. Small, in his book ISO 9000 for Executives said, "There is no substitute for practical experience! One of the most important ingredients an ISO 9000 consultant can bring is that they have actually been a part of an ISO 9000 registration (rather than merely talking about it). Experience will often allow clients to avoid costly mistakes and most certainly will reduce the learning curve—which will always prove to be a good investment.".
The Institute of Quality Assurance runs a Management Consultants Register which provides an organisation seeking assistance with the names of three consultants with the required expertise.
ISO 9001 Case Study
Related standards
ISO 10005 ISO 10006 Quality management; Guidelines to quality in project managements ISO 10011
See also
ISO 14000 - Environmental management standards ISO 18000 ISO 19011 - Guidelines for quality management systems auditing and environmental management systems auditing ISO 17025 - General requirements for the competence of testing and calibration laboratories ISO/IEC 17025 - ISO 9000 adaptation for testing and calibration laboratories ISO/TS 16949 - Quality management system requirements for automotive-related products suppliers (see TS16949) ISO 15189 - Quality management system requirements for medical labaratories
Retrieved from http://en.wikipedia.org/wiki/ISO_9000
Content derived from Wikipedia article on TickIT
TickIT
TickIT is a quality-management certification program for software, supported primarily by the United Kingdom and Swedish software industries.
In addition to a general objective of improving software quality, one of the principles of TickIT is to improve and regulate the behaviour of auditors working in the information technology sector through training, and subsequent certification of auditors. The International Register of Certificated Auditors manages the registration scheme for TickIT auditors.
Software development organisations seeking TickIT Certification are required to show conformity with ISO 9001:2000.
Major objective was to provide industry with a practical framework for the management of software development quality by developing more effective quality management system certification procedures. These involved:
publishing guidance material to assist software organizations interpret the requirements of ISO 9001 training, selecting and registering auditors with IT experience and competence, and introducing rules for the accreditation of certification bodies practising in the software sector
TickIT certification bodies
Some of accredited TickIT certification bodies:
BMT Quality Assessors Ltd BSI Quality Assurance Ltd Electricity Association Quality Assurance Lloyd's Register Quality Assurance Companies already certificated to ISO 9001 under TickIT are in over 50 different countries. These include every country in the European Union, USA, Canada, Mexico, Brazil, and Australia and many countries in Asia, including China, India, Japan, South Korea and Taiwan.
The TickIT Guide
TickIT also includes a guide. This provides guidance in understanding and applying ISO 9001 in the IT industry. It gives a background to the TickIT scheme, including its origins and objectives. Furthermore, it provides detailed information on how to implement a Quality System and the expected structure and content relevant to software activities. The TickIT guide also assists in defining appropriate measures and/or metrics. The TickIT Guide contains the official guidance material for TickIT. It is directed at a wide audience: senior managers and operational staff of software suppliers and in-house development teams, purchasers and users of software based systems, certification bodies and accreditation authorities, third party and internal auditors, auditor training course providers and IT consultants.
Part A: Introduction to TickIT and the Certification Process
This presents general information about the operation of TickIT and how it relates to other quality initiatives such as Process Improvement.
Part B: Guidance for Customers
This describes the issues relating to quality management system certification in the software field from the viewpoint of the customer who is initiating a development project, and explains how the customer can contribute to the quality of the delivered products and services.
Part C: Guidance for Suppliers
This presents information and guidance to software and software service providing organizations, including in house developers, on the construction of their quality management systems using the TickIT procedures. This part also indicates how organizations can assess and improve the effectiveness of their quality management systems.
Part D: Guidance for Auditors
This gives guidance to auditors on the conduct of assessments using the TickIT procedures.
Part E: Software Quality Management System Requirements – Standards Perspective
This contains guidance to help organizations producing software products and providing software-related services interpret the requirements of BS EN ISO 9001:2000. It follows the clause sequence of the Standard.
Part F: Software Quality Management System Requirements – Process Perspective
This identifies and elaborates upon the good practice required to provide effective and continuous control of a software quality management system. It is organized around the basic processes required for software development, maintenance and support and follows the structure set out in ISO/IEC 12207:1995.
Retrieved from http://en.wikipedia.org/wiki/TickIT
Content derived from Wikipedia articles on AS 9000 & AS 9100
AS9000
AS9000, Aerospace Basic Quality System Standard, was developed by a group of US aerospace prime contractors, including Allied-Signal. Allison Engine Company, Boeing, General Electric Aircraft Engines, Lockheed Martin. McDonnell Douglas, Northrop Grumman, Pratt Whitney, Rockwell Collins, Sikorsky Aircraft, and Hamilton Sundstrand. Significantly, the US government was not actively involved in the AS9000 standard's development. AS9000 was developed and issued under the auspices of the Society of Automotive Engineers.
The intent and concept behind AS9000 are similar to Boeing's D1-9000. The standard is based in ISO 9000, with 27 additional requirements unique to the aerospace industry. The intent is to standardize and streamline many of the other aerospace quality management standards
http://en.wikipedia.org/wiki/AS9000
AS9100
AS9100 is a widely adopted, quality management system or standard for aerospace industry. It was introduced by Society of Automotive Engineers in the Americas and the European Association of Aerospace Industries in Europe in October 1999.
http://en.wikipedia.org/wiki/AS9100
Retrieved from http://en.wikipedia.org/wiki/Automotive_design
Credits & Copyright: This page is licensed under the GNU Free Documentation License. It uses material from the multiple Wikipedia articles, each of which has been mentioned next to the corresponding content.
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