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Quality Management System

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Presentation on theme: "Quality Management System"— Presentation transcript:

1 Quality Management System

2 Project management International standards
The ISO standards ISO 9000, a family of standards for quality management systems, and the ISO 10006:2003, for Quality management systems and guidelines for quality management in projects.

3 Biomedical engineering - Regulatory issues
The same standard (ISO EN 13486) is usually applied for quality management systems in US and worldwide.

4 Audit - Quality audits A system of quality audits may verify the effectiveness of a quality management system

5 Quality management - Mutually beneficial supplier relationships
These eight principles form the basis for the quality management system standard ISO 9001:2008.

6 Quality management - Quality improvement
Simple one is Process Approach, which forms the basis of ISO 9001:2008 Quality Management System standard, duly driven from the 'Eight principles of Quality management', process approach being one of them

7 Quality management - Quality standards
The International Organization for Standardization (ISO) created the Quality Management System (QMS) standards in They were the ISO 9000:1987 series of standards comprising ISO 9001:1987, ISO 9002:1987 and ISO 9003:1987; which were applicable in different types of industries, based on the type of activity or process: designing, production or service delivery.

8 Quality management - Quality standards
The Quality Management System standards created by ISO are meant to certify the processes and the system of an organization, not the product or service itself. ISO 9000 standards do not certify the quality of the product or service.

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

10 ISO ISO 9001 vs ISO 22000 In comparison with ISO 9001, the standard is a more procedural orientated guidance than a principle based one. Apart from that, ISO is an industrial-specific risk management system for any type of food processing and marketing, which can be closely incorporated with the quality management system of ISO The detailed similarities and differences of the two standards can be found elsewhere , , ,.

11 ISO 14000 - Continual Improvement Process
The core requirement of a continual improvement process (CIP) is different from the one known from quality management systems. CIP in ISO has three dimensions (Gastl, 2009):

12 ISO/IEC 17025 Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory

13 ISO/IEC 17025 A prerequisite for a laboratory to become accredited is to have a documented quality management system

14 Industrial engineering - History
Comprehensive quality management system (TQM) developed in the forties was gaining momentum after World War II and was part of the recovery of Japan after the war.

15 ISO 9000 ISO 9000 deals with the fundamentals of quality management systems, including the eight management principles on which the family of standards is based

16 ISO Background BSI has been certifying organizations for their quality management systems since Its first certification (FM 00001) is still extant and held by Tarmac Limited, a successor to the original company which held this certificate. Today BSI claims to certify organizations at nearly 70,000 sites globally.

17 ISO Global adoption Worldwide total of ISO Quality Management Systems - Requirements certificates

18 ISO Contents of ISO 9001 The other two standards are supplementary and contain deeper information on how to sustain and improve quality management systems; they are therefore not used directly during third party assessment

19 Section 4: Quality Management System
ISO Contents of ISO 9001 Section 4: Quality Management System

20 ISO Certification Although commonly referred to as 'ISO 9000' certification, the actual standard to which an organization's quality management system can be certified is ISO 9001:2008

21 ISO 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:

22 ISO version ISO 9001:2008 basically renarrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.

23 ISO version ISO 9000:2005 "Quality management systems. Fundamentals and vocabulary"

24 ISO 9000 - Industry-specific interpretations
In 1998 QuEST Forum developed the TL 9000 Quality Management System to meet the supply chain quality requirements of the worldwide telecommunications industry

25 ISO 9000 - Industry-specific interpretations
ISO/TS 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.

26 ISO Effectiveness Does it help to implement an ISO 9001:2000-compliant quality management system?

27 ISO Advantages The quality principles in ISO 9000:2000 are also sound, according to Wade and also to Barnes, who says that "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive." Sroufe and Curkovic, (2008) found benefits ranging from registration required to remain part of a supply base, better documentation, to cost benefits, and improved involvement and communication with management

28 ISO 15189 ISO Medical laboratories — Particular requirements for quality and competence specifies the quality management system requirements particular to medical laboratories

29 ISO 13485 ISO is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN and EN (both 1997), the ISO published in 1996 and ISO (also 1996).

30 ISO 13485 The preferred method to prove conformity is the certification of the Quality Management System according ISO 9001 and/or ISO and ISO by a Notified Body

31 ISO 10006 ISO 10006:2003, Quality management systems - Guidelines for quality management in projects, is an international standard developed by the International Organization for Standardization.

32 TickIT 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:

33 TickIT - The TickIT Guide
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.

34 TickIT - The TickIT Guide
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.

35 TickIT - The TickIT Guide
Part E: Software Quality Management System Requirements – Standards Perspective

36 TickIT - The TickIT Guide
Part F: Software Quality Management System Requirements – Process Perspective

37 TickIT - The TickIT Guide
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.

38 Change control Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner.

39 IBM Rational Team Concert - Overview
Rational Team Concert integrates with several other products, including Subversion, Git, and IBM Rational ClearCase revision-control products, IBM Rational ClearQuest and JIRA change management products, IBM Rational Quality Manager and HP Quality Center quality management systems, and IBM Rational Build Forge, Hudson, Jenkins, CruiseControl, and Maven build and process automation tools.

40 Configuration management - Standards
ISO 10007:2003 Quality management systems - Guidelines for configuration management

41 Independent test organization - Affiliation of testing organizations
Many suppliers or vendors offer some chemical testing, physical testing, and software testing as a free service to customers. It is common for businesses to partner with reputable suppliers: Many suppliers have certified quality management systems such as ISO 9000 or allow customers to conduct technical and quality audits. Data from testing is commonly shared. There is sometimes a risk that supplier testing may tend to be self-serving and not completely impartial.

42 Software quality control
It is distinct from software quality assurance which includes audits of the quality management system against a standard. Whereas software quality control is a control of products, software quality assurance is a control of processes.

43 Quality (business) Quality applied in these forms was mainly developed by the procurement directorates of NASA, the military and nuclear industries from the 1960s and this is why so much emphasis was placed on Quality Assurance. The original versions of Quality Management System Standards (eventually merged to ISO 9001) were designed to contract manufacturers to produce better products, consistently and were focused on Producing, Checking and Quality Control.

44 Chartered Quality Institute - IRCA
consultants assisting organizations to develop and implement quality management systems

45 Software quality management - Links to IT methods
component „Quality in a project environment”, which describes necessity of double-checked and objective control of created products. It proposes using 4 elements: quality management system, function of quality control, planning quality and quality controls.

46 Software quality management - Links to IT methods
ISO 9000 – family of standards is related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to the product.

47 Quality assurance - Using contractors and/or consultants
Consultants and contractors will often employ Quality Management Systems (QMS), auditing and procedural documentation writing CMMI, Six Sigma, Measurement Systems Analysis (MSA), Quality Function Deployment (QFD), Failure Mode and Effects Analysis (FMEA), and Advance Product Quality Planning (APQP).

48 Medical software - International Standards
The quality management system requirements for manufacturing a software medical device, as is the case with any medical device, are described in the QSR regulations of the FDA and also in ISO 13485:2003.

49 Hazard analysis and critical control points - Standards
The seven HACCP principles are included in the international standard ISO FSMS This standard is a complete food safety and quality management system incorporating the elements of prerequisite programmes(GMP & SSOP), HACCP and the quality management system, which together form an organization's Total Quality Management system.

50 Verification and validation
Verification and Validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO The words "verification" and "validation" are sometimes preceded with "Independent" (or IV&V), indicating that the verification and validation is to be performed by a disinterested third party.

51 Humanitarian aid - Standards
develop and implement a Humanitarian Quality Management System

52 Packaging - Package development considerations
An effective quality management system and Verification and Validation protocols are mandatory for some types of packaging and recommended for all.

53 Quality management system
[ What is a Quality Management System?], Bizmanualz, Nov 18, 2013

54 Quality management system - Quality management organizations and awards
(ISO 9000:2005 provides information the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements).

55 McDonnell Douglas –1989 McDonnell Douglas then introduced a major reorganization called the Total Quality Management System (TQMS)

56 Certified reference materials
Quality management systems involving laboratory accreditation under national and international accreditation/certification international_standard|standards such as ISO 9000 and ISO/IEC require the use of Reference Materials.

57 Information technology governance
It has evolved from The Principles of Scientific Management, Total Quality Management and ISO 9001 Quality Management Systems

58 Occupational safety and health - International
ISO 9001 Quality Management Systems and ISO Environmental Management System can work in tandem with BS OHSAS 18001/18002 to complement each other and form a better overall system

59 Cold chain - Validation
A cold chain can be managed by a quality management system. It should be analyzed, measured, controlled, documented, and Validation (drug manufacture)|validated.

60 Corrective and preventive action
To ensure that corrective and preventive actions are effective, the systematic investigation of the root causes of failure is pivotal. CAPA is part of the overall quality management system (QMS).

61 Corrective and preventive action - Concepts
Implementation of corrective and preventive actions is the path towards improvement and effectiveness of Quality Management Systems

62 ** Achieved ISO 9001:2000 Certification of Quality Management System
IndosatM2 - History ** Achieved ISO 9001:2000 Certification of Quality Management System

63 OHSAS How they work Historically many organizations start with a quality management system (ISO 9001) and then add the environment management requirements from ISO 14001

64 Operations Management
In 1987 the International Organization for Standardization (ISO), recognizing the growing importance of quality, issued the ISO 9000, a family of standards related to quality management systems. There has been some controversy thought regarding the proper procedures to follow and the amount of paperwork involved.

65 Product certification - Certification process
Some certification schemes, or the product certifiers which operate those Schemes, may require that the product supplier operate a Quality Management System registered to ISO 9000, or that the testing be performed by a laboratory accredited to ISO ISO/IEC 17025:2005 The decision to set these requirements is most often made by the person or group which owns the Certification Scheme.

66 Specification - Process capability considerations
The process capability of materials and products needs to be compatible with the specified engineering tolerances. Process controls must be in place and an effective Quality management system, such as Total Quality Management, needs to keep actual production within the desired tolerances.

67 Specification - Web service specification
Web services specifications are often under the umbrella of a quality management system.

68 Process management improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. Source: clause 0.2 of ISO 9001:2000

69 Auditing - Quality audits
A system of quality audits may verify the effectiveness of a quality management system

70 PMI Colleges - Standardization
The ISO 9001:2000 Certification is an assurance to its students of quality management system leading to effective school governance and policies towards relevant and quality learning. It also runs parallel to the vision and mission of PMI Colleges to be a center of excellence in maritime and customs education in the Philippines as well as in the Southeast Asian region to be able to continuously produce the best marine and customs officers in the world.

71 PMI Colleges - Standardization
PMI Colleges’ quality management system for its maritime education was previously accredited and certified by Det Norske Veritas (DNV).

72 Gelatin - Safety concerns
All reputable gelatin manufacturers today follow the Quality Management System according to ISO 9001 to comply with all required physical, chemical, microbiological and technical production and quality standards

73 Iran Standard and Quality Inspection (ISQI) - History and development
ISQI was founded in 1989 with the goal of improvement and establishing Quality management systems in producing and service companies

74 TUBITAK Space Technologies Research Institute - Quality Policy
TÜBİTAK UZAY has the ISO 9001:2000 Quality Management System certificate since 7 December Quality policy of TÜBİTAK UZAY is determined in accordance with its mission, vision and range of activities.

75 Boryspil International Airport - History
In 2002 Boryspil airport was certified under the ISO 9001 quality management system.

76 Configuration management - Standards
* ISO 10007:2003 Quality management systems - Guidelines for configuration management

77 Advanced Card Systems - Awards and recognition
* 2007 ISO 9001:2000 standard certification for quality management systems

78 AIDA/Web - History In 2003 BiArt/ISO[ Uvod] Quality management system was built onto Aida's core document management functionally (which now forms the core of the Scribo CMS). In 2005 BiArt/BPM web-based Business Process Management framework for executing business processes according to standard BPMN was built using Aida/Web.

79 Medical electronics - Regulatory issues
The same standard (ISO EN 13485) is usually applied for quality management systems in US and worldwide.

80 Total productive maintenance - Total productive maintenance
One of the main objectives of TPM is to increase the productivity of plant and equipment with a modest investment in maintenance Total quality management|Total Quality management (TQM) and Total Productive Maintenance (TPM) are considered as the key operational activities of the quality management system

81 Quality improvement Simple one is Process Approach, which forms the basis of ISO 9001:2008 Quality Management System standard, duly driven from the 'Eight principles of Quality management', process approach being one of them

82 Quality improvement - Quality standards
The International Organization for Standardization (International Organization for Standardization|ISO) created the Quality Management System (QMS) standards in They were the ISO 9000:1987 series of standards comprising ISO 9001:1987, ISO 9002:1987 and ISO 9003:1987; which were applicable in different types of industries, based on the type of activity or process: designing, production or service delivery.

83 ISO 10006 'ISO 10006:2003', Quality management systems - Guidelines for quality management in projects, is an international standard developed by the International Organization for Standardization.

84 Indian Statistical Institute
In addition, the Institute has a network of units of Statistical Process Control|Statistical Quality Control and Operations Research at Vadodara, Coimbatore, Hyderabad, India|Hyderabad, Mumbai and Pune engaged in guiding the industries, within and outside India, in developing the most up–to–date quality management systems and solving critical problems of quality, reliability and productivity.

85 IT Governance It has evolved from The Principles of Scientific Management, Total Quality Management and ISO 9001 Quality Management Systems

86 BSI Group - Management Systems Assessment and Certification
* ISO (Quality management systems for medical devices)

87 BSI Group - Milestones * BSI pioneered the development of management systems standards: the first of which was BS 5750, the original quality management systems standard which formed the template for the ISO 9000 series of quality standards, first published in 1994.

88 Production Part Approval Process - PPAP approval
1) The client's requirements have been understood2) The product supplied meets those requirements 3) The process (including sub suppliers) is capable of producing conforming product 4) The production control plan and quality management system will prevent non-conforming product reaching the client or compromising the safety and reliability of finished vehicles

89 Quality audit 'Quality audit' is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of organization's quality management system and is a key element in the International Organization for Standardization|ISO quality system standard, ISO 9001.

90 Quality audit With the upgrade of the ISO9000 series of standards from the 1994 to 2008 series, the focus of the audits has shifted from purely procedural adherence towards measurement of the actual effectiveness of the Quality Management System (QMS) and the results that have been achieved through the implementation of a QMS.

91 * ISO 9000 Quality management systems – Fundamentals and vocabulary
List of International Organization for Standardization standards - ISO 5000 – ISO 9999 * ISO 9000 Quality management systems – Fundamentals and vocabulary

92 * ISO 9001 Quality management systems – Requirements
List of International Organization for Standardization standards - ISO 5000 – ISO 9999 * ISO 9001 Quality management systems – Requirements

93 List of International Organization for Standardization standards - ISO 10000 – ISO 14999
* ISO 10005:2005 Quality management systems – Guidelines for quality plans

94 List of International Organization for Standardization standards - ISO 10000 – ISO 14999
* ISO Quality management systems – Guidelines for quality management in projects

95 List of International Organization for Standardization standards - ISO 10000 – ISO 14999
* ISO Quality management systems – Guidelines for configuration management

96 List of International Organization for Standardization standards - ISO 10000 – ISO 14999
* ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes

97 List of International Organization for Standardization standards - ISO 15000 – ISO 19999
* ISO/TS Quality management systems – Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations

98 ISO 9002 ISO 9000 deals with the fundamentals of quality management systems, including the eight management principles upon which the family of standards is based

99 ISO Background BSI has been certifying organizations for their quality management systems since 1978

100 ISO Contents of ISO 9001 The other two standards are supplementary and contain deeper information on how to sustain and improve quality management systems; they are therefore not used directly during third party assessment

101 ** Section 4: Quality Management System
ISO Contents of ISO 9001 ** Section 4: Quality Management System

102 ISO Certification Although commonly referred to as ISO 9000 certification, the actual standard to which an organization's quality management system can be certified is ISO 9001:2008

103 ISO 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:

104 ISO version ISO 9001:2008 basically renarrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14000|ISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.

105 ISO version * ISO 9000:2005 Quality management systems. Fundamentals and vocabulary

106 ISO 9002 - Industry-specific interpretations
In 1998 QuEST Forum developed the TL 9000 Quality Management System to meet the supply chain quality requirements of the worldwide telecommunications industry

107 ISO 9002 - Industry-specific interpretations
* 'ISO/TS 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.

108 ISO Effectiveness #Does it help to implement an ISO 9001:2000-compliant quality management system?

109 ISO Advantages Journal of Operations Management, Volume 26, Issue 4, July 2008, Pages The quality principles in ISO 9000:2000 are also sound, according to Wade and Barnes, who says that ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive

110 Indian Institute of Technology - Technical and cultural festivals
Shaastra holds the distinction of being the first student-managed event in the world to implement a formal Quality Management System, earning ISO 9001:2000 certification

111 ISO 50001 The system is modeled after the ISO 9001 Quality Management System and the ISO Environmental Management System (EMS). Eccleston describes the procedural details of the ISO Energy Management System (EnMS) and compares its procedures with those of the ISO EMS.Eccleston C., March F., and Cohen T., Inside Energy: The Handbook for Implementing an ISO Energy Management Systems, CRC Press Inc. 300 pages (2011).

112 ISO Structure The structure of ISO is designed according to other ISO management system standards, in particular ISO 9001 (Quality Management Systems) and ISO (Environmental Management Systems). Since all three management systems are based on the PDCA cycle, ISO can be integrated easily to these systems. viewed 24 October 2012.

113 Farm assurance In the United Kingdom and Australia, the major farm assurance programmes are based on a quality management system for food safety that originated with the US space agency NASA, known as Hazard Analysis and Critical Control Points (HACCP)

114 Calibration - Quality Quality management systems call for an effective metrology system which includes formal, periodic, and documented calibration of all measuring instruments. ISO 9000ISO 9001: Quality management systems — Requirements (2008), section 7.6. and ISO 17025ISO 17025: General requirements for the competence of testing and calibration laboratories (2005), section 5. standards require that these traceable actions are to a high level and set out how they can be quantified.

115 Measurement Systems Analysis
MSA is an important element of Six Sigma methodology and of other quality management systems.

116 Measurement Systems Analysis - Factors affecting measurement systems
* Management: training programs, metrology system, support of people, support of quality management system, etc.

117 Project development - International standards
* The ISO standards ISO 9000, a family of standards for quality management systems, and the ISO 10006:2003, for Quality management systems and guidelines for quality management in projects.

118 Clinical Quality Management System
A 'Clinical Quality Management System (CQMS)' allows an entire practice staff to take part in increasing the quality of care delivered to their patients

119 Quality system [ What is a Quality Management System?], Bizmanualz, Nov 18, 2013

120 Quality management framework
Based on the iTQM (integrated total quality management system) which shows that research into this field is “about how to design a top-down orchestrated serviced oriented architecture to integrate TQM element cores into a whole system supported by advanced information technology, data mining, service policies, forced training and governance” (WANG 2008).Integrated Total Quality Management Wang, Wu The University of Sussex 2008 Focusing heavily on quality and process improvements these systems rely on separate processes to realise a robust security policy

121 AS9100 'AS9100' is a widely adopted and standardized quality management system for the aerospace industry.

122 ISO 9001:2000 ISO 9000 deals with the fundamentals of quality management systems, including the eight management principles upon which the family of standards is based

123 ISO 9001: Background BSI has been certifying organizations for their quality management systems since 1978

124 ISO 9001:2000 - Industry-specific interpretations
In 1998 QuEST Forum developed the TL 9000 Quality Management System to meet the supply chain quality requirements of the worldwide telecommunications industry

125 Indian Institute of Technology Roorkee - Student activities
Students conduct two fests every year, Cognizance (Technical festival) and Thomso (Cultural festival). Cognizance, India's second largest technical festival is 9001:2008 certified and operates a quality management system in organizing its events.

126 Software reliability - Definitions
There are many different definitions of quality. For some it is the capability of a software product to conform to requirements. (ISO/IEC 9001,International Organization for Standardization, ISO/IEC 9001: Quality management systems -- Requirements, commented by International Organization for Standardization, ISO/IEC 24765: Systems and software engineering — Vocabulary, 2010.) while for others it can be synonymous with customer value (Highsmith, 2002) or even defect level.

127 Rajendra S. Pawar - Biography
Crosby|Phil Crosby's Complete Quality Management System in NIIT

128 Shaastra Shaastra is entirely student managed and holds the distinction of being the first such event in the world to be ISO 9001:2000 certified for implementing a Quality Management System.

129 Saarang - Organisation
The Cores, 24 in total, lead the various departments of Finance, Publicity, Sponsorship, Events, Design, Hospitality, Facilities and Requirements, Security and QMS (Quality Management System). They are assisted by the co-ordinators(around 200 in number) who are assigned more specific roles

130 Higher education accreditation - Germany
These agencies accredit programs of study for Bachelor and Master degrees and quality management systems (system accreditation) from state or state recognized Higher Education institutions in Germany and abroad.Accreditation Council, [ Accreditation of Programs] AKAST only accredit programs of study.

131 Metrology - Metrological traceability
Traceability, accuracy and precision|accuracy, precision, systematic bias, evaluation of measurement uncertainty are critical parts of a quality management system.

132 Cosmetics - International
ISO provides a comprehensive approach for a quality management system for those engaged in the manufacturing, packaging, testing, storage, and transportation of cosmetic end products. The standard deals with all aspects of the supply chain, from the early delivery of raw materials and components until the shipment of the final product to the consumer.[ ISO Whitepaper] Retrieved 09/27/2012

133 Cosmetics - International
The standard is based on other quality management systems, ensuring smooth integration with such systems as ISO 9001 or the British Retail Consortium (BRC) standard for consumer products

134 Hazard Analysis and Critical Control Points - Standards
The seven HACCP principles are included in the international standard ISO FSMS This standard is a complete food safety and quality ISO FSMS 2005 management system incorporating the elements of prerequisite programmes(GMP SSOP), HACCP and the quality management system, which together form an organization's Total Quality Management system.

135 Hospital accreditation - International schemes
DNV Healthcare is a Norwegian-US health care accrediting organisation providing a quality management system constructed in accordance with ISO 9001 and approved by the U.S. Centers for Medicare and Medicaid Services (CMS).

136 Tolerance (engineering) - Considerations when setting tolerances
The process capability of systems, materials, and products needs to be compatible with the specified engineering tolerances. Process controls must be in place and an effective Quality management system, such as Total Quality Management, needs to keep actual production within the desired tolerances. A process capability index is used to indicate the relationship between tolerances and actual measured production.

137 Gold Coast, Queensland - Utilities
Gold Coast Water has also been recognised for its world leading HACCP water quality management system by the World Health Organisation which published Gold Coast Water's system as a good model for managing water quality and safety from catchment to tap. The Gold Coast desalination project|Gold Coast desalination plant, which opened in February 2009, has the capacity to supply up to 133 megalitres of desalinated water per day.

138 Bureau of Indian Standards - Management System Certification
* Quality Management System Certification Scheme IS/ISO 9001

139 Bureau of Indian Standards - Management System Certification
* Service Quality Management System Certification Scheme IS 15700

140 ISO 21500 ISO also designed this standard to align with other, related standards such as ISO 10006:2003, Quality management systems − Guidelines for quality management in projects, ISO 10007:2003, Quality management systems − Guidelines for configuration management, ISO 31000:2009, Risk management – Principles and guidelines

141 Crown Paints More than 1,250 employees work for Crown Paints, which has its headquarters in Darwen in Lancashire. Its manufacturing sites in Darwen and Hull operate to ISO 9001 quality management system and ISO environmental management system. Crown Paints holds the Investors in People standard, which in July 2013 was upgraded to the Gold award.

142 Food packaging - Regulations
Food packaging considerations may include: use of Hazard analysis and critical control points, Verification and validation protocols, Good manufacturing practices, use of an effective Quality management system, Track and trace systems, and requirements for label content

143 ISO ISO – ISO 14999 * ISO 10006:2003 Quality management systems – Guidelines for quality management in projects

144 ISO ISO – ISO 14999 * ISO/TR 10013:2001 Guidelines for quality management system documentation

145 ISO ISO – ISO 14999 * ISO 10019:2005 Guidelines for the selection of quality management system consultants and use of their services

146 ISO ISO – ISO 19999 ** ISO/IEC TS :2013 Conformity assessment -- Requirements for bodies providing audit and certification of management systems -- Part 3: Competence requirements for auditing and certification of quality management systems

147 Patient Management Software - History
In order to obtain a medical device licence, manufacturers must hold a quality management system (QMS) certificate issued by an accredited registrar showing that the QMS is compliant with ISO 13485: 2003 Medical devices – Quality management systems – requirements for regulatory purposes

148 Test method - Content of a test method
Quality management systems usually require full documentation of the procedures used in a test. The document for a test method might include:

149 Reusable packaging - Industrial shipping containers
Bulk foods, chemicals, and pharmaceuticals are often shipped in reusable and returnable containers. These need to be carefully inspected, cleaned and sanitized as part of the reuse cycle. An effective Quality Management System is necessary.

150 METRiQ 'METRiQ' is a trademarked linguistic quality management system developed by [ ForeignExchange Translations, Inc.] of Newton, Massachusetts. It makes use of a Web-based tool programmed to provide objective measurement of all tasks in a translation project workflow.

151 Manufacturing test requirement design specification
'Manufacturing test requirement design specification' ('MTRD') is a document which specifies how testing is to be implemented on a new or modified manufactured product. The specification includes which tests will be applied to different build processes, the percentage of coverage for each stage of those build process, and how data on errors and problems will be gathered and processed. It would be expected to refer heavily to the organisation's Quality Management System (QMS).

152 ISO/TS 16949 The 'International Organization for Standardization|ISO/TS16949' is an ISO technical specification aimed at the development of a quality management system that provides for continual improvement, emphasizing wikt:defect|defect prevention and the reduction of variation and waste in the supply chain. It is based on the ISO 9001 standard and the first edition was published in March 2002 as ISO/TS 16949:2002.

153 ISO/TS 16949 It was prepared by the International Automotive Task Force (IATF) and the Technical Committee of ISO. It harmonizes the country-specific regulations of quality Management systems.

154 ISO/TS 16949 About 30 percent of the more than 100 existing automobile manufacturers affiliate the requirements of the norm but especially the large Asian manufacturers have differentiated, own requirements for the quality management systems of their corporate group and their suppliers.

155 ISO/TS 16949 - Historical background
Many suppliers were asked by the car manufacturers (OEMs) to build and certify their quality management system according to the rules and regulations of their own country organizations, such as:

156 ISO/TS 16949 - Contents of the specification
* Chapter 4: Quality Management System (general requirements, control of documents and records)

157 ISO/TS 16949 - Contents of the specification
It looks at the business processes in a process environment in which there are interactions and interfaces that need to be recognized, mapped and controlled by the quality management system

158 ISO/TS 16949 - Contents of the specification
A key requirement of ISO / TS 16949:2009 is the fulfillment of customer-specific requirements, set up by the automotive manufacturer in addition to the quality management system of their suppliers. This may have decisively contributed to the worldwide recognition of the TS by many manufacturers.

159 Acceptance sampling - History
More recently, quality assurance broadened the scope beyond final inspection to include all aspects of manufacturing. Broader quality management systems include methodologies such as statistical process control, HACCP, six sigma, and ISO Some use of acceptance sampling still remains.

160 Verification (disambiguation)
* Verification and validation, in engineering or quality management systems, it is the act of reviewing, inspecting or testing, in order to establish and document that a product, service or system meets regulatory or technical standards.

161 ISO/TC Overview The scope of the committee is ‘Standardization in the field of quality management (generic quality management systems and supporting technologies), as well as quality management standardization in specific sectors at the request of the affected sector and the ISO Technical Management Board’.

162 ISO/TC 176 - ISO/TC 176/SC 2: Quality systems
* ISO 9001:2008 Quality management systems—Requirements

163 ISO/TC 176 - ISO/TC 176/SC 2: Quality systems
* ISO 10006:2003 Quality management systems—Guidelines for quality management in projects

164 APM Terminals - APM Terminals' recent developments
In 2012 APM Terminals Tangier received IMS certification in ISO 9001 (Quality Management Systems), ISO (Environmental Management Systems) and OHSAS (Health and Safety Management Systems)

165 ISO 13485:2012 'ISO 13485' is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.[ ISO Catalogue: ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes] This standard supersedes earlier documents such as EN and EN (both 1997), the ISO published in 1996 and ISO (also 1996).

166 Temperature data logger - Construction
Depending on the use, governing quality management systems sometimes require calibration to national standards and compliance with formal verification and validation protocols

167 Heat sealer - Seal quality
Heat sealing processes can be controlled by a variety of quality management systems such as HACCP, statistical process control, ISO 9000, etc. Verification and validation protocols are used to ensure that specifications are met and final materials/packages are suited for end-use.

168 Heat sealer - Seal Strength Testing
Quality management systems sometimes ask for periodic subjective evaluations: For example, some seals can be evaluated by a simple pull to determine the existence of a bond and the mechanism of failure

169 International Academy of Management and Economics - History
On March 21, 2003, I/AME became the first Makati City-based business school to fulfill the requirements of International Organization for Standardization|ISO 9001:2000 for establishing a Quality Management System for the Provision of Higher Education in Management, specifically for the design, delivery, and testing of business courses, and overall facilities management.I/AME Newsletter, April 2006 Issue, IAME Press.

170 Kitemark - History With the introduction of quality management systems standards in the 1970s Kitemark schemes were developed in areas such as double glazing and fire safety. Today there are more than 450 individual Kitemark schemes covering everything from printed circuit boards to cattle tags.

171 Kitemark - Availability
In addition, delivery of the product or service is audited against an accredited quality management system

172 Verband der Automobilindustrie
The VDA published a series of VDA 6.1|standards and recommendations. Among those is the Germany|German Quality Management System (QMS) for the automobile industry. The fourth edition was issued in December 1998, and became mandatory for all German car makers on April 1, 1999.

173 Bühler Motor Bühler Motor is certified for its quality management system under ISO/TS 16949|ISO/TS 16949:2002 and for its environmental management system under ISO 14001|DIN EN ISO 14001:2004. The Nuremberg and Monheim locations are also certified for its medical management system under EN ISO13485:2003/AC:2009 since 2011.

174 Global Load Control - Controversy
Since then, Global Load Control has received its Dekra ISO 9001:2008 certification, and states on its corporate website that it is committed to ...producing a quality service by focusing on the principles of safety, punctuality and economy..., and that its quality management systems are continually reviewed and improved.

175 Hostelling International - Quality
HI-Q is Hostelling International's quality management system. It takes the best practice from quality systems around the world and enables hostels to consistently improve and deliver high standards.

176 For More Information, Visit:
The Art of Service


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