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Quality management system

A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality are increasingly tied to these factors. Of QMS regimes, the ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011 audit regime applies to both and deals with quality and sustainability and their integration.

Other QMS, e.g. Natural Step, focus on sustainability issues and assume that other quality problems will be reduced as result of the systematic thinking, transparency, documentation and diagnostic discipline.

The term "Quality Management System" and the initialism "QMS" were invented in 1991 by Ken Croucher, a British management consultant working on designing and implementing a generic model of a QMS within the IT industry.

Elements

  1. Quality objectives
  2. Quality manual
  3. Organizational structure and responsibilities
  4. Data management
  5. Processes – including purchasing
  6. Product quality leading to customer satisfaction
  7. Continuous improvement including corrective and preventive action
  8. Quality instrument
  9. Document control
  10. Employee training and engagement
  11. Supplier quality management

Concept of quality – historical background

The concept of a quality as we think of it now first emerged from the Industrial Revolution. Previously goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking the product to meet 'quality criteria'. Mass production brought huge teams of people together to work on specific stages of production where one person would not necessarily complete a product from start to finish. In the late 19th century pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Birland established Quality Departments to oversee the quality of production and rectifying of errors, and Ford emphasized standardization of design and component standards to ensure a standard product was produced. Management of quality was the responsibility of the Quality department and was implemented by Inspection of product output to 'catch' defects.

Application of statistical control came later as a result of World War production methods, which were advanced by the work done of W. Edwards Deming, a statistician, after whom the Deming Prize for quality is named. Joseph M. Juran focused more on managing for quality. The first edition of Juran's Quality Control Handbook was published in 1951. He also developed the "Juran's trilogy", an approach to cross-functional management that is composed of three managerial processes: quality planning, quality control, and quality improvement. These functions all play a vital role when evaluating quality.

Quality, as a profession and the managerial process associated with the quality function, was introduced during the second half of the 20th century and has evolved since then. Over this period, few other disciplines have seen as many changes as the quality profession.

The quality profession grew from simple control to engineering, to systems engineering. Quality control activities were predominant in the 1940s, 1950s, and 1960s. The 1970s were an era of quality engineering and the 1990s saw quality systems as an emerging field. Like medicine, accounting, and engineering, quality has achieved status as a recognized profession[1]

As Lee and Dale (1998) state, there are many organizations that are striving to assess the methods and ways in which their overall productivity, the quality of their products and services and the required operations to achieve them are done.

Medical devices

The two primary, state of the art, guidelines for medical device manufacturer QMS and related services today are the ISO 13485 standards and the US FDA 21 CFR 820 regulations. The two have a great deal of similarity, and many manufacturers adopt QMS that is compliant with both guidelines.

ISO 13485 are harmonized with the European Union Regulation 2017/745 as well as the IVD and AIMD directives. The ISO standard is also incorporated in regulations for other jurisdictions such as Japan (JPAL) and Canada (CMDCAS).

Quality System requirements for medical devices have been internationally recognized as a way to assure product safety and efficacy and customer satisfaction since at least 1983 and were instituted as requirements in a final rule published on October 7, 1996.[2] The U.S. Food and Drug Administration (FDA) had documented design defects in medical devices that contributed to recalls from 1983 to 1989 that would have been prevented if Quality Systems had been in place. The rule is promulgated at 21 CFR 820.[3]

According to current Good Manufacturing Practice (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations, in Part 820 of the QS regulation.[3] As with GMP, operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements.

The FDA has identified in the QS regulation the 7 essential subsystems of a quality system. These subsystems include:

 
Quality system
  • Management controls;
  • Design controls;
  • Production and process controls
  • Corrective and preventative actions
  • Material controls
  • Records, documents, and change controls
  • Facilities and equipment controls

all overseen by management and quality audits.

Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement procedures tailored to their particular processes and devices. For example, if it is impossible to mix up labels at a manufacturer because there is only one label to each product, then there is no necessity for the manufacturer to comply with all of the GMP requirements under device labeling.

Drug manufacturers are regulated under a different section of the Code of Federal Regulations:

Organizations and awards

The International Organization for Standardization's ISO 9001:2015 series describes standards for a QMS addressing the principles and processes surrounding the design, development, and delivery of a general product or service. Organizations can participate in a continuing certification process to ISO 9001:2015 to demonstrate their compliance with the standard, which includes a requirement for continual (i.e. planned) improvement of the QMS, as well as more foundational QMS components such as failure mode and effects analysis (FMEA).[4]

ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a 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.

The Baldrige Performance Excellence Program educates organizations in improving their performance and administers the Malcolm Baldrige National Quality Award. The Baldrige Award recognizes U.S. organizations for performance excellence based on the Baldrige Criteria for Performance Excellence. The Criteria address critical aspects of management that contribute to performance excellence: leadership; strategy; customers; measurement, analysis, and knowledge management; workforce; operations; and results.

The European Foundation for Quality Management's EFQM Excellence Model supports an award scheme similar to the Baldrige Award for European companies.

In Canada, the National Quality Institute presents the 'Canada Awards for Excellence' on an annual basis to organizations that have displayed outstanding performance in the areas of Quality and Workplace Wellness, and have met the institute's criteria with documented overall achievements and results.

The European Quality in Social Service (EQUASS) is a sector-specific quality system designed for the social services sector and addresses quality principles that are specific to service delivery to vulnerable groups, such as empowerment, rights, and person-centredness.

The Alliance for Performance Excellence is a network of state and local organizations that use the Baldrige Criteria for Performance Excellence at the grassroots level to improve the performance of local organizations and economies. browsers can find Alliance members in their state and get the latest news and events from the Baldrige community.

Process

A QMS process is an element of an organizational QMS. The ISO 9001 standard requires organizations seeking compliance or certification to define the processes which form the QMS and the sequence and interaction of these processes. Butterworth-Heinemann and other publishers have offered several books which provide step-by-step guides to those seeking the quality certifications of their products[5], [6][7][8][9][10]

Examples of such processes include:

ISO 9001 requires that the performance of these processes be measured, analyzed and continually improved, and the results of this form an input into the management review process.

Software

Quality management software offers the techniques, processes, structure, and resources needed to simplify manufacturing and ERP activities while handling quality concerns efficiently and cost-effectively.

Helps manufacturers to monitor, control, and document quality processes electronically to guarantee that goods are made within tolerance, meet all necessary requirements, and are defect-free. Quality management software is often used in the manufacturing industry to identify potential issues before they occur.[3]

Some benefits of quality management software include:

  • real-time data monitoring
  • issue prevention
  • risk management
  • increased efficiency and productivity
  • process consistency
  • increased employee participation

Quality management software can be integrated with manufacturing execution systems (MES). A MES is a complete, dynamic software system for monitoring, tracking, documenting, and controlling the manufacturing process from raw materials to final products.[11] When combined with QMS, these systems:

  • ensure compliance
  • enable quality programs
  • eliminate waste
  • less product recalls
  • lower per-product cost
  • higher product quality
  • real-time information for increase in quality control
  • realistic production schedules
  • up-to-date inventory
  • product tracking

Quality management software focuses on 4 main elements:[1]

  1. Document management: Quality management software enables companies to manage all product and quality records and documents, including product specifications, work instructions, standard operating procedures (SOPs), quality policies, and training records, among other things, to fulfill highly regulated requirements. Quality management software centralizes the storage of these documents.
  2. Regulatory compliance: To decrease compliance risks, quality management software is used within companies to make sure they comply with ISO, OSHA, FDA, and other industry norms and requirements. The software makes closed-loop corrective and preventive action procedures (CAPA) possible, which result in faster issue resolution and issue prevention.
  3. Feedback loops: Quality management software permits staff to submit feedback or recommendations through centralized software. In turn, this way, managers gather insights from the shop floor creating a feedback loop.
  4. Training and skill management: To maintain product quality, quality management software can provide a fixed system through which employees and staff can be trained. This fixed system provides more clarity in the different tracking processes of the company and simplifies the tracking of different skill levels of employees.

Most quality management software are cloud-based and offer software as a service.

See also

References

  1. ^ a b American Society for Quality (ASQ) Certified Quality Engineer (CQE) http://prdweb.asq.org/certification/control/quality-engineer/index
  2. ^ "Homepage | ISPE | International Society for Pharmaceutical Engineering". ispe.org. Retrieved 2020-07-31.
  3. ^ a b c http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfr820_05.html
  4. ^ Poksinska, Bozena; Dahlgaard, Jens Jörn; Antoni, Marc (2002). "The state of ISO 9000 certification: A study of Swedish organizations". The TQM Magazine. 14 (5): 297. doi:10.1108/09544780210439734.
  5. ^ Anton, Doug; Carole Anton (2006). ISO 9001 Survival Guide, Third Edition. AEM Consulting Group, Inc. p. 100. ISBN 978-0-9672170-8-6.
  6. ^ Tricker, Ray; Bruce Sherring-Lucas (2005). ISO 9001:2008 In Brief, Second Edition. Butterworth-Heinemann. p. 192. ISBN 978-0-7506-6616-9.
  7. ^ Tricker, Ray (2005). ISO 9001:2000 Audit Procedures, Second Edition. Butterworth-Heinemann. p. 320. ISBN 978-0-7506-6615-2.
  8. ^ Tricker, Ray (2005). ISO 9001: 2000 For Small Businesses. Butterworth-Heinemann. p. 480. ISBN 978-0-7506-6617-6.
  9. ^ Hoyle, David (2005). ISO 9000 Quality Systems Handbook, Fifth Edition. Butterworth-Heinemann. p. 686. ISBN 978-0-7506-6785-2.
  10. ^ Dobb, Fred (2004). ISO 9001:2000 Quality Registration Step-by-Step, Third Edition. Butterworth-Heinemann. p. 292. ISBN 978-0-7506-4949-0.
  11. ^ "What Is an MES (Manufacturing Execution System)?". SAP.com. Retrieved 23 March 2022.

General references

  • (and see Clinical Quality Management System)
  • Pyzdek, T, "Quality Engineering Handbook", 2003, ISBN 0-8247-4614-7
  • Juran, Joseph M. and De Feo, Joseph A., "Juran's Quality Handbook", 6th Edition, 1999, ISBN 978-0-07-162973-7
  • Beernaerts, Indira (2022-02-16). "The key requirements of a good QMS system for manufacturing". Azumuta. Retrieved 2022-03-24.
  • "Quality Management Systems". Siemens.com. Retrieved 23 March 2022.
  • "What Is en MES (Manufacturing Execution System)?". SAP.com. 23 March 2022. Retrieved 23 March 2022.

External links

  • WHAT IS A QUALITY MANAGEMENT SYSTEM (QMS)?

quality, management, system, this, article, multiple, issues, please, help, improve, discuss, these, issues, talk, page, learn, when, remove, these, template, messages, this, article, includes, list, general, references, lacks, sufficient, corresponding, inlin. This article has multiple issues Please help improve it or discuss these issues on the talk page Learn how and when to remove these template messages This article includes a list of general references but it lacks sufficient corresponding inline citations Please help to improve this article by introducing more precise citations September 2010 Learn how and when to remove this template message This article needs additional citations for verification Please help improve this article by adding citations to reliable sources Unsourced material may be challenged and removed Find sources Quality management system news newspapers books scholar JSTOR October 2020 Learn how and when to remove this template message Learn how and when to remove this template message A quality management system QMS is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction It is aligned with an organization s purpose and strategic direction ISO 9001 2015 It is expressed as the organizational goals and aspirations policies processes documented information and resources needed to implement and maintain it Early quality management systems emphasized predictable outcomes of an industrial product production line using simple statistics and random sampling By the 20th century labor inputs were typically the most costly inputs in most industrialized societies so focus shifted to team cooperation and dynamics especially the early signaling of problems via a continual improvement cycle In the 21st century QMS has tended to converge with sustainability and transparency initiatives as both investor and customer satisfaction and perceived quality are increasingly tied to these factors Of QMS regimes the ISO 9000 family of standards is probably the most widely implemented worldwide the ISO 19011 audit regime applies to both and deals with quality and sustainability and their integration Other QMS e g Natural Step focus on sustainability issues and assume that other quality problems will be reduced as result of the systematic thinking transparency documentation and diagnostic discipline The term Quality Management System and the initialism QMS were invented in 1991 by Ken Croucher a British management consultant working on designing and implementing a generic model of a QMS within the IT industry Contents 1 Elements 2 Concept of quality historical background 3 Medical devices 4 Organizations and awards 5 Process 6 Software 7 See also 8 References 8 1 General references 9 External linksElements EditQuality objectives Quality manual Organizational structure and responsibilities Data management Processes including purchasing Product quality leading to customer satisfaction Continuous improvement including corrective and preventive action Quality instrument Document control Employee training and engagement Supplier quality managementConcept of quality historical background EditThe concept of a quality as we think of it now first emerged from the Industrial Revolution Previously goods had been made from start to finish by the same person or team of people with handcrafting and tweaking the product to meet quality criteria Mass production brought huge teams of people together to work on specific stages of production where one person would not necessarily complete a product from start to finish In the late 19th century pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output Birland established Quality Departments to oversee the quality of production and rectifying of errors and Ford emphasized standardization of design and component standards to ensure a standard product was produced Management of quality was the responsibility of the Quality department and was implemented by Inspection of product output to catch defects Application of statistical control came later as a result of World War production methods which were advanced by the work done of W Edwards Deming a statistician after whom the Deming Prize for quality is named Joseph M Juran focused more on managing for quality The first edition of Juran s Quality Control Handbook was published in 1951 He also developed the Juran s trilogy an approach to cross functional management that is composed of three managerial processes quality planning quality control and quality improvement These functions all play a vital role when evaluating quality Quality as a profession and the managerial process associated with the quality function was introduced during the second half of the 20th century and has evolved since then Over this period few other disciplines have seen as many changes as the quality profession The quality profession grew from simple control to engineering to systems engineering Quality control activities were predominant in the 1940s 1950s and 1960s The 1970s were an era of quality engineering and the 1990s saw quality systems as an emerging field Like medicine accounting and engineering quality has achieved status as a recognized profession 1 As Lee and Dale 1998 state there are many organizations that are striving to assess the methods and ways in which their overall productivity the quality of their products and services and the required operations to achieve them are done Medical devices EditThe two primary state of the art guidelines for medical device manufacturer QMS and related services today are the ISO 13485 standards and the US FDA 21 CFR 820 regulations The two have a great deal of similarity and many manufacturers adopt QMS that is compliant with both guidelines ISO 13485 are harmonized with the European Union Regulation 2017 745 as well as the IVD and AIMD directives The ISO standard is also incorporated in regulations for other jurisdictions such as Japan JPAL and Canada CMDCAS Quality System requirements for medical devices have been internationally recognized as a way to assure product safety and efficacy and customer satisfaction since at least 1983 and were instituted as requirements in a final rule published on October 7 1996 2 The U S Food and Drug Administration FDA had documented design defects in medical devices that contributed to recalls from 1983 to 1989 that would have been prevented if Quality Systems had been in place The rule is promulgated at 21 CFR 820 3 According to current Good Manufacturing Practice GMP medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System QS Regulation that are applicable to their specific products and operations in Part 820 of the QS regulation 3 As with GMP operating within this flexibility it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective and to establish methods and procedures to design produce and distribute devices that meet the quality system requirements The FDA has identified in the QS regulation the 7 essential subsystems of a quality system These subsystems include Quality system Management controls Design controls Production and process controls Corrective and preventative actions Material controls Records documents and change controls Facilities and equipment controlsall overseen by management and quality audits Because the QS regulation covers a broad spectrum of devices and production processes it allows some leeway in the details of quality system elements It is left to manufacturers to determine the necessity for or extent of some quality elements and to develop and implement procedures tailored to their particular processes and devices For example if it is impossible to mix up labels at a manufacturer because there is only one label to each product then there is no necessity for the manufacturer to comply with all of the GMP requirements under device labeling Drug manufacturers are regulated under a different section of the Code of Federal Regulations Organizations and awards EditSee also List of national quality awards The International Organization for Standardization s ISO 9001 2015 series describes standards for a QMS addressing the principles and processes surrounding the design development and delivery of a general product or service Organizations can participate in a continuing certification process to ISO 9001 2015 to demonstrate their compliance with the standard which includes a requirement for continual i e planned improvement of the QMS as well as more foundational QMS components such as failure mode and effects analysis FMEA 4 ISO 9000 2005 provides information on the fundamentals and vocabulary used in quality management systems ISO 9004 2009 provides guidance on a 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 The Baldrige Performance Excellence Program educates organizations in improving their performance and administers the Malcolm Baldrige National Quality Award The Baldrige Award recognizes U S organizations for performance excellence based on the Baldrige Criteria for Performance Excellence The Criteria address critical aspects of management that contribute to performance excellence leadership strategy customers measurement analysis and knowledge management workforce operations and results The European Foundation for Quality Management s EFQM Excellence Model supports an award scheme similar to the Baldrige Award for European companies In Canada the National Quality Institute presents the Canada Awards for Excellence on an annual basis to organizations that have displayed outstanding performance in the areas of Quality and Workplace Wellness and have met the institute s criteria with documented overall achievements and results The European Quality in Social Service EQUASS is a sector specific quality system designed for the social services sector and addresses quality principles that are specific to service delivery to vulnerable groups such as empowerment rights and person centredness The Alliance for Performance Excellence is a network of state and local organizations that use the Baldrige Criteria for Performance Excellence at the grassroots level to improve the performance of local organizations and economies browsers can find Alliance members in their state and get the latest news and events from the Baldrige community Process EditA QMS process is an element of an organizational QMS The ISO 9001 standard requires organizations seeking compliance or certification to define the processes which form the QMS and the sequence and interaction of these processes Butterworth Heinemann and other publishers have offered several books which provide step by step guides to those seeking the quality certifications of their products 5 6 7 8 9 10 Examples of such processes include order processes production plans product service process measurements to comply with specific requirements e g statistical process control and measurement systems analysis calibrations internal audit corrective and preventive action identification labeling and control of non conforming products to prevent its inadvertent use delivery or processing purchasing and related processes such as supplier selection and monitoringISO 9001 requires that the performance of these processes be measured analyzed and continually improved and the results of this form an input into the management review process Software EditQuality management software offers the techniques processes structure and resources needed to simplify manufacturing and ERP activities while handling quality concerns efficiently and cost effectively Helps manufacturers to monitor control and document quality processes electronically to guarantee that goods are made within tolerance meet all necessary requirements and are defect free Quality management software is often used in the manufacturing industry to identify potential issues before they occur 3 Some benefits of quality management software include real time data monitoring issue prevention risk management increased efficiency and productivity process consistency increased employee participationQuality management software can be integrated with manufacturing execution systems MES A MES is a complete dynamic software system for monitoring tracking documenting and controlling the manufacturing process from raw materials to final products 11 When combined with QMS these systems ensure compliance enable quality programs eliminate waste less product recalls lower per product cost higher product quality real time information for increase in quality control realistic production schedules up to date inventory product trackingQuality management software focuses on 4 main elements 1 Document management Quality management software enables companies to manage all product and quality records and documents including product specifications work instructions standard operating procedures SOPs quality policies and training records among other things to fulfill highly regulated requirements Quality management software centralizes the storage of these documents Regulatory compliance To decrease compliance risks quality management software is used within companies to make sure they comply with ISO OSHA FDA and other industry norms and requirements The software makes closed loop corrective and preventive action procedures CAPA possible which result in faster issue resolution and issue prevention Feedback loops Quality management software permits staff to submit feedback or recommendations through centralized software In turn this way managers gather insights from the shop floor creating a feedback loop Training and skill management To maintain product quality quality management software can provide a fixed system through which employees and staff can be trained This fixed system provides more clarity in the different tracking processes of the company and simplifies the tracking of different skill levels of employees Most quality management software are cloud based and offer software as a service See also EditCapability Maturity Model Integration Cleaner production Good manufacturing practice ISO 14001 List of management topics List of national quality awards Manufacturing process management Positive recall Process architecture Quality Quality assurance Quality control Quality management Software quality Standard operating procedure Technical documentation Total quality management Verification and validationReferences Edit a b American Society for Quality ASQ Certified Quality Engineer CQE http prdweb asq org certification control quality engineer index Homepage ISPE International Society for Pharmaceutical Engineering ispe org Retrieved 2020 07 31 a b c http www access gpo gov nara cfr waisidx 05 21cfr820 05 html Poksinska Bozena Dahlgaard Jens Jorn Antoni Marc 2002 The state of ISO 9000 certification A study of Swedish organizations The TQM Magazine 14 5 297 doi 10 1108 09544780210439734 Anton Doug Carole Anton 2006 ISO 9001 Survival Guide Third Edition AEM Consulting Group Inc p 100 ISBN 978 0 9672170 8 6 Tricker Ray Bruce Sherring Lucas 2005 ISO 9001 2008 In Brief Second Edition Butterworth Heinemann p 192 ISBN 978 0 7506 6616 9 Tricker Ray 2005 ISO 9001 2000 Audit Procedures Second Edition Butterworth Heinemann p 320 ISBN 978 0 7506 6615 2 Tricker Ray 2005 ISO 9001 2000 For Small Businesses Butterworth Heinemann p 480 ISBN 978 0 7506 6617 6 Hoyle David 2005 ISO 9000 Quality Systems Handbook Fifth Edition Butterworth Heinemann p 686 ISBN 978 0 7506 6785 2 Dobb Fred 2004 ISO 9001 2000 Quality Registration Step by Step Third Edition Butterworth Heinemann p 292 ISBN 978 0 7506 4949 0 What Is an MES Manufacturing Execution System SAP com Retrieved 23 March 2022 General references Edit ICH1 Guidance E6 Good Clinical Practice Consolidated guideline and see Clinical Quality Management System Pyzdek T Quality Engineering Handbook 2003 ISBN 0 8247 4614 7 Juran Joseph M and De Feo Joseph A Juran s Quality Handbook 6th Edition 1999 ISBN 978 0 07 162973 7 Beernaerts Indira 2022 02 16 The key requirements of a good QMS system for manufacturing Azumuta Retrieved 2022 03 24 Quality Management Systems Siemens com Retrieved 23 March 2022 What Is en MES Manufacturing Execution System SAP com 23 March 2022 Retrieved 23 March 2022 External links EditWHAT IS A QUALITY MANAGEMENT SYSTEM QMS Retrieved from https en wikipedia org w index php title Quality management system amp oldid 1116037117, wikipedia, wiki, book, books, library,

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