The document introduces several ISO standards related to conformity assessment. It provides brief descriptions of the purpose and scope of ISO/IEC 17011 on accreditation body requirements, ISO/IEC 17021-1 on management system certification body requirements, ISO/IEC 17020 on inspection body requirements, ISO/IEC 17024 on personnel certification body requirements, ISO/IEC 17025 on testing and calibration laboratory requirements, and ISO/IEC 17029 on validation and verification body requirements. The standards establish globally accepted principles and criteria to ensure consistent and reliable conformity assessment activities.
3 - Introduction to Conformity Assessment and ISO CASCO.pdfssuser035fe5
This document provides an introduction to conformity assessment and ISO/CASCO. It defines conformity assessment as demonstrating that a product, service or system meets specified requirements, usually contained in a standard. ISO/CASCO is the ISO committee that develops standards for conformity assessment bodies to ensure they are competent and impartial. It maintains a "toolbox" of over 35 standards covering testing labs, certification bodies, inspection bodies, and more. The document gives examples of common conformity assessment activities and standards.
The document provides a history of accreditation in the UK, beginning with the British Calibration Service established in 1966. It later merged with another organization to form the National Measurement Accreditation Service in 1985, which was renamed the UK Accreditation Service in 1995. The document also defines accreditation and certification, and explains that accreditation evaluates a laboratory's technical competence according to ISO/IEC 17025. It provides an overview of the requirements for laboratories to achieve and maintain accreditation.
The document provides a history of accreditation in the UK, beginning with the British Calibration Service established in 1966. It later merged with another organization to form the National Measurement Accreditation Service in 1985, which was renamed the UK Accreditation Service in 1995. The document also defines accreditation and certification, and explains that accreditation evaluates a laboratory's technical competence according to ISO/IEC 17025. It provides an overview of the requirements for laboratories to achieve and maintain accreditation.
The document provides information about the International Organization for Standardization (ISO) and two of its most widely implemented standards: ISO 9001 and ISO 17025. ISO is the world's largest developer of voluntary international standards, with over 20,000 standards covering almost all industries. ISO 9001 helps organizations implement quality management systems, while ISO 17025 provides requirements for competence and impartiality of testing and calibration laboratories. Both standards have been implemented by over a million organizations globally and facilitate international acceptance of certifications.
The document discusses conformity assessment and its benefits. Conformity assessment involves activities like testing, inspection, and certification to demonstrate that products or systems meet specified requirements. It facilitates international trade by building confidence in test results and certificates between countries. Mutual recognition agreements between accreditation bodies further increase acceptance of conformity assessment results across borders. Conformity assessment provides benefits to businesses, society, and governments by improving quality, protecting consumers, and supporting trade. Accreditation of conformity assessment bodies is important to ensure the reliability and impartiality of their assessments.
This document discusses the key requirements of ISO/IEC 17025 for testing and calibration laboratories. It covers management requirements, technical requirements, quality management systems, personnel requirements, accommodation and environmental conditions, test and calibration methods, equipment, measurement traceability, sampling, handling of test and calibration items, quality control, reporting of results, subcontracting, and opinions and interpretations. The main points are that ISO/IEC 17025 establishes the requirements for laboratories to demonstrate they are technically competent and able to produce valid results, laboratories must implement a quality management system, and personnel performing testing and calibrations must be qualified.
ISO/IEC 17024:2012 introduced several changes to the personnel certification standard, including incorporating requirements from other standards like ISO/IEC 17021 and IAF GD24. Key changes include more requirements around impartiality, developing and maintaining certification schemes, examining personnel competence, and clarifying terms and definitions. The revised standard has a stronger focus on ensuring valid, reliable, and fair assessment of personnel certification through requirements for examination design, impartiality of personnel, and managing conflicts of interest.
The document discusses ISO 9000 quality standards for hospitals. It explains that ISO 9000 provides a framework for designing quality management systems to improve efficiency and customer satisfaction for healthcare organizations. The key elements for healthcare providers include management responsibility, quality systems, contract reviews, design control, document control, purchasing, product identification, inspections, handling/storage, audits, and statistics. Benefits include uniformity, cost reductions, improved customer satisfaction. Costs include consultant/registration fees, employee time to implement the system.
3 - Introduction to Conformity Assessment and ISO CASCO.pdfssuser035fe5
This document provides an introduction to conformity assessment and ISO/CASCO. It defines conformity assessment as demonstrating that a product, service or system meets specified requirements, usually contained in a standard. ISO/CASCO is the ISO committee that develops standards for conformity assessment bodies to ensure they are competent and impartial. It maintains a "toolbox" of over 35 standards covering testing labs, certification bodies, inspection bodies, and more. The document gives examples of common conformity assessment activities and standards.
The document provides a history of accreditation in the UK, beginning with the British Calibration Service established in 1966. It later merged with another organization to form the National Measurement Accreditation Service in 1985, which was renamed the UK Accreditation Service in 1995. The document also defines accreditation and certification, and explains that accreditation evaluates a laboratory's technical competence according to ISO/IEC 17025. It provides an overview of the requirements for laboratories to achieve and maintain accreditation.
The document provides a history of accreditation in the UK, beginning with the British Calibration Service established in 1966. It later merged with another organization to form the National Measurement Accreditation Service in 1985, which was renamed the UK Accreditation Service in 1995. The document also defines accreditation and certification, and explains that accreditation evaluates a laboratory's technical competence according to ISO/IEC 17025. It provides an overview of the requirements for laboratories to achieve and maintain accreditation.
The document provides information about the International Organization for Standardization (ISO) and two of its most widely implemented standards: ISO 9001 and ISO 17025. ISO is the world's largest developer of voluntary international standards, with over 20,000 standards covering almost all industries. ISO 9001 helps organizations implement quality management systems, while ISO 17025 provides requirements for competence and impartiality of testing and calibration laboratories. Both standards have been implemented by over a million organizations globally and facilitate international acceptance of certifications.
The document discusses conformity assessment and its benefits. Conformity assessment involves activities like testing, inspection, and certification to demonstrate that products or systems meet specified requirements. It facilitates international trade by building confidence in test results and certificates between countries. Mutual recognition agreements between accreditation bodies further increase acceptance of conformity assessment results across borders. Conformity assessment provides benefits to businesses, society, and governments by improving quality, protecting consumers, and supporting trade. Accreditation of conformity assessment bodies is important to ensure the reliability and impartiality of their assessments.
This document discusses the key requirements of ISO/IEC 17025 for testing and calibration laboratories. It covers management requirements, technical requirements, quality management systems, personnel requirements, accommodation and environmental conditions, test and calibration methods, equipment, measurement traceability, sampling, handling of test and calibration items, quality control, reporting of results, subcontracting, and opinions and interpretations. The main points are that ISO/IEC 17025 establishes the requirements for laboratories to demonstrate they are technically competent and able to produce valid results, laboratories must implement a quality management system, and personnel performing testing and calibrations must be qualified.
ISO/IEC 17024:2012 introduced several changes to the personnel certification standard, including incorporating requirements from other standards like ISO/IEC 17021 and IAF GD24. Key changes include more requirements around impartiality, developing and maintaining certification schemes, examining personnel competence, and clarifying terms and definitions. The revised standard has a stronger focus on ensuring valid, reliable, and fair assessment of personnel certification through requirements for examination design, impartiality of personnel, and managing conflicts of interest.
The document discusses ISO 9000 quality standards for hospitals. It explains that ISO 9000 provides a framework for designing quality management systems to improve efficiency and customer satisfaction for healthcare organizations. The key elements for healthcare providers include management responsibility, quality systems, contract reviews, design control, document control, purchasing, product identification, inspections, handling/storage, audits, and statistics. Benefits include uniformity, cost reductions, improved customer satisfaction. Costs include consultant/registration fees, employee time to implement the system.
1) Maintaining quality in an analytical laboratory requires fully integrating quality pursuit into all activities and having staff practice quality at all times.
2) A quality system includes procedures and responsibilities to ensure staff have resources to satisfy clients. It involves quality management, assurance, and control.
3) Key aspects of a quality system include a quality manual, audits to ensure compliance, and management reviews to ensure the system meets needs.
The document provides an overview of ISO 9001:2000 quality management system standards. It discusses what ISO is, the history and requirements of ISO 9001:2000, including its key clauses around quality management systems, management responsibility, and continual improvement. It also defines important terms like processes, objectives, customers and suppliers in the context of a quality management system.
15. l'importance de l'iso cei 17025 pour l'infrastructure technique nationaleDavid Menezes
ISO/IEC 17025 is an international standard that contains the requirements for a laboratory to be competent to carry out tests and/or calibrations. It helps ensure that laboratories produce precise and accurate test and calibration results. Accreditation to ISO/IEC 17025 provides formal recognition that a laboratory is competent. The standard contains both management system requirements and technical requirements related to personnel, accommodation, test and calibration methods, equipment, measurement traceability, sampling, handling of test items, and reporting of results. Compliance with ISO/IEC 17025 helps laboratories demonstrate technical competence and provides confidence in laboratory test and calibration results.
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION(ISO)waseemakhtar120
ISO 9000 and ISO 14000 are quality and environmental standards established by the International Organization for Standardization. ISO 9000 addresses quality management by specifying processes to fulfill customer requirements and regulatory compliance. ISO 14000 documents a firm's environmental program and specifies actions to minimize environmental impacts. Certification requires an external audit to ensure standards are met. Benefits of certification include competitive advantages, quality consistency, and improved environmental performance.
Here is a sample audit plan:
Day 1:
09:00-10:00: Opening meeting
10:00-12:00: Quality management system documentation review
13:00-15:00: Production area audit (warehousing, batching, mixing)
15:00-16:00: Non-conformance review meeting
Day 2:
09:00-11:00: Laboratory area audit (QC, QA labs)
11:00-13:00: Packaging and labeling area audit
13:00-14:00: Lunch
14:00-16:00: Regulatory affairs and change control audit
16:00-17:00
Paper Presnetation on ISO/IEC 17025:2017 organized at Labtech2017 in Bahrain. The topics discussed in that presentation like what are the major changes, what is considered in revised ISO 17025:2017, requirements of ISO 17025:2017, etc. are explained in this ppt presentation.
ISO 17025 certification is the global quality standard for testing and calibration laboratories. It specifies both management and technical requirements that must be met for laboratories to demonstrate technical competence and produce reliable test and calibration results. Achieving ISO 17025 accreditation involves conducting a gap analysis, implementing corrective actions, and undergoing an audit by an independent accreditation body to verify compliance with the standard. Key benefits of accreditation include recognition in the industry, a competitive advantage, and improved customer satisfaction.
The document provides an overview of ISO 9001 quality management standards and certification. It discusses key aspects of ISO 9001 including the evolution of the standard, requirements, principles of quality management, and the structure and requirements of the ISO 9001 quality management system standard. The presentation aims to increase awareness and understanding of ISO 9001 among employees of Malladi Drugs & Pharmaceuticals Limited.
What are the Advantages of ISO 17025 certification in Oman? What are the Req...rakshithmv1
ISO 17025 Certification In Oman, laboratories must be ISO 17025 certified in order to test and calibrate their equipment. This is one of the management systems that the International Organization for Standardization published in 2000.
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO/IEC standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on somewhat more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body.
There have been three releases; in 1999, 2005 and 2017. The most significant changes between the 1999 and 2005 release were a greater emphasis on the responsibilities of senior management, explicit requirements for continual improvement of the management system itself, and communication with the customer. It also aligned more closely with the 2000 version of ISO 9001
ISO 17025 is an international standard for testing and calibration laboratories seeking accreditation. It has requirements for management, technical operations, and quality assurance. Accreditation increases confidence in test results, enhances customer satisfaction, and improves laboratory effectiveness through regular inspections. While accreditation requires costs for implementation and maintenance, it also provides benefits like reduced re-testing and an improved reputation. The standard has been adopted by accreditation bodies in several countries including Australia, New Zealand, and India.
ISO 9001 originated from quality standards developed during WWI for munitions production. It evolved over the 20th century and was combined with international standards in 1987. The 2008 version focuses on management principles and a process approach. It requires organizations to establish responsibilities, resource management, product realization, and measurement/improvement processes. Certification involves independent audits to verify a quality management system meets the ISO 9001 standard.
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO/IEC standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on somewhat more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body.
ISO 9001 is an international standard for quality management systems that originated from British defense standards in World War I. It has evolved over time from BS 5750 to the current ISO 9001:2008 standard. The standard is based on eight quality management principles and requires organizations to establish management responsibilities, resource management, product realization processes, and systems for measurement, analysis and improvement. Third party certification involves an independent assessment to verify an organization's quality management system meets the requirements of the ISO 9001 standard.
Product certification or product qualification is the process of certifying that a certain
product has passed performance tests and quality assurance tests, and meets
qualification criteria stipulated in contracts, regulations, or specifications (sometimes
called "certification schemes" in the product certification industry).
Most product certification bodies (or product certifiers) are accredited to or aligned with
ISO/IEC 17065 Conformity assessment -- Requirements for bodies certifying products,
processes and services (previously ISO/IEC Guide 65:1996) an international standard
for ensuring competence in those organizations performing product, process and service
certifications. The organizations that perform this accreditation are called Accreditation
Bodies, and they themselves are assessed by international peers against the ISO 17011
standard. In India Product certification is being monitored by BUREAU OF INDIAN
STANDARDS.
Examples of some certification schemes include the Safety Equipment Institute for
protective headgear, the U.S. Federal Communications Commission (FCC)
Telecommunication Certification Body (TCB) program for radio communication devices,
the U.S. Environmental Protection Agency Energy Star program, the International
Commission on the Rules for the Approval of Electrical Equipment Product Safety
Certification Body Scheme (IEECE CB Scheme), MAS (Materials Analytical Services)
Certified Green IEQ program, and the Greenguard Environmental Institute Indoor Air
Quality program. Certification schemes are typically written to include both the
performance test methods that the product must be tested to, as well as the criteria that
the product must meet to become Certified.
The document discusses quality management systems and ISO standards. It provides definitions for key terms like quality management systems and describes several ISO standards for quality management including ISO 9001, ISO 9002, ISO 9003. It discusses the benefits of ISO registration for organizations and customers. It also summarizes implementation of a quality management system, documentation requirements, and the purpose and objectives of internal audits.
PECB Webinar: Overview of ISO 13485 - Medical DevicesPECB
The webinar covers:
• The key section of ISO 13485
• The benefits of ISO 13485
• In brief how ISO 13485 & ISO 9001 correlate
Presenter:
This webinar was presented by Raza Shah, Chief Editor and Owner of Bitehqeeq.
Link of the recorded session published on YouTube: https://youtu.be/gZlhUlqgo1g
This document is the quality manual for a laboratory. It begins by explaining the purpose and importance of having a quality manual according to ISO/IEC 17025 standards. The manual then outlines what should be included in the contents such as the quality policy statement, organizational structure, procedures, and documentation control. It provides details on the specific sections and documentation requirements for the management system, technical requirements, and quality control processes according to ISO standards. The quality manual is the key document that describes all aspects of the laboratory's quality management system.
1) Maintaining quality in an analytical laboratory requires fully integrating quality pursuit into all activities and having staff practice quality at all times.
2) A quality system includes procedures and responsibilities to ensure staff have resources to satisfy clients. It involves quality management, assurance, and control.
3) Key aspects of a quality system include a quality manual, audits to ensure compliance, and management reviews to ensure the system meets needs.
The document provides an overview of ISO 9001:2000 quality management system standards. It discusses what ISO is, the history and requirements of ISO 9001:2000, including its key clauses around quality management systems, management responsibility, and continual improvement. It also defines important terms like processes, objectives, customers and suppliers in the context of a quality management system.
15. l'importance de l'iso cei 17025 pour l'infrastructure technique nationaleDavid Menezes
ISO/IEC 17025 is an international standard that contains the requirements for a laboratory to be competent to carry out tests and/or calibrations. It helps ensure that laboratories produce precise and accurate test and calibration results. Accreditation to ISO/IEC 17025 provides formal recognition that a laboratory is competent. The standard contains both management system requirements and technical requirements related to personnel, accommodation, test and calibration methods, equipment, measurement traceability, sampling, handling of test items, and reporting of results. Compliance with ISO/IEC 17025 helps laboratories demonstrate technical competence and provides confidence in laboratory test and calibration results.
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION(ISO)waseemakhtar120
ISO 9000 and ISO 14000 are quality and environmental standards established by the International Organization for Standardization. ISO 9000 addresses quality management by specifying processes to fulfill customer requirements and regulatory compliance. ISO 14000 documents a firm's environmental program and specifies actions to minimize environmental impacts. Certification requires an external audit to ensure standards are met. Benefits of certification include competitive advantages, quality consistency, and improved environmental performance.
Here is a sample audit plan:
Day 1:
09:00-10:00: Opening meeting
10:00-12:00: Quality management system documentation review
13:00-15:00: Production area audit (warehousing, batching, mixing)
15:00-16:00: Non-conformance review meeting
Day 2:
09:00-11:00: Laboratory area audit (QC, QA labs)
11:00-13:00: Packaging and labeling area audit
13:00-14:00: Lunch
14:00-16:00: Regulatory affairs and change control audit
16:00-17:00
Paper Presnetation on ISO/IEC 17025:2017 organized at Labtech2017 in Bahrain. The topics discussed in that presentation like what are the major changes, what is considered in revised ISO 17025:2017, requirements of ISO 17025:2017, etc. are explained in this ppt presentation.
ISO 17025 certification is the global quality standard for testing and calibration laboratories. It specifies both management and technical requirements that must be met for laboratories to demonstrate technical competence and produce reliable test and calibration results. Achieving ISO 17025 accreditation involves conducting a gap analysis, implementing corrective actions, and undergoing an audit by an independent accreditation body to verify compliance with the standard. Key benefits of accreditation include recognition in the industry, a competitive advantage, and improved customer satisfaction.
The document provides an overview of ISO 9001 quality management standards and certification. It discusses key aspects of ISO 9001 including the evolution of the standard, requirements, principles of quality management, and the structure and requirements of the ISO 9001 quality management system standard. The presentation aims to increase awareness and understanding of ISO 9001 among employees of Malladi Drugs & Pharmaceuticals Limited.
What are the Advantages of ISO 17025 certification in Oman? What are the Req...rakshithmv1
ISO 17025 Certification In Oman, laboratories must be ISO 17025 certified in order to test and calibrate their equipment. This is one of the management systems that the International Organization for Standardization published in 2000.
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO/IEC standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on somewhat more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body.
There have been three releases; in 1999, 2005 and 2017. The most significant changes between the 1999 and 2005 release were a greater emphasis on the responsibilities of senior management, explicit requirements for continual improvement of the management system itself, and communication with the customer. It also aligned more closely with the 2000 version of ISO 9001
ISO 17025 is an international standard for testing and calibration laboratories seeking accreditation. It has requirements for management, technical operations, and quality assurance. Accreditation increases confidence in test results, enhances customer satisfaction, and improves laboratory effectiveness through regular inspections. While accreditation requires costs for implementation and maintenance, it also provides benefits like reduced re-testing and an improved reputation. The standard has been adopted by accreditation bodies in several countries including Australia, New Zealand, and India.
ISO 9001 originated from quality standards developed during WWI for munitions production. It evolved over the 20th century and was combined with international standards in 1987. The 2008 version focuses on management principles and a process approach. It requires organizations to establish responsibilities, resource management, product realization, and measurement/improvement processes. Certification involves independent audits to verify a quality management system meets the ISO 9001 standard.
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO/IEC standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on somewhat more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body.
ISO 9001 is an international standard for quality management systems that originated from British defense standards in World War I. It has evolved over time from BS 5750 to the current ISO 9001:2008 standard. The standard is based on eight quality management principles and requires organizations to establish management responsibilities, resource management, product realization processes, and systems for measurement, analysis and improvement. Third party certification involves an independent assessment to verify an organization's quality management system meets the requirements of the ISO 9001 standard.
Product certification or product qualification is the process of certifying that a certain
product has passed performance tests and quality assurance tests, and meets
qualification criteria stipulated in contracts, regulations, or specifications (sometimes
called "certification schemes" in the product certification industry).
Most product certification bodies (or product certifiers) are accredited to or aligned with
ISO/IEC 17065 Conformity assessment -- Requirements for bodies certifying products,
processes and services (previously ISO/IEC Guide 65:1996) an international standard
for ensuring competence in those organizations performing product, process and service
certifications. The organizations that perform this accreditation are called Accreditation
Bodies, and they themselves are assessed by international peers against the ISO 17011
standard. In India Product certification is being monitored by BUREAU OF INDIAN
STANDARDS.
Examples of some certification schemes include the Safety Equipment Institute for
protective headgear, the U.S. Federal Communications Commission (FCC)
Telecommunication Certification Body (TCB) program for radio communication devices,
the U.S. Environmental Protection Agency Energy Star program, the International
Commission on the Rules for the Approval of Electrical Equipment Product Safety
Certification Body Scheme (IEECE CB Scheme), MAS (Materials Analytical Services)
Certified Green IEQ program, and the Greenguard Environmental Institute Indoor Air
Quality program. Certification schemes are typically written to include both the
performance test methods that the product must be tested to, as well as the criteria that
the product must meet to become Certified.
The document discusses quality management systems and ISO standards. It provides definitions for key terms like quality management systems and describes several ISO standards for quality management including ISO 9001, ISO 9002, ISO 9003. It discusses the benefits of ISO registration for organizations and customers. It also summarizes implementation of a quality management system, documentation requirements, and the purpose and objectives of internal audits.
PECB Webinar: Overview of ISO 13485 - Medical DevicesPECB
The webinar covers:
• The key section of ISO 13485
• The benefits of ISO 13485
• In brief how ISO 13485 & ISO 9001 correlate
Presenter:
This webinar was presented by Raza Shah, Chief Editor and Owner of Bitehqeeq.
Link of the recorded session published on YouTube: https://youtu.be/gZlhUlqgo1g
This document is the quality manual for a laboratory. It begins by explaining the purpose and importance of having a quality manual according to ISO/IEC 17025 standards. The manual then outlines what should be included in the contents such as the quality policy statement, organizational structure, procedures, and documentation control. It provides details on the specific sections and documentation requirements for the management system, technical requirements, and quality control processes according to ISO standards. The quality manual is the key document that describes all aspects of the laboratory's quality management system.
Similar to 7._Conformity_Assessment_Standards.pptx (20)
Jennifer Schaus and Associates hosts a complimentary webinar series on The FAR in 2024. Join the webinars on Wednesdays and Fridays at noon, eastern.
Recordings are on YouTube and the company website.
https://www.youtube.com/@jenniferschaus/videos
Preliminary findings _OECD field visits to ten regions in the TSI EU mining r...OECDregions
Preliminary findings from OECD field visits for the project: Enhancing EU Mining Regional Ecosystems to Support the Green Transition and Secure Mineral Raw Materials Supply.
Working with data is a challenge for many organizations. Nonprofits in particular may need to collect and analyze sensitive, incomplete, and/or biased historical data about people. In this talk, Dr. Cori Faklaris of UNC Charlotte provides an overview of current AI capabilities and weaknesses to consider when integrating current AI technologies into the data workflow. The talk is organized around three takeaways: (1) For better or sometimes worse, AI provides you with “infinite interns.” (2) Give people permission & guardrails to learn what works with these “interns” and what doesn’t. (3) Create a roadmap for adding in more AI to assist nonprofit work, along with strategies for bias mitigation.
This report explores the significance of border towns and spaces for strengthening responses to young people on the move. In particular it explores the linkages of young people to local service centres with the aim of further developing service, protection, and support strategies for migrant children in border areas across the region. The report is based on a small-scale fieldwork study in the border towns of Chipata and Katete in Zambia conducted in July 2023. Border towns and spaces provide a rich source of information about issues related to the informal or irregular movement of young people across borders, including smuggling and trafficking. They can help build a picture of the nature and scope of the type of movement young migrants undertake and also the forms of protection available to them. Border towns and spaces also provide a lens through which we can better understand the vulnerabilities of young people on the move and, critically, the strategies they use to navigate challenges and access support.
The findings in this report highlight some of the key factors shaping the experiences and vulnerabilities of young people on the move – particularly their proximity to border spaces and how this affects the risks that they face. The report describes strategies that young people on the move employ to remain below the radar of visibility to state and non-state actors due to fear of arrest, detention, and deportation while also trying to keep themselves safe and access support in border towns. These strategies of (in)visibility provide a way to protect themselves yet at the same time also heighten some of the risks young people face as their vulnerabilities are not always recognised by those who could offer support.
In this report we show that the realities and challenges of life and migration in this region and in Zambia need to be better understood for support to be strengthened and tuned to meet the specific needs of young people on the move. This includes understanding the role of state and non-state stakeholders, the impact of laws and policies and, critically, the experiences of the young people themselves. We provide recommendations for immediate action, recommendations for programming to support young people on the move in the two towns that would reduce risk for young people in this area, and recommendations for longer term policy advocacy.
Donate to charity during this holiday seasonSERUDS INDIA
For people who have money and are philanthropic, there are infinite opportunities to gift a needy person or child a Merry Christmas. Even if you are living on a shoestring budget, you will be surprised at how much you can do.
Donate Us
https://serudsindia.org/how-to-donate-to-charity-during-this-holiday-season/
#charityforchildren, #donateforchildren, #donateclothesforchildren, #donatebooksforchildren, #donatetoysforchildren, #sponsorforchildren, #sponsorclothesforchildren, #sponsorbooksforchildren, #sponsortoysforchildren, #seruds, #kurnool
Jennifer Schaus and Associates hosts a complimentary webinar series on The FAR in 2024. Join the webinars on Wednesdays and Fridays at noon, eastern.
Recordings are on YouTube and the company website.
https://www.youtube.com/@jenniferschaus/videos
Monitoring Health for the SDGs - Global Health Statistics 2024 - WHOChristina Parmionova
The 2024 World Health Statistics edition reviews more than 50 health-related indicators from the Sustainable Development Goals and WHO’s Thirteenth General Programme of Work. It also highlights the findings from the Global health estimates 2021, notably the impact of the COVID-19 pandemic on life expectancy and healthy life expectancy.
2. Introduction
The following section is intended to be an introduction to the
core standards of the ISO/IEC 17000 series and not to
cover them in detail.
More information can be found on iso.org where some
presentations are available on published standards that go
in more details.
3. CASCO Toolbox Standards
Management
Systems
Product Process Service People Inspection Claims Laboratory
Core conformity
assessment standards
ISO/IEC 17021-1
and parts
ISO/IEC 17065 ISO/IEC 17024 ISO/IEC 17020 ISO/IEC 17029 ISO/IEC 17025
Audit duration
ISO/IEC TS 17023
Fundamentals for
products ISO/IEC
17067
Certification
scheme for
process
ISO/IEC 17032
Example of
certification
schemes
ISO/IEC TR
17028
Vocabulary for
personnel
ISO/IEC 17027
Proficiency
testing ISO/IEC
17043
Tangible products
ISO/IEC TR 17026
Reference
material
producers ISO
17034
Suppliers declaration ISO/IEC 17050 parts 1 and 2
Use of marks ISO/IEC Guide 23 and ISO Guide 27
Use of marks by third
parties
ISO/IEC 17030
Good CA practices ISO/IEC Guide 60
Accreditation standard ISO/IEC 17011
Peer assessment ISO/IEC 17040 and ISO/IEC Guide 68
Terms and definitions ISO/IEC 17000
Guide for drafting
normative documents
ISO/IEC 17007
Note: valid in 2019
The standards in yellow are further described in this slide deck
5. Purpose of ISO/IEC 17011
Introduction – “. . . specifies requirements for accreditation
bodies accrediting conformity assessment bodies.”
“. . . activities covered by accreditation include testing,
calibration, inspection, certification of management systems,
persons, products, processes and services, provision of
proficiency testing, production of reference materials,
validation and verification.”
“This document can be used to support peer evaluation
mechanisms which have been created at regional and
international levels and through which confidence is provided
that accreditation bodies are operating in according with this
document.”
7. Purpose of ISO/IEC 17021-1
To set out the requirements for certification bodies
performing certification of management systems.
Accompanied by a set of principles on which the
requirements are based to provide credible and
reliable certification.
Requirements cover competence of persons involved
in certification, the legal status, resources and
structure of the certification body, the certification
process, etc.
8. Purpose of ISO/IEC 17021-1
Requirements are generic and do not address specifically
the detailed requirements for a certification body as it
implements the process and resource requirements for a
specific standard e.g. an Environmental Management
system or a Business Continuity Management system.
Additional requirements relating to certification of specific
management system standards can be found in related
standards all based on ISO/IEC 17021-1
9. Some related requirements for certification bodies performing
certification to different management system (MS) standards
• ISO/IEC 17021-2 competence for Environmental MS
• ISO/IEC 17021-3 competence for Quality MS
• ISO/IEC TS 17021-4 competence for Event Sustainability MS
• ISO/IEC TS 17021-5 competence for Asset MS
• ISO/IEC TS 17021-6 competence for Business Continuity MS
• ISO/IEC TS 17021-7 competence for Road Traffic Safety MS
• ISO/IEC TS 17021-8 competence for Sustainable Development in Communities MS
• ISO/IEC TS 17021-9 competence for Anti-bribery MS
• ISO/IEC TS 17021-10 competence for Occupational Health & Safety MS
• ISO/IEC TS 17021-11 competence for Facility MS
• ISO TS 22003 requirements for certification of Food Safety MS
• ISO 28003 requirements for certification of Supply Chain Security MS
• ISO 50003 requirements for certification of Energy MS
• ISO/IEC 27006 requirements for certification of Information Security MS
• etc.
11. Purpose of ISO/IEC 17020
To provide confidence in the bodies performing inspection
Contains requirements for the competence, impartiality and
consistent operation of laboratories.
Specifies how an Inspection body should perform assessments with
the objective of providing information about the conformity of
inspected items with regulations, standards, specifications,
inspection schemes or contracts. Specifies the competence of
inspectors as many types of inspection involve professional
judgement to determine acceptability against general requirements.
Categorizes inspection bodies as type A, B or which is a measure of
their independence
12. Purpose of ISO/IEC 17020
Inspection can be an activity embedded in a larger process. For
example, inspection can be used as a surveillance activity in a
product certification scheme.
Demonstrable independence of an inspection body can strengthen
the confidence of the inspection body's clients with respect to the
body's ability to carry out inspection work with impartiality.
Inspection covers activities such as examination of materials,
products, installations, plants, processes, work procedures or
services.
Unlike others forms of conformity assessment the performing the
assessment (the inspector) makes the decision on conformity
14. Purpose of ISO/IEC 17024
Standard for Personnel Certification
Official Title – General requirements for bodies operating
certification of persons
Introduction – “. . . Has been drawn up with the objective of
achieving and promoting a globally accepted benchmark for
organizations operating certification of persons”
Introduction – “. . .This international standard should be the basis for
the recognition of the certification bodies and their certification
schemes, in order to facilitate their acceptance at the national and
international levels.”
15. Purpose of ISO/IEC 17024
Achieve and promote a globally accepted benchmark for
organizations managing the certification of persons
Create confidence in certification thru globally accepted
processes of assessment, subsequent surveillance and
periodic re-assessment
Harmonize a system to develop and maintain certification
programs
Establish an environment for mutual recognition and global
exchange of personnel
17. Purpose of ISO/IEC 17025
Scope: ….’specifies the general requirements for the competence,
impartiality and consistent operation of laboratories.’ Also
addresses use of the standard: ….’Laboratory customers, regulatory
authorities, organizations and schemes using peer-assessment,
accreditation bodies, and others use this document in confirming or
recognizing the competence of laboratories.’
Definition for laboratory:…body that performs one or more of the
following activities:
- testing;
- calibration;
- sampling, associated with subsequent testing or calibration
18. Purpose of ISO/IEC 17025
Provide framework for laboratories to demonstrate
competence and impartiality
Provide basis to harmonize a system to develop and maintain
confidence in the competence of laboratories and consistent
generation of reliable results
Establish an environment for mutual recognition and global
exchange of results from laboratories
20. Purpose of ISO/IEC 17029
Standard for validation and verification bodies – covering 1st, 2nd and 3rd
party assessment
Validation and verification as conformity assessment are understood to
be a confirmation of reliability of information contained in claims. Other
terms in use for the object of assessment by validation/verification are
statement, declaration, assertion, prediction or report
Validation is applied to claims regarding an intended use or projected
effect (confirmation of plausibility), while verification is applied to claims
regarding events that have already occurred or results that have already
been obtained (confirmation of truthfulness)...”
21. Purpose of ISO/IEC 17029
a programme for validation/verification is needed specify definitions, principles,
rules, processes, and requirements for validation/verification process steps and
competence of validators/verifiers. Programmes can be legal frameworks,
international, regional or national standards, global initiatives, sector applications
as well as individual agreements with clients of the validation/verification body’
Assurance is provided and gives confidence to stakeholders and parties
interested in the claim. The programme can define levels of assurance, e.g. a
reasonable or limited level of assurance’
By defining validation/verification as confirmation, these activities are
differentiated from other CASCO tools as neither resulting in a characterisation
(testing) nor providing examination (inspection) or an attestation of conformity for
a defined period (certification)’
It does not apply to situations where validation/verification activities are being
undertaken as steps within the process of testing (ISO/IEC 17025, ISO 15189),
inspection (ISO/IEC 17020) or certification (ISO/IEC 17021-1, ISO/IEC 17065)’
22. Purpose of ISO/IEC 17029
Achieve and promote a globally accepted generic approach
to validation and verification of claims
Harmonize a system to develop and maintain validation or
verification programmes
Create confidence in validation and verification (be they 1st,
2nd or 3rd party) thru globally accepted processes of selection,
determination and review and attestation (including a
decision on issuing a validation/verification statement).
Create confidence that a claim conforms with the initially
specified requirements, whether they are general or detailed,
and is free from material misstatements.
Establish an environment for mutual recognition of validation
and verification bodies
24. Purpose of ISO/IEC 17065
Standard for Products, Processes, Services Certification
Introduction – “. . . The overall aim of certifying products,
processes or services is to give confidence to all interested
parties that a product, process or service fulfill specified
requirements. The value of certification is the degree of
confidence and trust that is established by an impartial and
competent demonstration of fulfillment of specified
requirements by a third party….”
25. Purpose of ISO/IEC 17065
Introduction – “. . .This international standard specifies
requirements, the observance of which is intended to ensure
that certification bodies operate certification schemes in a
competent and impartial manner, thereby facilitating the
recognition of such bodies and the acceptance of certified
products, processes and services on a national and
international basis and so furthering international trade….”
Product certification is perhaps the most visible type of
certification because it is usually accompanied by a mark that
is recognized and appreciated by regulators, consumers and
other stakeholders. It is therefore crucial ensuring the
reliability of these claims.
Editor's Notes
Explanatory note
Needs update regularly
For up to date information: https://www.iso.org/committee/54998/x/catalogue/p/1/u/0/w/0/d/0
Guides are in the process of undergoing review or incorporation into existing documents (standards)
ADD explanation about deliverables IS, TS, TR
All the additions to the generic requirements of ISO/IEC 17021-1 listed contain requirements. While Parts 2 and 3 are international standards and 4 to 11 are technical specification the only difference is the level of consensus as they all contain competence requirements
The rest of documents in the list contain additional requirement than those related to competence such as audit duration, calculation…
All of these documents have been developed in joint WG between the relevant ISO technical committees and ISO CASCO