This document provides an overview of the revision process from ISO/IEC Guide 65 to ISO/IEC 17065, the new standard for product, process, and service certification bodies. It outlines the timeline of the revision from 2007 to 2012, the purpose of aligning with new CASCO requirements, and highlights key changes between the standards. These include improved definitions, separating the application and evaluation processes, more detailed surveillance and management requirements, and aligning with other conformity assessment standards like ISO/IEC 17000 and ISO/PAS 17003. Cross-references are also provided between clauses of the old and new standards.
This presentation is about ISO 17021:2015 Documentation kit which is required for accreditation of certifying body. It talked about ISO 17021 Documentation in details. This ISO 17021 Documentation kit having sample documents required for ISO 17021:2015 certification.
ISO 17025 certification gives testing and calibration laboratories the same type of accreditation that ISO 9001 gives to manufacturing and service organizations. Learn more at http://www.CEBOS.com
139 pages MS word document gives detailed description of the IMS processes and their interaction and might be selected by the Organization as the Only IMS document.
Compliant with the new versions of ISO 9001:2015 and ISO 14001:2015
ISO IEC 17025 Clause Changes from 2005 to the new standard 2017Bywater Training
The document discusses changes made to ISO/IEC 17025:2005 in the 2017 update. Key changes include restructuring clause numbers, additional requirements for impartiality, risk assessment, complaints handling, and data management. Laboratories have three years to transition to the new standard. The document also provides information on training courses to help laboratories understand and implement the changes required to comply with ISO/IEC 17025:2017.
ISO 17020 documents are designed for ISO/IEC 17020:2012, conformity assessment — Requirements for the operation of various types of bodies performing inspection for inspection agency
This document provides an overview of the timeline and key changes between ISO/IEC Guide 65 and the new standard ISO/IEC 17065 for product, process, and service certification bodies. Some of the main changes discussed include more detailed definitions, separating the selection and determination functions, improved descriptions of evaluation resources and processes, and aligning the management system requirements with ISO standards. The presentation aims to support a harmonized transition to the new ISO/IEC 17065 standard for conformity assessment bodies and other interested parties.
An in-depth discussion on the new automotive Quality Mangement System Standard 16949: 2016 and the challenges in moving to this new version from the old ISO/TS 16949. From processes to procedures, work instructions to risks, Michael Wolfe and Jonathan Brun discuss the best practices to stay in complete compliance with the standard.
International organization for standardization Chirag Tewari
1) The International Organization for Standardization (ISO) is an independent, non-governmental international organization with 164 national standards body members that develops voluntary consensus-based international standards.
2) ISO was founded in 1947 and is headquartered in Geneva, Switzerland. It began in 1926 as the International Federation of the National Standardizing Associations.
3) ISO standards cover a wide range of industries and technologies and aim to harmonize technical specifications of products and services globally.
This presentation is about ISO 17021:2015 Documentation kit which is required for accreditation of certifying body. It talked about ISO 17021 Documentation in details. This ISO 17021 Documentation kit having sample documents required for ISO 17021:2015 certification.
ISO 17025 certification gives testing and calibration laboratories the same type of accreditation that ISO 9001 gives to manufacturing and service organizations. Learn more at http://www.CEBOS.com
139 pages MS word document gives detailed description of the IMS processes and their interaction and might be selected by the Organization as the Only IMS document.
Compliant with the new versions of ISO 9001:2015 and ISO 14001:2015
ISO IEC 17025 Clause Changes from 2005 to the new standard 2017Bywater Training
The document discusses changes made to ISO/IEC 17025:2005 in the 2017 update. Key changes include restructuring clause numbers, additional requirements for impartiality, risk assessment, complaints handling, and data management. Laboratories have three years to transition to the new standard. The document also provides information on training courses to help laboratories understand and implement the changes required to comply with ISO/IEC 17025:2017.
ISO 17020 documents are designed for ISO/IEC 17020:2012, conformity assessment — Requirements for the operation of various types of bodies performing inspection for inspection agency
This document provides an overview of the timeline and key changes between ISO/IEC Guide 65 and the new standard ISO/IEC 17065 for product, process, and service certification bodies. Some of the main changes discussed include more detailed definitions, separating the selection and determination functions, improved descriptions of evaluation resources and processes, and aligning the management system requirements with ISO standards. The presentation aims to support a harmonized transition to the new ISO/IEC 17065 standard for conformity assessment bodies and other interested parties.
An in-depth discussion on the new automotive Quality Mangement System Standard 16949: 2016 and the challenges in moving to this new version from the old ISO/TS 16949. From processes to procedures, work instructions to risks, Michael Wolfe and Jonathan Brun discuss the best practices to stay in complete compliance with the standard.
International organization for standardization Chirag Tewari
1) The International Organization for Standardization (ISO) is an independent, non-governmental international organization with 164 national standards body members that develops voluntary consensus-based international standards.
2) ISO was founded in 1947 and is headquartered in Geneva, Switzerland. It began in 1926 as the International Federation of the National Standardizing Associations.
3) ISO standards cover a wide range of industries and technologies and aim to harmonize technical specifications of products and services globally.
The Accreditation to CB's engaged certifying products, process, and services is a procedure by which an iso 17065 accreditation body gives formal recognition of technical competence for specific products, processes, and services based on third party conformity assessment. Like other International certification, the standard ISO/IEC 17065 Documentation is a primary requirement that conforming to the requirements of the Conformity Assessment of certifying bodies.
This document provides a 3-part summary of a food safety certification scheme document:
1) The document outlines the requirements for a food safety certification scheme that certifies food safety systems in compliance with ISO 22000 and technical specifications for different food sectors.
2) The certification scheme is intended to harmonize certification requirements and methods to ensure trustworthy and comparable food safety certificates across the food supply chain.
3) The scheme consists of four parts that outline requirements for organizations seeking certification, certification bodies, accreditation bodies, and a Board of Stakeholders that governs the scheme.
ISCC Supply Chain Model Mass Balance (Presentation Slides for Mills).pptWanZahir3
The document discusses the International Sustainability & Carbon Certification (ISCC) framework. ISCC promotes sustainable biomass production across the supply chain. It aims to ensure traceability, reduce greenhouse gas emissions, and encourage sustainable land use and social practices. Certification covers the entire biomass and biofuel production process, from farms and mills to refineries, transport, and biodiesel plants. Effective traceability systems must be implemented to document and track sustainable biomass at each stage of the supply chain. Key requirements include management systems, procedures, training, infrastructure, auditing and ensuring proper documentation is maintained.
How to successfully implement ISO 9001:2015 with a minimal documents approachPECB
The webinar covers:
• Replacing the Quality Manual
• Replacing All Other Procedures
• Checking Yourself to Ensure You've Met All Requirements
Presenter:
This webinar was presented by Debra Hay Hampton, PECB Certified Trainer and Lead Auditor of Quality and Environmental Management Systems.
Link of the recorded session published on YouTube: https://youtu.be/PnCjPlGGb68
ISO 22000:2018 FSMS standards gives more comfort to implement the food safety system in your food business, its based the HLS and Risk based approaches.
Dokumen tersebut membahas pemahaman sistem manajemen mutu ISO 9001:2015, meliputi fakta ISO, interpretasi klausul-klausul ISO 9001:2015, dan pedoman penerapan sistem manajemen mutu ISO 9001:2015.
Dokumen tersebut merangkum persyaratan dokumen wajib dan rekaman wajib sesuai dengan standar ISO 9001:2015 dan ISO 14001:2015. Dokumen tersebut juga menjelaskan dokumen-dokumen opsional yang sering digunakan untuk mendukung implementasi sistem manajemen mutu dan lingkungan sesuai dengan standar-standar tersebut.
The document discusses the process for updating an existing ISO/IEC 17025:2005 accredited laboratory management system to comply with the revised ISO/IEC 17025:2017 standard. It outlines 8 key steps, including conducting awareness training on the revisions, reviewing and revising documentation, implementing risk-based thinking, training auditors, conducting internal audits, addressing nonconformities, applying for an updated accreditation certificate, and undergoing a final assessment audit. Accredited laboratories must complete the upgrade process within 3 years of the 2017 standard's release.
Typical Quality Management System Based On Iso 9001 2008Isidro Sid Calayag
This document outlines the key elements of a quality management system (QMS) based on ISO 9001:2008. It discusses the objectives of implementing a QMS, including achieving organizational success and meeting requirements. The QMS focuses on customer focus, leadership, involvement of people, process approach, and continual improvement. It addresses management responsibility, resource management, product realization, measurement and improvement to ensure a process-based approach that meets customer needs and enhances supplier relationships.
What Documentation Required for ISO 17025:2017 Accreditation?Global Manager Group
Global Manager Group has prepared presentation to provide information about Calibration and Testing Laboratory Accreditation Standard - ISO 17025 and about Documentation Requirements. All the documents like quality manual, procedures, audit checklist, etc that required for the ISO 17025:2017 Accreditation process are described in details in this presentation.
ISO 14001:2015 Integrity in Implementation and Auditing the New EMS StandardPECB
The webinar covers:
• How ISO 14001:2015 has created new opportunities for consultants and auditors alike.
• How ISO 14001:2015 has improved into a practical EMS with clear scope and expectations;
• What are the principles of auditing?
Presenter:
This webinar was hosted by Mr. Cecil Corloncito, Managing Consultant of Aquagem Environment, and who is also PECB Certified Trainer.
Link of the recorded session published on YouTube: https://youtu.be/VrdTQhimLDQ
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.
ISO 20000-1:2018 Awareness and Auditor Training PPT Presentation kit for ITSMGlobal Manager Group
A Ready-to-use ISO 20000-1:2018 Training kit that helps the organization to ensure micro-level system is well established as per latest requirements.The main goal of thist training kit is for strengthening the company by system establishment and providing best training materials for ISO 20000 Certification.For more details please visit: https://www.globalmanagergroup.com/Products/iso-20000-auditor-training-ppt.htm
The document provides guidance on implementing the requirements of the ISO 22000:2018 food safety management system standard. It begins with an introduction to ISO 22000, including a brief history of its development. It then explains the benefits of implementing an ISO 22000-compliant food safety management system, such as improved health and safety, customer satisfaction, and meeting regulatory requirements. The document reviews key aspects of ISO 22000:2018, including its adoption of the Annex SL structure for management system standards, its use of process-based thinking and risk-based audits, and the 10 clauses that comprise the standard.
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 9001 is an international standard for quality management systems. It was first published in 1987 and has been revised several times since to keep up with changes in business and quality practices. The latest version, ISO 9001:2015, includes several changes from previous versions, including a new annex called Annex SL that establishes a common framework for all ISO management system standards. This high level structure includes elements like scope, leadership responsibilities, planning, support, operations, performance evaluation, and improvement. The standard emphasizes risk-based thinking, organizational context, leadership involvement, and flexibility over documentation requirements. It aims to help organizations better meet customer and regulatory requirements through an effective quality management approach.
ISO/IEC 17025 is an international standard that establishes the requirements for competence of testing and calibration laboratories. It provides requirements for laboratories to demonstrate that they operate competently and generate valid results. The standard was updated in 2017 to better serve laboratories and take into account developments in technology and changes in working practices. It incorporates the use of computer systems, electronic records, and production of electronic results and reports. ISO/IEC 17025 is intended to facilitate cooperation between laboratories and acceptance of results between countries.
This document provides guidance on the ISO 9001:2015 quality management system standard. It discusses the history and development of the ISO 9001 standard. The key changes in the ISO 9001:2015 version include a new high level structure that is now common across management system standards, a greater emphasis on risk-based thinking and the organization's context, and increased responsibilities for top management. The guidance is split into two parts - Part 1 provides an introduction to ISO 9001:2015 including the requirements and principles, while Part 2 provides guidance on implementing each clause of the standard.
The Accreditation to CB's engaged certifying products, process, and services is a procedure by which an iso 17065 accreditation body gives formal recognition of technical competence for specific products, processes, and services based on third party conformity assessment. Like other International certification, the standard ISO/IEC 17065 Documentation is a primary requirement that conforming to the requirements of the Conformity Assessment of certifying bodies.
This document provides a 3-part summary of a food safety certification scheme document:
1) The document outlines the requirements for a food safety certification scheme that certifies food safety systems in compliance with ISO 22000 and technical specifications for different food sectors.
2) The certification scheme is intended to harmonize certification requirements and methods to ensure trustworthy and comparable food safety certificates across the food supply chain.
3) The scheme consists of four parts that outline requirements for organizations seeking certification, certification bodies, accreditation bodies, and a Board of Stakeholders that governs the scheme.
ISCC Supply Chain Model Mass Balance (Presentation Slides for Mills).pptWanZahir3
The document discusses the International Sustainability & Carbon Certification (ISCC) framework. ISCC promotes sustainable biomass production across the supply chain. It aims to ensure traceability, reduce greenhouse gas emissions, and encourage sustainable land use and social practices. Certification covers the entire biomass and biofuel production process, from farms and mills to refineries, transport, and biodiesel plants. Effective traceability systems must be implemented to document and track sustainable biomass at each stage of the supply chain. Key requirements include management systems, procedures, training, infrastructure, auditing and ensuring proper documentation is maintained.
How to successfully implement ISO 9001:2015 with a minimal documents approachPECB
The webinar covers:
• Replacing the Quality Manual
• Replacing All Other Procedures
• Checking Yourself to Ensure You've Met All Requirements
Presenter:
This webinar was presented by Debra Hay Hampton, PECB Certified Trainer and Lead Auditor of Quality and Environmental Management Systems.
Link of the recorded session published on YouTube: https://youtu.be/PnCjPlGGb68
ISO 22000:2018 FSMS standards gives more comfort to implement the food safety system in your food business, its based the HLS and Risk based approaches.
Dokumen tersebut membahas pemahaman sistem manajemen mutu ISO 9001:2015, meliputi fakta ISO, interpretasi klausul-klausul ISO 9001:2015, dan pedoman penerapan sistem manajemen mutu ISO 9001:2015.
Dokumen tersebut merangkum persyaratan dokumen wajib dan rekaman wajib sesuai dengan standar ISO 9001:2015 dan ISO 14001:2015. Dokumen tersebut juga menjelaskan dokumen-dokumen opsional yang sering digunakan untuk mendukung implementasi sistem manajemen mutu dan lingkungan sesuai dengan standar-standar tersebut.
The document discusses the process for updating an existing ISO/IEC 17025:2005 accredited laboratory management system to comply with the revised ISO/IEC 17025:2017 standard. It outlines 8 key steps, including conducting awareness training on the revisions, reviewing and revising documentation, implementing risk-based thinking, training auditors, conducting internal audits, addressing nonconformities, applying for an updated accreditation certificate, and undergoing a final assessment audit. Accredited laboratories must complete the upgrade process within 3 years of the 2017 standard's release.
Typical Quality Management System Based On Iso 9001 2008Isidro Sid Calayag
This document outlines the key elements of a quality management system (QMS) based on ISO 9001:2008. It discusses the objectives of implementing a QMS, including achieving organizational success and meeting requirements. The QMS focuses on customer focus, leadership, involvement of people, process approach, and continual improvement. It addresses management responsibility, resource management, product realization, measurement and improvement to ensure a process-based approach that meets customer needs and enhances supplier relationships.
What Documentation Required for ISO 17025:2017 Accreditation?Global Manager Group
Global Manager Group has prepared presentation to provide information about Calibration and Testing Laboratory Accreditation Standard - ISO 17025 and about Documentation Requirements. All the documents like quality manual, procedures, audit checklist, etc that required for the ISO 17025:2017 Accreditation process are described in details in this presentation.
ISO 14001:2015 Integrity in Implementation and Auditing the New EMS StandardPECB
The webinar covers:
• How ISO 14001:2015 has created new opportunities for consultants and auditors alike.
• How ISO 14001:2015 has improved into a practical EMS with clear scope and expectations;
• What are the principles of auditing?
Presenter:
This webinar was hosted by Mr. Cecil Corloncito, Managing Consultant of Aquagem Environment, and who is also PECB Certified Trainer.
Link of the recorded session published on YouTube: https://youtu.be/VrdTQhimLDQ
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.
ISO 20000-1:2018 Awareness and Auditor Training PPT Presentation kit for ITSMGlobal Manager Group
A Ready-to-use ISO 20000-1:2018 Training kit that helps the organization to ensure micro-level system is well established as per latest requirements.The main goal of thist training kit is for strengthening the company by system establishment and providing best training materials for ISO 20000 Certification.For more details please visit: https://www.globalmanagergroup.com/Products/iso-20000-auditor-training-ppt.htm
The document provides guidance on implementing the requirements of the ISO 22000:2018 food safety management system standard. It begins with an introduction to ISO 22000, including a brief history of its development. It then explains the benefits of implementing an ISO 22000-compliant food safety management system, such as improved health and safety, customer satisfaction, and meeting regulatory requirements. The document reviews key aspects of ISO 22000:2018, including its adoption of the Annex SL structure for management system standards, its use of process-based thinking and risk-based audits, and the 10 clauses that comprise the standard.
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 9001 is an international standard for quality management systems. It was first published in 1987 and has been revised several times since to keep up with changes in business and quality practices. The latest version, ISO 9001:2015, includes several changes from previous versions, including a new annex called Annex SL that establishes a common framework for all ISO management system standards. This high level structure includes elements like scope, leadership responsibilities, planning, support, operations, performance evaluation, and improvement. The standard emphasizes risk-based thinking, organizational context, leadership involvement, and flexibility over documentation requirements. It aims to help organizations better meet customer and regulatory requirements through an effective quality management approach.
ISO/IEC 17025 is an international standard that establishes the requirements for competence of testing and calibration laboratories. It provides requirements for laboratories to demonstrate that they operate competently and generate valid results. The standard was updated in 2017 to better serve laboratories and take into account developments in technology and changes in working practices. It incorporates the use of computer systems, electronic records, and production of electronic results and reports. ISO/IEC 17025 is intended to facilitate cooperation between laboratories and acceptance of results between countries.
This document provides guidance on the ISO 9001:2015 quality management system standard. It discusses the history and development of the ISO 9001 standard. The key changes in the ISO 9001:2015 version include a new high level structure that is now common across management system standards, a greater emphasis on risk-based thinking and the organization's context, and increased responsibilities for top management. The guidance is split into two parts - Part 1 provides an introduction to ISO 9001:2015 including the requirements and principles, while Part 2 provides guidance on implementing each clause of the standard.
Update of the upcoming ISO 9001 - EOQ Congress 2014Tina Bohlin
The document summarizes an upcoming revision to the ISO 9001 quality management standard. It outlines the key inputs that informed changes in ISO 9001:2015, including feedback from 12,000 users. Main changes include adopting a new high-level structure common across ISO management standards, strengthening leadership and risk-based requirements, and increasing flexibility around documentation. The revised standard will be published in September 2015, starting a three-year transition period until full implementation is required in September 2018.
Introduction About ISO Certificates - Eng. Mohamed Abazamilemadinah
The document summarizes the history and development of ISO (International Organization for Standardization) over the past 70 years since its founding in 1947. It began with 65 delegates from 25 countries who decided to create a new international organization to facilitate the coordination and unification of industrial standards. Over the decades, ISO has grown to include 163 members and over 21,000 standards covering almost all aspects of technology and business. Some of ISO's most well-known and widely implemented standards are ISO 9001 for quality management, ISO 14001 for environmental management, and ISO 45001 for occupational health and safety management. The document also provides an overview of ISO's standards development process and outlines some of the key economic and non-economic benefits that organizations can
The ISO 22000 Standard is the first international standard for implementation of a certified food safety management system. The consequences of unsafe food can be serious and ISO’s food safety management standards help organizations identify and control food safety hazards. As many of today's food products repeatedly cross national boundaries, International Standards are needed to ensure the safety of the global food supply chain. This webinar provides you with a timeline history of the standard and other details your organization needs to know when implementing ISO 22000.
Main points covered:
• Introduction to ISO 22000:2005
• Why is it a global demand
• Who are the famous companies implementing ISO 22000:2005
• Why is ISO 22000:2005 a main drive of food
• Methodology & benefits in implementing ISO 22000:2005
Presenter:
This webinar was presented by Tawfik Soukieh, Managing Director of Global Experience Consulting Company and PECB Certified Trainer.
Link of the recorded session published on YouTube: https://youtu.be/9rYc88KpP60
Kym Henderson - ISO EVM Presentation IPMW 2019 BaltimoreAllison Wong
This presentation focused on the role and responsibilities of ISO and ISO Technical Committee 258 (project and programme management); ISO EVM Standards - 21508:2018; and the current status of the Working Group 12 (WG12) ISO EVM Implementation Guide project which Kym Henderson is leading.
KH ISO EVM Presentation IPMW 2019 BaltimoreKym Henderson
This document provides an overview of ISO/TC 258 and its work on developing international standards for project, program, and portfolio management. It summarizes the ISO EVM standard 21508:2018 and the work of Working Group 12 to develop an ISO implementation guide for EVM. WG12 has 63 members from 20 countries working over 2.5 years to produce committee drafts, working drafts, and publish the final implementation guide to promote global adoption and use of EVM as defined in the ISO standard.
This document provides guidance for organizations transitioning to the updated ISO 9001:2008 standard from ISO 9001:2000. It outlines that the changes are intended to clarify requirements and improve compatibility with ISO 14001:2004, without adding new requirements or changing intent. Organizations should review the clarifications for potential impact on their quality management system and make any necessary changes. Certification bodies will continue accepting ISO 9001:2000 certification for two years, after which all certifications must be to ISO 9001:2008. The guidance recommends organizations familiarize themselves with ISO 9001:2008 and determine if clarifications require adjustments to interpretations or processes.
This document outlines requirements for certification bodies that certify products, processes, and services. It covers general requirements such as legal responsibilities, impartiality, confidentiality, and structuring of the certification body. It also specifies requirements for certification body personnel, resources, processes for application review, evaluation, certification decisions, surveillance activities, and management systems. Conformity with these requirements is necessary for bodies certifying products, processes, or services. The document aims to ensure certifications are issued on an impartial and consistent basis by competent certification bodies.
The document provides an overview of the ISO 22000 family of standards for food safety management systems. It describes the key standards within the family, including ISO 22000 on food safety management systems, ISO 22003 on certification requirements, and ISO 22005 on traceability. It explains how these standards help food businesses improve food safety planning and documentation to better control hazards and meet regulatory requirements.
PECB Webinar: Understanding the basics of laboratory management with ISO/IEC ...PECB
We will cover:
• Components and implementation of Laboratory Management System based on ISO 17025
• Principal process of Laboratory management system
• Quality, administrative and technical systems/requirements that govern the operations of a laboratory
Presenter:
This webinar will be presented by Dotun Bolade. He is a Certified PECB ISO/IEC 17025 Lead Assessor and Trainer.
This document provides an overview and introduction to quality management systems and the ISO 9001:2015 and IATF 16949:2016 standards. It discusses key aspects of quality management including the basics of a QMS, requirements of the ISO and IATF standards, differences between the versions, transitioning processes, and implementing risk-based thinking. The document is intended to educate participants on quality management system requirements and certification.
State of play for food me and apples.pptedwarhanna3
ISO 22000 is an international food safety standard developed by ISO Technical Committee 34. It combines elements of ISO 9000 quality management and HACCP food safety principles. The standard provides requirements for a food safety management system covering the entire food supply chain. It is intended to be used voluntarily by organizations as a basis for food safety management with or without third-party certification. While it received approval for publication, some comments expressed concern that it does not fully meet the requirements of GFSI benchmarked standards and may not be practical for all small organizations.
PECB Webinar: ISO 9001:2015 Transition – Understanding the changes PECB
This webinar was organized and presented by PECB International to learn about the changes of ISO 9001 standard, which is the world’s most popular standard for quality management.
In this webinar, you will learn about:
• Why ISO 9001 is changing?
• The new ISO 9001 structure
• What are the significant proposed changes?
• Understanding the difference between ISO 9001: 2008 and ISO 9001: 2015
• Planning the QMS transition
• Benefits of the new standard
This webinar was hosted by Lorika Bina, Course Development Manager for Quality Management Systems (QMS) at PECB International. She is in charge of developing and maintaining training courses related to QMS. Lorika holds a B.S. in Business Management from Rochester Institute of Technology.
Standards are written guidelines that help things be done more efficiently or safely through a formal consensus process. The International Organization for Standardization (ISO) is an international standard-setting body founded in 1947 that promulgates worldwide industrial and commercial standards through technical committees. ISO 9000 is a family of quality management system standards, with ISO 9001 specifying requirements such as documented processes for control of documents, records, audits, and corrective/preventive actions.
The document discusses ISO 9000 standards for quality management systems. It provides an overview of ISO 9000, including its origins, organization, and key elements. The standards consist of requirements for quality management systems, including management responsibility, resource management, product realization, measurement, analysis and improvement. ISO 9000 certification involves developing and implementing a quality system, selecting a registrar, conducting self and third-party audits, and taking corrective actions.
The document discusses the upcoming revisions to the ISO 9001 quality management standard. It provides a brief history of ISO 9001 and its previous revisions in 1987, 1994, 2000, and 2008. The 2015 revision will feature a new high-level structure that is intended to align the format, text, terms and definitions of all ISO management system standards. Some of the key changes in the 2015 standard include extending its coverage to better apply to service industries, focusing more on understanding organizational context and stakeholder needs, and emphasizing leadership involvement in the quality management system. The final version of ISO 9001:2015 is expected to be released in September 2015.
ISO 22000:2018 is the newly revised International Food Safety standard, designed to harmonize on a global scale the requirements for food safety management for businesses within the food chain.
ISO 22000 combines and supplements the core elements of ISO 9001 and HACCP to provide an effective framework for the development, implementation, monitorization and continual improvement of a documented Food Safety Management System (FSMS) within the context of the organization’s overall business risks.
This implementation guide will help you run through the benefits, PDCA Cycle and 10 clauses in detail for implementing ISO 22000.
Find out more or get a quote for certification here – https://www.nqa.com/en-gb/certification/standards/iso-22000
ISO 15189:2012 Documentation Kit for medical laboratory accreditation, which can be used as a ready-reference tool to complete the ISO 15189 documentation process. This readymade documentation kit will help medical laboratories in developing a documented quality management system and assessing their own competence in accordance with ISO 15189 requirements and finally achieve ISO 15189 accreditation from a recognized accreditation body anywhere in the world.
During preparation of ISO 15189 documentation, medical laboratories need to prepare a ISO 15189 quality manual, procedures, SOPs, exhibits and forms to establish a good working system. Our experienced team of QMS consultants have designed sample documents to help medical laboratories and consultants in establishing an effective documentation for quick ISO 15189:2012 accreditation.
For more information, you can visit here:
https://www.certificationconsultancy.com/
Guidance on guide 62 issue 3 (from greg)youssefpec
A person who accompanies and assists an auditor during an audit but who is not
qualified or approved to perform audits independently or make audit decisions.
G.1.3.2. The term "certification/registration body" is used throughout this document to refer to
bodies operating assessment and certification/registration of quality management systems.
G.1.3.3. The term "accreditation body" refers to a body that performs accreditation of
certification/registration bodies.
The document provides guidance for bodies operating product certification systems on the application of ISO/IEC Guide 65:1996. It aims to enable accreditation bodies to harmonize their assessment of certification bodies and facilitate mutual recognition of accreditation. The guidance notes the terms that shall and should be used and covers topics like scope, definitions, organization of certification bodies, personnel qualifications, certification requirements and procedures, surveillance, use of licenses and marks, and complaints. It is intended to form the basis for mutual recognition agreements between accreditation bodies.
This document provides guidance for bodies operating assessment and certification of environmental management systems. It aims to enable harmonization among accreditation bodies in their assessment of certification bodies against ISO/IEC Guide 66. The guidance clarifies and provides recommendations for interpreting requirements in ISO/IEC Guide 66. It is intended to form the basis for mutual recognition agreements between accreditation bodies assessing certification bodies for EMS certification. The guidance covers requirements for certification body structure, personnel, assessment processes, decision making, and surveillance activities.
Este documento presenta las normas de acreditación de la Joint Commission International para hospitales, 3ra edición. Establece los estándares para la gestión, prestación de servicios y mejora continua de la calidad y seguridad de la atención al paciente en hospitales.
The document outlines an accreditation procedure that involves an initial assessment followed by potential follow up visits, unannounced visits, and a re-assessment every three years. The process includes application, document review, conducting assessments, reporting findings, submitting recommendations, and granting accreditation. Corrective actions must be submitted within 40 working days of receiving findings.
This document outlines the process for witness audits conducted by the Social Accountability Accreditation Services (SAAS). It describes the purpose, scope, definitions, references, and instructions for planning and conducting witness audits of certification bodies applying for or maintaining SAAS accreditation. The key steps include planning the audit, conducting opening/closing meetings, witnessing the certification body's audit activities, identifying any nonconformities, and issuing corrective action requests. Post-audit activities include submitting audit reports and analyzing responses to corrective actions. The goal is to verify that certification bodies are effectively implementing their accredited certification systems.
The document outlines the accreditation process for certification bodies by the Egyptian Accreditation Council (EGAC). It involves an application, documentation review, initial assessment of the management system, witnessed assessments, and a final closing meeting. If nonconformities are found, corrective actions must be taken and verified before accreditation is granted. The process involves a Technical Advisory Committee review and final approval by the EGAC Accreditation Committee.
This document provides guidance on applying ISO/IEC Guide 65 for product certification bodies. It aims to help accreditation bodies harmonize their assessment of certification bodies to Guide 65. The guidance clarifies key terms, addresses requirements for certification schemes and documents, and provides direction on assessing organization, operations, personnel, decision making and surveillance for consistency with Guide 65. It is intended to support mutual recognition of accredited certifications globally.
This document outlines requirements for inspection bodies performing inspections according to ISO/IEC 17020:2012. It details requirements across several clauses, including: general requirements for impartiality and independence; structural requirements for administration, organization, management and resources; process requirements for inspection methods, procedures, handling of items, and records; and reporting requirements for inspection reports and certificates. The document provides the inspection body's comments and findings for each requirement, referencing its manuals and procedures.
This document provides guidance on interpreting ISO/IEC 17020 for inspection bodies seeking accreditation. It was produced by the Asia Pacific Laboratory Accreditation Cooperation (APLAC) Technical Committee. The guidance clarifies requirements around scope of accreditation, independence, quality systems, personnel, facilities, equipment, and records. It is intended to help inspection bodies understand what will be examined during accreditation assessments.
Accredited third party_certification_and_food_safety_management_...youssefpec
1) Accredited third party certification (A3PC) provides a new model for food safety compliance through well-defined HACCP-based standards and competent third party auditing and certification of suppliers.
2) The Global Food Safety Initiative (GFSI) was launched in 2000 and recognizes standards like SQF, IFS, BRC that ensure consistency and reliability through acceptance of equivalent standards worldwide.
3) A3PC provides advantages like checks and balances, competent auditors, and stakeholder confidence compared to the old system of individual audits against many standards.
1. Page 1Page 1
ISO/IEC 17065:2012
Conformity assessment – Requirements for bodies certifying products,
processes and services
Presentation on the new standard
2012-09-26
2. Page 2
Introduction
This presentation has been developed by the Drafting Group of ISO CASCO WG 29.
The aim is to support all interested parties concerned by the implementation of this
new standard, e.g. conformity assessment bodies, accreditation bodies, industries with
general information and contribute to an harmonized transition.
This is an open presentation without any copyrights and can be used by anyone.
We welcome any information about product certification in your region, country, e. g.
number of schemes, number of accredited certification bodies, number of certificates
under ISO/IEC Guide 65 / ISO/IEC 17065, if you have any please send it to
charlet@iso.org
ISO CASCO Secretary ISO CASCO Convenor WG 29
Sean MacCurtain Christian Priller
2012-09-26
3. Page 3
Table of content
• Importance / Impact of product certification for global trade 4
• Product, Process and Service Certification 5
• Timeline of Revision ISO/IEC Guide 65 to ISO/IEC 17065 7
• Purpose of Revision ISO/IEC Guide 65 to ISO/IEC 17065 10
• Content of ISO/IEC Guide 65 to ISO/IEC 17065 11
• Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 13
• ISO/IEC 17065:2012 22
• Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 37
• Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 46
•Back-up slides: examples 55
2012-09-26
4. Page 4
Examples - Importance and Impact
of product certification for global
tradeAn unknown number of sectors, regulators, schemes and CB‘s run their operation
under this requirements with an unknown number of certificates and products, this
shows the great importance.
2012-09-26
Europe:
New Legilation Framework (NLF) over 20
European Directives, Trade volume 1500
mrd €, about 2000 Notified Bodies
974 accredited certification bodies in Europe
(source: European Co-operation Accreditation)
International level
IEC CB Scheme:
74 National Certification Bodies
382 CB Testing Laboratories
45 Satellite Laboratories
2800 Manufacturer's Testing Laboratories
70'000 CB Test Certificates issues in 2011
Asia
Japan
JIS-mark : 25 certification bodies
JAS-mark: 142 certification bodies
PSE-mark: 10 certification bodies
PSC-mark : 9 certification bodies
PAL : 13 certification bodies
China:
35 accredited Certification Bodies
10 Certification Bodies response for China
Compulsory Certification (CCC)
50,728 companies with 280,000 certificates
for CCC
New Zealand/Australia
36 certification bodies for product certification
70 product certification schemes delivered by 36
accredited bodiesBrasil
70 accredited Certification Bodies
USA
120 Accredited Certification Bodies
Germany:
GS-mark
91 bodies
7. Page 7
Timeline of Revision ISO/IEC Guide 65
to ISO/IEC 17065
2012-09-26
date activity output Participants Results ballot
2007-04
1st WG 29 meeting – definition of
scope and structure of revision WD1 30
2007-09 1st
DG meeting WD2
2008-04 2nd
DG meeting WD3
2008-04 2nd
WG 29 meeting WD4 35
2008-10 3rd
DG meeting WD5
2009-03 4th
DG meeting WD6
2009-06 3rd
WG 29 meeting CD1 37
2009-07 CD out for ballot
78% approval
1040 comments
submitted
2010-03
Change of Convenor Mario
Wittner > Christian Priller
2010-04 4th
WG 29 meeting 43
8. Page 8
Timeline of Revision ISO/IEC Guide 65
to ISO/IEC 17065
date activity output Participation Results ballot
2010-06 5th
DG WG 29 meeting CD2
2010-08 CD2 out for ballot for two months
91% approval
570 comments
submitted
2011-01 6th
DG meeting
2011-02
5th
WG 29 meeting in conjunction with WG
32 DIS 35
2011-05 DIS out for ballot
88% approval
440 comments
submitted
2012-01 7th
DG meeting (Geneva)
2012-02 6th
WG 29 meeting (Munich) FDIS 30
2012-04 FDIS out for vote
2012-07 FDIS approved 95% approval in ISO
and 100% in IEC
2012-09 Publication IS
2012-09-26
9. Page 9
Timeline of Revision ISO/IEC Guide 67
to ISO/IEC 17067
Status of ISO/IEC 17067
Date Activity WG 32 Output Participation Results (comments/voting)
2010-02
1st WG 32 meeting –
definition of scope and
structure of revision
WD0 12
2010-09 2nd WG meeting WD1 10
2011-02 3rd
WG meeting WD2 15
2011-10 4th
WG meeting CD 12
2011-11 CD out for ballot 88% approval
2012-04 5th
WG meeting DIS 15
2012-06 DIS out for ballot
2013-02 6th
WG meeting FDIS
Q2 2013 FDIS out for ballot
Q3 2013 IS out
2012-09-26
10. Page 10
Purpose of Revision ISO/IEC Guide 65
to ISO/IEC 17065
2012-09-26
Maintain the proven
parts of Guide 65
Improve where
necessary
Maintain the proven
parts of Guide 65
Improve where
necessary
ISO IEC Guide 65 ISO IEC
17065
11. Page 11
Content of ISO/IEC Guide 65 to
ISO/IEC 17065 (1)
2012-09-26
The content is aligned with the new structural requirements decided by
ISO CASCO (8 chapters instead of 15 in ISO/IEC Guide 65)
12. Page 12
Content of ISO/IEC Guide 65 to
ISO/IEC 17065 (2)
2012-09-26
The obligatory requirements of the ISO/PAS are included in
ISO/IEC17065
* The PAS requirements may also be addressed in other parts of the
standards than the ones listed above
13. Page 13
Changes of revision ISO/IEC Guide 65
to ISO/IEC 17065 (1)
2012-09-26
14. Page 14
Changes of revision ISO/IEC Guide 65
to ISO/IEC 17065 (2)
2012-09-26
15. Page 15
Changes of revision ISO/IEC Guide 65
to ISO/IEC 17065 (3)
2012-09-26
The definition chapter is considerably improved by definitions on
16. Page 16
Changes of revision ISO/IEC Guide 65
to ISO/IEC 17065 (4)
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17. Page 17
Changes of revision ISO/IEC Guide 65
to ISO/IEC 17065 (5)
2012-09-26
18. Page 18
Changes of revision ISO/IEC
Guide 65 to ISO/IEC 17065 (6)
The process chapter 7 follows the functional approach provided in
ISO/IEC 17000 which consists of
– selection
– determination
– review
– attestation
– surveillance
The functions “selection” and “determination” are in 17065 combined as
function “evaluation”
2012-09-26
evaluation
Decision and insuance of certificate if relevant
19. Page 19
Changes of revision ISO Guide 65 to
ISO/IEC 17065 (7)
2012-09-26
20. Page 20
Changes of revision ISO/IEC Guide 65
to ISO/IEC 17065 (8)
2012-09-26
21. Page 21
Changes of revision ISO/IEC Guide 65
to ISO/IEC 17065 (9)
2012-09-26
Detailed presentation of the most important clauses of the new
ISO/IEC17065:2012
25. Page 25
ISO/IEC 17065:2012
2012-09-26
Clause 4.3
Liability and
financing
ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 4.4
Non-discrimi-
natory conditions
Clause 4.5
Confidentiality
Clause 4.6
Publicly
available
informations
4. General requirements
26. Page 26
ISO/IEC 17065:2012
2012-09-26
Clause 5.1
Organization
ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 5.2
Safeguarding
Impartiality
5. Structural requirements
Significant changes related to ISO/IEC Guide 65 by
introducing a mechanism for safeguarding impartiality
which can be
a committee established by one or more CB’s
a committee implemented by a scheme owner
a governmental authority or an equivalent party.
27. Page 27
ISO/IEC 17065:2012
2012-09-26
6.1 Personnel
ISO/IEC 17065 and relation to ISO/IEC Guide 65
6.2 Evaluation
resources
6. Resource requirements
Significant changes related to ISO/IEC Guide 65 by
introducing a more detailed description of internal and
external resources. In ISO/IEC Guide 65, external resources
is called subcontracting. Internal resources can also be
resources under the direct control of the CB.
28. Page 28
ISO/IEC 17065:2012
2012-09-26
Clause 7.1
Scheme
ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 7.2/7.3
Application
7. Process Requirements
Application clause in ISO/IEC Guide 65 (8.2) is replaced in
ISO/IEC 17065 by clauses 7.2 “application” and 7.3
“application review” which provides a more detailed
information.
30. Page 30
ISO/IEC 17065:2012
2012-09-26
ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 7.5
Review
7. Process Requirements
Introducing the function „review“ based on the
functional approach provided in ISO/IEC 17000.
A certification body must have all information and results
related to the evaluation to complete the review
33. Page 33
ISO/IEC 17065:2012
2012-09-26
Clause 7.9
Surveillance
ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 7.10
Changes
7. Process Requirements
Clause 7.11
Status
Improvement related to ISO Guide 65 by more detailed
description of termination, reduction, suspension or withdrawal
of certification.
Improvement related to ISO Guide 65 by introducing a more
detailed description of changes affecting certification
(introduced by the scheme or initiated by the client).
34. Page 34
ISO/IEC 17065:2012
2012-09-26
7.12 Records
ISO/IEC 17065 and relation to ISO/IEC Guide 65
7.13 Complaints /
Appeals
7. Process Requirements
Alignment with ISO PAS 17003
36. Page 36
ISO/IEC 17065:2012
2012-09-26
Principles
(Annex A)
ISO/IEC 17065 and relation to ISO/IEC Guide 65
Process and
services
(Annex B)
The informative Annex B provides explanations for
application of this standard for certification of processes
and services.
56. Page 56
History and Relationship
2012-09-26
1990 2000 20101980
ISO Guide 40
1983
ISO Guide 23
1982
ISO Guide 67
1981
ISO Guide 65
1996
ISO Guide 23
1982
ISO Guide 67
1981
ISO/IEC 17065
ISO/IEC 17067
2013
until than
existing ISO
Guide 23
and 67
2012
57. Page 57
Relation between certification body
and scheme owner
Scheme owner
runs a scheme
Scheme owner
runs a scheme
Guidelines for
schemes are
given in
ISO/IEC 17067
Guidelines for
schemes are
given in
ISO/IEC 17067
Requirements
for certification
bodies are
given in ISO/IEC
17065
Requirements
for certification
bodies are
given in ISO/IEC
17065
Stakeholder
manufactorer,
operator,
deliverer of a
product, process or
services
Certification Body
and
Conformity
assessment
Customer
Scheme owner can be the certification body, governmenal authority,
trade association, group of CB‘S, …..
ISO/IEC 17030
for the labels
and their use
ISO/IEC 17030
for the labels
and their use
2012-09-26
58. Page 58
Examples of resources used for
testing, inspection and auditing
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All those examples are covered in Clauses 6 of ISO/IEC 17065
Certification body
59. Page 59
Examples of Resources Personnel
2012-09-26
All those examples are covered in Clause 6 of ISO/IEC 17065
60. Page 60
Examples: how a CB can be
positioned in a bigger organisation
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This shows possible position of a CB within a bigger organisation
61. Page 61
Example of possible arrangement
for Organizational Control
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Organizational Control is to
supervise that the related
company does not influence
the person in its work for the
CB
Agreement to
follow CB rules
and procedure
Work contract
This relates to Clause 7.6.4 of ISO/IEC 17065. This is one possibility for
organisational control among many
62. Page 62
Functional Approach
2012-09-26
Evaluation
Insuance of a
certificate after
decision
The right part of the chart (evaluation – Insuance of certificate) is the terminology
used in ISO/IEC 17065
The functional approach is described in ISO/IEC 17000 (left part of the chart below)
64. Page 64
Maintenance group (1)
2012-09-26
The level of work is expected to be limited. There is no meeting foreseen. It
is mainly required from the members to be available to fulfill the functions
described above.
Suggestion is that the members of the drafting group would be the members
of the maintenance group.
Mandate
65. Page 65
Maintenance group (2) Members
2012-09-26
Mr. Sumio Asada JISC (Japan)
Ms. Andrea Barroso Melo Monteiro de Queiroz ABNT (Brazil)
Mr. Alister Dalrymple AFNOR (France)
Ms. Yunhua Chen SAC (China)
Mr. Ian Cleare BSI (United Kingdom)
Mr. Graeme Drake SA (Australia)
Mr. Reinaldo Figueiredo ANSI (USA)
Mr. Steve Keeling SA (Australia)
Mr. Pedro Loste AENOR (Spain)
Mr. Leif Madsen DS (Denmark)
Mr. Paul Moliski IAF
Mr. Keith Mowry ANSI (USA)
Mr. Christian Priller (Convenor WG 29) DIN (Germany)
Mr Jaap Prummel NEN (Netherlands)
Mr. Lorenz Roggli SNV (Switzerland) – ILAC
Mr. Hinrich Schaub ON (Austria)
Mr. Thomas Facklam IAF
Mr. Hanspeter Ischi SNV (Switzerland) – ILAC alternate
Mr. Heribert Schorn (DIN – Germany)
Mr. Alan Squirrell ILAC
Mr. Pierre de Ruvo IEC
66. Page 66
Thank you … a great work goes to
finish …
After a long and intensive work with ISO CASCO WG 29 over the last years
I like to say Thank you as your Convenor,
hopefully not to forget somebody or something now, If so, I say sorry in advance.
I like to say Thank you to ISO Secretary, to all of them,
To my parent Convenor Mario Wittner,
To all of you and to everybody for your great credit, support and nice and hard discussions,
To the support of the Drafting Group, without them it would not be possible for me.
Looking in front of, I see the result of a very well balanced new standard for the economic system
and all participants in the system.
And hope to see you all soon, it was a pleasure for me to work so close with you !
I wish you all good luck, health and success
Yours Christian Priller, Convenor
2012-09-26