This document provides an overview and introduction to Diamondback America's Quality Management System which is certified to ISO 9001. It explains that ISO 9001 provides standardized rules and requirements for quality systems to ensure customer requirements are met. Diamondback America has implemented a Quality Management System according to ISO 9001 and all employees have responsibilities to understand quality documents, processes and procedures relevant to their roles. The QMS aims to satisfy customers, continually improve, and manage quality through objectives and monitoring.
The document discusses quality management systems and ISO 9001 standards. It outlines the key aspects of a quality management system including quality objectives, processes, reviews, facilities, documentation, training, and audits. It also describes how the company manages its quality management system through its quality policy statement, quality manual, and procedures like document control, record control, internal audits, non-conforming product control, corrective action, and preventive action. The benefits are highlighted as doing work safely, correctly, and within time limits through continuous improvement.
1) The document discusses leadership requirements in ISO 9001:2015, including demonstrating leadership commitment, establishing a quality policy, and defining organizational roles and responsibilities.
2) Top management must ensure the quality management system is effective and integrated, that resources are available, and that quality objectives align with strategic goals. Customer focus and satisfaction must also be promoted.
3) The quality policy provides a framework for quality objectives and commits the organization to satisfying requirements and continual improvement. It must be communicated and available as documented information.
This document provides an overview and template for quality management review. It includes sections on quality management approach, requirements and standards, and assurance. The quality management approach section defines how quality will be managed for both products and processes, including establishing metrics to measure quality. The requirements and standards section describes how quality standards will be identified and compliance demonstrated. Quality assurance focuses on iterative quality processes and audits to ensure standards compliance and continuous improvement.
This document provides an overview of quality management systems and ISO 9001:2008 certification. It discusses how customer expectations have changed from a time when customers had less choice to today's buyer's market where customers expect high quality and reliability. Implementing a quality management system helps organizations understand customer requirements and establish processes to consistently meet those requirements. Obtaining ISO 9001:2008 certification provides both internal benefits like improved productivity and employee satisfaction, as well as external benefits such as improved quality image and ability to enter global markets.
Quality Assurance and Quality Control - Areas of ImprovementImran Jamil
A brief presentation, focusing on the improvement areas of Quality Assurance and Quality Control in an organization. The presentation also discusses about some of the myths about quality.
The document provides an overview of a Quality Management System (QMS). It explains that a QMS is a system that can be adopted by any organization to meet customer requirements and enhance customer satisfaction. It also describes the key parts of a QMS including processes, objectives, policies, leadership, support/operation, performance evaluation, and planning. Finally, it discusses measuring customer satisfaction, process conformance, and performance to identify areas for improvement.
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.
This document provides an overview of ISO 9001:2015 quality management system standard. It discusses the key principles such as customer focus, leadership, process approach, and continual improvement. The main clauses of ISO 9001:2015 are summarized, including context of the organization, leadership, planning, support, operation, performance evaluation, and improvement. Planning addresses risk management, quality objectives, and managing changes. Support covers resources, competence, awareness, communication, and documented information. The document emphasizes that ISO 9001 employs the PDCA cycle and risk-based thinking for continual improvement of processes and meeting customer requirements.
The document discusses quality management systems and ISO 9001 standards. It outlines the key aspects of a quality management system including quality objectives, processes, reviews, facilities, documentation, training, and audits. It also describes how the company manages its quality management system through its quality policy statement, quality manual, and procedures like document control, record control, internal audits, non-conforming product control, corrective action, and preventive action. The benefits are highlighted as doing work safely, correctly, and within time limits through continuous improvement.
1) The document discusses leadership requirements in ISO 9001:2015, including demonstrating leadership commitment, establishing a quality policy, and defining organizational roles and responsibilities.
2) Top management must ensure the quality management system is effective and integrated, that resources are available, and that quality objectives align with strategic goals. Customer focus and satisfaction must also be promoted.
3) The quality policy provides a framework for quality objectives and commits the organization to satisfying requirements and continual improvement. It must be communicated and available as documented information.
This document provides an overview and template for quality management review. It includes sections on quality management approach, requirements and standards, and assurance. The quality management approach section defines how quality will be managed for both products and processes, including establishing metrics to measure quality. The requirements and standards section describes how quality standards will be identified and compliance demonstrated. Quality assurance focuses on iterative quality processes and audits to ensure standards compliance and continuous improvement.
This document provides an overview of quality management systems and ISO 9001:2008 certification. It discusses how customer expectations have changed from a time when customers had less choice to today's buyer's market where customers expect high quality and reliability. Implementing a quality management system helps organizations understand customer requirements and establish processes to consistently meet those requirements. Obtaining ISO 9001:2008 certification provides both internal benefits like improved productivity and employee satisfaction, as well as external benefits such as improved quality image and ability to enter global markets.
Quality Assurance and Quality Control - Areas of ImprovementImran Jamil
A brief presentation, focusing on the improvement areas of Quality Assurance and Quality Control in an organization. The presentation also discusses about some of the myths about quality.
The document provides an overview of a Quality Management System (QMS). It explains that a QMS is a system that can be adopted by any organization to meet customer requirements and enhance customer satisfaction. It also describes the key parts of a QMS including processes, objectives, policies, leadership, support/operation, performance evaluation, and planning. Finally, it discusses measuring customer satisfaction, process conformance, and performance to identify areas for improvement.
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.
This document provides an overview of ISO 9001:2015 quality management system standard. It discusses the key principles such as customer focus, leadership, process approach, and continual improvement. The main clauses of ISO 9001:2015 are summarized, including context of the organization, leadership, planning, support, operation, performance evaluation, and improvement. Planning addresses risk management, quality objectives, and managing changes. Support covers resources, competence, awareness, communication, and documented information. The document emphasizes that ISO 9001 employs the PDCA cycle and risk-based thinking for continual improvement of processes and meeting customer requirements.
This document outlines the key sections and processes of an ISO 9001:2015 quality management system for an organization. It includes sections on leadership and commitment, planning, support, operation, performance evaluation, and improvement. The operation section specifically addresses control of externally provided processes and products, customer communication, design and development, production and service provision, and control of nonconforming products. Planning processes incorporate determining requirements, reviewing requirements, managing changes to requirements, and controls. Performance is evaluated through monitoring, measurement, internal audits and management reviews. Improvement involves nonconformity corrective action and continual improvement.
Iso 9001 2015 Quality Transition ISO Consultant Implementation Certification...Robert Jasper
BEST PRACTICE STRATEGIES FOR IMPLEMENTATION OR TRANSITIONING TO QMS BASED ON ISO 9001:2015
ISO Consultant Robert Jasper explains in this "Hands On" presentation, ehich artifacts have to be in place to pass ISO Thid Party Audits for Quality Management systems based on ISO 9001:2015.
Iso 9001 2015 Quality Transition ISO Consultant Implementation Certification Training Support Orlando Florida
FOR MORE INFORMATION PLEASE CONTACT:
Robert Jasper
Certified Auditor ISO 9001 based Quality Management Systems and ISO 9001 Consultant/Trainer
The Art of Quality CONSULTING
a Brand of Technology Applications International LLC. Orlando
5528 Force Four Parkway
Orlando, 32839, Florida, United States
Phone: 001 407-342-8458
Fax: 001 407-442-3016
email: info@theartofquality.com
www.artofqualityconsulting.com
This document outlines the key phases and requirements of a new product development process according to IATF 16949:2016 standards. The phases include determining customer requirements, design and development, product design review, packaging design, manufacturing process design, prototype testing, and mass production. Key requirements addressed in each phase involve multidisciplinary collaboration, risk analysis, statutory compliance, and management reviews. The overall flowchart illustrates how each phase feeds into the next with approval checkpoints until the product is ready for mass production and delivery to the customer.
This document provides an overview of an ISO 9001:2015 Awareness Program. The purpose of the program is to increase awareness of ISO 9001:2015 and promote self-improvement and improvements to an organization's quality management system. The program covers background information on ISO, the ISO family of standards, quality management principles, ISO 9001:2015 requirements, and more. Key topics include the process approach, management principles like customer focus and continual improvement, ISO 9001 clauses, documentation requirements, and the PDCA cycle used in ISO management systems. The program aims to help participants better understand ISO 9001:2015 and how to implement or improve their organization's quality management system.
This document lists the mandatory documents and records required by ISO 13485:2016 for an effective quality management system. It includes 39 mandatory procedures that must be established, such as procedures for document control, management review, design and development, purchasing, production, and corrective actions. It also lists 46 types of records that must be created and maintained, including records of management review, risk management activities, design and development, supplier evaluation, calibration of equipment, complaints, internal audits, corrective and preventive actions. Compliance with these requirements is an important step in implementing an ISO 13485 certified quality management system.
This document summarizes an awareness program on quality management systems (ISO 9001:2008). It discusses the growth of QMS standards since the 1990s and key elements of ISO 9001:2008, including a process approach. The quality management principles of customer focus, leadership, and continual improvement are covered. An overview is provided of the sections and requirements of a quality management system, including documentation, management responsibility, resource management, product realization, and measurement/improvement. The document encourages registering for training courses to upgrade skills in these areas.
Quality management has three main components: quality control, quality assurance, and quality improvement. Quality management focuses on both product quality and the means to achieve it using quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is the ongoing effort to maintain integrity of a process to reliably achieve outcomes. Quality assurance is the planned actions to provide enough confidence that products or services will meet requirements. Quality improvement distinguishes itself from quality control by purposefully changing processes to improve reliability of outcomes.
Global Manager Group provides this presentation that talks about mandatory documents required for ISO 9001:2015 Certification. The key documents like quality manual, procedures, SOPs, audit checklist, etc required for certification are described in details. Also give information about how Global Mananger Group helps in quick certification by providing ISO 9001:2015 Documentation kit.
For more information visit @ http://www.globalmanagergroup.com/
The document outlines the key components of a Quality Management System (QMS) implementation, including developing an organizational system to ensure quality and continual process improvement throughout the organization. It lists elements such as a quality manual, procedures, work instructions, objectives and targets, internal audits, and continual improvement. A balanced scorecard approach is also recommended to cascade objectives and targets down from policy levels and departments to individual employees.
The document discusses basic quality concepts and terminology related to quality assurance and management. It defines key terms like quality, reliability, maintainability, supplier, customer, quality policy, quality management, quality system, quality control, and quality assurance. It also discusses how quality assurance aims to encourage individual responsibility and getting work right the first time to minimize rework. Quality costs and benefits are examined, noting how quality construction can reduce costs from replacements, delays, and disputes while increasing goodwill and lowering maintenance costs.
This document provides an overview of a presentation on quality management systems and ISO standards. It discusses the history and formation of ISO, key ISO standards like ISO 9000 and 9001, benefits of ISO certification like reduced errors and increased customer satisfaction, and sector-specific standards for industries like automotive and telecommunications. The presentation covers topics like quality management principles, documentation requirements, internal audits, and implementing an ISO-compliant quality management system.
This document discusses corrective and preventive action (CAPA) systems and how they are used to mitigate risk. It provides three key points:
1) CAPA systems use non-conformances, deviations, and potential problems to investigate quality issues, identify corrective and preventive actions, and track the implementation of these actions.
2) CAPA aims to define the risk level associated with quality events and ensure appropriate actions are taken based on risk level, from further investigation and corrective actions for high risks to no action for low risks.
3) Effective CAPA systems incorporate change control to evaluate and document any changes made as a result of corrective actions to avoid introducing new risks.
ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.
The document discusses upcoming changes to the ISO 9001 standard for quality management systems. ISO 9001 is being revised in 2015 to include a new common structure across management system standards. Major changes include new requirements for determining organizational context, stakeholder needs and expectations, adopting a process approach, and using a risk-based approach rather than preventative action. The draft version will be released in April 2014 with the official revised standard expected in September 2015. Organizations should educate themselves on the changes, identify gaps in their current system, and plan implementation of new requirements.
Awareness session on iatf 16949 2016 standardAmit Mishra
This document provides an agenda for training on IATF 16949. The training will cover an overview of IATF 16949 and how it relates to ISO 9001:2015. It will discuss the key changes between ISO/TS 16949:2009 and IATF 16949, including 14 specific changes. It will also cover the IATF structure, goals of IATF 16949, high level structure, notable changes in terminology, and clause-wise additions and explanations. The training will identify 17 documented processes required by IATF 16949 and certain frequency requirements.
This document discusses quality awareness and defines quality in several ways. It begins by defining quality as how a recipient views a product or service before, during, and after use. It then discusses previous definitions of quality as meeting predetermined criteria and specifications at a given cost. The main portion defines modern views of quality as conforming to requirements, being fit for use, meeting and exceeding customer expectations, and comparing favorably to competitors. It lists quality characteristics for products and services and defines internal and external customers. It emphasizes that quality is everyone's responsibility in an organization.
The most valuable Helpful PDF file that extremely can boost your ability to understand well the New version of QMS in accordance to ISO 9001:2015 as well as ease the documentation transition process toward ISO 9001:2015
The document provides information about conducting internal audits of a quality management system. It describes the responsibilities of an internal auditor, the purpose of internal audits, and how to plan and perform an audit. Key aspects covered include understanding ISO 9001:2015 requirements, using a process-based approach, planning audits, gathering objective evidence during audits, and writing factual audit reports to help improve the management system.
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
This document provides an overview of quality management systems and key concepts such as ISO 9001, AS9100, auditing, and corrective action. It explains that a quality management system involves ensuring customer requirements are met through inspection, measurement, feedback and improvement. ISO 9001 provides standardized rules for quality systems and AS9100 adds additional requirements for the aerospace industry. Companies implement these standards and undergo external auditing to prove their quality systems are good. The document also outlines various quality system processes such as purchasing, production controls, and handling nonconforming parts. Employees have responsibilities in promoting quality, identifying issues, and participating in audits and corrective action.
The document provides an overview of Global Technology and Engineering's quality management system. It discusses that the company has implemented a Quality Management System based on ISO 9001 and AS9100 standards to ensure it meets customer requirements. The summary describes key aspects of the system including that it is documented in a quality manual and procedures, requires training and monitoring of processes, and has procedures to control nonconforming parts and documents.
This document outlines the key sections and processes of an ISO 9001:2015 quality management system for an organization. It includes sections on leadership and commitment, planning, support, operation, performance evaluation, and improvement. The operation section specifically addresses control of externally provided processes and products, customer communication, design and development, production and service provision, and control of nonconforming products. Planning processes incorporate determining requirements, reviewing requirements, managing changes to requirements, and controls. Performance is evaluated through monitoring, measurement, internal audits and management reviews. Improvement involves nonconformity corrective action and continual improvement.
Iso 9001 2015 Quality Transition ISO Consultant Implementation Certification...Robert Jasper
BEST PRACTICE STRATEGIES FOR IMPLEMENTATION OR TRANSITIONING TO QMS BASED ON ISO 9001:2015
ISO Consultant Robert Jasper explains in this "Hands On" presentation, ehich artifacts have to be in place to pass ISO Thid Party Audits for Quality Management systems based on ISO 9001:2015.
Iso 9001 2015 Quality Transition ISO Consultant Implementation Certification Training Support Orlando Florida
FOR MORE INFORMATION PLEASE CONTACT:
Robert Jasper
Certified Auditor ISO 9001 based Quality Management Systems and ISO 9001 Consultant/Trainer
The Art of Quality CONSULTING
a Brand of Technology Applications International LLC. Orlando
5528 Force Four Parkway
Orlando, 32839, Florida, United States
Phone: 001 407-342-8458
Fax: 001 407-442-3016
email: info@theartofquality.com
www.artofqualityconsulting.com
This document outlines the key phases and requirements of a new product development process according to IATF 16949:2016 standards. The phases include determining customer requirements, design and development, product design review, packaging design, manufacturing process design, prototype testing, and mass production. Key requirements addressed in each phase involve multidisciplinary collaboration, risk analysis, statutory compliance, and management reviews. The overall flowchart illustrates how each phase feeds into the next with approval checkpoints until the product is ready for mass production and delivery to the customer.
This document provides an overview of an ISO 9001:2015 Awareness Program. The purpose of the program is to increase awareness of ISO 9001:2015 and promote self-improvement and improvements to an organization's quality management system. The program covers background information on ISO, the ISO family of standards, quality management principles, ISO 9001:2015 requirements, and more. Key topics include the process approach, management principles like customer focus and continual improvement, ISO 9001 clauses, documentation requirements, and the PDCA cycle used in ISO management systems. The program aims to help participants better understand ISO 9001:2015 and how to implement or improve their organization's quality management system.
This document lists the mandatory documents and records required by ISO 13485:2016 for an effective quality management system. It includes 39 mandatory procedures that must be established, such as procedures for document control, management review, design and development, purchasing, production, and corrective actions. It also lists 46 types of records that must be created and maintained, including records of management review, risk management activities, design and development, supplier evaluation, calibration of equipment, complaints, internal audits, corrective and preventive actions. Compliance with these requirements is an important step in implementing an ISO 13485 certified quality management system.
This document summarizes an awareness program on quality management systems (ISO 9001:2008). It discusses the growth of QMS standards since the 1990s and key elements of ISO 9001:2008, including a process approach. The quality management principles of customer focus, leadership, and continual improvement are covered. An overview is provided of the sections and requirements of a quality management system, including documentation, management responsibility, resource management, product realization, and measurement/improvement. The document encourages registering for training courses to upgrade skills in these areas.
Quality management has three main components: quality control, quality assurance, and quality improvement. Quality management focuses on both product quality and the means to achieve it using quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is the ongoing effort to maintain integrity of a process to reliably achieve outcomes. Quality assurance is the planned actions to provide enough confidence that products or services will meet requirements. Quality improvement distinguishes itself from quality control by purposefully changing processes to improve reliability of outcomes.
Global Manager Group provides this presentation that talks about mandatory documents required for ISO 9001:2015 Certification. The key documents like quality manual, procedures, SOPs, audit checklist, etc required for certification are described in details. Also give information about how Global Mananger Group helps in quick certification by providing ISO 9001:2015 Documentation kit.
For more information visit @ http://www.globalmanagergroup.com/
The document outlines the key components of a Quality Management System (QMS) implementation, including developing an organizational system to ensure quality and continual process improvement throughout the organization. It lists elements such as a quality manual, procedures, work instructions, objectives and targets, internal audits, and continual improvement. A balanced scorecard approach is also recommended to cascade objectives and targets down from policy levels and departments to individual employees.
The document discusses basic quality concepts and terminology related to quality assurance and management. It defines key terms like quality, reliability, maintainability, supplier, customer, quality policy, quality management, quality system, quality control, and quality assurance. It also discusses how quality assurance aims to encourage individual responsibility and getting work right the first time to minimize rework. Quality costs and benefits are examined, noting how quality construction can reduce costs from replacements, delays, and disputes while increasing goodwill and lowering maintenance costs.
This document provides an overview of a presentation on quality management systems and ISO standards. It discusses the history and formation of ISO, key ISO standards like ISO 9000 and 9001, benefits of ISO certification like reduced errors and increased customer satisfaction, and sector-specific standards for industries like automotive and telecommunications. The presentation covers topics like quality management principles, documentation requirements, internal audits, and implementing an ISO-compliant quality management system.
This document discusses corrective and preventive action (CAPA) systems and how they are used to mitigate risk. It provides three key points:
1) CAPA systems use non-conformances, deviations, and potential problems to investigate quality issues, identify corrective and preventive actions, and track the implementation of these actions.
2) CAPA aims to define the risk level associated with quality events and ensure appropriate actions are taken based on risk level, from further investigation and corrective actions for high risks to no action for low risks.
3) Effective CAPA systems incorporate change control to evaluate and document any changes made as a result of corrective actions to avoid introducing new risks.
ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.
The document discusses upcoming changes to the ISO 9001 standard for quality management systems. ISO 9001 is being revised in 2015 to include a new common structure across management system standards. Major changes include new requirements for determining organizational context, stakeholder needs and expectations, adopting a process approach, and using a risk-based approach rather than preventative action. The draft version will be released in April 2014 with the official revised standard expected in September 2015. Organizations should educate themselves on the changes, identify gaps in their current system, and plan implementation of new requirements.
Awareness session on iatf 16949 2016 standardAmit Mishra
This document provides an agenda for training on IATF 16949. The training will cover an overview of IATF 16949 and how it relates to ISO 9001:2015. It will discuss the key changes between ISO/TS 16949:2009 and IATF 16949, including 14 specific changes. It will also cover the IATF structure, goals of IATF 16949, high level structure, notable changes in terminology, and clause-wise additions and explanations. The training will identify 17 documented processes required by IATF 16949 and certain frequency requirements.
This document discusses quality awareness and defines quality in several ways. It begins by defining quality as how a recipient views a product or service before, during, and after use. It then discusses previous definitions of quality as meeting predetermined criteria and specifications at a given cost. The main portion defines modern views of quality as conforming to requirements, being fit for use, meeting and exceeding customer expectations, and comparing favorably to competitors. It lists quality characteristics for products and services and defines internal and external customers. It emphasizes that quality is everyone's responsibility in an organization.
The most valuable Helpful PDF file that extremely can boost your ability to understand well the New version of QMS in accordance to ISO 9001:2015 as well as ease the documentation transition process toward ISO 9001:2015
The document provides information about conducting internal audits of a quality management system. It describes the responsibilities of an internal auditor, the purpose of internal audits, and how to plan and perform an audit. Key aspects covered include understanding ISO 9001:2015 requirements, using a process-based approach, planning audits, gathering objective evidence during audits, and writing factual audit reports to help improve the management system.
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
This document provides an overview of quality management systems and key concepts such as ISO 9001, AS9100, auditing, and corrective action. It explains that a quality management system involves ensuring customer requirements are met through inspection, measurement, feedback and improvement. ISO 9001 provides standardized rules for quality systems and AS9100 adds additional requirements for the aerospace industry. Companies implement these standards and undergo external auditing to prove their quality systems are good. The document also outlines various quality system processes such as purchasing, production controls, and handling nonconforming parts. Employees have responsibilities in promoting quality, identifying issues, and participating in audits and corrective action.
The document provides an overview of Global Technology and Engineering's quality management system. It discusses that the company has implemented a Quality Management System based on ISO 9001 and AS9100 standards to ensure it meets customer requirements. The summary describes key aspects of the system including that it is documented in a quality manual and procedures, requires training and monitoring of processes, and has procedures to control nonconforming parts and documents.
General Employee Training Presentation ISO 9001Tumwine2
This document provides an overview of a company's quality management system that complies with ISO 9001. It discusses that a quality management system ensures customer requirements are met through quality management activities like inspections, measurements, and process improvement. ISO 9001 provides standardized rules for quality systems so customers know a company's system is good. The company intends to implement the ISO 9001 rules and certify its quality system through audits. It outlines responsibilities for employees and documentation requirements.
General Employee Training Presentation ISO 9001 - rev 0.pptxjohan698445
This document provides an overview and introduction to a company's ISO 9001 quality management system for employees. It defines key terms like quality, quality management, and quality management systems. It explains that ISO 9001 provides standardized rules for quality systems and that certification involves external audits. It outlines the company's quality system documentation, processes, and procedures. It discusses quality audits, corrective and preventive action, and emphasizes continual improvement. The overall purpose is to educate employees on the company's ISO-certified quality system and their roles and responsibilities.
ISO 9001-2015 complete guidance and its implementation in your organization.
its helps to get understand to employee of ISO requirement and its regulations.
Quality Management System awareness for all ANUPAM RAY
I covered benefit and utilization ISO 9001:2015 standard, 8 quality principle, Root cause analysis, what is ISO, and basic auditing principle. Kindly comment and let me know how I can improve this.
This document provides an overview of the Quality Management System (QMS) being implemented at MSM based on the ISO 9001:2015 standard. It introduces key aspects of the QMS including quality policies, processes, roles and responsibilities, and the Corrective Action Preventive Action (CAPA) system for continual improvement. The goal is to meet and exceed customer requirements through focus on business process improvement and quality of products/services. All employees have a role to play in quality including following procedures, identifying issues, and helping with audits and improvements.
The document discusses ISO 9001, an international standard for quality management systems. It provides an overview of ISO 9001, including its history and timeline, key requirements, benefits, and the revised 2015 version. The standard is applicable to organizations of all sizes and sectors. Certification involves a two-stage audit process to verify the organization's quality management system meets ISO 9001 requirements. Maintaining certification requires ongoing activities like internal audits, corrective actions, and training.
J.F. DeBetz—CEO and Process Improvement Specialist of The Business Fixers—delivers a comprehensive overview of ISO.
Learning how to get ISO certified doesn't need to be a burden, we're here to make it easy!
This workshop includes:
- How to navigate ISO 9001 and ISO 14001
- Generate the elements for successful certification—from audits to consultants
- Avoid common mistakes, like lack of management support and reviews
- ... and more
This document provides an overview of an organization's integrated management system covering quality, health and safety, and environmental policies and procedures. It discusses the organization's quality management system which follows the Six Sigma DMAIC methodology. It also outlines the organization's health and safety policies covering OHSAS 18001 requirements, duties of employees and management, and safety committees. The document aims to train employees on the organization's integrated management system.
Use this ppt presentation to educate groups on what is ISO 9001:2015 standard, what are the requirements of ISO 9001:2015 certification, etc.
For more information visit: https://www.globalmanagergroup.com/
International organization for standarzation sonalgupta200
The document discusses International Organization for Standardization (ISO) and provides information on various ISO standards and certifications. It defines ISO as a non-governmental organization that develops voluntary international standards to ensure quality, safety and efficiency. It describes common ISO standards like ISO 9001 for quality management systems, ISO 14001 for environmental management systems. The document also provides steps for implementing ISO 9001 and 14001 standards and gaining certification.
This document discusses factors that affect the quality of medical records documentation in hospitals. Semi-structured interviews were conducted with 28 managers and administrators from educational hospitals in Iran. Facilitators and barriers to quality documentation were categorized as organizational, environmental, or personal. Key facilitating factors included organizational structure and culture, management support, and individual characteristics. Barriers included issues with the program structure, beliefs, and individual characteristics. The identification of these factors can help health managers improve documentation quality by strengthening facilitators and overcoming barriers. This is important as high-quality documentation is necessary to achieve the goal of improved care through accreditation programs.
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 summarizes information about the International Organization for Standardization (ISO) 9001 quality management system standard. It discusses ISO's history and purpose, as well as the key principles and requirements of ISO 9001, including customer focus, measurement and improvement processes, document control, audits and reporting. The summary also outlines some advantages of adopting ISO 9001 such as improved customer satisfaction and productivity, as well as potential disadvantages like high implementation costs and emphasis on documentation. Challenges to implementation include gaining top management support and allocating sufficient resources.
When you are satisfied that your organization is working within the guidelines of the Quality Management System, now it’s a time to call an ISO 9001 Certification Body. The audit can be conducted by a number of different Certification bodies; however it is necessary to note that not all ISO 9001 auditing organizations are UKAS Accredited. UKAS accredited ISO 9001 Certification are issued by URS Certification.
ISO 9001 provides requirements for quality management systems to help organizations ensure customer satisfaction. ISO 14001 provides requirements for environmental management systems to help organizations minimize environmental impacts and comply with regulations. Both standards can be applied generically to any organization and certify management of key processes rather than products or services. Widespread use of the standards benefits organizations and economies through improved efficiency, compliance and international trade.
Similar to General Employee Training Presentation ISO 9001 - rev 0.pptx (20)
3. Quality Management System (QMS)
• “Quality” means “meeting customer
requirements.”
• Form, fit, function of hardware products
• Quality of services provided
• Prompt delivery
• Product/service Consistency
• Customer service
• Responsiveness to customer complaints
Q
M
S
4. Quality Management System (QMS)
• “Quality Management” is the activities
performed by the company to ensure
those customer requirements are met.
• Inspections
• Measurements
• Customer feedback review
• Improvement activities
Q
M
S
5. Quality Management System (QMS)
• “Quality Management System” is the set
of processes a company utilizes to execute
its quality management activities.
• The processes in the company that impact on
quality
• Management of those processes through
objectives and metrics
• Improving those processes to enhance quality
and customer satisfaction
Q
M
S
6. Quality Management System (QMS)
• Every company has a quality system in place
whether it knows it or not.
• The QMS may be:
– Good or bad
– Formal or informal
– Documented or undocumented
7. Two Quality Systems
Joe’s Pizza
• Amount of dough,
cheese, etc.
• Spices used
• Oven temperature
• Bake time
• Boxes used
• Delivery methods (pick
up, deliver by car, etc.)
ABC Machine Shop
• Make parts according to
prints
• Use raw materials from
approved suppliers
• Inspect parts before
shipment
• Repair defects found
• Package properly
• Ship all parts express
8. A Third Quality System
Lenny’s Machine
Shop o’ Horrors
• Make whatever
• Ship Whatever
• If customer complains, say
“whatever.”
“At Lenny’s, we
promise never to
promise!”
9. Standardizing Quality Systems
• Because a company can have any kind of
quality system it wants, customers do not
know in advance whether the system is good
or bad.
• Does a company inspect its work before delivery?
• Does a company have a way to handle
complaints?
• Does a company use good raw materials?
• Are employees properly trained?
10. Enter ISO
• The world recognized that
this was a problem.
• The International
Organization for
Standardization (ISO)
intended to correct this,
by standardizing quality
systems.
11. What is ISO?
• ISO is based in Geneva Switzerland.
• Over 170 countries are members of ISO,
including the US.
• ISO develops all kinds of standards, such as
traffic symbols, material standards, inspection
practices, and more.
12. Example: an ISO Standard
• If credit cards didn’t comply
with ISO 7810, they wouldn’t
physically fit in bank machines
ISO standardized credit card sizes
Source: Wikipedia
13. What is ISO 9001?
• In 1987 ISO published “ISO 9001” a document
(or standard) that lists some internationally-
accepted, basic rules for a model quality
system.
• Remember:
– “ISO” is an organization
– “ISO 9001” is a document
14. ISO 9001 “Rules”
• ISO 9001 does nothing more than just list
some rules for managing a company’s quality
system.
• These rules have been recognized by the
world as generally-accepted “good practices”
15. Adopting ISO 9001
• Companies voluntarily adopt the ISO 9001
rules in order to prove that their systems are:
– GOOD
– Based on internationally-accepted criteria
– Meet minimum requirements for quality
16. Certification
• Anyone can SAY they comply to ISO 9001. So
“certification” was developed.
• Certification (or “registration”) to ISO 9001 is
accomplished through regular, recurring
“audits” by an independent ISO registrar, who
comes on-site and inspects the company’s
compliance with the standards.
17. Our Intent
• It is our company’s intent to implement the
commonsense rules of ISO 9001 and then
certify it.
• Our certification body (or
“registrar”) is DEKRA.
• The registrar will audit us
periodically to ensure we are
complying with ISO 9001.
19. Your Responsibilities
• Everyone in the company has a responsibility
to understand and improve the quality
system. This means:
• Understand the Quality Policy
• Understand the Quality Manual (managers)
• Understand the Procedures related to your area
• Make suggestions for improvement, or report
existing problems
20. Where to Find Documents
• Company server
• Specially marked binders in your area.
• Front Office (Faith)
21. Quality Policy
The Diamondback America companies are
committed to satisfying all customer and applicable
requirements, and to producing high-quality
products that are respected in the industries we
serve. We are committed to continual improvement
of our products, processes and quality management
system. We manage our quality system through the
use of process-based performance objectives to
help ensure efficiency and quality.
22. Quality Policy – Key Points
The Diamondback America companies are
committed to satisfying all customer and applicable
requirements, and to producing high-quality
products that are respected in the industries we
serve. We are committed to continual improvement
of our products, processes and quality management
system. We manage our quality system through the
use of process-based performance objectives to
help ensure efficiency and quality.
24. Understanding the Quality Policy
• As an employee, you must be familiar with the
Quality Policy as it defines how you should
approach everything you do while working
with our company.
• PLUS, auditors will ask you what the Quality
Policy is and how it affects your job.
25. Quality Manual
• Derived from the Quality
Policy is the Quality
Manual.
• It addresses how we meet
the requirements of ISO
9001.
26. Quality Manual
• The Quality Manual must be read by all managers.
• Managers must be sure to implement the
requirements in your department or area.
• All other employees may read it optionally.
• Some of it will not apply to your position.
27. QMS Processes
• QMS Administration
• Improvement
• Sales Order Entry
• Product Design
• Purchasing & Inventory
• Production: CNC
• Production: Barrels
• Production: Firearm Assembly
• Packaging & Delivery
• The QMS is
comprised of nine
top processes:
• You should recognize
your role in at least one
of these processes.
28. Process Definition
• Each of the 9 processes has
a “Process Definition”
document
• This defines the process in
a medium-level of detail,
and includes a process
map.
• You must read the Process
Definition for each process
you work under.
29. Procedures
• In addition, we have some
“Procedures” which give
more detailed
descriptions of how to
carry out tasks, operate
equipment, etc.
• You must only read and
understand the
procedures that apply to
your work.
30. Controlled Documents
• Manuals, procedures and forms are
“controlled” to ensure you have the latest
information.
• Use only hardcopy procedures and manuals
issued by management.
• Or you may use electronic files pulled from
the server files.
• Do not photocopy controlled documents.
• Do not mark up controlled documents.
31. Do Not Use Uncontrolled Docs
• These are:
– Manuals, procedures, specs or instructions NOT
issued by management.
– Documents you’ve written yourself and have not
sent in for control.
– Documents from other companies.
– Documents without revision numbers or letters.
– Documents marked “OBSOLETE”
– Documents you know are obsolete.
32. Forms
• You may write on and photocopy forms.
• Always be sure you are using the latest
revision of a form by checking with your
supervisor or with the management
33. Correcting a Record
• If you make a mistake when entering data on a
hardcopy form, it is important not to use
correction fluid (which eventually flakes off) .
• The proper method is:
34. Correcting a Document
• We don’t want employees blindly following
procedures if they are wrong, or just bad.
• If you find something wrong with a document,
you can see that it gets fixed!
• Submit a CPAR when you find an error in a
document.
• We’ll discuss CPARs in a moment.
36. Management’s Job
• ISO 9001 and our Quality System require top
management:
• Care about quality
• Care about the customers
• Promote quality and the customer
• Assess risks and opportunities
• Supply necessary resources
• Measure and monitor the company’s performance
37. Training
• All employees must be trained to bring them
up to speed for position requirements
• Training must also be done to continually
improve how we do things
38. Understand the Customer’s
Requirements
• Contracts must “capture” and review all
customer requirements.
• This is to ensure we can actually make what
the customer wants.
• This must happen before we take an order.
39. Purchasing
• Items we purchase for use in our products
must be bought from proven suppliers.
• We have to clearly tell the supplier what we
want.
• We have to monitor supplier performance.
40. Production Controls
• When we make product, we must:
• Make sure we plan first
• Use approved equipment
• Use approved methods
• Preserve the product (good handling, packaging,
etc.)
• Keep products properly identified
• NOT use expired chemicals or material
41. Calibration
• Tools used by QC for inspection must be
calibrated.
• Check your tool for a sticker.
• If it’s not up to date, NOTIFY QC IMMEDIATELY.
42. Shop Traveler Rules
• ALL lines to be signed off or marked “N/A”
• Performing operations out of sequence is okay
with verbal approval from manager or
supervisor
• NO OTHER CHANGES TO ROUTERS ALLOWED
WITHOUT TALKING TO QUALITY OR
ENGINEERING!
• No white out!
43. Nonconforming Parts
• Whenever a part fails an inspection or test, it
does not conform to requirements, so it is
called a “nonconforming part.”
• NCP can be:
• Raw materials or parts we receive from suppliers
• Parts or products we are in the process of making
for our customers.
• Finished product ready for shipment to our
customer.
44. Controlling NCP
• ISO requires that we identify defective
material or parts and prevent it from being
mistaken for good material or parts.
• Keep it tagged!
• Keep it segregated!
• If applicable, keep any nonconformance
documentation and/or tags ON THE PART(s)
45. Things to Consider
• How does the quality of my work affect the
customer?
• How does the quality of my work affect us as a
company?
• If I do something wrong, how does this affect
the customer?
47. What is Auditing?
• As part of ISO 9001 and our Quality System,
we have committed our company to both
internal and external quality audits.
• These are not financial audits, or audits by
immigration or any other body.
• These audits aim to ensure our ongoing
compliance with ISO 9001, and to drive
internal improvement.
48. External Audits
• As we discussed, we intend to prove to the
world it is complying with ISO 9001 through
independent audits by a third-party
“registrar”.
• The Registrar will visit us periodically and
compare:
– What we do vs. internal procedures
– What we do vs. ISO 9001
49. Ongoing External Auditing
• We must pass each audit to maintain ISO 9001
certification.
• The auditor may speak with anyone in the
company. This may mean you!
50. Internal Audits
• We also have to conduct “internal audits” to
ensure we are sticking to our Quality Manual
policies and the ISO 9001 requirements.
• Some of you will be selected and trained as
internal auditors.
51. Typical Audit Questions
• What are you doing?
• How do you do that?
• Do you have a procedure?
• Have you been trained?
• What do you do when something goes wrong?
• What is the Quality Policy?
52. Auditing Processes, Not People
• Audits are conducted to confirm PROCESS
adequacy.
• People are not the focus of audits!
“YOU” are not audited,
the PROCESS is!
54. Continual Improvement
• One of the requirements of ISO 9001 is that
the company must continually improve.
• In order to do this, we have implemented the
CPAR program.
• ALL EMPLOYEES must become familiar with
this!
55. What is a CPAR?
• A CPAR is a form submitted whenever we have
to report:
– A report of a problem
– A customer complaint
– Audit findings
• If you find a problem, obtain the CPAR form
and fill it out.
56. Corrective vs. Preventive
• You use the CPAR form:
– To report an EXISTING problem
– To report a POSSIBLE problem
– To suggest an improvement
57. CPAR Form
• This is the CPAR form
• Copies are available
on the server, in the
QC department, the
Front Office and
other locations
around the plant
58. CPAR Form
• To report an issue, complete the top portion
of the CPAR and return this to Faith or to QC.
59. The Only Rule
• The only rule for submitting a one of these is
that the issue you are reporting be somehow
quality related.
– Do not “write up” people
– Do not “grind axes”
– Make a quality case for your issue!
61. Things to Remember
• Understand the Quality Policy
• Understand the Quality Manual (managers)
• Understand the Process Definitions and
Procedures related to your area
• Sweep your area for uncontrolled documents!
62. Things to Remember
• Make suggestions for improvement and report
existing problems through the CPAR system
• Get ready for an audit!