This document provides an introduction and overview of ISO 9001:2015 Quality Management Systems. It discusses the history and development of the ISO standard. The document then summarizes each chapter and clause of ISO 9001:2015, providing a high-level overview of the requirements and concepts covered, including the process approach, risk-based thinking, PDCA cycle, leadership responsibilities, planning, support, operations, performance evaluation and improvement. It gives concise explanations of key terms and the objectives and approach required by each clause.
This document provides an overview of ISO 19011 guidelines for auditing management systems. It defines an audit as a systematic, independent, and documented process for gathering objective evidence to determine if audit criteria are fulfilled. The key phases of an audit are planning, preparation, performance and review, reporting, and follow-up. Planning establishes objectives, scope, criteria and resources. Preparation includes document review and developing checklists and questionnaires. Performance involves on-site activities like opening/closing meetings, collecting evidence, and identifying findings. Reporting documents the audit process, findings, and agreed corrective actions. Follow-up verifies effectiveness and closure of non-conformities.
The document outlines continual quality improvement methods based on 7 quality management principles including customer focus, leadership, employee engagement, and evidence-based decision making. It describes a quality control process involving in-process quality control, final goods quality assurance through sampling and testing, and procedures for approving, segregating, or reworking non-conforming products before dispatch.
http://qualitymanagementsystem.com/total-quality-management/designing-a-quality-management-system/
When it comes to creating quality management systems (QMS), sometimes quality leaders just don’t know where to begin or what to do. Let’s review the basic steps to implementing Total Quality Management (TQM) with a quality management system.
ISO 9001 - It sets out the criteria for a quality management system and is th...Tushar Sadhye
ISO 9001 - It sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement).
ISO over one million companies and organizations in over 170 countries implement 9001:2008.
This document outlines the items to be reviewed at a minimum annual quality meeting. It includes reviewing activities from the previous meeting, results of internal audits, status of corrective and preventive actions, product and process non-conformities, customer communication, resource availability, quality goals and objectives, quality policy, supplier performance, marketing strategy, recommendations for improvement, and other organizational impact factors. The document also has sections to document the meeting details, signatories, and resulting action items including responsible parties and commitment dates.
Management Review is always conducted in the organization who has received ISO 9001 certification. But the problems are, Management Review is not adding value.
This presentation helps you to understand the problems may occurred in the Management Review and finally to get add values from this Review.
This document discusses the need for and benefits of implementing an ISO 9001:2015 Quality Management System (QMS) in the Philippine government. It begins by outlining the challenges facing the Philippine government and how a QMS can help address issues like erosion of public trust and inefficient service delivery. It then provides an overview of the key requirements for establishing a QMS based on ISO 9001:2015, including developing documented processes and procedures, conducting internal audits, and achieving third-party certification. The document emphasizes that a QMS can help streamline government services, improve employee performance and pride, and increase citizen satisfaction.
The document discusses conducting a management review for a quality management system. It outlines that a management review is a formal meeting of senior management to review the status and effectiveness of the quality system. An agenda should be prepared in advance by the quality manager covering inputs like policy reviews, audit results, customer feedback, quality indicators, and more. Preparation is important to manage the information in the allotted time. Graphical summaries and data analysis help identify issues and monitor progress. The meeting should result in documented action plans to address items discussed and feed into strategic planning.
This document provides an overview of ISO 19011 guidelines for auditing management systems. It defines an audit as a systematic, independent, and documented process for gathering objective evidence to determine if audit criteria are fulfilled. The key phases of an audit are planning, preparation, performance and review, reporting, and follow-up. Planning establishes objectives, scope, criteria and resources. Preparation includes document review and developing checklists and questionnaires. Performance involves on-site activities like opening/closing meetings, collecting evidence, and identifying findings. Reporting documents the audit process, findings, and agreed corrective actions. Follow-up verifies effectiveness and closure of non-conformities.
The document outlines continual quality improvement methods based on 7 quality management principles including customer focus, leadership, employee engagement, and evidence-based decision making. It describes a quality control process involving in-process quality control, final goods quality assurance through sampling and testing, and procedures for approving, segregating, or reworking non-conforming products before dispatch.
http://qualitymanagementsystem.com/total-quality-management/designing-a-quality-management-system/
When it comes to creating quality management systems (QMS), sometimes quality leaders just don’t know where to begin or what to do. Let’s review the basic steps to implementing Total Quality Management (TQM) with a quality management system.
ISO 9001 - It sets out the criteria for a quality management system and is th...Tushar Sadhye
ISO 9001 - It sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement).
ISO over one million companies and organizations in over 170 countries implement 9001:2008.
This document outlines the items to be reviewed at a minimum annual quality meeting. It includes reviewing activities from the previous meeting, results of internal audits, status of corrective and preventive actions, product and process non-conformities, customer communication, resource availability, quality goals and objectives, quality policy, supplier performance, marketing strategy, recommendations for improvement, and other organizational impact factors. The document also has sections to document the meeting details, signatories, and resulting action items including responsible parties and commitment dates.
Management Review is always conducted in the organization who has received ISO 9001 certification. But the problems are, Management Review is not adding value.
This presentation helps you to understand the problems may occurred in the Management Review and finally to get add values from this Review.
This document discusses the need for and benefits of implementing an ISO 9001:2015 Quality Management System (QMS) in the Philippine government. It begins by outlining the challenges facing the Philippine government and how a QMS can help address issues like erosion of public trust and inefficient service delivery. It then provides an overview of the key requirements for establishing a QMS based on ISO 9001:2015, including developing documented processes and procedures, conducting internal audits, and achieving third-party certification. The document emphasizes that a QMS can help streamline government services, improve employee performance and pride, and increase citizen satisfaction.
The document discusses conducting a management review for a quality management system. It outlines that a management review is a formal meeting of senior management to review the status and effectiveness of the quality system. An agenda should be prepared in advance by the quality manager covering inputs like policy reviews, audit results, customer feedback, quality indicators, and more. Preparation is important to manage the information in the allotted time. Graphical summaries and data analysis help identify issues and monitor progress. The meeting should result in documented action plans to address items discussed and feed into strategic planning.
Top 5 reasons to implement a quality management systemQuality Management
http://qualitymanagementsystem.com/top-5-reasons-to-implement-a-quality-management-system/
Like any business decision, there has to be some good reasons for implementing a Quality Management System (QMS). Some people think that total quality management through quality management systems are a never-ending expense that businesses have to engage in to ensure products or services are not defective or meet basic requirements.
A proper QMS, however, delivers real value and benefits to the organization. Let review the top reasons for implementing a Quality Management System.
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.
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.
The document discusses applying lean principles to quality management reviews to make them more efficient and effective. It proposes a process-based model for quality management reviews and identifies opportunities to eliminate waste, such as streamlining documentation and approval processes. It also emphasizes the importance of presenting both positive and negative quality system performance data to facilitate continuous improvement and compliance with regulations. The goal is to conduct quality management reviews that are both lean, by reducing waste, and compliant, by fully evaluating the quality system's effectiveness.
The CIS Production Support 2000 department has several objectives for the year including improving customer satisfaction, stabilizing and improving the production environment, reducing project cycle times, transferring application knowledge to team members, and developing metrics to measure customer expectations and department performance. Leadership will focus on developing processes to transfer knowledge, stabilize production, improve development handoffs, and gather customer feedback.
JARO Thermal ISO9001 2015 internal auditor training 20170118Ryan Chen
This document provides an overview and summary of an internal auditor training on the ISO9001:2015 Quality Management System standard. It outlines the agenda which includes an introduction to ISO9001:2015, the major changes from the previous version, and skills needed for internal auditing. It then summarizes each section of ISO9001:2015 including scope, leadership, planning, support, operations, performance evaluation and improvement. Key concepts like process approach, PDCA cycle and risk-based thinking are also explained.
Total Quality Management (TQM) is a comprehensive, organization-wide effort to improve quality. It involves integrating quality principles into an organization's management systems. The document discusses key TQM concepts like quality perspectives, levels, history, philosophies of Deming, Juran and Crosby, and tools for process management, control and improvement like flow charts, check sheets, control charts and kaizen. It emphasizes continuous improvement through small group activities like quality circles and kaizen teams.
This document discusses quality audits and their purpose. It defines a quality audit as an independent examination to verify conformity with quality standards. Quality audits can be internal or external, and audit products, processes, or entire quality systems. The objectives of quality audits are to ensure standards are met, quality is maintained, and areas for improvement can be identified. A quality audit process typically involves planning the audit, conducting interviews and documentation reviews, reporting findings, and identifying corrective actions.
This document discusses quality management systems for construction projects. It defines quality management as the organizational structure and processes for implementing quality control. The objectives are to develop quality in construction, understand quality control procedures, determine a suitable method, gain knowledge of quality assurance, and complete projects meeting objectives of quality, cost, safety and speed. It describes the quality control and quality assurance processes, including contractor quality control and third party quality assurance. The expected outcomes are improving material management, minimizing past failures, sharing successes, learning from others' experiences, identifying failures, and having corrective actions for typical problems.
Hello guys i prepared QMS kick off meet PPT. Here I have shown how to start a project in any organization. What contents we need to discuss with top management at the time of start of QMS implementation. Kindly comment and share your views.
Kindly write your comment it will greatly help me to create new PPT and it will definitely motivate me.
The document discusses quality management systems (QMS). The goal of a QMS is to improve quality and institutionalize quality activities throughout an organization. A QMS documents policies, processes, and procedures to clearly define user requirements, produce better products, ensure customer satisfaction, and manage internal processes. The objectives of a QMS are to set measurable quality outcomes and specify actions to achieve them. A QMS documentation hierarchy exists at the industry and organization levels, including standards, policies, standardized processes, and documentation of processes using the ETVX method of entry and exit criteria, tasks, verification, and exit criteria.
1. The document discusses quality management in software development including quality assurance standards, quality design, and quality control.
2. It emphasizes establishing quality standards upfront, performing quality reviews, and using automatic software evaluation to test against standards.
3. Quality metrics are discussed as a way to measure the software product and analyze measurements, though interpreting results requires considering all circumstances as there are no universal metrics.
http://qualitymanagementsystem.com/total-quality-management/how-to-create-a-quality-management-plan/
In today’s competitive global marketplace, a company’s quality management plan can help identify gaps in customer expectations, determine where corrective action is necessary and provide a system for continuous improvement. While some departments, such as operations or production may have strict controls and inspections, others may operate “on the fly” without any documented procedures or work instructions. An integrated total management system brings all departments under the same total quality management (TQM) umbrella.
Quality Management - Guidelines for realizing financial and economic benefitsGovind Ramu
Presentation summary
Quality Management System (QMS) is often misperceived as a paperwork exercise done to ensure the organization has an ISO 9001 certificate hanging on the wall. Perhaps, a contractual obligation. This misperception often results in quality management professionals becoming an easy target for headcount reduction. This shortsighted cost cutting blurs the long-term vision of achieving a sustainable and more resilient organization.
Quality professionals often don’t do a great job of making top management and other interested parties aware of everything quality management encompasses and why it’s important to understand a holistic approach to achieving quality. As a result, top management often sees quality as a transactional activity, not a strategic advantage.
This interactive session will focus on presenting ideas for realizing financial and economic benefits from the quality management system implementation. Effective QMS is "quietly saving" in every area of the organization. These implicit savings aren’t publicized to the organization because they aren’t obvious. I will discuss these savings and receive inputs from the participants. I will also discuss how quality management system is tied to organization's bottom line, innovation and growth.
The document discusses quality management in projects. It defines quality as the degree to which a product or service meets customer requirements. High quality does not necessarily mean high scope and vice versa. Quality management involves quality planning, assurance, and control. Quality planning defines metrics and processes. Quality control monitors performance against the quality baseline and initiates corrective actions when needed. Common quality tools include control charts, flow charts, and Pareto analysis to identify the most impactful issues. The goal is continuous improvement to maximize customer satisfaction.
This document provides an overview of an internal quality auditor course, including its sections, workshops and topics. The course covers ISO 9000 standards, quality management principles and terms. It discusses the benefits of quality systems and ISO 9001 certification. Workshops include interviewing partners about their quality experience, discussing quality benefits and principles, and mapping processes. The document defines key terms and explains the process approach, audits and ISO 9000 revisions over time.
This document discusses quality management in health laboratories. It defines quality and outlines approaches to quality management including planning, organizing, staffing, leading and controlling processes. Key elements of a quality management system are described such as organization, personnel, equipment, purchasing, process control, information management, documents/records, occurrence management and assessment. The document emphasizes that a quality management system involves coordinated activities across all aspects of laboratory operations to ensure quality. External quality assessment through proficiency testing is also discussed as an important tool for evaluating laboratory performance.
This document provides an overview of ISO 9001:2015 requirements for process owners. It begins by defining key terms like quality management system and total customer satisfaction. It then discusses the history and purpose of ISO and some key changes between the 2008 and 2015 versions. The core content reviews each clause of ISO 9001:2015 including the context of the organization, leadership responsibilities, planning processes, the PDCA cycle, and requirements for support functions. Several worked examples are provided to demonstrate how to map business processes, identify key metrics, and plan for risk mitigation and continual improvement as required by the standard.
This document provides an overview of an ISO 9001:2015 quality management system training program. It summarizes key aspects of the PDCA cycle and various ISO 9001 clauses related to planning, leadership, performance evaluation, and improvement. The clauses discussed include understanding organizational context, leadership responsibilities, internal audits, management reviews, corrective actions, and continual improvement processes. The training aims to help organizations understand and effectively implement the requirements of the ISO 9001 standard.
Top 5 reasons to implement a quality management systemQuality Management
http://qualitymanagementsystem.com/top-5-reasons-to-implement-a-quality-management-system/
Like any business decision, there has to be some good reasons for implementing a Quality Management System (QMS). Some people think that total quality management through quality management systems are a never-ending expense that businesses have to engage in to ensure products or services are not defective or meet basic requirements.
A proper QMS, however, delivers real value and benefits to the organization. Let review the top reasons for implementing a Quality Management System.
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.
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.
The document discusses applying lean principles to quality management reviews to make them more efficient and effective. It proposes a process-based model for quality management reviews and identifies opportunities to eliminate waste, such as streamlining documentation and approval processes. It also emphasizes the importance of presenting both positive and negative quality system performance data to facilitate continuous improvement and compliance with regulations. The goal is to conduct quality management reviews that are both lean, by reducing waste, and compliant, by fully evaluating the quality system's effectiveness.
The CIS Production Support 2000 department has several objectives for the year including improving customer satisfaction, stabilizing and improving the production environment, reducing project cycle times, transferring application knowledge to team members, and developing metrics to measure customer expectations and department performance. Leadership will focus on developing processes to transfer knowledge, stabilize production, improve development handoffs, and gather customer feedback.
JARO Thermal ISO9001 2015 internal auditor training 20170118Ryan Chen
This document provides an overview and summary of an internal auditor training on the ISO9001:2015 Quality Management System standard. It outlines the agenda which includes an introduction to ISO9001:2015, the major changes from the previous version, and skills needed for internal auditing. It then summarizes each section of ISO9001:2015 including scope, leadership, planning, support, operations, performance evaluation and improvement. Key concepts like process approach, PDCA cycle and risk-based thinking are also explained.
Total Quality Management (TQM) is a comprehensive, organization-wide effort to improve quality. It involves integrating quality principles into an organization's management systems. The document discusses key TQM concepts like quality perspectives, levels, history, philosophies of Deming, Juran and Crosby, and tools for process management, control and improvement like flow charts, check sheets, control charts and kaizen. It emphasizes continuous improvement through small group activities like quality circles and kaizen teams.
This document discusses quality audits and their purpose. It defines a quality audit as an independent examination to verify conformity with quality standards. Quality audits can be internal or external, and audit products, processes, or entire quality systems. The objectives of quality audits are to ensure standards are met, quality is maintained, and areas for improvement can be identified. A quality audit process typically involves planning the audit, conducting interviews and documentation reviews, reporting findings, and identifying corrective actions.
This document discusses quality management systems for construction projects. It defines quality management as the organizational structure and processes for implementing quality control. The objectives are to develop quality in construction, understand quality control procedures, determine a suitable method, gain knowledge of quality assurance, and complete projects meeting objectives of quality, cost, safety and speed. It describes the quality control and quality assurance processes, including contractor quality control and third party quality assurance. The expected outcomes are improving material management, minimizing past failures, sharing successes, learning from others' experiences, identifying failures, and having corrective actions for typical problems.
Hello guys i prepared QMS kick off meet PPT. Here I have shown how to start a project in any organization. What contents we need to discuss with top management at the time of start of QMS implementation. Kindly comment and share your views.
Kindly write your comment it will greatly help me to create new PPT and it will definitely motivate me.
The document discusses quality management systems (QMS). The goal of a QMS is to improve quality and institutionalize quality activities throughout an organization. A QMS documents policies, processes, and procedures to clearly define user requirements, produce better products, ensure customer satisfaction, and manage internal processes. The objectives of a QMS are to set measurable quality outcomes and specify actions to achieve them. A QMS documentation hierarchy exists at the industry and organization levels, including standards, policies, standardized processes, and documentation of processes using the ETVX method of entry and exit criteria, tasks, verification, and exit criteria.
1. The document discusses quality management in software development including quality assurance standards, quality design, and quality control.
2. It emphasizes establishing quality standards upfront, performing quality reviews, and using automatic software evaluation to test against standards.
3. Quality metrics are discussed as a way to measure the software product and analyze measurements, though interpreting results requires considering all circumstances as there are no universal metrics.
http://qualitymanagementsystem.com/total-quality-management/how-to-create-a-quality-management-plan/
In today’s competitive global marketplace, a company’s quality management plan can help identify gaps in customer expectations, determine where corrective action is necessary and provide a system for continuous improvement. While some departments, such as operations or production may have strict controls and inspections, others may operate “on the fly” without any documented procedures or work instructions. An integrated total management system brings all departments under the same total quality management (TQM) umbrella.
Quality Management - Guidelines for realizing financial and economic benefitsGovind Ramu
Presentation summary
Quality Management System (QMS) is often misperceived as a paperwork exercise done to ensure the organization has an ISO 9001 certificate hanging on the wall. Perhaps, a contractual obligation. This misperception often results in quality management professionals becoming an easy target for headcount reduction. This shortsighted cost cutting blurs the long-term vision of achieving a sustainable and more resilient organization.
Quality professionals often don’t do a great job of making top management and other interested parties aware of everything quality management encompasses and why it’s important to understand a holistic approach to achieving quality. As a result, top management often sees quality as a transactional activity, not a strategic advantage.
This interactive session will focus on presenting ideas for realizing financial and economic benefits from the quality management system implementation. Effective QMS is "quietly saving" in every area of the organization. These implicit savings aren’t publicized to the organization because they aren’t obvious. I will discuss these savings and receive inputs from the participants. I will also discuss how quality management system is tied to organization's bottom line, innovation and growth.
The document discusses quality management in projects. It defines quality as the degree to which a product or service meets customer requirements. High quality does not necessarily mean high scope and vice versa. Quality management involves quality planning, assurance, and control. Quality planning defines metrics and processes. Quality control monitors performance against the quality baseline and initiates corrective actions when needed. Common quality tools include control charts, flow charts, and Pareto analysis to identify the most impactful issues. The goal is continuous improvement to maximize customer satisfaction.
This document provides an overview of an internal quality auditor course, including its sections, workshops and topics. The course covers ISO 9000 standards, quality management principles and terms. It discusses the benefits of quality systems and ISO 9001 certification. Workshops include interviewing partners about their quality experience, discussing quality benefits and principles, and mapping processes. The document defines key terms and explains the process approach, audits and ISO 9000 revisions over time.
This document discusses quality management in health laboratories. It defines quality and outlines approaches to quality management including planning, organizing, staffing, leading and controlling processes. Key elements of a quality management system are described such as organization, personnel, equipment, purchasing, process control, information management, documents/records, occurrence management and assessment. The document emphasizes that a quality management system involves coordinated activities across all aspects of laboratory operations to ensure quality. External quality assessment through proficiency testing is also discussed as an important tool for evaluating laboratory performance.
This document provides an overview of ISO 9001:2015 requirements for process owners. It begins by defining key terms like quality management system and total customer satisfaction. It then discusses the history and purpose of ISO and some key changes between the 2008 and 2015 versions. The core content reviews each clause of ISO 9001:2015 including the context of the organization, leadership responsibilities, planning processes, the PDCA cycle, and requirements for support functions. Several worked examples are provided to demonstrate how to map business processes, identify key metrics, and plan for risk mitigation and continual improvement as required by the standard.
This document provides an overview of an ISO 9001:2015 quality management system training program. It summarizes key aspects of the PDCA cycle and various ISO 9001 clauses related to planning, leadership, performance evaluation, and improvement. The clauses discussed include understanding organizational context, leadership responsibilities, internal audits, management reviews, corrective actions, and continual improvement processes. The training aims to help organizations understand and effectively implement the requirements of the ISO 9001 standard.
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.
The document provides an overview of the key changes between ISO 9001:2008 and ISO 9001:2015. Some of the main changes include an increased emphasis on leadership and risk-based thinking. ISO 9001:2015 also focuses on understanding organizational context and the needs of interested parties. It introduces requirements for process approach, planning actions to address risks and opportunities, and reviewing quality management system performance.
Pearl Confectionery (Pvt.) Ltd is providing training on quality management systems. The training covers fundamentals of quality management including roles of auditors and auditees, the PDCA cycle, and the 8 principles of quality. It also covers ISO 9001:2008 requirements including the standard's structure and clauses. The training includes sessions on internal quality audits. Attendees must pass a test with 60% to complete the training.
The document outlines the key clauses of the ISO 9001:2015 quality management standard. It discusses the standard's scope and references in clauses 1-3. Clause 4 covers understanding the organization's context and interested parties. Clause 5 addresses leadership and management commitment. Clause 6 discusses quality planning. Clause 7 covers resource management and documentation. Clause 8 focuses on operational planning, design, and control of outputs. Clause 9 is about performance evaluation through monitoring, measurement, and management review. Finally, clause 10 covers improvement through nonconformity handling and continual improvement.
This document provides an overview and summary of ISO 9001:2015 quality management standards. It discusses key aspects of the standard including quality management principles, a process approach, plan-do-check-act cycles, risk-based thinking, and the relationship to other standards. It also summarizes the 10 clauses of the quality management system covering topics such as leadership, planning, support, operations, performance evaluation, and improvement. The document is intended to provide awareness training on ISO 9001:2015 requirements.
Presented for ASQ India on 3/22/2016 7PM - 8PM IST (6.30 AM -7.30AM PST). Govind will briefly discuss key changes, new requirements and a high level transition plan. The new standard is more aligned with business than ever. However this new standard also bring challenges for auditing. As a QMS manager, auditor or even a practitioner you will be expected to apply this management system standard at work.
This document provides an overview and agenda for a presentation on quality management systems and ISO 9001:2008. The presentation covers definitions of quality and the evolution of quality management systems. It discusses the key drivers for quality management systems and the PDCA cycle that ISO 9001 is based on. The eight quality management principles and benefits of ISO 9001 certification are also reviewed. The presentation provides an overview of the clauses and elements of ISO 9001:2008, including requirements for documentation, management responsibility, and product realization. Implementation and certification processes are discussed along with potential pitfalls.
This presentation gives a bried overview of the various parts & purpose of the ISO 9001:2015 QMS.
It revolves around the PDCA Cycle and useful in Manufacture & construction Industry.
The document summarizes ISO 9000 and ISO 22000 quality management standards. It provides an overview of the evolution and principles of ISO 9000 from its initial publication in 1987 to the most recent 2015 version. Key changes included greater emphasis on leadership involvement, risk-based thinking, and continuous improvement. It also summarizes ISO 22000, which was published in 2005 to provide international harmonization for food safety management systems using HACCP principles.
This document provides an overview of an upcoming ISO 9001 training course. It introduces the instructor and outlines the course agenda, objectives, and who should attend. The course will cover the history and content of ISO 9001 as well as the new version ISO 9001:2015. It will explain key changes in ISO 9001:2015 around areas like documentation, management responsibilities, and risk-based thinking. The goal is to help businesses understand and effectively implement the new standard to improve efficiency and customer satisfaction.
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.
QMS UNDERSTANDING & IMPLEMENTING ISO 9001 2015.pptxinfoqtc
The document provides an agenda for a two-day training course on understanding and implementing ISO 9001:2015. Day 1 covers introductions to quality and the ISO standard, as well as context of the organization, leadership, planning, support, and performance evaluation and improvement. Presentation topics include what is quality, customer requirements, responsibility for quality, and the structure and requirements of ISO 9001:2015. Day 2 will focus on operation, monitoring and measurement, internal auditing, and management review.
FINAL IMS PPT - Read-Only - Compatibility Mode.pdfKShah24
The document provides information on changes to ISO standards 9001, 14001, and 45001. Some key changes include a new risk-based approach, increased emphasis on strategic planning and leadership responsibilities, common structures across standards, and terminology changes around documented information. The standards now focus on understanding organizational context, risks and opportunities, and improving performance and environmental protection. Documentation requirements are reduced in favor of risk-based controls.
PECB Webinar: Aligning ISO 25000 and CMMI for DevelopmentPECB
We will cover:
• Overview of ISO 25000 - Software Product Quality Requirements and Evaluation (SQuaRE)
• How CMMI for Development best practices address development activities
• Complementary values that ISO 25000 and CMMI bring
• How ISO 25000 and CMMI help software development and service companies to improve customer satisfaction
Presenter:
This webinar will be presented by PECB Trainer Orlando Olumide Odejide, an experienced Enterprise Architect and Chief Trainer for Training Heights Limited
The document discusses changes between the ISO 9001:2008 and ISO 9001:2015 standards and actions required to upgrade an organization's quality management system. Key points include:
1. Top management must take more accountability for the effectiveness of the quality management system and ensure integration into business processes under the new standard.
2. Risk-based thinking is emphasized, requiring organizations to identify risks and opportunities related to products, services and the quality system.
3. Several changes were made to clauses around quality objectives, planning, documentation and more to incorporate an increased focus on processes, risk management and interested parties.
4. A comprehensive upgrade program is needed to address all changes between the standards and bring the organization
Similar to Risk elimination and safety committee (20)
Panther Captan 50% WP is a broad spectrum fungicide belonging to the phthalimide group. It has protective and curative action against a wide variety of fungal infections in crops. It works by inhibiting fungus respiration and energy production. Panther is effective against diseases like brown rot, downy mildew, early blight and late blight in several crops including apple, cherry, grapes, potato and tomato. The document then provides information about each of these crops and the diseases Panther helps control for each one.
HPM Hindustan M-45 (Fungicides) PresentationHpm India
- The document discusses Hindustan M-45, a broad-spectrum fungicide that provides disease control for many major crops like potato, tomato, wheat, rice, sorghum, banana, grapes, guava, and apple.
- It controls diseases caused by all four major classes of fungi through its multisite mode of action, making resistance less likely to develop. It also provides nutrients as it degrades harmlessly in soil and water.
- Examples of diseases it controls include late blight and early blight of potato, early blight and leaf spot of tomato, brown rust and bacterial leaf blight of wheat, blast disease of rice, leaf spot diseases of sorghum, banana diseases
HPM X-Pert Power (Insecticides) PresentationHpm India
X-pert Power (Emamectin benzoate 1.9% EC) is a highly potent insecticide and acaricide that has both systemic and contact action. It is a broad spectrum pesticide that can be used on field crops like cotton and soybeans as well as vegetables, fruits, and cereals. The insecticide works by enhancing the effect of the neurotransmitter GABA and disturbing neurotransmission, causing insects to stop moving and die quickly. It should be applied at 75-250 ml/acre during the first incidence of pests and repeated as needed, taking precautions like wearing protective clothing and avoiding inhalation or direct contact with skin.
This document discusses a herbicide called Clodinafop Propargyl 9% + Metribuzin 20% WP that can be used to control various wheat weeds including Phalaris minor, Medicago spp, and Melilotus spp. The herbicide is effective against these three common wheat weeds as well as Chenopodium album.
The six fundamental warehouse processes are receiving, putaway, storage, picking, packing, and shipping. Receiving involves verifying the right product is received in the right quantity, condition, and time. Putaway involves moving goods from receiving to optimal storage locations to maximize efficiency. Picking collects products to fulfill orders and is the most costly process, comprising 55% of expenses. Packing consolidates picked items and prepares them for shipment. Shipping is the final process that delivers orders to customers on time and accurately.
Porter's Five Forces model analyzes five competitive forces that shape an industry: 1) rivalry among existing competitors, 2) threat of new entrants, 3) bargaining power of suppliers, 4) bargaining power of buyers, and 5) threat of substitute products. The model helps businesses understand the profitability and attractiveness of an industry sector by identifying its weaknesses and strengths. Analyzing these competitive forces can help companies improve their profitability by adjusting their strategy accordingly.
The document discusses the GE Nine Cell Matrix, which is a portfolio analysis tool developed by McKinsey & Company for General Electric in the 1970s. It evaluates business units based on their market attractiveness and business strength. Market attractiveness depends on factors like market size, growth rate, and profit margins. Business strength is assessed by metrics such as market share, brand strength, and competitiveness. The matrix plots business units into nine cells that indicate whether a unit should be invested in, maintained, or harvested. It provides a more nuanced analysis than the Boston Consulting Group matrix.
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- Heijunka aims to level production volume and mix over time to efficiently meet demand while minimizing inventories and costs.
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Bcg matrix (boston consultancy group matrix)Hpm India
The BCG Matrix is a tool used to evaluate products based on their market share and growth rate. It categorizes products into four quadrants: Stars, which have high growth and market share; Cash Cows, which have high share but low growth; Question Marks, which have high growth but low share; and Dogs, which have low growth and share. Understanding where products fall in the matrix allows companies to determine the best investment and strategic approach for each.
Annual operation planning & budgeting processHpm India
The document outlines the annual operations planning and budgeting (AOPB) process for HPM Chemicals and Fertilisers. The process involves 4 workshops to develop the annual plan and budget. Workshop 1 is for annual sales planning where the sales team develops the sales plan and identifies any gaps vs management targets. Workshop 2 identifies constraints for production, procurement and gross contribution. Workshop 3 develops the tentative budget and Workshop 4 finalizes the annual plan and budget. The process aims to improve visibility, reliability and control of sales targets, resource allocation and costs through defined activities, roles and timelines.
How to give effective presentation kunziteHpm India
The document discusses the different types and purposes of presentations: to inform, educate, persuade, entertain, and inspire. It provides examples for each type and notes their key characteristics. Presentations to inform provide facts to audiences, while those to educate aim to teach and have audiences leave knowing more. Persuasive presentations try to convince audiences of a viewpoint or product. Entertaining presentations seek to make audiences feel good through humor or positive experiences. Inspiring presentations aim to motivate change through emotional stories. The document also provides tips for effectively planning, preparing, practicing and delivering a presentation.
This document discusses SWOT analysis, a technique for assessing the strengths, weaknesses, opportunities, and threats of a business. It provides tips for conducting an effective SWOT analysis, including selecting the right team, using a well-drafted format, and periodically reviewing the analysis. The document also gives examples of internal and external factors that could be considered for each component of a SWOT analysis. Conducting a SWOT analysis can help businesses with strategic planning by providing a clear understanding of success factors, risks, and decisions.
The document discusses corrective and preventive actions for an incident involving a leaking oil drum. It describes stopping the leakage, disposing of the leaked oil as hazardous waste, and performing a risk assessment to determine the root cause. Permanent corrective actions would be implemented to address the root cause, such as improving control points and escape points. The actions would be properly planned, implemented, communicated, and validated to ensure effectiveness. Similar processes would also implement the same actions through horizontal deployment, work instructions, training, and verification.
The document discusses corrective and preventive actions for an incident involving a leaking oil drum. It describes stopping the leakage, disposing of the leaked oil as hazardous waste, and performing a risk assessment to determine the root cause. Permanent corrective actions would be implemented to address the root cause, such as improving control points and escape points. The actions would be properly planned, implemented, communicated, and validated to ensure effectiveness and prevent future occurrences.
Lead time takt time cycle time and throughputHpm India
The document defines and compares various production timing metrics:
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The document discusses corrective and preventive actions for an incident involving a leaking oil drum. It describes stopping the leakage, disposing of the leaked oil as hazardous waste, and performing a risk assessment to determine the root cause. Permanent corrective actions would be implemented to address the root cause, such as improving control points and escape points. The actions would be properly planned, implemented, communicated, and validated to ensure effectiveness and prevent future occurrences.
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This document provides guidance on defining your target market and generating sales leads. It recommends answering questions about who will buy your product and what value you offer to define your audience. Existing customers should be marketed to through bundling products, upselling, discounts, and rewards to increase sales. Potential new customers can be identified by analyzing metrics on how current customers were obtained and networking, and various outreach strategies like advertising, affiliates, and websites can generate new leads.
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The document discusses inventory management. It defines inventory as any items a business holds for resale or repair. Effective inventory management requires tracking inventory levels and sales to avoid stock-outs or overstocking. Stock-outs occur when inventory is unavailable, potentially losing sales, while overstocking ties up capital in unsold goods that incur storage costs. The document provides tips for inventory management, including categorizing items by sales volume, tracking product information, auditing inventory counts, and using formulas to determine optimal order quantities.
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2. Chapter 1 : Introduction
This international system is based upon the quality
management principles and process approach.
3. Chapter 01 : Introduction (cont.)
History:-
First time introduced in 1987
First revision in 1994
Second revision in 2000
Third revision in 2008
Fourth revision in 2015 (23rd sep 2015)
4. Chapter 01 : Introduction (cont.)
ISO draft:-
National
ISO
member
body
National
ISO
member
body
National
ISO
member
body
National
ISO
member
body
International organization for standardization
5. Chapter 01 : Introduction (cont.)
ISO draft:- Preparing international standard is carried
out through ISO/TC (technical committee).
ISO closely collaborate with international electro-
technical commission (IEC) on all matters of electro-
technical standardization.
Committee responsible for this document is technical
committee ISO/TC 176, Quality management and
Quality Assurance.
6. Chapter 01 : Introduction (cont.)
Based upon 07 QMP (Quality management principles)
1. Customer focus
2. Leadership
3. Engagement of people
4. Process Approach
5. Improvement
6. Evidence-based decision making
7. Relationship management
7. Chapter 02 : Process Approach
•Understanding and managing interrelated processes as a
system.
•Contributes effectiveness and efficiency in achieving intended
results.
•Overall performance of the org. can be enhanced using PDCA
cycle.
•Focuses on the Risk based thinking.
•Aimed at taking advantages of the opportunities.
•Preventing undesirable results.
8. Chapter 02 : Process Approach (cont.)
Input
Source of Input
Output
Receivers of Output
Activities
Possible controls
and check point
to monitor and
measure
performance
10. Chapter 03 : PDCA cycle (cont.)
Plan:- Establish the objectives of the system and its processes,
resources needed, customers requirements, Org. policies and identify
and address risks and opportunities.
Do:- Implement what was planned.
Check:- Monitor and measure processes, product and services and
report the results.
Act:- Take actions to improve performance .
11. Chapter 04 : Risk Based Thinking
•Essential to achieve an effective Quality management system.
•Organization needs to plan and implement actions to address risk
and opportunities.
•Risk is effect of the an uncertainty.
•A positive deviation arising form a risk can provide an opportunity.
13. Clause 1 Scope of the QMS 9001:2015
•This international standard specifies
requirements for a QMS when an Organization:
•Needs to demonstrate its ability to consistently
provide products and services and applicable
statutory and regulatory requirements.
•Aims to enhance customer satisfaction.
14. Clause 2 Normative references
•Latest edition to the reference document
(including any amendment) applies.
•ISO 9000:2015 Fundamental and vocabulary.
15. Clause 3 terms and Definitions
•Management System:- Set of Interrelated or interacting elements of and
organization to establish Policies and objectives and processes to achieve those objectives.
•Organization:- Person or group of people that has its own functions with
responsibilities, authorities and relationships to achieve its objectives.
•Top management:- person or group of people who directs and control the
organization at highest level.
•Objective:- results to be achieved.
•Requirement:- need or expectation that is stated generally implied or obligatory.
16. Clause 3 terms and Definitions cont.
•Compliance obligation:- legal requirements and other requirements.
•Legal requirement:- are the requirements that org. has to comply with.
•Other requirement:- Organization has to or choose to comply with.
•Risk:- effect of uncertainty.
•Competence:- ability to apply knowledge and skills to achieve intended results.
17. Clause 3 terms and Definitions cont.
•Documented information:- information required to be controlled and maintained
by the organization and the media in which it is contained.
•Process:- set of interrelated or interacting activities which transforms inputs into
outputs.
•Audit:- Systematic, independent and documented process for obtaining audit evidence
and evaluating it objectively to determine the extent to which the audit criteria is fulfilled.
•Conformity:- fulfillment of a requirement.
•Non- conformity:- non-fulfillment of a requirement.
18. Clause 4 Context of the Organization (planning)
4.1 Understanding the organization and its context
Org. shall determine the external and internal issues
•Relevant to its purpose,
•Relevant to its strategic direction
•Affect its ability to achieve proposed results of QMS.
19. Clause 4 Context of the Organization (planning)
4.1 Understanding the organization and its context
Org. shall determine the external and internal issues
•Relevant to its purpose,
•Relevant to its strategic direction
•Affect its ability to achieve proposed results of QMS.
20. Clause 4 Context of the Organization (planning)
cont.
4.2 Understanding the needs and expectation of
interested parties.
Org. shall determine:
•Interested parties relevant to QMS
•Requirements of these interested parties relevant to QMS
Org. shall monitor and review above information.
21. Clause 4 Context of the Organization (planning)
cont.
4.3 Scope of Quality Management System:-
Org. shall consider:
•External and internal issues
•Requirements of relevant interested parties
•Products and services of the organization.
Scope shall be available and maintained as
documented information.
22. Clause 4 Context of the Organization (planning)
cont.
4.4 Scope of Quality Management System:-
Org. shall establish implement, maintain and continually
improve QMS:
•Determine the inputs and outputs from processes
•Determine the sequence of the processes
•Determine and apply the criteria
•Determine and apply the criteria to measure and monitors the
effectiveness of these processes
•Determine the resources needed for processes
•Assign responsibilities and authorities for these processes
•Address the risk and opportunity
•Evaluation of these processes
•Improve these processes an QMS
•Maintain and retain the required documented information.
23. Clause 5 Leadership
5.1 Leadership and commitment :-
Top management shall
•Take accountability for the effectiveness of the QMS
•Quality policy and quality objectives are established
•Ensure the integration of QMS into org. Business process.
•Process approach and risk based thinking
•Ensure the resources needed are available
•Communication of the QMS
•Promoting improvement
•Commitment with respect to customer focus
24. Clause 5 Leadership
5.2 Policy :-
Establishing the Quality policy
•Top mgt. Shall establish, implement and maintain a
policy which is compatible with the context of the
organisation,
•Provide framework for quality objectives,
•Includes a commitment to satisfy applicable requirements
•Includes a commitment to continual improvements
•Communicating the quality policy, maintain as
documented information understood within the
organisation and be available to the interested parties.
25. Clause 5 Leadership
5.2 Policy :-
DMB quality policy says that;-
Achieving total customer satisfaction by manufacturing tailor-made master batches, additives
and engineering compounds with incomparable quality; consistently meeting every customer’s
individual requirements/specifications;thereby providing a benchmark for our line of
products.
Meeting all statutory and regulatory requirements and complying with all International
standards like RoHS, ELV, IMDS and FDA in all our products.
Continual improvement of quality by research and development, upgrading technology
of plant, process, persons and product and delivering value for money to the customer.
•Integrating “Quality, Environmental, Health & Safety” in all our processes and
improving the quality of life of our employees both within and outside its plants and
offices.
26. Clause 5 Leadership
5.3 Organisational roles and responsibility and authorities :-
Top management shall assign the responsibilities and
authorities for
•Ensuring that QMS confirms the requirement of international
standard
•Ensure that processes are delivering the intended results
•Reporting on the performance of QMS and on opportunities for
improvement
•Ensuring the performance of customer focus
•Ensuring the integrity of the QMS is maintained when
changes occurs
27. Clause 6 Planning
6.1 Actions to address risk and opportunities :-
6.1.1 Organisation shall considers the issues of 4.1
(internal and external issues) requirements and risk
and opportunities.
6.1.2 actions to address these risk and opportunities
•6.2 quality objectives and planning to achieve them
•6.2.1 establish quality objectives at relevant function,
levels and processes
•6.2.2 plan how to achieve its quality objectives
•6.3 planning of the changes
28. Clause 7 Support
7.1 Resources :-
•People
•Infrastructure
•Environment for the operation of the processes
•Monitoring and measuring resources
•Organisational knowledge
7.2 Competence (determine, hiring , train/educate and evaluate)
7.3 Awareness (quality policy, objectives, benefits of QMS)
7.4 Communication (what, when, to whom, how and who)
7.5 Documented information (creating & updating and control of the
documented information)
29. Clause 8 Operation
8.1 Operational planning and control :-
•A.) determining the requirements for the products and
services
•B.) establishing the criteria for the processes, the
acceptance of the products and services
•C.) determining the resources needed
•D.) implementing the controls of the processes
•E.) determining, maintaining and retaining documented
information to the extent necessary
30. Clause 8 Operation
8.2 Requirements for products and services:-
•8.2.1 customer communication shall include :
•Providing information relating to the products and services,
•Handling inquiries, contracts and order including changes,
•Obtaining customer feedback including customer complaints
•Handling and controlling customer properties
•8.2.2 Determining the requirements for the products and services
•Any applicable statutory or regulatory requirement
•Requirement considered necessary by organisation
•Ensure org. Can meet the claims for the products and services it offers
31. Clause 8 Operation
8.2 Requirements for products and services:-
•8.2.3 Review of the requirements for products and services
8.2.3.1 Organisation shall conduct a review before committing to supply products
and services to include
Specified by the customer including requirements for delivery and post delivery
activities
•Requirement not stated by the customer, but specified or intended use, when
known
•Requirement specified by the organization
•Statutory and regulatory requirements contract or order requirements
•8.2.3.2. Organization shall retain documented information on the results of the
review and any new requirement for the products and services
32. Clause 8 Operation
8.4 Control for externally provided processes, products
and services.
•8.4.1 General
Organization shall
•Ensure EPS confirms to requirements
•Determine the controls to be applied to EPS
•Determine and apply criteria for evaluation ,
selection and monitoring and evaluation of EPS .
33. Clause 8 Operation
8.4 Control for externally provided processes, products
and services.
•8.4.2 Type and Extent of control
•Organization shall
•Ensure EPS do not adversely affects org. ability
•Remains within the applied control
•Consider effectiveness of the controls applied
•Determine the verification that EPS meets requirements
34. Clause 8 Operation
8.4 Control for externally provided processes, products
and services.
•8.4.3 Information for external providers
•Org. Shall communicate its requirements,
approval, competence required, control and
monitoring and verification of the
effectiveness of the EPS
35. Clause 8 Operation
8.5 Production and service provision.
•8.5.1 Control of production and service provision
•8.5.2 Identification and traceability
•8.5.3 Property belonging to customer or external
providers
•8.5.4 Preservation
•8.5.5 Post delivery activities
•8.5.6 Control of changes
36. Clause 8 Operation
8.6 Release of product and services.
Organization shall implement, verify that products and
services requirements have been met.
After ensuring the products and services conformity martial
to be release
Organization shall maintain an retain documented
information on the release of product and services
Documented information shall include the evidence of
conformity and traceability of the person authorizing the
release.
37. Clause 8 Operation
8.7 Control of non confirming output.
8.7.1 Org. Shall ensure that output that do not conform to
their requirements are identified and controlled to prevent
their unintended use.
Take appropriate action to deals with the no conformity
8.7.2 Org shall retain and maintain documented
information that describes non conformity, caption taken,
any concession obtained and authority deciding the actions
in respect of the conformity.
38. Clause 9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation.
9.2 Internal Audit
9.2.1 Org. Shall conduct internal audits at a planned
intervals to provide information that QMS conforms to
own /standard requirements , QMS effectively
implemented and maintained
9.2.2 Org shall plan audit program, criteria and scope,
select auditors, conduct audits, results are informed to
relevant management
Take appropriate CAPA without undue delay, retain
documented information of the audit program.
39. Clause 9 Performance evaluation
9.3 Management review.
9.3.1 General:- Review QMS at planned intervals to ensure suitability,
adequacy and effectiveness and alignment with strategic directions of
organization
9.3.2 Management review inputs includes audit findings monitoring
and measuring results customer satisfaction feedback, risk and opportunities
etc.
9.3.2 Management review outputs shall include decisions and
action related to opportunities for improvements, any need for the change in
the QMS, resource required
Org. Shall retain documented information as evidence of the results of the
management reviews
40. Clause 10 Improvement
10.1 General
Org. Shall determine and select opportunities for improvements and
implement to meet customer requirements and satisfaction
10.2 Non conformity and corrective action org. Shall react to
non conformity and take action to control and correct it, evaluate the need for
action to eliminate the cause of NC, implement action, review the effectiveness
of corrective actions, update risk and opportunities determined etc.
Org. Shall retain documented information as evidence
10.3 Continual improvement shall include continually improve the
suitability, adequacy and effectiveness of the QMS