ISO - Planning
•
0 likes•1,062 views
This document outlines the planning requirements for a quality management system (QMS). It discusses planning quality objectives and changes to the QMS, as well as addressing risks and opportunities. Key steps include understanding organizational context, stakeholder needs and expectations, and QMS scope. Quality objectives must be relevant, enhance customer satisfaction, and have documented information on evaluation. Changes to the QMS must consider purpose, impacts, system integrity, and resource availability. Management reviews cover status of actions, issues, performance data, audit results, resource adequacy, and opportunities for improvement.
Report
Share
Report
Share
Download to read offline
Recommended
ISO - Leadership
This document discusses quality management system requirements including leadership commitment, customer focus, quality policy, organizational roles and responsibilities, and management review. It addresses leadership accountability for quality management system effectiveness, integrating the system into business processes, ensuring adequate resources, and promoting continual improvement. Customer requirements and regulatory compliance are also addressed. Quality objectives, management responsibilities, and review of quality performance data and opportunities for improvement are discussed.
ISO - Context
This document discusses the key elements of Section 4 of the ISO 9001 quality management system standard, which includes understanding the organization and its context, the needs and expectations of interested parties, determining the scope of the quality management system, and designing quality management system processes. It provides details on each of these elements, such as identifying internal and external issues, requirements of interested parties, products and services covered by the scope, and factors to consider when designing processes such as inputs, outputs, sequence, interactions, criteria and methods for monitoring and improvement. Records are required to support process operation and demonstrate that processes are carried out as planned.
ISO - Philosophy of New Revision
The document discusses the key changes and improvements in the revised ISO 9001 quality management standard, including:
1) Increased emphasis on risk-based thinking throughout all processes and a process-based implementation approach.
2) A requirement for organizations to define their context and plan their quality management system related to their business objectives and risks.
3) Greater flexibility with less prescriptive requirements around documents and more focus on performance and results to improve customer satisfaction.
4) Alignment of the standard with other ISO management system standards using a common framework defined in Annex SL.
Continuous Improvement
Continuous improvement is a planned, ongoing process for systematically reviewing and improving policies, procedures, products, and services to generate better outcomes for clients and meet changing needs. It allows organizations to constantly review performance against standards and plan ongoing improvements. Continuous improvement involves collecting, analyzing, and acting on relevant feedback from clients, staff, and other stakeholders.
Thc3 leadingpractices
Leading organizations carefully manage important value creation and support processes. They translate customer requirements into product requirements early in the design process. They ensure quality is built into products and services through appropriate engineering tools during development. Leading organizations also define supplier performance requirements and develop partnering relationships. They continuously improve processes to achieve better quality and performance.
Quality management at anb
QC training on key QC concepts (what is quality, cost of quality, cost and quality trade offs, voice of customer, critical to quality)
Apics cpim
APICS - CPIM
Certification Training Course at Zabeel Institute – Dubai | Abu Dhabi | Sharjah
APICS, The Association for Operations Management is the global leader and premier source of the body of knowledge in supply chain and Operations Management, including Production, Inventory, Materials Management, Purchasing and Logistics. APICS recognizes the contributions of supply chain and operations management professionals make to their employers and the global economy and have developed a comprehensive suite of Educational resources.
For more information on APICS –CPIM: https://tinyurl.com/y66yt6pg
Call: 00971 4 3974905
Whatsapp:- +971508429092 / +971505358421
Email: mail@zabeelinstitute.ae
QC-Manual
This quality control manual provides definitions and guidance for quality assurance processes. It outlines key terms like quality manual, efficiency, effectiveness, continual improvement, and quality policy. It describes the benefits of authorization like increased reliability and production. The manual establishes organizational roles and responsibilities and defines inspection, testing, and procedures. It presents a quality assurance process that includes calibration, welding control, material control, repair and alteration, and examinations and inspections. Finally, it provides details on inspection points and controlling fabrication.
Recommended
ISO - Leadership
This document discusses quality management system requirements including leadership commitment, customer focus, quality policy, organizational roles and responsibilities, and management review. It addresses leadership accountability for quality management system effectiveness, integrating the system into business processes, ensuring adequate resources, and promoting continual improvement. Customer requirements and regulatory compliance are also addressed. Quality objectives, management responsibilities, and review of quality performance data and opportunities for improvement are discussed.
ISO - Context
This document discusses the key elements of Section 4 of the ISO 9001 quality management system standard, which includes understanding the organization and its context, the needs and expectations of interested parties, determining the scope of the quality management system, and designing quality management system processes. It provides details on each of these elements, such as identifying internal and external issues, requirements of interested parties, products and services covered by the scope, and factors to consider when designing processes such as inputs, outputs, sequence, interactions, criteria and methods for monitoring and improvement. Records are required to support process operation and demonstrate that processes are carried out as planned.
ISO - Philosophy of New Revision
The document discusses the key changes and improvements in the revised ISO 9001 quality management standard, including:
1) Increased emphasis on risk-based thinking throughout all processes and a process-based implementation approach.
2) A requirement for organizations to define their context and plan their quality management system related to their business objectives and risks.
3) Greater flexibility with less prescriptive requirements around documents and more focus on performance and results to improve customer satisfaction.
4) Alignment of the standard with other ISO management system standards using a common framework defined in Annex SL.
Continuous Improvement
Continuous improvement is a planned, ongoing process for systematically reviewing and improving policies, procedures, products, and services to generate better outcomes for clients and meet changing needs. It allows organizations to constantly review performance against standards and plan ongoing improvements. Continuous improvement involves collecting, analyzing, and acting on relevant feedback from clients, staff, and other stakeholders.
Thc3 leadingpractices
Leading organizations carefully manage important value creation and support processes. They translate customer requirements into product requirements early in the design process. They ensure quality is built into products and services through appropriate engineering tools during development. Leading organizations also define supplier performance requirements and develop partnering relationships. They continuously improve processes to achieve better quality and performance.
Quality management at anb
QC training on key QC concepts (what is quality, cost of quality, cost and quality trade offs, voice of customer, critical to quality)
Apics cpim
APICS - CPIM
Certification Training Course at Zabeel Institute – Dubai | Abu Dhabi | Sharjah
APICS, The Association for Operations Management is the global leader and premier source of the body of knowledge in supply chain and Operations Management, including Production, Inventory, Materials Management, Purchasing and Logistics. APICS recognizes the contributions of supply chain and operations management professionals make to their employers and the global economy and have developed a comprehensive suite of Educational resources.
For more information on APICS –CPIM: https://tinyurl.com/y66yt6pg
Call: 00971 4 3974905
Whatsapp:- +971508429092 / +971505358421
Email: mail@zabeelinstitute.ae
QC-Manual
This quality control manual provides definitions and guidance for quality assurance processes. It outlines key terms like quality manual, efficiency, effectiveness, continual improvement, and quality policy. It describes the benefits of authorization like increased reliability and production. The manual establishes organizational roles and responsibilities and defines inspection, testing, and procedures. It presents a quality assurance process that includes calibration, welding control, material control, repair and alteration, and examinations and inspections. Finally, it provides details on inspection points and controlling fabrication.
ISO - Support
This document discusses the requirements for resources in section 7.1 of the quality management system standard. It covers determining the capabilities and constraints of resources, obtaining external resources, infrastructure including IT, the work environment, monitoring and measuring resources, and organizational knowledge. Section 7.2 discusses competence requirements which include determining necessary competence, ensuring competence through education and training, evaluating effectiveness, and retaining documented information. Section 7.3 covers awareness of quality policy, objectives, and implications of nonconformance. Section 7.4 discusses internal and external communication requirements. Section 7.5 covers documented information requirements around referencing other standards, creation and updating, and control of documented information.
Presentation, Daria Bochnar and Miroslawa Boryczka, joint SIGMA ReSPA PIFC re...
Presentation, Daria Bochnar and Miroslawa Boryczka, joint SIGMA ReSPA PIFC re...Support for Improvement in Governance and Management SIGMA
Presentation on management and control systems - how to asses them, Daria Bochnar, SIGMA expert, and Miroslawa Boryczka, SIGMA, at the joint SIGMA-ReSPA PIFC regional conference for EU candidate countries and potential candidates, Skopje, 19 September 2019.Standard operating procedures, records and good practice of production
This document discusses standard operating procedures, documentation, and record keeping in the pharmaceutical industry. It defines key terms like standard operating procedure, documentation, and different types of records. It explains the importance of SOPs and documentation in ensuring uniformity, quality control, and compliance. It also outlines the typical contents, types, and processes involved in SOPs, documentation and maintaining different records like batch records, quality control records, and distribution records.
Internal Audit Procedure
How to write an intenal audit procedure, that not only matching ISO standards, but very CLEAR and SHORT?
The method is looking at the standard sections and then create a matching section, inside the procedure document, for each TOPIC.
Take a look at a READY TO USE internal audit procedure, that you can download.
Quality metrics
Quality Metrics are used to monitor the overall quality of pharmaceutical products and helps to improve product quality and implementing the culture in manufacturing facility.
Mom resume
Jyoti Kothari has over 24 years of experience in quality assurance, manufacturing, and packaging in the pharmaceutical industry. She currently works as a Validation Specialist at Nesher Pharmaceuticals, where she is responsible for equipment qualification and preparing documentation. Previously, she was Associate Manager of Quality Assurance Compliance at Cadila Healthcare, where she led audits, reviewed documents, and ensured regulatory compliance. She has a diploma in pharmacy and is eligible to work in the US.
Quality assurance program
This document defines quality and quality assurance in healthcare. It outlines the objectives of quality assurance as ensuring quality patient care and demonstrating efforts to provide the best results. General principles of quality assurance are that services should be fit for purpose and mistakes eliminated. Quality assurance involves retrospective, concurrent reviews and has strategic, tactical, and operational components. Key steps in the quality assurance process include planning, setting standards, monitoring quality, identifying problems, analyzing issues, developing solutions, and evaluating improvements. Ensuring quality aims to improve health outcomes, meet expectations, use resources efficiently, standardize care, and fulfill ethical duties while factors like weak leadership and lack of resources can hinder quality assurance efforts.
Cost of quality
Organizations have come to understand that poor quality has high costs. There are two main categories of quality costs: quality control costs which are incurred to prevent and find defects, and quality failure costs which are the consequences of poor quality products and lost customers. Quality control costs include prevention costs like planning and design, as well as appraisal costs for inspection and testing. Quality failure costs contain external costs like warranties and legal issues for defects found after delivery, and internal costs like rework and scrap from defects found before delivery.
Iso
The document discusses ISO 9000, a quality management standard that provides criteria for organizations to ensure customer satisfaction. It defines requirements for an effective quality management system, including meeting customer and regulatory requirements. The standard can be applied to any organization and aims to improve quality, increase profitability, and ensure products and services are fit for their intended purpose. Compliance is assessed through internal and external auditing. Benefits of certification include more efficient operations and increased customer satisfaction, marketing advantages, and profitability.
RTT Trans Africa Duties and Responsibilities
The document outlines the duties and responsibilities of a Responsible Pharmacist & RDC Manager at a bonded warehouse from February 2011 to October 2011. Key responsibilities included initiating and reviewing standard operating procedures, overseeing the receipt, order picking, dispatch, and storage of pharmaceutical products according to quality standards, compiling inspection reports and ensuring corrective actions were implemented, managing staff performance, and ensuring regulatory compliance.
Program Analyst & Contracting Officer
Managed the 2009 Recovery Act grant by coordinating fiscal oversight, reviewing state program plans, and ensuring requirements were met before awarding funds. Provided technical assistance through weekly reviews and meetings, and resolved issues through compliance conferences. Developed a Monitoring Action Plan to track projects and increase fiscal transparency. Independently managed education technology grants, provided ongoing assistance and fiscal monitoring, and led reviews to update monitoring procedures, reducing non-compliance. Conducted oversight of $168 million in Recovery Act funds for education technology projects to ensure grantee compliance.
Build in quality +
The document discusses moving quality inspections earlier in the production process to reduce costs. It presents a model showing the distribution of quality costs throughout production, from development to after sales. The goal is to shift from a reactive, trust-based quality system to a proactive, fact-based one by building quality into decision making, supplier qualifications, and development processes. A five-level quality system maturity model ranges from local and random inspections to an intelligent system that integrates quality across the business through data-driven decision making, supplier audits, and clear quality performance goals.
OPERATING AND MANAGEMENT OF AUDIT IN AUDIT AND REGULATORY COMPLIANCE
This document defines an audit as a systematic and documented process for obtaining evidence and evaluating it objectively to determine if criteria are fulfilled. It states that the objectives of a quality audit are to determine conformity and nonconformity, effectiveness of quality systems, improve quality, meet regulatory requirements, and create a register of auditing organizations and quality systems. The components of an audit discussed are risk assessment, scope statement, audit program, audit procedure, and work papers. It also defines a management audit and provides references.
Auditing of manufacturing facilities by international regulatory agencies ppt
This document discusses auditing of manufacturing facilities by international regulatory agencies. It defines an audit as a systematic, independent and documented process for obtaining evidence and evaluating it objectively. There are three main types of audits: product, process, and system audits. Audits are further classified as internal, external, or regulatory. Regulatory audits are carried out by bodies like the USFDA and MCA to ensure compliance with Good Manufacturing Practices for pharmaceutical production. The purpose of regulatory audits is to build confidence between authorities and facilitate quality systems and global harmonization. The audit process involves notice of inspection, on-site activities like document review and employee interviews, and a final report.
What is quality
The document discusses quality assurance and quality control. Quality assurance is a proactive process that focuses on processes and preventing defects by understanding requirements upfront and developing plans to meet them. Quality control is reactive and focuses on operational activities like inspection and testing to identify defects and ensure deliverables meet requirements. The quality control process receives input from quality assurance, and if defects are found during quality control, quality assurance will investigate and implement corrective actions to prevent reoccurrence.
SETA Accreditation req -_updated
The document provides guidelines for providers seeking accreditation from Services SETA (SSETA) in South Africa. It outlines the 8 core criteria SSETA requires providers to meet, including having a quality management system, staff and learner policies, assessment policies, and management systems and policies. Providers must apply online, use registered assessors and moderators, develop learning content and assessments, and comply with all 8 criteria to be accredited by SSETA.
Tqm an overview
This document discusses total quality management (TQM). It begins with an introduction stating that quality has become an important factor for companies facing global competition. It then discusses the evolution of quality management approaches, including inspection, quality control, quality assurance, and TQM. TQM involves applying quality principles to all aspects of an organization, including customers and suppliers, and integrating quality into key business processes. The document provides details on each approach and how they built upon each other to progress toward today's focus on TQM.
Quality Assurance and Improvement Standards for OVC Services in Ethiopia
The document discusses establishing quality assurance and improvement standards for orphan and vulnerable children services in Ethiopia. It describes the process of developing draft standards through workshops with stakeholders. The draft standards focused on dimensions of quality and minimum activities for areas like food/nutrition, shelter/care, health, education etc. The draft was piloted by NGO programs and reviewed by technical specialists. Revisions were made to make the standards more relevant and feasible. The expected outcomes are creating an enabling environment for vulnerable children, delivering integrated services of good quality, and enhancing capacity for service delivery.
Iso 9001 2000 Sample
The document outlines the key sections and requirements of the ISO 9001:2000 quality management standard. It discusses terms and definitions that have been updated from the 1994 version to better reflect current supply chain vocabulary. Management responsibility requirements include demonstrating commitment to the quality management system, communicating quality policy and objectives, and conducting management reviews. Preventive actions should be based on evaluating data trends and risks to drive continuous improvement.
Role of Top management
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.
Lect.02.09.13
This document discusses management responsibility in quality management systems including establishing quality objectives and continual improvement. It outlines key quality management principles such as customer focus, leadership, and process approach. It emphasizes management's commitment to developing, implementing, and continually improving the quality management system. This includes establishing a quality policy and objectives and conducting management reviews. The document provides guidance on establishing quality objectives, corrective and preventive actions, and using tools and metrics to monitor performance and drive continual improvement.
Iso 9001
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.
More Related Content
What's hot
ISO - Support
This document discusses the requirements for resources in section 7.1 of the quality management system standard. It covers determining the capabilities and constraints of resources, obtaining external resources, infrastructure including IT, the work environment, monitoring and measuring resources, and organizational knowledge. Section 7.2 discusses competence requirements which include determining necessary competence, ensuring competence through education and training, evaluating effectiveness, and retaining documented information. Section 7.3 covers awareness of quality policy, objectives, and implications of nonconformance. Section 7.4 discusses internal and external communication requirements. Section 7.5 covers documented information requirements around referencing other standards, creation and updating, and control of documented information.
Presentation, Daria Bochnar and Miroslawa Boryczka, joint SIGMA ReSPA PIFC re...
Presentation, Daria Bochnar and Miroslawa Boryczka, joint SIGMA ReSPA PIFC re...Support for Improvement in Governance and Management SIGMA
Presentation on management and control systems - how to asses them, Daria Bochnar, SIGMA expert, and Miroslawa Boryczka, SIGMA, at the joint SIGMA-ReSPA PIFC regional conference for EU candidate countries and potential candidates, Skopje, 19 September 2019.Standard operating procedures, records and good practice of production
This document discusses standard operating procedures, documentation, and record keeping in the pharmaceutical industry. It defines key terms like standard operating procedure, documentation, and different types of records. It explains the importance of SOPs and documentation in ensuring uniformity, quality control, and compliance. It also outlines the typical contents, types, and processes involved in SOPs, documentation and maintaining different records like batch records, quality control records, and distribution records.
Internal Audit Procedure
How to write an intenal audit procedure, that not only matching ISO standards, but very CLEAR and SHORT?
The method is looking at the standard sections and then create a matching section, inside the procedure document, for each TOPIC.
Take a look at a READY TO USE internal audit procedure, that you can download.
Quality metrics
Quality Metrics are used to monitor the overall quality of pharmaceutical products and helps to improve product quality and implementing the culture in manufacturing facility.
Mom resume
Jyoti Kothari has over 24 years of experience in quality assurance, manufacturing, and packaging in the pharmaceutical industry. She currently works as a Validation Specialist at Nesher Pharmaceuticals, where she is responsible for equipment qualification and preparing documentation. Previously, she was Associate Manager of Quality Assurance Compliance at Cadila Healthcare, where she led audits, reviewed documents, and ensured regulatory compliance. She has a diploma in pharmacy and is eligible to work in the US.
Quality assurance program
This document defines quality and quality assurance in healthcare. It outlines the objectives of quality assurance as ensuring quality patient care and demonstrating efforts to provide the best results. General principles of quality assurance are that services should be fit for purpose and mistakes eliminated. Quality assurance involves retrospective, concurrent reviews and has strategic, tactical, and operational components. Key steps in the quality assurance process include planning, setting standards, monitoring quality, identifying problems, analyzing issues, developing solutions, and evaluating improvements. Ensuring quality aims to improve health outcomes, meet expectations, use resources efficiently, standardize care, and fulfill ethical duties while factors like weak leadership and lack of resources can hinder quality assurance efforts.
Cost of quality
Organizations have come to understand that poor quality has high costs. There are two main categories of quality costs: quality control costs which are incurred to prevent and find defects, and quality failure costs which are the consequences of poor quality products and lost customers. Quality control costs include prevention costs like planning and design, as well as appraisal costs for inspection and testing. Quality failure costs contain external costs like warranties and legal issues for defects found after delivery, and internal costs like rework and scrap from defects found before delivery.
Iso
The document discusses ISO 9000, a quality management standard that provides criteria for organizations to ensure customer satisfaction. It defines requirements for an effective quality management system, including meeting customer and regulatory requirements. The standard can be applied to any organization and aims to improve quality, increase profitability, and ensure products and services are fit for their intended purpose. Compliance is assessed through internal and external auditing. Benefits of certification include more efficient operations and increased customer satisfaction, marketing advantages, and profitability.
RTT Trans Africa Duties and Responsibilities
The document outlines the duties and responsibilities of a Responsible Pharmacist & RDC Manager at a bonded warehouse from February 2011 to October 2011. Key responsibilities included initiating and reviewing standard operating procedures, overseeing the receipt, order picking, dispatch, and storage of pharmaceutical products according to quality standards, compiling inspection reports and ensuring corrective actions were implemented, managing staff performance, and ensuring regulatory compliance.
Program Analyst & Contracting Officer
Managed the 2009 Recovery Act grant by coordinating fiscal oversight, reviewing state program plans, and ensuring requirements were met before awarding funds. Provided technical assistance through weekly reviews and meetings, and resolved issues through compliance conferences. Developed a Monitoring Action Plan to track projects and increase fiscal transparency. Independently managed education technology grants, provided ongoing assistance and fiscal monitoring, and led reviews to update monitoring procedures, reducing non-compliance. Conducted oversight of $168 million in Recovery Act funds for education technology projects to ensure grantee compliance.
Build in quality +
The document discusses moving quality inspections earlier in the production process to reduce costs. It presents a model showing the distribution of quality costs throughout production, from development to after sales. The goal is to shift from a reactive, trust-based quality system to a proactive, fact-based one by building quality into decision making, supplier qualifications, and development processes. A five-level quality system maturity model ranges from local and random inspections to an intelligent system that integrates quality across the business through data-driven decision making, supplier audits, and clear quality performance goals.
OPERATING AND MANAGEMENT OF AUDIT IN AUDIT AND REGULATORY COMPLIANCE
This document defines an audit as a systematic and documented process for obtaining evidence and evaluating it objectively to determine if criteria are fulfilled. It states that the objectives of a quality audit are to determine conformity and nonconformity, effectiveness of quality systems, improve quality, meet regulatory requirements, and create a register of auditing organizations and quality systems. The components of an audit discussed are risk assessment, scope statement, audit program, audit procedure, and work papers. It also defines a management audit and provides references.
Auditing of manufacturing facilities by international regulatory agencies ppt
This document discusses auditing of manufacturing facilities by international regulatory agencies. It defines an audit as a systematic, independent and documented process for obtaining evidence and evaluating it objectively. There are three main types of audits: product, process, and system audits. Audits are further classified as internal, external, or regulatory. Regulatory audits are carried out by bodies like the USFDA and MCA to ensure compliance with Good Manufacturing Practices for pharmaceutical production. The purpose of regulatory audits is to build confidence between authorities and facilitate quality systems and global harmonization. The audit process involves notice of inspection, on-site activities like document review and employee interviews, and a final report.
What is quality
The document discusses quality assurance and quality control. Quality assurance is a proactive process that focuses on processes and preventing defects by understanding requirements upfront and developing plans to meet them. Quality control is reactive and focuses on operational activities like inspection and testing to identify defects and ensure deliverables meet requirements. The quality control process receives input from quality assurance, and if defects are found during quality control, quality assurance will investigate and implement corrective actions to prevent reoccurrence.
SETA Accreditation req -_updated
The document provides guidelines for providers seeking accreditation from Services SETA (SSETA) in South Africa. It outlines the 8 core criteria SSETA requires providers to meet, including having a quality management system, staff and learner policies, assessment policies, and management systems and policies. Providers must apply online, use registered assessors and moderators, develop learning content and assessments, and comply with all 8 criteria to be accredited by SSETA.
Tqm an overview
This document discusses total quality management (TQM). It begins with an introduction stating that quality has become an important factor for companies facing global competition. It then discusses the evolution of quality management approaches, including inspection, quality control, quality assurance, and TQM. TQM involves applying quality principles to all aspects of an organization, including customers and suppliers, and integrating quality into key business processes. The document provides details on each approach and how they built upon each other to progress toward today's focus on TQM.
Quality Assurance and Improvement Standards for OVC Services in Ethiopia
The document discusses establishing quality assurance and improvement standards for orphan and vulnerable children services in Ethiopia. It describes the process of developing draft standards through workshops with stakeholders. The draft standards focused on dimensions of quality and minimum activities for areas like food/nutrition, shelter/care, health, education etc. The draft was piloted by NGO programs and reviewed by technical specialists. Revisions were made to make the standards more relevant and feasible. The expected outcomes are creating an enabling environment for vulnerable children, delivering integrated services of good quality, and enhancing capacity for service delivery.
Iso 9001 2000 Sample
The document outlines the key sections and requirements of the ISO 9001:2000 quality management standard. It discusses terms and definitions that have been updated from the 1994 version to better reflect current supply chain vocabulary. Management responsibility requirements include demonstrating commitment to the quality management system, communicating quality policy and objectives, and conducting management reviews. Preventive actions should be based on evaluating data trends and risks to drive continuous improvement.
What's hot (19)
Presentation, Daria Bochnar and Miroslawa Boryczka, joint SIGMA ReSPA PIFC re...
Presentation, Daria Bochnar and Miroslawa Boryczka, joint SIGMA ReSPA PIFC re...
Standard operating procedures, records and good practice of production
Standard operating procedures, records and good practice of production
OPERATING AND MANAGEMENT OF AUDIT IN AUDIT AND REGULATORY COMPLIANCE
OPERATING AND MANAGEMENT OF AUDIT IN AUDIT AND REGULATORY COMPLIANCE
Auditing of manufacturing facilities by international regulatory agencies ppt
Auditing of manufacturing facilities by international regulatory agencies ppt
Quality Assurance and Improvement Standards for OVC Services in Ethiopia
Quality Assurance and Improvement Standards for OVC Services in Ethiopia
Similar to ISO - Planning
Role of Top management
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.
Lect.02.09.13
This document discusses management responsibility in quality management systems including establishing quality objectives and continual improvement. It outlines key quality management principles such as customer focus, leadership, and process approach. It emphasizes management's commitment to developing, implementing, and continually improving the quality management system. This includes establishing a quality policy and objectives and conducting management reviews. The document provides guidance on establishing quality objectives, corrective and preventive actions, and using tools and metrics to monitor performance and drive continual improvement.
Iso 9001
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.
Topic 8 - Project Quality Management.pdf
The document discusses project quality management. It provides an overview of quality concepts, quality planning techniques, and the three processes involved in quality management: plan quality management, manage quality, and control quality. Key points include defining quality and quality levels, using tools like cost-benefit analysis and control charts for quality planning, and techniques like audits, problem solving and process analysis that are used to manage and control quality during project execution.
QMS Risk Workshop.pptx
This document provides information about an upcoming training on quality management systems according to ISO 9001:2015 standards. The training will cover risk-based thinking, preparing a risk and opportunities analysis and action plan, conducting root cause analysis, and addressing non-conformities. It will explain how considering risks and opportunities is addressed in various ISO 9001 clauses and how to identify, evaluate, and take action to mitigate risks. The training will also review the PDCA cycle and how it is applied to DENR processes to achieve objectives and continually improve.
ISO 9001: 2015 QUALITY MANAGEMENT PRINCIPLES
PPT on ISO 9001: 2015 QUALITY MANAGEMENT PRINCIPLES
Reference: https://www.iso.org/publication/PUB100080.html
Aweareness about ISO 9001-2015.pptx
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.
Iso 9001 transition checklist
Here is an easy to use checklist for the transition of ISO 9001 to the 2015 edition if you require any advise please call CAW Consultancy Business Solutions on 01772 932058 or our 24 hour hotline 07427535662
Risk elimination and safety committee
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.
ISO 9001 2015 DIS 6.0 Planning Slides
The document compares the planning processes between ISO 9001:2008 and ISO 9001:2015. Key differences include greater emphasis on identifying and planning for risks and opportunities, and planning for changes to the quality management system. The new standard also requires customer satisfaction information and supplier performance to be reviewed during management reviews.
ISO 9001:2015 What Are the Main Changes?
This webinar provides a quick guide for your review to either prepare you for the transition or to check yourself to make sure your bases are covered for your next third party audit. This webinar is presented by a third party auditor in a simple manner that you will understand.
Main points covered:
• What are the benefits of the ISO 9001
• The key concepts of ISO 9001
• New terminology and important definitions introduced in ISO 9001
• Important tips on how to prepare for changes
Presenter:
This webinar was presented by Debra Hay Hampton, PECB Certified Trainer and Lead Auditor of Quality and Environmental Management Systems.
Link of the recorded webinar published on YouTube: https://youtu.be/dTsFHDz01ws
SQMC briefing on ISO 9001 2015
The international Standard for Quality Management Systems, ISO 9001:2008, is being revised. ISO 9001:2015 is due to be published by the end of 2015. This slideshow is compiled from the first Committee Draft by Ian Hannah, Fellow of the Chartered Quality Institute; and was originally used for staff development purposes at his ISO Training and Consultancy firm, SQMC Ltd.
Iso Process Audit Training
This document provides an agenda and overview for a two-day process auditing training workshop. Day 1 covers introductions, process definitions, customer satisfaction, continual improvement, and process auditing methodology. Day 2 covers audit performance, nonconformances, auditing top management, and concludes with a wrap-up session. The workshop aims to provide auditors with skills to conduct process audits and add value to their organization.
Session 12 4th edition PMP
This document discusses project quality management. It defines quality as the degree to which a project fulfills requirements. Quality management includes creating and following policies and procedures to ensure a project meets customer needs. Completing a project with no deviations from requirements is the goal. The document discusses quality planning, assurance, and control processes. It also discusses quality concepts, tools like control charts and benchmarking, and influential quality management thinkers like Deming, Crosby, and Juran.
9001 2008 details
The document provides an overview of ISO 9001 and its evolution over time. It summarizes the key requirements of ISO 9001:2008, including developing, documenting, implementing and maintaining a quality management system. It outlines requirements for management responsibility, resource management, product realization, measurement and customer satisfaction.
ISO9001:2015 presentation
The document provides an overview of key changes between the ISO 9001:2008 and ISO 9001:2015 standards and suggestions for addressing these changes. Some of the major changes discussed include a shift to a process-based approach, consideration of interested parties and risks, and expanded leadership responsibilities. The presentation recommends implementing process mapping, collecting stakeholder needs and expectations, conducting risk assessments, and clarifying roles and responsibilities to meet the new standard requirements. It also provides guidance on specific clauses and how different roles within an organization should view the standard. The intent is to help organizations understand and address the new provisions in ISO 9001:2015.
ISO 9001: 2015
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.
Day 1
This document discusses result-based monitoring and evaluation (M&E). It defines monitoring as the systematic collection of data on indicators, and evaluation as the objective assessment of a project or program's design, implementation and results. The purpose of M&E is to assess progress, determine relevance and fulfillment of objectives, and enhance transparency and accountability. Key aspects of result-based M&E covered include logical frameworks, methods/tools like rapid appraisal and impact evaluation, and essential actions to build an effective result-based M&E system like formulating goals and indicators to measure outcomes.
PROJECT QUALITY MANAGEMENT for Project.ppt
The document discusses project quality management. It describes the three main processes as plan quality, perform quality assurance, and perform quality control. Plan quality involves identifying quality requirements. Perform quality assurance involves auditing quality requirements and ensuring standards are followed. Perform quality control involves monitoring results, assessing performance, and recommending changes. It provides details on key activities, tools, and outputs for each of the three processes.
ISO 9001:2015 DIS Changes, Requirements and Implementation
This presentation discusses new requirements to ISO 9001 based on the Draft International Standard (DIS). Guidance for transition to new revision is proposed for planning, communication and execution.
Similar to ISO - Planning (20)
ISO 9001:2015 DIS Changes, Requirements and Implementation
ISO 9001:2015 DIS Changes, Requirements and Implementation
Recently uploaded
Digital Transformation Frameworks: Driving Digital Excellence
[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
This presentation is a curated compilation of PowerPoint diagrams and templates designed to illustrate 20 different digital transformation frameworks and models. These frameworks are based on recent industry trends and best practices, ensuring that the content remains relevant and up-to-date.
Key highlights include Microsoft's Digital Transformation Framework, which focuses on driving innovation and efficiency, and McKinsey's Ten Guiding Principles, which provide strategic insights for successful digital transformation. Additionally, Forrester's framework emphasizes enhancing customer experiences and modernizing IT infrastructure, while IDC's MaturityScape helps assess and develop organizational digital maturity. MIT's framework explores cutting-edge strategies for achieving digital success.
These materials are perfect for enhancing your business or classroom presentations, offering visual aids to supplement your insights. Please note that while comprehensive, these slides are intended as supplementary resources and may not be complete for standalone instructional purposes.
Frameworks/Models included:
Microsoft’s Digital Transformation Framework
McKinsey’s Ten Guiding Principles of Digital Transformation
Forrester’s Digital Transformation Framework
IDC’s Digital Transformation MaturityScape
MIT’s Digital Transformation Framework
Gartner’s Digital Transformation Framework
Accenture’s Digital Strategy & Enterprise Frameworks
Deloitte’s Digital Industrial Transformation Framework
Capgemini’s Digital Transformation Framework
PwC’s Digital Transformation Framework
Cisco’s Digital Transformation Framework
Cognizant’s Digital Transformation Framework
DXC Technology’s Digital Transformation Framework
The BCG Strategy Palette
McKinsey’s Digital Transformation Framework
Digital Transformation Compass
Four Levels of Digital Maturity
Design Thinking Framework
Business Model Canvas
Customer Journey Map
HOW TO START UP A COMPANY A STEP-BY-STEP GUIDE.pdf
How to Start Up a Company: A Step-by-Step Guide Starting a company is an exciting adventure that combines creativity, strategy, and hard work. It can seem overwhelming at first, but with the right guidance, anyone can transform a great idea into a successful business. Let's dive into how to start up a company, from the initial spark of an idea to securing funding and launching your startup.
Introduction
Have you ever dreamed of turning your innovative idea into a thriving business? Starting a company involves numerous steps and decisions, but don't worry—we're here to help. Whether you're exploring how to start a startup company or wondering how to start up a small business, this guide will walk you through the process, step by step.
Best Forex Brokers Comparison in INDIA 2024
Navigating the world of forex trading can be challenging, especially for beginners. To help you make an informed decision, we have comprehensively compared the best forex brokers in India for 2024. This article, reviewed by Top Forex Brokers Review, will cover featured award winners, the best forex brokers, featured offers, the best copy trading platforms, the best forex brokers for beginners, the best MetaTrader brokers, and recently updated reviews. We will focus on FP Markets, Black Bull, EightCap, IC Markets, and Octa.
The Genesis of BriansClub.cm Famous Dark WEb Platform
BriansClub.cm, a famous platform on the dark web, has become one of the most infamous carding marketplaces, specializing in the sale of stolen credit card data.
Business storytelling: key ingredients to a story
Storytelling is an incredibly valuable tool to share data and information. To get the most impact from stories there are a number of key ingredients. These are based on science and human nature. Using these elements in a story you can deliver information impactfully, ensure action and drive change.
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.
This letter, written by Kellen Harkins, Course Director at Full Sail University, commends Anny Love's exemplary performance in the Video Sharing Platforms class. It highlights her dedication, willingness to challenge herself, and exceptional skills in production, editing, and marketing across various video platforms like YouTube, TikTok, and Instagram.
Structural Design Process: Step-by-Step Guide for Buildings
The structural design process is explained: Follow our step-by-step guide to understand building design intricacies and ensure structural integrity. Learn how to build wonderful buildings with the help of our detailed information. Learn how to create structures with durability and reliability and also gain insights on ways of managing structures.
Top mailing list providers in the USA.pptx
Discover the top mailing list providers in the USA, offering targeted lists, segmentation, and analytics to optimize your marketing campaigns and drive engagement.
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Fin...
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Fin...❼❷⓿❺❻❷❽❷❼❽ Dpboss Kalyan Satta Matka Guessing Matka Result Main Bazar chart
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Final ank Satta Matka Dpbos Final ank Satta Matta Matka 143 Kalyan Matka Guessing Final Matka Final ank Today Matka 420 Satta Batta Satta 143 Kalyan Chart Main Bazar Chart vip Matka Guessing Dpboss 143 Guessing Kalyan night Organizational Change Leadership Agile Tour Geneve 2024
Organizational Change Leadership at Agile Tour Geneve 2024
Best practices for project execution and delivery
A select set of project management best practices to keep your project on-track, on-cost and aligned to scope. Many firms have don't have the necessary skills, diligence, methods and oversight of their projects; this leads to slippage, higher costs and longer timeframes. Often firms have a history of projects that simply failed to move the needle. These best practices will help your firm avoid these pitfalls but they require fortitude to apply.
Industrial Tech SW: Category Renewal and Creation
Every industrial revolution has created a new set of categories and a new set of players.
Multiple new technologies have emerged, but Samsara and C3.ai are only two companies which have gone public so far.
Manufacturing startups constitute the largest pipeline share of unicorns and IPO candidates in the SF Bay Area, and software startups dominate in Germany.
Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...
Dive into the steadfast world of the Taurus Zodiac Sign. Discover the grounded, stable, and logical nature of Taurus individuals, and explore their key personality traits, important dates, and horoscope insights. Learn how the determination and patience of the Taurus sign make them the rock-steady achievers and anchors of the zodiac.
The APCO Geopolitical Radar - Q3 2024 The Global Operating Environment for Bu...
The Radar reflects input from APCO’s teams located around the world. It distils a host of interconnected events and trends into insights to inform operational and strategic decisions. Issues covered in this edition include:
Company Valuation webinar series - Tuesday, 4 June 2024
This session provided an update as to the latest valuation data in the UK and then delved into a discussion on the upcoming election and the impacts on valuation. We finished, as always with a Q&A
Digital Marketing with a Focus on Sustainability
Digital Marketing best practices including influencer marketing, content creators, and omnichannel marketing for Sustainable Brands at the Sustainable Cosmetics Summit 2024 in New York
Dpboss Matka Guessing Satta Matta Matka Kalyan Chart Satta Matka
Dpboss Matka Guessing Satta Matta Matka Kalyan Chart Satta Matka➒➌➎➏➑➐➋➑➐➐Dpboss Matka Guessing Satta Matka Kalyan Chart Indian Matka
Dpboss Matka Guessing Satta Matta Matka Kalyan Chart Indian Matka Indian satta Matka Dpboss Matka Kalyan Chart Matka Boss otg matka Guessing Satta Recently uploaded (20)
Digital Transformation Frameworks: Driving Digital Excellence
Digital Transformation Frameworks: Driving Digital Excellence
HOW TO START UP A COMPANY A STEP-BY-STEP GUIDE.pdf
HOW TO START UP A COMPANY A STEP-BY-STEP GUIDE.pdf
The Genesis of BriansClub.cm Famous Dark WEb Platform
The Genesis of BriansClub.cm Famous Dark WEb Platform
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.
Structural Design Process: Step-by-Step Guide for Buildings
Structural Design Process: Step-by-Step Guide for Buildings
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Fin...
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Fin...
Organizational Change Leadership Agile Tour Geneve 2024
Organizational Change Leadership Agile Tour Geneve 2024
Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...
Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...
The APCO Geopolitical Radar - Q3 2024 The Global Operating Environment for Bu...
The APCO Geopolitical Radar - Q3 2024 The Global Operating Environment for Bu...
Company Valuation webinar series - Tuesday, 4 June 2024
Company Valuation webinar series - Tuesday, 4 June 2024
Dpboss Matka Guessing Satta Matta Matka Kalyan Chart Satta Matka
Dpboss Matka Guessing Satta Matta Matka Kalyan Chart Satta Matka
ISO - Planning
- 1. PLANNING Quality is Culture 1 November 2016
- 2. 2 *
- 3. 3 *
- 4. * Recall: 4.1 Understanding the organization and it context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the QMS 4.4 Quality Management System and its processes 4
- 5. * 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of Changes 5
- 6. * 6.1 Actions to address risks and opportunities Consider the issues and determine the risks and opportunities that need to be addressed to: a. Give assurance that that the QMS can achieve intended results b. Prevent, or reduce undesired effects c. Achieve continual improvement Plan: - Actions to address these risks and opportunities - How to integrate/implement actions into QMS - Evaluation effectiveness of these actions 6
- 7. * * Note: Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing risk, or retaining risk by informed decision. 7
- 8. * 6.2 Quality Objectives - similar to previous revision - relevant and enhancement of customer satisfaction - retain documented information on the quality objectives Determine: - What will be done, what resources, who will be responsible, when completed, how evaluated. 8
- 9. * 6.3 Planning of changes: This is new Changes (to QMS) shall be carried out in a planned manner. Consider: a) Purpose of the change and potential consequences b) the integrity of the QMS c) availability of resources d) allocation or reallocation of responsibilities and authorities <Feedback loop Management Review 9.3.2.c.2> 9
- 10. * 9.3 Management Review a) Status of actions b) Changes in external and internal issues that are relevant to the QMS c) Information on the performance and effectiveness of the QMS, including trends in: - Customer satisfaction and feedback from relevant interested parties; - The extent to which quality objectives have been met; - Process performance and conformity of products and services; - Nonconformities and corrective actions; - Monitoring and measuring results; - Audit results; - The performance of external providers; d) The adequacy of resources e) The effectiveness of action taken to address risks and opportunities (see 6.1) f) Opportunities for improvement Outputs: decisions and actions related to: - Opportunity for improvement - Changes to QMS - Resource needs 10