This document is the quality management system manual for XYZ. It describes the quality management system which complies with ISO 9001:2008. The manual includes sections on scope, exclusions, documentation requirements, management responsibility, and other quality system processes. It provides the table of contents and outlines the organization and control of the quality management system documents.
The document discusses quality management systems and practices. It provides background on the history and pioneers of quality management, including Frederick Taylor, Philip Crosby, Joseph Juran, and W. Edwards Deming. It describes the purpose and significance of quality management systems and procedures. It also provides an overview of the International Organization for Standardization (ISO) quality management standards, including ISO 9000, ISO 9001, and ISO 14000.
This document discusses Total Quality Management and ISO 9000 quality standards. It provides an overview of ISO 9001 requirements and certification process. The main points covered include the development and requirements of ISO 9000 standards, the quality management principles, ISO 9001 clauses, documentation requirements, and the benefits of ISO certification such as increased customer satisfaction, market opportunities, and process improvements.
The document provides information about ISO and ISO standards. It discusses:
- ISO is an independent international organization that develops voluntary standards to ensure products/services are safe and of good quality.
- ISO 9001 provides requirements for a quality management system to ensure customer satisfaction. ISO 14001 provides requirements for an environmental management system.
- Certification to the standards by an independent body verifies an organization's management system meets the standard's requirements but certification is not required to implement the standards.
The document discusses ISO 9001, a quality management standard. It describes ISO 9001's requirements and benefits, including improved customer satisfaction, staff motivation, and continual improvement. A quality management system based on ISO 9001 provides a framework for organizations to monitor and improve performance. Certification involves an external audit to verify an organization's quality management system meets ISO 9001's requirements.
The document discusses quality management systems and ISO standards. It provides definitions for key terms like quality management systems and describes several ISO standards for quality management including ISO 9001, ISO 9002, ISO 9003. It discusses the benefits of ISO registration for organizations and customers. It also summarizes implementation of a quality management system, documentation requirements, and the purpose and objectives of internal audits.
The document provides an overview of the Quality Management System (QMS) at NOV Devin. It discusses the history and standards that inform the QMS, including ISO and API. The QMS aims to ensure products and services conform to requirements through documented processes and procedures. It outlines the key elements, clauses, and sub-clauses that make up the system, covering topics like management responsibility, documentation control, purchasing, production, monitoring and improvement. The overarching goals of the QMS are to maintain quality, meet customer expectations, and comply with industry standards.
This document discusses Total Quality Management (TQM). It provides an overview of TQM principles and history, including contributions from quality gurus like Deming, Juran, and Crosby. It also describes the evolution of quality standards like ISO 9000 and how a quality management system can be implemented based on a process approach across an organization.
The document discusses quality management systems and practices. It provides background on the history and pioneers of quality management, including Frederick Taylor, Philip Crosby, Joseph Juran, and W. Edwards Deming. It describes the purpose and significance of quality management systems and procedures. It also provides an overview of the International Organization for Standardization (ISO) quality management standards, including ISO 9000, ISO 9001, and ISO 14000.
This document discusses Total Quality Management and ISO 9000 quality standards. It provides an overview of ISO 9001 requirements and certification process. The main points covered include the development and requirements of ISO 9000 standards, the quality management principles, ISO 9001 clauses, documentation requirements, and the benefits of ISO certification such as increased customer satisfaction, market opportunities, and process improvements.
The document provides information about ISO and ISO standards. It discusses:
- ISO is an independent international organization that develops voluntary standards to ensure products/services are safe and of good quality.
- ISO 9001 provides requirements for a quality management system to ensure customer satisfaction. ISO 14001 provides requirements for an environmental management system.
- Certification to the standards by an independent body verifies an organization's management system meets the standard's requirements but certification is not required to implement the standards.
The document discusses ISO 9001, a quality management standard. It describes ISO 9001's requirements and benefits, including improved customer satisfaction, staff motivation, and continual improvement. A quality management system based on ISO 9001 provides a framework for organizations to monitor and improve performance. Certification involves an external audit to verify an organization's quality management system meets ISO 9001's requirements.
The document discusses quality management systems and ISO standards. It provides definitions for key terms like quality management systems and describes several ISO standards for quality management including ISO 9001, ISO 9002, ISO 9003. It discusses the benefits of ISO registration for organizations and customers. It also summarizes implementation of a quality management system, documentation requirements, and the purpose and objectives of internal audits.
The document provides an overview of the Quality Management System (QMS) at NOV Devin. It discusses the history and standards that inform the QMS, including ISO and API. The QMS aims to ensure products and services conform to requirements through documented processes and procedures. It outlines the key elements, clauses, and sub-clauses that make up the system, covering topics like management responsibility, documentation control, purchasing, production, monitoring and improvement. The overarching goals of the QMS are to maintain quality, meet customer expectations, and comply with industry standards.
This document discusses Total Quality Management (TQM). It provides an overview of TQM principles and history, including contributions from quality gurus like Deming, Juran, and Crosby. It also describes the evolution of quality standards like ISO 9000 and how a quality management system can be implemented based on a process approach across an organization.
This document provides an overview of ISO 9001:2008. It discusses that ISO 9001 is an international standard for quality management systems. It was created by the International Organization for Standardization to standardize quality systems globally. The standard is based on several quality management principles like customer focus, leadership, involvement of people, and continual improvement. It outlines the requirements for a quality management system, which organizations can implement on a voluntary basis and get certified by external registrars. The standard uses a process approach and is based on Plan-Do-Check-Act cycle of continual improvement.
This document summarizes a quality documentation system for a GMP bioprocessing facility. The system is divided into 5 folders: Facility, Equipment, Production, Quality Control, and Quality Assurance. Each folder contains standard operating procedures, data record forms, and other documents pertaining to that area. The aim of the documentation system is to efficiently organize operations and ensure compliance with GMP guidelines.
ISO 9000 AND TOTAL QUALITY MANAGEMENT: THE RELATIONSHIPDian Hermawan
The document provides an introduction to quality management systems and ISO 9000. It discusses that ISO 9000 establishes requirements for quality management systems to ensure customer satisfaction and continual improvement. It outlines the key principles of a quality management system such as customer focus, leadership, process approach and continual improvement. Organizations can get certified through independent audits to assure customers that their quality management system meets the ISO 9000 requirements. The summary is:
1. ISO 9000 establishes requirements for quality management systems and certification ensures systems meet requirements.
2. Quality management systems are based on principles like customer focus, leadership and continual improvement.
3. Organizations can get certified through independent audits to assure customers of meeting ISO 9000 standards
The document discusses the key aspects and requirements of the ISO 9001:2008 quality management standard. It explains that ISO 9001 specifies six compulsory documented procedures around document control, record control, internal audits, nonconforming products, corrective action, and preventive action. It also requires that organizations document a quality policy and maintain a quality manual. The standard has specific requirements for maintaining records related to management reviews, training, product releases, design and development activities, supplier assessments, validation, traceability, calibration, internal audits, nonconforming products, corrective actions, and preventive actions.
ISO 9000 is a family of standards related to quality management systems and procedures. It helps organizations ensure they meet customer and stakeholder needs while complying with legal requirements. The standards are based on eight quality management principles including customer focus, leadership, and continual improvement. ISO 9000 deals with quality management fundamentals, while ISO 9001 provides requirements for quality assurance in design and manufacturing. Implementing an ISO-certified quality management system helps organizations improve quality, meet regulations, and increase market credibility.
The document discusses quality standards and ISO certification. It describes how the International Organization for Standardization developed the ISO 9000 quality management system standards in 1987 to help organizations ensure customer satisfaction and meet regulatory requirements. Over 130 countries have adopted the ISO standards, including India which introduced them through the Bureau of Indian Standards. The standards were restructured in 2000 as ISO 9000:2000 and cover topics like quality assurance, objectives of certification, its importance for international trade, and advantages for organizations.
Although it is difficult to define quality as every organization looks at it differently but the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs is most commonly considered as quality. If your organization is committed to ensure that its products and services are made as per customers’ requirements and intend to stay in the business by understanding and optimizing the whole system of value exchange; a quality management system can help you in fulfilling all these requirements.
This document provides an overview of ISO 9001:2008 requirements for quality management systems. It defines key terms related to QMS such as quality, quality policy, quality control, quality assurance, documents, records, processes, procedures, audits, conformity and non-conformity. It also describes the eight principles of QMS, the PDCA cycle for continual improvement, and lists procedures for an example organization's QMS. The document aims to introduce readers to the basic concepts and requirements of the ISO 9001:2008 standard.
This document provides an overview of a presentation on quality management systems and ISO standards. It discusses the history and formation of ISO, key ISO standards like ISO 9000 and 9001, benefits of ISO certification like reduced errors and increased customer satisfaction, and sector-specific standards for industries like automotive and telecommunications. The presentation covers topics like quality management principles, documentation requirements, internal audits, and implementing an ISO-compliant quality management system.
ISO establishes voluntary international standards to ensure quality, safety, and efficiency. ISO's most popular standards are ISO 9001 for quality management, ISO 14001 for environmental management, and ISO/IEC 27001 for information security. ISO 9001 focuses on meeting customer needs and continual improvement. ISO 14001 focuses on minimizing environmental impacts and conforming to regulations. Certification to ISO standards is done by independent auditors and provides benefits like improved operations, customer satisfaction, and international trade compliance.
A quality management system is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction
The document provides an overview of key requirements of ISO 9001:2000 standards. It discusses the structure and requirements of the standard which are specified in clauses 4 through 8 relating to quality management system, management responsibility, resource management, product realization, measurement, analysis and improvement. Key requirements covered in each clause are summarized including documentation requirements, management reviews, internal communication, monitoring and measurement, and continual improvement.
This document outlines the key elements of a quality management system, including a quality policy, quality objectives, quality manual, organizational structure, data management, purchasing processes, customer satisfaction, continuous improvement, quality instruments, and document control. The quality policy is a statement by top management regarding product quality expectations. Quality objectives define measurable goals for achieving the quality policy. The quality manual details how the quality management system operates. The organizational structure links quality responsibility to executive levels. Data management develops architectures and procedures for information lifecycles. Purchasing and other processes are also covered.
This document provides an overview of quality management systems and ISO 9000 standards. It discusses that a quality management system is a system used by organizations to document processes, procedures, and responsibilities for ensuring quality policies are followed. It also describes key aspects of quality management like documentation requirements, common ISO quality standards like ISO 9001, and sector-specific standards tailored for industries like aerospace and automotive. Finally, it provides a high-level process flow of how a quality management system is implemented and improves over time within an organization and its suppliers.
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.
A quality management system (QMS) formalizes processes and procedures to achieve quality policies and meet customer and regulatory requirements. It coordinates activities to continuously improve effectiveness and efficiency. Key elements include quality manuals, procedures, records, data management, processes, customer satisfaction, and improvement opportunities. Implementing a QMS affects all aspects of an organization by meeting customer needs to gain confidence and trust, and meeting organizational needs for compliance, cost efficiency, and growth. ISO 9001 provides requirements for an organization to manage quality processes.
ISO 9001:2008 (shared using http://VisualBee.com).VisualBee.com
This document discusses ISO 9001:2008 quality management system standards. It provides an overview of the benefits of ISO 9001 certification for growing organizations, including improved quality, productivity, financial performance and long-term sustainability. It also summarizes the key requirements of the ISO 9001:2008 standard, including establishing documented procedures, conducting management reviews, ensuring customer focus, setting quality policies and objectives, and defining responsibilities.
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.
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.
This document outlines the requirements for an ISO 9001:2000 quality management system. It discusses key aspects such as scope, documentation requirements, management responsibility, resource management, and product realization. The summary focuses on providing a high-level overview of the content and structure rather than detailed requirements.
The document establishes requirements for a quality management system including developing, documenting, implementing, maintaining and continually improving the system. It addresses topics like leadership and commitment from top management, customer focus, quality policy and objectives, planning, responsibilities and resources. Product realization is also covered, from planning to meeting customer requirements and monitoring processes.
ISO 9001 is a process standard for a quality management system, known worldwide. This standard is suitable for any size company or organization that wants to meet its customers ’ and regulatory requirements and consistently improve.
This document provides an overview of ISO 9001:2008. It discusses that ISO 9001 is an international standard for quality management systems. It was created by the International Organization for Standardization to standardize quality systems globally. The standard is based on several quality management principles like customer focus, leadership, involvement of people, and continual improvement. It outlines the requirements for a quality management system, which organizations can implement on a voluntary basis and get certified by external registrars. The standard uses a process approach and is based on Plan-Do-Check-Act cycle of continual improvement.
This document summarizes a quality documentation system for a GMP bioprocessing facility. The system is divided into 5 folders: Facility, Equipment, Production, Quality Control, and Quality Assurance. Each folder contains standard operating procedures, data record forms, and other documents pertaining to that area. The aim of the documentation system is to efficiently organize operations and ensure compliance with GMP guidelines.
ISO 9000 AND TOTAL QUALITY MANAGEMENT: THE RELATIONSHIPDian Hermawan
The document provides an introduction to quality management systems and ISO 9000. It discusses that ISO 9000 establishes requirements for quality management systems to ensure customer satisfaction and continual improvement. It outlines the key principles of a quality management system such as customer focus, leadership, process approach and continual improvement. Organizations can get certified through independent audits to assure customers that their quality management system meets the ISO 9000 requirements. The summary is:
1. ISO 9000 establishes requirements for quality management systems and certification ensures systems meet requirements.
2. Quality management systems are based on principles like customer focus, leadership and continual improvement.
3. Organizations can get certified through independent audits to assure customers of meeting ISO 9000 standards
The document discusses the key aspects and requirements of the ISO 9001:2008 quality management standard. It explains that ISO 9001 specifies six compulsory documented procedures around document control, record control, internal audits, nonconforming products, corrective action, and preventive action. It also requires that organizations document a quality policy and maintain a quality manual. The standard has specific requirements for maintaining records related to management reviews, training, product releases, design and development activities, supplier assessments, validation, traceability, calibration, internal audits, nonconforming products, corrective actions, and preventive actions.
ISO 9000 is a family of standards related to quality management systems and procedures. It helps organizations ensure they meet customer and stakeholder needs while complying with legal requirements. The standards are based on eight quality management principles including customer focus, leadership, and continual improvement. ISO 9000 deals with quality management fundamentals, while ISO 9001 provides requirements for quality assurance in design and manufacturing. Implementing an ISO-certified quality management system helps organizations improve quality, meet regulations, and increase market credibility.
The document discusses quality standards and ISO certification. It describes how the International Organization for Standardization developed the ISO 9000 quality management system standards in 1987 to help organizations ensure customer satisfaction and meet regulatory requirements. Over 130 countries have adopted the ISO standards, including India which introduced them through the Bureau of Indian Standards. The standards were restructured in 2000 as ISO 9000:2000 and cover topics like quality assurance, objectives of certification, its importance for international trade, and advantages for organizations.
Although it is difficult to define quality as every organization looks at it differently but the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs is most commonly considered as quality. If your organization is committed to ensure that its products and services are made as per customers’ requirements and intend to stay in the business by understanding and optimizing the whole system of value exchange; a quality management system can help you in fulfilling all these requirements.
This document provides an overview of ISO 9001:2008 requirements for quality management systems. It defines key terms related to QMS such as quality, quality policy, quality control, quality assurance, documents, records, processes, procedures, audits, conformity and non-conformity. It also describes the eight principles of QMS, the PDCA cycle for continual improvement, and lists procedures for an example organization's QMS. The document aims to introduce readers to the basic concepts and requirements of the ISO 9001:2008 standard.
This document provides an overview of a presentation on quality management systems and ISO standards. It discusses the history and formation of ISO, key ISO standards like ISO 9000 and 9001, benefits of ISO certification like reduced errors and increased customer satisfaction, and sector-specific standards for industries like automotive and telecommunications. The presentation covers topics like quality management principles, documentation requirements, internal audits, and implementing an ISO-compliant quality management system.
ISO establishes voluntary international standards to ensure quality, safety, and efficiency. ISO's most popular standards are ISO 9001 for quality management, ISO 14001 for environmental management, and ISO/IEC 27001 for information security. ISO 9001 focuses on meeting customer needs and continual improvement. ISO 14001 focuses on minimizing environmental impacts and conforming to regulations. Certification to ISO standards is done by independent auditors and provides benefits like improved operations, customer satisfaction, and international trade compliance.
A quality management system is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction
The document provides an overview of key requirements of ISO 9001:2000 standards. It discusses the structure and requirements of the standard which are specified in clauses 4 through 8 relating to quality management system, management responsibility, resource management, product realization, measurement, analysis and improvement. Key requirements covered in each clause are summarized including documentation requirements, management reviews, internal communication, monitoring and measurement, and continual improvement.
This document outlines the key elements of a quality management system, including a quality policy, quality objectives, quality manual, organizational structure, data management, purchasing processes, customer satisfaction, continuous improvement, quality instruments, and document control. The quality policy is a statement by top management regarding product quality expectations. Quality objectives define measurable goals for achieving the quality policy. The quality manual details how the quality management system operates. The organizational structure links quality responsibility to executive levels. Data management develops architectures and procedures for information lifecycles. Purchasing and other processes are also covered.
This document provides an overview of quality management systems and ISO 9000 standards. It discusses that a quality management system is a system used by organizations to document processes, procedures, and responsibilities for ensuring quality policies are followed. It also describes key aspects of quality management like documentation requirements, common ISO quality standards like ISO 9001, and sector-specific standards tailored for industries like aerospace and automotive. Finally, it provides a high-level process flow of how a quality management system is implemented and improves over time within an organization and its suppliers.
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.
A quality management system (QMS) formalizes processes and procedures to achieve quality policies and meet customer and regulatory requirements. It coordinates activities to continuously improve effectiveness and efficiency. Key elements include quality manuals, procedures, records, data management, processes, customer satisfaction, and improvement opportunities. Implementing a QMS affects all aspects of an organization by meeting customer needs to gain confidence and trust, and meeting organizational needs for compliance, cost efficiency, and growth. ISO 9001 provides requirements for an organization to manage quality processes.
ISO 9001:2008 (shared using http://VisualBee.com).VisualBee.com
This document discusses ISO 9001:2008 quality management system standards. It provides an overview of the benefits of ISO 9001 certification for growing organizations, including improved quality, productivity, financial performance and long-term sustainability. It also summarizes the key requirements of the ISO 9001:2008 standard, including establishing documented procedures, conducting management reviews, ensuring customer focus, setting quality policies and objectives, and defining responsibilities.
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.
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.
This document outlines the requirements for an ISO 9001:2000 quality management system. It discusses key aspects such as scope, documentation requirements, management responsibility, resource management, and product realization. The summary focuses on providing a high-level overview of the content and structure rather than detailed requirements.
The document establishes requirements for a quality management system including developing, documenting, implementing, maintaining and continually improving the system. It addresses topics like leadership and commitment from top management, customer focus, quality policy and objectives, planning, responsibilities and resources. Product realization is also covered, from planning to meeting customer requirements and monitoring processes.
ISO 9001 is a process standard for a quality management system, known worldwide. This standard is suitable for any size company or organization that wants to meet its customers ’ and regulatory requirements and consistently improve.
Sample ISO 13485 Quality Manual & Procedures Package ComplianceOnline
This procedure describes Management Responsibilities for the Quality Management System (QMS) at Your Company.
For more Information please visit and copy paste in browser.
http://www.complianceonline.com/iso-13485-quality-manual-procedures-package-standards-10218-prdp
This checklist identifies areas that need to be addressed for an organization to be compliant with ISO 9001:2000. It includes sections for management responsibility, quality system, contract review, design control, document and data control, purchasing, process control, control of nonconforming product, corrective and preventative action, handling, storage and delivery, internal quality audits, training, and statistical techniques. Auditors are to use this checklist during audits to identify any areas of non-compliance and provide additional comments. The completed checklist is to be left with the client upon completion of the audit.
The document provides an overview of ISO 9000 quality management standards. It explains that ISO 9000 is a family of standards maintained by ISO that establish requirements for quality management systems. The requirements include procedures for key processes, monitoring processes, record keeping, defect checking, reviewing processes for effectiveness, and continual improvement. Certification requires documenting procedures, management responsibility, resource management, product realization, measurement and improvement.
This quality manual outlines Raj Pharmaceutical Inc.'s quality management system which is based on ISO 9001:2008. It describes the scope of the quality system, references, terms, documentation requirements, management responsibilities, resource management, product realization processes, measurement and improvement processes. Key elements include establishing quality objectives and policies, defining roles and responsibilities, conducting management reviews, ensuring competence and training of employees, controlling documents and records, and addressing nonconformances and continual improvement. The manual is the top level document that describes all aspects of Raj Pharmaceutical's quality system.
Sample of the first 8-9 pages of the manual. The manual is available online at https://www.complianceresourcelibrary.co.uk/product-category/certified-business-resources/qms-iso-9001_2015/
This document provides guidance for auditors certifying companies to AS9100 quality management standards. It outlines Bureau Veritas Certification's expectations, including defining key processes and their interactions, establishing measurable objectives for monitoring processes, and ensuring control of outsourced processes. The guidance is intended to promote a common understanding of AS9100 requirements while not modifying the standard itself.
The document discusses the principles and concepts of audits according to ISO 9001:2008. It provides three main points:
1) Audits are an important part of the PDCA cycle and help uncover system deficiencies to facilitate continual improvement. They help reduce quality costs from errors.
2) There are three main types of audits - system audits, process audits, and product audits. System audits assess the quality management system, process audits assess individual processes, and product audits establish if products meet specifications.
3) Audits provide benefits like ensuring requirements are met, aiding improvements, and providing an internal control mechanism. They are an important tool for organizations to continually improve.
This document provides the requirements for an ISO 9001:2008 quality management system. It outlines 10 sections that define the minimum requirements for a quality management system, including scope (section 1), normative references (section 2), terms and definitions (section 3), quality management system (section 4), management responsibility (section 5), resource management (section 6), product realization (section 7), measurement, analysis and improvement (section 8), and relationships with other management systems standards (sections 0.1-0.4). The document emphasizes the importance of a process approach and continual improvement.
This document outlines an interactive quality control manual created by Abraham W. Bolden, Sr. It provides an outline and definitions for an ISO 9000 quality manual, including sections on quality policy, organization, quality procedures and responsibilities, management review, and audits. The document establishes a quality management system framework to ensure products and services meet customer requirements.
This document provides information and guidance on implementing a quality management system that is compliant with ISO 9001 standards. It outlines 14 steps for implementation, including gaining management commitment, establishing an implementation team, conducting training and audits, developing documentation, and achieving certification. It also lists various quality management tools like check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms that can be used in a quality management system. Additional online resources on quality management topics are provided.
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.
Quality manual for small and medium companiesbillwillis66
This quality manual describes Connor Winfield Corp.'s quality management system which is compliant with ISO 9001:2008. The manual outlines the company's quality policies, procedures, responsibilities, and documentation processes. It provides an overview of the quality system covering topics such as management commitment, customer focus, quality planning, resource management, product realization, measurement and improvement. The manual is divided into sections that follow the structure of the ISO 9001 standard.
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.
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.
Implementing Automated Qms For Business ExcellenceKhalizan Halid
The document discusses implementing an automated quality management system. It begins with background on diagnostic and analytical markets dealing with large sample volumes. Typical issues faced are resource-intensive documentation, limited auditing, and unreported issues. The need for automation is driven by increased regulations and resources. Challenges include financial resources, resistance to change, and user-friendliness. The document outlines the quality management process and developing quality management capability through generations. It emphasizes benefits like improved processes and compliance.
The document provides information on ISO 9001:2008 quality management standards. It defines ISO 9001:2008 as an international standard that ensures a company has effective quality assurance systems in place to deliver quality products and services. It describes the key aspects of conforming to the standard, including having management establish quality policies and objectives, documenting procedures, implementing the quality system, and undergoing external audits to certify compliance. It also provides definitions of related terms like "quality management" and "quality assurance."
IT standards like ISO 9001, ISO 27001, and ISO 20000 are important for effective IT governance and management. They provide a framework for processes like documentation, monitoring, review, and continual improvement. While standards provide benefits, their effectiveness depends on proper implementation and alignment with business needs and existing management systems. Integrating IT standards into an organization's quality management system involves appointing a team to document IT procedures according to ISO requirements.
This contract establishes an employment relationship between an employee and employer. It outlines the job title and duties of the employee, the duration of employment, compensation and benefits to be provided, confidentiality terms, and conditions for termination. Key details include the employee's job as [TITLE], a salary of [AMOUNT], health insurance and vacation benefits, confidentiality of trade secrets, and requirements for advance notice of resignation or termination by either party.
This company is committed to meeting customer requirements and satisfaction by providing high quality services and products. They will maintain an effective quality management system by motivating employees and continually improving the system. The policy is signed, showing approval.
This document contains various quality management forms used by an organization including forms related to employees, training, non-conformances, inquiries and orders, quotations, customer feedback, purchase orders, suppliers, manufacturing, inspection, calibration, and instruments. The forms provide templates for collecting information on topics such as employee details, training plans, non-conformity reports, purchase orders, supplier registration, inspection reports, calibration plans, and lists of machines and instruments.
Larry Page and Sergey Brin developed the idea for Google while PhD students at Stanford. Their search engine examined link relationships between web pages rather than just keywords. Google now dominates search and has over $66 billion in annual sales, with Page and Brin each worth almost $30 billion. Mark Zuckerberg launched Facebook from his "hot or not" website at Harvard and within a decade turned it into a $250 billion company, making him worth over $35 billion.
Module 15 career planning and portfolio developmentJigba
This document outlines a module on career planning and portfolio development. The module aims to help students understand career planning, the job application process, and developing a portfolio. It is 10 hours long and covers topics like career planning basics, applying for jobs, interview skills, and maintaining employment. Students will complete worksheets on their skills and attributes. They will also develop the framework for a personal portfolio to organize their experience and qualifications. The goal is for students to have the skills needed to pursue jobs or contracts after completing the program.
This module focuses on developing self-management skills, especially for those who are self-employed. It aims to help students understand the meaning and benefits of self-management, identify relevant work-based skills, and recognize potential obstacles. The module contains four topics that are covered over five hours: positive effects of self-management, key self-management skills, challenges to self-management, and monitoring self-management skills. Activities include identifying personal top skills, discussing skills in pairs, and collecting cards with skills into a "Treasury Envelope" for future reference. The overall goal is for students to create an effective framework for applying self-management when working independently.
Module 13 developing business relationships power pointJigba
This document provides guidance on developing professional relationships. It discusses leaving personal baggage behind, understanding customer culture, and focusing on attributes that build solid relationships. Core principles like assessing, planning, implementing and evaluating are presented as anchors for building relationships and customer service strategies. Relationship mind mapping and practicing introductions and small talk are recommended for personal development in pursuing productive professional relationships.
The document provides an overview of Module 13 on customer service standards, which aims to help students develop knowledge of professionalism in meeting customer needs and expectations. The module covers topics like defining customer service, developing business relationships, understanding customer expectations, and presenting a suitable personal image. Upon completing the module, students should be able to cultivate professional relationships with customers and make effective decisions that present them as competent braille transcribers.
This document discusses customer service and provides guidance on defining and implementing good customer service practices. It covers:
- Customer service is an attitude, not a department.
- Unhappy customers online can negatively impact a business more than unhappy offline customers.
- Sample definitions of customer service focus on meeting customer needs, providing agreed services, and having a positive attitude.
- Good customer skills include product knowledge, communication, problem-solving, professionalism, and being goal-oriented. When handling complaints, it's important to listen, validate, and work toward solutions while staying calm and positive.
This document discusses ethical behaviors and provides definitions and examples. It defines ethical behavior as actions that are morally right and consistent with generally accepted principles of good conduct. Unethical behaviors are given as the opposite and include examples like dishonesty, discrimination, and fraud. Building a reputation of ethical behaviors can benefit a business by reducing risks. The document prompts reflection on what ethical behaviors mean personally and which ones someone wants to demonstrate.
The module explores ethical behavior and professional ethics for a home-based business practice as a braille transcriber. It contains five lessons over 4.5 hours covering the concepts of ethical and unethical behaviors, maintaining confidentiality and integrity, and identifying personal working standards. The key takeaway is emphasizing ethical behavior as a microenterprise home-based business. Activities include reviewing the Braillist's Pledge of Professional Ethics, discussing scenarios involving ethical dilemmas, and developing a personal code of ethical behaviors and standards. The goal is for students to understand ethics concepts and apply them to their work.
This document provides an overview of a problem solving module, including its objectives, topics, activities, and scenarios. The module aims to teach students to recognize problems, develop problem solving plans, and evaluate outcomes. It covers defining problems, learning problem solving models, and applying the models to real life scenarios. Students practice with problem solving worksheets and roleplaying scenarios to develop their skills. The instructor materials provide guidance on preparing and delivering the various module elements.
This module focuses on developing critical thinking skills. It includes lessons on defining critical thinking, assessing personal skill levels, observing critical thinking in others, and improving skills. Students learn to analyze information, evaluate circumstances, and develop the ability to critically assess data outside of their own perspectives. The goals are to promote accurate understanding of situations and enhance performance through strengthened critical evaluation.
The document outlines Module 9 of a time management training program. The module aims to help students understand the importance of managing time efficiently when running a home-based business. It covers assessing personal time use, organizing time using a time log, and learning time management strategies. The module is split into three lessons over 2 hours and 45 minutes. Students will complete time logs and assessments, discuss challenges, and learn techniques to organize their time after completing the braille transcriber training program.
Module 8 focuses on organization strategies and techniques. It aims to help students understand the importance of applying organization based on their personal preferences and patterns. The module contains three topics: 1) Understanding personal organization preferences and patterns, 2) Identifying organization methods that support preferences and patterns, and 3) Building a toolkit of organization strategies and techniques for starting a business. The goal is for students to leave with small, manageable organization changes that fit their natural styles.
This module focuses on prioritization strategies. It contains four topics to be covered in three hours: prioritization scenarios, the "who, what, when, where, why, and how" strategy, understanding personal work styles, and prioritization methods. Students will work through scenarios in groups, learn the six elements of prioritization, reflect on their own work styles, and review various prioritization techniques. The goal is for students to recognize essential and non-essential tasks and develop methods for addressing non-essential tasks to avoid missed deadlines.
The document outlines a soft skills module on goal orientation. The module has four lessons over 3.5 hours aimed at helping students identify goal-oriented behaviors, understand how to set realistic goals, create a goal-based plan, and monitor/evaluate progress. Key topics include goal setting tips, creating a vision board, and using handouts to facilitate goal writing and evaluation. The overarching goals are for students to understand the importance of goal orientation and be able to develop measurable goals and plans.
This document provides an overview of Module 5 which focuses on effective communication skills, including listening, speaking, writing, and interpreting. The module aims to equip students with practical communication abilities that can help them as braille transcribers and small business owners. It consists of six lessons over eight hours covering topics such as active listening, speaking clearly, understanding non-verbal cues, interpreting written information, and writing skills. Activities are designed to be hands-on and allow students to practice their communication skills.
This module focuses on expanding cognitive skills for starting a microenterprise business. It includes 3 lessons over 4 hours: (1) understanding divergent and convergent thinking through brainstorming exercises; (2) using critical, creative, and intuitive skills to analyze self and business venture choices; (3) objectively discussing the positives and negatives of a home-based business. The goal is for students to apply cognitive skills in exploring home-based business opportunities.
This module focuses on learning styles and helping students understand their own preferred learning styles. It includes four main objectives: 1) Know personal preferred learning and working styles, 2) Understand and articulate strengths and attributes, 3) Identify compensation methods for non-preferred styles. The module involves students completing several learning style assessments, creating a personal learning styles profile, discussing styles with peers, and keeping a learning journal. The goal is for students to better understand how to apply their preferred styles and compensate when needed.
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Quality management system
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Quality Management System
ISO 9001:2008
XYZ
Address
Manufacture, Supply, Export & Job Work of S.S. Baluster Railing,
Hand Railing, Interior Furniture and S.S. Fabrication
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TITLE: TABLE OF CONTENTS SECTION: QM 0.1
Sr.
No.
Description
ISO 9001 Clause
Ref.
Section No. Page Nos.
01 Table of Contents -- QM-0.1 2
02 Revision History -- QM-0.2 3
03 List of Controlled Manual Holders -- QM-0.3 4
04 Introduction -- QM-1.0 5
05 Scope of the Quality Management System -- QM-2.0 6
06 Exclusions & Justifications -- QM-3.0 7
07 Quality Management System 4.0 QM-4.0 8 -9
08 Management Responsibility 5.0 QM-5.0 10–14
09 Resource Management 6.0 QM-6.0 15
10 Product Realization 7.0 QM-7.0 16–18
11 Measurement Analysis and Improvement 8.0 QM-8.0 19–21
12 Organogram -- QM-9.0 22
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TITLE: REVISION HISTORY SECTION: QM 0.2
Sr.
No.
Brief Description of Change Rev. No. Page No.
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TITLE: LIST OF CONTROLLED MANUAL HOLDERS SECTION: QM 0.3
Sr.
No.
Manual Holders Copy No.
01 Top Management / Management Representative 01 (Master Copy)
02
Production / Stores / Quality Control /Purchase / Marketing-In-
charges
02
03 Certification Agency 03
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TITLE: INTRODUCTION SECTION: QM 1.0
Our Company is one of the leading companies in its class.
We at our company are dedicated to supply quality products with High Quality Testing Equipment, Highly
qualified technical staff, in-house tool room, checking & packing we are confident of handling customer’s
requirements.
The company is backed by the strong technical expertise. Generous and ambitions management well equipped
plant with adoption of modern technology and runs under close observation by learned technicians. Expertise to
enrich quality product by breakthrough innovative ideas. The company has devoted and hard working work
force in all field of the work.
Qualified and experienced management may able to lead and guide them for the proper way of work to be
done.
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TITLE: SCOPE OF THE QUALITY MANAGEMENT SYSTEM SECTION: QM 2.0
Scope of the Quality Management System is implemented as per ISO 9001:2008 standard.
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TITLE: EXCLUSIONS & JUSTIFICATIONS SECTION: QM 3.0
The Following Clauses of ISO 9001:2008 Standard are not applicable in purview with the Scope of the
Organization:
Clause 7.3 Design & Development
The Organization is manufacturing, as per Standard specifications hence this clause is not applicable.
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TITLE: QUALITY MANAGEMENT SYSTEM SECTION: QM 4.0
4.1 GENERAL REQUIREMENTS
Organization has established, documented, implemented and maintained a quality manag ement system to
continually improve its effectiveness in accordance with ISO 9001:2008 QMS standards The process needed
for quality management system and their applications throughout the Organization are identified.
The sequences and interaction of these processes are determined and documented in respective sections of
this manual and in respective documents. Also a Flow chart for Sequence & interaction of processes is
prepared.
The criteria and methods needed to ensure that both operation and control o f these processes are effective are
determined. Availability of resources and information necessary to support the operation and monitoring of
these processes are ensured. These processes are monitored, measured and analyzed. Action necessary to
achieve planned results and continual improvement of these processes are implemented.
These processes are managed by company in accordance with the requirements of ISO 9001:2008
Organization has not outsourced any type of job work at present Detail of outsource process.
4.2 DOCUMENTATION
4.2.1 General
The Quality Management System Documentation includes:
Quality Policy and Quality Objectives
Quality Manual
Quality System Activities required by ISO 9001:2008 standards, which is identified by the Organization
for its operations to be effective.
Work instructions, SOPs, product specifications, inspection and testing procedures, supplier provided
standards, etc.
Quality records
4.2.2 Quality Manual
This manual is in full conformity with requirements of ISO 9001: 2008 Standards and is supported by further
levels of documentation as detailed in 4.2.1. The scope of quality management system covers activities relating
to “scope” The documented procedures established for the quality management activities under the scope are
defined in level ‘B’ documentation.
This manual and cross-reference procedures in Process Interactions Chart describe the interaction between
various processes under the scope of Quality Management System.
4.2.3 Control of Documents
Documents as described in 4.2.1 are controlled, implemented, circulated, and approved as activity flow charts,
referred as under:
4.2.4 Control of Records
It is essential that Quality Records are maintained, since the records are the objective evidence that the system
is operating effectively at all stages. The activities for Control of Records are referred as under:
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TITLE: MANAGEMENT RESPONSIBILITY SECTION: QM 5.0
5.1 MANAGEMENT COMMITMENT
Organization commits itself to the development and implementation of quality management system and
continually improves its effectiveness. Regular meetings wherein the importance of meeting customer
requirements and feedback are communicated to employees whenever necessity arises will achieve this. The
administrative personnel are briefed regularly about the statutory and regulatory requirements in meeting.
The quality policy is established and the text of the Quality Policy is given in 5.3 The Quality Policy is supported
by tangible Quality Objectives as given in 5.4.1 Management Reviews are conducted regularly to ascertain
effectiveness of QMS (refer 5.6) Organization ensures that adequate resources are made available to meet
customer requirement, Quality System requirements as well as statutory and regulatory requirements.
5.2 CUSTOMER FOCUS
Organization has belief in the philosophy that, CUSTOMER is the purpose of its business. Employees are
regularly trained on customer focus. The feedback from customer in terms of quality, delivery, quality
complaints etc. are accorded top priority and their cause and preventive measures are immediately
implemented.
Customer Satisfaction is enhanced through regular meeting with customer/representatives and fulfilling their
targets in terms of quality, delivery lead-time and price expectations. Periodically customer feedback form is
sent to ascertain their needs and expectations.
5.3 QUALITY POLICY
Considering the needs and expectations of customers and our company’s business strategy, Top Management
has formulated the quality policy:
The quality policy of Organization is defined, documented and made known to all the employees by way of
display at prominent places and emphasizing its intents in regular training at all level. The policy is regularly
reviewed in management review meeting for its continuing suitability and revised as and when necessary.
5.4.1 QUALITY OBJECTIVES
The quality objective is segmented department wise and the measures to evaluate its achievements are
defined. These objectives are periodically reviewed, updated and MR identifies actions for implementation.
5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING
The Management Representative ensures that the quality management system is planned with defined
responsibility and authorities, which is documented in Quality Activities. The system is planned to meet the
requirements of clause 4.1 and quality objectives as defined in clause 5.4.1 of the manual.
The integrity of the QMS is ensured by way of review of the system, when the scope of the system is enhanced
or when new product lines are introduced. Quality Manual and Quality Activities are reviewed for changes as
and when required. Internal audit results are reviewed and the corrective actions are standardized in the quality
system Documents.
Product configuration changes are reviewed and product related documents are updated as applicable.
Corrective and preventive actions are reviewed and the changes are standardized in appropriate documents.
The result of internal and external audit is reviewed and appropriate corrective and preventive actions are
initiated.
5.5.1 Responsibility, Authority and Communication
The Organization chart included in Section 09.0 of this manual shows the relationships between the respective
functions. All employees are responsible for the quality of their own work and for advising their responsible
Manager or supervisor of any conditions that are adverse to the quality of the work being produced or adverse
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to the satisfactory operations of the quality system. Managers and supervisors are responsible, and have the
authority within their defined areas of control for:
the quality of work carried out
initiating action to prevent the occurrence of nonconformance
identifying and recording quality problems
Initiating, recommending and providing solutions to quality problems.
The responsibilities and authorities of the Organization Chart are described as below:
TOP MANAGEMENT
Responsibility:
a) Overall business development of the Organization
b) Financial Management of the Organization
c) Recruit executives in Managerial Cadre
d) Formulate quality policy with objectives for the Organization
e) Overall responsible for implemented quality management system
Authority:
a) Make key decisions and can supercede decisions taken by others
b) Approve purchase of capital goods
c) Approve the formulated quality management system
d) Final authority in all policies of the company
HEAD OF DEPARTMENT
Responsibility:
a) Maintain Harmonic cultures in the company
b) Liaison and handling prospective customers
c) Recruitment of personnel at works
d) Handling and resolving customer complaints
e) Execution of work orders in time
Authority:
a) Approve recruitment personnel at works
b) Sanction commercial transactions at work
c) Approve the formulated quality management system
5.5.2 MANAGEMENT REPRESENTATIVE
Top Management has appointed of Management Representative. Besides his functional responsibilities he has
been given additional Responsibilities and Authorities which includes:
Preparation, Updating and maintenance of Quality Manual
Issue of Quality Manual. Quality Activities
Implementation of Quality Systems.
Review of document & data control, making current version available, precludes use of obsolete
documents, identifying nature of change.
Control of quality records is means of identification, coll ection, and indexing, disposition and retention
time.
Liaison with external agency for ISO 9001 certification
Conducting the internal quality audit as per schedule, recording non-conformities, and verification of
effectiveness of corrective action against non-conformities.
Conducting the Management Review Meeting and reporting the finding of IQA to Top Management.
Promoting the awareness of customer requirements throughout the Organization.
5.5.3 INTERNAL COMMUNICATION
Internal communication channels are ensured as follows:
Quality Policy: Display, Induction Program & Training
Quality Objectives: Distribution of documents
Customer Feed Back: Meetings, Letters, Emails, Feedback form & proactive actions
Internal Audit, C & P Actions: Management Review Meetings
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MR is overall responsible to maintain internal communication channels.
5.6 MANAGEMENT REVIEW
5.6.1 General
Top Management with all HODs will conduct Management Review Meeting once in every six months or as and
when required. The purpose of the meeting is to ensure that Quality System meets or exceeds the requirement
of ISO 9001: 2008 standard.
In addition it will assess the Quality System’s continued suitability with respect to achieving company’s Quality
Policy and Objectives and opportunity for improvement in quality management system, quality policy and quality
objectives.
The MR records review inputs in agenda for management review. Review outputs are recorded in minutes of
MRM and communicated to all concerned.
5.6.2 Review Input
The input to management review shall include:
a) Results of internal audit and external audit
b) Customer feedback and complaints
c) Routine Operational performance of the Organization and product conformity
d) Status of corrective and preventive actions taken
e) Pending actions from previous management reviews
f) Changes that are required/affected in QMS
g) Recommendations for improvement.
5.6.3 Review Output
The review output is recorded by MR and shall include decisions and actions, target date and responsibility
related to:
a) Improvement of effectiveness of quality management system
b) Improvement in processes to meet customer requirements
c) Requirement of resources necessary for effective overall functioning
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TITLE: RESOURCE MANAGEMENT SECTION: QM 6.0
6.1 PROVISION OF RESOURCES
Organization ensures provision of resources that are needed:-
To implement and maintain the quality management system and continually improve its effectiveness.
To enhance customer satisfaction by meeting customer requirements.
The resource needs are identified through activities such as product planning, internal audit,
management reviews and review of quality objectives.
6.2 HUMAN RESOURCES
6.2.1 General
Organization ensures that personnel performing work affecting product quality are competent on the basis of
appropriate education, training, skills and experience.
6.2.2 Competence, Awareness & Training
Necessary competence needed for performing work affecting product quality are determined by the MR and
HODs and documented. The personnel are assessed on the basis of determined competence requirements.
Gaps, if any, are assessed and training is provided to personnel to meet the competence need. The training
may be in-house or external classroom training.
The effectiveness of the actions taken in terms of enhancing the competence levels is evaluated. Employees
are made known the requirement of skills and knowledge required relating to the jobs they handle and how they
contribute for attaining quality objectives. Appropriate records are maintained regarding, education, training,
skills & experience
6.3 INFRASTRUCTURE
Infrastructure needs are assessed on the basis of the resource requirement and business plan. The
infrastructure such as building and amenities for the operators are provided. Tools & Tackles, Testing
Instruments, Testing facilities are provided on the basis of quality plan. Need for supporting services such as
logistics, computer support, etc. are provided.
6.4 WORK ENVIRONMENT
Organization ensures that proper layout, adequate ventilation, lighting, house keeping systems and safety
devices maintain the work environment neatly where appropriate.
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TITLE: PRODUCT REALIZATION SECTION: QM 7.0
7.1 PLANNING OF PRODUCT REALIZATION
Organization plans the requirement of quality and identifies the controls of the process, inspection and test
methods, measurement needs and standards of acceptability, acquisition of any controls, equipment, etc.
The quality planning also includes the compatibility of product/process, establishment inspection and test
activities, development of newer measurement methods, identification of inspection and testing requirement,
identification and preparation of quality records. For each product line, such controls are defined in quality plan
and are used as a means of controlling quality. Quality Plan is prepared for final approval of equipment
7.2 CUSTOMER RELATED PROCESS
7.2.1 Development of requirements related to products
Organization identifies the requirements specified by customer though work order inputs and application details
provided by customer, delivery schedules desired by customers and feedback on products supplied.
Requirements not specified by customer, who is required for intended use are identified by Departmental Head.
Statutory and regulatory requirements related to the products are identified through customer communication.
Any additional requirements related to the products are identified based on the Organization’s experience in
supplying products to similar application
7.2.2 Review of requirements related to the product
Organization ensures to review the requirements related to the product as follows:-
Product specification/application is reviewed during the order processing and any mismatch or incompatibility is
reported to the customer. Order requirements are reviewed and recorded. Delivery requirements are reviewed
and recorded.
During this review, if any product or order requirements are deviating from those previously expressed, they are
resolved. Where the customer requirements are communicated verbally, the customer requirements are
confirmed in review documents as above, prior to acceptance. When the product requirements are changed,
the amendments are reviewed and the changes are incorporated on all relevant internal documents. The
document changes are made known and communicated to relevant functions.
7.2.2 Customer Communication
The various communication systems to customers are as follows
Product information: sales executives communicate product configuration and price information.
Order handling, queries and amendment handling are carried out by Marketing Personnel and communicated to
customers. Customer feed back and complaints are analyzed and communicated to them.
7.3 DESIGN AND DEVELOPMENT
Excluded
7.4 PURCHASING
7.4.1 Purchasing Process
The Quality System Activities ensure that products, Raw material & Packaging Material are purchased form
approved sources only. Any new source of product / make shall approve based of evaluation and/or trial
production, which shall access the ability of the source to meet the company’s quality and delivery
requirements.
The extent of control on the source of supply is based on the product criticality. This is defined in product quality
plan. The results of supplier performance in terms of adherence to quality and delivery requirements are
monitored. The data is reviewed by HOD Purchase and Top Management and the supplier are evaluated once
in a year. Records of evaluation, re-evaluation and ratings are maintained.
7.4.2 Purchasing information
Purchasing specification describes the following data. Product configuration, code, makes, size and other
unique information. Requirements of approval of product such as test certificates, need for Quality system
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Certificates and as per Raw Material Testing Plan. Organization ensures that adequacy of Purchase
requirements are reviewed prior to release.
7.4.3 Verification of purchased products
The purchased products are verified by one of the following methods.
Verification of Test Certificates
Product evaluation through a plan of evaluation
Receiving inspection as per receiving inspection plan
Where specified by customer or when required by the company, the verification may be done at
supplier’s premises by company or by Customer.
The verification method may include product evaluation, Supplier Quality System Audit.
In such case, purchasing information shall specify the method of verification and sub-sequent product release.
7.5 PRODUCTION AND SERVICE PROVISION
7.5.1 Control of Production and Service Provision
The production activity is carried out under controlled condition. The information about the product configuration
is provided to the Technicians and Engineers. Operations are carried out as per work instruction/ purchase
order. The equipment used for Production and testing is ensured have the requisite capability through
preventive maintenance of equipments. Technicians and Engineers are provided with necessary Equipments
and Instruments. The monitoring of process and testing is as per Quality Plan. The products are released to the
next stage and delivery after due verification and recording.
7.5.2 Validation of process for production
Special process is validated and records for the same are being maintained.
7.5.3 Identification and Traceability
The constituent parts, products in-process, finished products and packed products ready for dispatch are
identified by means of status boards, displayed besides the product. The status of products after each
verification stage is clearly identified as passed or failed by way of recording on the Inspection Reports.
Traceability of constituent parts is accomplished by means of unique num
7.5.4 Customer property
We are providing after sales services.
7.5.5 Preservation of Products
The products and constituent parts of the products are preserved appropriately to avoid any damage or
deterioration during storage, handling, packaging and delivery. Suitable work instructions are issued to the
personnel carrying-out these activities.
7.6 CONTROL OF MONITORING AND MEASURING EQUIPMENT
The selection of the Instruments and test equipments is done in such a way that measurement uncertainty is
known and is consistent with accuracy required. To control, calibrate and maintain inspection, measuring and
test equipment to provide evidence of conformity of product to specified requirements the procedure for
calibration and Maintenance of Instrument is followed.
It is also ensured that monitoring and measurements are carried out and in a manner that is consistent with the
monitoring and measurement requirements. For this purpose, list of measuring and test equipment is prepared.
To ensure valid results, measuring equipment is Calibrated at specified intervals, or prior to use, against
measurement standards traceable to international or national measurement standards; where no such standard
exists, the basis used for calibration or verification is recorded.
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TITLE: MEASUREMENT ANALYSIS AND IMPROVEMENT SECTION: QM 8.0
8.1 GENERAL
Organization plans and implements the monitoring, measurement, analysis and improvement process as
follows:-
To demonstrate that products produced conform to specification
To ensure that quality management system requirements are conformed
To continually improve the effectiveness of quality management system
In order to measure, analyze and continually improve, methods including statistical methods are used.
The extent of use of statistical method are explained in 8.2.3
8.2 MEASUREMENT AND MONITORING
8.2.1 Customer Satisfaction
In addition to other method, performance of the Quality Management system is also measured by monitoring
the information related to customer perception provided by customers.
8.2.2 Internal Quality Audit
Internal audits are conducted at regular intervals in six months. The purpose of such audits is to ascertain:-
Whether the planned system as outlined in this manual, Activities and other quality system Documents as
defined in 4.2.1 are complied with and whether the documented system is in accordance with the requirements
of ISO 9001:2008 standards. Whether the implemented system is effective and maintained
An audit program is planned as follows:-
The frequency and duration of an audit is determined based on the volume of activity, importance of
the activity.
The area or department to be audited and
Results of previous audits
8.2.3 Monitoring and Measurement of Processes
Methods such as analysis reports are used to demonstrate that the processes achieved or deviate from the
targets. When planned results are not achieved, appropriate plans are identified and implemented to effect
correction and corrective actions to ensure conformity of the product.
8.2.4 Monitoring and Measurement of Products
Organization ensures that the products are verified at appropriate stages viz., on receipt, various production
process stages and pre delivery stage. The requirements are verified against the receiving inspection plan, in-
process quality plans and customer purchase order.
Evidence of conformity of the products as defined above is maintained in the form of inspection reports, test
log/test report. These records indicate the persons authorizing product release for the next stage or delivery to
customer. The deliveries of products are affected only after all quality requirements are completed satisfactorily.
8.3 CONTROL OF NON-CONFORMING PRODUCT
Organization ensures that products, which do not conform to product requirements, are Identified and controlled
to avoid inadvertent use or delivery. Activity for non-conforming products describes the controls involved in
segregating non-conforming products, quarantine areas for non-conforming products, the responsibilities and
authorities for evaluation, notification and disposal of non-conforming products.
The methods of dealing with non-conforming products are :-
Required actions such as rework, to eliminate the detected non-conformity
By authorizing use non-conforming products, or release for dispatch or accept under authorized
concessions by the authority as defined 5.5.1, or where applicable, by customer.
By taking action to scrap after due care that the scrapped products do not find its way to the original
intended use.
8.4 ANALYSIS OF DATA
Organization determines the data to be collected, analyzed to demonstrate suitability and effectiveness of
quality management system and to effect continual improvement.
The various data collected are:
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Measurement data
Defect data
Customer feedback data
Analysis of these data shall provide information on :
Level of customer satisfaction
Level of conformity to specification
Trends of product specification compliance, opportunity for improvement
Supplier performance
Tools and techniques such as graphs, charts, brainstorming etc. are used in the analysis of data
8.5 IMPROVEMENT
8.5.1 Continual Improvement
Continuous improvement in the effectiveness of quality management system is achieved through the use of:
Well defined Quality policy
Measurable quality Objectives
Audits that identify opportunities for improvement
Analysis of data of product conformance and operational performance, customer satisfaction and
supplier performance
Corrective and preventive actions
Management review
Improvement opportunities are tracked for effective implementation and achievement of desired results
8.5.2 Corrective Action
Organization takes appropriate action to eliminate the cause of non-conformities in order to prevent recurrence.
The corrective actions will be appropriate to the effects of non-conformities.
Activity for corrective action ensures the following requirements are defined:
The methods followed to review non-conformities and customer complaints
The determination of cause of non-conformities
Develop solutions that are needed to eliminate the recurrence of non-conformity
8.5.3 Preventive Action
Organization takes appropriate action to eliminate the potential cause of non-conformities in order to prevent
occurrence. The preventive actions will be appropriate to the effects of non-conformities.
Activities for preventive action ensures the following requirements are defined:
The determination of potential cause of non-conformities
Recommend actions that are needed to prevent occurrence of non-conformity
Implement the actions identified to prevent occurrence of nonconformity
Records of the results of action taken
Reviewing the preventive actions taken
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TITLE: ORGANAZITION CHART SECTION: QM 09.0
Executives /
Workers
Marketing In
charge
Stores
In charge
Production
In charge
Q.C
In charge
Purchase
In charge
Top Mgt/ MR
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ISO 9001:2008 PROCEDURES – SOPs
Purpose: To establish flow chart for process activities
Scope: The scope of process flow chart is applicable to MANAGEMENT activities
PRO
CED
URE
No.
PROCEDUR
E TITLE
FUNCTIONAL ACTIVITIES
ISO
CL
REF:
RESP.
MGT/
P/01
CONTROL
OF
DOCUMENT
S
1. Documents are reviewed by MR &
approved by TM.
2. MR issues documents/formats for
implementation.
3. The document numbering is done as below:
First three alphabets indicates Department.
Next alphabet indicates Procedure / Format.
Next two digit code indicates the serial
number of format/document for the
particular department.
4. In case of revisions, Doc. Change request is
filled and new no. is given and old
documents are removed & marked as
obsolete copy.
5. External documents are controlled and
listed in control of external documents with
their latest revision. The same are reviewed
for their applicability and latest versions
every six months over internet / available
resources.
6. All documents, when issued are dated for
date of issue and the first issue has revision
no. as “00”.
7. The original copy of documents is
maintained in soft copy and marked as
“Master Copy” and issue copies are
maintained in hard copies and are marked
as “Controlled Copy”.
4.2.3 M R
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URE
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E TITLE
FUNCTIONAL ACTIVITIES
ISO
CL
REF:
RESP.
MGT/
P/02
CONTROL
OF
RECORDS
1. The records are generated in accordance to
ISO 9001:2008 standards.
2. All records are kept till retention period with
relevant details pertaining to the nature of
records.
3. Records which are maintained in soft copies
are periodically protected with backup
facilities and virus protection. All records are
easily retrievable when needed.
4. After the retention period, the records are
removed from the point of use and are
either destroyed by crushing or stored
separately.
4.2.4 M R
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P/03
INTERNAL
QUALITY
AUDITS
1. Internal audits are planned in way that all
functional areas are audited once in six
months or as & when required.
2. Audit plan is prepared, wherein date of
audit, auditor, auditee, dept. etc in noted.
3. Internal Audit is done as per plan and
evidences collected during IQA are noted in
Internal Auditor Notes.
4. Non-conformities encountered during IQA
are discussed and noted in the Corrective /
Preventive Action Report and in
Management Review Meeting.
5. For all non-conformities recorded,
necessary corrective actions are initiated by
concerned personnel.
8.2.2 M R
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Control of NC
Product
1. Data generated by the organization are
collected and compiled for evaluation once
in a year.
2. Analysis of data is reported in the
management review meetings.
8.3 M R
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CORRECTIV
E ACTIONS
1. CA are initiated upon findings through
internal & external audits, Customer Feed
backs & complaints etc.
2. Root causes are analyzed jointly by all
concerned persons.
3. CAs initiated are noted in C & P action
report.
4. Actions taken are regularly reviewed &
reported in MRM.
8.5.2 M R
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PREVENTIV
E ACTIONS
1. Preventive measures are taken considering
the necessary CA actions taken and by
identifying probable non conformities which
may occur in future
2. Root causes are analyzed jointly by all
concerned persons
3. PA are taken after consultations with all
concerned persons
4. Actions taken are regularly reviewed &
reported in MRM
8.5.3 MR
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QUALITY POLICY
We are committed to meet Customer
Requirements and Satisfaction by
providing Best Quality Services &
Products.
We will always achieve and maintain
effectiveness of Quality
Management System by Employee
Motivation and bring Continual
Improvement in the System
Signature
Rev. 00