This document provides an agenda for a training on practical auditing for internal quality auditors. It discusses key audit concepts like the PDCA cycle and process approach. It also covers important audit skills like interview techniques, note taking, report writing, and auditing difficult clauses. Common audit findings are presented along with tips for auditing undocumented processes and improving audit practices. The document concludes with an auditor code of ethics emphasizing integrity, objectivity, confidentiality and competence.
This document provides an overview of internal quality auditing techniques and common ISO 9001 requirements. It discusses using a process approach and PDCA cycle in audits. Interview skills like questioning techniques and taking notes are covered. Creating checklists and potential issues with "cheat sheets" are also summarized. The document reviews writing audit reports and addressing nonconformities. It identifies some of the toughest ISO 9001 clauses to audit and the most common nonconformities found in internal and registrar audits.
Practical approach to auditing is a presentation intended to help new auditors to quickly grab the skills and approach to audit engagements. The material touched on the attributes of auditors, audit planning, work programmes, audit journaling, working papers, audit test procedures, compliance and substantive test, elements of an audit report, file referencing etc..
This document provides an introduction to quality management system audits. It defines an audit as a systematic, independent and documented process for evaluating evidence objectively to determine if audit criteria are fulfilled. Audits are required by ISO 9001:2008 and help monitor/measure the management system, identify improvement opportunities, and promote continuous improvement. The benefits of auditing include increased awareness, reduced risk of failure, and achievement of planned results. The document then describes the types of audits, principles for auditors and audits, the PDCA methodology, elements of quality management system audits, typical audit activities from initiation to follow up, and techniques for collecting evidence and generating findings.
ISO 9001:2008 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits. This presentation will guide you in upgrading your quality management system to the latest version of the standard
Here is a draft checklist I would use for the Final Inspection and Testing department with references to the applicable ISO 9001:2015 clauses:
Final Inspection and Testing Department Audit Checklist
Clause 7.1.5 - Monitoring and measuring resources: Are the inspection and testing equipment calibrated and maintained?
Clause 7.1.6 - Organizational knowledge: Do inspectors and testers have appropriate knowledge and skills?
Clause 8.2.4 - Monitoring and measurement of product: Is there a documented procedure for inspection and testing with acceptance criteria?
Clause 8.3 - Control of nonconforming product: Is nonconforming product identified, documented, and dispositioned properly?
Clause 9.
The document provides guidance on planning an effective internal audit by preparing adequately. It recommends allocating two to three times as much time preparing as the actual audit will take. Preparation involves learning the process, identifying interfaces with the ISO 9001 standard, reviewing documentation, identifying process interfaces and potential failure modes, and developing audit questions and a plan. Key steps in preparation include creating a process map, reviewing procedures and manuals, understanding inputs/outputs and how the process relates to others. Thorough preparation is essential for a successful audit.
Internal audits play a critical role in verifying and improving an organization's food safety management system. The document outlines the steps for conducting effective internal audits, including developing an audit program and schedule, performing audits using checklists and procedures as references, documenting any nonconformances found, and holding closing meetings to discuss audit findings. Key attributes for auditors include strong communication and interviewing skills to objectively evaluate processes, observe operations, and ensure auditees understand any nonconformances identified.
The document discusses quality audits of quality management systems. It defines a quality audit and explains that the purpose is to ensure compliance with standards and identify opportunities for improvement. It describes the roles and responsibilities of auditors and auditees. The audit process includes developing an audit plan and checklist, performing the audit, documenting any non-compliances, issuing reports, and conducting follow-up. Key elements of a quality audit are independence, preparation, documentation, and verification of corrective actions.
This document provides an overview of internal quality auditing techniques and common ISO 9001 requirements. It discusses using a process approach and PDCA cycle in audits. Interview skills like questioning techniques and taking notes are covered. Creating checklists and potential issues with "cheat sheets" are also summarized. The document reviews writing audit reports and addressing nonconformities. It identifies some of the toughest ISO 9001 clauses to audit and the most common nonconformities found in internal and registrar audits.
Practical approach to auditing is a presentation intended to help new auditors to quickly grab the skills and approach to audit engagements. The material touched on the attributes of auditors, audit planning, work programmes, audit journaling, working papers, audit test procedures, compliance and substantive test, elements of an audit report, file referencing etc..
This document provides an introduction to quality management system audits. It defines an audit as a systematic, independent and documented process for evaluating evidence objectively to determine if audit criteria are fulfilled. Audits are required by ISO 9001:2008 and help monitor/measure the management system, identify improvement opportunities, and promote continuous improvement. The benefits of auditing include increased awareness, reduced risk of failure, and achievement of planned results. The document then describes the types of audits, principles for auditors and audits, the PDCA methodology, elements of quality management system audits, typical audit activities from initiation to follow up, and techniques for collecting evidence and generating findings.
ISO 9001:2008 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits. This presentation will guide you in upgrading your quality management system to the latest version of the standard
Here is a draft checklist I would use for the Final Inspection and Testing department with references to the applicable ISO 9001:2015 clauses:
Final Inspection and Testing Department Audit Checklist
Clause 7.1.5 - Monitoring and measuring resources: Are the inspection and testing equipment calibrated and maintained?
Clause 7.1.6 - Organizational knowledge: Do inspectors and testers have appropriate knowledge and skills?
Clause 8.2.4 - Monitoring and measurement of product: Is there a documented procedure for inspection and testing with acceptance criteria?
Clause 8.3 - Control of nonconforming product: Is nonconforming product identified, documented, and dispositioned properly?
Clause 9.
The document provides guidance on planning an effective internal audit by preparing adequately. It recommends allocating two to three times as much time preparing as the actual audit will take. Preparation involves learning the process, identifying interfaces with the ISO 9001 standard, reviewing documentation, identifying process interfaces and potential failure modes, and developing audit questions and a plan. Key steps in preparation include creating a process map, reviewing procedures and manuals, understanding inputs/outputs and how the process relates to others. Thorough preparation is essential for a successful audit.
Internal audits play a critical role in verifying and improving an organization's food safety management system. The document outlines the steps for conducting effective internal audits, including developing an audit program and schedule, performing audits using checklists and procedures as references, documenting any nonconformances found, and holding closing meetings to discuss audit findings. Key attributes for auditors include strong communication and interviewing skills to objectively evaluate processes, observe operations, and ensure auditees understand any nonconformances identified.
The document discusses quality audits of quality management systems. It defines a quality audit and explains that the purpose is to ensure compliance with standards and identify opportunities for improvement. It describes the roles and responsibilities of auditors and auditees. The audit process includes developing an audit plan and checklist, performing the audit, documenting any non-compliances, issuing reports, and conducting follow-up. Key elements of a quality audit are independence, preparation, documentation, and verification of corrective actions.
The document provides information on conducting internal audits, including:
1) It discusses auditor competence and responsibilities, such as being objective, ethical, and maintaining confidentiality.
2) It explains how to manage an audit program, including establishing objectives and procedures, scheduling audits, and maintaining records.
3) It describes the audit process, from planning and document review, to conducting on-site activities like interviews and observations, and preparing the audit report.
Firstly, it will be clarify some of the misunderstandings of some of the fundamental audit concepts and principals that are implemented during the audit or planning of the audit program, focusing on audit guidelines, auditor principles, audit process principles and types of audits. Furthermore, gaining understanding of the management and preparation of an ISO 9001 audit through audit program pillars, good audit practices and prepared work documents and checklists. Outline how to conduct and close an ISO 9001 audit in a professional manner with the precise audit review.
Main points covered:
• Fundamental audit concepts and principles
• Managing an ISO 9001 audit program
• Preparation of an ISO 9001 audit
• Conduct of an ISO 9001 audit & Closing the audit
Presenter:
This webinar was presented by Kefah El-Ghobbas, PECB Certified Trainer and Organizational Development expert and operations manager at TURBO CARBO.
Link of the recorded session published on YouTube:https://youtu.be/kK8pAc3QM5E
This document provides an introduction to internal audits, including defining what an internal audit is, who conducts and is audited, what documents are reviewed, how the audit process is planned and conducted, and how findings are reported. It describes internal auditors as competent professionals who independently audit processes by reviewing documents, conducting inspections and interviews to make objective assessments. It outlines what areas and documents are reviewed, how audit plans and schedules are developed, where audits take place, the audit process, and how findings are categorized and addressed.
The document provides tips for conducting effective internal audits according to ISO 9001. It emphasizes that auditors should be competent and trained. Audits should be planned, systematic, and focus on evaluating processes and identifying opportunities for improvement rather than finding faults. The document also stresses the importance of understanding how processes interact across the organization and using this understanding to plan audits by following audit trails between different clauses and departments.
ISO 9001:2008 Internal Auditing of Quality Management Systems - IntroductionKanriConsulting
ISO 9001 is a quality management system that ensures customer requirements are met. It originated from military standards in 1959 and contains elements of management, resources, services/products, and monitoring. Key principles include customer focus, leadership, involvement of people, process approach, and continuous improvement. Certification requires registration and external audits, while internal audits are also conducted. The audit process involves planning, document review, on-site activities, reporting, completion, and follow up. Records related to auditing include plans, reports, nonconformities, and corrective actions.
An audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
This presentation illustrates:
- The Audit definition
- Possible reasons for auditing
- Audit Types
- How to conduct an audit
0- Audit preparation
0 Audit performance
0- Audit reporting
0- Audit follow up and closure
- Auditor key skills
* For business possibilities, feel free to contact me.
Internal Audit Training.
Training Objectives.
What is an audit?
How to prepare for and plan an audit?
How to conduct an audit?
How to report on an audit?
What is audit follow-ups?
Contact:
nomanaleemft@gmail.com
00923084089243
The document provides information about conducting internal audits of a quality management system. It describes the responsibilities of an internal auditor, the purpose of internal audits, and how to plan and perform an audit. Key aspects covered include understanding ISO 9001:2015 requirements, using a process-based approach, planning audits, gathering objective evidence during audits, and writing factual audit reports to help improve the management system.
The document outlines the competencies and attributes required of quality auditors. It states that auditors should have knowledge of audit principles and techniques, management systems, applicable laws and regulations, quality methods and products/processes. Additionally, auditors should be ethical, open-minded, diplomatic, observant, versatile, tenacious, decisive and self-reliant. For internal auditors, the document recommends at minimum a secondary education, two years' experience in the organization, auditor training, participation in three audits and training in quality control methods.
The document provides an overview of ISO 19011:2018, which are guidelines for auditing management systems. It discusses the International Organization for Standardization (ISO) and the purpose of ISO 19011. The presentation summarizes the key aspects of ISO 19011:2018, including the differences between the current and previous versions, the table of contents which outlines the standard's scope and guidance, and defines different types of audits that can be conducted.
This document discusses quality audits and their purpose. It defines a quality audit as an independent examination to verify conformity with quality standards. Quality audits can be internal or external, and audit products, processes, or entire quality systems. The objectives of quality audits are to ensure standards are met, quality is maintained, and areas for improvement can be identified. A quality audit process typically involves planning the audit, conducting interviews and documentation reviews, reporting findings, and identifying corrective actions.
This document provides a checklist for auditing an organization's quality management system based on the ISO 9001:2008 standard. It includes questions relating to the documentation requirements, management responsibility, resource management, product realization, measurement, analysis and improvement sections of the standard. The checklist is intended to be used by auditors to evaluate if an organization's quality system meets the requirements of the ISO 9001 standard. It provides guidelines for auditing, identifies what documents and records should be reviewed, and includes spaces for auditors to record evidence and comments.
- QE 19011S is a U.S. supplement to ISO 19011 that provides additional guidance for quality and environmental management system auditing, especially for internal and supplier audits.
- It addresses limitations in ISO 19011 regarding competence requirements, internal/supplier audits, and use by small organizations.
- The supplement retains the full ISO 19011 text and adds guidance in supplemental text to provide a more complete standard for auditing management systems.
The document discusses project life cycle and project management systems (PMS). It describes the typical stages of a project life cycle as initiate, plan, execute, monitor & control, and close out. It notes that actual costs alone do not indicate work progress. An effective PMS provides uniform monitoring and reporting, allows real-time project tracking, enables optimized project execution through baseline monitoring, and facilitates tracking of changes and forecasts. Key questions a PMS can answer relate to schedule, cost, variances, trends, and forecasts. Benefits of a PMS include early warning of issues and enabling corrective actions.
This document provides an overview of quality management. It discusses traditional business strategies and how most companies now focus on quality. It defines inspection and quality, and describes the nature, objectives, and scope of inspections. It also covers statistical quality control, acceptance sampling techniques, total quality management, and modern quality management approaches including Deming's work. The key aspects covered include the importance of quality, different approaches to quality control, defining inspection and quality, the objectives and scope of inspections, statistical process control using charts, acceptance sampling plans, total quality management principles, and Deming's contributions to modern quality management.
The document discusses principles of auditing, including definitions of audits and different types of audits such as internal, external, first party, second party, and third party audits. It also covers the audit process, including planning, conducting the audit, analyzing results, and follow-up. Requirements for internal audits according to ISO/TS 16949:2002 are summarized, including auditing the quality management system, manufacturing processes, and products to verify conformity.
This document contains accounting transactions and adjusting entries for multiple companies. It lists entries related to accounts receivable, uncollectible accounts, interest income, cash accounts, payroll expenses and customer credit balances. Key figures include total accounts receivable of $769,574, allowance for bad debts of $17,457, interest income of $4,586 and receivables from officers and employees of $9,700.
The document discusses conducting a human resource audit. It defines an HR audit as examining an organization's HR policies, procedures, documentation and practices. The purpose is to analyze and improve the HR functions by identifying strengths and weaknesses. It outlines the scope, steps, components, and practices that should be reviewed in an HR audit. These include staffing, compensation, training, performance management, and personnel records. The document also discusses using a SWOT analysis and providing audit feedback and recommendations to further improve the HR system.
The document provides information on conducting internal audits, including:
1) It discusses auditor competence and responsibilities, such as being objective, ethical, and maintaining confidentiality.
2) It explains how to manage an audit program, including establishing objectives and procedures, scheduling audits, and maintaining records.
3) It describes the audit process, from planning and document review, to conducting on-site activities like interviews and observations, and preparing the audit report.
Firstly, it will be clarify some of the misunderstandings of some of the fundamental audit concepts and principals that are implemented during the audit or planning of the audit program, focusing on audit guidelines, auditor principles, audit process principles and types of audits. Furthermore, gaining understanding of the management and preparation of an ISO 9001 audit through audit program pillars, good audit practices and prepared work documents and checklists. Outline how to conduct and close an ISO 9001 audit in a professional manner with the precise audit review.
Main points covered:
• Fundamental audit concepts and principles
• Managing an ISO 9001 audit program
• Preparation of an ISO 9001 audit
• Conduct of an ISO 9001 audit & Closing the audit
Presenter:
This webinar was presented by Kefah El-Ghobbas, PECB Certified Trainer and Organizational Development expert and operations manager at TURBO CARBO.
Link of the recorded session published on YouTube:https://youtu.be/kK8pAc3QM5E
This document provides an introduction to internal audits, including defining what an internal audit is, who conducts and is audited, what documents are reviewed, how the audit process is planned and conducted, and how findings are reported. It describes internal auditors as competent professionals who independently audit processes by reviewing documents, conducting inspections and interviews to make objective assessments. It outlines what areas and documents are reviewed, how audit plans and schedules are developed, where audits take place, the audit process, and how findings are categorized and addressed.
The document provides tips for conducting effective internal audits according to ISO 9001. It emphasizes that auditors should be competent and trained. Audits should be planned, systematic, and focus on evaluating processes and identifying opportunities for improvement rather than finding faults. The document also stresses the importance of understanding how processes interact across the organization and using this understanding to plan audits by following audit trails between different clauses and departments.
ISO 9001:2008 Internal Auditing of Quality Management Systems - IntroductionKanriConsulting
ISO 9001 is a quality management system that ensures customer requirements are met. It originated from military standards in 1959 and contains elements of management, resources, services/products, and monitoring. Key principles include customer focus, leadership, involvement of people, process approach, and continuous improvement. Certification requires registration and external audits, while internal audits are also conducted. The audit process involves planning, document review, on-site activities, reporting, completion, and follow up. Records related to auditing include plans, reports, nonconformities, and corrective actions.
An audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
This presentation illustrates:
- The Audit definition
- Possible reasons for auditing
- Audit Types
- How to conduct an audit
0- Audit preparation
0 Audit performance
0- Audit reporting
0- Audit follow up and closure
- Auditor key skills
* For business possibilities, feel free to contact me.
Internal Audit Training.
Training Objectives.
What is an audit?
How to prepare for and plan an audit?
How to conduct an audit?
How to report on an audit?
What is audit follow-ups?
Contact:
nomanaleemft@gmail.com
00923084089243
The document provides information about conducting internal audits of a quality management system. It describes the responsibilities of an internal auditor, the purpose of internal audits, and how to plan and perform an audit. Key aspects covered include understanding ISO 9001:2015 requirements, using a process-based approach, planning audits, gathering objective evidence during audits, and writing factual audit reports to help improve the management system.
The document outlines the competencies and attributes required of quality auditors. It states that auditors should have knowledge of audit principles and techniques, management systems, applicable laws and regulations, quality methods and products/processes. Additionally, auditors should be ethical, open-minded, diplomatic, observant, versatile, tenacious, decisive and self-reliant. For internal auditors, the document recommends at minimum a secondary education, two years' experience in the organization, auditor training, participation in three audits and training in quality control methods.
The document provides an overview of ISO 19011:2018, which are guidelines for auditing management systems. It discusses the International Organization for Standardization (ISO) and the purpose of ISO 19011. The presentation summarizes the key aspects of ISO 19011:2018, including the differences between the current and previous versions, the table of contents which outlines the standard's scope and guidance, and defines different types of audits that can be conducted.
This document discusses quality audits and their purpose. It defines a quality audit as an independent examination to verify conformity with quality standards. Quality audits can be internal or external, and audit products, processes, or entire quality systems. The objectives of quality audits are to ensure standards are met, quality is maintained, and areas for improvement can be identified. A quality audit process typically involves planning the audit, conducting interviews and documentation reviews, reporting findings, and identifying corrective actions.
This document provides a checklist for auditing an organization's quality management system based on the ISO 9001:2008 standard. It includes questions relating to the documentation requirements, management responsibility, resource management, product realization, measurement, analysis and improvement sections of the standard. The checklist is intended to be used by auditors to evaluate if an organization's quality system meets the requirements of the ISO 9001 standard. It provides guidelines for auditing, identifies what documents and records should be reviewed, and includes spaces for auditors to record evidence and comments.
- QE 19011S is a U.S. supplement to ISO 19011 that provides additional guidance for quality and environmental management system auditing, especially for internal and supplier audits.
- It addresses limitations in ISO 19011 regarding competence requirements, internal/supplier audits, and use by small organizations.
- The supplement retains the full ISO 19011 text and adds guidance in supplemental text to provide a more complete standard for auditing management systems.
The document discusses project life cycle and project management systems (PMS). It describes the typical stages of a project life cycle as initiate, plan, execute, monitor & control, and close out. It notes that actual costs alone do not indicate work progress. An effective PMS provides uniform monitoring and reporting, allows real-time project tracking, enables optimized project execution through baseline monitoring, and facilitates tracking of changes and forecasts. Key questions a PMS can answer relate to schedule, cost, variances, trends, and forecasts. Benefits of a PMS include early warning of issues and enabling corrective actions.
This document provides an overview of quality management. It discusses traditional business strategies and how most companies now focus on quality. It defines inspection and quality, and describes the nature, objectives, and scope of inspections. It also covers statistical quality control, acceptance sampling techniques, total quality management, and modern quality management approaches including Deming's work. The key aspects covered include the importance of quality, different approaches to quality control, defining inspection and quality, the objectives and scope of inspections, statistical process control using charts, acceptance sampling plans, total quality management principles, and Deming's contributions to modern quality management.
The document discusses principles of auditing, including definitions of audits and different types of audits such as internal, external, first party, second party, and third party audits. It also covers the audit process, including planning, conducting the audit, analyzing results, and follow-up. Requirements for internal audits according to ISO/TS 16949:2002 are summarized, including auditing the quality management system, manufacturing processes, and products to verify conformity.
This document contains accounting transactions and adjusting entries for multiple companies. It lists entries related to accounts receivable, uncollectible accounts, interest income, cash accounts, payroll expenses and customer credit balances. Key figures include total accounts receivable of $769,574, allowance for bad debts of $17,457, interest income of $4,586 and receivables from officers and employees of $9,700.
The document discusses conducting a human resource audit. It defines an HR audit as examining an organization's HR policies, procedures, documentation and practices. The purpose is to analyze and improve the HR functions by identifying strengths and weaknesses. It outlines the scope, steps, components, and practices that should be reviewed in an HR audit. These include staffing, compensation, training, performance management, and personnel records. The document also discusses using a SWOT analysis and providing audit feedback and recommendations to further improve the HR system.
auditing is an examination of accounting
records undertaken with a view to establish whether they correctly and completely reflect the transactions to which they relate.
Introduction to Internal Quality System AuditingJeffStevens
This document provides guidance on conducting audits according to basic auditing assumptions and definitions. It outlines the responsibilities of auditors and auditees, as well as qualifications needed by auditors. Guidelines are provided for audit quality assurance, working papers, lead auditor responsibilities, interview tips, audit plans, reports, techniques for understanding quality management systems, auditor attributes, inquiry categories, interview considerations, principles of audit reporting, process requirements, and sampling. The document describes elements of a successful audit from planning through closure.
Auditing ensures monitoring and provides a review and correction mechanism. It emerged as an independent, professional medium separate from business services. Auditing examines facts independently and provides expert opinions and advice to ensure quality standards. The objectives of an audit are to express an expert opinion, detect and prevent errors and frauds, and ensure financial statements present a true and fair view. Auditing is needed to increase the reliability and credibility of financial information and ensure the proper reporting of an entity's financial position.
1. Auditing originated in the 18th century with the rise of large-scale industries and businesses, which led to more complex accounting practices.
2. Auditing involves the systematic and independent examination of a company's financial records and documents to verify that the financial statements accurately reflect the company's transactions and financial position.
3. Auditing provides benefits such as detecting errors and fraud, protecting shareholder interests, checking directors and management, and giving an independent opinion on the business's financial health. However, auditors also face limitations like not detecting every fraud and having to rely on information from company personnel.
This document provides an overview of ISO 9001:2015 requirements for quality management systems. It describes the quality management principles, PDCA cycle, risk-based management approach and the 10 clauses of the standard. Each clause is broken down into requirements and examples of evidence that would be audited to ensure compliance. Organizations must understand the standard, plan how to implement it, and provide evidence that key processes are documented, monitored and improving in order to achieve certification.
This document provides an overview of ISO 9001:2015 requirements for quality management systems. It discusses key quality management principles like customer focus, leadership and engagement. The PDCA cycle and risk-based management approaches are covered. The main clauses of the ISO standard are outlined, including context of the organization, leadership, planning, support, operation, performance evaluation and improvement. Audit evidence requirements are listed for evaluating conformance to the standard. Overall it provides information on implementing and maintaining an effective quality management system.
This document provides an overview of ISO 9001:2015 requirements for quality management systems. It describes the quality management principles, PDCA cycle, risk-based management approach and the 10 clauses of ISO 9001:2015. Each clause is broken down into its requirements and the types of evidence expected to be presented during an audit. The goal of ISO 9001 is to ensure consistency and quality of products/services through all aspects of planning, operations, evaluation and improvement of an organization's processes.
Quality Management Systems in different industries - from ISO 9001 to cGxPPauwels Consulting
This presentation is about the design and implementation of Quality Management Systems (QMS) in different industries.
In this presentation you will learn more about the history and development of quality management systems (QMS),
the importance and benefits of a QMS for various industries,
quality principles and Good Manufacturing Practices (GMP) in life sciences, the most important requirements of an ISO 9001 QMS,
the most important requirements of GMP regulations and how to develop and implement a QMS for various industries.
The speakers, Luc Marivoet and Luc Huybreghts, both work in very different industries. They both talked about quality management systems from their own experience and very different and interesting angles.
This presentation is ideal for all professionals who want to include quality management in their projects and daily activities and who want to take the overall quality level of their organization to the next level.
Do you have any questions regarding quality management or the implementation of a QMS for your organization? Don't hesitate and visit our website at www.pauwelsconsulting.com
This document provides information about an ISO 9001:2008 Lead Auditor training course, including details about the course content, assessment, delivery style, and auditor requirements. The course covers quality management principles, ISO standards, auditing planning and techniques, and continual improvement. It emphasizes a process-based approach and includes workshops to develop process-based checklists. The document outlines auditor competencies including business and technical knowledge, as well as attributes like impartiality and ethical behavior.
This document discusses quality and quality management. It defines quality as conformance to specified requirements. Quality management involves continual improvement through planning, checking, doing, and acting on processes. The ISO 9000 standards provide guidelines for quality management systems, focusing on customer satisfaction and continual improvement. Implementing a quality management system based on ISO 9000 can lead to benefits like reduced costs, better customer satisfaction, and improved business performance.
This document discusses quality control and quality assurance. It defines quality control as focused on fulfilling requirements, while quality assurance provides confidence that requirements will be fulfilled. Quality control is reactive and finds defects, while quality assurance is proactive and prevents defects. The document then discusses ISO 9000 standards for quality management systems, including definitions, principles, documentation structure, and clauses. It provides details on quality control and quality assurance procedures and responsibilities.
continuous improvement in school management (4) .pdflynnmdasuki1
This document provides an overview of concepts related to continuous quality improvement in school management. It defines key terms like quality control, quality assurance, and total quality management. It also discusses ISO 9001 certification and the PDCA cycle. The document outlines the total quality management process and discusses Deming's 14 points. It provides examples of quality management system requirements and differences between the 1994 and 2000 versions of ISO 9001 standards.
ISO 90012008 Understanding and Internal Auditing.pptFirozKhan158275
This document provides an overview of quality management systems and ISO 9001 certification. It discusses what ISO and ISO 9001 are, how ISO 9001 can help businesses, common misunderstandings about the standard, and the requirements and processes involved in achieving certification. The roles and responsibilities of different parties in the certification process are also outlined.
Pearl Confectionery (Pvt.) Ltd is providing training on quality management systems. The training covers fundamentals of quality management including roles of auditors and auditees, the PDCA cycle, and the 8 principles of quality. It also covers ISO 9001:2008 requirements including the standard's structure and clauses. The training includes sessions on internal quality audits. Attendees must pass a test with 60% to complete the training.
This document outlines the objectives, contents, and concepts of an internal quality audit course. The course aims to train prospective internal quality auditors on quality management system auditing principles and practices. The contents will cover topics like quality management systems, audit planning, conduction, reporting, corrective action, and follow-up. It will provide concepts on quality, auditing techniques, and the requirements of ISO standards. The document also provides examples of management responsibility principles, customer focus, quality policies, objectives, management reviews, monitoring of processes, analysis of data, and continual improvement.
This document outlines the structure and requirements for documentation in an ISO 9001:2008 quality management system. It describes four levels of documentation including a quality manual, procedures, work instructions, and records/forms. The six mandatory procedures are also listed. Key requirements for procedures, work instructions, and the 20 mandatory records specified by the standard are provided. Guidance is given on document control including versioning, approvals, and distribution. Contact information is provided for assistance with ISO documentation and implementation needs.
How to prepare for an audit and maintain oversight within your e qmsMontrium
In this webinar, not only will we take you through what you’ll need to do to prepare for an audit, but we will also share what you can do to contribute to continuously improve and maintain oversight of your QMS.
The document discusses internal auditing and ISO 9001:2015 requirements. It defines an internal audit as a systematic, independent process to evaluate conformance and effectiveness. The key points covered include: establishing an audit program that considers risk; planning audits by defining criteria, scope and methods; executing audits by gathering objective evidence through interviews, records review and observation; and identifying any nonconformities or opportunities for improvement. The goal of internal auditing is to help ensure the quality management system is functioning as intended and driving continual improvement.
How to Perform a Successful Internal Quality AuditGreenlight Guru
You already know internal quality audits are required by both FDA 21 CFR Part 820 and ISO 13485.
You also probably already know they are a big hassle to conduct.
What you might not know is that they are one of the most powerful weapons at your disposal for preventing 483's and observations.
Why?
Because they are one of the most effective and efficient ways to make sure you and your team are always prepared if FDA or NB decided to show up unexpectedly.
So how do you “establish” the right procedures? How do you ensure your auditor is competent and properly qualified? And what do you do if you find non-conformances?
View this presentation by our guest Kyle Rose, President at Rook Quality Systems, where you will find the answers to all those questions and more.
Specifically, you will learn:
- How to conduct an effective internal quality audit based on process identification, sampling and questioning
- How to plan a internal quality audit and develop an audit schedule
- How to find and use competent and qualified auditors
- Why certain auditors shouldn’t audit certain areas
- How to properly report the findings of your internal quality audit
- How to concisely document non-conformances
- How to determine what needs corrective actions and how to follow up on them
The document discusses laboratory audits and continuous quality improvement. It describes the steps to take when conducting an internal audit, including developing an audit plan and schedule, assigning responsibilities, conducting the audit, reporting findings, and taking corrective actions. The results of audits, both internal and external, provide opportunities for improvement and help ensure laboratories meet quality standards through monitoring and evaluation.
This document discusses quality standards and quality management processes for surveying projects. It defines key terms like quality, standards, quality assurance and quality control. It describes the benefits of standards and outlines the Plan-Do-Check-Act model for quality processes. Quality standards help ensure accurate, reliable survey results and monitoring is needed to check that standards and requirements are met. The three main quality management processes are quality planning, quality assurance and quality control.
Starts with the basic learning in Critical Path Method and continued with the the use of MS Project software. Even though the software is upgraded to teh latest version, the basic fundamentals in using the software does not change
This document provides a suggested template for preparing and presenting a project kick-off meeting. The template includes sections for an introduction stating the objective, agenda, project overview with a short description, scope defining logical boundaries, team organization listing members and responsibilities, major deliverables and descriptions, estimated effort including budget, infrastructure, manpower allocation and timeline, assumptions, risks and issues, and project acceptance conditions. The presentation advises preparing a project quality plan and following standard processes to deal with contingencies.
This document provides an introduction and overview of quality management tools for root cause analysis (RCA) and problem solving. It covers two modules: Module 1 focuses on basic RCA tools like histograms, Pareto charts, and cause-and-effect diagrams. Module 2 will cover the 8-D problem solving method. The document provides definitions of key terms, objectives for each module, and examples to illustrate how to create and use the different tools for analyzing problems and identifying root causes.
5 s – a program to improve project.ppt [compatibility mode]Isidro Sid Calayag
5S is the name of a workplace organization method that uses a list of five Japanese words: seiri, seiton, seiso, seiketsu, and shitsuke. Transliterated into English, they all start with the letter "S".
This document summarizes changes made to TPI's quality management system to comply with the updated ISO 9001:2008 standard. Some key changes include defining outsourced processes, focusing on measuring process effectiveness, adding training requirements to achieve competence, and including physical and environmental factors in the definition of work environment. The update resulted in changes to TPI's QMS manual and procedures.
This document provides an overview of a Microsoft Project 2007 training module that introduces participants to project management concepts and planning projects using Microsoft Project. The training covers topics such as the basics of project management, using Microsoft Project to plan tasks and resources, and project scheduling techniques like PERT charts and the critical path method. The course objectives are to teach participants how to identify, organize, manage and schedule tasks, resources, time and costs to complete a project.
The document outlines the 5S methodology, which is a program used to improve project performance through workplace organization and standardization. It describes the five steps of 5S - Sort, Set In Order, Shine, Standardize, and Sustain. For each step, it provides definitions, examples of activities that can be done, and how success can be measured. The overall goal of 5S is to enhance work efficiency, reduce costs, eliminate waste, and improve productivity and work ethics through an organized, standardized workplace.
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Typical Quality Management System Based On Iso 9001 2008Isidro Sid Calayag
This document outlines the key elements of a quality management system (QMS) based on ISO 9001:2008. It discusses the objectives of implementing a QMS, including achieving organizational success and meeting requirements. The QMS focuses on customer focus, leadership, involvement of people, process approach, and continual improvement. It addresses management responsibility, resource management, product realization, measurement and improvement to ensure a process-based approach that meets customer needs and enhances supplier relationships.
The document discusses quality assurance and quality control concepts in construction projects based on ISO 9001:2008. It outlines a quality management system with four levels - quality manual, procedures, plans, and forms/records. Key elements include defining roles for QA/QC departments in verifying requirements and monitoring activities. Quality control focuses on inspection, monitoring and reducing variation. The presentation provides an example of applying the quality system to a HOYA construction project, with the goal of zero defects and identifying problems before customers.
This document provides a template for a project kick-off meeting presentation. It includes an introduction outlining the purpose and objectives, an agenda with sections on the project overview including description and goals, scope, team organization, major deliverables, estimated effort including budget, infrastructure, manpower allocation and timeline, assumptions risks and issues, project acceptance including customer acceptance conditions, and concludes with an end of presentation slide. The template provides placeholders for specific project details.
The document discusses quality management tools for root cause analysis. It introduces histograms and Pareto charts for analyzing problems, and cause-and-effect diagrams for identifying possible causal factors. The document provides examples and guidance for constructing Pareto charts to identify the main issues contributing to a problem. It also outlines the root cause analysis process of defining a problem, collecting data, identifying causes, identifying root causes, and recommending solutions.
The document outlines an introduction to quality management tools for root cause analysis, including Pareto charts and Ishikawa diagrams. It will cover how to create and interpret Pareto charts to identify the most common issues and focus corrective efforts. Ishikawa or cause-and-effect diagrams will also be explained as a tool to visually map out the potential causes of a problem across categories like equipment, materials, procedures and people. The training aims to equip participants with basic tools to effectively analyze problems and identify root causes.
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During the budget session of 2024-25, the finance minister, Nirmala Sitharaman, introduced the “solar Rooftop scheme,” also known as “PM Surya Ghar Muft Bijli Yojana.” It is a subsidy offered to those who wish to put up solar panels in their homes using domestic power systems. Additionally, adopting photovoltaic technology at home allows you to lower your monthly electricity expenses. Today in this blog we will talk all about what is the PM Surya Ghar Muft Bijli Yojana. How does it work? Who is eligible for this yojana and all the other things related to this scheme?
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2. Agenda
• PDCA and Process Approach
• Interview/Question Technique
• Notes, Check List & Cheat Sheet
• Report Writing
• Toughest ISO 9001:2000 Clauses
• How to Audit Difficult Clauses
• How to Audit Undocumented Process
• Auditor’s Code of Ethics
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3. Warm-up Exercise
The exercise will be used to gauge your
present knowledge must be completed in
10 minutes.
Countdown starts now. . .
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7. Interview Reason
• Supplements the documented process
• Determines the actual defined process
• Principal way of obtaining information
• Allows auditee to explain work
practices
• Ascertains understanding and
commitment
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8. Interview Steps -1
• Interview persons at their workplace
• Conduct interviews during normal
hours
• Put person at ease (lower anxiety
level)
• Explain your purpose (what you want)
• Ask about their job (question; observe)
• Verify responses (confirm
understanding)
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9. Interview Steps - 2
• Check the facts (use other sources)
• Record evidence (notes on checklist)
• Make tentative conclusion (no secrets)
• Give opportunity to discuss other
topics
• Thank for their time and cooperation
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10. Summary on Interview
• Remember, it is an interview, not
an interrogation!
• Investigate a claim; accept an
admission.
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11. Questioning Techniques - 1
• Ask question and then actively listen
• Rely primarily on open-ended questions
• Avoid closed question (except to confirm)
• Ask for explanations and examples
• Rephrase your question for clarification
• Restate answer for your understanding
• Keep neutral; don't disagree or interrupt
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12. Questioning Techniques - 2
• Ask "suppose" or "what if" questions
• Find basic flaws with simple questions
• Ask the blunt question about quality
• Nod in agreement to maintain dialog
• Use silence for expanded responses
• Observe unguarded facial expressions
• Learn from remarks of nearby people
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13. Close and Open-ended Question
• Open-ended question can be used in
determining the actual process during
the interview.
• Close-ended question can be used to
conclude the result of the interview.
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Sample
14. Summary on Questioning Techniques
• STOP TALKING - LISTEN
Do not ask closed questions unless to conclude item
Maintain a 20% talking : 80% listening ratio
• USE THE SIX HONEST SERVING MEN
“I keep six honest serving men
They taught me all I knew
Their names were WHAT and WHY and WHEN
And HOW and WHERE and WHO”
(The Elephant Child - Kipling)
• SHOW ME
15. Notes, Check List & Cheat List
• Taking Notes in an Audit
• Check List
• Cheat List
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16. Taking Notes in an Audit
• One use of a checklist is as a repository for your
notes
• Take brief notes on what you have read,
heard, and seen
• Capture specific references
• record what people are telling you about their
practices
• Some of your notes will be used immediately
for your next line of questioning
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17. Check List
Requirements for check list
• Standard requirement
• Customer requirement
• Organizational requirement
• Legal requirement
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18. Advantages on Using Check List
Checklists, if developed and used properly:
• Promote planning for the assigned audit
• Ensure a consistent audit approach
• Act as a sampling plan and time manager
• Serve as a memory aid and confidence builder
• Provide a repository for notes on evidence
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19. Drawback on Using Check List
Drawback
• May result in poor coverage.
• Restrict interview questions
• May cause the auditor to use an outdated
tool if not updated according to the new
standard
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20. Summary on Check List
• A checklist should guide auditors through the
system flow from quality policy, to objectives,
to processes, to measurements, to results, to
actions, and eventually to continual
improvement.
• Auditors should use the checklist as a planning
tool for their assignment and be willing to
pursue other areas of investigation.
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21. Cheat Sheet
• A "cheat sheet" is a concise set of notes used for
quick reference
• Job notes may not accurately describe the tasks, in
conflict with written instructions, or unapproved by
management.
ISO 9001:2000, clause 4.2.3 states that "Documents required
by the quality management system shall be controlled." So, if
cheat sheets are needed by employees to carry out their
activities, these would be viewed as documents that must be
controlled.
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22. Report Writing
• Use CPLANES as a reminder
• C – Clause
• P -- Procedure or Instruction
• L -- Location
• A – Activity
• N – Nature of Deficiency
• E – Evidence
• S – Scale of Deficiency
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24. Exercise No. 1
How well do you know the new ISO 9001:2000 standard? Can you identify the
clauses for these requirements?
1. Reviewing the system at planned intervals
2. Identifying the status of product measurements
3. Maintaining process equipment
4. Handling, packaging, and storing products
5. Preventing the "recurrence" of nonconformities
6. Maintaining evidence of conformity of acceptance criteria
7. Ensuring requirements are complete and unambiguous
8. Identifying the control of outsourced processes
9. Planning for design review, verification, and validation
10. Including a quality manual in the documentation
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answer
25. Toughest Requirements
• 4.1 General Requirements
• 5.1 Management Commitment
• 5.4.1 Quality Objectives
• 5.4.2 Quality Management System
Planning (vs. 7.1 Planning of Product
Realization)
• 7.3.1 Design and Development Planning
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26. Toughest Requirements
• 7.5.2 Validation of Processes for
Production and Service Provision
• 8.2.1 Customer Satisfaction
• 8.5.1 Continual Improvement
• 8.5.3 Preventive Action
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27. Most Common Audit Findings
* Internal Audit Findings
• 1. Customer satisfaction data and assessment (8.2.1 . . .
• 2. Documentation gaps (4.2.3 . . .
• 3. Continual improvement process (8.5.1 . . .
• 4. Objectives not measurable (5.4.1 . . .
• 5. Collection and analysis of data (8.4 . . .
• 6-7. Top management commitment and responsibility (5.4 . . .
• 6-7. Record keeping gaps (4.2.4 . . .
• 8-9. Competency requirements (6.2.2 . . .
• 8-9. Effective control of processes (4.1 . . .
* Ref. : <http://standardsgroup.asq.org/news/psi/IMS06-2002E-Implementing_ISO_9001-BD.pdf>
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28. Most Common Audit Findings
* Registrar Audit Findings
• 1. Documentation gaps
• 2-3. Objectives not measurable
• 2-3. Top management commitment and responsibility
• 4. Continual improvement process
• 5-6. Customer satisfaction data and assessment
• 5-6. Effective control of processes
• 7-8. Collection and analysis of data
• 7-8. Record keeping gaps
• 9. Competency requirements
* Ref. : <http://standardsgroup.asq.org/news/psi/IMS06-2002E-Implementing_ISO_9001-BD.pdf>
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29. Comparison of Rankings
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Internal Audit Findings
• 1. Customer satisfaction data and
assessment
• 2. Documentation gaps
• 3. Continual improvement process
• 4. Objectives not measurable
• 5. Collection and analysis of data
• 6-7. Top management commitment and
responsibility
• 6-7. Record keeping gaps
• 8-9. Competency requirements
• 8-9. Effective control of processes
Registrar Audit Findings
• 1. Documentation gaps
• 2-3. Objectives not measurable
• 2-3. Top management commitment
and responsibility
• 4. Continual improvement process
• 5-6. Customer satisfaction data and
assessment
• 5-6. Effective control of processes
• 7-8. Collection and analysis of data
• 7-8. Record keeping gaps
• 9. Competency requirements
30. How to Audit Difficult Clauses
4.1 General Requirements
Clause 4.1 covers the requirement for your
organization to set up a quality management system
and broadly defines the associated activities. These
activities are described in greater detail in the
remainder of the standard. And, when you audit
these other clauses, you are in essence auditing
clause 4.1.
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31. How to Audit ISO 9001:2000, Clause 4.1
• By recognizing its linkages to the clauses in the
remainder of the standard.
• Audit those other areas well and you are in effect
auditing clause 4.1.
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32. How to Audit Difficult Clauses
5.0 Management Responsibility
• 5.1 Management Commitment
• 5.4.1 Quality Objectives
• 5.4.2 Quality Management System
Planning (vs. 7.1 Planning of Product
Realization)
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33. How to Audit Difficult Clauses
5.1 Management Commitment
Look for evidence on how top managers
ensure their commitment is well known
throughout the organization and records
that show how they are keeping their
promise
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34. How to Audit Difficult Clauses
5.4.1 Quality Objective
Are You Setting SMART Quality Objectives?
• Is it specific?
• Is it measurable
• Is it achievable
• Is it relevant
• Is it timed?
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35. How to Audit Difficult Clauses
5.4.2 Quality Management System Planning
(vs. 7.1 Planning of Product Realization)
Organizations must decide how to monitor, measure,
and analyze their processes, as well as, be ready to
implement the actions necessary to achieve planned
results and continually improve the processes. Even
outsourced processes are included in the planning.
Determine how this is done using process approach.
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36. How to Audit Difficult Clauses
7.0 Product Realization
• 7.1 Planning of Product Realization
• 7.3.1 Design and Development Planning
• 7.5.2 Validation of Processes for Production
and Service Provision
Determine how the quality plan is developed.
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37. How to Audit Difficult Clauses
8.0 Measurement, analysis and Improvement
• 8.2.1 Customer Satisfaction
• 8.5.1 Continual Improvement
• 8.5.3 Preventive Action
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39. Summary on Audit Practice
Audits examine compliance from three perspectives:
1. Documents (or definitions) that indicate the
process is adequate
2. Records that show the process is implemented
(being practiced)
3. Results that prove the process is effective
(objectives are met)
By using the process approach in auditing, you will be
able to gather all the evidence that you need in
auditing for any clause that you may encounter in the
field.
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40. EXERCISE No. 2
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The purpose of the exercise is to provide
practice in assessing evidence in an objective
manner..
41. Auditor Training rev 0 022009 41
Workshop
Mock-up audit of Engineering Department
• 5.4.1 Quality Objectives
• 7.3.1 Design and Development Planning
42. Tips on Auditing
• Adjust your audit approach
• Evaluate the effectiveness of the system
• Remind auditors how to verify conformity
• Know how to audit an undocumented
process
• Improve your current internal audit
practices
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43. Auditor Conduct
• Be critical
• Be side-tracked
• Argue
• Swear
• Be late
• Be sarcastic
• Compare
• Pass opinions
• Apportion blame
AN AUDITOR SHOULD NOT
44. Code of Conduct for Auditors
Purpose
To communicate the integrity, objectivity,
confidentiality, and competence expected of
internal auditors, as well as, to provide a means
for them to pledge their commitment to these
principles.
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45. Code of Conduct for Auditors
Integrity
The integrity of internal auditors establishes trust
and provides the basis for relying on their
judgment. As an internal auditor, I pledge to:
1. Perform my work with honesty, accuracy,
fairness, and responsibility.
2. Not engage in activities that might discredit
the audit profession or my organization.
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46. Code of Conduct for Auditors
Objectivity
Internal auditors must be objective in gathering, evaluating,
and communicating information about the activities being
examined. They must make a balanced and impartial
assessment of all the relevant facts and not be unduly
influenced by their interests, or those of others, in making
judgments. As an internal auditor, I pledge to:
3. Not join in any activity or relationship that may affect my
unbiased assessment.
4. Not accept anything that may impair, or appear to impair,
my judgment.
5. Disclose all the material facts to avoid any distortion of my
audit report.
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47. Code of Conduct for Auditors
Confidentiality
Internal auditors must respect the value and ownership of the
information they receive and not disclose it without the
appropriate authority (unless obligated for legal or
professional reasons). As an internal auditor, I pledge to:
6. Be prudent in the use and protection of the information
acquired during my audit duties.
7. Not use the information for personal gain or in any way
detrimental to the organization.
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48. Code of Conduct for Auditors
Competence
Internal auditors must apply their knowledge, skills, and experience in
the performance of their assessment duties. As an internal auditor, I
pledge to:
8. Engage only in audits where I possess the needed knowledge, skills,
and experience.
9. Perform audits in accordance with the procedures and practices of
my organizations.
10. Continually improve my proficiency and the quality and value of
my audit services.
11. Assist other auditors under my supervision to develop their audit
management skills.
12. Report any complaints regarding my performance and address
them to avoid recurrence.
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49. Addendum
• Exercise No. 3 – take home exercise
• ISO 9000 : 2005 –
• ISO 9001: 2008 –
• Sample Question for Top Management
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50. Exercise No. 3
This is an exercise to see how
nonconformities are reported
This is a take-home exercise. The
answer shall be submitted later.
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51. Internal Auditor Quiz
Answers for the ISO 9001:2000 Clause Quiz
The correct clauses for the ten requirements are:
1. Reviewing the system at planned intervals = 5.6.1 [also 8.2.2 regarding audits]
2. Identifying the status of product measurements = 7.5.3
3. Maintaining process equipment = 6.3 (b)
4. Handling, packaging, and storing products = 7.5.5
5. Preventing the "recurrence" of nonconformities = 8.5.2 (not 8.5.3)
6. Maintaining evidence of conformity of acceptance criteria = 8.2.4
7. Ensuring requirements are complete and unambiguous = 7.3.2 [implied by 7.2.2 (a)]
8. Identifying the control of outsourced processes = 4.1
9. Planning for design review, verification, and validation = 7.3.1 (b) [implied by 7.1]
10. Including a quality manual in the documentation = 4.2.1 (b)
How did you do on the quiz? Do you agree with these answers?
51Auditor Training rev 0 022009
Back
52. ISO 9000:2005
• It makes no changes to the basic
principles of quality management stated
in ISO 9000:2000
• It is essentially a tidying-up exercise to
ensure consistency within ISO Standards
• It will probably have little, or no real
impact on our quality system
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53. ISO 9001:2008
• ISO 9001:2000 is due for an update in
2008.
• It is currently at Draft International
Standard (DIS) stage
• Changes to the standard are very small
• It will replace ISO 9001:2000
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54. How to Audit Difficult Clauses
6.0 Resource Management
• 6.1 Provision of Resources
• 6.2 Human Resources
• 6.3 Infrastructure
• 6.4 Work Environment
54Auditor Training rev 0 022009
Process Approach
Interview
Question
PDCA
Note
Check List
Cheat Sheet
55. Sample Question for Top Management
• How do you influence/oversee the quality policy?
• What quality targets have been set for each
department for this fiscal year? What about plant-
wide targets? How did you influence these targets?
What is your basis?
• How do you ensure that the integrity of the quality
management system is maintained when changes
are implemented? (i.e., costdowns, new products,
hirings/layoffs...)
• How do you use our "Key Measurables" information to
ensure continual improvement in quality?
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56. Sample Question for Top Management
• How are your Objectives developed?
• How do you use the Policy?
• What does the System gain from Management
Review?
• Please provide an example of Improvement
within the company.
• "If you could do it, what one thing in the
Management System would you improve?“
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57. Sample Question for Top Management
• How do you contribute to achieving your
organization's objectives?
• How are objectives determined?
• How are employees trained on objectives?
• How is progress against objectives communicated to
the organization?
• What processes and/or tools are in place to help
achieve objectives?
• Is there evidence of progress?
Auditor Training rev 0 022009 57
Back