Effective Internal Audit Planning:

Save this PDF as:
Size: px
Start display at page:

Download "Effective Internal Audit Planning:"

Transcription

1 Audit practices that add the most value! Effective Internal Audit Planning: ISO 9000 Users Group - ASQ Section 509, Wednesday, January 20, 2010 By David Collingham, CQA/CQE

2 Outline Definitions of Key Audit Terms Types of Audits Nonconformance Types ISO 9001:2008 Internal Audit Requirement Common NCR s isued by Registrars related to Audits Miss-Conceptions About Auditing What does the Industry and Product/Process have to do with Planning an Audit? How much do I invest in Auditing? Why do we Audit? First Party Audit Process Steps Planning Audits Typical Audit Schedules and Forms

3 Definitions of Key Audit Terms Effective - producing or capable of producing an intended result or having a striking effect Planning - the act or process of drawing up plans or layouts for some project or enterprise Audit - a methodical examination or review of a condition or situation

4 Audit Types First Party When a Company uses an internal person to perform an Audit on itself. Second Party When a Company uses an internal person to perform an Audit on its Supplier or an other organization. Third Party When a Company is Audited by a third party independent of the Company s Customer.

5 Major Minor Comment Nonconformance Types When the Quality System exhibits a void where an element of the system has not been documented, implemented or is not effective. In addition, the nonconformance does risk the shipment or delivery of nonconforming material to the Customer When the Quality System is documented, implemented and effective, but has exhibited a random nonconformance. The nonconformance does not risk the shipment or delivery of nonconforming material to the Customer When an Auditor identifies an improvement opportunity that is not a major or minor

6 Effective Internal Auditor Planning ISO 9001:2008 Key Elements Key 4.0 Value-adding activities Information flow Continual Improvement of the Quality Management System 5.0 Management Responsibility Customers Customers Measurement, Analysis and Improvement Resource Management Satisfaction 7.0 Requirements Input Product Realization Product Output

7 ISO 9001:2008 Internal Audit Requirement Internal Audit Measurement, Analysis and Improvement The organization shall conduct internal audits at planned intervals to determine whether the quality management system: a) conforms to the planned arrangements, to the requirements of this ISO Standard and to the quality management system requirements established by the organization, and b) is effectively implemented and maintained. The audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. The selection of the auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.

8 Common NCR s isued by Registrars related to Audits Audit Plan/Schedule does not address all elements (major paragraphs) of the ISO 9001:2008 standard Audit Plan/Schedule does not address multiple facility locations, work shifts (shift 1, 2 & 3) or scope of business/registration Audit plan/schedule is not approved Audits are not completed as scheduled Audits are performed by personnel who audited their own work Audit results do not have written signature or electronic signature by Auditor with date Audits were not conducted in an effective manner Auditor(s) received no internal auditor training

9 Miss-Conceptions About Auditing There needs to be 35 Internal Audits performed for ISO 9001:2008 (i.e , 4.23, 4.24, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 6.1, 6.2, 6.3, 6.4, 7.1, 7.2, 7.3, 7.4, 7.4.3, 7.5.1, 7.5.2, 7.5.3, 7.5.4, 7.5.5, 7.5.6, 7.6, 8.1, 8.2.1, 8.2.2, 8.2.3, 8.2.4, 8.3, 8.4, 8.5.1, 8.5.2, 8.5.3) I can not conduct 1 audit of the ISO 9001:2008 QMS each year We must use an outside contractor to perform our audits All the ISO 9001:2008 elements need to be audited every year If you don t spend 2-5 hours on each audit, then you are not doing your job The Auditor must prepare a checklist list using his or her own questions in order to perform an effective audit I can use typed audit checklists with typed in results with typed in names and dates (no written or electronic signature) If the Audit Report does not weight 3 pounds, then it must not have been performed correctly We can t use the receptionist or finance person to conduct audits, because she/he does not know what we do

10 What does the Industry and Product/Process have to do with planning an Audit? Critical, High Risk and High Exposure Industries/Products/Processes:

11 How much do I invest in Auditing? High $ Industry/Product/Process High Risk High Complexity Critical to End Mission Point 2 High Maintenance High Failure/Reject Rate Appraisal/ Prevention Investment; Audits Low Risk Point 1 Low Complexity Not Critical to End Mission Low Maintenance Low Failure/Reject Rate (*) Graph not to scale Risk Level High

12 Why do we Audit? Provides Senior Management an independent examination of business processes To identify improvement opportunities in processes/products/services Proactive approach to prevent/reduce the risk of producing defective product/services To identify needs for training, tools/fixtures, methods, etc. Enhances communication and training Provides a means for operator feedback

13 First Party Audit Process Steps Audit Process Steps: A - Prepare Audit Schedule and Obtain Management Approval B - Schedule the Audit(s) C - Obtain Audit Requirements D - Examine prior Audit Results and Corrective Actions E - Prepare Audit Check List(s) and Any Other Support Questions F - Conduct Audit Investigation G - Record Audit Finds and Obtain Auditee Acknowledgment H - Prepare Audit Report I - Obtain Corrective Action(s) J - Follow-Up On Corrective Action(s)

14 Planning Audits What is the budget for conducting audits? Hours? Dollars? How many audits do we need to do? How I m I going to be value-added? What does Senior Management feel is critical to the business success? Gain a clear understanding of what is expected from conducting the audits? If we spend money from the Overhead Budget for conducting audits, what is expected for the investment? What are the critical processes/products that need to be examined? What does our past internal audit results tell us to focus on? Do we have any new areas/processes/staffing/equipment/vendors that requires more focus than other areas? What facility locations, functions, processes/products and work shifts need to be included in the schedule? What is the best time to conduct the audits? High Volume? Low Volume? Before Lunch? After Lunch? At the end of work shift? Etc.

15 Example 1 Effective Internal Auditor Planning Planning Audits (continued) Approved By: Jim Brown Date: 01/14/10

16 Example 1 Effective Internal Auditor Planning Planning Audits (continued) s Approved By: Jim Brown Date: 01/14/10

17 Example 1 Planning Audits (continued) Approved By: Jim Brown Date: 01/14/10

18 Example 1 s Planning Audits (continued) Approved By: Jim Brown Date: 01/14/10

19 Example 1 Planning Audits (continued) Approved By: Jim Brown Date: 01/14/10

20 Typical Audit Schedules and Forms AUDIT FORMS & RECORDS Schedule Procedure

21 Typical Audit Schedules and Forms (continued) AUDIT FORMS & RECORDS Audit Summary Audit Checklist

22 Typical Audit Schedules and Forms (continued) AUDIT FORMS & RECORDS Audit Summary Example

ISO 9001 (2000) QUALITY MANAGEMENT SYSTEM ASSESSMENT REPORT SUPPLIER/ SUBCONTRACTOR

ISO 9001 (2000) QUALITY MANAGEMENT SYSTEM ASSESSMENT REPORT SUPPLIER/ SUBCONTRACTOR Page 1 of 20 ISO 9001 (2000) QUALITY MANAGEMENT SYSTEM ASSESSMENT REPORT SUPPLIER/ SUBCONTRACTOR SUPPLIER/ SUBCONTRACTOR NAME: ADDRESS: CITY AND STATE: ZIP CODE: SUPPLIER/MANUFACTURER NO PHONE: DIVISION:

More information

ISO 9001:2000 Gap Analysis Checklist

ISO 9001:2000 Gap Analysis Checklist ISO 9001:2000 Gap Analysis Checklist Type: Assessor: ISO 9001 REQUIREMENTS STATUS ACTION/COMMENTS 4 Quality Management System 4.1 General Requirements Processes needed for the quality management system

More information

ISO 9001:2000 AUDIT CHECKLIST

ISO 9001:2000 AUDIT CHECKLIST ISO 9001:2000 AUDIT CHECKLIST No. Question Proc. Ref. Comments 4 Quality Management System 4.1 General Requirements 1 Has the organization established, documented, implemented and maintained a quality

More information

ISO 9001:2008 Clause 8.2.2 PR018 Internal Audit Procedure

ISO 9001:2008 Clause 8.2.2 PR018 Internal Audit Procedure ISO 9001:2008 Clause 8.2.2 PR018 Internal Audit Procedure Strode Park Foundation Page 1 of 9 Approvals The signatures below certify that this procedure has been reviewed and accepted, and demonstrates

More information

ISO 9001 : 2008 QUALITY MANAGEMENT SYSTEM AUDIT CHECK LIST INTRODUCTION

ISO 9001 : 2008 QUALITY MANAGEMENT SYSTEM AUDIT CHECK LIST INTRODUCTION INTRODUCTION What auditors should look for: the items listed in these headings that the ISO requirement is met that the requirement is met in the manner described in the organization's documentation Page

More information

ISO 14001:2004 EMS Internal Audit Checklist & Gap Analysis

ISO 14001:2004 EMS Internal Audit Checklist & Gap Analysis Page 1 of 31 Audit Date Audit Description Lead Auditor Audit Team Members ISO 14001:2004 Auditable Clauses: (Tick those to be evaluated during this audit) 1. The checklist should be used by auditors to

More information

Supplier Quality Management System Audit Checklist (ISO 9000:2000, TS 16949:2002)

Supplier Quality Management System Audit Checklist (ISO 9000:2000, TS 16949:2002) Supplier Quality Management System Audit Checklist (ISO 9000:2000, TS 16949:2002) Supplier: Plant/Location: Date: Audit Team: Scope of Audit: Number of C.A.R. s: Corrective Action Due: Potential suppliers

More information

ISO-9001:2000 Quality Management Systems

ISO-9001:2000 Quality Management Systems ISO-9001:2000 Quality Management Systems REQUIREMENTS 10/10/2003 ISO-9001:2000 Requirements 1 Process Based Approach C U S MANAGEMENT RESPONSIBILITY RESOURCE MANAGEMENT C U S T O M Requirements PRODUCT

More information

ISO 9001:2008 Internal Audit & Gap Analysis Checklist

ISO 9001:2008 Internal Audit & Gap Analysis Checklist Page 1 of 54 Audit Date: Audit Description: Lead Auditor: Audit Team Members: ISO 9001:2008 Auditable Clauses (Tick those to be evaluated during this audit) Each auditor should complete the section of

More information

ISO 9001:2008 Audit Checklist

ISO 9001:2008 Audit Checklist g GE Power & Water ISO 9001:2008 Audit Checklist Organization Auditor Date Page 1 Std. 4.1 General s a. Are processes identified b. Sequence & interaction of processes determined? c. Criteria for operation

More information

ISO 9001:2000 - A Quality Manual for the Transition Period and Beyond

ISO 9001:2000 - A Quality Manual for the Transition Period and Beyond ISO 9001:2000 - A Quality Manual for the Transition Period and Beyond By Mark Kaganov Abstract This article shows a practical approach to converting an ISO 9001:1994 quality manual into the new ISO 9001:2000

More information

ISO 9001:2008 Requirements Explained - An Adobe PDF File for Use on a Network System

ISO 9001:2008 Requirements Explained - An Adobe PDF File for Use on a Network System 1-2 3 4 5 6 9 9 29 37 44 57 64 67 70 77 85 90 93 97 101 110 112 113 122 125 127 135 139 146 150 157 161 165 168 172 175 180 187 190 193 201 206 209 212 216 227 233 235 247 251 258 264 272 274 286 1 of

More information

AUDITOR GUIDELINES. Responsibilities Supporting Inputs. Receive AAA, Sign and return to IMS with audit report. Document Review required?

AUDITOR GUIDELINES. Responsibilities Supporting Inputs. Receive AAA, Sign and return to IMS with audit report. Document Review required? 1 Overview of Audit Process The flow chart below shows the overall process for auditors carrying out audits for IMS International. Stages within this process are detailed further in this document. Scheme

More information

ISO 13485:201x What is in the new standard?

ISO 13485:201x What is in the new standard? ISO 13485:201x What is in the new standard? Eric Finegan, Quality Mgr, BTE Technologies, Inc. 2015-09-10 1 Presentation Slides This slide deck is the presentation performed on 2015-09-10. A more detailed

More information

Free Download ISO/TS 16949:2009. Requirements Checklist. 29 of 57 pages (PDF) For additional information see www.rcglobal.com

Free Download ISO/TS 16949:2009. Requirements Checklist. 29 of 57 pages (PDF) For additional information see www.rcglobal.com RCGLOBAL.COM Free Download ISO/TS 16949:2009 Requirements Checklist 29 of 57 pages (PDF) For additional information see www.rcglobal.com RCGLOBAL(Canada), for internal use only. Page 1 of 57 Review performed

More information

DNV GL Assessment Checklist ISO 9001:2015

DNV GL Assessment Checklist ISO 9001:2015 DNV GL Assessment Checklist ISO 9001:2015 Rev 0 - December 2015 4 Context of the Organization No. Question Proc. Ref. Comments 4.1 Understanding the Organization and its context 1 Has the organization

More information

ISO 9001:2008 STANDARD OPERATING PROCEDURES MANUAL

ISO 9001:2008 STANDARD OPERATING PROCEDURES MANUAL 8200 Brownleigh Drive Raleigh, NC 27617-7423 Phone: (919) 510-9696 Fax: (919) 510-9668 ISO 9001:2008 STANDARD OPERATING PROCEDURES MANUAL ALLIANCE OF PROFESSIONALS & CONSULTANTS, INC. - 1 - Table of Contents

More information

Quality Management System Manual

Quality Management System Manual Effective Date: 03/08/2011 Page: 1 of 17 Quality Management System Manual Thomas C. West Eric Weagle Stephen Oliver President ISO Management General Manager Representative Effective Date: 03/08/2011 Page:

More information

Auditing Process-based Quality Management Systems. Charlie Cianfrani and Jack West

Auditing Process-based Quality Management Systems. Charlie Cianfrani and Jack West Auditing Process-based Quality Management Systems Charlie Cianfrani and Jack West Agenda Course objectives What is an audit? How to prepare for and plan an audit How to conduct an audit How to report

More information

ISO/TS 16949:2002 Guidance Document

ISO/TS 16949:2002 Guidance Document ISO/TS 16949:2002 Guidance Document Introduction ISO/TS 16949:2009 emphasizes the development of a process oriented quality management system that provides for continual improvement, defect prevention,

More information

Row Manufacturing Inc. Quality Manual ISO 9001:2008

Row Manufacturing Inc. Quality Manual ISO 9001:2008 Row Manufacturing Inc. Quality Manual ISO 9001:2008 Row Manufacturing 210 Durham Drive Athens, Alabama 35611 Phone:256.232.4151 Fax:256.232.4133 Page 2 of 33 This Page intentionally left Blank Page 3 of

More information

EMS Example Example EMS Audit Procedure

EMS Example Example EMS Audit Procedure EMS Example Example EMS Audit Procedure EMS Audit Procedures must be developed and documented with goals which: Ensure that the procedures incorporated into the EMS are being followed; Determine if the

More information

INTRODUCTION TO ISO 9001 REVISION - COMMITTEE DRAFT

INTRODUCTION TO ISO 9001 REVISION - COMMITTEE DRAFT INTRODUCTION TO ISO 9001 REVISION - COMMITTEE DRAFT AGENDA Introduction Annex SL Changes to ISO 9001 Future Development How SGS can support you 2 INTRODUCTION ISO 9001 Revision Committee Draft Issued 2013

More information

Preparation for ISO 45001 OH&S Management Systems

Preparation for ISO 45001 OH&S Management Systems Preparation for ISO 45001 OH&S Management Systems HEALTH & SAFETY MANAGEMENT QUALITY MANAGEMENT ACCESSIBILITY ENVIRONMENTAL MANAGEMENT ENERGY MANAGEMENT ISO 45001 TIMELINE ISO project committee ISO PC

More information

Briefing on ISO 9001, ISO. requirements

Briefing on ISO 9001, ISO. requirements Briefing on ISO 9001, ISO 14001 & OHSAS 18001 requirements Going for ISO 9001 ISO 14001 OHSAS 18001 Quality, Environment, Health & Safety Certification IMS: Integrated Management System ISO 9001 -Quality

More information

AS9100 B to C Revision

AS9100 B to C Revision AS9100 B to C Revision Key: Additions Deletions Clarifications 1.2 Application AS9100C Key Additions This standard is intended for use by organizations that design, develop and/or produce aviation, space

More information

Contents of the ISO 9001:2000 Quality System Checklist

Contents of the ISO 9001:2000 Quality System Checklist Contents of the ISO 9001:2000 Quality System Checklist Page Hyperlinks (click underlines) This SAMPLE document includes 4 clauses of the standard. You receive the Windows.doc file (with hyperlinks). You

More information

Comparison ISO/TS 16949 (1999) to VDA 6.1 (1998)

Comparison ISO/TS 16949 (1999) to VDA 6.1 (1998) 1 APPLICABILITY VDA 6.1: Section: 3.1; 7 new: In addition to the applicability for supplier sites for production, services and their subcontractors for: products and production materials, or services like

More information

QUALITY MANAGEMENT SYSTEM Corporate

QUALITY MANAGEMENT SYSTEM Corporate Page 1 of 12 4 Quality Management System 4.1 General Requirements The Peerless Pump Quality Management System shall include: Documented statements of a quality policy and of quality objectives; A quality

More information

NORTH AMERICA OPERATIONS. (Fairmont and Montreal Facilities) QUALITY MANUAL. Prepared to comply with the requirements of ISO 9001:2008

NORTH AMERICA OPERATIONS. (Fairmont and Montreal Facilities) QUALITY MANUAL. Prepared to comply with the requirements of ISO 9001:2008 WEIGH-TRONIX CANADA ULC NORTH AMERICA OPERATIONS (Fairmont and Montreal Facilities) QUALITY MANUAL Prepared to comply with the requirements of ISO 9001:2008 Meets or exceeds the requirements for design,

More information

ISO 20000-1:2005 Requirements Summary

ISO 20000-1:2005 Requirements Summary Contents 3. Requirements for a Management System... 3 3.1 Management Responsibility... 3 3.2 Documentation Requirements... 3 3.3 Competence, Awareness, and Training... 4 4. Planning and Implementing Service

More information

Chapter 1. The ISO 9001:2000 Standard and Certification Process

Chapter 1. The ISO 9001:2000 Standard and Certification Process CH01_pp.001-008 15/08/01 12.15 pm Page 1 Chapter 1 The ISO 9001:2000 Standard and Certification Process Overview Introduction This chapter describes the ISO 9000 Standards, ISO 9001:2000 concepts, and

More information

Quality Manual. 14910 SE Morning Way Suite 102 Clackamas OR 97015

Quality Manual. 14910 SE Morning Way Suite 102 Clackamas OR 97015 Quality Manual 14910 SE Morning Way Suite 102 Clackamas OR 97015 Effective Date: 10/27/08 Schedule QM 01 Revision: 1 Page 1 of 1 This document has been approved for use by... (ISO Representative) at Revision

More information

QUALITY MANUAL ISO 9001:2015

QUALITY MANUAL ISO 9001:2015 Page 1 of 22 QUALITY MANUAL ISO 9001:2015 Quality Management System Page 1 of 22 Page 2 of 22 Sean Duclos Owner Revision History Date Change Notice Change Description 11/02/2015 1001 Original Release to

More information

ISO 9001:2008 Quality Management System Requirements (Third Revision)

ISO 9001:2008 Quality Management System Requirements (Third Revision) ISO 9001:2008 Quality Management System Requirements (Third Revision) Contents Page 1 Scope 1 1.1 General. 1 1.2 Application.. 1 2 Normative references.. 1 3 Terms and definitions. 1 4 Quality management

More information

QUALITY MANAGEMENT SYSTEM REVIEW AND APPROVAL TEMPLATE (DOE G 414.1-2A, Appendix A, 6-17-05)

QUALITY MANAGEMENT SYSTEM REVIEW AND APPROVAL TEMPLATE (DOE G 414.1-2A, Appendix A, 6-17-05) QUALITY MANAGEMENT SYSTEM REVIEW AND APPROVAL TEMPLATE (DOE G 414.1-2A, Appendix A, 6-17-05) This review template is intended for use by the DOE for evaluating a DOE Site Office or Contractor Quality Assurance

More information

ABC COMPANY INC ISO 9001:2000 QUALITY MANUAL

ABC COMPANY INC ISO 9001:2000 QUALITY MANUAL Page 1 of 25 ABC COMPANY INC QUALITY MANUAL Page 2 of 25 DOCUMENT INTRODUCTION PURPOSE OF THIS MANUAL This describes the quality management system at ABC Company Ltd, Buffalo, USA described as the Organization,

More information

Improving Management Review Meetings Frequently Asked Questions (FAQs)

Improving Management Review Meetings Frequently Asked Questions (FAQs) Improving Management Review Meetings Frequently Asked Questions (FAQs) Questions from Conducting and Improving Management Review Meetings Webinar Answers provided by Carmine Liuzzi, VP SAI Global Training

More information

QUALITY MANAGEMENT SYSTEM REQUIREMENTS General Requirements. Documentation Requirements. General. Quality Manual. Control of Documents

QUALITY MANAGEMENT SYSTEM REQUIREMENTS General Requirements. Documentation Requirements. General. Quality Manual. Control of Documents Chapter j 38 Self Assessment 729 QUALITY MANAGEMENT SYSTEM REQUIREMENTS General Requirements 1. Establishing and implementing a documented quality management system 2. Implementing a documented quality

More information

QW Enterprises, LLP. Quality Manual

QW Enterprises, LLP. Quality Manual QW Enterprises, LLP Quality Manual ISO 9001:2008 Quality Manual 9001 2008 D1 Quality Manual 9001 2008 D1 Page 2 of 34 0 Table of contents 0 Table of contents 2 1 General 5 1.1 Purpose and scope 5 1.2 Application

More information

QUALITY MANAGEMENT SYSTEM (QMS) ASSESSMENT CHECKLIST

QUALITY MANAGEMENT SYSTEM (QMS) ASSESSMENT CHECKLIST 1. QUALITY MANAGEMENT SYSTEM QUALITY MANAGEMENT SYSTEM (QMS) ASSESSMENT CHECKLIST 1.1 Quality Management System General 1.1.1 Is objective evidence available to demonstrate that the MDSAP site has defined,

More information

QUALITY MANUAL ISO 9001. Quality Management System

QUALITY MANUAL ISO 9001. Quality Management System Page 1 of 20 QUALITY MANUAL ISO 9001 Quality Management System Printed copies are not controlled unless marked "CONTROLLED". Upon receipt of this document, discard all previous copies. Page 2 of 20 Approval

More information

OUTSOURCING STRATEGIES & RISKS FROM AN ISO 9001-2000 PERSPECTIVE. Amera-Veritas. Amera-Veritas. Experts in in Quality, Safety & Supply Chain Assurance

OUTSOURCING STRATEGIES & RISKS FROM AN ISO 9001-2000 PERSPECTIVE. Amera-Veritas. Amera-Veritas. Experts in in Quality, Safety & Supply Chain Assurance OUTSOURCING STRATEGIES & RISKS FROM AN ISO 9001-2000 PERSPECTIVE Amera-Veritas Amera-Veritas Experts in in Quality, Safety & Supply Chain Assurance TOPICS 1. Outsourcing - Requirements of ISO 9001:2000

More information

Quality Management System Manual ISO9001:2008

Quality Management System Manual ISO9001:2008 Quality Management System Manual ISO9001:2008 Controlled Copy Rev. 3 Page 1 of 21 7/1/13 Table of Contents Company Profile...5 Past...5 Present...5 Mission...5 Vision...5 Locations...6 1 Scope...6 1.1

More information

Quality Management Standard BS EN ISO 9001:2008. www.imsworld.org

Quality Management Standard BS EN ISO 9001:2008. www.imsworld.org Quality Management Standard BS EN ISO 9001:2008 The Origin of Quality Standards Ministry of Defence Marks & Spencer Ford Motor Company All had their own Quality standards, which they expected their suppliers

More information

ISO 9001:2015 QUALITY MANAGEMENT SYSTEM ***** ISO 14001:2015 ENVIRONMENTAL MANAGEMENT SYSTEM

ISO 9001:2015 QUALITY MANAGEMENT SYSTEM ***** ISO 14001:2015 ENVIRONMENTAL MANAGEMENT SYSTEM ISO 9001:2015 QUALITY MANAGEMENT SYSTEM ***** ISO 14001:2015 ENVIRONMENTAL MANAGEMENT SYSTEM ***** OHSAS 18001:2007 OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEM ***** QMS-EMS-OHS MANUAL Your Company

More information

ISO 9001:2015. A look at the Revised Standard 9/23/2015 1

ISO 9001:2015. A look at the Revised Standard 9/23/2015 1 ISO 9001:2015 A look at the Revised Standard 9/23/2015 1 Quotes Quality management is a journey, not just a destination. Emily Rhinehart If you can t explain it simply, you don t understand it well enough.

More information

Single Manufacturing Site with. Extended Manufacturing Site(s)

Single Manufacturing Site with. Extended Manufacturing Site(s) Single Manufacturing Site with Extended Manufacturing Site(s) 1 Content Background of Proposed Changes Solution: SI 13 SI 13 Key Terms and Phrases What is Included? What is Excluded? IATF Expectations

More information

Quality management systems

Quality management systems L E C T U R E 9 Quality management systems LECTURE 9 - OVERVIEW Quality management system based on ISO 9000 WHAT IS QMS (QUALITY MANAGEMENT SYSTEM) Goal: Meet customer needs Quality management system includes

More information

ISO 14001 & ISO 18001 Legal Compliance Know Your Risk - Reduce your Risk"

ISO 14001 & ISO 18001 Legal Compliance Know Your Risk - Reduce your Risk American Society For Quality -Toronto Section ISO 14001 & ISO 18001 Legal Compliance Know Your Risk - Reduce your Risk" Copyright: Coudenys Management Systems Inc. RISK DEFINED Occurrence of the event

More information

Quality & Safety Manual

Quality & Safety Manual Purpose: This Quality & Safety Manual is intended to clarify and document the Quality and Health & Safety policies of GGS Oil and Gas Systems and to describe how the organization organizes its activities

More information

Maseno University. Towards ISO 9001:2008. Certification

Maseno University. Towards ISO 9001:2008. Certification Maseno University Towards ISO 9001:2008 Certification Introduction In 2007 Maseno University started working towards attaining ISO 9001:2000 Certification for its service through Kenya Bureau of standards

More information

Module 15: Nonconformance And Corrective And Preventive Action

Module 15: Nonconformance And Corrective And Preventive Action Module 15: Nonconformance And Corrective And Preventive Action Guidance...15-2 Figure 15-1: Root Cause Diagram...15-3 Tools and Forms...15-6 Tool 15-1: Corrective & Preventive Action Worksheet...15-6 Tool

More information

Internal Quality Management System Audit Checklist (ISO9001:2015) Q# ISO 9001:2015 Clause Audit Question Audit Evidence 4 Context of the Organization

Internal Quality Management System Audit Checklist (ISO9001:2015) Q# ISO 9001:2015 Clause Audit Question Audit Evidence 4 Context of the Organization Internal Quality Management System Audit Checklist (ISO9001:2015) Q# ISO 9001:2015 Clause Audit Question Audit Evidence 4 Context of the Organization 4.1 Understanding the organization and its context

More information

Quality Manual TABLE OF CONTENTS APPROVAL SIGNATURE PAGE 1.1 1 AMENDMENT RECORD 1.2 2 SCOPE 2.0 3 EXCLUSIONS 2.1 3

Quality Manual TABLE OF CONTENTS APPROVAL SIGNATURE PAGE 1.1 1 AMENDMENT RECORD 1.2 2 SCOPE 2.0 3 EXCLUSIONS 2.1 3 TABLE OF CONTENTS DESCRIPTION SECTION PAGE INTRODUCTION 1.0 1 APPROVAL SIGNATURE PAGE 1.1 1 AMENDMENT RECORD 1.2 2 SCOPE 2.0 3 EXCLUSIONS 2.1 3 CORPORATE POLICY 3.0 3 QUALITY MANAGEMENT SYSTEM 4.0 4 GENERAL

More information

ISO 14001:2015 Client Transition Checklist

ISO 14001:2015 Client Transition Checklist ISO 14001:2015 Client Transition Checklist How to use this document: It is not mandatory to use this document. It is a guide to give you an indication of your readiness for audit against ISO 14001:2015.

More information

ISO 9001:2008 Internal Audit Guidance

ISO 9001:2008 Internal Audit Guidance ISO 9001:2008 Internal Audit Guidance Contents Introduction... 3 About the Internal Audit Solution... 3 Forms & Records... 3 Internal Audit Procedure... 3 Document Reference Numbering... 4 Navigating the

More information

I NTERNATIONAL. Why industry specific?

I NTERNATIONAL. Why industry specific? ISO/TS 29001 set to become oil and gas industry s unique QMS standard Photo Hydro A successful partnership between ISO and the international oil and gas industry has resulted in the publication of a new

More information

SMALL BUSINESS OH&S SELF APPRAISAL

SMALL BUSINESS OH&S SELF APPRAISAL SMALL BUSINESS OH&S SELF APPRAISAL This questionnaire is designed to help you judge whether your Occupational Health & Safety Management System (OHSMS) is ready for assessment. Completing this questionnaire

More information

BLOOM AND WAKE (ELECTRICAL CONTRACTORS) LIMITED QUALITY ASSURANCE MANUAL

BLOOM AND WAKE (ELECTRICAL CONTRACTORS) LIMITED QUALITY ASSURANCE MANUAL 130 Wisbech Road Outwell Wisbech Cambridgeshire PE14 8PF Tel: (01945) 772578 Fax: (01945) 773135 Copyright 2003. This Manual and the information contained herein are the property Bloom & Wake (Electrical

More information

Business Management System Manual. Context, Scope and Responsibilities

Business Management System Manual. Context, Scope and Responsibilities Business Management System BMS Manual Page 1 of 11 Business Management System Manual Context, Scope and Responsibilities ISO 9001:2015 BMS.0100 R1 MAS Solutions LLC 29810 FM 1093 Suite C Fulshear, TX 77441

More information

Implementing ISO 9001

Implementing ISO 9001 If you are faced with implementing ISO 9001, or anticipate it may soon become a requirement for your organization, keep reading. This article identifies reasons to implement the standard, summarizes its

More information

The way from ISO/TS 16949:2002 Model to EFQM Excellence Modelcomparisons

The way from ISO/TS 16949:2002 Model to EFQM Excellence Modelcomparisons 51 st EOQ Congress, Prague 2007 The way from ISO/TS 16949:2002 Model to EFQM Excellence Modelcomparisons & consequences. Jan HNÁTEK IATF Reg. Auditor, EEA Assessor Vicepresident Czech Society for Quality

More information

ISO 9001 Quality Management Systems. Tips for Internal Auditing

ISO 9001 Quality Management Systems. Tips for Internal Auditing ISO 9001 Quality Management Systems Tips for Internal Auditing ...taking steps to improving your internal auditing. ISO 9001 Tips for Internal Auditing If you are developing or modifying your internal

More information

CUSTOMER SPECIFIC REQUIREMENTS

CUSTOMER SPECIFIC REQUIREMENTS CUSTOMER SPECIFIC REQUIREMENTS For Use With ISO 9001:2008 & ISO/TS 16949:2009 Page 1 SYSTEMS POLICY MANUAL CONTENTS Revision History Approval Document Distribution and Control General Application Background

More information

G & R Labs. Quality Assurance Manual. G&R Labs. 2996 Scott Boulevard Santa Clara CA 95054. Light Meters and Calibration

G & R Labs. Quality Assurance Manual. G&R Labs. 2996 Scott Boulevard Santa Clara CA 95054. Light Meters and Calibration G & R Labs Light Meters and Calibration Quality Assurance Manual G&R Labs 2996 Scott Boulevard Santa Clara CA 95054 QM01 QUALITY MANUAL ISO9001:2008 Manual Contents QM 01 Manual Contents 2 QM 02 Copy Holder

More information

INTERNAL QUALITY AUDITS

INTERNAL QUALITY AUDITS Page 1 of 12 INTERNAL QUALITY AUDITS Name Prepared: Quality Management Representative Signature 14/6/2010 Date Approved By : Director 14/6/2010 Page 2 of 12 Contents 1. GENERAL... 3 1.1 PURPOSE... 3 1.2

More information

Revision Date Author Description of change. 10 07Jun13 Mark Benton Removed Admin. Manager from approval

Revision Date Author Description of change. 10 07Jun13 Mark Benton Removed Admin. Manager from approval Page 2 of 15 Document Revision History Revision Date Author Description of change 10 07Jun13 Mark Benton Removed Admin. Manager from approval 12Feb13 Mark Benton 08 01Oct12 Mark Benton 07 8/30/2012 Refer

More information

ISO 9001:2008 Quality Manual Clause 3.7.4

ISO 9001:2008 Quality Manual Clause 3.7.4 ISO 9001:2008 Quality Manual Clause 3.7.4 Strode Park Foundation for People with Disabilities Approvals The signatures below certify that this Quality Manual has been reviewed and accepted, and demonstrates

More information

IRCA Certificated QMS Lead Auditor Training Course. Programme

IRCA Certificated QMS Lead Auditor Training Course. Programme IRCA Certificated QMS Lead Auditor Training Course Programme Day 1 08.30 Registration 09.00 Introductions / Course overview / Delegate assessment IRCA and the Auditor Certification Scheme 09.45 An Overview

More information

ISO 9001:2015 vs. ISO 9001:2008

ISO 9001:2015 vs. ISO 9001:2008 ISO 9001:2015 vs. ISO 9001:2008 (A side by side comparison) Many people are understandably curious about how the new ISO 9001:2015 stacks up against the existing ISO 9001:2008 standard. Perry Johnson Registrars

More information

Abu Dhabi EHSMS Regulatory Framework (AD EHSMS RF)

Abu Dhabi EHSMS Regulatory Framework (AD EHSMS RF) Abu Dhabi EHSMS Regulatory Framework (AD EHSMS RF) Technical Guideline Audit and Inspection Version 2.0 February 2012 Table of Contents 1. Introduction... 3 2. Definitions... 3 3. Internal Audit... 3 3.1

More information

UNCONTROLLED COPY FOR REFERENCE ONLY

UNCONTROLLED COPY FOR REFERENCE ONLY CLOVER MACHINE AND MFG. 800 MATHEW ST. #101 SANTA CLARA, CA 95050 727-3380 727-7015 fax REVISION: DATE: PAGE 1 OF 45 QUALITY POLICY MANUAL DISTRIBUTION LIST: President Purchasing Manager Vice President

More information

www.transition-support.com

www.transition-support.com Can we include all products and services in the QMS but limit the scope of registration? According to ISO/TC 176/SC 2/N 524, organizations are not obliged to include all the products that it provides within

More information

Eagle Machining, Inc. Quality Management System

Eagle Machining, Inc. Quality Management System Eagle Machining, Inc. Quality Management System 1 of 10310 Antoine Drive Bldg D, Houston, Texas 77086 BUSINESS OPERATING MANUAL (QUALITY MANUAL) Revision Date: 08/01/2014 Approved By: Joseph Vu Date: 08/01/2014

More information

ISO 14001:2004 EMS Internal Audit Guidance

ISO 14001:2004 EMS Internal Audit Guidance ISO 14001:2004 EMS Internal Audit Guidance Contents Introduction... 3 About the Internal Audit Solution... 3 Forms & Records... 3 Audit Procedure... 3 Document Reference Numbering... 4 Navigating the Documents...

More information

Quality Manual ISO 9001:2015 Quality Management System

Quality Manual ISO 9001:2015 Quality Management System Quality management input comprises the standard requirements from ISO 9001:2015 which are deployed by our organization to achieve customer satisfaction through process control. Quality Manual ISO 9001:2015

More information

Quality Thinking in other Industries. Dominic Parry Inspired Pharma Training. WEB www.inspiredpharma.com GMP BLOG inspiredpharmablog.

Quality Thinking in other Industries. Dominic Parry Inspired Pharma Training. WEB www.inspiredpharma.com GMP BLOG inspiredpharmablog. Quality Thinking in other Industries Dominic Parry Inspired Pharma Training WEB www.inspiredpharma.com GMP BLOG inspiredpharmablog.com Welcome The traditional focus on quality Quality in the eyes of GMP

More information

John Tighe ISO 9001 Lead Auditor & Scheme Champion. Alongside CD1, the ballot for 3 specific questions agreed in Sept 2013.

John Tighe ISO 9001 Lead Auditor & Scheme Champion. Alongside CD1, the ballot for 3 specific questions agreed in Sept 2013. ISO 9001:2015 Draft. Fergal O Byrne, Head of Business Excellence Certification. John Tighe ISO 9001 Lead Auditor & Scheme Champion. NSAI 1 Alongside CD1, the ballot for 3 specific questions agreed in Sept

More information

ISO 9001:2000 Its Impact on Software

ISO 9001:2000 Its Impact on Software ISO 9001:2000 Its Impact on Software Norman P. Moreau, PE, CSQE, CQA Theseus Professional Services, LLC Westminster, Maryland 410-857-0023 / nmoreau@erols.com / http://theseuspro.com Presented to American

More information

TOTAL QUALITY MANAGEMENT II QUALITY AUDIT

TOTAL QUALITY MANAGEMENT II QUALITY AUDIT TOTAL QUALITY MANAGEMENT II Chapter 13: QUALITY AUDIT Dr. Shyamal Gomes Introduction: The term audit was defined in the 16th Century as the official examination of the accounts with verification by reference

More information

Process Mapping and Process- Based Internal Audits

Process Mapping and Process- Based Internal Audits Process Mapping and Process- Based Internal Audits Presented by Shannon Craddock of Perry Johnson Registrars, Inc. September 21, 2011 Today s Topics Why Are We Doing This? Process Terminology Process Mapping

More information

Table of Contents INTEGRATED MANAGEMENT SYSTEM MANUAL

Table of Contents INTEGRATED MANAGEMENT SYSTEM MANUAL Table of Contents INTRODUCTION... 4 COMMON REQUIREMENTS... 5 1. SCOPE... 7 1.1 DESCRIPTION OF ORGANIZATION... 7 1.2 SCOPE OF CERTIFICATION... 7 1.3 THIRD PARTY CERTIFICATION... 7 2. REFERENCES... 8 3.

More information

DEPARTMENT OF COMMERCE ENVIRONMENTAL MANAGEMENT SYSTEM

DEPARTMENT OF COMMERCE ENVIRONMENTAL MANAGEMENT SYSTEM DEPARTMENT OF COMMERCE ENVIRONMENTAL MANAGEMENT SYSTEM Audit Report Audit Dates: November 14-15, 2012 Prepared by: Kurt Schlomberg National Renewable Energy Laboratory For Internal Use Only ii. Table of

More information

Introduction to AS 9100

Introduction to AS 9100 Introduction to AS 9100 Rev. C 1 Questions we will cover today: What is AS9100? What does a company need to do to Register to AS9100 Rev C? What are the requirements? Section 4 General Requirements Section

More information

ISO 9001:2015 Internal Audit Checklist

ISO 9001:2015 Internal Audit Checklist Page 1 of 14 Client: Date: Client ID: Auditor Audit Report Key - SAT: Satisfactory; OBS: Observation; NC: Nonconformance; N/A: Not Applicable at this time Clause Requirement Comply Auditor Notes / Evidence

More information

QUALITY MANUAL 3 KENDRICK ROAD WAREHAM, MA 02571 508-295-9591 FAX 508-295-6752

QUALITY MANUAL 3 KENDRICK ROAD WAREHAM, MA 02571 508-295-9591 FAX 508-295-6752 QUALITY MANUAL 3 KENDRICK ROAD WAREHAM, MA 02571 508-295-9591 FAX 508-295-6752 Section 1. REVISION STATUS Revision 01 Initial Issue 02/13/95 Revision 02 ECO No.Q-0032 05/07/96 Revision 03 ECO No.97171

More information

Correlation matrices between 9100:2009 and 9100:2016

Correlation matrices between 9100:2009 and 9100:2016 Correlation matrices between 9100:2009 and 9100:2016 This document gives correlation matrices from 9100:2009 to 9100:2016. This document can be used to highlight where the new and revised clauses are located.

More information

When printed the document is for reference only and is considered uncontrolled - refer to the Document Control System for the most current version

When printed the document is for reference only and is considered uncontrolled - refer to the Document Control System for the most current version QM-1 SUPPLEMENT QUALITY MANAGEMENT SYSTEMS MANUAL Revision 6 Page: 1 of 6 APPROVED BY: TITLE DATE Electronic Signature on file Quality Director 10/3/15 D. Picciotti Page: 2 of 6 DOCUMENT REVISION HISTORY

More information

QMS - Johtaminen. Tom Ståhlberg 20.3.2013. FiHTA

QMS - Johtaminen. Tom Ståhlberg 20.3.2013. FiHTA QMS - Johtaminen Tom Ståhlberg 20.3.2013 FiHTA Management subsystem QSR and ISO 13485:2003 Responsibilities Quality Policy Resources Management representative Management Review Quality planning Quality

More information

Six Sigma, ISO 9001 and Baldrige

Six Sigma, ISO 9001 and Baldrige Six Sigma, ISO 9001 and Baldrige Many organizations ask How Do these programs, processes and standards support each other? These initiatives are not mutually exclusive, in fact, understanding and applying

More information

Control No: QQM-02 Title: Quality Management Systems Manual Revision 10 07/08/2010 ISO 9001:2008 Page: 1 of 22

Control No: QQM-02 Title: Quality Management Systems Manual Revision 10 07/08/2010 ISO 9001:2008 Page: 1 of 22 ISO 9001:2008 Page: 1 of 22 Central Technologies has developed a Quality Management System, and the associated procedures and work instructions, to be compliant to ISO 9001:2008. Utilizing this Quality

More information

SAMPLE POLICY FROM ISO 9001 QMS POLICIES, PROCEDURES AND FORMS MANUAL INCLUDES A LIST OF TOPICS AND FORMS

SAMPLE POLICY FROM ISO 9001 QMS POLICIES, PROCEDURES AND FORMS MANUAL INCLUDES A LIST OF TOPICS AND FORMS US$ 595.00 How to Order: Online: www.bizmanualz.com By Phone: 314-384-4183 866-711-5837 Email: sales@bizmanualz.com ISO 9001 Quality Procedures For Quality Management Systems The Bizmanualz ISO 9001 Quality

More information

WORKPLACE HEALTH AND SAFETY AUDITING GUIDELINES

WORKPLACE HEALTH AND SAFETY AUDITING GUIDELINES WHS UNIT WORKPLACE HEALTH AND SAFETY AUDITING GUIDELINES Contents 1 Purpose... 1 2 Scope... 1 3 Definitions... 1 4 Responsibilities... 1 4.1 WHS Unit... 1 4.2 Auditor(s)... 1 4.3 Managers of Faculties

More information

Auditing HACCP Programs

Auditing HACCP Programs Auditing HACCP Programs Roger Roeth Executive Technical Officer 2016 EAGLE Certification Group includes EAGLE Registrations Inc. and EAGLE Food Registrations Inc. 1 Overview This training is applicable

More information

Quality Assurance System Manual

Quality Assurance System Manual The online version of this procedure is official. Therefore, all printed versions of this document are unofficial copies. St. Louis Public Schools Quality Assurance System Manual 801 North 11 th Street

More information

ISO 9001 : 2000 Quality Management Systems Requirements

ISO 9001 : 2000 Quality Management Systems Requirements A guide to the contents of ISO 9001 : 2000 Quality Management Systems Requirements BSIA Form No. 137 February 2001 This document is the copyright of the BSIA and is not to be reproduced without the written

More information

ISO 9001 Quality Management System Lead Auditor Training (IRCA)

ISO 9001 Quality Management System Lead Auditor Training (IRCA) ISO 9001 Quality Management System Lead Auditor Training (IRCA) Course Description BSI s Quality Management Systems (QMS) Auditor/Lead Auditor Training Course (ISO 9001) course teaches the principles and

More information

The following paragraphs, identified to coincide with the OHSAS 18001:2007 numbering system, provide a clause-by-clause summary of the standard.

The following paragraphs, identified to coincide with the OHSAS 18001:2007 numbering system, provide a clause-by-clause summary of the standard. Summary of OHSAS 18001:2007 Requirements With this article, the 18000 store provides a brief and clear summary of the OHSAS 18001:2007 requirements. First of all, OHSAS 18001 is an international standard

More information