Process Auditing Overview. Webinar Presented by the Northern Michigan Section of ASQ

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Process Auditing Overview. Webinar Presented by the Northern Michigan Section of ASQ"

Transcription

1 Process Auditing Overview Webinar Presented by the Northern Michigan Section of ASQ

2 Presentation Overview Quick Refresh of Process Auditing Benefits Tools - Organizing for Process Audit Success Create Checklists to Capture Process Flow Internal Auditors Become Knowledgeable of ISO 9001:2015 Group Audit Exercise Using Several Requirements from ISO 9001:2015

3 Handouts In advance of this program, attendees should have received 4 checklists and 1 process matrix. A copy of ISO 9001:2015 is not necessary. If you did not receive, please to request the handouts.

4 Introduction As a third party auditor, I continue to see internal auditors struggling with process-based auditing because more prep time is required to develop system effectiveness questions and to review appropriate process metrics. This overview will present a quick refresher of process-based auditing and some prep tools and ideas to promote successful audit planning. ISO 9001:2015 is so constructed that it would be difficult to audit section by section achieve any benefit for driving the quality system for improvement. As part of a learning objective, we will conduct a group exercise using two new concepts from the revised standard Context of Organization and Risk Plan.

5 Section by Section Audits Ineffective Auditing section by section does not fulfill requirements of ISO 9001: nor ISO 9001: Sequence and interactions of processes will not be tested. Auditors can not evaluate goals for effectiveness by auditing sections of standard.

6 Process Auditing Benefits Auditing natural business processes, and checking to see that management is documenting their goals and watching to verify they are met or exceeded provides value to an organization. Employees know how their processes function - process auditing uses employee knowledge to document that the process is working or that action plans have been developed to improve the process.

7 Tools - Organize for Process Auditing Begin by obtaining or developing a good flow chart of how the organization functions. Create list of process names to be audited. Develop master set of checklists with processes to be audited. Begin audits by using master checklists - solicit feedback from internal auditor group regarding checklist effectiveness following first audit. Example did auditors review each listed element from the master checklist(s)? Was there enough time to cover all elements? Were these items documented? Checklist improvement ideas? Should checklists be split to create another separate audit?

8 Example Business Map System Processes: Document Control Records Control Competent Personnel C U S T O M E R Management Review Approved Suppliers Order Material Sales Order Rec d & Entered Scrap Receive & Inspect Material Check Inventory Metrics Objectives Nonconforming Material Generate Work Order Manuf. Eng. Pass? Internal Audit Risk plan and Evaluation Build Order Corrective Action Design Eng. Product Objectives Test or Inspect Ship or Stock Facilities ISO IAC 7 8 C U S T O M E R r

9 Process Map Tool Does Two Things It defines sequence and interactions of organization s main processes. Circled items identify key or core processes to be addressed: - Management and office processes - Design of the product and facilities engineering - Manufacturing and inspection of the product - Measurement and analysis of performance

10 More Tools - Master Set of Checklists Master checklist set is starting point and should be adjusted as program is tested. Some elements of the process may change if groupings or boxes on the process flow chart and checklist are too large to address in one audit, more process audits might be necessary. Example - possible changes might be office processes which include customer processes, purchasing, and leadership. Second change could be the manufacturing process. This would allow adequate time for inspection, shipping/stocking and non-conforming material.

11 Review Checklist Tools for Similarity and Differences Handouts: A ISO process audit checklist B ISO two page process audit checklist C Blank turtle diagram D - F-3036 PEAR E - ISO 9001:2015 Matrix Ø Inputs, activities, and outputs are clearly identified. Metrics(KPIs, Quality Objectives) identified, documented and space provided for documenting action plans when goals are not met.

12 Process Matrix - Tool Matrix in some form or another helps to complete audit schedule. Ensures that when all process audits are completed, all clauses of standard have been included and checklists and records capture completeness of audit schedule. Use the matrix document tool after all checklists have been created and adjusted.

13 Exercises - Develop Process Flow and Process-Based Checklist for Several 2015 Requirements Context of the Organization and Strategic Direction b (use process audit checklist) Risk Plan 4.4.1f 5.5.1d (use turtle diagram) e 9.3.2e

14 Review - Context of Organization 4.1 Understanding the organization Determine the external and internal issues that are relevant to the strategic direction and its ability to achieve the intended results. 4.2 Understanding the needs and expectations of interested parties a) Interested parties that are relevant to QMS b) Requirements of these interested parties Organization shall monitor & review information about these interested parties. 4.3 Determining the scope of QMS Maintain documented information

15 Context of Organization Page QMS and its processes Definition of its processes their sequence and interactions To the extent necessary a) maintain documented information b) retain documented information 5 Leadership Leadership and commitment 5.5.1b) Ensure Quality Policy, Quality Objectives are compatible with the context and strategic direction 6.2 Quality Objective maintain documented information

16 Context of Organization Page Management Review Top Management shall review the QMS to ensure alignment with strategic direction Management review shall: c) customer satisfaction & feedback from interested parties c) extent to which Quality Objectives have been met Management Review output. retain as documented information

17 Auditing Context of Organization What are the inputs? What are the activities? What are the outputs? What metrics might there be?

18 Exercise Review If auditor conducts an audit of Context of Organization early in the audit schedule, what information can be obtained that will be valuable during the remainder of the system audit?

19 Another Example of New Process - Risk Plan 6.1 Develop & maintain effectiveness of organization s risk planning Define risk - create list of departments where risk might be evaluated? Definition of Risk (ISO 9000, 3.7.9) = effect of uncertainty Notes to risk definition - risk could be both positive and negative most times risk only associated with negative events! 1) Quoting and contract review 2) 3)

20 Risk Activities to Observe Quoting & Contract Review - asking for more information when specifications have not been provided - risk mitigation. No quoting business - avoiding risk Purchasing - supplier selection process retaining risk by informed decision Manufacturing - error proofing eliminating risk source. Use of FMEAs, or FEAs changing likelihood or consequences. Opportunities - new products, new practices, using new technologies and other desirable effects. Data analysis, management review, corrective action changing likelihood or consequences or retaining risk by informed decisions.

21 Exercise - Develop Audit Plan for Risk Develop a flow chart using a turtle diagram: Inputs - what are the inputs that might be evaluated? What locations in a facility would auditors want to visit to question process owners relating to risk and the retained information? Name some outputs of a good risk plan? What questions should be asked of top management regarding risk and management review?

22 Exercise - Auditing Management Review e the effectiveness of actions taken to address risk and opportunities Management Review - presented with information to make an informed decision about organization s risk plan and effectiveness. Retained documented information should be available to help in this decision process.

23 Questions?

24 Suggestions for Internal Auditor Training Two to four hour training to focus on new components of ISO 9001:2015 including strategic direction, context of organization, risk plan, and documentation. Review organization s sequence/interaction map for firm s processes. Exercises to introduce auditors to process-based checklists. Conduct 2 to 4 hour process audit (teams of 2 or 3) using checklist. Conduct short debrief or end of audit training discussion seeking feedback for audit system improvement.

25 Summary Stronger focus on process auditing. Introducing the auditing of Context of the Organization, Risk Plan, and Management Review. Re-evaluate adjusting audit checklists to capture key components of ISO 9001:2015.

26 Thank You for Participating Further questions:

HOW TO IMPLEMENT ISO 9001

HOW TO IMPLEMENT ISO 9001 HOW TO IMPLEMENT ISO 9001 CHECKLISTS 2015 Page 1 Overview of - Quality management systems What needs to be in place? Before you start your quality journey or your organization has decided to review what

More information

A Risk Assessment-driven Quality Management System. A way forward to ISO 9001:2015. Juan Carlos Cerón Vinueza Bureau Veritas Australia

A Risk Assessment-driven Quality Management System. A way forward to ISO 9001:2015. Juan Carlos Cerón Vinueza Bureau Veritas Australia A Risk Assessment-driven Quality Management System A way forward to ISO 9001:2015 Juan Carlos Cerón Vinueza Bureau Veritas Australia 0. Introduction With the release of the new ISO 9001:2015 standard,

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

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

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

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

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

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

Karas Engineering AS9100 QUALITY MANAGEMENT SYSTEM MANUAL

Karas Engineering AS9100 QUALITY MANAGEMENT SYSTEM MANUAL Karas Engineering AS9100 QUALITY MANAGEMENT SYSTEM MANUAL Revision D October 27, 2015 Statement of Commitment and Authority Commitment This Quality Management System Manual (QMSM) delineates the processes,

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

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

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

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

Micro Plastics, Inc. Quality Manual

Micro Plastics, Inc. Quality Manual ISO 9001:2008 11 Industry Lane Flippin, Arkansas 72634 QM-001-2008-F Page 2 of 39 Introduction Micro Plastics, Inc. developed and implemented a Quality Management System in order to document the company

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

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

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

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

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

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

Moving from ISO 9001:2008 to ISO 9001:2015 Transition Guide

Moving from ISO 9001:2008 to ISO 9001:2015 Transition Guide ISO Revisions Latest update New and Revised Moving from ISO 9001:2008 to ISO 9001:2015 Transition Guide ISO 9001 - Quality Management System - Transition Guide Successful businesses understand the value

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

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 9001:2008 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

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

RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE. Quality Manual

RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE. Quality Manual RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE Quality Manual AS9100 & ISO9001: 2000 NTI/QM/001 CONTENTS Clauses of the standard Pg. # 1. Scope 4 1.1 General 4 1.2 Permissible exclusions 4

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

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

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

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

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

Quality Management System Manual QM-QUA-001

Quality Management System Manual QM-QUA-001 Quality Management System Manual QM-QUA-001 Nelson-Miller Inc. 2800 Casitas Avenue Los Angeles, Ca 90039 P a g e 2 Revision Date Description of the Change N/C 10/10/79 Initial release of documented inspection

More information

Quality Manual. UK Wide Security Solutions Ltd. 1 QM-001 Quality Manual Issue 1. January 1, 2011

Quality Manual. UK Wide Security Solutions Ltd. 1 QM-001 Quality Manual Issue 1. January 1, 2011 Quality Manual 1 QM-001 Quality Manual Issue 1 January 1, 2011 This document is uncontrolled when printed. Please verify with Quality Management Representative 16 Dukes Close, West Way, Walworth Industrial

More information

TÜV UK Ltd Guidance & Self Evaluation Checklist

TÜV UK Ltd Guidance & Self Evaluation Checklist ISO 9001:2015 Revision TÜV UK Ltd Guidance & Self Evaluation Checklist Why ISO 9001 is changing All ISO management system standards are subject to a periodic review under the rules by which they are written.

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

Cartel Electronics. AS 9100 Quality Systems Manual

Cartel Electronics. AS 9100 Quality Systems Manual Cartel Electronics AS 9100 Quality Systems Manual 1900 C Petra Lane Placentia, California 92870 Introduction Cartel Electronics, as a global supplier to the aviation, space, and space industries, has developed

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

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

ISO 9001:2015 Transition Guide

ISO 9001:2015 Transition Guide ISO 9001:2015 Transition Guide Updated May 12, 2016 ISO 9001:2015 Transition Guide It Doesn t Need to be Difficult Whether your organization is transitioning from ISO 9001:2008 to the new ISO 9001:2015,

More information

ISO 9001:2008 Implementation The 9000 Store Page 1 of 10

ISO 9001:2008 Implementation The 9000 Store  Page 1 of 10 Project Manager s Guide ISO 9001:2008 Implementation Page 1 of 10 Table of Contents Introduction...3 Project Plan...4 Scheduling and Conducting the Gap Analysis...6 The Planning Meetings...8 Holding Task

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

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

ISO 9001:2015 Draft International Standard. By ISOQAR (Hellas) Ltd

ISO 9001:2015 Draft International Standard. By ISOQAR (Hellas) Ltd ISO 9001:2015 Draft International Standard By ISOQAR (Hellas) Ltd!" Purpose The main purpose of this presentation is to provide an update on the expected contents of the ISO 9001:2015 (based on the ISO

More information

ISO Revisions. ISO 9001 Whitepaper. The importance of risk in quality management. Approaching change

ISO Revisions. ISO 9001 Whitepaper. The importance of risk in quality management. Approaching change ISO Revisions ISO 9001 Whitepaper The importance of risk in quality management Approaching change Background and overview to the ISO 9001:2015 revision As an International Standard, ISO 9001 is subject

More information

ISO 9001:2015 Your implementation guide

ISO 9001:2015 Your implementation guide ISO 9001:2015 Your implementation guide ISO 9001 is the world s most popular management system standard Updated in 2015 to make sure it reflects the needs of modern-day business, ISO 9001 is the world

More information

Advanced Product Quality Planning and Control Plans based on APQP 2 nd Edition

Advanced Product Quality Planning and Control Plans based on APQP 2 nd Edition Advanced Product Quality Planning and Control Plans based on APQP 2 nd Edition Mark A. Morris ASQ Automotive Division Webinar February 8, 2012 mark@mandmconsulting.com www.mandmconsulting.com Five Fundamental

More information

ISO 9001 Quality Systems Manual

ISO 9001 Quality Systems Manual ISO 9001 Quality Systems Manual Revision: D Issue Date: March 10, 2004 Introduction Micro Memory Bank, Inc. developed and implemented a Quality Management System in order to document the company s best

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

THE PROCESS APPROACH IN ISO 9001:2015

THE PROCESS APPROACH IN ISO 9001:2015 International Organization for Standardization BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland Tel: +41 22 749 01 11, Web: www.iso.org THE PROCESS APPROACH IN ISO 9001:2015 Purpose

More information

I S O 9 0 0 1 2 0 1 5 T R AN S L AT ED I N T O P L AI N E N G L IS H 4. C O N T EX T

I S O 9 0 0 1 2 0 1 5 T R AN S L AT ED I N T O P L AI N E N G L IS H 4. C O N T EX T 4.1 UNDERSTAND YOUR ORGANIZATION AND ITS UNIQUE CONTEXT 1 Identify and understand your organization's context. An organization s context is its business environment. It includes all of the internal 2 Identify

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

FINE LOGISTICS. Quality Manual. Document No.: 20008. Revision: A

FINE LOGISTICS. Quality Manual. Document No.: 20008. Revision: A FINE LOGISTICS Quality Manual Document No.: 20008 Revision: A 20008 Rev. A FINE LOGISTICS, Quality Manual Page 1 of 24 Quality Manual: Table of contents Number Section Page 1. GENERAL 3 1.1 Index and revision

More information

ISO 9001:2008 Requirements Summary

ISO 9001:2008 Requirements Summary ISO 9001:2008 Requirements Summary In Plain English Created by Larry Whittington RABQSA Lead QMS Auditor (2406) IRCA Lead QMS Auditor (A6472) ASQ Senior Member Whittington & Associates, LLC Distributed

More information

Virginia Transformer Corp. 220 Glade View Drive Roanoke, Virginia 24012 USA C0098193. Audit Type Surveillance Audit. Auditor Jennifer Edwards

Virginia Transformer Corp. 220 Glade View Drive Roanoke, Virginia 24012 USA C0098193. Audit Type Surveillance Audit. Auditor Jennifer Edwards Virginia Transformer Corp. 220 Glade View Drive Roanoke, Virginia 24012 USA C0098193 Audit Type Surveillance Audit Auditor Jennifer Edwards Standard (Exp Date: 16-JUL-2015) Recommendation : Surveillance:

More information

KENYA FOREST SERVICE DOCUMENT TITLE: INTERNAL QUALITY AUDITS

KENYA FOREST SERVICE DOCUMENT TITLE: INTERNAL QUALITY AUDITS REF NO: KFS-MP-IQA-04 ISSUE NO: 1 PAGE: 1 of 13 ISSUE HISTORY ISSUE DESCRIPTION OF CHANGE PROCESS PILOT EFFECTIVE DATE 1 None, no change has been done. Management Representative REFERENCED DOCUMENTS COPY

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

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

ISO 9001:2008 Quality Systems Manual

ISO 9001:2008 Quality Systems Manual ISO 9001:2008 [Company Name] ADDRESS Phone: Phone: Fax: Fax: The holder of this manual is cautioned that the information contained herein must not be loaned or circulated outside of [Company Name] except

More information

Effective Internal Audit Planning:

Effective Internal Audit Planning: 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 Outline Definitions of Key Audit

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

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 9001:2008 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

Recent Changes. Aerospace Standards: What You Need to Know. White Paper. An ABS Quality Evaluations. What You Need to Know

Recent Changes. Aerospace Standards: What You Need to Know. White Paper. An ABS Quality Evaluations. What You Need to Know Recent Changes Changes in Aerospace Standards: in Aerospace Standards: An ABS Quality Evaluations White Paper 16855 Northchase Dr. Houston, TX 77060 1-281-673-2843 www.abs-qe.com Recent Changes Changes

More information

ISO Revisions Whitepaper

ISO Revisions Whitepaper ISO Revisions ISO Revisions Whitepaper What is the difference between a procedures and a process approach? Approaching change Process vs procedures: What does this mean? The concept of process management

More information

ISO 9000 Introduction and Support Package: Guidance on the Documentation Requirements of ISO 9001:2008

ISO 9000 Introduction and Support Package: Guidance on the Documentation Requirements of ISO 9001:2008 Document: ISO/TC 176/SC 2/N 525R2 ISO 9000 Introduction and Support Package: 1 Introduction Two of the most important objectives in the revision of the ISO 9000 series of standards have been a) to develop

More information

Rev: Issue 4 Rev 4 Quality Manual AOP0101 Date: 10/07/13. Quality Manual. CBT Technology, Inc. 358 North Street Randolph, MA 02368

Rev: Issue 4 Rev 4 Quality Manual AOP0101 Date: 10/07/13. Quality Manual. CBT Technology, Inc. 358 North Street Randolph, MA 02368 Quality Manual CBT Technology, Inc. 358 North Street Randolph, MA 02368 Issue 4 Revision 4 Note: updates are in italics Page 1 of 18 1.0 Scope and Exclusions Scope This Quality Manual contains policies

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

AS9100:2016 Transition Guide

AS9100:2016 Transition Guide AS9100:2016 Transition Guide Updated August 24, 2016 AS9100 Series Overview AS9100 Aerospace Management Systems is a widely adopted and standardized quality management system for the aerospace industry.

More information

Updates on CD/ISO 9001:2015

Updates on CD/ISO 9001:2015 Updates on CD/ISO 9001:2015 Presented by Zainab Ibrahim, Senior Auditor, TUV SUD PSB Pte Ltd 30 th January 2014 27/01/2014 Corporate Presentation Slide 1 Agenda 1 About ISO 9001 & the Revision Timeline

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 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 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

Luminus Devices, Inc Quality Management Systems Manual ISO 9001:2008

Luminus Devices, Inc Quality Management Systems Manual ISO 9001:2008 Luminus Devices, Inc Quality Management Systems Manual ISO 9001:2008 This document belongs to Luminus Devices, Inc. It cannot be reproduced without authorized authority. Area: Quality System Document Page

More information

IATF Future Direction & Changes to ISO/TS16949

IATF Future Direction & Changes to ISO/TS16949 IATF Future Direction & Changes to ISO/TS16949 21 st April 2016 During presentations (10:30 11:00) everyone will be muted so that only the presenters will be heard. The presentation will be followed by

More information

System Development Life Cycle Guide

System Development Life Cycle Guide TEXAS DEPARTMENT OF INFORMATION RESOURCES System Development Life Cycle Guide Version 1.1 30 MAY 2008 Version History This and other Framework Extension tools are available on Framework Web site. Release

More information

QUALITY MANUAL REVISION RECORD

QUALITY MANUAL REVISION RECORD Page 2 of 31 REVISION RECORD Date Rev Description Jun 18, 2007 N/C Original Issue Sep 16, 2009 A Update to ISO 9001:2008 Standard. Feb 04, 2010 B Revised exclusions, removed (Except 7.3.7 from the exclusion

More information

VERTECHS ENTERPRISES, INC.

VERTECHS ENTERPRISES, INC. Page 1 of 32 VERTECHS ENTERPRISES, INC. Dba LUCHNER TOOL ENGINEERING 788 Greenfield Drive El Cajon, CA 92021 Ph No. 1-858-578-3900. Fax No. 1-858-578-2910 Reviewed and Approved By: Geosef (Joey) Straza

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

QMS Manual 2350 Helen Street, N. St. Paul, MN 55109 Page 1 of 5. Quality Management System Manual

QMS Manual 2350 Helen Street, N. St. Paul, MN 55109 Page 1 of 5. Quality Management System Manual 2350 Helen Street, N. St. Paul, MN 55109 Page 1 of 5 AETRIUM Quality Management System Manual 2350 Helen Street, N. St. Paul, MN 55109 Page 2 of 5 Introduction It is a strategic decision by Aetrium management

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

GENERIC STANDARDS CUSTOMER RELATIONSHIPS FURTHER EXCELLENCE CUSTOMISED SOLUTIONS INDUSTRY STANDARDS TRAINING SERVICES THE ROUTE TO

GENERIC STANDARDS CUSTOMER RELATIONSHIPS FURTHER EXCELLENCE CUSTOMISED SOLUTIONS INDUSTRY STANDARDS TRAINING SERVICES THE ROUTE TO PROCESSES SUPPLY CHAIN SKILLED TALENT CUSTOMER RELATIONSHIPS FURTHER EXCELLENCE GENERIC STANDARDS INDUSTRY STANDARDS CUSTOMISED SOLUTIONS TRAINING SERVICES THE ROUTE TO ISO 9001:2015 FOREWORD The purpose

More information

The President of Inductors Inc. is the senior executive responsible for operations.

The President of Inductors Inc. is the senior executive responsible for operations. Title: Quality Management System Manual Page: 1 of 20 INTRODUCTION Inductors Inc., founded in 1991, specializes in the distribution of inductive components, including but not limited to standard and custom

More information

Quality Systems Manual

Quality Systems Manual Quality Systems Manual This manual was developed to support ISO 9001 elements Revision Description of Change Author Effective Date 5-28-02 Initial Release Support ISO 9001: 2000 L. Hook 5-28-02 7-01-02

More information

Suburban Manufacturing Inc. 10531 Dalton Avenue NE Monticello, MN 55362 (800) 782-5752 www.gosuburban.com. Quality Manual

Suburban Manufacturing Inc. 10531 Dalton Avenue NE Monticello, MN 55362 (800) 782-5752 www.gosuburban.com. Quality Manual Suburban Manufacturing Inc. 10531 Dalton Avenue NE Monticello, MN 55362 (800) 782-5752 www.gosuburban.com Quality Manual Engineering Value through Quality and Innovation Suburban Manufacturing, Inc. proudly

More information

Supplier Guide. Suppliers for production material or services may be qualified for the list in one or more of the following ways:

Supplier Guide. Suppliers for production material or services may be qualified for the list in one or more of the following ways: Supplier Guide Purpose The purpose of this guide is to inform potential and current Suppliers to Jay Industries, Inc. of our policies as well as quality and performance requirements. Application This guide

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

AS9100 Quality Manual

AS9100 Quality Manual Origination Date: August 14, 2009 Document Identifier: Quality Manual Revision Date: 8/5/2015 Revision Level: Q AS 9100 UNCONTROLLED IF PRINTED Page 1 of 17 1 Scope Advanced Companies (Advanced) has established

More information

Camar Aircraft Products Co. QUALITY MANUAL Revision D

Camar Aircraft Products Co. QUALITY MANUAL Revision D QUALITY MANUAL Revision D Gujll'y Manual Introduction The purpose of this manual is to describe the Quality Assurance Program implemented by Camar Aircraft Products Co. (hereafter referred to as C.A.P.C.)

More information

Chapter 2 ISO 9001:2008 QMS

Chapter 2 ISO 9001:2008 QMS Chapter 2 ISO 9001:2008 QMS For internal use of BSNL only Page 1 ISO 9001:2008 QMS Introduction Everyone wants to achieve profits. Profits can come by more sales with some profit margin and also by cutting

More information

Advanced Quality Planning: A Guide for Any Organization

Advanced Quality Planning: A Guide for Any Organization Advanced Quality Planning: A Guide for Any Organization Most organizations already have some system in place that can be adapted to avoid starting from scratch. by Laurence C. Thisse MANY ORGANIZATIONS

More information

ISO 9001:2015 Overview of the Revised International Standard

ISO 9001:2015 Overview of the Revised International Standard ISO 9001:2015 Overview of the Revised International Standard Introduction This document provides: a summary of the new ISO 9001:2015 structure. an overview of the new and revised ISO 9001:2015 requirements

More information

14620 Henry Road Houston, Texas 77060 PH: 281-447-3980 FX: 281-447-3988. WEB: www.texasinternational.com QUALITY MANUAL

14620 Henry Road Houston, Texas 77060 PH: 281-447-3980 FX: 281-447-3988. WEB: www.texasinternational.com QUALITY MANUAL 14620 Henry Road Houston, Texas 77060 PH: 281-447-3980 FX: 281-447-3988 WEB: www.texasinternational.com QUALITY MANUAL ISO 9001:2008 API Spec Q1, 9th Edition API Spec 8C 5 Th Edition MANUAL NUMBER: Electronic

More information

CENTRIS CONSULTING. Quality Control Manual

CENTRIS CONSULTING. Quality Control Manual CENTRIS CONSULTING Quality Control Manual ISO 9001:2008 Introduction Centris Consulting developed and implemented a Quality Management System in order to document the company s best business practices,

More information

Quality Management: Co-ordinated activities to direct and control an organisation with regards to quality ISO9000

Quality Management: Co-ordinated activities to direct and control an organisation with regards to quality ISO9000 Plan the Development of Your Quality System Half a day spent thinking and planning how you will approach your ISO 9001 accreditation and certification will leave you with a project scope that makes sense,

More information

Quality, Environmental, Health and Safety Manual Toshiba International Corporation

Quality, Environmental, Health and Safety Manual Toshiba International Corporation Quality, Environmental, Health and Safety Manual Toshiba International Corporation Doc. No. QEHS 001 Rev. 19 (12/12) Title: Prepared By: Revision No.: Table of Contents and Cross Reference Ken Mori/Homer

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 Quality Management Systems Professional

ISO 9001 Quality Management Systems Professional ISO 9001 Quality Management Systems Professional Professional Certifications Sample Questions Sample Questions 1. The non-fulfillment of a specified requirement is called a: A. Concession B. Nonconformity

More information

When Recognition Matters WHITEPAPER ISO GUIDANCE ON PROJECT MANAGEMENT.

When Recognition Matters WHITEPAPER ISO GUIDANCE ON PROJECT MANAGEMENT. When Recognition Matters WHITEPAPER ISO 21500 GUIDANCE ON PROJECT MANAGEMENT www.pecb.com CONTENT 3 4 4 7 8 8 Introduction An Overview of ISO 21500:2012 Key Clauses of ISO 21500:2012 Link between ISO 21500

More information

What changes will ISO 9001:2015 bring?

What changes will ISO 9001:2015 bring? What changes will ISO 9001:2015 bring? 1 Introduction This presentation will cover the following topics: The ISO 9001 Revision Process Key Inputs to ISO 9001:2015 The High Level Structure Key Changes in

More information

Appreciative Internal Audit:

Appreciative Internal Audit: Appreciative Internal Audit: A Strength-Based Approach to System Quality Auditing Presented to ASQ Section 0511 20 May 2009 by Robert Zimman, CQA Session Overview Why Appreciative Internal Audits? What

More information