DESIGN AND DEVELOPMENT
|
|
|
- Elaine McDonald
- 6 years ago
- Views:
Transcription
1 DESIGN AND DEVELOPMENT Requirements - ISO 9001:2008 (7.3) Supplemental Guidance - ISO 9004:2000 1
2 Design Planning (7.3.1) 2 The organization shall plan and control the design and development of product. During the design and development planning the organization shall determine the design and development stages, the review, verification and validation that are appropriate to each design and development stage, and the responsibilities and authorities for design and development. The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Planning output shall be updated, as appropriate, as the design and development progresses.
3 Design Inputs (7.3.2) Inputs relating to product requirements shall be determined and records maintained. These shall include: functional and performance requirements, applicable statutory and regulatory requirements, where applicable, information derived from previous similar designs, and other requirements essential for design and development. These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other. 3
4 Design Inputs - External customer or marketplace needs and expectations, needs and expectation of other interested parties, supplier's contributions, user input to achieve robust design and development, changes in relevant statutory and regulatory requirements, international or national standards, and industry codes of practice; 4
5 Design Inputs - Internal policies and objectives, needs and expectations of people in the organization, including those receiving the output of the process, technological developments, competence requirements for people performing design and development, feedback information from past experience, records and data on existing processes and products, and outputs from other processes; 5
6 Design Inputs - Other inputs that identify those characteristics of processes or products that are crucial to safe and proper functioning and maintenance, such as: operation, installation and application, storage, handling and delivery, physical parameters and the environment, and requirements for disposal of the products. 6
7 Design Outputs (7.3.3) The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. Design and development outputs shall meet the input requirements for design and development, provide appropriate information for purchasing, production and for service provision, contain or reference product acceptance criteria, and specify the characteristics of the product that are essential for its safe and proper use. 7
8 Examples - Design Outputs data demonstrating the comparison of process inputs to process outputs, product specifications, including acceptance criteria, process specifications, material specifications, testing specifications, training requirements, user and consumer information, purchase requirements, and reports of qualification tests. 8
9 Design Reviews (7.3.4) At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements to evaluate the ability of the results of design and development to meet requirements, and to identify any problems and propose necessary actions. Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained. 9
10 Examples - Design Reviews adequacy of input to perform the design and development tasks, progress of the planned design and development process, meeting verification and validation goals, evaluation of potential hazards or fault modes in product use, life-cycle data on performance of the product, control of changes and their effect during the design and development process, identification and correction of problems, opportunities for design and development process improvement, and potential impact of the product on the environment. 10
11 Design Verification (7.3.5) Verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained. 11
12 Examples - Design Verification comparisons of input requirements with the output of the process, comparative methods, such as alternative design and development calculations, evaluation against similar products, testing, simulations or trials to check compliance with specific input requirements, and evaluation against lessons learned from past process experience, such as nonconformities and deficiencies. 12
13 Design Validation (7.3.6) Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, when known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained. 13
14 Supplemental - Design Validation Validation of the output of the design and development processes is important for the successful reception and use by customers, suppliers, people in the organization and other interested parties. Participation by the affected parties permits the actual users to evaluate the output by such means as validation of engineering designs prior to construction, installation or application, validation of software outputs prior to installation or use, and validation of services prior to widespread introduction. Partial validation of the design and development outputs may be necessary to provide confidence in their future application. 14
15 Change Control (7.3.7) Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be maintained. 15
16 Design Records Design records specified by ISO 9001:2008: Design Input reviews Design Output approvals Design Reviews (including input) Design Verification results Design Validation results and actions Design Change records 16
17 Contact Us MAS Solutions LLC Westheimer Rd #1 Houston TX Website: 17
ISO 9001:2015 TRANSITIONS
Copyright 2015 MAS Solutions LLC. All Rights Reserved. 1 ISO 9001:2015 TRANSITIONS 6.3 Planning of Changes Copyright 2015 MAS Solutions LLC. All Rights Reserved. 2 MANAGING CHANGE IN ISO 9001:2015 Jean
ISO 9001: 2000 (December 13, 2000) QUALITY MANAGEMENT SYSTEM DOCUMENTATION OVERVIEW MATRIX
In completing your Documented Quality Management System Review, it is important that the following matrix be completed and returned to us as soon as possible. This will save time during the review and
Subject: Quality Management System. Clause 8 - Operation
Subject: Quality Management System Clause 8 - Operation 31.3.2016. HOMEWORK? I cannot teach anybody anythink. I can only make them think. Socrates (Greek philosopher, 470/469 399 BC ) Contents ISO 9001:2015
UPGRADE ASSESSMENT CHECKLIST
Checklist Instructions : Prior to auditing each element, the auditor shall review the documentation and mark a 0 in each box where functions /departments are referenced. As each function/department is
4. Quality Management System 4.1 GENERAL REQUIREMENTS
Checklist Instructions : Prior to auditing each element, the auditor shall review the documentation and mark an 0 in each box where functions /departments are referenced. As each function/department is
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
Machined Integrations, LLC
QUALITY MANUAL Machined Integrations, LLC ISO9001: 2008 Electronically Controlled by Quality Representative, Rev2, January 2014 Page 2 of 25 TABLE OF CONTENTS SECTION ELEMENT PAGE No A Revision and Approval
INTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 9001 Third edition 2000-12-15 Quality management systems Requirements Systèmes de management de la qualité Exigences Reference number ISO 9001:2000(E) ISO 2000 Contents Page
Design Quality. Indu Lakshman
Design Quality Indu Lakshman Overview New product development (NPD) covers the complete process of bringing a new product to market. In commercial terms, new product development is described in the literature
ISO9001:2008 SYSTEM KARAN ADVISER & INFORMATION CENTER QUALITY MANAGEMENT SYSTEM SYSTEM KARAN ADVISER & INFORMATION CENTER
SYSTEM KARAN ADVISER & INFORMATION CENTER QUALITY MANAGEMENT SYSTEM WWW.SYSTEMKARAN.COM 1 www.systemkaran.org Foreword... 5 Introduction... 6 0.1 General... 6 0.2 Process approach... 6 0.3 Relationship
1 Management Responsibility 1 Management Responsibility 1.1 General 1.1 General
1 Management Responsibility 1 Management Responsibility 1.1 General 1.1 General The organization s management with executive The commitment and involvement of the responsibility shall define, document
ISO 9001:2000 The International Quality Management Business System
ISO 9001:2000 The International Quality Management Business System Table of Contents What is ISO 9000? Page 1 The Benefits of ISO 9001:2000 Page 1 Why an ISO 9001:2000 System? Page 2 Major Steps to Implementation
Osprey Technologies, LLC. Quality Manual ISO9001:2008 Rev -
February 8, 2015 1 Osprey Technologies, LLC Quality Manual ISO9001:2008 Rev - February 8, 2015 Released by Dave Crockett President 6100 S. Maple Avenue, Suite 117 Tempe, AZ 85283 www.osprey-tech.com February
RULES FOR A QUALITY STANDARDS SYSTEM (QSS) IN MARITIME ACADEMIES/INSTITUTIONS
RULES FOR A QUALITY STANDARDS SYSTEM (QSS) IN MARITIME ACADEMIES/INSTITUTIONS I. Introduction 1. Background The international Convention on Standards of Training, Certification and Watchkeeping (STCW)
The following is an example systems manual from a low volume (TE, but not an automotive supplier) company.
The following is an example systems manual from a low volume (TE, but not an automotive supplier) company. You will note that this is essentially a copy of ISO 9001:2000. I take this path because long
ISO /TS 29001:2010 SYSTEMKARAN ADVISER & INFORMATION CENTER SYSTEM KARAN ADVISER & INFORMATION CENTER
SYSTEM KARAN ADVISER & INFORMATION CENTER PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES -- SECTOR-SPECIFIC QUALITY MANAGEMENT SYSTEMS -- REQUIREMENTS FOR PRODUCT AND SERVICE SUPPLY ORGANIZATIONS
25 D.L. Martin Drive Mercersburg, PA (717)
QUALITY MANUAL D. L. MARTIN CO. 25 D.L. Martin Drive Mercersburg, PA 17236 (717) 328-2141 Revision 14 August 2012 Michael A. White Manager, QA & Engineering D.L. Martin Co. Quality Manual UNCONTROLLED
INTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 9001 Quality management systems Requirements Systèmes de management de la qualité Exigences Fourth edition 2008-11-15 Reference number ISO 9001:2008(E) ISO 2008 PDF disclaimer
UNIVERSITY OF NAIROBI
Q# UNIVERSITY OF NAIROBI 4 CONTEXTS OF THE ORGANIZATION Yes No Remarks 4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT 1 Have we determined the external and internal issues that are relevant to our
BELDEN QUALITY SYSTEM OVERVIEW
BELDEN QUALITY SYSTEM OVERVIEW Table of Contents 1.0 Introduction 2.0 Quality Management System 3.0 Resource Management 4.0 Product Realization 5.0 Measurement, Analysis, and Improvement 1.0 Introduction
Correspondence between ICMED criteria and ISO 13485: 2012
Annexure A (Informative) Correspondence between ICMED 13485 criteria and ISO 13485: 2012 Green Font is additional ICMED 13485 criteria requirement. Additional ICMED 13485 criteria Requirements are also
CHAPTER 8 INTEGRATION OF QMS AND LMS
152 CHAPTER 8 INTEGRATION OF QMS AND 8.1 QUALITY MANAGEMENT SYSTEM There are various reasons for implementing a quality system that conforms to an ISO standard. The primary reason is that customers are
INTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 9001 Third edition 2000-12-15 Quality management systems Requirements Systèmes de management de la qualité Exigences Reference number ISO 9001:2000(E) ISO 2000 PDF disclaimer
Quality Management System Manual
SpecSys, Inc. recognizes its responsibility as a provider of quality products and services. To this end, SpecSys, Inc. has documented, implemented and maintains a System that complies with ISO 9001 2000.
ISO 9001:2015 Gap Analysis Check Sheet
CONTEXT OF THE ORGANIZATION 4.1 Understanding the organization and its context Organization shall determine external and internal issues that are relevant to its purpose and strategic direction and that
Railroad Friction Products Corporation
Railroad Friction Products Corporation Our Quality Philosophy: "At Railroad Friction Products Corporation we will consistently provide products that meet and exceed customer and regulatory requirements
Quality Assurance Manual, Revision F Page 1 of 20
Quality Assurance Manual, Revision F Page 1 of 20 AUTOMATION TECHNOLOGY QUALITY ASSURANCE MANUAL Prepared By: Joseph Pollard Date: 7/6/2015 Quality Assurance Manager Quality Management System Representative
ISO 13485:2016 The Final Countdown
ISO 13485:2016 The Final Countdown 03 April 2018 Robert G. Ruff Executive Director, Medical Device Certification and Training 1 This document is intended to facilitate an oral briefing. It is not intended
Internal Quality Auditing Procedure
Bundaberg Regional Council Organisational Services Issue Date: 12-08-2014 Review Date: 28-01-2018 Internal Quality Auditing Procedure PD-8-004. Rev. 3 1.0 PURPOSE The purpose of this procedure is to provide
Monroe Engineering is committed to customer satisfaction; we strive for Continuous Improvement in our products and our people.
Title: AS9100D Quality Manual Revision Date.: 05/04/2018 Page 1 of 22 The Quality Policy of Monroe Engineering is defined in the following statement: Monroe Engineering is committed to customer satisfaction;
UNCONTROLLED DOCUMENT
Rheem Manufacturing Company Fort Smith, Arkansas Original Release: 4/06/09 Revision Date: 10/25/16 Quality Management System D. Presley 05 1 of 1 Manual Contents A. Johnson 10/25/16 0 Section Title Revision
ISO 9001:2015 GAP ANALYSIS CHECKLIST
Context of the Organization 4.1 Understanding the organization and its context Organization shall determine external and internal issues that are relevant to its purpose and strategic direction and that
Project Procedure 1.0 PURPOSE 2.0 SCOPE 3.0 REFERENCES 4.0 DEFINITIONS. No.: P /21/2012 PAGE 1 OF 8 INTERNAL QUALITY AUDITS
Project Procedure INTERNAL QUALITY AUDITS 09/21/2012 PAGE 1 OF 8 1.0 PURPOSE The purpose of this procedure is to establish the requirements for a comprehensive system of planned and documented internal
APS Cleaning Quality Management System Scope of Certification The provision of commercial and industrial cleaning services throughout Queensland.
Quality Management System Scope of Certification The provision of commercial and industrial cleaning services throughout Queensland. Table of Contents Contents 1. Introduction... 3 1.1. Process Approach...
Specification for Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry
Addendum 1 June 2010 Effective Date: December 1, 2010 Specification for Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry ANSI/API SPECIFICATION Q1 EIGHTH EDITION, DECEMBER 2007
Sensor Scientific, Inc.
Sensor Scientific, Inc. 6 Kings Bridge Road Fairfield, New Jersey Quality Manual Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 1 of 21 Table of Contents Page 1. Introduction 3 2. Purpose
QUALITY MANUAL. Number: M-001 Revision: C Page 1 of 18 THIS DOCUMENT IS CONSIDERED UNCONTROLLED UNLESS ISSUED IDENTIFIED AS CONTROLLED
Page 1 of 18 THIS DOCUMENT IS CONSIDERED UNCONTROLLED UNLESS ISSUED IDENTIFIED AS CONTROLLED Page 2 of 18 REVISION HISTORY DATE CHANGE DESCRIPTION 10/11/06 Original release 10/21/09 Revised to ISO9001:2008
AEROSPACE STANDARD. Quality Systems - Aerospace - Model for Quality Assurance in Design, Development, Production, Installation and Servicing
AEROSPACE STANDARD AS9100 Technically equivalent to AECMA pren 9100 Issued 1999-11 Revised 2001-08 Superseding AS9100 REV. A Quality Systems - Aerospace - Model for Quality Assurance in Design, Development,
Mapping ISO/IEC 27001:2005 -> ISO/IEC 27001:2013
Mapping ISO/IEC 27001:2005 -> ISO/IEC 27001:2013 Carlos Bachmaier http://excelente.tk/ - 20140218 2005 2013 In 2005 0 Introduction 0 Process approach PDCA In 2013 0 No explicit process approach ISMS part
NATO QUALITY ASSURANCE REQUIREMENTS FOR DESIGN, DEVELOPMENT AND PRODUCTION AQAP-110
AQAP-110 NATO QUALITY ASSURANCE REQUIREMENTS FOR DESIGN, DEVELOPMENT AND PRODUCTION AQAP-110 FEBRUARY 1995 I AQAP-110 NORTH ATLANTIC TREATY ORGANIZATION MILITARY AGENCY FOR STANDARDIZATION NATO LETTER
SYSTEMKARAN ADVISER & INFORMATION CENTER QUALITY MANAGEMENT SYSTEM ISO9001:
SYSTEM KARAN ADVISER & INFORMATION CENTER QUALITY MANAGEMENT SYSTEM ISO9001:2015 WWW.SYSTEMKARAN.ORG 1 WWW.SYSTEMKARAN.ORG Foreword... 5 Introduction... 6 0.1 General... 6 0.2 Quality management principles...
CORPORATE MANUAL OF INTEGRATED MANAGEMENT SYSTEM
CORPORATE MANUAL OF INTEGRATED MANAGEMENT SYSTEM SIAD Macchine Impianti, the Company leader of SIAD Group's Engineering Pag. 1 di 20 Contents INTRODUCTION... 4 FOREWORD... 4 1. SCOPE... 5 2. REFERENCES...
Comparison Matrix ISO 9001:2015 vs ISO 9001:2008
Comparison Matrix ISO 9001:2015 vs ISO 9001:2008 Description: This document is provided by American System Registrar. It shows relevant clauses, side-by-side, of ISO 9001:2008 standard and the ISO 9001:2015
ISO 9001:2008 Quality Management System QMS Manual
2501 Kutztown Road Reading, PA, 19605 Tel. 610-929-3330 Fax 610-921-6861 ISO 9001:2008 Quality Management System QMS Manual The information contained in this document is Fidelity Technologies Corporation
ISO9001 QUALITY POLICY MANUAL
1 OF 26 Metalife Industries, Inc. Serial No.: Master Revision: 1 Issue Date: October 14, 2011 Originator: Becky Wentling ISO9001 QUALITY POLICY MANUAL Prepared By (Document Controller): Becky Wentling
QUALITY SYSTEM MANUAL
QUALITY SYSTEM MANUAL This Manual is a Proprietary Document and any Unauthorized Reproduction is prohibited. ISSUE DATE July 26, 2012 AUTHORIZED BY: Quality Management Representative Eric Hoff Managing
Correlation Matrix & Change Summary
The correlation matrix compares the new requirements of ISO 9001:2015 to the requirements of ISO 9001:2008, and provides a summary of the changes. Correlation Matrix & Change Summary Introduction Correlation
The Skyworks Quality Management System strives to:
Skyworks has embraced a workplace where Quality is the number one differentiator to achieve Customer Loyalty. Skyworks has adopted a single Quality Management System which drives efficiency, consistency
Supplier Quality Survey. 1. Type of Business: g) Commodities supplied? Supplier Changes/comments: 2. Headcount breakdown by group: Purchasing
Supplier: Phone: Prime Contact/Title: Sales Contact/Title: Address: Fax: e-mail address e-mail address Quality Contact/Title: e-mail address 1. Type of Business: a) Number of years in business? b) Company
Quality Procedure Internal Audit
Quality Procedure Table of Contents 1 INTERNAL AUDITS... 3 1.1 INTRODUCTION & PURPOSE... 3 1.1.1 Process Activity Map... 3 1.1.2 References... 3 1.1.3 Terms & Definitions... 3 1.2 APPLICATION & SCOPE...
OPERATIONS MANUAL ISO 9001 Quality Management System
OPERATIONS MANUAL * ISO 9001 Quality Management System Page: 1 of 19 Revision History Date Change Notice Change Description 5/30/2012 Original Original Release. 9/20/2012 005 Clarify post-delivery exclusion
AS 9100 Rev C Quality Systems Manual AS-050C-QM
AS 9100 Rev C Quality Systems Manual AS-050C-QM Innovative Control Systems, Inc. 10801 N. 24 th Ave. Suite 101-103 Phoenix, AZ 85029 U.S.A. www.icsaero.com +01-602-861-6984 VOICE +01-602-588-9440 FAX Table
How to conduct Stage 1 and Stage 2 Audits
How to conduct Stage 1 and Stage 2 Audits As per ISO 9001 2015 & ISO 19011 FREE Professional Development Seminar Series At the end of the class, please fill the training feedback and referral forms! Return
Association of American Railroads Quality Assurance System Evaluation (QASE) Checklist Rev. 1/12/2017
Company: Prepared By: Date: Changes from previous version highlighted in yellow. Paragraph Element Objective Evidence 2.1 Objective of Quality Assurance Program 2.2 Applicability and Scope 2.3 QA Program
UNIT 10 CLAUSE-WISE INTERPRETATION OF ISO 22000: 2005
ISO 22000:2005 UNIT 10 CLAUSE-WISE INTERPRETATION OF ISO 22000: 2005 Structure 10.0 Objectives 10.1 Introduction 10.2 Clause-wise Explanation of the Standard 10.2.1 Clause 1: Scope 10.2.2 Clause 2: Normative
QUALITY and ENVIRONMENTAL, HEALTH & SAFETY MANAGEMENT SYSTEM MANUAL
00 Revision E February 009 ECOM OUTSIDE PLANT & QUALITY and ENVIRONMENTAL, HEALTH & SAFETY MANAGEMENT SYSTEM MANUAL 00 www.tycoelectronics.com www.telecomosp.com www.ampnetconnect.com 00 DCR TQ09/005 Revision
Moving from ISO/TS 16949:2009 to IATF 16949:2016. Transition Guide
Moving from ISO/TS 16949:2009 to IATF 16949:2016 Transition Guide IATF 16949:2016 - Automotive Quality Management System - Transition Guide An effective Quality Management System is vital for organizations
MALAYSIAN STANDARD. Licensed to UNIMAP LIBRARY / Downloaded on : 22-Dec :14:03 PM / Single user license only, copying and networking prohibited
MALAYSIAN STANDARD MS ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (FIRST REVISION) (ISO 9001:2008, IDT) (PUBLISHED BY STANDARDS MALAYSIA IN 2009) ICS: 03.120.10 Descriptors: quality management,
Proposed Document. Global Harmonization Task Force GHTF/SG4(PD)/N83R5:2009
1 2 3 4 5 GHTF/SG4(PD)/N83R5:2009 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 Global Harmonization Task Force Proposed Document Title: Guidelines for Regulatory Auditing
MALAYSIAN STANDARD QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (FIRST REVISION) (ISO 9001:2008, IDT) (PUBLISHED BY STANDARDS MALAYSIA IN 2009)
MALAYSIAN STANDARD MS ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (FIRST REVISION) (ISO 9001:2008, IDT) (PUBLISHED BY STANDARDS MALAYSIA IN 2009) ICS: 03.120.10 Descriptors: quality management,
NOT YOUR FATHER S STANDARD. Wali Alam Quality Institute of America ASQ-Houston Section 1405-May
NOT YOUR FATHER S STANDARD What is Changing and How to deal with the upcoming ISO 9001:2015 Wali Alam Quality Institute of America ASQ-Houston Section 1405-May 21-2015 RISK BASED THINKING (approach) Agenda
JDI Quality Assurance Guideline
JDI Quality Assurance Guideline For Supplier, 2017 Japan Display Inc. 7/1/2017 - Table of Contents - 1. Introduction... - 7-1.1. Purpose of this Guideline...- 8-1.2. Structure of this Guideline...- 8-1.3.
SCHEDULE M-III [See Rule 76]
![SCHEDULE M-III [See Rule 76]](/thumbs/82/85923554.jpg "SCHEDULE M-III [See Rule 76]")
SCHEDULE M-III [See Rule 76] QUALITY MANAGEMENT SYSTEM FOR NOTIFIED MEDICAL DEVICES AND IN-VITRO DIAGNOSTICS 1. General This schedule specifies requirements for a quality management system that shall be
QuEST Forum. TL 9000 Quality Management System. Requirements Handbook
QuEST Forum TL 9000 Quality Management System Requirements Handbook Point Release 6.1 The ICT Quality Management System Performance Excellence through Global ICT Quality Copyright Copyright 2017 Quality
Quality Management System MANUAL. SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702
Quality Management System MANUAL SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702 Doc. No. G5500 Rev. 11 Status : APPROVED Effective: 09/07/2017 Page 2 of 32 Quality Manual Table of Contents
ISO/TS TECHNICAL SPECIFICATION
TECHNICAL SPECIFICATION ISO/TS 29001 Third edition 2010-06-01 Petroleum, petrochemical and natural gas industries Sector-specific quality management systems Requirements for product and service supply
Supplier Quality Survey. 1. Type of Business: g) Commodities supplied? Supplier Changes/comments: 2. Headcount breakdown by group: Purchasing
Supplier: Phone: Prime Contact/Title: Sales Contact/Title: Address: Fax: e-mail address e-mail address Quality Contact/Title: e-mail address 1. Type of Business: a) Number of years in business? b) Company
FUNDAMENTALS OF SAFETY MANAGEMENT SYSTEMS IN NUCLEAR POWER PLANTS
FUNDAMENTALS OF SAFETY MANAGEMENT SYSTEMS IN NUCLEAR POWER PLANTS June 2004 CONTENTS 1 Preface 1 2 General 2 2.1 Aim of the 'Fundamentals' 2 2.2 Procedure for preparing the 'Fundamentals' 2 2.2.1 State
Quality Manual. Ingenuity at its best WEST INDUSTRIES LLC Silverton, Suite 924 San Diego, CA USA
7949 Silverton, Suite 924 San Diego, CA 92126 USA This document is approved for use Copy Holder Copy Holder: President Copy Number: 1 Scope: This Covers the activities and functions performed by operating
Comparison ISO/TS (1999) to QS 9000, 3 rd edition (1998)
1 SCOPE QS 9000: new: Introduction, applicability In addition to the applicability for supplier sites for production and services and their subcontractors for: - parts or materials, or - services like
IEC Functional Safety Assessment
IEC 61508 Functional Safety Assessment Project: Rosemount 5300 Series 4-20mA HART Guided Wave Radar Level and Interface Transmitter Device Label SW 2.A1 2.J0 Customer: Rosemount Tank Radar (an Emerson
ISO AUDIT PREPARATION KIT 2016
ISO AUDIT PREPARATION KIT 2016 IQY Technical College Table of Contents ISO... 3 ISO 9001:2008 Fact Sheet... 6 Further Information... 6 Preparing for the ISO 9001:2008 Audit - 2016... 7 ISO 9001:2008 Definitions...
Quality Manual Power Engineering & Manufacturing Inc th Lane NE Blaine Minnesota MN 55449
Quality Manual Power Engineering & Manufacturing Inc 1463 94th Lane NE Blaine Minnesota MN 55449 COVER PAGE PD 0002 rev. 3 Section QM 01 Page 1 of 17 This document is approved for use Manual Contents Section
Continental Steel & Tube Co. Quality Manual
312 SE 22 nd Street Fort Lauderdale, FL 33316 Mailing address P.O. Box 030040 Fort Lauderdale, FL 33303-0040 954-332-2290 Fax 954-332-2296 info@continentalsteel.com www.continentalsteel.com Introduction
Our Ref. April 28, 2005 Page 1/9. 1. Introduction References Certification... 4
April 28, 2005 Page 1/9 Table of Contents 1. Introduction... 2 2. References... 3 3. Certification... 4 4. Procedures... 5 4.1 Management responsibility... 5 4.1.1 Quality Policy... 5 4.1.2 Responsibility...
To establish supplier quality requirements applicable to the type of product or service procured by Hudson MFG LLC.
1.0 PURPOSE To establish supplier quality requirements applicable to the type of product or service procured by Hudson MFG LLC. 2.0 APPLICATION When (QAM) Appendix 8.4 is specified on the purchase order,
Desk Audit of. Based on Federal Transit Administration (FTA) Quality Assurance and Quality Control Guidelines FTA-IT
Desk Audit of Based on Federal Transit Administration (FTA) Quality Assurance and Quality Control Guidelines FTA-IT-90-5001-02.1 Reviewed by: Element Requirements Applicable 1. Is a quality policy defined
UPPLIER ANUAL. Issued: 01 Aug 13
UPPLIER ANUAL Issued: 01 Aug 13 Table of Contents Our Company 3 Our Vision 3 Scope and Purpose 4 Responsibilities 4 General Expectations and Requirements 5 Supplier Quality Management System 6 Supplier
Engenharia e Tecnologia Espaciais ETE Engenharia e Gerenciamento de Sistemas Espaciais CSE Métodos e Processos na Área Espacial
Engenharia e Tecnologia Espaciais ETE Engenharia e Gerenciamento de Sistemas Espaciais CSE-300-4 Métodos e Processos na Área Espacial L.F. Perondi 03.09.2018 SUMÁRIO - DESENVOLVIMENTO DE SISTEMAS - DEFINIÇÕES
DOCUMENT CONTROL INFORMATION
DOCUMENT CONTROL INFORMATION System: Document Title: Document Status: Quality Manual Approved 5 11/5/2014 Current Document Revision Details Formal review. Added section 2, 3. Revised section 5.5.2, 6.2,
Doc. No: UPHDB/QM/01 Prepared By: AMR Issue No.:01 Rev. No.: 00 Eff. Date: Page: 1 of 18 Issued by: MR
Doc. No: UPHDB/QM/01 Prepared By: A Page: 1 of 18 Issued by: 7.1 PLANNING OF UPHDB has established a system to plan and develop the processes needed for product realisation. The planning of the product
ISMS AUDIT CHECKLIST
4.1 REQUIREMENT REFER TO BS ISO / IEC 27001 : 2005 Has the organisation developed a documented ISMS based on the PDCA model? Checked at Stage 1 for development and Stage 2/surveillance for implementation,
Revision. Quality Manual. Multilayer Prototypes. Compliant to ISO / AS9100 Rev C
1 of 29 Quality Manual Multilayer Prototypes Compliant to ISO 9001-2008 / AS9100 Rev C This Quality Manual sets forth the quality system policies and Defines compliance with the ISO 9001-2008 SAE AS 9100
Quality management systems Requirements
BSI Standards Publication NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW raising standards worldwide Quality management systems Requirements Incorporating corrigendum July 2009
CMI Guidance Document
CMI Guidance Document for Product Quality Plan Requirements Reference CMI-GD-PQP This document has been produced by the Administration Department of CertMark International (CMI). For technical information
Quality Systems Manual
Quality Systems Manual ISO9001:2008 Prepared By: Date: 06/28/2013 President Approved by: Date: 06/28/2013 Quality Assurance Manager Introduction Cal-Tron Corp has developed and implemented a Quality Management
Stanley Industries, Inc. ISO 9001:2008 Quality Policy Manual
Stanley ISO 9001:2008 Table of Contents and STANLEY Document Reference Related STANLEY Section Page Procedure(s) 1. Introduction 1 None 2. Scope 1 None 3. Organizational Structure & 1 STANLEY Company History
1 Introduction. 20 August 1995; 19:29 1 Master04.Doc
1 Introduction This master thesis concludes the study of computer science at the Rijks Universiteit of Leiden. The mentor for this project is dr. L.P.J. Groenewegen. The topic addressed in this master
ENVIRONMENTAL MANUAL. Page 1 of 26 Uncontrolled when printed NCH Env Manual Vers 11.0 date 01/02/18
ENVIRONMENTAL MANUAL Page 1 of 26 Uncontrolled when printed NCH Env Manual Vers 11.0 date 01/02/18 Document Control Identification and Approval Status Document Title: Environmental Manual Version Number:
CORPORATE QUALITY MANUAL
Corporate Quality Manual Preface The following Corporate Quality Manual is written within the framework of the ISO 9001:2008 Quality System by the employees of CyberOptics. CyberOptics recognizes the importance
A02 Assessment Rating Guide Revision 2.9 August 21, 2016
Revision 2.9 August 21, 2016 Laboratory Name: Assessment Date: (Lead) Assessor: Signature: ! TABLE OF CONTENTS 1.0! INTRODUCTION... 1 2.0! ASSESSOR NOTES ON THE USE OF CALA A02 ASSESSMENT RATING GUIDE...
ISO 9001: 2015 Quality Management System Certification. Awareness Training
ISO 9001: 2015 Quality Management System Certification Awareness Training ISO 9001: 2015 STRUCTURE The new standard is modeled around the ISO Directive Annex SL, a high level structure (HSL) based on the
Preventive Action. Ameritube LLC 1000 N. Hwy 77, Hillsboro TX Revision Level: Procedure No. A. QPS-007 Revision Date: 5/8/2012 Page No.
Preventive ction 5/8/2012 Page No. 1 of 7 Date Description Of Change Signature Rev. Level 5/8/2012 New Document Jeremy Wilson Procedure pproval: Company Title: Date: Quality Manager 5/8/2012 Preventive
Quality Assurance Manual Revision 8 3/16/18
Quality Assurance Manual Revision 8 3/16/18 Uncontrolled Copy Table of Contents 1.0 SCOPE... 4 1.1 General...4 1.2 Application...4 2.0 NORMATIVE REFERENCE... 4 3.0 TERMS AND DEFINITIONS... 4 4.0 CONTEXT
How EN 9110 and the ICOP Scheme can support effective management of maintenance organisations
How EN 9110 and the ICOP Scheme can support effective management of maintenance organisations Part 1 The EN 9110 and MDM.055 Flavio Izzo EAQG MRO Relationship Growth Strategy Stream Leader About IAQG The
Checklist for the assessment based on the standards
ISO & MDD & Checklist for the assessment based on the standards ISO :2016 ISO :2016 associate with EC Directive 93/42 EEC Where applicable EC Directive 93/42/EEC Annex II/V/VI Company: Audit date Auditor:
THE KOCOUR COMPANY 4800 S. St. Louis Avenue, Chicago, IL 60632
THE KOCOUR COMPANY 4800 S. St. Louis Avenue, Chicago, IL 60632 Metal Finishing Instrumentation, Equipment and Supplies ISO 9001: 2015 QUALITY MANAGEMENT MANUAL ISSUED: 03/01/02(REV. 0) REVISION NO: 5 DATE:
Awareness to ISO 9001:2000
Awareness to ISO 9001:2000 Tutor s Introduction Course Objectives Be able to understand and interpret the requirements of the standard Planning to implement the requirements of the standard Course Structure
Changes in the EXCiPACT 2017 Edition Requirements from the 2012 Edition
Changes in the EXCiPACT 2017 Edition Requirements from the 2012 Edition Blue text indicates changes to both GMP and GDP requirements Orange text indicates specific changes to the GDP requirements Items
MDSAP Purchasing Process
MDSAP Purchasing Process The Medical Device Single Audit Program, MDSAP, evaluates companies on their compliance to requirements based on ISO 13485:2016 and national regulations. An MDSAP audit looks at