ISO 13485:2016 Mandatory documentation requirements & MyEasyISO
|
|
- Bethanie Taylor
- 6 years ago
- Views:
Transcription
1 ts & Mandatory documents All below mandatory documents can be created using Documented information module of. An organization can use their own procedures but if required can provide these procedures to our Large enterprise plan customers with biennial subscription. Note: The text in green indicates the availability of this feature in Mandatory document Clause of ISO 13485: Document the role(s) undertaken by the organization Written quality agreements with outsource partners Procedure for the validation of the application of computer software 4.1.6, 7.5.6, Quality manual Quality policy Quality objectives Procedure for document control Procedure for record control Responsibilities and authorities Procedure for management review Procedure for competence, training and awareness Requirements for the infrastructure Requirements for the maintenance activities Requirements for the work environment Procedure to monitor and control the work environment Requirements for health, cleanliness and clothing of personnel Arrangements for the control of contaminated or potentially contaminated product Requirements for control of sterile medical device contamination 6.4.2
2 ts & 19. Processes for risk management in product realization Arrangements for communicating with customers Procedure for design and development Procedure for purchasing Procedure and methods for the control of production Requirements for cleanliness of product Requirements for medical device installation and acceptance criteria for verification of installation Procedure for servicing activities of medical devices Procedures for validation of processes Procedure for the validation of processes for sterilization Procedure for product identification Procedure for traceability Procedure for preserving the conformity of product Procedure for monitoring and measuring equipment Procedure for customer feedback gathering Procedure for complaint handling Procedure for internal audit Procedure for control of nonconforming product Procedure for issuing advisory notices Procedure for rework Procedure for analysis of data Procedure for corrective actions Procedure for preventive actions 8.5.3
3 Mandatory records provides online compliance with more than 75% mandatory records requirements. Specific customization is possible for our large enterprise subscription clients. Note: The text in green indicates the availability of this feature in Mandatory record Clause of ISO 13485: Records of software validation activities 4.1.6, Medical device file Records of management review Records of education, training, skills and experience Records of the maintenance activities Records of risk management activities Outputs of product realization planning Records of the results and actions arising from review of requirements related to product Records of product requirements changes Design and development planning documents Design and development inputs Design and development outputs Records of design and development review Records of the results and conclusions of the design and development verification Design and development validation plans Records of the results and conclusion of design and development validation Results and conclusions of the design and development transfer 7.3.8
4 18. Records of design and development changes Design and development file Records of the results of evaluation, selection, monitoring and reevaluation of supplier Records of the purchased product verification Record for each medical device or batch of medical devices Records of medical device installation and verification of installation Records of servicing activities Records of the sterilization process parameters Records of the results and conclusion of validation Records of the results and conclusion of sterile medical device validation Records of traceability Records of the name and address of the shipping package consignee Report to the customer about changes on his property Records of the results of calibration and verification of monitoring and measuring equipment Customer feedback report Complaint handling records Records of reporting to regulatory authorities Internal audit plan Internal audit report Evidence of conformity of products with the acceptance criteria Identity of the person authorizing release of product Identity of personnel performing any inspection or testing of implantable medical devices Record of nonconformity Records of the product acceptance by concession and the identity of the person authorizing the concession 8.3.2
5 42. Records of actions relating to the issuance of advisory notices Records of rework Records of the results of data analyses Records of corrective actions Records of preventive actions In addition to this provides online consulting and implementation assistance to subscribers. DIVERSE MANAGEMENT CONSULTANCY LTD P.O Box Nairobi, Kenya Tel: +254 (0)
YOU RE CLOSER THAN YOU THINK
YOU RE CLOSER THAN YOU THINK ISO 13485:2016 READINESS CHECKLIST We understand that some of our customers would like to be able to check how close they are to meeting the requirements of ISO 13485:2016.
More informationCorrelation matrices between ISO 9001:2008 and ISO 9001:2015
Correlation matrices between ISO 9001:2008 and ISO 9001:2015 ISO 9001:2015 ISO 9001:2008 1 Scope 1 Scope 1.1 General 4 Context of the organization 4 Quality management system 4.1 Understanding the organization
More informationAAMI Quality Systems White Paper: Comparison of 21 CFR Part 820 to ISO 13485:2016 1
AAMI s White Paper Comparison of 21 CFR Part 820 to ISO 13485:2016 February 2017 AUTHORS Seb Clerkin, GMP Advisory Services Nicola Martin, Owner, Nicola Martin Consulting Jack Ward, Owner, Ward Sciences
More informationFDA 21 CFR Part 820 vs. ISO 13485:2016 Comparison Table created by greenlight.guru
FDA 21 CFR Part 820 vs. ISO 13485:2016 Comparison Table created by greenlight.guru FDA QSR (21 CFR Part 820) ISO 13485:2016 820.1 Scope 1 Scope 2 Normative References 820.3 Definitions 3 Terms and Definitions
More informationClause Map IATF 16949:2016 to ISO/TS 16949:2009
Table of Contents Table of Contents Foreword Foreword + Foreword Automotive QMS Standard + History + Goal + 0.5 Goal of this Technical Specification + Remarks for Certification + Remarks for Certification
More informationSections of the Standard. Evidence / Comments. (Y) / Nonconforming (NC)
Date: Sections of the Standard 4 Context of the Organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope
More informationQUALITY 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
More informationQuality and Medical Devices: ISO 13485:2003
Quality and Medical Devices: ISO 13485:2003 Quality Management System requirements for Medical Devices manufacturers O3 Enterprise s.r.l. ISO 13485 Quality Management Systems Medical Device O3 Enterprise
More informationINTEGRATING ISO 9000 METHODOLOGIES WITH PROJECT QUALITY MANAGEMENT
INTEGRATING ISO 9000 METHODOLOGIES WITH PROJECT QUALITY MANAGEMENT M a r ch 2015 OBJECTIVE ISO and Project Quality Management Process Are they different or the same? ISO 9000 QMS FAMILY ISO 9000:2005 Vocabulary
More informationISO 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
More informationCorrelation 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
More informationQMS Team: MR and all HODs (Internal Auditors) MR March 10. Quality policy Define quality policy The Steering committee Objectives and targets
QMS Roles, Responsibility and Authority Process Clause Activities Records Required Responsibility Authority Deadline Clause 4: Process Development 4.1 Develop processes and sequence, operation controls
More informationCorrespondence Between ISO 13485:2016 and 21 CFR Part 820 QMS Requirements
Correspondence Between and 21 CFR Part 820 QMS Requirements 10411 Corporate Drive, Suite 102, Pleasant Prairie, WI 53158 262.842.1250 262.842.1240 info@rcainc.com rcainc.com 2 4 Quality Management System
More informationQUALITY 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
More informationQM-1 QUALITY MANAGEMENT SYSTEMS MANUAL. Revision 10
QM-1 QUALITY MANAGEMENT SYSTEMS MANUAL Revision 10 Page: 1 of 54 TABLE OF CONTENTS 1. DOCUMENT REVISION HISTORY... 5 2. INTRODUCTION... 6 2.1 Purpose... 6 2.2 Scope... 7 Figure 1: Sequence and Interaction
More informationQuality Manual Revision: C Effective: 03/01/10
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 informationMDSAP 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
More information25 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
More informationSUPPLIER QUALITY SYSTEM SURVEY
SUPPLIER QUALITY SYSTEM SURVEY DATE (M/d/yy): 55 Dragon Court Woburn, MA 01801 Tel: (781) 933-7300 Fax: (781) 935-4529 GENERAL INFORMATION Supplier Name: Physical Address: City: State: Zip: Sr. Company
More informationSpecification 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
More informationQuality 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
More informationAVNET Logistics & EM Americas. Quality Manual
AVNET Logistics & EM Americas Quality Manual Avnet is committed to ensuring customer satisfaction while meeting all customer and applicable legal, statutory and regulatory requirements. This is accomplished
More informationExpert Commentary on BS EN ISO 13485:2016, Medical devices Quality management systems Requirements for regulatory purposes
Expert Commentary on BS EN ISO 13485:2016, Medical devices Quality management systems Requirements for regulatory purposes Author: Eamonn Hoxey, PhD, F.R.Pharm.S., Vice President, Medical Devices Quality
More informationUPGRADE 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
More informationVendor Qualification Survey
1200 West 96 th St Minneapolis, MN 55431 Ph: 952-888-7900 Fax: 952-888-2719 Vendor Qualification Survey Vendor Information Company Name: Date: Address: City: Phone Number: email address: Product or Service
More informationComparison 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
More informationSubject: 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
More informationSummary of ISO 9001:2015 New and Changed Requirements
This is a summary of the new and changed ISO 9001:2015 requirements compared to ISO 9001:2008. 4. Context of the Organization 4.1 Changes Understanding the Organization and its Context New requirement
More informationFitting ISO 9001:2000 into a 20 Element Quality System
Fitting ISO 9001:2000 into a 20 Element Quality System ASQ Washington DC Section 0509 Rockville Maryland Presented by Norman P. Moreau, P.E., CSQE, CQA President Theseus Professional Services 410-857-0023
More informationAB. OUR ISO CONFORMANCE AUDIT QUESTIONNAIRES 8. ASSESS HOW WELL YOU CONFORM TO ISO S REMEDIAL REQUIREMENTS
8.1 PLANNING REQUIREMENTS 1 Do you plan monitoring, measurement, and analytical processes? 2 Do you plan how monitoring will be used to ensure conformity and effectiveness? 3 Do you plan how it will be
More informationList of Documented Information (Document & Records)
As per IATF 16949:2016 Clause Type Clause Reference 4.3 Determining the scope of the quality management system 5.1.1.1 Corporate responsibility The only permitted exclusion for this Automotive QMS Standard
More informationThe 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
More informationCorrespondence 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
More information9110 Correlation matrices
9110 Correlation matrices 9110:2016 to 9110:2012 9110:2012 to 9110:2016 This document provides correlation matrices from 9110:2016 to 9110:2012 and 9110:2012 to 9110:2016. This document can be used to
More informationISO /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
More informationThis document describes the minimum quality assurance requirements suppliers of RUAG Switzerland Ltd. have to comply with.
of 14.02.2013 Page 1 / 6 This document describes the minimum quality assurance requirements suppliers of RUAG Switzerland Ltd. have to comply with. This requirements are not terminal, but may be additional
More informationDesk 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
More informationAEROSPACE 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,
More informationTOOL ENGINEERING OLD GROVE RD. SAN DIEGO, CA
Page 1 of 42 VERTECHS ENTERPRISES, INC. Dba LUCHNER TOOL ENGINEERING 10051 OLD GROVE RD. SAN DIEGO, CA 92131 Ph No. 1-858-578-3900. Fax No. 1-858-578-2910 Reviewed and Approved By: Geosef (Joey) Straza
More informationSupplier Quality Agreements
Supplier Quality Agreements Dan O Leary CBA, CQA, CQE, CRE, SSBB, CIRM President Ombu Enterprises, LLC Dan@OmbuEnterprises.com www.ombuenterprises.com 603-209-0600 OMBU ENTERPRISES, LLC 1 Outline QSR Requirements
More informationISO 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
More informationPART 820 QUALITY SYSTEM REGULATION. 21 CFR Ch. I ( Edition)
814.126 (b) Withdrawal of IRB approval. A holder of an approved HDE shall notify FDA of any withdrawal of approval for the use of a HUD by a reviewing IRB within 5 working days after being notified of
More information21 CFR Ch. I ( Edition) Personnel Design controls Identification Traceability.
Pt. 820 device together with an explanation of the basis for the estimate; (iv) Information describing the applicant s clinical experience with the device since the HDE was initially approved. This information
More informationQUALITY MANAGEMENT SYSTEM QUALITY MANUAL
AERO SUPPLY USA 21941 US HWY 19 NORTH Clearwater, FL. 33765 USA P.(727) 754-4915 F.(727) 754-4920 Website: www.aerosupplyusa.com Email: sales@aerosupplyusa.com QUALITY MANAGEMENT SYSTEM QUALITY MANUAL
More informationHACCP audit checklist
Requirement HACCP audit checklist Prerequisite Program Management Commitment 1. Senior management ensures that the responsibilities and authorities are defined and communicated within the company Internal
More informationINTERNATIONAL 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
More informationQuality Manual. AARD Spring & Stamping Quality Manual
Quality Manual Page 1 of 25 AARD Spring & Stamping QM/5.0 Title: QM 5.0 AARD Spring & Stamping Quality Manual Copy Approval Date: 1/27/2011 Reviewer(s): Sign / Print Title Date Dan Wheeler Document Originator
More informationMALAYSIAN 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,
More informationEVANS CAPACITOR COMPANY
DISTRIBUTION LIST: Location Book # Quality Manager 0001 President 0002 CEO 0003 Engineering Manager 0004 Production Manager 0005 Office Manager 0006 Page 1 of 33 REV A 11/18/03 TABLE OF CONTENTS Page Distribution
More information0. 0 TABLE OF CONTENTS
QUALITY MANUAL Conforming to ISO 9001:2008 0. 0 TABLE OF CONTENTS Section Description ISO 9001 Clause Page 0 TABLE OF CONTENTS n/a 2 1 PIMA VALVE, INC. DESCRIPTION n/a 3 2 QUALITY MANUAL DESCRIPTION 4.2.2
More informationBusiness Management System: Manual 00-BMS-001
Business Management System: Manual 00-BMS-001 Preface This manual defines the Business Management System (BMS) established by GM Nameplate. The BMS is comprised of the processes needed to support GM Nameplate
More informationLuminus 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 information14620 Henry Road Houston, Texas PH: FX: WEB: 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 informationFood and Drug Administration, HHS Pt Sec Scope Definitions Quality system.
Food and Drug Administration, HHS Pt. 820 authorized designee. If, however, a physician in an emergency situation determines that approval from an IRB cannot be obtained in time to prevent serious harm
More informationINS QA Programme Requirements
Specification Date: 20/3/17 INS QA Programme Requirements UNCONTROLLED WHEN PRINTED Author: J Cooch AUTHORISATION Date: 20/3/17 A Brown Owner: J Cooch (Signature) N.B. only required for hard copy If issued
More informationDocument Number: QM001 Page 1 of 19. Rev Date: 10/16/2009 Rev Num: 1. Quality Manual. Quality Manual. Controlled Copy
QM001 Page 1 of 19 Quality Manual QM001 Page 2 of 19 Table of Contents Page Company Profile 4 Approval 4 Revision History 4 Distribution List 4 1.0 Scope 5 Section 2: Normative Reference 6 2.0 Quality
More informationBusiness Management System Manual Conforms to ISO 9001:2015 Table of Contents
Table of Contents 1.0 Welcome to Crystalfontz... 3 2.0 About the Crystalfontz Business Systems Manual... 4 3.0 Terms and Conditions... 5 4.0 Context of the Organization... 6 4.1. Understanding the Organization
More informationEPICOR, INCORPORATED QUALITY ASSURANCE MANUAL
EPICOR, INCORPORATED QUALITY ASSURANCE MANUAL Revision: 6 Date 05/18/09 EPICOR, INCORPORATED 1414 E. Linden Avenue P.O. Box 1608 Linden, NJ. 07036-0006 Tel. 1-908-925-0800 Fax 1-908-925-7795 Table of Contents:
More informationWebster - Hoff Corporation. Quality Manual
Registered to ISO 9001:2008 ANSI/ISO/ASQ Q9001-2008 QM-1 Page 2 of 35 TABLE OF CONTENTS Section Name Page Management Approval Of / List of Exclusions 3 Corporate Quality Policy 4 Webster-Hoff Corporation,
More informationQUALITY MANAGEMENT SYSTEM MANUAL ISO 9001:2008
QUALITY MANAGEMENT SYSTEM MANUAL ISO 9001:2008 Revision: 9 Issue Date: 28 April 2014 CONTROLLED COPY Number: Issued to: UNCONTROLLED COPY A.M.S. Electronics, Inc. 113 Pillow Street, Butler, PA 16001 (724)
More informationBeaver Machine. Quality Manual
Beaver Machine Quality Manual This manual has been written to the ISO 9001:2000 International Quality Standard Beaver Machine Inc. 5273 Hanson Court Minneapolis, MN 55429 763-535-2204 www.beavermachine.com
More informationQuality Manual. This manual has been written to the ISO 9001:2000 International Quality Standard
Sceptre CNC Machining Inc. Quality Manual This manual has been written to the ISO 9001:2000 International Quality Standard Sceptre CNC Machining Inc. Unit 401 1485 Coast Meridian Road Port Coquitlam, B.C.
More informationAS9003A QUALITY MANUAL
AS9003A QUALITY MANUAL Origination Date: (month/year) Document Identifier: Date: Document Status: Document Link: AS9003A Latest Revision Date Draft, Redline, Released, Obsolete Location on Server (if used)
More informationQUALITY MANUAL. This document defines the requirements, processes, structure and documentation for the Teledyne DGO Quality Management System.
Page 1 of 13 1. PURPOSE This document defines the requirements, processes, structure and documentation for the Teledyne DGO Quality Management System. 2. SCOPE The Teledyne DGO Quality Management System
More informationSupplier Quality Agreement
Supplier Quality Agreement Clyde, OH Poplar Bluff, MO Brampton, Ontario Jeffersonville, IN Page 1 of 15 TABLE OF CONTENTS Table of Contents 1. Administrative Elements... 4 1.1. Scope... 4 1.2. Parties
More informationKEVLIN CORPORATION DIVISION OF COBHAM DEFENSE ELECTRONIC SYSTEMS
1.doc KEVLIN CORPORATION DIVISION OF COBHAM DEFENSE ELECTRONIC SYSTEMS QUALITY POLICY MANUAL QPM 4. 596 Lowell St Methuen, MA 01844 USA 2.doc TABLE OF CONTENTS Clauses Procedure Description of Contents
More informationQUALITY MANAGEMENT SYSTEM POLICIES AND PROCEDURES
Your Company Name QUALITY MANAGEMENT SYSTEM POLICIES AND PROCEDURES Origination Date: XXXX Document Identifier: Date: Document Revision: QMS-00 QMS Policies and Procedures Latest Revision Date Abstract:
More informationBAITY SCREW MACHINE PRODUCTS QUALITY MANUAL
BAITY SCREW MACHINE PRODUCTS QUALITY MANUAL Page 1 of 33 TABLE OF CONTENTS SECTION TITLE PAGE 0 Company Introduction... 4 0 Organizational Chart.. 5 1 Scope.. 6 2 Related Documents... 6 3 Terminology...
More informationSADCAS POLICY ISO/IEC 17020:2012 TRANSITION
SADCAS POLICY ISO/IEC 17020:2012 TRANSITION Prepared by: SADCAS Approved by: SADCAS CEO Approval Date:2012 09 25 Effective Date: 2012 10 01 Page 1 of 11 Table of Contents Page 1. INTRODUCTION... 3 2. TRANSITION
More informationQUALITY MANUAL. IFS DOCUMENT CLASS: QLTY-100 IFS DOCUMENT NUMBER: QM4.2.2 PAGE 2 of 27 EFFECTIVE DATE: 30 MAY 2017 REV Q
IFS DOCUMENT CLASS: QLTY-100 IFS DOCUMENT NUMBER: QM4.2.2 PAGE 2 of 27 Introduction Value Plastics, Inc., dba Nordson MEDICAL created a Quality Management System (QMS) to document the company s best business
More informationMoving 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
More informationIATF 16949:2016 TRANSITION INFORMATION
IATF 16949:2016 TRANSITION INFORMATION ISO/TS 16949 Overview ISO/TS 16949 Technical Specification for Automotive Quality Management Systems, in conjunction with ISO 9001, defines the quality system requirements
More informationComparison of Requirements ISO/TS vs. AS9100 and ISO 13485
ISO/TS 16949 vs. AS9100 and ISO 13485 Introduction If your business is starting to diversify into the Medical or Aerospace industries, your existing ISO/TS 16949 certified quality management system (QMS)
More informationQUALITY MANUAL Revision H
QUALITY MANUAL Revision H JADE PRECISION MEDICAL COMPONENTS, LLC 3063 B Philmont Avenue Huntingdon Valley, PA 19006 Page: 1 of 15 Table of Contents 1. Purpose & Scope... 2 2. Applicable Standards... 2
More informationFEC QUALITY MANUAL. Federal Equipment Company River Rd. Cincinnati, Ohio
QMS-20 2016 FEC QUALITY MANUAL Federal Equipment Company 5298 River Rd Cincinnati, Ohio 45233 www.federalequipment.com www.fecheliports.com www.usdrillhead.com www.orionseals.com www.tkf.com REVISION:
More informationSelf-Evaluation/Audit Checklist for Food Supplement Manufacturers
Self-Evaluation/Audit Checklist for Food Supplement Manufacturers This checklist has been developed by the EHPM quality working group. It combines work carried out by EHPM various national associations
More informationP. 1. Identify the Differences between ISO9001:2000 與 ISO9001:2008 ISO9001:2008 ISO9001:2000 版本的異同. 5 January 2009 ISO 9000 SERIES
Identify the Differences between ISO9001:2000 and ISO 9001:2008 審視 ISO9001:2000 與 ISO9001:2008 版本的異同 ISO 9000 SERIES ISO 19011 ISO9000 5 January 2009 ISO9001 ISO9004 2 ISO 9000 SERIES ISO 9001 ISO 9000
More informationAudit Report No: QE /12 - S. Hooks Industrial, Inc. Contact Person: Mr. John Valentine Phone: « »
Audit Report No: QE - 43699-2/12 - S Company Name: Hooks Industrial, Inc. Contact Person: Mr. John Valentine Phone: «281 251-9551» Report Date: 2013-10-22 Audit Dates: 2013-10-22-2013-10-22 Audit Duration:
More informationQUALITY SYSTEM MANUAL
TITLE: QUALITY SYSTEM MANUAL Page 1 of 15 QUALITY SYSTEM MANUAL TITLE: QUALITY SYSTEM MANUAL Page 2 of 15 Index PARAGRAPH TITLE... PAGE 1.0 GENERAL INFORMATION... 3 2.0 DEFINITIONS... 5 3.0 RELATED DOCUMENTS...
More informationQuality 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
More informationADVANCED INTERNAL AUDIT WORKSHOP
ADVANCED INTERNAL AUDIT WORKSHOP By Paul J. Kunder RABQSA QMS Lead Auditor/Aerospace Industry Experienced Auditor RABQSA Approved Aerospace Auditor Transition Training (AATT) Trainer Vice Chair U.S. Z1A
More informationSpecification for Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry
Specification for Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry ANSI/API SPECIFICATION Q1 EIGHTH EDITION, DECEMBER 2007 EFFECTIVE DATE: JUNE 15, 2008 CONTAINS API MONOGRAM
More informationPRODUCTS AND SERVICES:
COMPANY INFORMATION: Company Name: Newcastle Aviation Partners, LLC Address: 3201 West County Road 42, Unit 104 Burnsville, MN 55306 Phone: 952-223-0317 Facsimile: 952-223-4470 AOG phone number: 952-223-0317,
More informationTechnical Manufacturing Corporation (TMC)
Revision: 21 Pages: 1 of 14 Date Issued: 05/11/2016 Technical Manufacturing Corporation (TMC) Quality Manual 15 Centennial Drive Peabody MA 01960 Revision: 21 Pages: 2 of 14 Date Issued: 05/11/2016 1.
More informationPRECISION SENSORS QUALITY ASSURANCE MANUAL THIS DOCUMENT IS CONTROLLED ONLY IF COPY IS STAMPED CONTROLLED IN RED INK
SAE AS9100 DOCUMENT PRECISION SENSORS QUALITY ASSURANCE MANUAL THIS DOCUMENT IS CONTROLLED ONLY IF COPY IS STAMPED CONTROLLED IN RED INK REV. 005 10/27/10 Page 2 Page 4 Page 5 Page 6 Page 7 Page 8 Page
More informationQuality Manual ISSUED JANUARY Approved By: January 12, 2004 (President & Chief Executive Officer)
Quality Manual ISSUED JANUARY 2004 Approved By: January 12, 2004 (President & Chief Executive Officer) (Date) Quality Policy To be the industrial control industry's most preferred supplier of sensor integration
More informationQuality Manual ISO 9001:2000
Quality Manual ISO 9001:2000 Page 2 of 23 TABLE OF CONTENTS COVER PAGE...1 TABLE OF CONTENTS...2 SIGNATURES...3 QUALITY POLICY...4 INTRODUCTION...5 CORPORATE PROFILE...9 4.O QUALITY MANAGEMENT SYSTEM...10
More informationZOLL Document Number: 90E0021 Page 6 of 50 QUALITY SYSTEM MANUAL ZOLL Document Number: 90E0021 Page 7 of 50 1 EXECUTIVE MANAGEMENT APPROVAL... 10 2 INTRODUCTION... 11 3 QUALITY SYSTEM... 12 3.1 QUALITY
More informationMANUAL QUALITY CONTROL & QUALITY ASSURANCE
MANUAL QUALITY CONTROL & QUALITY ASSURANCE METROTEC ENGINEERING LLC P.O. BOX: 26045, DUBAI U.A.E TEL : 043889771 FAX:043889772 E Mail: metrotecengg@yahoo.com info@metrotec.ae Web: www.metrotec.ae 2 TABLE
More informationISO 9001:2015. October 5 th, Brad Fischer.
ISO 9001:2015 October 5 th, 2017 Brad Fischer www.sdmanufacturing.com Purpose of presentation Provide a summary of notable changes from ISO 9001:2008 to ISO 9001:2015 Key perspectives ISO 9001 needs to
More informationAPS 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...
More informationROTEK. IIInnInstI Instrument Corp. ISO 9001 Quality System Manual
ROTEK IIInnInstI Instrument Corp. ISO 9001 Quality System Manual QSM900100-01 REV O MANUAL NO: 10 ISSUED TO: Rotek Web Site DATE OF ISSUE: 17 July 2002 APPROVALS: ORIGINATOR: Lawrence E. Weissbach Lawrence
More informationISO 22000:2005 Standard INTERNATIONAL STANDARDS REGISTRATIONS
ISO 22000:2005 Standard Food Safety Management System INTERNATIONAL STANDARDS REGISTRATIONS 3.1 FOOD SAFETY concept that food will not cause harm to the consumer when it is prepared and/or eaten according
More informationComparison 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
More informationA-M SYSTEMS QUALITY MANUAL
A-M SYSTEMS QUALITY MANUAL ORIGINATED BY: TITLE: DATE: Robert J. Thompson Quality Manager 22-Sept-2011 APPROVED BY: TITLE: DATE: Arthur B. Green III President 22-Sept-2011 Revision History Page: 2 of 32
More informationKey Process Audit Checklist Record answers and notes on blank turtle diagrams or audit checklist or note page
What machines, equipment, software, and materials are used to do this process? Are there adequate resources? Is the equipment maintained and supported? Are there gauges that require calibration? What Inputs
More informationISO/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
More informationISO 9001:2015 READINESS CHECKLIST YOU RE CLOSER THAN YOU THINK EXECUTIVE SUMMARY CLAUSE 4 - CONTEXT OF THE ORGANISATION CLAUSE 5 - LEADERSHIP
EXECUTIVE SUMMARY CLAUSE 4 - CONTEXT OF THE ORGANISATION CLAUSE 5 - LEADERSHIP CLAUSE 6 - PLANNING CLAUSE 7 - RESOURCES CLAUSE 8 - OPERATIONS CLAUSE 9 - PERFORMANCE EVALUATION CLAUSE 10 - IMPROVEMENTS
More informationD107: DEMO OF ISO: FOOD SAFETY DOCUMENT KIT Price 360 USD
Chapter-1.0 CONTENTS OF ISO 22000 DOCUMENT KIT (More than 100 document files) A. The entire Document kit has 5 main directories as below. Sr. No. List of Directory Document of Details 1. Food Safety Manual
More information