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THORLABS, INC. QUALITY MANUAL REVISION HISTORY:

THORLABS, INC. QUALITY MANUAL REVISION HISTORY:

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<strong>THORLABS</strong>, <strong>INC</strong>.<strong>QUALITY</strong> <strong>MANUAL</strong><strong>REVISION</strong> <strong>HISTORY</strong>:<strong>REVISION</strong> DATE OFCHANGEDESCRIPTION OF CHANGE<strong>REVISION</strong>ORIGINATOR1 3/14/96 DRAFT RELEASE J. CIEKURSA 3/25/97 INITIAL RELEASE J. CIEKURSB 6/2/97 UPDATED POLICY <strong>MANUAL</strong> J. CIEKURSC 6/27/97 UPATED POLICY <strong>MANUAL</strong> SECTIONS 4.6, 4.7, J. CIEKURS4.8D 12/15/97 Updated per registration audit J. CIEKURSE 2/15/99 Updated per winman software changes J. CIEKURSF 08/15/99 Updated to include shop processes and general ISO T. WALDRONcoordinatorG 10/01/00 Organizational chart revised to reflect new positions T. ROSSH 06/30/01 Org chart update, ISO Coordinator. Update R. SLOCKBOWERI 2/24/02 Update of Qual. Policy Statement, org. chart, R. SLOCKBOWERISO9000:2000 compliance; insert hyperlinks;removed grandfathered vendor classificationJ 9/13/02 Update <strong>QUALITY</strong> ASSURANCE MANAGER – A. MorrisGENERAL ISO COORDINATOR to Andy MorrisK 3/2/04 Revise manual content and organization A. MorrisL 12/9/05 Reword and revise to reflect business unit structure A. MorrisM 12/29/06 Revise to reflect changes in operationalresponsibilities and simplification of some processesA. MorrisPage 2 of 21DOC # 0242-D01 REVM, 12/29/06


Quality Manual Index1.0 Scope 41.1. About Thorlabs Inc. 51.2. The Thorlabs’ Mission Statement 51.3. Thorlabs’ Commitment to Quality (Quality Policy) 51.4. Thorlabs’ Eight Management Principles 51.5. Thorlabs Management Team Endorsement 61.6. Quality Management System Documentation 61.7. Manual maintenance and distribution 62.0 Normative Reference 63.0 Terms, Definitions and Abbreviations 64.0 Quality Management System 74.1. General 74.2. Documentation Requirements 74.2.1. General 74.2.2. Quality Manual 74.2.3. Control of Documents 74.2.4. Control of Records 95.0 Management Responsibility 95.1. Management Commitment 95.2. Customer Focus 95.3. Quality Policy 105.4. Quality Planning and Objectives 105.4.1. Quality Objectives 105.4.2. Quality Management System Planning 105.5. Responsibility, Authority, and Communication 105.5.1. Responsibility and authority 105.5.2. Management Representative (QMS Manager / QMS Representative) 105.5.3. Internal Communication 105.6. Management Review 125.6.1 General 125.6.2 Review Input 125.6.3 Review Output 126.0 Resource Management 136.1. Provision of Resources 136.2. Human Resources 136.2.1. General 136.2.2. Competence, Awareness, and Training 136.3. Infrastructure 136.4. Work Environment 137.0 Product Realization 147.1 Planning for Product Realization 147.2 Customer Related Processes 147.2.1. Determining Requirements Related to the Product 147.2.2. Review of Requirements 147.2.3. Customer Communication 147.3. Design and Development 157.3.1 Design and Development Planning 157.3.2 Design Inputs 157.3.3 Design Outputs 157.3.4 Design and Development Review 157.3.5 Design Verification 157.3.6 Design Validation 15Page 3 of 21DOC # 0242-D01 REVM, 12/29/06


7.3.7 Control of Design and Development Changes 157.4. Purchasing 167.4.1 Purchasing Process 167.4.2 Purchasing Information 167.4.3 Verification of Purchased Product 167.5 Production and Service Provision 167.5.1. Control of Production 167.5.1.1. Identification and packaging 167.5.1.2 Fabrication, machining, and assembly 167.5.1.3 Documentation 167.5.2 Process Validation 177.5.3 Customer property 177.5.4 Identification and Traceability 177.5.5. Preservation of Product 177.6. Control of Monitoring and Measuring Devices 187.6.1 Calibration 187.6.2 Control 188.0 Measurement, Analysis and Improvement 188.1 General 188.2 Monitoring and Measurement 188.2.1 Customer Satisfaction 188.2.2 Internal Audit 188.2.3 Monitoring and Measurement of Processes 198.2.4 Monitoring and Measurement of Product 198.3 Control of Nonconforming Product 198.4 Analysis of Data 208.5 Improvement 208.5.1 Continuous Improvement 208.5.2 Corrective Action 208.5.3 Preventive Action 21Page 4 of 21DOC # 0242-D01 REVM, 12/29/06

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