1 QUALITY MANAGEMENT SYSTEM (QMS) MANUAL This document and the data contained herein are the property of ISOLINK, and shall not, without prior written permission, be reproduced or used for any unintended purpose.
2 2 of 21 REVISION HISTORY Rev Description of Change Author Approval Submit Date 0 Initial Release John Steeves 11/24/201 1 ECN #129 Joseph Rosario 12/19/201 2 ECN #106 Joseph Rosario 1/2/2014 ECN #141 Joseph Rosario 4/24/2014
3 of 21 Company Profile Company Overview: Isolink, founded in 1987,is a subsidiary of Skyworks Solutions, Inc. Isolink is the leading supplier of high performance and high quality optoelectronic radiation tolerant components worldwide. Isolink's mission is to provide products and services to the high-reliability, military, aerospace, hybrid, industrial, medical, and telecommunications markets. The company specializes in the manufacture of high-performance miniature hybrids and hermetically sealed devices. Isolink pioneered the miniaturization of some of the most advanced optoelectronic components. Our expertise in optoelectronic components enables us to make products of high quality, achieving high isolation voltages. A hallmark of Isolink's products is high common mode rejection and radiation tolerance for high demand environments.
4 4 of Scope, Exclusions and Justification 1.1 Scope of Certification Isolink has implemented and maintains a Quality Management System that meets the requirements of ISO 9001:2008. Design, Manufacture and Testing of optoelectronic components. Scope of Certification includes the following locations: Corporate Office 880 Yosemite Way Milpitas, CA Exclusions The following specific exclusions apply to ISOLINK QMS. Section 7..6 Design and Development Validation has been intentionally excluded. Isolink does not validate requirements of the application or intended use for products, this is performed by the end customer in the application. Section Service has been intentionally omitted as we do not provide after sales (post-delivery) service at this time. Section Process Validation has been intentionally omitted as we do not have manufacturing processes that cannot be verified by subsequent inspection and-or monitoring (testing). 2.0 Referenced Documents 2.1 The following external documents contain provisions, which through reference in this document constitute provisions of this manual. The latest edition of the documents referred to apply.
5 5 of 21 Document Number ISO 9001 RoHS Document Title International Organization for Standardization Quality Management Systems - Requirements DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment.0 Definitions Acronyms / Terminology QMS Process Procedure Product Realizations Record Description / Definition Quality Management System, encompassing the Quality Management System (ISO 9001 based). A defined methodology to achieve a given objective. A written manifestation of a process. In this Manual, a referenced procedure is understood to be documented, implemented, and maintained. The system of interrelated processes to bring a product to market and deliver it to the customer. Evidence of the implementation and effectiveness of the QMS. 4.0 Quality Management System 4.1 Quality Management System (QMS) General Requirements Isolink has established, documented, implemented, maintains and continually improves our Quality Management System that encompasses requirements based on the ISO 9001 internationally recognized standard. Isolink has: Determined the processes needed to support the QMS are defined and applied throughout the organization (as described in this QMS Manual) Determined the sequence and interaction of these processes (as described in Section 4.2 of this QMS Manual) Determined the criteria and methods required needed to ensure both the operation and control of these processes are effective (as described in Section 5.4 of this QMS Manual)
6 6 of 21 Ensured the availability of resources and information necessary to support the operation and maintenance of these process (as described in Section 5.5 and Section 6 of this QMS Manual) Monitored, Measured (as applicable) and analyzed these processes (as described in Sections 8.2 and 8.4 of this QMS Manual) Implemented actions necessary to achieve planned results and continual improvement of these processes (as described in Section 8.5 of this QMS Manual). These processes are aligned with the requirements of ISO Where Isolink chooses to outsource any process that affects our ability to meet conformity to product requirements, Isolink will ensure control over the outsourced processes. This is accomplished by the processes described in Section 7.4 of this QMS Manual. 4.2 Documentation Requirements General Requirements Isolink s QMS documentation includes: Documented statements of an QMS Policy and Objectives (See Sections 5. and 5.4 of this Quality Manual) A Quality Manual (this document) Documented procedures and records as mandated by ISO 9001 and needed to ensure the effective operation of the QMS (as referenced in this Quality Manual) Quality Manual Requirements Isolink s has established a Quality Manual that includes: The Scope of the Quality Manual and a listing or exclusions and justification for these exclusions (as described in Sections 2 of this QMS Manual. A reference to the documents that support the QMS (referenced as appropriate in this document). A description of the interaction of the processes of the Quality Management System (see below):
7 7 of 21 Customer RFQs, Quotes, Orders Market Research QMS PROCESS MAP Resources RMP 01 Personnel Competence and Skills PRP 01 Sales & Order Processing PRP 09 Product Design RMP 02 RMP 0 Information, Facilities, Doc. Control & Equipment & Inf. Tech Work Environment Resource Mngmnt Processes (RMP) PRP 02 Purchasing PRP 0 Receiving PRP 04 Inspection Management PRP 07 Inventory PRP 05 Production Final/Pack PRP 08 Production and Quality Planning Product Realization Processes (PRP) Policies & Directions MRP 0 Continual Improvement Policies & Directions Management Responsibility Processes (MRP) Resource Needs MRP 01 Planning & Objectives MRP 02 Management Review QMS Performance Data Measurement, Analysis and Improvement Processes (MIP) PRP 06 Delivery MIP 01 Control of NC Product Product/ Process Data MIP 02 Int. Audit & Analysis of Data MIP 04 Customer Complaints/ Satisfaction MIP 0 C&P Action Customer
8 8 of Control of Documents Documents required by the QMS are controlled. A documented procedure has been created that describes the controls needed to: Approve documents for adequacy prior to issue Review and update as necessary and re-approve documents, Ensure that changes and the current revision status of documents are identified, Ensure that relevant versions of applicable documents are available at points of use, Ensure that documents remain legible and readily identifiable, Ensure that documents of external origin determined by Isolink to be necessary for the planning and operation of the QMS are identified and their distribution controlled, and to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose Control of Records Records have been established and are controlled which provides evidence of conformity to requirements and of the effective operations of our QMS. A documented procedure has been established that define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records. SOP-QA-0001 Document and Record Control 5.0 Management Responsibility 5.1 Management Commitment Isolink s executive management team ensures commitment to the development and implementation of the QMS and continually improving its effectiveness by: Communicating to Isolink personnel the importance of meeting customer, as well as the statutory and regulatory requirements (See Section of this Manual) Establishing the Quality Policy (See Section 5. of this Manual) Ensuring that QMS objectives are established (See Section 5.4 of this Manual) Conducting management reviews (See Section 5.6 of this Manual) Ensuring the availability of resources (See Section 5.5 of this Manual)
9 9 of Customer Focus Isolink s executive management team ensures that customer requirements are determined and met, with the aim of enhancing customer satisfaction. This requirement is supported further in sections and Quality Policy At Isolink, we are committed to the never ending quest for perfect quality. No Field Failures No Customer Returns No Reliability Failures No Yield Loss. The General Manager has defined the Isolink Quality Policy and ensures that it is communicated and understood within the organization. The Quality Policy is made available in our Corporate Lobby as well as on our intranet site. The Quality Policy is reviewed at Management Review meetings for continuing suitability and is updated as appropriate. 5.4 Planning Quality Management System Objectives Top management ensures that QMS Objectives are set at relevant functions and levels of Isolink. These objectives are measurable, have established targets and supporting plans that align with the intentions described in our Quality Policy Quality Management System Planning Plans are developed to support the achievement of the QMS Objectives and to meet the overall scope of our QMS (as described in Section 2 of this QMS Manual). Our change control processes (See Sections 4.2. and Section 7..7 of this QMS Manual) ensure that the integrity of the QMS is maintained as changes and improvements occur. SOP-AD-0002 Business Scorecard Procedure SOP-QA-0001 Document and Record Control 5.5 Responsibility, Authority, and Communication Responsibility and Authority
10 10 of 21 Isolink s executive management team ensures that responsibilities and authorities are defined and communicated within the organization Management Representative Top management has appointed the Quality Engineering Manager who, irrespective of his other responsibilities, has responsibility and authority that includes: Ensuring that processes needed for the QMS are established, implemented and maintained Reporting to top management on the performance of the QMS and any need for improvement, and Ensuring the promotion of awareness of customer and regulatory requirements throughout the organization that relate to the QMS Internal Communications Top management ensures that appropriate communication processes are established within Isolink and that communication takes place regarding the effectiveness of the QMS. SOP-AD-0001 Organizational Responsibility SOP-AD-0002 Business Scorecard Procedure 5.6 Management Review General The Executive Team formally reviews Isolink s QMS semi-annually to ensure its continuing suitability, adequacy, and effectiveness. The review includes assessing opportunities for improvement and the need for changes to the QMS, including a review of the Quality policy and QMS objectives. Records from the Management Review meetings are maintained by the Management Representative Management Review Input The input to management review includes information on: Results of audits (both internal and external) Customer feedback (including customer complaints) Process performance and product conformity Status of preventive and corrective actions Follow-up actions from previous management reviews
11 11 of 21 Changes that could affect the QMS Recommendations for improvement Review of the Quality Policy for ongoing appropriateness 5.6. Management Review Output The output from the management review includes any decisions and actions related to improvement of the effectiveness of the QMS and its processes, improvements, product-related issues, customer requirements, and resource needs. 6.0 Resource Management 6.1 Provision of Resources/Resource Management Isolink has determined and provides the resources needed to implement and maintain the QMS and continually improve its effectiveness, and to enhance customer satisfaction by meeting customer requirements. 6.2 Human Resources General Personnel performing work affecting conformity to product requirements are competent on the basis of appropriate education, training, skills and experience Competence, Awareness and Training To ensure personnel competence is maintained, Isolink: Determines the necessary competence for personnel performing work affecting conformity to product requirements. Where applicable, provides training or take other actions to achieve the necessary competence. Ensures the necessary competence has been achieved, ensure that those who work for Isolink are aware of the relevance and importance of their activities and how they contribute to the achievement of the QMS objectives. Ensures personnel who work for Isolink are aware of the Quality Policy. Maintains appropriate records of education, training, skills and experience.
12 12 of 21 SOP-AD-0001 Organizational Responsibility SOP-AD-0008 Employee Competency and Training 6. Infrastructure Isolink determines, provides, and maintains the proper infrastructure required to achieve conformity to product requirements. Infrastructure includes the following, as applicable: Buildings, workspace and associated utilities Process equipment (both hardware and software) Supporting services (such as IT and communication) SOP-AD-0009 IT/MIS Procedures SOP-AD-0007 Infrastructure Procedure 6.4 Work Environment Isolink determines and manages the work environment needed to achieve conformity to product requirements. SOP-AD-0007 Infrastructure Procedure SOP-OP-000 Lab Environment Control SOP-QA-0005 ESD Control 7.0 Resource Management 7.1 Planning of Product Realization Isolink plans and develops required processes for product realization, and ensures that they are consistent with the requirements of the other processes within the QMS. In Planning Product Realization, Isolink determines the following: Quality objectives and requirements for the product. Need to establish processes, documents, and provide resources specific to the product. Required verification, validation, monitoring, inspecting, and test activities specific to the product and the criteria for product acceptance.
13 1 of 21 Records needed to provide evidence that the realization processes and resulting product meet requirements. SOP-OP-0002 Product Flow Control 7.2 Customer-related Processes Definition of Requirements Related to the Product Isolink determines: Requirements specified by the customer, including the requirements for delivery. Requirements not stated by the customer, but necessary for specified or intended use, where known. Statutory and regulatory requirements related to the product. Any additional requirements determined by Isolink Review of Requirements Related to the Product Isolink reviews requirements related to the product prior to our commitment to supply a product to the customer and we ensure that: Product requirements are defined and documented Contract or order requirements differing from those previously expressed are resolved, and Isolink has the ability to meet defined requirements. Records of the results of the review and actions arising from the review are maintained. Where product requirements are changed (amended), Isolink ensures that these requirements are reviewed, and if accepted, that relevant documents are amended and that relevant personnel are made aware of the changed requirements Customer Communications Isolink determines and implements effective arrangements for communicating with customers in relation to: Product information. Enquires, contracts or order handling, including amendments. Customer feedback, including customer complaints.
14 14 of 21 SOP-AD-0010 Customer Order Review Process SOP-AD-000 Customer Communications 7. Design and Development 7..1 Design Planning Isolink has defined a New Product Development protocol that defines a Phased Approach to development that includes a definition of specific deliverables for design reviews, verifications, and validation. For specific design projects, a design plan is created that includes deliverables, assigned responsibilities and timeframes for design and development activities. Isolink manages the interfaces between different groups (e.g. hardware, software, marketing, operations, etc.) involved in design and development to ensure effective communication and clear assignment of responsibility. Planning output is updated during the course of the design and development Design Inputs Design requirements are defined and documented. Design inputs include functional and performance requirements of the product; applicable statutory and regulatory requirements; where applicable, information derived from previous similar designs; and other requirements essential for design and development. These inputs are reviewed for completeness, adequacy and to address inherent conflicts. Records of design inputs are maintained. 7.. Design Outputs Design and development output is provided in a form that allows for verification against the input and is approved prior to release or the product. Design output also includes appropriate information for purchasing, production and test activities as well as a reference to product acceptance criteria. The design output also specifies the characteristics of the product that are essential for the product s safe and proper use Design Reviews Systematic reviews of design and development are performed 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 design reviews include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of design reviews are be maintained Design Verification Design verification is performed 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 are maintained.
15 15 of Design Validation Design and development validation (Qualification) is performed to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use (where known.) Validation is completed prior to release of the product. Records of the results of design validation are maintained Design Changes Design and development changes are identified and records are maintained. Design changes are reviewed, verified and validated, as appropriate, and approved prior to implementation. The review of proposed changes includes evaluation of the effect of the changes on constituent parts and product already delivered. SOP-DE-0001 Design and Development SOP-OP-0002 Product Flow Control Procedure SOP-QA-0001 Document and Record Control 7.4 Purchasing Purchasing Process Isolink ensures that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product is dependent upon the effect of the purchased product on subsequent product realization and/or the final product. Isolink evaluates and selects suppliers based on their ability to supply product in accordance with our organization s requirements. Criteria for supplier approval and re-evaluation have been established. Records of the results of evaluations and any necessary actions arising from these evaluations are maintained Purchasing Information Purchasing information provide to the supplier through our PO System describes the product or service to be purchased, including where appropriate: Requirements for approval of product, procedures, processes and equipment Requirements for qualification of personnel QMS requirements (such as ISO 9001 Certification) Statutory and Regulatory Requirements that must be met (such as RoHS requirements) Isolink ensures the adequacy of specified purchase requirements prior to their communication to the supplier.
16 16 of Verification of Purchased Product Isolink has established and implemented the inspection or verification activities necessary for ensuring that purchased product meets specified purchase requirements. Isolink provides detailed instructions to suppliers regarding verification of purchased product in instances where verification of purchased product is performed at the supplier s site. Purchased materials, process equipment or services requiring inspection or qualification prior to release to production are inspected and qualified by trained and responsible ISOLINK-SKYWORKS personnel to ensure that they meet specified purchase requirements. Where purchased material, process equipment or service is verified by Skyworks personnel at the supplier s or subcontractor s premises, verification arrangements are specified in the purchasing documents. SOP-PC-0001 Purchasing Procedures SOP-QA-0009 Incoming Inspection SOP-QA-0008 Supplier Control 7.5 Production and Service Provision Control of Production and Service Provision Isolink and suppliers to Isolink, plan and carry out production and service provision under controlled conditions. Controlled conditions include, as applicable: the availability of information that describes characteristics of the product (such as specifications and drawings) The availability of work instructions, as necessary, The use of suitable equipment, The availability and use of monitoring and measuring devices, The implementation of monitoring and measurement, and The implementation of product release (e.g. final Inspection/QC) and delivery Validation of Processes For Production and Service Provision Isolink does not have manufacturing processes that cannot be verified by subsequent inspection and/or monitoring (testing) and we have therefore excluded this requirement of ISO Identification and Traceability Where appropriate, Isolink identifies the product by suitable means throughout product realization.
17 17 of 21 Where appropriate, Isolink identifies the product status with respect to inspection and test status throughout product realization. Where traceability is a requirement, Isolink controls and records the unique identification of the product and maintains records Customer Property Isolink exercises care with customer property while it is under our control. Isolink identifies, verifies, protects and safeguards customer property (e.g. customer equipment, materials, Intellectual Property), provided for use or incorporation into our product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, Isolink reports this to the customer and maintain records of this communication Preservation of Product Isolink preserves the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation of product (e.g. ESD protection) includes identification, handling, packaging, storage and protection. Preservation also applies to the constituent parts of a product. SOP-OP-0001 Manufacturing Overview SOP-OP-0002 Product Flow Control Procedure SOP-AD-0006 Customer Owned Property SOP-QA-0005 ESD Control Procedure SOP-PC-0002 Material Control 7.6 Control of Monitoring and Measuring Devices Isolink determines the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements. When necessary, to ensure valid results, measuring equipment is: Calibrated or verified at specified intervals, or prior to use, against measurement standards to international or national measurement standards; where no such standards exist, the basis used for calibration or verification is recorded Adjusted or readjusted as necessary Identified to enable the calibration status to be determined Safeguarded from adjustments that would invalidate the measurement result Protected from damage and deterioration during handling, maintenance and storage
18 18 of 21 In addition, Isolink assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements. Isolink takes appropriate action on the equipment and any product affected. Records of the results of calibration and verification are maintained. Isolink does not use test instruments where the software is not incorporated (firmware) into the test device and as such, the requirements for calibration or verification of test software has been intentionally omitted. SOP-OP-0004 Calibration Control 8.0 Measurement, Analysis and Improvement 8.1 General Isolink plans and implements the monitoring, measurement, analysis and improvement processes needed: To demonstrate conformity of the product, (See Section of this QMS Manual) To ensure conformity of the QMS, (See Section of this QMS Manual) and To continually improve the effectiveness of the Quality Management System (See Section 8.5 of this QMS Manual). 8.2 Monitoring and Measurement Customer Satisfaction Isolink monitors information relating to customer perception as to whether we have met customer requirements Internal Audit Isolink conducts internal audits to determine whether the QMS is implemented, effective and conforms to documented QMS requirements and ISO 9001 requirements. An audit program is in place, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods are defined and documented. Selection of auditors ensures objectivity and impartiality of the audit process. Auditors do not audit their own work. Functional Management is responsible for the area being audited and ensuring that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up actions include the verification of the actions taken and the reporting of verification results.
19 19 of Monitoring and Measurement of Processes Isolink monitors and measures the performance of the QMS. These methods demonstrate the ability of our business processes to achieve planned results. When planned results are not achieved, corrective action are taken, as appropriate, to ensure conformity Monitoring and Measurement of Product Isolink and our suppliers monitor and measure the characteristics of the product to verify that product requirements have been met. This is carried out at appropriate stages of the product realization process in accordance with planned arrangements. Evidence of conformity with product acceptance criteria are maintained by us or our suppliers. Records indicate the person(s) authorizing release of product to the customer. The release of product to the customer does not proceed until planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority within Isolink and, where applicable, by the customer. SOP-AD-0004 Customer Satisfaction SOP-QA-0007 Internal Audit SOP-OP-0002 Product Flow Control SOP-AD-0002 Business Scorecard 8. Control of Nonconforming Product Isolink ensures that product which does not conform to product requirements are identified and controlled to prevent its unintended use or delivery. Where practicable, Isolink and our suppliers deal with nonconforming product by one or more of the following ways: By taking action to scrap the detected nonconformity. By authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer. By taking action to rework the product so that it meets all specifications of the product. By taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are maintained. When nonconforming product is reworked, it is subjected to re-verification to demonstrate conformity to requirements.
20 20 of 21 SOP-QA-000 Nonconforming Material 8.4 Analysis of Data Isolink determines, collects, and analyzes appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the effectiveness of the QMS can be made. This includes data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data provides information about: Customer satisfaction Conformity to product requirements Characteristics and trends of processes and products including opportunities for preventive action Suppliers SOP-AD-0004 Customer Satisfaction SOP-QA-0008 Supplier Control SOP-OP-0002 Product Flow Control SOP-AD-0002 Business Scorecard 8.5 Improvement Continual Improvement Isolink continually improves the effectiveness of the QMS through the use of the Quality Policy, QMS objectives, audit results, analysis of data, corrective and preventive actions, and management reviews Corrective Action Isolink takes action to eliminate the cause of product Quality nonconformities in order to prevent recurrence. Corrective actions are appropriate to the effects of the nonconformities encountered. A procedure has been established to define requirements for: Reviewing nonconformities (including customer complaints), Determining the causes of nonconformities,
21 21 of 21 Evaluating the need for action to ensure that nonconformities do not recur, Determining and implementing action needed, Maintaining records of the results of action taken Reviewing corrective action taken to ensure effectiveness Preventive Action Isolink determines actions to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions are appropriate to the effects of the potential problems. A procedure has been established to define requirements for: Determining potential nonconformities and their causes, Evaluating the need for action to prevent occurrence of nonconformities, Determining and implementing action needed, Maintaining records of action taken, and Reviewing preventive action taken to ensure effectiveness. SOP-QA-0002 Corrective-Preventative Action
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
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
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
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
Page 1 of 12 4 Quality Management System 4.1 General Requirements The Peerless Pump Quality Management System shall include: Documented statements of a quality policy and of quality objectives; A quality
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,
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
Chapter j 38 Self Assessment 729 QUALITY MANAGEMENT SYSTEM REQUIREMENTS General Requirements 1. Establishing and implementing a documented quality management system 2. Implementing a documented quality
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
INTRODUCTION What auditors should look for: the items listed in these headings that the ISO requirement is met that the requirement is met in the manner described in the organization's documentation Page
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:
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
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
Page 1 of 19 (Formerly: Quality Management System Manual) When the ISO 9001:2008 standard is identifying the Quality Manual or Quality Management System, Turbonetics is representing this requirement with
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
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
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
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
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
ISO 9001:2008 QUALITY MANUAL Revision B Because we want you to achieve the highest levels of performance, we connect care Because with leading we want science you to achieve continuously the highest improve,
ISO 9001:2008 Page: 1 of 22 Central Technologies has developed a Quality Management System, and the associated procedures and work instructions, to be compliant to ISO 9001:2008. Utilizing this Quality
Quality Management System Manual 10V Gill Street Woburn, MA USA 01801 INTRODUCTION RL CONTROLS, LLC RL Controls, LLC is a privately held company headquartered in Woburn, MA, USA. RLC has more than 80 years
Quality Management System Manual This manual has been reviewed and approved for use by: Jack Zazulak President, Aurora Machine Limited March 07, 2011 Date - Copyright Notice - This document is the exclusive
इ टरन ट म नक Disclosure to Promote the Right To Information Whereas the Parliament of India has set out to provide a practical regime of right to information for citizens to secure access to information
Quality Management System Manual Assurance ISO / AS Manual Quality Management System EXCEEDING ALL EXPECTATIONS Since our inception in 1965, Swiss-Tech has supplied the medical, aerospace, hydraulic, electronic
Page 2 of 15 Document Revision History Revision Date Author Description of change 10 07Jun13 Mark Benton Removed Admin. Manager from approval 12Feb13 Mark Benton 08 01Oct12 Mark Benton 07 8/30/2012 Refer
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,
MAIL-IN / ONSITE This report is intended to furnish data relative to the Suppliers capability to control the quality of supplies and services furnished to Ontic UK. Please complete this Survey and return
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
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
Quality Manual Date: 11 th March, 2014 Issue: 5 Review Date: 10 th March 2015 VSS-COM-PRO-001 SCOPE This Quality Manual specifies the requirements for the Quality Management System of Vigilant Security
Quality Management System Requirements for the Suppliers Of Arçelik A.Ş. Rev : 0.1 Date of issue : September 2005-1/23- -2/23- 0. INTRODUCTION... 5 0.1. GENERAL... 5 1. SCOPE... 5 1.1. GENERAL... 5 1.2.
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:
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.)
The online version of this procedure is official. Therefore, all printed versions of this document are unofficial copies. St. Louis Public Schools Quality Assurance System Manual 801 North 11 th Street
Company Name Street Address City, State, Zip code Phone Number Fax Company Website Email Address ORGANIZATION NAME PHONE NUMBER EMAIL ADDRESS President/CEO General Manager Engineering Manager Production
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
PAGE 1 OF 40 QUALITY Note: The revision level of this document and any referenced documents must be verified for latest issue before use QOP-00-02 TITLE QUALITY ASSURANCE SYSTEM MANUAL APPROVALS DATE REVISIONS
AS 9100 Rev C Quality Management System Manual B&A Engineering Systems, Inc. 3554 Business Park Drive, Suite A-1 Costa Mesa, CA 92626 Doc. No. AS9100C Rev E Effective Date: 01 JAN 2013 Page 2 of 45 CONTROLLED
1. QUALITY MANAGEMENT SYSTEM QUALITY MANAGEMENT SYSTEM (QMS) ASSESSMENT CHECKLIST 1.1 Quality Management System General 1.1.1 Is objective evidence available to demonstrate that the MDSAP site has defined,
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
SOUTHWEST RESEARCH INSTITUTE QUALITY SYSTEM MANUAL July 2015 Revision 5 Quality System Manual Page iii TABLE OF CONTENTS 1.0 PURPOSE... 1 2.0 SCOPE... 1 3.0 TERMS AND DEFINITIONS... 2 4.0 QUALITY MANAGEMENT
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,
Corporate Quality Manual Preface The following Corporate Quality Manual is written within the framework of ISO 9001:2008 Quality System by the employees of CyberOptics. CyberOptics recognizes the importance
ISO 9001: 2008 Boosting quality to differentiate yourself from the competition xxxx November 2008 ISO 9001 - Periodic Review ISO 9001:2008 Periodic Review ISO 9001, like all standards is subject to periodic
ISO 9001:2008 Quality Manual Clause 3.7.4 Strode Park Foundation for People with Disabilities Approvals The signatures below certify that this Quality Manual has been reviewed and accepted, and demonstrates
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,
The online version of this document is controlled. Therefore, all printed versions of this document are unofficial copies. QUALITY MANAGEMENT SYSTEM MANUAL 6901 Charles Street Towson, Maryland 21204 Manual
Specialties Manufacturing Talladega Castings & Machine Co., Inc. ISO 9001:2008 This document is the property of TMS and may not be reproduced, wholly, or in part, without the express consent of TMS. Rev.
AEROSPACE STANDARD AS9100C Issued 1999-11 Revised 2009-01 Superseding AS9100B Quality Management Systems - Requirements for Aviation, Space and Defense Organizations RATIONALE This standard has been revised
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
ALABAMA RESEARCH & DEVELOPMENT This complies with the Requirements of ISO 9001:2008. Prepared By: Phyllis Olsen Release Date: 03/19/09 Quality Policy & Objectives s quality policy is to achieve sustained,
QUALITY ASSURANCE MANUAL JPM OF MISSISSIPPI, INC. Hattiesburg, MS Revision E 01/19/11 Revised to ISO 9001:2008 on July 9, 2009 JPM OF MISSISSIPPI, INC. MANAGEMENT QUALITY POLICY It is the goal of JPM of
INTEGRATED MANAGEMENT SYSTEM MANUAL IMS Based on ISO 9001:2008 and ISO 14001:2004 Standards Approved by Robert Melani Issue Date 30 December 2009 Issued To Management Representative Controlled Y N Copy
Quality Management System Burns Engineering, Inc. 10201 Bren Road East Minnetonka, MN 55343 4. 4.1 General Requirements The Quality Manual consists of the quality system policy documents and the quality
FOR INFORMATION ONLY. NOT A CONTROLLED DOCUMENT IF PRINTED 3230 Lawson Blvd. Oceanside, New York 11572 Phone: 516-678-6141 Fax: 516-678-6704 Website: www.lndinc.com E-mail: email@example.com ISO 9001:2008
LH Sleightholme Ltd, Westfield Works, Helperthorpe, Malton, North Yorkshire YO17 8TQ Quality Management System MANUAL ISO 9001:2008 This Quality Management System Manual has been issued on the authority
IFS DOCUMENT CLASS: QLTY-100 IFS DOCUMENT NUMBER: QM4.2.2 PAGE 2 of 25 Introduction Value Plastics, Inc., dba Nordson MEDICAL created a Quality Management System (QMS) to document the company s best business
Digital Internal Use Only DEC STD 017-2 - ISO 9002 - Quality Systems - Model for Quality Assurance in Production and Installation DOCUMENT IDENTIFIER: A-DS-EL00017-02-0000 Rev A, ABSTRACT: This standard
Contents of the ISO 9001:2008 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
Far West Technology, Inc. ISO 9001 Quality Manual Document No.: QM Revision: 0 Issue Date: 27 August 1997 Approval Signatures President/CEO Executive Vice President Vice President/CFO Change Record Rev
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
Washington Division Quality Management Systems Manual ISO 13485:2003 DOCUMENT NUMBER 01-QM-MED REVISION LEVEL 01 PAGE 1 of 40 This manual describes the quality management systems structure at GM Nameplate
Indian Standard QUALITY MANAGEMENT SYSTEMS REQUIREMENTS FOR SERVICE QUALITY BY PUBLIC SERVICE ORGANIZATIONS ICS 03.120.10 BIS 2005 BUREAU OF INDIAN STANDARDS MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG NEW
G & R Labs Light Meters and Calibration Quality Assurance Manual G&R Labs 2996 Scott Boulevard Santa Clara CA 95054 QM01 QUALITY MANUAL ISO9001:2008 Manual Contents QM 01 Manual Contents 2 QM 02 Copy Holder
This complies with the Requirements of ISO 9001:2008 and ISO/IEC 80079-34, Explosive Atmospheres - Edition 1.0 2011-04 Prepared By: Phyllis Olsen Release Date: 10/28/15 Certificate No: CERT-08776-2006-AQ-HOU-RvA
Rockwell Automation Quality Management System Our Quality Policy Rockwell Automation is committed to a global quality system focused on customer solutions. We achieve this through superior products and
CUSTOMER SPECIFIC REQUIREMENTS For Use With ISO 9001:2008 & ISO/TS 16949:2009 Page 1 SYSTEMS POLICY MANUAL CONTENTS Revision History Approval Document Distribution and Control General Application Background
1029 A West State Blvd. Ft Wayne, Indiana 46808 QUALITY MANAGEMENT SYSTEM POLICY MANUAL Based on: ISO 9001:2008 AND ISO/TS 16949:2009 Authorized By: Randy Shepherd VP of Quality Issue Date: March 1, 2004
Page 1 of 51 PURPOSE OF THE QUALITY POLICY MANUAL This manual is issued to describe the Quality Assurance System to be employed by Trostel, Ltd. This manual and the systems and processes it describes will