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 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
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 of 21 1.0 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 9505 1.2 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 7.5.1 Service has been intentionally omitted as we do not provide after sales (post-delivery) service at this time. Section 7.5.2 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 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 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 9001. 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 4.2.1 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). 4.2.2 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 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 of 21 4.2. 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. 4.2.4 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 5.5.2 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 of 21 5.2 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 7.2.1 and 8.2.1. 5. 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 5.4.1 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. 5.4.2 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 5.5.1 Responsibility and Authority
10 of 21 Isolink s executive management team ensures that responsibilities and authorities are defined and communicated within the organization. 5.5.2 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. 5.5. 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 5.6.1 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. 5.6.2 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 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 6.2.1 General Personnel performing work affecting conformity to product requirements are competent on the basis of appropriate education, training, skills and experience. 6.2.2 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 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.
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 7.2.1 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. 7.2.2 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. 7.2. 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 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. 7..2 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. 7..4 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. 7..5 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 of 21 7..6 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. 7..7 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 7.4.1 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. 7.4.2 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 of 21 7.4. 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 7.5.1 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. 7.5.2 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 9001. 7.5. Identification and Traceability Where appropriate, Isolink identifies the product by suitable means throughout product realization.
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. 7.5.4 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. 7.5.5 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 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 8.2.4 of this QMS Manual) To ensure conformity of the QMS, (See Section 8.2.2 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 8.2.1 Customer Satisfaction Isolink monitors information relating to customer perception as to whether we have met customer requirements. 8.2.2 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 of 21 8.2. 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. 8.2.4 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 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 8.5.1 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. 8.5.2 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 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. 8.5. 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