GENERAL. Index and Revision Status

Transcription

1 Quality Manual Facility ELMA Electronic Inc. Horsham GENERAL Section 0.1 Section Rev. 19 Rev. Date: 6/3/2015 Section Page 1 of 7 Index and Revision Status QUALITY SYSTEM MANUAL GENERAL 0.1 Index and Revision Status Rev Introduction Rev Scope and Application Rev8 SECTION 4 - QUALITY MANAGEMENT SYSTEM 4.1 General Requirements Rev Documentation and Records Rev. 8 SECTION 5 - MANAGEMENT RESPONSIBILITY 5.1 Management Commitment Rev Customer Focus Rev Quality Policy Rev Quality System Planning Rev Organization and Communication Rev Management Review Rev. 8 SECTION 6 - RESOURCE MANAGEMENT 6.1 Provision of Resources Rev Competence, Awareness and Training Rev Infrastructure Rev Work Environnement Rev. 7 Approved by: David Cook Sr. QA Manager

2 QUALITY MANUAL Section 0.1 Section Page 2 OF 7 Index and Revision Status SECTION 7 - PRODUCT REALIZATION 7.1 Planning of Product Realization Rev Customer-related Processes Rev Design Control Rev Purchasing Rev Operations Rev Monitoring and Measuring Equipment Rev. 9 SECTION 8 - MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 Planning of Monitoring and Measurement Rev Monitoring and Measurement Rev Control of Nonconforming Product Rev8 8.4 Analysis of Data Rev Continual Improvement Rev. 8 OPERATIONAL PROCEDURES 1 Control of Documents Rev Control of Quality Records Rev. 6 3 Internal Audit Rev. 9 4 Control of Nonconforming Product Rev Corrective and Preventive Action Rev. 9 6 ESD Protection Rev RMA Procedure Rev. 7

3 QUALITY MANUAL Section 0.1 Section Page 3 OF 7 Index and Revision Status 8 Order Processing for Catalog Products Rev. 6 9 Order Processing for Custom Products Rev Production Control Rev. 7

4 QUALITY MANUAL Section 0.1 Section Page 4 OF 7 Index and Revision Status REVISION HISTORY 10/07/03 1. Section Section Procedure 2 4. Procedure Procedure 4 6. Procedure 6 7. Procedure 8 1/13/05 1. Section Section Section Section Procedure 3 6. Procedure 4 7. Procedure 6 8/15/05 Section 0.1 Incorrectly listed the Rev of Operational Procedure 6 at 2 it should have been 3.

5 QUALITY MANUAL Section 0.1 Section Page 5 OF 7 Index and Revision Status REVISION HISTORY 12/09/05 1. Section Section Section Procedure 1 5. Procedure 4 6. Procedure 7 12/03/07 1. Section Procedure 3 3. Procedure 4 4. Procedure 5 5. Procedure 6 6. Procedure 7 7. Index and Revision Status Changed Section 0.3 from Exclusions to Scope and Application 1/14/ Procedure 5 2. Procedure 6

6 QUALITY MANUAL Section 0.1 Section Page 6 OF 7 Index and Revision Status 11/29/ General, Sections 4,5,6,7 and 8 2. Procedures 1, 4,5,6 and 7 1/21/2010 Procedure 6 05/23/ All Sections 2. Procedures 1,2,4,5,6,8,9,10 11/10/2011 Section /1/2011 Procedure 3 11/20/2012 Section 7.6 Procedure 1 Procedure 6 6/12/2014 All Sections All Procedures 8/20/2014 Section 7.4 9/23/2014 All Sections All Procedures

7 QUALITY MANUAL Section 0.1 Section Page 7 OF 7 Index and Revision Status 11/21/2014 Section 0.2 Section /30/2014 Procedure 1 6/3/2015 All Sections Procedures 1,2,4,5,6,8,9,10

8 Quality Manual Facility ELMA Electronic Inc. Horsham GENERAL Section 0.2 Section Rev. 8 Rev. Date:6/3/2015 Section Page 1 of 2 Introduction ELMA Horsham developed and implemented a quality management system to demonstrate its ability to provide consistent product that meets customer and applicable regulatory requirements, and to address customer satisfaction through the effective application of the system, including continual improvement and the prevention of nonconformity. The quality system complies with the international standard ISO 9001: The manual is divided into four sections modeled on the sectional organization of the ISO 9001 (2008) standard. Sections are further subdivided into several subsections representing main quality system elements or activities. Each subsection starts with a general policy statement expressing the commitment to implement the basic principles of the pertinent quality system element or activity. The general policy statement is followed by more specific procedural policies outlining how the general policy is implemented, and referencing applicable operational procedures. The purpose of this manual is to define and describe the quality system, to define authorities and responsibilities of the management personnel involved in the operation of the system, and to provide general procedures for all activities comprising the quality system. Another purpose of this manual is to present the quality system to our customers and other external interested parties, and to inform them what specific controls are implemented at ELMA Horsham to assure quality. Approved by David Cook Sr. QA Manager

9 QUALITY MANUAL Section 0.2 Section Page 2 Introduction Revision history 11/29/2009 Jim Waynick 1. Changed in header and body Advanced Control Technology, Inc. to ACT/Technico a Division of ELMA Electronic Inc. 2. Changed ISO9001:2000 to ISO9001: Changed titles in signature area President to Director of Systems Integration Vice President to Director of Business Development Removed Treasurer signature. 05/23/2011 Jim Waynick 1.Changed in header ACT/Technico a Division of ELMA Electronic Inc. to ELMA Electronic Inc. Warminster Facility. 2. Changed ACT/Technico in body to ELMA Warminster 6/12/2014 Jim Waynick Deleted reference to Chris Kuebler and Ken Grob Added footer approval block. 9/23/2014 Jim Waynick Changed section approval from VP Manufacturing/QA to Sr. QA Manager 11/21/2014 Jim Waynick Under Introduction changed consistently to constant. 6/3/2015 Jim Waynick Changed Warminster to Horsham

10 Quality Manual Facility ELMA Electronic Inc. Horsham GENERAL Section 0.3 Section Rev 8 Rev. Date: 6/3/2015 Section Page 1 of 3 Scope and Application GENERAL POLICY The quality management system shall be relevant to the nature of our organization and products, and to customer and regulatory requirements. For this reason, those requirements of ISO 9001: 2008 that do not apply are excluded from the scope of our quality system. Scope The Quality Management System (QMS) covers the organization s design, development, assembly,, service, repair and sale of integrated products for real-time and embedded computer systems. PROCEDURAL POLICIES Following rules and criteria are used for excluding irrelevant requirements: 1. An ISO 9001 (2008) requirement may be excluded only when both of the following conditions are met: The requirement must be within ISO 9001 Clause 7, Product Realization; and The exclusion may not affect our ability, nor absolve us from the responsibility, to provide product that meets customer and applicable regulatory requirements. 2. The Quality Control Manager is responsible for identifying those requirements of ISO 9001:2008 that do not apply to our organization or products, and to propose exclusions of such requirements from the scope of the quality system. 3. Top management has the responsibility and authority for evaluating whether the proposed exclusions are appropriate, and for approving them. Evaluation and approval of exclusions are conducted within the framework of management reviews of the quality system. 4. Any exclusions taken are documented in this section of the quality manual. The Approved by : David Cook Sr. QA Manager

11 QUALITY MANUAL Section 0.3 Section Page 2 of 3 Exclusions excluded requirements are precisely identified with reference to specific clauses and/or statements in the standard. There is also a brief justification why the exclusion is taken and why it is appropriate. None EXCLUSIONS

12 QUALITY MANUAL Section 0.3 Section Page 3 of 3 Exclusions Revision History 11/29/ Jim Waynick 1. Changed in header Advanced Control Technology, Inc. to ACT/Technico a Division of ELMA Electronic Inc. 2. Added service and repair to Scope. 3. Changed reference to ISO91001(2000) to ISO9100(2008) in General Policy and sentence 1 and Changed President to Director in signature box. 5/23/2011 Jim Waynick Changed in header ACT/Technico a Division of ELMA Electronic Inc. to ELMA Electronic Inc. Warminster Facility.. 6/12/2014 Jim Waynick Changed section approval from Director to VP Manufacturing/QA 9/23/2014 Jim Waynick Changed section approval from VP Manufacturing/QA to Sr. QA Manager 6/3/2015 Jim Waynick Changed Warminster to Horsham.

13 Quality Manual Facility ELMA Electronic Inc. Horsham QUALITY MANAGEMENT SYSTEM Section 4.1 Section Rev. 7 Rev. Date: 6/3/2015 Section Page 1 of 4 General Requirements GENERAL POLICY ELMA Horsham. is committed to establish, document, implement and maintain a quality management system, and continually improve its effectiveness, in conformance with requirements of ISO 9001:2008 International Standard. 1. Quality system processes PROCEDURAL POLICIES 1.1 Processes needed for the quality management system are identified in this quality manual and in associated operational procedures and work instructions. The documentation defines these quality system processes and their sequence and interaction, and instructs on how to implement and apply them throughout the organization. 1.2 Quality system documentation also defines criteria and methods needed to ensure that the operation and control of quality system processes are effective. This usually includes assignment of responsibilities and allocation of resources for the process, instructions on how to carry out (or operate) the process, and definition of methods for monitoring and/or measuring the effectiveness of the process. 1.3 Operational Procedure 1, Quality System Documentation, explains in more detail how quality system processes are defined and documented. 2. Resources and information 2.1 Quality Control manager is responsible for determining resource and information requirements necessary to support the operation and monitoring of quality system processes, and for communicating these requirements to the top management. The top executive management is responsible for ensuring the availability of necessary resources and information. Section 6.1 of this quality manual, Provision of Resources, explains in more detail how resource requirements are identified and satisfied. Approved by David Cook Sr. QA Manager

14 QUALITY MANUAL Section 4.1 Section Page 2 of 4 General Requirements 3. Monitoring and measurement 3.1 The performance of quality system processes is systematically monitored and/or measured. This is to ensure their effectiveness and identify opportunities for improvement. 3.2 The performance of product realization processes is usually monitored by measuring process parameters and/or product characteristics resulting from the process; and through the program of inspections and tests applied to the product. The performance of processes required for quality management is usually monitored through internal quality audits. The overall performance of the quality system is monitored by measuring customer satisfaction. 3.3 Monitoring and measuring activities are defined in Sections 8.1 and 8.2 of this quality manual, and in the corresponding operational procedures. 4. Conformance and continual improvement 4.1 Quality management system processes are regularly reviewed by the top management to identify any possible failures or breakdowns, as well as opportunities for improvement. Actions necessary to address actual or potential problems and to improve the quality system are implemented through corrective and preventive actions and management improvement projects. Sections 5.6 and 8.5 of this quality manual and the corresponding operational procedures define how management reviews and corrective/preventive actions are used to ensure conformance and improvement. 5. Outsourced processes 5.1 When processes that affect product conformity are outsourced, special controls are implemented to ensure that these processes meet specified requirements. Such controls may include, as appropriate: evaluation and pre-qualification of suppliers; assessment of supplier realization processes and quality system; monitoring of supplier quality performance; requirements for inspection, testing or other records demonstrating product conformity; or containment and verification of the supplied product. Section 7.4 of this quality manual and the corresponding operational procedures define such purchasing control system. Quality Manual: All sections ASSOCIATED DOCUMENTS

15 QUALITY MANUAL Section 4.1 Section Page 3 of 4 General Requirements Operational Procedure 1: Quality System Documentation

16 QUALITY MANUAL Section 4.1 Section Page 4 of 4 General Requirements Revision History 11/29/09 - Jim Waynick 1. Changed in header Advanced Control Technology, Inc. to ACT/Technico a Division of ELMA Electronic Inc. 2. Changed in General Policy ISO9001:2000 to ISO9001: Signature block changed from President to Director 5/23/2011 Jim Waynick 1. Changed in header ACT/Technico a Division of ELMA Electronic Inc. to ELMA Electronic Inc.Warminster Facility.. 2. In General Policy section changed Advanced Control Technology to ELMA Warminster 6/12/2014 Jim Waynick Changed section approval from Director to VP Manufacturing/QA 9/23/2014 Jim Waynick Changed section approval from VP Manufacturing/QA to Sr. QA Manager 6/3/2015 Jim Waynick Changed Warminster to Horsham

17 Quality Manual Facility ELMA Electronic Inc. Horsham QUALITY MANAGEMENT SYSTEM Section 4.2 Section Rev. 8 Rev. Date: 6/3/2015 Section Page 1 of 5 Documentation and Records GENERAL POLICY Scope of the quality system documentation is defined. Establishment and revision of documents, and their distribution, are controlled. New documents and revisions are reviewed and approved prior to issue; and are identified with respect to their revision level. Appropriate documents are available at locations where they are used. Obsolete documents are removed from points of use. Documents of external origin are identified and their distribution is controlled. Quality records are identified and indexed to facilitate their retrieval, and are stored in a suitable environment to minimize deterioration. Quality records are retained for a period of time at least one year after shipment of the product or as required by customer contract or regulation. 1. Scope PROCEDURAL POLICIES 1.1.ELMA Horsham s quality system documentation comprises the following types of documents: Quality manual (including a documented quality policy); Documented statements of quality objectives Operational procedures; Departmental procedures and Work instructions; Standards and other technical reference materials; Engineering documents, including drawings, specifications, procedures, and other documents defining products; Customer engineering documents; Product realization and control plans as required by contract. Approved by: David Cook Sr. QA Manager

18 QUALITY MANUAL Section 4.2 Section Page 2 of 5 Documentation and Records Purpose, scope, and responsibility for controlling various types of documents are defined in Operational Procedure 1, Control of Documentation. 2. Quality Manual 2.1 The top-level document defining the overall quality management system is the Quality Manual. It includes: The scope of the quality system, including details of and justification for any exclusions (refer to Section 0.3); Description of quality system processes, their sequence, and interrelation. This is described in an attachment to this section. References to appropriate documented procedures, if required for clarity or completeness. The Quality Control Manager is authorized to review, edit, control and publish the Quality Manual. The Sr. QA Manager is authorized to review and approve the Quality Manual. 3. Document control 3.1 ELMA Horsham is transitioning from paper to electronic documentation. As this transition progresses, new categories of documents are transferred from paper to electronic document control system. Both systems are currently used, and are defined in Operational Procedure 1, Control of Documents. 3.2 New documents and document changes may be initiated by anyone in the organization, but may only be issued by an authorized function. The authorized functions and the rules governing the issue of documents are defined in Operational Procedure 1, Control of Documents. All documents are reviewed and approved prior to issue. 3.3 A paper document is officially issued for use when it is approved by authorized function. An electronic document is issued by being placed in a public directory accessible from the network. 3.4 Documents are distributed to personnel and locations where they are used. When appropriate and relevant, documents display a distribution list. Electronic documents are available on the network and are accessible at relevant terminals and computers.

19 QUALITY MANUAL Section 4.2 Section Page 3 of 5 Documentation and Records Document placement is regulated by Operational Procedure Obsolete documents are removed from points of use. Retained masters or copies of obsolete documents are properly marked and are kept separate from active documents. Obsolete electronic documents are removed from the network and, if retained, are stored in directories that are accessible only to authorized personnel. 3.6 Document changes are reviewed and authorized by the same function that issued the original document or as otherwise authorized by the Quality Control Manager. Revised documents are distributed with a change brief summarizing the changes, except revised forms, for which users are verbally informed or notified by regarding revisions. Each department issuing paper documents maintains a master list or set of lists specifying the latest issues and revisions of its documents. For electronic documents such list is not necessary, as only the latest issue and revision of a documents is available on the network. 4. Control of quality records 4.1 Quality records are established and maintained to provide evidence that: Product designs satisfy design input requirements; Materials, components, and production processes meet specified requirements; Finished products conform to specifications: and The quality system is operated in accordance with documented procedures and that it is effective. Where required, quality records also include traceability information. 4.2 Records are established by personnel performing the task, operation, or activity the results of which need to be recorded. Records are dated; and identify the product, person, or event to which they pertain. 4.3 Records are indexed and grouped to facilitate their retrieval. Cabinets, binders, computer disks, and other storage media containing records are clearly labeled with identification of their content. 4.4 Records except sales orders and associated records are normally stored by the same department that initially established the record. Records of customer jobs are stored in the Sales area. Records are stored in dry and clean areas, and electronic records are regularly backed up. Quality records and documents may not be stored in private desk

20 QUALITY MANUAL Section 4.2 Section Page 4 of 5 Documentation and Records drawers, unauthorized computer drives, or other obscure locations that are not generally known. 4.5 Retention periods for quality records are determined on the basis the lifetime of the product or the event to which the record pertains, and on regulatory and contractual requirements. 4.6 All categories of quality records maintained by ELMA Horsham. are listed in Operational Procedure 2, Control of Quality Records. The list identifies specific types of records for each category; their storage location; and retention period. ASSOCIATED DOCUMENTS Operational Procedure 1: Control of Documents Operational Procedure 2: Control of Quality Records

21 QUALITY MANUAL Section 4.2 Section Page 5 of 5 Documentation and Records Revision History 11/29/2009 Jim Waynick 1. Changed in header Advanced Control Technology, Inc. to ACT/Technico a Division of ELMA Electronic Inc. 2. In Section 2. Quality Manual changed President to Director of Systems Integration 3. In signature box changed President to Director. 4. Section 3.1 changed Advanced Control Technology Inc to ACT/Technico. 5/23/2011 Jim Waynick 1. Changed in header ACT/Technico a Division of ELMA Electronic Inc. to ELMA Electronic Inc.Warminster Facility. 2. Section 1,1 and 3.1 ACT/Technico changed to ELMA Warminster 3. Section 4.6 Advanced Control Technology changed to ELMA Warminster 6/12/2014 Jim Waynick 1. Changed section approval from Director to Vice President Manufacturing/QA. 2. In Section 2.1 changed Quality Manual approval from Director to VP Manufacturing/QA. 9/23/2014 Jim Waynick 1. Changed section approval from VP Manufacturing/QA to Sr. QA Manager. 2. In Section 2.1 changed Quality Manual approval from VP Manufacturing/QA to Sr. QA Manager. 6/3/2015 Jim Waynick Changed Warminster to Horsham

22 Quality Manual Facility ELMA Electronic Inc. Horsham MANAGEMENT RESPONSIBILITY Section 5.1 Section Rev.7 Rev. Date:6/3/2015 Section Page 1 of 3 Management Commitment GENERAL POLICY The top management is ultimately responsible for establishing, implementing, maintaining, and improving the quality system. Management commitment is demonstrated by communicating to the organization the importance of meeting requirements, establishing the quality policy and quality objectives, conducting management reviews of the quality system, and ensuring the availability of necessary resources. 1. Top management PROCEDURAL POLICIES 1.1 For the purpose of administrating the quality management system, top management includes the group of managers defined in this manual in Section 5.5, Organization and Communication. 2. Customer requirements 2.1 Top management is committed to communicate the importance of meeting customer as well as regulatory and legal requirements. Management representative is responsible for implementing this commitment by promoting awareness of customer requirements throughout the organization. This responsibility of management representative is stipulated in Section 5.5, Organization and Communication. 3. Quality policy and quality objectives 3.1 Top management defines the purpose and objectives for the quality management system. They are documented and communicated in the form of quality policy and quality objectives. Processes for establishing the quality policy and quality objectives are defined in this manual in Section 5.3, Quality Policy, and Section 5.4, Quality System Planning. Approved by David Cook Sr. QA Manager

23 QUALITY MANUAL Section 5.1 Section Page 2 of 3 Management Commitment 4. Management reviews 4.1 Top management periodically reviews the quality management system to ensure its continuing suitability, adequacy, and effectiveness. The review evaluates current status and performance of the quality system and initiates actions for further improvement of the system. The process for conducting management reviews is defined in Section 5.6 of this manual. 5. Resources 5.1 Top management is committed to providing resources necessary for establishing, implementing, and improving the quality management system. Section 6.1 of this manual defines processes for identifying resource requirements and allocation of resources for specific activities and projects. None ASSOCIATED DOCUMENTS

24 QUALITY MANUAL Section 5.1 Section Page 3 of 3 Management Commitment Revision History 11/29/2009 Jim Waynick 1. Changed in header Advanced Control Technology, Inc. to ACT/Technico a Division of ELMA Electronic Inc. 2. Section 1.1 changed President to Director. 3. Changed President to Director in signature box. 5/23/2011 Jim Waynick Changed in title header ACT/Technico a Division of ELMA Electronic Inc. to ELMA Electronic Inc Warminster Facility. 6/12/2014 Jim Waynick 1. Changed section approval from Director to VP Manufacturing/QA 2. In Section 1 removed Director as part of part of top management. 9/23/2014 Jim Waynick Changed section approval from VP Manufacturing/QA to Sr. QA Manager 6/3/2015 Jim Waynick Changed Warminster to Horsham

25 Quality Manual Facility ELMA Electronic Inc. Horsham MANAGEMENT RESPONSIBILITY Section 5.2 Section Rev. 7 Rev. Date: 6/3/2015 Section Page 1 of 3 Customer Focus GENERAL POLICY The principal objective of the quality management system is to focus our organization on the customer, and in particular, on customer satisfaction. The key to achieving high customer satisfaction is a good understanding of customer requirements and a capability to consistently fulfill these requirements. 1. Determining customer requirements PROCEDURAL POLICIES 1.1 Customer requirements are understood broadly to include all aspects of product offering and associated services that are relevant to customer satisfaction. When appropriate, this may also include customer needs and expectations. 1.2 Customer requirements are determined and verified through the process of order review. This process is defined in this manual in Section 7.2, Customer-related Processes, and in Operational Procedures 8, Order Processing for Catalog Products, and 9, Order Processing for Custom Products. 2. Meeting customer requirements 2.1 The processes and elements of the quality system are designed and implemented specifically to ensure that customer requirements are met. This starts with provision of required training, and adequate infrastructure and suitable work environment (Section 6, Resource Management). Next follows planning and implementation of reliable and effective product realization processes (Section 7, Product Realization). And finally, activities related to product and process monitoring and verification (Section 8, Measurement, Analysis and Improvement). 2.2 Meeting of customer requirements is monitored and/or verified by methods described in Section 8.2, Monitoring and Measurement. Results of these verification activities are recorded to provide evidence of product conformity, as defined in Section 4.2, Approved by: David Cook QAManager

26 QUALITY MANUAL Section 5.2 Section Page 2 of 3 Customer Focus Documentation and Records. 3. Customer satisfaction 3.1 Focusing on customer requirements and on meeting these requirements should result in enhancing customer satisfaction. In fact, the level of customer satisfaction is used as a measure of the effectiveness of the whole quality system. 3.2 Methods for determining customer satisfaction are defined in quality manual Section 8.2. The quality control manager reports and the organization uses this information as input as described in Section 5.6, Management Review. ASSOCIATED DOCUMENTS Operational Procedure 8: Order Processing for Catalog Products Operational Procedure 9: Order Processing for Custom Products

27 QUALITY MANUAL Section 5.2 Section Page 3 of 3 Customer Focus Revision History 11/29/2009 Jim Waynick 1. Changed in header Advanced Control Technology, Inc. to ACT/Technico a Division of ELMA Electronic Inc 2. Changed President to Director in signature box. 5/23/2011 Jim Waynick Changed in header ACT/Technico a Division of ELMA Electronic Inc. to ELMA Electronic Inc. Warminster Facility. 6/12/2014 Jim Waynick Changed section approval from Director to VP Manufacturing/QA 9/23/2014 Jim Waynick Changed section approval from VP Manufacturing/QA to Sr. QA Manager 6/3/2015 Jim Waynick Changed Warminster to Horsham

28 Quality Manual Facility ELMA Electronic Inc. Horsham GENERAL Section 5.3 Section Rev.: 8 Rev. Date: 6/3/2015 Section Page 1 of 3 Quality Policy PROCEDURAL POLICIES 1. Authority 1.1 The Quality Policy is established by the top management. and is approved by the President Any changes to the policy must likewise be approved by the President. 2. Role of the policy 2.1 The main role of the quality policy is to communicate the company s commitments and aspirations with regard to quality, and to define principal objectives for the quality management system. 2.2 The quality policy provides a framework for establishing specific quality objectives, and provides direction for the continual improvement effort. The use of quality policy in setting quality objectives is addressed in this manual in Section 5.4, Quality Planning. The use of the policy to facilitate continual improvement is explained in Section 8.5 of this manual. 3. Communication 3.1 The quality policy is posted throughout the company, and its role is explained and discussed at the general orientation training provided to all employees. 3.2 The quality policy is also communicated to customers, consumers and other interested parties. For this purpose, it is displayed in the reception area and posted on the company s internet site. 4. Review 4.1 The quality policy is periodically reviewed within the framework of management reviews of the quality system. This is to ensure its continual relevance and suitability. The process for reviewing the quality policy is defined in this manual in Section 5.6, Management Review. Approved by David Cook Sr. QA Manager

29 QUALITY MANUAL Section 5.3 Section Page 2 of 3 Quality Policy None ASSOCIATED DOCUMENTS

30 QUALITY MANUAL Section 5.3 Section Page 3 of 3 Quality Policy Revision History 11/29/2009 Jim Waynick 1. Changed in header Advanced Control Technology, Inc. to ACT/Technico a Division of ELMA Electronic Inc. 2. In Section 1.1 changed President to Director of Systems Integration. 3. Changed President to Director in signature box. 5/23/2011 Jim Waynick Changed in header ACT/Technico a Division of ELMA Electronic Inc. to ELMA Electronic Inc.Warminster Facility. 6/12/2014 Jim Waynick 1. Section 1.1 changed Quality Policy approval from Director to VP Manufacturing/QA. 2. Changed section approval from Director to VP Manufacturing/QA. 9/23/2014 Jim Waynick 1. Changed section approval from VP Manufacturing/QA to Sr. QA Manager. 2. Section 1.1 changed Quality Policy approval from VP Manufacturing/QA to the President. 6/3/2015 Jim Waynick Changed Warminster to Horsham.

31 Quality Manual Facility ELMA Electronic Inc. Horsham MANAGEMENT RESPONSIBILITY Section 5.4 Section Rev. 7 Rev. Date: 6/3/2015 Section Page 1 of 3 Quality System Planning GENERAL POLICY Quality objectives are established to support and implement the quality policy and continual improvement. Quality planning includes identification and determination of quality system processes (including any exclusions of ISO 9001 requirements); priorities for continual improvement; and resources needed to achieve quality objectives and to maintain and improve the quality system. Quality plans are periodically reviewed and updated to maintain the integrity of the quality system during organizational and other changes. 1. Quality objectives PROCEDURAL POLICIES 1.1 Quality objectives are established throughout the organization to implement the quality policy, to meet requirements for products and processes, and to improve quality system and quality performance. 1.2 Quality objectives define the direction and priorities for continual improvement. Use of quality objectives for facilitating continual improvement is explained in Section 8.5 of this manual. 1.3 Quality objectives are classified into the following four categories: Policy objectives: These are principal, strategic objectives that apply to the whole organization. They are typically included in the quality policy itself, or may be communicated in memoranda from the top management. Policy objectives are authorized by the Director of Systems Integration. Quality performance objectives: These objectives set specific, measurable targets for improving operational performance to ensure product conformity and customer satisfaction. They apply to departments and functions having direct responsibility for activities that require improvement. Performance objectives are established, documented, and monitored within the framework of management reviews of the Approved by: David Cook Sr. QA Manager

32 QUALITY MANUAL Section 5.4 Section Page 2 of 3 Quality System Planning quality system, in accordance with Section 5.6 of this manual, Management Review. Product quality objectives: These objectives pertain to improvement of products and associated services. Product objectives are established by the Director of Systems Integration and top executive managers responsible for marketing and product development. They can be documented in product briefs, memoranda, or minutes of meetings; and apply to functions responsible for research, design, and development of products and services. Quality system objectives: These objectives pertain to improvement of quality system processes and performance. Quality system objectives are established, documented, and monitored within the framework of management reviews of the quality system, in accordance with Section 5.6 of this manual, Management Review. 2. Quality system planning 2.1 Quality system elements and processes are planned to ensure that the system is appropriate for its intended purpose, and that it is effective and efficient. The purpose of the quality system is: To achieve the quality policy; To ensure and demonstrate our ability to provide consistently product that meets customer and regulatory requirements; To ensure high level of customer satisfaction; To facilitate continual improvement; and To comply with requirements of ISO 9001 standard. 2.2 The output of quality system planning is documented in this quality manual, in associated operational procedures, and in other referenced documents. These documents identify and define all elements and processes of the quality system. 2.3 Changes to the quality system are planned within the framework of management reviews and other needs and opportunities identified by management. These changes may be in response to changing circumstances, such as product, process, capacity, or other operational or organizational change; or to improve the effectiveness and efficiency of the quality system.

33 QUALITY MANUAL Section 5.4 Section Page 3 of 3 Quality System Planning 3. Product realization and verification planning 3.1 Planning of product realization, verification, and validation processes is addressed in Section 7.1 of this manual. 4. Continual improvement planning 4.1 Improvements of the quality system are planned within the framework of management reviews and other internal reviews. The output of this planning is expressed in the form of quality system objectives, as defined above in Clause 1.3 of this section, and in this manual, Sections 8.5, Continual Improvement; and 5.6, Management Review. None Revision History ASSOCIATED DOCUMENTS 11/29/2009 Jim Waynick 1. Changed in header Advanced Control Technology, Inc. to ACT/Technico a Division of ELMA Electronic Inc. 2. In Section 1.3 changed President to Director of Systems Integration. 3. Changed President to Director in signature box. 5/23/2011 Jim Waynick Changed in title ACT/Technico a Division of ELMA Electronic Inc. to ELMA Electronic Inc.and added Warminster Facility. 6/12/2014 Jim Waynick Changed section approval from Director to VP Manufacturing/QA. 9/23/2014 Jim Waynick Changed section approval from VP Manufacturing/QA to Sr. QA Manager. 6/3/2015 Jim Waynick Changed Warminster to Horsham.

34 Quality Manual Facility ELMA Electronic Inc. Horsham MANAGEMENT RESPONSIBILITY Section 5.5 Section Rev. 10 Rev. Date 6/3/ /29/200911/29/20091 Organization and Communication Section Page 1 of 13 GENERAL POLICY Functions and their interrelation within the company are defined and communicated. Top management appoints a management representative responsible for establishment and maintenance of the quality system, and for reporting to the top management on the performance of the system. Issues regarding the quality system are communicated internally though distribution of pertinent documents, meetings, training and awareness programs, and management reviews. 1. Responsibility and authority PROCEDURAL POLICIES 1.1 Departments, groups and functions within the company, and their interrelations, are defined in the organizational chart enclosed at the end of this section. 1.2 All departments and functions in the company are responsible for implementing, maintaining, and improving the quality system. Following specific responsibilities and authorities are assigned: Top Management Formulates the quality policy Provides resources necessary to maintain and improve the quality system Conducts management reviews of the quality system Throughout this manual, the term Top Management refers to a management team responsible for manufacturing, engineering, marketing/sales, and quality control. Approved by: David Cook Sr. QA Manager

35 QUALITY MANUAL Section 5.5 Section Page 2 of 13 Organization and Communication Engineering Manages product and process development and associated projects Develops design and prototype quality plans Prepares (or reviews) design input specifications Designs products and product improvements Conducts design reviews Verifies and tests designs Documents design outputs Assists in product realization and verification planning Prepares work instructions/traveler sheets for new, modified-standard, and semistandard products/programs Controls engineering documentation throughout the company Manufacturing Plans production facilities, equipment, and processes Develops production processes Develops process operator and set-up instructions Schedules production personnel Establishes production travelers for standard items Controls and monitors processes Performs self-inspection of work in process Applies and maintains in-process product identification Operates the finished product stockroom Maintains production equipment Provides training for its personnel

36 QUALITY MANUAL Section 5.5 Section Page 3 of 13 Organization and Communication Material Management Selects qualified supplies and subcontractors Prepares and approves purchasing documents Monitors and evaluates supplier performance Receives purchased products Performs first-stage receiving inspection Applies or verifies product identification for purchased products Operates the material stockroom Packages products (secondary packaging) Ships products to customers Marketing and Sales Conducts market research to anticipate customer expectations Determines customer satisfaction Establishes specifications for new products (product briefs) Advertises and promotes company's products Carries out contract and order reviews Provides customer liaison and service Provides product information Handles customer feedback and complaints Function located in Fremont CA office and controlled by their ISO 9001 Procedure(s). Human Resources Defines personnel qualification requirements Coordinates company-wide training Function located in Fremont CA office and controlled by their ISO 9001

37 QUALITY MANUAL Section 5.5 Section Page 4 of 13 Organization and Communication Procedure(s). Quality Control Establishes and maintains the quality management system Audits implementation and effectiveness of the quality system Identifies opportunities for improvement of the quality system Develops quality plans and control plans Develops product test plans Initiates corrective and preventive actions Maintains and calibrates measuring and test equipment Carries out subcontractor quality surveys and audits Conducts in-process inspections Performs inspections and testing Identifies the need for the use of statistical techniques Handles nonconforming products Coordinates document control activities Maintains, or coordinates the maintenance of quality records Coordinates collection of quality performance data Provides required training for its personnel. 2. Management representative 2.1 ELMA Electronic, Inc. appoints as the management representative the Quality Control Manager. Management representative has the authority and responsibility to: Ensure that the quality management system is implemented, maintained and continually improved; Promote awareness of customer requirements throughout the organization; Report to the top management on the performance of the quality system, including needs for improvement; and

38 QUALITY MANUAL Section 5.5 Section Page 5 of 13 Organization and Communication Coordinate communication with external parties on matters relating to the quality system and ISO 9001:2008 registration. 3. Internal communication 3.1 Internal communication regarding the quality system flows two ways: The management communicates to the organization the quality policy and objectives; customer and regulatory requirements; product and process specifications; verification and validation requirements; and instructions on how to implement and use the quality system. The organization communicates to the management information and data regarding customer needs and expectations, customer satisfaction, quality performance, the effectiveness of the quality system, and opportunities for improvement. 3.2 The information is communicated through manuals, operational procedures, instructions, drawings, specifications, quality records, reports, etc.; and through training, on-the-job instruction, and meetings. Operational Procedure 1, Control of Documents, and Quality Manual Section 4.2, regulate these activities. 3.3 Management review meetings have a special role in ensuring proper communication between the top management and the organization. The meeting provides the framework for the organization to report on the status of quality-related issues and activities, and for the management to formulate policies and directives to change and/or improve the quality system. 3.4 Quality Control Manager has the overall responsibility for ensuring that all pertinent documents, reports and records are distributed to appropriate departments and functions, and that information and data about quality performance and the effectiveness of the quality system are reported to the top management.

39 QUALITY MANUAL Section 5.5 Section Page 6 of 13 Organization and Communication ORGANIZATIONAL CHART H o r s h a m P A F a c i l i t y I n s i d e S a l e s M g r. F r e m o n t C A D i r e c t o r o f I T F r e m o n t C A V P M a n u f a c t u r i n g F r e m o n t C A S r. Q u a l i t y M a n a g e r F r e m o n t C A D i r e c t o r o f M a t e r i a l s F r e m o n t C A V P E n g. F r e m o n t C A I n s i d e S a l e s A d m i n i s t r a t o r N e t w o r k O p e r a t i o n s P r o d u c t i o n F o r e m a n Q u a l i t y / T e s t M a n a g e r S r B u y e r / P l a n n e r E n g i n e e r i n g M a n a g e r P r e s i d e n t F r e m o n t C A A s s e m b l e r R M A T e c h n i c i a n M a t e r i a l s M a n a g e r S e n i o r S o f t w a r e E n g i n e e r D i r e c t o r o f E m b e d d e d T e c h n o l o g y A s s e m b l e r T e c h n i c i a n S t o c k r o o m C o n t r o l S e n i o r E l e c t r i c a l D e s i g n E n g i n e e r D i r e c t o r o f S a l e s a n d M a r k e t i n g F r e m o n t C A I n s p e c t o r R e c e i v e r / S h i p p e r L e a d P r o j e c t E n g i n e e r P r o d u c t M a r k e t i n g M a n a g e r M e c h a n i c a l D e s i g n / P r o j e c t E n g i n e e r S e n i o r M e c h a n i c a l D e s i g n e r P C B D e s i g n e r / D r a f t e r

40 QUALITY MANUAL Section 5.5 Section Page 7 of 13 Organization and Communication IN T E R A C T IO N O F P R O C E S S E S -- IN F O R M A T IO N F L O W How to re a d this ta ble : The inte rse ction of a ny row a nd colum n re pre se nts the inte ra ction of na m e d proce sse s. If a n a rrow occupie s the inte rse ction ce ll, it points in the dire ction of the inform a tion flow. * Function managed by Coporate office in Fremont, CA Do cum en te d Q uality System Imp rovement Proce sses Mana gement In volvement Do cum en t Co ntrol - Q uality * Do cumen t Co ntrol - Eng ineerin g * Cu stomer Processes * De sign /D eve lo pment * Purchasing Interna l Audits * Customer Focus Re ceiving/stockroom /Kittin g Inco min g Inspectio n & Test No nco nforming Produ ct Ca lib ration * Subcontractin g Prod uction In-Process In spe ction Doc um ented Quality S ys tem < -- < -- < -- < -- Im provem ent P roces ses < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- M anagem ent Involvem ent < -- < -- < -- < -- < -- < -- < -- Doc um ent Control - Quality < -- < -- Doc um ent Control - Engineering < -- < -- Cus tom er P roces ses < -- < -- < -- < -- < -- < -- < -- Des ign/developm ent < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- P urc has ing < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- Internal A udits < -- < -- Cus tom er Foc us < -- < -- < -- < -- < -- < -- < -- Rec eiving/s toc k room /K itting < -- < -- < -- < -- < -- < -- < -- < -- Inc om ing Ins pec tion & Test < -- < -- < -- < -- < -- < -- < -- < -- Nonconform ing P roduc t < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- Calibration < -- < -- S ubcontracting < -- < -- < -- < -- < -- < -- P roduction < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- < -- In-P roces s Inspection < -- < -- < -- < -- < -- < -- Final Inspection & Tes t < -- < -- < -- < -- < -- < -- < -- < -- < -- E S D P rotec tion < -- < -- < -- < -- < -- < -- < -- < -- S hipping < -- < -- < -- < -- < -- < -- < -- < -- Training < -- < -- < -- < -- < -- < -- < -- < -- S ervic e and Repair < -- < -- < -- < -- < -- < -- < -- Final In spe ction & Test ESD Pro te ction Shipping *Tra in ing Service an d R epa ir

41 LEADS CUSTOMER MARKETING SALES ORDER ENTRY ORDER CUSTOMER REQUIREMENTS (NEW PRODUCT DEVELOPMENT) CUSTOM PRODUCT CUSTOMER FEEDBACK Y CUSTOMER REQUIREMENTS ENGINEERING DESIGN PRODUCT DESIGN SALES ORDER PRODUCT ENGINEERING DOCUMENTATION A DOCUMENTATION B C QUALITY MANUAL Section 5.5 Section Page 8 of 13 Organization and Communication MAJOR PROCESS FLOW DIAGRAM PART 1

42 B C A PRODUCT DOCUMENTATION SALES ORDER PURCHASING PURCHASE ORDER PURCHASE ORDERS VENDOR/ SUBCONTRACTOR PURCHASED MATERIAL REJECTED MATERIAL RECEIVING TRAVELERS NON- CONFORMING MATERIAL CUSTOMER FEEDBACK VERIFY QTY, P/N NO SHIPPING DAMAGE N Y ACCEPTED MATERIAL DAMAGED MATERIAL WRONG P/N QUANTITY INCORRECT SUBCONTRACTED MATERIAL Y INCOMING INSPECTION PASS N SUBCONTRACTED MATERIAL SUBCONTRACTED MATERIAL CATALOG ITEMS Y STOCKROOM/ KITTING C D CATALOG AND SUBCONTRACTED MATERIAL QUALITY MANUAL Section 5.5 Section Page 9 of 13 Organization and Communication MAJOR PROCESS FLOW DIAGRAM PART 2 REJECTED MATERIAL REPORT N REJECTED MATERIAL ACCEPTED MATERIAL PAGE 2

43 QUALITY MANUAL Section 5.5 Section Page 10 of 13 Organization and Communication MAJOR PROCESS FLOW DIAGRAM PART 3 SHIP TO CUSTOMER ACCEPTED MATERIAL FINAL ASSEMBLIES FINAL INSPECTION AND TEST TESTED MATERIAL REJECTED MATERIAL REPORT REJECTED MATERIAL PASS N Y FINAL ASSEMBLY REWORK NON- CONFORMING MATERIAL PASS Y ACCEPTED MATERIAL N REJECTED MATERIAL REJECTED MATERIAL NON- CONFORMING MATERIAL CUSTOMER FEEDBACK IN-PROCESS INSPECTION REJECTED MATERIAL REPORT REJECTED MATERIAL SUBASSEMBLIES PRODUCTION KITTED MATERIAL D C

44 QUALITY MANUAL Section 5.5 Section Page 11 of 13 Organization and Communication ASSOCIATED DOCUMENTS Operational Procedure 1: Control of Documents

45 QUALITY MANUAL Section 5.5 Section Page 12 of 13 Organization and Communication Revision History 10/7/03 Jim Waynick 1. Revised Org Chart, moved shipper from Production to Material Management. 2. Added Major Process Flow Diagram. 11/29/2009 Jim Waynick 1. Changed in header and body Advanced Control Technology, Inc. to ACT/Technico a Division of ELMA Electronic Inc. 2. Modified Major Process Flow Diagram a. Added feedback from Order Entry to Sales (Part 1) b. Added Rework between Non-Conforming Material and Final Assembly (Part 3). 3. Modified Organizational Chart to reflect the ELMA transision. 4. Changed in Section 1.2 a. Top Management Section changed President to Director of Systems Integration, Vice President to Director of Business Development and removed Treasure/Human Resources. b. Added a line in Marketing and Sales, Human Resources that these functions are controlled by the Fremont CA office. 5. Added controlled by Fremont CA to some process in the Interaction of Processes Information Flow Diagram. 6. Changed President to Director in signature block. 5/23/2011 Jim Waynick 1.Changed in header ACT/Technico a Division of ELMA Electronic Inc.to ELMA Electronic Inc. Warminster Facility 2.Updated Organizational Chart 3. Added Service and Repair to Interaction of Process Flow Diagram 6/12/2014 Jim Waynick 1. Updated organizational chart to reflect current personnel. 2. Removed any references to the Director of System Integration Changed any references to the Director of Business Development to Director of Embedded Technology 3. Changed section approval from Director to VP Manufacturing/QA 9/23/2014 Jim Waynick

46 QUALITY MANUAL Section 5.5 Section Page 13 of 13 Organization and Communication 1. Changed section approval from VP Manufacturing/QA to Sr. QA Manager. 2. Updated organizational chart to reflect current personnel. 11/21/2014 Jim Waynick 1. Section 2.1 removed Advanced Control Technology and replaced it with Elma Electronic Inc. 2. Corrected spelling error in org. chart. 6/3/2015 Jim Waynick Changed Warminster to Horsham

47 Quality Manual Facility ELMA Electronic Inc. Horsham MANAGEMENT RESPONSIBILITY Section 5.6 Section Rev. 8 Rev. Date: 6/3/2015 Section Page 1 of 3 Management Review GENERAL POLICY Top management conducts periodic reviews of the quality system. The review evaluates the suitability and effectiveness of the system, identifies opportunities for improvement, and considers the need for changes to the quality policy and quality objectives. Results of the review are documented. 1. General PROCEDURAL POLICIES 1.1 The purpose of management reviews is to: Evaluate the suitability, adequacy and effectiveness of the quality system; Consider changes to the quality management system and to the quality policy and quality objectives; Identify opportunities for improvement of the quality system, processes and products. 1.2 Management reviews are chaired by the Quality Manager and are attended by managers representing Product Development, Engineering, Manufacturing, and Material Management. 1.3 Management reviews are conducted at least once a year. More frequent reviews are scheduled in periods when organizational or product changes, or other circumstances require increased attention and input from the top management. 2. Review input 2.1 Input into the management reviews consists of information and data related to quality performance of the organization. At a minimum, this includes: Results of audits, Approved by David Cook Sr. /QA Manager