avnet logistics em americas quality...

Quality Manual QM0492 Rev. BE Logistics & EM Americas

Printed documents are uncontrolled copies – access the Intranet Quality System to verify the latest revision of this document

Avnet, Inc. of 33 Business Use Only

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 by ensuring that the Quality Management System (QMS)and Environmental Management System (EMS), as applicable is implemented, effective and continually improving to meet the ever changing needs of our customers, community, and Avnet. Top Management is committed to lead the organization using the eight (8) Quality Management Principles: 1. Customer Focus 2. Leadership 3. Involvement of People 4. Process Approach 5. System Approach to Management 6. Continual Improvement 7. Factual Approach to Decision-making 8. Mutually beneficial supplier relationships This Quality System Manual defines the policies and procedures used to ensure that products and services meet the customer requirements. Maintenance of this manual is the responsibility of the VP Global Quality, Robert Brenner. All questions regarding this manual should be directed to him. Approval:

Robert Brenner Sr. V.P. Logistics and Warehousing Americas & Global Quality




Table of Content

Page

Paragraph

Subject Title

ISO 9001:2008 Clause #

ISO 14001:2004 Clause #

1 Cover Page

2-3 Table of Content

4 1.0 Purpose 4.2.1; 4.2.2 4.4.4

4 2.0 Scope 4.2.1; 4.2.2 4.1; 4.4.4

4-5 3.0 Exclusions and Not Applicable Clauses 4.2.2

5 4.0 Relevant Documents

5-6 5.0 Management Responsibility 4.2.1; 5.0; 5.1; 5.2; 5.3; 5.4.1; 5.5.3; 8.5.1

4.2; 4.3.3; 4.4.3; 4.4.4; 4.6

6 6.0 Organization 5.5; 5.5.1 4.4.1

7 7.0 Management Representative 5.5.2 4.4.1

7 8.0 Management Review 5.6; 5.6.1; 5.6.2; 5.6.3; 8.5.1

4.6

7 9.0 Customer Satisfaction 8.2.1; 8.5.1

8 10.0 Resources 6.0; 6.1; 6.3; 8.5.1

4.4.1

8 11.0 Training 6.2.1; 6.2.2 4.4.2

8 12.0 Planning 5.4.2; 7.1 4.3; 4.3.1; 4.3.2; 4.3.3

9 13.0 Customer Requirements 5.2; 7.2; 7.2.1; 7.2.2; 7.2.3

9 14.0 Documentation 4.0; 4.1; 4.2.1; 4.2.2

4.1; 4.4.4; 4.4.5

9-10 15.0 Document Control 4.2.1; 4.2.3 4.4.4; 4.4.5

10 16.0 Control of Records 4.2.1; 4.2.4 4.5.4

10-11 17.0 Purchasing 7.4; 7.4.1; 7.4.2; 7.4.3

11 18.0 Control of Customer Supplied Product 7.5.4

11 19.0 Product Identification and Traceability 7.5.3

11-12 20.0 Process Control 4.1; 6.3; 6.4; 7.5; 7.5.1

4.4.6

12 21.0 Inspection and Testing 7.4.3; 8.2.3; 8.2.4; 8.3

12-13 22.0 Control of Monitoring and Measuring Equipment

7.5.1; 7.6 4.5.1

13 23.0 Control of Nonconforming Product 8.3 4.5.3

13 24.0 Corrective Action and Preventive Action 8.5.2; 8.5.3 4.5.3

14 25.0 Handling, Storage, Preservation, Packaging, and Delivery

7.5.1; 7.5.5

14 26.0 Internal Audits 8.2.2 4.5.5

14 27.0 Statistical Techniques 8.0; 8.1; 8.4 4.5.1

14 28.0 Continual Improvement 8.5; 8.5.1 4.1; 4.3.3

14 29.0 Design and Development (Not Applicable) 7.3

14-15 30.0 Emergency Preparedness and Response (EMS) 4.4.7

15 31.0 Evaluation of Compliance (EMS) 4.5.2

15 32.0 Communications (EMS) 4.4.3




Table of Content (Continued)

Page

Paragraph

Subject Title

AS9100 Clause #

15-20 33.0 Supplemental Requirements for AS9100 Registered Facilities

4.2.1; 4.2.4; 5.2; 5.5.2; 7.1; 7.1.1; 7.1.2; 7.1.3; 7.1.4; 7.2.2; 7.4.1; 7.4.2; 7.4.3; 7.5.1; 7.5.1.1; 7.5.1.2; 7.5.1.3; 7.5.1.4; 7.5.3; 7.5.5; 7.6; 8.2.1; 8.2.3; 8.2.4; 8.3; 8.5.1; 8.5.2

Page

Paragraph

Subject Title

ISO 13485 Clause #

20-25 34.0 Supplemental Requirements for ISO 13485 Registered Facilities

4.2.1; 4.2.3; 4.2.4; 5.5.1; 5.5.2; 5.6.2; 5.6.3; 6.1; 6.3; 6.4; 7.1; 7.2.2; 7.2.3; 7.4.1; 7.4.2; 7.4.3; 7.5.1.1; 7.5.1.2; 7.5.1.2.1; 7.5.1.2.2; 7.5.1.2.3; 7.5.1.3; 7.5.2.1; 7.5.2.2; 7.5.3.1; 7.5.3.2; 7.5.3.2.1; 7.5.3.2.2; 7.5.3.3; 7.5.5; 7.6; 8.1; 8.2.1; 8.2.4.2; 8.3; 8.4; 8.5.1; 8.5.2; 8.5.3

Page

Paragraph

Subject Title

TS16949 Clause #

25-33 35.0 Supplemental Requirements for TS16949 Registered Facilities

4.1.1; 4.2.3.1; 4.2.4.1; 5.1.1; 5.4.1.1; 5.5.1.1; 5.5.2.1; 5.6.1.1; 5.6.2.1; 6.2.2.2; 6.2.2.3; 6.2.2.4; 6.3.1; 6.3.2; 6.4.1; 6.4.2; 7.1.1; 7.1.2; 7.1.3; 7.1.4; 7.2.1.1; 7.2.2.1; 7.2.2.2; 7.2.3.1; 7.3; 7.3.1.1; 7.3.2.2; 7.3.2.3; 7.3.3.2; 7.3.4.1; 7.3.5; 7.3.6.1; 7.3.6.2; 7.3.6.3; 7.4.1.1; 7.4.1.2; 7.4.1.3; 7.4.3.1; 7.4.3.2; 7.5.1.1; 7.5.1.2; 7.5.1.3; 7.5.1.4; 7.5.1.5; 7.5.1.6; 7.5.1.7; 7.5.1.8; 7.5.2.1; 7.5.3.1; 7.5.4.1; 7.5.5.1; 7.6.1; 7.6.2; 7.6.3.1; 7.6.3.2; 8.1.1; 8.1.2; 8.2.1.1; 8.2.2.1; 8.2.2.2; 8.2.2.3; 8.2.2.4; 8.2.2.5; 8.2.3.1; 8.2.4.1; 8.2.4.2; 8.3.1; 8.3.2; 8.3.3; 8.3.4; 8.4.1; 8.5.1.1; 8.5.1.2; 8.5.2.1; 8.5.2.2; 8.5.2.3; 8.5.2.4;

Appendices

Appendix I Registered Facilities

Appendix II Organization Chart

Appendix III Processes - ISO 9001 & ISO 14001

Appendix IV QMS/EMS Procedures

Appendix V Programming QMS Processes - TS16949

Appendix VI AS9100 Cross Reference Document

Appendix VII Logistics QMS Processes - AS9100

Appendix VIII Value-Add Assembly QMS Processes - AS9100

Appendix IX Programming QMS Processes - AS9100

Appendix X Elements of EMS Interaction

Appendix XI ATS Business Process Documents




1.0 Purpose

1.1 This manual defines the policies and procedures used at Avnet to document the:

Quality Policies (QMS and EMS), Quality Objectives, Requirements of ISO 9001 and ISO 14001, Supplemental requirements of AS9100, ISO 13485, and TS16949, Requirements for effective planning, operation and control of processes, and Records maintained.

1.2 Supplemental requirements for facilities registered to AS9100 are in section 33.0 of this manual.

1.3 Supplemental requirements for facilities registered to ISO 13485 are in section 34.0 of this manual.

1.4 Supplemental requirements for facilities maintaining compliance to TS16949 are in section 35.0 of this manual.

2.0 Scope

2.1 This manual defines the QMS and EMS requirements, as applicable used at each Logistics Americas facility defined in Appendix I.

2.1.1 Appendix I reference to ISO 9001 registered facilities, activities and clauses not applicable at each location are listed on page 1.

2.1.2 Appendix I reference to AS9100 registered facilities, activities and clauses not applicable at each location are listed on page 2.

2.1.3 Appendix I reference to ISO14001 registered facilities, and the scope of each facility is listed on page 2.

2.1.4 Appendix I reference to ISO13485 registered facilities and the scope of each facility is listed on page 2.

3.0 Exclusions and Not Applicable Clauses

3.1 ISO 9001

3.1.1 Clause 7.3 Design and Development, is not performed within Avnet Logistics and Avnet EM Americas, since all locations distribute, program and/or assemble electronic components/computer products/cables/connectors for franchised suppliers and/or to customer requirements. Product Design and Development is the responsibility of the customer.

3.1.2 Clause 7.5.2, Production and Service Operations, is not applicable. No processes exist that cannot be verified by subsequent measurement or monitoring. Clause 7.5.2 is addressed by Supplement III for ISO 13485.

3.2 AS9100

3.2.1 Clause 7.3, Design and Development, is not performed within Avnet EM Americas and Avnet Logistics, since all locations distribute, program and/or assemble electronic components/computer products/cables/connectors for franchised suppliers and/or to customer requirements. Product Design and Development is the responsibility of the customer.

3.2.2 Clause 7.5.1.1 of AS9100, Production Process Verification is not applicable for Connector Assembly. Avnet is the QPL assembler for Connector Manufacturers and assemble the connectors for customer orders to manufacturer’s instructions.

3.2.3 Clause 7.5.1.4 of AS9100, Post Delivery Support is not applicable in facilities registered to AS9100. Servicing is not applicable to Avnet’s distribution, assembly, or value-add business.




3.3 ISO 13485

3.3.1 Clause 7.3 of ISO13485, Product Design is the responsibility of the customer in ISO13485 registered facilities.

3.3.2 Clauses of ISO13485 which are not applicable to Avnet’s product or business are:

a) Clause 7.5.1.2 Control of production and service provision

b) Clause 7.5.1.2.1 Cleanliness of product and contamination control

c) Clause 7.5.1.2.2 Installation activities

d) Clause 7.5.1.2.3 Servicing activities

e) Clause 7.5.1.3 Particular requirements for sterile medical devices

f) Clause 7.5.2.2 Particular requirements for sterile medical devices

g) Clause 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices

h) Clause 8.2.4.2 Monitoring and measurement of product for active implantable

3.4 Clauses that are not applicable to a specific location are specified on the ISO Registered Facilities List, Appendix I.

4.0 Relevant Documents

4.1 ISO 9001:2008 Quality Management Systems Requirements

4.2 ISO/TS16949:2009 Quality Management Systems – Particular Requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations

4.3 AS9100C Quality Management Systems – Requirements for Aviation, Space and Defense Organizations

4.4 ISO 14001:2004 Environmental Management Systems – Requirements with Guidance for Use

4.5 ISO 13485:2003 Medical Devices – Quality management systems - Requirements For regulatory purposes

5.0 Management Responsibility

5.1 Top management for each division has established the Quality and Environmental Policies, as applicable and Quality Objectives. Top management ensures that the Quality and Environmental Policies are appropriate to the purpose of the organization, that they include their commitment to comply with requirements and continually improve the effectiveness of the QMS and EMS, are communicated and understood within all levels of the Organization, are reviewed for continuing suitability and that they provide the framework for establishing and reviewing Quality Objectives and Environmental Objectives and Targets.

5.2 Top management has defined the Quality and Environmental Policies. The Environmental Policy will be made available to the public upon request.

Quality Policy

Each Avnet employee will provide defect-free services and products that fully meet established requirements to our internal and external customers, and is committed to continually improve the effectiveness of the Quality Management System. We will achieve this through the process of defining and understanding, as well as agreeing and conforming, to customer requirements.




Environmental Policy

Avnet is committed to practicing environmentally responsible business processes. Our goal is continual improvement, prevention of pollution, and compliance with applicable legal and other requirements relating to our environmental aspects.

5.3 Top management communicates to the organization its commitment to the QMS and EMS

through system news, newsletters, broadcasts, etc.

5.4 Management in all areas communicates to their organization at all levels the effectiveness of the QMS and the importance of meeting customer as well as legal, statutory and regulatory requirements.

5.5 Top management has defined measurable objectives for quality for the applicable division, which are derived from the objectives set by Executive Management. These objectives include product requirements, are consistent with the Quality Policy, and are measurable. Quality objectives are measurable and the achievement of the objectives is included in management review. The Quality Objectives are located on the Quality Assurance Intranet site.

5.5.1 Environmental objectives and targets are facility specific. Management at each location registered to ISO14001 has established and documented the locations’ environmental objectives and targets, assigned responsibility for achieving objectives and targets and methods, resources and time-frame by which they are to be achieved. The objectives and targets are measurable, where practicable, and the achievement of the objectives and targets is included in management review.

6.0 Organization

6.1 The organization is comprised of:

Marketing/Sales Human Resources Purchasing Logistics Value Add (Programming, Integration, Connector & Cable Assembly) Quality Assurance Information Services

6.2 Organization charts that show the relationship of the organizations to the corporate management structure and the relationship of the various functions to each other are maintained on the Avnet Intranet. The corporate organization is shown in Appendix II and is comprised of the Product Business Groups and Sales for the three major product types represented by EM Americas, Broadline and Memec (Integrated Circuits and Semiconductors), and IP&E Interconnect, Passive and Electro Mechanical). Also, represented is ATS Americas, which is comprised of Sales & Marketing, Purchasing, Materials, and Support Operations. Located within the Logistic Center Group are the warehouses, value add assembly, programming centers and integration that support EM Americas and ATS Americas.

6.3 Employees within the organization have a clear understanding of their roles and responsibilities within the company through training and as defined in specific work instructions.

6.4 Job descriptions define each employee's general job requirements and are posted on the Avnet Intranet or maintained within job description manuals at each location. Annual goal setting to define specific tasks and responsibilities for the current year are given to each employee.

http://home.avnet.com/logistics/global/quality/Pages/default.aspx

http://home.avnet.com/logistics/global/quality/Pages/default.aspx




7.0 Management Representative

7.1 The Sr. V.P. Logistics and Warehousing & Global Quality, Robert Brenner has appointed a Management Representative, Kelley Brown, Director Quality Engineering, to ensure that the QMS and EMS are established, implemented, and maintained. The Management Representative is responsible for reporting to Top Management on the overall performance of the QMS and EMS and the need for improvement on an annual basis.

7.2 Quality Representatives have been assigned for each registered location specified in Appendix I, for reviewing and reporting the performance of the QMS and EMS (as applicable) for that location and the need for improvement within that location as a minimum on an annual basis. Some locations may perform on a quarterly basis. The Quality Representatives are responsible for ensuring that processes needed for the QMS and EMS are established, implemented, and maintained and for ensuring all employees are aware of the customer requirements. The Quality Representatives also, have the responsibility to act as a liaison with external customers/suppliers on matters relating to the QMS and EMS, as applicable.

8.0 Management Review

8.1 Management review is performed on an annual basis at a minimum to ensure the QMS and EMS continues to be suitable, adequate, and effective using inputs from the quarterly, as applicable and annual reviews performed by each facility's quality representative. The management reviews include:

Results of internal audits performed, Results of compliance evaluations with legal requirements and with other subscribing requirements for EMS registered locations, Results of customer surveys, Facilities' Quality and Environmental Performance, as applicable, Extent to which objectives and targets have been met in EMS registered facilities, Product and process nonconformities, Suppliers’ quality performance, Status of corrective and preventive actions, Communication(s) from external interested parties, including complaints, in EMS registered facilities, Follow-up actions from previous management reviews, Changes that could affect the QMS, Changing circumstances, including developments in legal and other requirements related to its environmental aspects in EMS registered facilities, Recommendations for improvement.

8.2 The management review is utilized by Top Management to ensure the quality and

environmental policies and objectives continue to meet needs, identify areas for improvement/change of the QMS and its processes and the EMS, as applicable and product/service related to customer requirements and any additional resources needed.

9.0 Customer Satisfaction

9.1 Internal generated customer surveys, Industry Comparative Surveys, customer returns and customer corrective action requests are used as a means of evaluating the customer's perception of Avnet and whether the customer's requirements are met. This information gathered from surveys is evaluated, analyzed by the Avnet customer satisfaction team, and used to identify areas for improvement.




10.0 Resources

10.1 Top management has identified and provided the resources needed to implement, maintain, and continually improve the effectiveness of the QMS and EMS while enhancing customer satisfaction by meeting customer and regulatory requirements. Personnel have also been identified for the performance of work and verification activities. Management has identified the equipment, buildings, work environment, communication systems, transportation, utilities, information systems, security, computers, software and support services needed to ensure customers’ requirements are consistently achieved.

11.0 Training

11.1 Documented procedures for identifying training needs and providing for the training of all personnel performing activities affecting conformity to product requirements and/or that have the potential to cause a significant environmental impact have been established and maintained. Personnel performing specific assigned tasks are qualified based on appropriate education, training, and/or experience as required. If employees do not have the required education and/or experience, the necessary training is provided to ensure employees are competent to perform the assigned tasks. The training provided is periodically assessed to determine its effectiveness. Records of training and appropriate education or experience are maintained.

11.2 Employees working in an EMS registered facility will be made aware of the importance of conformity to the environmental policy and procedures and the EMS, the significant environmental aspects and related actual or potential impacts associated with their work and the benefits of improved personal performance, their roles and responsibilities in achieving conformity with the requirements of the EMS, and the potential consequences of departure from procedures.

12.0 Planning

12.1 Planning is used as a method of achieving the Quality Policy and objectives and the Environmental Policy and objectives and targets; and as a means for meeting the requirements for products, projects, or contracts. Planning is consistent with documented requirements found throughout the quality and EMS systems. These requirements are found within, but not limited to documents known as quality plans, business plans, marketing plans, improvement plans, procedures, work instructions, Customer Inspection Instructions (CII's), Special Handling Codes (SHC's), statement of work (SOW), customer specifications and build procedures.

12.2 The Quality Manager at each EMS registered facility co-ordinates the identification of the environmental aspects of the facilities activities, products and services that it can control and those that it can influence and to determine those aspects that have or can have a significant impact on the environment. The environmental aspects, impacts and significance will be documented and kept up to date.

12.3 Each location registered to ISO14001 has identified the legal and other requirements applicable for that location and how those requirements apply to its environmental aspects.




13.0 Customer Requirements

13.1 Top Management ensures that customer requirements are determined and are met with an aim of enhancing customer satisfaction. Management has provided for a sales team that has the responsibility to communicate all information with the customers. Sales representatives receive customer’s requirements electronically, verbally, or in writing. The customer's requirements are reviewed to determine if capability exists to meet the requirements and if the requirements are adequately defined prior to acceptance of a contract or order. This includes any statutory and regulatory requirements applicable to the product. Any differences between the actual contract or order requirements and those specified in the quote are communicated to the customer and resolved prior to accepting the order. Any changes to the order or contract are made via written deviations/waivers, purchase order changes or verbal communications and are communicated to concerned functions within the organization and with the customer in writing or by issuance of a new order or contract. Records of the results of the review are maintained by the applicable sales representative.

14.0 Documentation

14.1 Quality and environmental management systems have been established, documented, and maintained as a means of ensuring that product conforms to specified requirements and that the environmental scope is defined and applicable to each applicable location. This includes the preparation and effective implementation of documented quality and environmental management system procedures and instructions, as required.

14.2 The process flow chart shown in Appendix III depicts the sequence and interaction of the processes included in the overall QMS. The process flow for each facility's processes has been developed and is controlled in that facility.

14.2.1 The main elements of the EMS and their interaction and reference to related documents are shown in Appendix X.

14.3 The documentation outline is a three (3)-tier structure. A Quality Manual has been developed, which documents the requirements of ISO9001 and ISO14001. The second level Quality System and EMS (as applicable) Procedures, documents the requirements for accomplishing the objectives of the Quality System and the documents necessary to ensure effective planning, operation, and control of processes that relate to the significant environmental aspects. The third level provides further detail as needed for specific business operations and product lines and includes specific work instructions.

14.4 Quality and Environmental System procedures, plans, and work instructions have been formally documented and maintained as defined in second level procedures. The range and detail of the procedures are dependent on the complexity of the work, the methods used, and the skills and training needed by personnel involved in performing the activity. Reference to the Quality and Environmental Management System Procedures is as specified in Appendix IV.

14.4.1 Appendix XI is intended to bridge the QMS of Integration facilities procedures.

15.0 Document Control

15.1 Documented procedures have been established and maintained to control documents that relate to the requirements of the QMS and EMS, including documents needed to ensure effective planning, operation, and control of processes, and as applicable documents of external origin determined to be necessary for the planning and operation of the QMS, such as military standards, manufacturers/suppliers’ standards/procedures, and customer drawings, and any other applicable legal, statutory or regulatory documents. Documents may be hard copy or electronic media.

15.2 Documents and data are reviewed and approved for adequacy by authorized personnel prior to issue.




15.3 Current revisions of appropriate documents are available at all locations where operations essential to the effective functioning of the quality and environmental (as applicable) system is performed. Invalid and/or obsolete documents are promptly removed from all points of issue and/or use. If obsolete documents are retained for legal and/or knowledge preservation, the documents are identified to prevent unintended use.

15.4 Documents are reviewed as required, changes made when required, and these

incorporations are coordinated with the customer and/or regulatory authority, as applicable. Changes to documents are reviewed and approved by the same functions/organizations that performed the original review and approval, unless specifically designated otherwise prior to issuance.

16.0 Control of Records

16.1 Documented procedures for the identification, storage, protection, retrieval, retention time, and disposition of records have been established and maintained. The records are controlled, legible, readily identifiable, traceable and retrievable. Records are maintained to demonstrate conformance to specified requirements and the effective operation of the quality and environmental systems. When contractually specified by the customer, quality records are made available to the customer or the customer's representative for evaluation for an agreed period. Records may be in the form of any type of media, such as hard copy or electronic media.

16.2 As a minimum, the following records are controlled:

Supplier/subcontractor Evaluations, Traceability (Unique ID of product), Customer Supplied Product report of damage/loss to customer, Calibration results and verification, Internal Audit, Inspector’s Identification, Nonconforming Product, Results of corrective actions taken and follow-up activities, Results of preventive actions taken and follow-up activities, Periodic evaluation of compliance with applicable legal requirements (EMS only), Periodic evaluation of compliance with other environmental requirements (EMS only).

17.0 Purchasing

17.1 Suppliers/subcontractors have been evaluated and selected based on their ability to meet product and quality requirements including quality system and any specific quality assurance requirements. Suppliers/subcontractors are periodically assessed and product quality reviewed as a means of controlling suppliers and subcontractors. This control is dependent upon the type of product, the impact of the supplied product/service on the quality of the final product and where applicable on quality audit reports and/or quality records of the performance of suppliers/subcontractors. Lists of acceptable suppliers and subcontractors are maintained.

17.2 Purchasing documents contain information that clearly describes the product to be ordered. This information includes where applicable type, class, grade, or other precise identification, title or other positive identification and applicable issues of specifications, drawings, process requirements, inspection instructions and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment and personnel, and title, number and issue of any quality system standard to be applied.




17.3 When it has been determined to verify purchased product/services at the supplier/subcontractor, the purchasing documents specify these verification arrangements and the method for release of product. When specified in a customer contract, the customer or his representative may verify at the supplier/subcontractor or upon receipt at Avnet that product conforms to specified requirements. Verification by the customer does not absolve Avnet of its responsibility to provide acceptable product nor does it preclude subsequent rejection by the customer. When customer or his designated representative elects to perform verification at the supplier/subcontractor's facility, such verification is not used as evidence of effective control.

18.0 Control of Customer Supplied Product

18.1 Any customer supplied product used for value-add processing/warranty repair/rework is identified, verified, protected, and safeguarded. Any customer supplied product that is lost, damaged or is otherwise unsuitable for use is recorded and reported to the customer.

19.0 Product Identification and Traceability

19.1 The product supplied is identified with the manufacturer's part number, an internal part number, and if applicable the customer’s part/drawing number.

19.2 When the customer specifies traceability as a requirement, the unique identification of individual product or batches such as date codes/lot codes/serial numbers is provided. This identification is recorded on the applicable traceability quality record.

19.3 The status of the product throughout all processing including all monitoring and measurement is maintained by use of reject tags, acceptance labels, work orders, shippers, invoices, travelers, routers, shop tickets, etc. These documents include the identification of the employee performing the operation/inspection/test.

20.0 Process Control

20.1 The distribution and production processes which directly affect quality and the operations that are associated with the significant environmental aspects have been identified and planned and are carried out under controlled conditions.

20.1.1 Any processes that affect product conformity, which are outsourced are controlled via audits, procedures/work instructions, and/or inspections of the process and/or results of the process performed, as applicable.

20.2 Documented procedures/work instructions defining the requirements of the distribution, value add and the production/assembly processes have been developed and maintained at each location where the absence of such procedures could adversely affect quality. These procedures/work instructions include any required requirements from statutory and regulatory documents. Procedures and work instructions defining the requirements for support groups such as sales, purchasing and information services are maintained and controlled by the specific support group, as required using their own method of control.

20.2.1 Documented procedure(s) have been established, implemented and maintained to control situations where their absence could lead to deviation from the environmental policy, objectives and targets and to stipulate the operating criteria.

20.2.2 Procedures have been established, implemented and maintained related to the identified significant environmental aspects of goods and services used and communicating these procedures and requirements to applicable suppliers and subcontractors.

20.3 Suitable distribution, value-add, production/assembly, and monitoring and measuring equipment is in use at each location. Preventive maintenance is performed on the required equipment to ensure continual operation.




20.4 Monitoring, measuring and control of suitable process parameters and product characteristics are performed, where applicable.

20.5 The work environment is controlled to the extent necessary to achieve conformity of product requirements or as specified in regulatory documents.

21.0 Inspection and Testing

21.1 Documented procedures for inspection and testing activities have been established and maintained in order to verify that the specified requirements for the product are met. The required inspection and testing and the records to be established are detailed in these procedures.

21.2 An inspection is performed upon receipt of product from the suppliers. No material may be used or processed until it has been inspected or otherwise verified upon receipt as conforming to specified requirements.

21.3 In-Process Inspection and Testing is performed in accordance with established documented procedures as applicable to the operations being performed.

21.4 Final inspection and/or testing are performed in accordance with documented procedures to provide the evidence of conformance of the finished product to the specified requirements. Documented procedures for final inspection and testing require that all specified inspections and tests including those specified either upon receipt of product or in-process have been carried out and that the results meet specified requirements.

21.5 Records provide evidence that the product has been inspected and/or tested, clearly show that the product has passed or failed the inspection and/or test according to the defined acceptance criteria and identify the inspection authority responsible for the release of product.

21.6 Any material rejected at Receiving, In-Process, or Final Inspection and Test, is positively identified, segregated from the flow of acceptable product, and processed in accordance with requirements specified in the Control of Nonconforming Product procedure. Documented procedures ensure that only after product has been subjected to all required inspections and tests, required data recorded and reviewed is the product identified as acceptable, and permitted to progress to the next process step. No product is dispatched until all the activities specified in the documented procedures have been satisfactorily completed and the associated data and documentation is available and authorized.

22.0 Control of Monitoring and Measuring Equipment

22.1 Documented procedures to control, calibrate, and maintain inspection, measuring and test equipment (including test software) used to demonstrate the conformance of product to the specified requirements and/or used to monitor and measure key characteristics that can have a significant environmental impact, as applicable have been established and maintained. All measuring and test equipment that can affect product quality or is used to monitor and measure key characteristics that can have a significant environmental impact, has been identified, calibrated or verified or both, and/or adjusted at prescribed intervals, or prior to use, against certified equipment having known valid relationship to international or nationally recognized standards. If no such standards exist, the basis used for calibration is documented in calibration procedures.

22.2 The inspection, measuring and test equipment is documented in records and/or procedures, which include the details of equipment type, unique identification, location, frequency of checks, check method, acceptance criteria and the action to be taken when results are unsatisfactory. The equipment is identified with a sticker or other approved suitable indicator to show the calibration status and identification of equipment.

22.3 An assessment is made and documented on the validity of previous inspection and test results when inspection, measuring, or test equipment is found to be out of tolerance when calibrated. Appropriate action is taken on equipment and any product affected.




22.4 Inspection, measuring and test equipment is calibrated/adjusted in the same environment as used and is protected from damage and deterioration during handling, maintenance, and storage. Safeguards are applied to inspection, measuring and test equipment, including both test hardware and test software, to prevent adjustments, which would invalidate the calibration setting.

23.0 Control of Nonconforming Product

23.1 Documented procedures have been established and maintained to ensure that product that does not conform to specified requirements is prevented from unintended use and the individuals who have the responsibility and authority for the disposition of the product is specified. Control is provided for identification, documentation, evaluation, segregation (when practical), and disposition and for notification to the functions concerned.

23.1.1 Documented procedures have been established, implemented and maintained for dealing with actual or potential nonconformities associated with environmental issues. The procedure defines the process for identifying and correcting the nonconformity and action(s) taken to mitigate its environmental impacts, investigating nonconformities, determining their causes and taking actions in order to avoid recurrences.

23.2 Nonconforming product may be reworked to meet the specified requirements, accepted with or without repair by waiver, rejected or scrapped. The proposed use or repair of product, which does not conform to specified requirements, is reported for waiver to the customer or customer's representative. Repaired and/or reworked product is re-inspected to ensure it complies with the specified requirements.

23.3 The use of a positive recall system is used when deemed prudent and is documented as part of containment in associated Avnet Quality Feedback System responses, as applicable. Where applicable, organization specific procedures have been created.

23.4 Any product found to be defective after shipment to the customer may be returned for evaluation as authorized by the applicable sales and marketing representative.

24.0 Corrective Action and Preventive Action

24.1 Documented procedures for implementing corrective and preventive action have been established and maintained.

24.2 Corrective actions are taken when corrective action requests are received from customers, when problems occur in process, with product, process, quality or environmental system, or reported environmental issues and when audit findings are identified. The nonconformity identified is corrected, an investigation conducted to determine the root cause and an action implemented to prevent the recurrence of the nonconformity. Results of the investigation and the corrective action taken are documented and records maintained. Follow-up is performed on corrective action responses to ensure that the corrective action was implemented and effective in correcting the nonconformity.

24.2.1 Actions taken for environmental issues or EMS nonconformities are appropriate to the magnitude of the problems and the environmental impacts encountered.

24.2.2 Any changes to the EMS are made, as necessary as a result of the actions taken for identified nonconformities.

24.3 Appropriate sources of information such as processes and work operations that affect product quality, waivers, audit results, quality and environmental records, and customer complaints are periodically reviewed to detect, analyze, and eliminate potential causes of nonconformities. The records maintained include the analysis performed in determining the preventive action identified, the steps needed to be performed for implementation, the controls to be applied to ensure it is effective and the review to determine effectiveness of the preventive action implemented.




25.0 Handling, Storage, Preservation, Packaging, and Delivery

25.1 Documented procedures for handling, storage, packaging, preservation, and delivery of product have been established and maintained in order to maintain conformity to requirements. The methods used to handle product prevents damage and/or deterioration. Designated storage areas and stockrooms to prevent damage or deterioration of product pending use and delivery are maintained. Appropriate methods for authorizing receipt to and dispatch from such areas are utilized. In order to detect deterioration, the condition of product is assessed at appropriate intervals.

26.0 Internal Audits

26.1 Documented procedures for planning and implementing internal quality and environmental system audits to verify whether the QMS and EMS and related activities and results comply with planned arrangements and to determine the effectiveness and implementation of the quality and environmental management systems have been established and maintained. Internal quality and environmental management system audits are scheduled on the basis of the status and importance of the activity to be audited and are carried out by personnel independent of those having direct responsibility for the activity being audited.

26.2 Results of audits are recorded and are brought to the attention of the personnel having responsibility for the area audited. Management personnel responsible for the area audited shall ensure that corrective actions and necessary corrections on deficiencies found during the audit to eliminate detected nonconformities and their causes are taken without undue delay. Follow-up audit activities to determine implementation and effectiveness of the corrective action taken are verified and recorded. The results of internal quality and environmental audits are reported to the management representative for inclusion in the management review.

27.0 Statistical Techniques

27.1 The need for statistical techniques required for establishing, controlling and verifying process capability, and product characteristics and to continually improve the effectiveness of the QMS has been identified. Avnet has established and maintains documented procedures to implement and control the application of the statistical techniques identified.

27.2 Data collected from processes and products is analyzed to demonstrate continual improvement of the effectiveness of the QMS and areas where continual improvement of the QMS can be made. Analysis of the data provides information on customer satisfaction, conformity to product requirements, characteristics and trends of processes and products including opportunities for preventive action and suppliers.

27.3 Each location compliant to ISO14001 will identify the monitoring and measuring to be performed on the identified key characteristics of its operation that can have a significant environmental impact.

28.0 Continual Improvement

28.1 Continual improvement of the effectiveness of the QMS and EMS is evaluated through the use of the quality and environmental policies, quality objectives, environmental objectives and targets, audit results, analysis of data, corrective and preventive actions and management review.

29.0 Design and Development (Not Applicable)

30.0 Emergency Preparedness and Response (EMS)

30.1 Procedures have been established, implemented and maintained to identify potential emergency situations and potential accidents that can have an impact on the environment and the method for responding to them. Any emergency situations or accidents will be responded to immediately to prevent or mitigate associated adverse environmental impacts.




30.2 A review is periodically performed, where necessary to revise emergency preparedness and response procedures, in particular, after an occurrence of an accident or emergency situation.

30.3 Where practicable, tests will be performed to check for emergency preparedness and response.

31.0 Evaluation of Compliance (EMS)

31.1 Compliance with applicable legal and other requirements is periodically performed by an auditor knowledgeable in the applicable legal and requirements at each facility registered to ISO14001. A report is generated and corrective actions taken. The report of the evaluation results and the corrective actions taken are kept on file.

32.0 Communications (EMS)

32.1 Employees at all levels located in facilities registered to ISO14001 will receive EMS awareness training, which will include information on the facility identified environmental aspects and environmental programs.

32.2 Periodically employees will receive updates regarding the performance of the environmental programs and the achievement of the objectives and targets.

32.3 Requests for information received by the facilities regarding the significant environmental aspects and EMS will be forwarded to Avnet’s legal department, as applicable.

33.0 Supplemental Requirements for AS9100 Registered Facilities

This section is supplemental and is intended to be used in conjunction with sections 1.0 through 29.0 in facilities registered to AS9100.

Documentation (AS9100 – 4.2.1)

33.1 QMS documentation is available to all Avnet personnel on the Avnet Quality Assurance website. Managers of each affected area are notified of documents and changes to documents via electronic broadcasts and are responsible to notify their applicable employees.

33.2 The process flow charts shown in Appendix VII, Appendix VIII, and Appendix IX depict the sequence and interaction of the processes included in the overall QMS at Logistics, Value-Add, and Programming facilities. The process flow for each facility's processes has been developed and is controlled in that facility.

33.3 The relationship between the requirements of AS9100 and the documented procedures are defined in Appendix VI.

Records (AS9100 – 4.2.4)

33.4 Records supplied by product suppliers are maintained in accordance with the Quality Records procedure listed in Appendix VI. Records retained by the suppliers are maintained and controlled by the supplier’s internal procedures.

Customer Focus (AS9100 – 5.2)

33.5 Product conformity and on-time delivery performance is measured and reported during management review to Top Management. Appropriate action is taken if planned results are not or will not be achieved.

Management Representative (AS9100 – 5.5.2)

33.6 The Management Representative has been given the responsibility and authority to resolve matters pertaining to quality and has unrestricted access to Top Management.




Planning of Product Realization (AS9100 – 7.1)

33.7 In planning of product realization the following is determined as appropriate:

a) Configuration management appropriate to the product.

b) Resources have been identified to support the use and maintenance of the product for assembly.

Project Management (AS9100 – 7.1.1)

33.8 As appropriate to Avnet and the product, Avnet plans and manage product realization in a structured and controlled manner to meet requirements at acceptable risk, within resource and schedule constraints.

Risk Management (AS9100 – 7.1.2)

33.9 Avnet has established, implemented and maintains a process for managing risk to the achievement of applicable requirements that includes, as appropriate to the organization and the product:

a) assignment of responsibilities for risk management,

b) definition of risk criteria (e.g., likelihood, consequences, risk acceptance),

c) identification, assessment and communication of risks throughout product realization,

d) identification, implementation and management of actions to mitigate risks that exceed the defined risk acceptance criteria, and

e) acceptance of risks remaining after implementation of mitigating actions.

Configuration Management (AS9100 – 7.1.3)

33.10 Avnet has established, implemented and maintains a configuration management process that includes, as appropriate to the product:

a) configuration management planning,

b) configuration identification,

c) change control,

d) configuration status accounting, and

e) configuration audit.

Configuration management is not applicable to the product supplied by Avnet. Configuration management for the product is the responsibility of the customer or component manufacturer. Configuration management is the Quality Management System as defined in this Quality Manual Supplement and Appendix VI.

Control of Work Transfers (AS9100 – 7.1.4)

33.11 Avnet has established, implemented and maintains a process to plan and control the temporary or permanent transfer of work (e.g., from one Avnet facility to another, from Avnet to the Supplier, from one supplier to another supplier) and verifies the conformity of work to requirements.

Review of Requirements Related to the Product (AS9100 – 7.2.2)

33.12 Special requirements of the product are determined during the quoting process.

33.13 Risks (e.g., new technology, short delivery time frame) have been identified during the quoting process.




Purchasing Process (AS9100 – 7.4.1)

33.14 When specified by the contract, products, materials, and services are purchased from customer approved sources. The conformity of the purchased products is ensured even though customer designated sources are specified.

33.15 Avnet approved suppliers of product are listed on the company’s line card including the products available from each supplier.

33.16 Periodic reviews are performed with suppliers on the Suppliers performance. Records of the reviews are maintained by the Product Business units.

33.17 Suppliers quality performance is reviewed during the periodic performance review and actions assigned for improvement. Supplier Corrective Action Requests (SCAR’s) may be requested for poor performance through the Avnet corrective action system.

33.18 When specified in the contract, uses of customer approved special process sources are used.

33.19 The processes, responsibilities and authorities for the approval status decision, changes to the approval status and conditions for a controlled use of suppliers depending on the supplier’s approval status are defined, as required.

33.20 The risk has been determined and is managed when selecting and using suppliers.

33.21 Suppliers of materials used directly in the assembly of products are purchased from the OEM manufacturer, the distributor for the products specified in the OEM specifications or as directed by the customer for custom customer assemblies. A list of these suppliers is maintained by the applicable Avnet assembly facility.

Purchasing Information (AS9100 – 7.4.2)

33.22 Where appropriate the following items are included in the purchase documents:

a) Identification and revision status specifications, drawings, process requirements, inspection/verification instructions, and other relevant technical data,

b) Requirements for design, test, inspection, verification (including production process verification), use of statistical techniques for product acceptance, and related instructions for acceptance, and as applicable, critical items key characteristics,

c) Requirements for test specimens (e.g., production method, number, storage conditions) inspection/verification, investigation or auditing,

d) Requirements regarding the need for suppliers to notify Avnet of nonconforming product and to obtain Avnet’s approval for nonconforming product disposition, for supplier notification of changes in product and/or process, changes of suppliers, changes of manufacturing facility location, and where required, obtain Avnet’s approval, and to flow down applicable requirements to sub-tier suppliers,

e) Record retention requirements, and

f) Right of access to all applicable areas in suppliers’ facilities by Avnet, customers and regulatory authorities involved in the order and to all applicable records.

Verification of Purchased Product (AS9100 – 7.4.3)

33.23 Purchased product is not allowed to be released for use until it has been verified as acceptable. The use of a positive recall system is used when deemed prudent and is documented as part of containment in associated Avnet Quality Feedback System responses, as applicable. Where applicable, organization specific procedures have been created.

33.24 Avnet does not delegate verification of purchased product to the supplier.




Control of Production and Service Provision (AS9100 – 7.5.1)

33.25 Key characteristics, in-process verification, which cannot be performed at a later stage, design, manufacture, and use of tooling and special processes, are not applicable to Avnet’s business.

33.26 Product during assembly and/or programming is accounted for by notations on the lot traveler. This includes quantities, splits, rework, and rejects.

33.27 All production steps and inspections/tests are documented on the lot traveler.

33.28 A documented program for the prevention, detection, and removal of foreign objects is maintained.

33.29 Shelf life controls are in place for applicable materials use in assembly. No utilities or other supplies affect product conformity to product requirements.

33.30 Workmanship standards have been developed as applicable.

33.31 Planning Considerations, as appropriate:

a) No critical items or process controls with key characteristics have been identified nor are applicable to Avnet’s business.

b) No tooling is designed, manufactured or used to measure variable data.

c) In-process inspection/verification points have been identified within the applicable assembly work instructions.

d) No special processes have been identified.

Production Process Verification (AS9100 – 7.5.1.1)

33.32 Avnet uses a representative part from the first part produced for custom assembly and programming orders to verify the process, production documentation and tooling are capable of producing parts and assemblies that meet customer requirements. This process is repeated when changes occur that invalidate the original results (e.g., engineering changes, customer requirement changes, equipment changes, program changes). This verification may also be satisfied through a first article process.

Control of Production Process Changes (AS9100 – 7.5.1.2)

33.33 Changes to assembly and programming processes, production, equipment, tools or software programs are made through the document control system and/or through a first article approval process. Any changes made to processes must be approved by the same functions specified in the document control and/or first article procedure.

Control of Production Equipment, Tools, and Software Programs (AS9100 – 7.5.1.3)

33.34 All new equipment, tools and software are validated prior to use and periodically inspected per the calibration and preventive maintenance procedures. Equipment and tools are stored to prevent any damage or deterioration.

Post Delivery Support (AS9100 – 7.5.1.4)

33.35 Servicing is not applicable to Avnet’s operations.

Identification and Traceability (AS9100 – 7.5.3)

33.36 Product configuration is the responsibility of the product supplier and/or customer. Product received from the product supplier is received with the supplier’s part number. Product built to customer drawings maintains the customer’s part number. These numbers are maintained through-out all processing.

33.37 A documented procedure has been established which defines the controls required for the use of stamps, electronic identification and passwords used to identify employees.




Preservation of Product (AS9100 – 7.5.5)

33.38 Provisions have been included in documented procedures and work instructions for the following, as applicable:

a) cleaning;

b) prevention, detection and removal of foreign objects;

c) special handling for sensitive products;

d) marking and labeling including safety warnings;

e) shelf life control and stock rotation; and

f) special handling for hazardous materials.

Control of Monitoring and Measuring Equipment (AS9100 – 7.6)

33.39 The calibration system includes an equipment recall list of all equipment requiring calibration used for inspection. The system requires all employees owned and customer supplied equipment to be included in the calibration system. The list and/or records of calibration include calibration procedure used, equipment type, unique identification, location, frequency of checks, check method, and acceptance criteria.

33.40 Environmental conditions are suitable for the calibrations, inspections, measurements, and tests being carried out. The temperature and humidity of the environment during calibration is recorded on the Certificate of Calibration. Environmental conditions are monitored during device programming and assembly as appropriate to the product.

33.41 An equipment list is maintained, which includes the calibration due date of each piece of calibrated equipment. The list is used to recall each piece of equipment requiring calibration or verification when due.

Customer Satisfaction (AS9100 – 8.2.1)

33.42 As a minimum, the information to be monitored and used to evaluate customer satisfaction includes product conformity, on-time delivery performance, customer complaints and corrective action requests. Results of the monitoring and evaluations of the data are reviewed to address deficiencies identified by the evaluations and assess the effectiveness of the results.

Monitoring and Measurement of Processes (AS9100 – 8.2.3)

33.43 If any process nonconformities are detected, corrective action is promptly taken to correct the nonconforming process, evaluate if the process has produced any nonconforming product, determine if the process nonconformity is limited to a specific occurrence or if it could have affected other processes or products, and identify and control the nonconforming product in accordance with the applicable nonconforming product procedure.

Monitoring and Measurement of Product (AS9100 – 8.2.4)

33.44 Inspection requirements are documented in procedures and work instructions. The procedures include criteria for acceptance and/or rejection, where in the process the inspections and/or tests are performed, records to be maintained and the inspection and/or test equipment used. If required, test records shall show actual test results data and indication of acceptance or rejection at a minimum.

33.45 No key characteristics have been identified.

33.46 When not specified by the customer, supplier and/or regulatory agency, sample plans used are statistically valid and appropriate for use based on recognized statistical documented industry standards. The acceptance allowed is zero.




33.47 The use of a positive recall system is used when deemed prudent and is documented as part of containment in associated Avnet Quality Feedback System responses, as applicable. Where applicable, organization specific procedures have been created.

33.48 If product qualifications are required, the records shall provide evidence that the product meets defined requirements.

33.49 All documents required to accompany the product are included at shipping. Documents required to accompany product are specified in procedures, work instructions, and/or special instructions on each order. Each order requiring accompanying documents is checked to ensure documents are available at shipping. Documents are placed in a protective envelop identified as containing documents.

Control of Nonconforming Product (AS9100 – 8.3)

Note: Nonconforming product includes product returned from the customer.

33.50 The documented procedure for handling and control of nonconforming product defines the responsibility and authority for review and disposition of nonconforming product and the process for approval of personnel making these decisions.

33.51 Customers will be notified of product shipped to them which has been reported as nonconforming by the product supplier or identified by Avnet, which affects reliability or safety. Notification shall include a clear description of the nonconformity, which will include as necessary parts affected, customer and/or organization part numbers, quantities, and date(s) delivered.

33.52 In dealing with nonconforming product the necessary actions to contain the effect of the nonconformity on other processes or products are taken.

33.53 Use-as-is or repair dispositions are not to be used unless specifically authorized by the customer, if the product is produced to customer design or the nonconformity results in a departure from the contract requirements.

33.54 Product disposition for scrap shall be conspicuously and permanently marked, or positively controlled, until physically rendered unusable.

Continual Improvement (AS9100 – 8.5.1)

33.55 Continual improvement projects are followed-up on to ensure that they are implemented and effective.

Corrective Action (AS9100 – 8.5.2)

33.56 Corrective actions are requested from the supplier when it has been determined that the supplier is responsible for the nonconformity.

33.57 Corrective actions which have not been provided in a timely manner are escalated to the next higher level of management. A new corrective action is issued when the original corrective action response is found to be ineffective in correcting the problem.

33.58 Corrective action evaluations include determining if additional nonconforming product exists based on the nonconformities and taking further action, if required.

34.0 Supplemental Requirements for ISO 13485 Registered Facilities

This section is supplemental and is intended to be used in conjunction with sections 1.0 through 29.0 in facilities registered to ISO 13485.




Quality Management System Requirements (ISO 13485 – 4.1)

Note: Documents which define the key ATS business processes are specified in Appendix XI.

Note: Documents which define the key Cable and Connector Assembly Business processes are specified in Appendix IV.

Documentation (ISO 13485 – 4.2.1; 4.2.3; 4.2.4)

34.1 No documents specified by national or regional regulations have been identified for application to Avnet’s business. When such requirements become known, they will be implemented into the Avnet’s build instructions.

34.2 Files are maintained for each type or model of medical device which either contains or identifies documents defining product specifications and QMS requirements. These documents define the complete manufacturing process.

34.3 At least one copy of obsolete controlled documents and changed process documents are retained as specified by the customer, regulatory agency and Avnet, as applicable.

34.4 Changes to documents are reviewed and approved by the original approving function or by an alternate designated function that has pertinent background information upon which to base the decision for a change.

34.5 Records are retained for a period of time at least equivalent to the lifetime of the medical device, as defined in Avnet procedures, but not less than two years from the date of product release or as specified by relevant regulatory requirements.

Management Responsibility (ISO 13485 – 5.5.1)

34.6 The interrelation of personnel who manage, perform and verify work affecting quality has been defined by top management. Job descriptions are utilized to define the responsibility and authority for employees through the organization. The interrelation of personnel who manage, perform, and verify work affecting quality and who need the independence, freedom and authority to perform these tasks are defined in key process procedures.

Management Representative (ISO 13485 – 5.5.2)

34.7 The Management Representative has been given the responsibility to promote awareness of regulatory requirements throughout the organization. Currently there are no projects requiring special regulatory requirements for medical customers. When projects are identified that require special regulatory requirements, the management representative will be notified.

Management Review (ISO 13485 – 5.6.2; 5.6.3)

34.8 New and or revised regulatory requirements will be included as an input to management review.

34.9 Improvements identified to maintain and/or enhance the effectiveness of the QMS and processes will be included as an output from management review.

Provision of Resources (ISO 13485 – 6.1)

34.10 Resources are provided to meet regulatory and customer requirements.

Infrastructure (ISO 13485 – 6.3)

34.11 Requirements for maintenance activities have been documented, including the required frequency when the maintenance activities or lack of maintenance activities could affect product quality. Records of the maintenance performed are maintained as required by the records procedure.




Work Environment (ISO 13485 – 6.4)

34.12 Documented requirements for health, cleanliness and clothing of personnel have not been established, since contact of personnel and the product or work environment does not adversely affect the quality of the product. Documented requirements have been established for ESD controls, where appropriate for prevention of damage due to electrostatic discharge. Other considerations may be implemented based on customer specific requirements.

34.13 No work environment conditions have been identified that could have an adverse effect on product quality; therefore requirements for work environment conditions, monitoring and controlling these environmental conditions have not been documented in procedures and work instructions. Documented requirements have been established for ESD controls, where appropriate for prevention of damage due to electrostatic discharge. Other considerations may be implemented based on customer specific requirements.

34.14 No personnel have been identified to work temporarily under special environmental conditions within the work environment to require appropriate training or supervised by trained personnel.

34.15 Product supplied does not have the potential to contaminate other product, the work environment or personnel.

The organization does not supply invasive medical devices; therefore work environment controls applicable to devices of that nature in terms of health, cleanliness and sterilization (and training and monitoring to those requirements are not applicable).

Planning of Product Realization (ISO 13485 – 7.1)

34.16 Verification and validation of product design including risk management resides with the customer, as the customer maintains design ownership.

34.17 Risk management for the applicable product realization processes are defined, assessed, and documented. Records of the risk assessment are maintained in accordance with the records procedure.

Review of Requirements Related to the Product (ISO 13485 – 7.2.2)

34.18 All product requirements, including those given verbally are documented for subsequent review and approval.

Customer Communication (ISO 13485 – 7.2.3)

34.19 Central point of contact has been established in departmental areas (i.e. sales, engineering, etc.) for order handling/status/and change requests and disseminating advisory notices.

Purchasing Process (ISO 13485 – 7.4.1)

34.20 Procedures have been established to control the quality of purchased products from franchised suppliers, non-franchised suppliers and value added subcontractors and to ensure that purchased product and/or services conform to specified requirements.

Purchasing Information (ISO 13485 – 7.4.2)

34.21 Traceability is maintained from receiving to shipping to the customer, as applicable and records maintained.

Verification of Purchased Product (ISO 13485 – 7.4.3)

34.22 Records of the verification of the product are maintained in accordance with the records retention procedure.

Control of Production and Service Provision-General Requirements (ISO 13485 – 7.5.1.1)

34.23 Work instructions are available as necessary to adequately perform work.




34.24 Labeling and packaging requirements have been implemented and controlled as required by customer requirements within build instructions.

34.25 Identification and traceability of individual batches of medical devices is maintained. This includes traceability of system components to the assembly level, where required. The identification and traceability is recorded and identifies the amount manufactured and amount approved for distribution. The record is verified and approved.

Control of Production and Service Provision-Specific Requirements

(ISO 13485 – 7.5.1.2; 7.5.1.2.1; 7.5.1.2.2; 7.5.1.2.3; 7.5.1.3)

Clauses 7.5.1.2 through 7.5.1.3 are not applicable to Avnet’s business.

Validation of Processes for Production-General Requirements (ISO 13485 – 7.5.2.1)

34.26 All production processes are validated internally and as requested by the customer.

34.27 Criteria for the review and approval of the processes are defined in the build instructions.

34.28 Equipment is designated within the build instruction and controlled per the equipment calibration and maintenance process. Personnel are qualified in accordance with the training process.

34.29 Methods and procedures have been documented, implemented and controlled per the document control process.

34.30 Control of records and the maintenance of the required records are as specified in the records procedure and records retention chart.

34.31 Revalidation as applicable is specified within the build instructions.

34.32 Validation of computer software is documented unless deemed as inappropriate.

34.33 Records of computer software validation are maintained in accordance with the records procedure unless deemed as inappropriate.

Particular Requirements for Sterile Medical Devices (ISO 13485 – 7.5.2.2)

No sterile medical devices are processed by Avnet.

Identification (ISO 13485 – 7.5.3.1)

34.34 The identification of product is documented within the integration and packaging procedures.

34.35 A documented procedure defines how medical product that has been shipped and returned is identified and distinguished from conforming product.

Traceability (ISO 13485 – 7.5.3.2; 7.5.3.2.1; 7.5.3.2.2)

34.36 A documented procedure has been established for traceability. The procedure defines the requirements for product traceability and the records to be maintained.

Avnet does not produce any active implantable medical devices or implantable medical devices.

Status Identification (ISO 13485 – 7.5.3.3)

34.37 Identification of the status of the product is maintained throughout production, storage, installation, and servicing of product. This includes inspection and test status. Product is only released after it has met all inspection and test criteria; where deviation to a process is required, it is documented through issuance of a Quality Bulletin.

Preservation of Product (ISO 13485 – 7.5.5)

34.38 Documented procedures and/or work instructions are maintained for preserving the conformity of product during internal processing and delivery to the customer.




34.39 Where shelf life product is used it is controlled and conditions for control are documented in procedures and work instructions, as applicable.

Control of Monitoring and Measuring Devices (ISO 13485 – 7.6)

34.40 Subject matter experts determine the monitoring and measurement activities appropriate to demonstrate conformity of product to predetermined requirements that are documented within procedures and build instructions or subsequent customer inspection instructions.

Measurement, Analysis, and Improvement-General (ISO 13485 – 8.1)

34.41 Internal audits are conducted with the goal of continually improving the processes and maintaining the effectiveness of the QMS.

Feedback (ISO 13485 – 8.2.1)

34.42 Avnet continually seeks feedback from customers to determine if their requirements are achieved. This feedback takes place during the prototype process and post build vehicles for product, process and business related feedback.

34.43 Customer Advisory Council and Avnet Customer Loyalty Program activities serve to proactively seek feedback from customers on a regular basis. Corrective and preventive actions are recorded within reports and the Process Improvement Request process.

34.44 No national or regional regulations have been identified that require Avnet to gain experience from the post-production phase for inclusion into the feedback system.

Active Implantable Medical Devices and Implantable Medical Devices (ISO 13485 – 8.2.4.2)

Not applicable to the products supplied. Implantable devices are not being supplied.

Control of Nonconforming Product (ISO 13485 – 8.3)

34.45 The responsibility for review and disposition including acceptance of product under concession is only authorized if regulatory requirements have been met. Records of the identity of the person (s) authorizing the concession are maintained.

34.46 Instructions for rework, including re-inspection are accessible to and utilized by the appropriate personnel. Reworked product is re-inspected in accordance with the designated processes, build instructions and/or applicable quality plans, work instructions, and workmanship standards. The documentation for rework is subject to the same review and approval as the original build documentation.

Analysis of Data (ISO 13485 – 8.4)

34.47 Data analyzed to determine the effectiveness of the QMS includes process, product, customer satisfaction (feedback), supplier performance, and trends identifying opportunities for improvement within the business as described in the Analysis of Data procedure.

34.48 Records of the results of the analysis of data are maintained in accordance with the record retention procedure.

Improvement (ISO 13485 – 8.5.1)

34.49 The nonconforming procedure includes the requirements for issue and implementation of advisory notices.

34.50 Customer complaint investigations are recorded and maintained within the corrective action system. If a customer complaint is not followed by a corrective/preventive action, the reason shall be authorized and recorded. If investigations determine that the component manufacturers or subcontractors contributed to the customer complaint, corrective actions shall be obtained from them.

34.51 Notification to regulatory authorities of any adverse events shall be made as required by national or regional regulations require.




Corrective Action (ISO 13485 – 8.5.2)

34.52 Documents are updated, if appropriate, as a result of actions identified.

34.53 Results of corrective action investigations are recorded.

Preventive Action (ISO 13485 – 8.5.3)

34.54 Results of preventive action investigations are recorded.

34.55 Preventive action taken and its effectiveness are reviewed.

35.0 Supplemental Requirements for TS16949 Registered Facilities

This section is supplemental and is intended to be used in conjunction with sections 1.0 through 29.0 in facilities maintaining compliance to TS16949.

Quality Management System-General Requirements (TS16949 – 4.1.1)

35.1 When product is sent to subcontractors for additional processing, the subcontractors are audited and approved to ensure customers’ requirements are met, unless the customer specifies a specific subcontractor to be used.

Documentation (TS16949 – 4.2.3.1; 4.2.4.1)

35.2 Customer drawings, specifications, and/or procedures are reviewed, distributed and implemented when received by the sales organization. This review does not exceed two working weeks and records maintained of the date the change is implemented into production.

35.3 As a minimum, retention times satisfy regulatory and customer requirements.

35.4 The process flow chart shown in Appendix V depicts the sequence and interaction of the processes included in the overall QMS at Programming facilities. The process flow for each facility's processes has been developed and is controlled in that facility.

Process Efficiency (TS16949 – 5.1.1)

35.5 Top management reviews the value added processes and support processes to ensure their effectiveness and efficiency during the management review process.

Quality Objectives (TS16949 – 5.4.1.1)

35.6 Quality Objectives and measurements are defined by top management, included in the Strategic Business Plan and are used to deploy the Quality Policy. The Strategic Business Plan is considered to be a company proprietary document.

35.7 The Facility Quality Assurance Manager/ Operations Manager are promptly informed of Products or processes that do not conform to requirements.

35.8 All employees are responsible for quality and have been given the authority to stop production to correct quality problems.

35.9 The shift supervisors on each shift have been delegated the responsibility for ensuring product quality.

Customer Representative (TS16949 – 5.5.2.1)

35.10 Top Management has given Sales and Marketing Representatives (SMR’s) the responsibility and authority to identify any customer requirements including customer special characteristics during the contract review process.

35.11 Top Management identifies quality objectives for the company, then, delegates the dissemination of the objectives and any related training to the lower tiers of management at each location.




35.12 Facility Quality Assurance Managers at each location have been given the responsibility to resolve corrective actions and ensure preventive actions are implemented.

Management Review (TS16949 – 5.6.1.1; 5.6.2.1)

35.13 The management reviews include all elements of the quality management system, performance trends as part of continual improvement, monitoring of quality objectives and the reporting and evaluation of the cost of poor quality. The records of the management reviews are maintained by the Management Representative and include achievement of the business plan quality objectives and customer satisfaction with the product supplied.

35.14 If the customer has provided information on potential field failures, an analysis of the failure and its impact on quality, safety, or the environment is included in the management review.

Competence, Awareness, and Training (TS16949 – 6.2.2.2; 6.2.2.3; 6.2.2.4)

35.15 A documented procedure has been established and is maintained for identifying training needs and achieving competence of all personnel performing activities affecting product quality. Personnel performing specific assigned tasks have been qualified on the basis of education, training, skills, and/or experience, as required. Training is provided, as appropriate, to satisfy customer specific requirements.

35.16 On the job training is provided for all jobs affecting quality, this includes any temporary employees. All employees whose work affects quality are informed of the consequences to the customer when nonconformances to customer requirements occur.

35.17 Employees are motivated to achieve quality objectives, to make continual improvements and create an environment to promote innovation, through the use of the RESULTS, POP, and Circle of Excellence programs as a minimum. The process includes the promotion of quality and technological awareness throughout the whole organization through company meetings, training and awareness sessions. The extent to which employees are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives is measured through personnel reviews and quality audit results.

Infrastructure (TS16949 – 6.3.1; 6.3.2)

35.18 A Multi-disciplinary approach is used for the planning of new plant, facilities, and equipment. Plant layouts optimize material travel, handling, and value-added use of floor space, and facilitate synchronous material flow. Existing operations are periodically evaluated and monitored for effectiveness.

35.19 Contingency plans are made to satisfy customer requirements in the event of an emergency such as utility interruptions, labor shortages, key equipment failure, and field returns. The contingency plan is available on the Avnet Intranet website.

Work Environment (TS16949 – 6.4.1; 6.4.2)

35.20 Product safety and the means to minimize potential risks to employees are addressed in the process procedures, equipment operation procedures, safety instructions, and during the manufacturing process design and development.

35.21 Premises are maintained in a state of order, cleanliness, and repair.

Planning of Product Realization (TS16949 – 7.1.1)

35.22 Customer requirements and references to their technical requirements are included in the product realization planning as a component of the production documents. When required by the customer, any requirements for advanced process planning such as failure mode effects and analysis (FMEA), control plan generation and production part approval (PPAP) are complied with. The output from the product realization planning is defined as documented control plans, process and operational procedures, work instructions, and forms as appropriate.




Acceptance Criteria (TS16949 – 7.1.2)

35.23 Acceptance criteria are defined in inspection and test procedures and are approved by the customer, if required. Any attribute data sampling uses an acceptance level of zero defects.

Confidentiality (TS16949 – 7.1.3)

35.24 The confidentiality of customer-contracted projects, projects under development and related product information is maintained under secure conditions and is not released to any unauthorized persons.

Change Control (TS16949 – 7.1.4)

35.25 Changes that impact product realization are controlled and reacted to, including those changes initiated by the customer. Production changes are assessed, verified, and validated by technical staff to ensure compliance to customer requirements. Changes are validated by the customer before implementation using the First Article Approval System, (AFA). When required by the customer, any additional customer specific verifications/ identification requirements are met.

Customer-designated Special Characteristics (TS16949 – 7.2.1.1)

35.26 Any customer designated special characteristics conform to customer requirements for designation, documentation and control when specified by the customer.

Review of Requirements Related to the Product (TS16949 – 7.2.2.1; 7.2.2.2)

35.27 Waiving of any requirements related to the product requires customer approval.

35.28 Manufacturing feasibility of the proposed products is performed during the contract review process, including risk analysis and records maintained. This is satisfied through a first article approval process.

Customer Communication (TS16949 – 7.2.3.1)

35.29 The ability to communicate necessary information, including data, in the customer specified language and format such as computer-aided design data, electronic data exchange, etc. is available when set-up with the customer and included in the customers contract.

Design and Development (TS16949 – 7.3)

Note: Product design is not performed. Design is the responsibility of the customer. The applicable requirement relating to design in this section relate to manufacturing process design only.

Design and Development Planning (TS16949 – 7.3.1.1)

35.30 A Multi-disciplinary approach is used to prepare for production processes, including:

a) Development/finalization and monitoring of any special characteristics.

b) Development and review of FMEAs including action to reduce potential risks.

c) Development and review of Control plans.

Design and Development Inputs (TS16949 – 7.3.2.2; 7.3.2.3)

35.31 The manufacturing process design input includes reviewing, identifying, and documenting of any program data provided by the customer, targets for productivity, process capability, and cost, customer requirements for identification, serialization and packaging and experience from previous developments.

35.32 If special characteristics are identified by the customer, they are included in the control plans, comply with customer specified definitions and symbols and are identified on applicable process control documents, FMEAs, and operator instructions. The customer's special characteristic symbols are use, if special characteristic symbols are specified.




Design and Development Outputs (TS16949 – 7.3.3.2)

35.33 The manufacturing process design output is expressed in terms that can be verified and validated against manufacturing process design input requirements. The manufacturing process design outputs include:

a) Specification for the process.

b) Manufacturing process flow charts/layout.

c) Manufacturing process FMEAs.

d) Control plan.

e) Work instructions.

f) Process approval acceptance criteria.

g) Results of error-proofing activities, as appropriate.

h) Methods of rapid detection and feedback of production/manufacturing process nonconformities.

Design and Development Review (TS16949 – 7.3.4.1)

35.34 Measurements made at specified stages of any new process design and development is defined, analyzed, and reported as an input to management review.

Design and Development Verification (TS16949 – 7.3.5)

35.35 Verification is performed to ensure that the process design and development outputs have met the process design and development input requirements. Records of the verifications and any actions are maintained.

Design and Development Validation (TS16949 – 7.3.6.1; 7.3.6.2; 7.3.6.3)

35.36 Validation is performed to ensure that the process is capable of meeting the requirements for the processing of the product in the intended application or use, if provided by the customer. Validation is performed prior to shipment, where practical. Records of the validation and any actions are maintained.

35.37 The production process validation is performed in accordance with any customer requirements including program timing.

35.38 When required by the customer, a prototype program and control plan is developed. Wherever possible, the same tooling, manufacturing processes, and subcontractors, if used, are used for the prototype program as used in production. All performance testing activities are monitored for timely completion and for conformance to requirements. If any services are outsourced, full responsibility is taken by the company, including technical direction.

35.39 Product Approval Process (PPAP) has been implemented and conforms to the customer's product and process approval procedure, when requested. The product and manufacturing process approval procedure is applied to suppliers as requested by the customer.

Purchasing Process (TS16949 – 7.4.1.1; 7.4.1.2; 7.4.1.3)

35.40 All products and materials used in the process satisfy applicable regulatory requirements.

35.41 Sub-contracted processes that affect quality are performed by sub-contractors that are registered to ISO 9001:2008 by an accredited third party certification body, unless otherwise specified by the customer. Supplier quality management system development is performed with suppliers with the goal of supplier compliance to ISO/TS16949.

35.42 When specified by the contract, products, materials, and services are purchased from customer approved sources. The quality of the purchased products is ensured even though customer-designated sources are specified.




Verification of Purchased Product (TS16949 – 7.4.3.1; 7.4.3.2)

35.43 In order to ensure the quality of purchased product, the incoming product is verified by one or more of the following methods:

a) Receipt of statistical data from the supplier.

b) Receiving inspection and/or testing such as sampling based on performance.

c) Second or third party assessments or audits of supplier sites, when coupled with records of acceptable quality performance.

d) Evaluation by a designated laboratory.

e) Another method agreed by the customer.

35.44 Suppliers are encouraged to monitor their manufacturing processes. Supplier performance is monitored through the following indicators on product received from the supplier:

a) Delivered part quality performance.

b) Customer disruptions including field returns.

c) Delivery schedule performance, including incidents of premium freight.

d) Special status customer notifications related to quality or delivery issues.

Control Plan (TS16949 – 7.5.1.1)

35.45 Control plans for the programming and packaging processes that take into account the manufacturing process FMEA outputs have been developed. Control plans are reviewed and updated as necessary, when changes occur which affect product, manufacturing process, measurement, logistics, supply sources, and/or, FMEA. The control plans take into consideration the following:

a) Controls used for the processes.

b) Methods for monitoring and control exercised over special characteristics, as applicable.

c) Any customer required information.

d) Initiating the specified reaction plan when the process becomes unstable or not statistically capable.

Work Instructions (TS16949 – 7.5.1.2)

35.46 Work instructions have been documented and are available at the work station for all employees having responsibilities for the operation of processes. The work instructions are derived from sources such as the quality plan, control plan, and the production processes.

Verification of Job Set-ups (TS16949 – 7.5.1.3)

35.47 Job set-ups are verified such as the initial run of a job, material changeover, or job change. Work instructions are available for set-up personnel. Statistical methods of set-up verification are used, where applicable.

Preventive and Predictive Maintenance (TS16949 – 7.5.1.4)

35.48 Machine/equipment maintenance is provided for key process equipment through the use of a preventive maintenance system. Records of maintenance are maintained and evaluated for the purpose of improving maintenance objectives. Predictive maintenance methods are used to continually improve the effectiveness and efficiency of the process equipment. The preventive maintenance system includes the following:

a) Planned maintenance activities.

b) Preservation of equipment, tooling, and gauging.




c) Availability of replacement parts for key manufacturing equipment.

Management of Production Tooling (TS16949 – 7.5.1.5)

35.49 Resources have been identified for the design, fabrication, and verification of any necessary tooling; including the outsourcing of these activities. The production tooling management system includes:

a) Maintenance and repair facilities and personnel.

b) Tool storage and identification to define the status of tooling.

Production Scheduling (TS16949 – 7.5.1.6)

35.50 Production scheduling is customer order driven. A computerized information system provides access to production information at key stages in the process.

Feedback of Information from Service (TS16949 – 7.5.1.7)

35.51 Any notifications from the customer of nonconformances that occur externally are recorded and reviewed for any necessary corrective actions in the production process.

Service Agreement with Customer (TS16949 – 7.5.1.8)

35.52 Service agreements are not entered into with customers.

Validation of Processes for Production (TS16949 – 7.5.2.1)

35.53 All production processes are validated internally and as requested by the customer.

Identification and Traceability (TS16949 – 7.5.3.1)

35.54 The identification of parts is maintained throughout all stages of production by the use of related paperwork and/or marking on the part.

Customer-owned Production Tooling (TS16949 – 7.5.4.1)

35.55 Any customer-owned tools, manufacturing, test, inspection, tooling, and equipment are permanently marked so that ownership of each item is visible, and can be determined.\

Storage and Inventory (TS16949 – 7.5.5.1)

35.56 The condition of stock is assessed at appropriate planned intervals to detect deterioration. A first-in-first-out (FIFO) system is used to assure stock rotation.

Measurement System Analysis (TS16949 – 7.6.1)

35.57 Statistical studies are conducted to analyze the variation present in each type of measuring and test equipment system referenced in the control plan. The analytical methods and acceptance criteria used, conforms to customer requirements, e.g. reference manuals on measurement systems analysis.

Calibration/Verification Records (TS16949 – 7.6.2)

35.58 Records of calibration for all gauges, measuring and test equipment are maintained and includes any employee and customer owned gauges.

35.59 Calibration records include:

a) Equipment identification, including the measurement standard against which the equipment is calibrated;

b) Revisions following engineering changes to product specific gauging as applicable;

c) Any out-of-specification readings as received for calibration;




d) An assessment of the impact of the out-of-specification condition;

e) A statement of conformance to specification after calibration;

f) The notification to the customer if suspect product has been shipped to the customer.

Laboratory Requirements (TS16949 – 7.6.3.1; 7.6.3.2)

35.60 The internal laboratory has a defined scope that includes its capability to perform the required inspection and testing. The laboratory controls include the following:

a) Laboratory procedures for inspection and test;

b) Suitable qualifications of the Technicians;

c) Capability to perform testing correctly, with traceable to the relevant process standard;

d) Reviews of the related quality records.

35.61 External laboratories used for inspection/test or calibrations have a defined scope that includes the capability to perform the required service and are accredited to ISO/IEC 17025 or a national equivalent; or the laboratory is acceptable to the customer.

Measurement, Analysis, and Improvement-General (TS16949 – 8.1.1; 8.1.2)

35.62 Appropriate statistical tools are determined during advanced quality planning and included in the control plan.

35.63 A basic knowledge of statistical concepts such as variation, control, (stability), process capability and over adjustment are understood and utilized.

Customer Satisfaction (TS16949 – 8.2.1.1)

35.64 Customer satisfaction is monitored through continual evaluation of the performance of the value-add processes. The performance indicators include:

a) Delivered part quality performance.

b) Customer disruptions, including field returns if notified by the customer.

c) Delivery schedule performance including incidences of premium freight.

d) Customer notifications related to quality or delivery issues.

Internal Audit (TS16949 – 8.2.2.1; 8.2.2.2; 8.2.2.3; 8.2.2.4; 8.2.2.5)

35.65 Audits of the quality management system are used to verify compliance to ISO/TS16949; as well as, any other quality management system requirements.

35.66 The manufacturing processes are audited to determine effectiveness of the processes.

35.67 Product audits are performed at appropriate stages of production and shipping to verify conformance to specified requirements, at a defined frequency.

35.68 Internal audits cover all quality management related processes, activities, and shifts. Audits are scheduled according to an annual plan. The frequency of audits will be increased if internal/external non-conformities or customer complaints occur.

35.69 Internal auditors are trained to audit to the requirements of ISO/TS16949.




Monitoring and Measurement of Manufacturing Processes (TS16949 – 8.2.3.1)

35.70 The monitoring of the Quality System processes is achieved by internal audit results, nonconformance reports and management reviews. When areas of concern are identified, corrective action to ensure conformity of product is initiated. Process performance studies are conducted on all new manufacturing processes to verify process capability and to provide any additional input for process control. The results of the process studies are documented as appropriate in production instructions, measurement and test instructions, and maintenance instructions. These documents include objectives for manufacturing process capability, reliability of the process, and maintainability of the process, as appropriate. Manufacturing process capability, or performance, is maintained as specified by the customer part approval process requirements. The control plan and process flow diagram requirements are implemented, including:

a) Measurement techniques.

b) Sampling plans.

c) Acceptance criteria.

d) Reaction plans when the acceptance criteria are not met. Significant events such as equipment repair are noted on the production control documents. A reaction plan is initiated if product characteristics become either unstable or non-capable. The reaction plans include containment of product and 100% inspection as appropriate. Corrective action plans indicate specific timing and assigned responsibilities to assure the process becomes stable and capable. Reaction plans are reviewed with and approved by the customer, as required. Records are maintained of the effective dates of any process changes.

Monitoring and Measurement of Product (TS16949 – 8.2.4.1; 8.2.4.2)

35.71 Layout inspections and functional verifications are performed to applicable customer performance standards at sufficiently frequent intervals as specified in the control plan. The results are available for customer review.

35.72 Appearance items requirements are not applicable to the products supplied.

Control of Nonconforming Product (TS16949 – 8.3.1; 8.3.2; 8.3.3; 8.3.4)

35.73 Unidentified or suspect product is classified as nonconforming product.

35.74 Instructions for rework, including re-inspection are accessible to and utilized by the appropriate personnel.

35.75 Customers are promptly informed in the event that nonconforming or suspect product is shipped.

35.76 A waiver or deviation is obtained from the customer prior to further processing whenever the product or process is different from that currently approved. Records are maintained of the expiration date or quantity authorized. Compliance to the original or superseding specifications is ensured when the authorization expires. Product shipped on a waiver or deviation is identified on each shipping container as required by the customer. The waiver authorization system applies equally to purchased product. Requests from suppliers for a waiver are agreed to before submission to the customer.




Analysis and Use of Data (TS16949 – 8.4.1)

35.77 Trends in quality and operational performance are compared with progress toward objectives and lead to action to support the following:

a) Development of priorities for prompt solutions to customer-related problems.

b) Determination of key customer-related trends and correlation to support status review, decision-making, and longer term planning.

c) An information system for the timely reporting of product information arising from usage.

Continual Improvement (TS16949 – 8.5.1.1; 8.5.1.2)

35.78 A process for continual improvement of the organization has been defined.

35.79 Continual improvement focuses on control and reduction of variation in the production process parameters.

Corrective Action (TS16949 – 8.5.2.1; 8.5.2.2; 8.5.2.3; 8.5.2.4)

35.80 A defined process for problem solving leading to root cause identification and elimination has been determined and documented. A customer-prescribed problem solving format is utilized when requested by the customer.

35.81 Error proofing methods are included in the corrective action process.

35.82 Corrective actions are applied to similar process and products to eliminate the cause of nonconformities.

35.83 Parts rejected by the customer are analyzed in a timely manner with the perspective of initiating corrective action to prevent recurrence. Records of the analysis are kept and made available to the customer upon request.

Appendix I Rev. AA


Avnet, Inc. Page 1 of 2 Business Use Only

ISO 9001 Registered Facilities

Location Scope File # Location Clauses Not Applicable Activities

60 South McKemy Ave. Chandler, AZ 85226

Head Office Support functions for all Avnet EM Americas locations. Top Management, Document Control, Corrective Action center, Supplier Quality, Customer Satisfaction, Internal Audits, Purchasing,, and Management Review Responsibilities.

026620 7.2, Customer Related Processes is not performed at this location.

Corr Action; Cust Satisfaction; Doc Ctrl; HR; Internal Audit; Top Mgmt; Purchasing; Quality; Supplier Quality


The Distribution of Military/ Commercial Semiconductors/ IC’s, Established Reliability/ Commercial Passive Components, Connector Products Military/ Commercial/Value Add, and Programming/ Modification.

026620 7.2, Customer Related Processes is not performed at this location except quotes for Subcontracted Value Add work is performed.

Programming; HR; Quality; Distribution; Purchasing (Subcontracted Services)

Av Iteso 8900 Edif 1 B Parque Industrial Tecnologics Tlaquepaque, Jalisco Mexico 45080

Programming and distribution of Integrated Circuits

013722* 7.4, Purchasing is not performed at this location. Programming; Distribution

2110 Zanker Road San Jose, CA 95131

Programming and distribution of Integrated Circuits

013147* 7.2, Customer Related Processes and 7.4, Purchasing are not performed at this location.

Programming; Distribution

26 Clinton Drive Hollis, NH 03049

Post manufacturing services to semiconductor devices including customer specified programming, testing, tape and reeling, material procurement and management and engineering analysis test services.

1621316* None Programming

400 Franklin Rd, Ste 260 Marietta, GA 30067

Distribution of XYZ Products, Military Packaging, sales, Marketing, and Purchasing.

005485* 7.5.4, Customer Property is not handled at this location.

Sales; Purchasing (IP&E & XYZ Only); Quality; Distribution

6700 W Morelos Place Chandler, AZ 85226

Distribution of Computer Components for the computer technology sector.


Distribution; Quality

Calzada Industrial Nuevo Nogales #1061, Fraccionamiento: Parque Industrial Nuevo Nogales, Nogales, Sonora, MX C.P. 84094

The assembly of electronic connectors, cables, and wiring harnesses.

1609379* 7.2, Customer Related Processes is not performed at this location.

Quality; Cable Assy; Connector Assy; Doc Ctrl; Quote Center; Purchasing; Distribution; Integration


Custom configuration, integration, and distribution of computer products for the computer technology sector.

1611724* 5.2, Customer Focus and 7.4, Purchasing are not performed at this location.

Engineering; HR; Integration; Quality; Top Mgmt; Doc Ctrl; Supplier Quality; Corr Action; Internal Audit

8700 South Price Rd Tempe, AZ 85284


1611728

5.3, Quality Policy; 5.4, Planning; 5.6, management Review; 7.1, Planning of Product Realization; 7.5, Production and Service provision; 7.6, Control of Monitoring and Measuring Equipment; 8.2, Monitoring & Measurement

Sales; Configuration Mgmt; Purchasing; Quote Center; Cust Satisfaction; HR

6550 North Loop 1604 East San Antonio, TX 78247


1611730 5.3, Quality Policy; 5.4, Planning; 5.6, Management Review; 7.1 Planning of Product Realization

Sales; Configuration Mgmt; HR; Purchasing; Quote Center

8 Craig Road Acton, MA 01720


1611729* 5.3, Quality Policy; 5.6, Management Review; 7.2, Sales, 7.4, Purchasing.

Engineering; Integration; Quality; Distribution; Internal Audit

326 Charcot Avenue San Jose, CA 95131


1622180 5.3, Quality Policy; 5.6, Management Review; 7.2, Sales; 7.4, Purchasing

Engineering; Quality; Integration; Configuration Mgmt

2100 NW 97th Ave. #101 Miami, FL 33172

The Distribution and Integration of Computer Products



2110 Zanker Road San Jose, CA 95131




*Site may be dependent on activities performed at site with file #026620.

Appendix I Rev. AA



AS9100 Registered Facilities




026620

7.1.f, Identification of resources to support the use and maintenance of product is not applicable to distribution ; 7.2, Customer Related Processes is not performed at this location except quotes for Subcontracted Value Add work is performed.

Programming; HR; Quality; Distribution; Purchasing (Subcontracted Services)



1609379*

7.1.f, Identification of resources to support the use and maintenance of product is not applicable to distribution ; 7.2, Customer Related Processes is not performed at this location except quotes for Subcontracted Value Add work is performed; 7.5.1.1, Production Process Verification is not applicable to Connector Assembly.

Quality; Cable Assy; Connector Assy; Doc Ctrl; Quote Center; Purchasing; Distribution

*Site may be dependent on activities performed at site with file #026620.


Location Scope File #



026620


The distribution of computer components, and networking equipment, customer configuration, integration and services for OEM's to support value added resellers and end-user markets in the computer technology sector.

1058174


Assembly of electronic connectors, cables, and wiring harnesses.

1609379




Contract manufacturer of computer systems used in medical devices.

1611724 5.2, Customer Focus and 7.4, Purchasing are not performed at this location.

Engineering; HR; Integration; Quality; Top Mgmt; Doc Ctrl; Supplier Quality; Corr Action; Internal Audit



1609379

7.1.f, Identification of resources to support the use and maintenance of product is not applicable to distribution ; 7.2, Customer Related Processes is not performed at this location except quotes for Subcontracted Value Add work is performed; 7.5.1.1, Production Process Verification is not applicable to Connector Assembly.

Quality; Cable Assy; Connector Assy; Doc Ctrl; Integration; Quote Center; Purchasing

Appendix II Rev. M



Avnet, Inc.

President/CEO

Avnet, Inc.

Quality Assurance

Connector, Cable VAD

Nogales, MX

Logistic Centers

Chandler, AZ McKemy

Chandler, AZ Morelos

Miami, FL

San Jose, CA

Sales & Marketing

Operations

Materials

Purchasing

Programming Centers

Chandler, AZ McKemy

Hollis, NH

San Jose, CA

Guadalajara, MX

Customer Loyalty

Integration

Chandler, AZ Morelos

Acton, MA

San Antonio, TX

San Jose, CA

CIO

Avnet, Inc

President ATS

President ATS

Americas

Group Sr VP-Dir

Exec Sales-

Americas

Defense/Aero

Electro-Air Marietta, GA

Sales & Marketing

Operations

Materials

Purchasing

Sr. V. P. Logistics

and Warehousing

Americas & Global

Quality

Chief Global

Logistics &

Operations Officer

QMS/EMS Mgt Rep

Sr. V. P.

Programming

V. P. Customer

Engagement

V. P. Global Traffic

& Transportation

President EM

President EM

Americas

Appendix III Rev. D



INPUT TRANSFORMATION OUTPUT

CUSTOMER

REQUIREMENTSSALES

REVIEW

PURCHASING

CUSTOMER

SUPPLIED

PRODUCT

DIRECT SHIP

VALUE ADD

CONNECTOR

ASSEMBLY

CABLE

ASSEMBLY

PROGRAMMING

PRODUCT ID

AND

TRACEABILITY

SUPPORT FUNCTIONS

DOCUMENT CONTROL

CALIBRATION

PREVENTIVE ACTION

QUALITY RECORDS

INTERNAL QUALITY AUDITS

STATISTICAL TECHNIQUES

QUALITY SYSTEM

MANAGEMENT RESPONSIBILITY

INFORMATION SERVICES

HANDLING &

DELIVERY

SHIP TO

CUSTOMER

CORRECTIVE

ACTION

NONCONFORMIN

G PRODUCT

INSPECTION

& TEST

STATUS

INSPECTION

AND TESTING

PROCESS

CONTROL

RMA'SCORRECTIVE

ACTION

CUSTOMER

SATISFACTION

PROCESSES - ISO 9001 & ISO 14001

INTEGRATION

Appendix IV Rev. H



QMS/EMS Procedures

QMS Requirement Manual Tier II Procedure

Contract Review QM0492 02-CON-01

Document Control QM0492 02-DOC-01

Purchasing QM0492 02-PUR-01

Customer Supplied Product QM0492 02-PSP-01

Product ID & Traceability QM0492 02-TRA-01

Process Control QM0492 02-PRO-01

Inspection & Testing QM0492 02-INT-01

Calibration QM0492 02-CAL-01

Records QM0492 02-RCD-01

Internal Audits QM0492 02-AUD-01

Handling, Storage, Packaging, Preservation, and Delivery QM0492 02-HST-01

Nonconforming Product QM0492 02-NCM-01

Corrective & Preventive Action QM0492 02-CAR-01

Statistical Techniques QM0492 02-SPC-01

Training QM0492 02-TRN-01

Environmental Management QM0492 02-ENV-01

Appendix V Rev. B



Appendix V Rev. B



Customer Fulfillment Process

Store Ship

Set up

Programming

Labeling

Marking

Verification

Tape & Reel

Verification

Lead Scan (As

applicable)

Baking (As

applicable)

Package/Label

Packaging

Contract

review

Schedule/

Planning

Purchasing

Receiving

First Article

APQP

FEMA

PPAP

RFQ

Appendix VI Rev. A



AS9100 Cross Reference Document

QMS Requirement AS9100 Clauses Document

Quality System 4.1; 4.2; 4.2.1; 4.2.2 QM0492

Document Control 4.2.3 02-DOC-01

Records 4.2.4 02-RCD-01

Configuration Management 4.3 02-CFG-01

Training 6.2.2 02-TRN-01

Contract Review 7.1; 7.2 02-CON-01

Purchasing 7.4 02-PUR-01

Process Control 6.3; 6.4; 7.5.1 02-PRO-01

Identification & Traceability 7.5.3 02-TRA-01

Customer Supplied Product 7.5.4 02-PSP-01

Handling, Storage, Packaging, Preservation, and Delivery 7.5.1; 7.5.5 02-HST-01

Calibration 7.6 02-CAL-01

Statistical Techniques 8.0 02-SPC-01

Inspection & Testing 7.1; 7.4; 8.2.4 02-INT-01

Customer Satisfaction 8.2.1 QM0492

Audits 8.2.2 02-AUD-01

Nonconforming Product 8.3 02-NCM-01

Corrective & Preventive Action/Continual Improvement 8.5.1; 8.5.2 02-CAR-01

Appendix VII Rev. A



Logistics QMS Processes – AS9100

• Business Planning

• Management Review

Completed Shipments

Cu

sto

mer S

atis

factio

n

Cu

sto

mer R

eq

uir

em

en

ts

Input Output

Leadership and Direction

• Training

• Maintenance

• Fixture Control

• Calibration

Resource Management• Customer Satisfaction (On-Line Website)

• Informal Customer Complaints (Sales Branch)

• Corrective Action (Chandler)

• Nonconforming Material

• Preventive action

• Returned Material Analysis

Measurement, Analysis, Improvement

•Scheduling/Planning

• Logistics

• Design

• Purchasing

• Receiving

• Put Away Inventory

• Pick Process

• Pack Process

• Ship Process

Customer Fulfillment

(See Flow Diagram)

• Labeling

• Marking

• Verification

• Storage

• Packaging

• Shipping

RFQ

(Sales Branches)

Contract Review

(Sales Branches)

Top Management

Product Design

(Customer)

Top Management

Internal System

Audits

(Chandler)

Document Control

(Chandler)

Subcontracted Processes

(As applicable)

Appendix VII Rev. A




Ship

Order download to

RF. Operator

picks per

instructions.

Product is

packaged to

specification.

Order is inspected

as required, and

processed to ship

area.

Contract

review

Schedule/Pla

nning

Order

Processed

Receiving

Purchasing

RFQ

Appendix VIII Rev. A



Value-Add Assembly QMS Processes – AS9100

• Business Planning

• Management Review

Finished Goods

Connectors/Cables

Cu

sto

me

r S

atis

fac

tion

Cu

sto

me

r R

eq

uir

em

en

ts

Input Output

Leadership and Direction

• Training

• Maintenance

• Materials

• Calibration

Resource Management• Customer Satisfaction (On-Line Website)

• Informal Customer Complaints (Sales Branch)

• Corrective Action (Chandler)

• Nonconforming Material

• Preventive Action

• Returned Material Analysis

Measurement, Analysis, Improvement

•Customer Design

• Review

• Scheduling/Planning

• Assembly Process

• Design

• Purchasing

• Receiving

• Kitting

• First Article (As Applicable)

Customer Fulfillment

(See Flow Diagram)

• First Piece Build

• 1st Article (As

Applicable)

• Assembly (Production)

• Marking

• labeling

• First assembly Insp.

• Out Gassing (As

Applicable)

• Packaging

• Storage (Build to Stock

Only)

• Shipping

RFQ

(Sales Branches)

Contract Review

(Sales Branches)

Top Management

Product Design

(Customer)

Top Management

Internal System

Audits

(Chandler)

Document Control

(Chandler)

Appendix VIII Rev. A




Ship

• 1st Piece Build

(Cable)

•1st Article (As

Applicable)

•Assembly

•Marking

•Labeling

•Final Inspection

•Degas/Out Gas

(As Applicable)

•Storage (build

to Stock Only)

•Documentation

(Certificates as

Applicable)

•Packaging

Contract

Review

Schedule/

Planning

Purchasing

Receiving

RFQ

Store

Build-to-

Stock Items

First Article

(As Applicable)

Appendix IX Rev. A



Appendix IX Rev. A




Store Ship

Set up

Programming

Labeling

Marking

Verification

Tape & Reel

Verification

Lead Scan (As

applicable)

Baking (As

applicable)

Package/Label

Packaging

Contract

Review

Schedule/

Planning

Purchasing

Receiving

First Article

RFQ

Appendix X Rev. B



EMS Elements Interaction & Related Documents

•02-CAR-01

Continual Improvement

• QM0492

Management Review •QM0492

Environmental Policy

Checking

• 02-NCM-01 02-CAL-01 02-AUD-01

• 02-CAR-01 02-RCD-01 QM0492

Planning

•02-ENV-01 QM0492

Implementation and Operation

•02-DOC-01 02-TRN-01 02-ENV-01

•02-PRO-01 QM0492

Appendix XI Rev. B



ATS Business Process Documents

Document Number Title

KP03-0002 ATS Business System Overview

KP01-0001 TS Strategic Planning Process

KP06-0004 Control of Records

KP06-0001 Control of Documents

KP02-0001 Business Management System Review

KP05-0001 Training & Development

WI02-0025 ESD Procedure

KP08-0004 Technical Operations Prototype Process

KP08-0003 Product Change Request - ECN

KP08-0002 First Article & Validate

KP10-0001 Embedded Solutions Order Schedule

KP09-0001 Supplier Onboarding Process

KP08-0001 Requirements Development

KP08-0005 AGSC Solutions Desk – Quote Process

KP13-0003 Control of Nonconforming Product

KP10-0004 Product Integration & Final

KP04-0001 Equipment Calibration & Maintenance

WI02-0006 Quality Bulletin

KP12-0001 Internal Audit

KP14-0002 Corrective & Preventive Action

KP13-0001 Failure Evaluation

KP13-0002 Problem Solving

KP03-0001 ATS Business Quality Manual (URL’s)

KP14-0001 Continual Improvement

KP06-0003 Data Control & Maintenance

KP07-0001 AES Account Management

KP07-0004 Genesis Order Flow Through Credit

KP09-0004 Inventory Management

KP09-0002 Material Procurement