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igus Inc. Quality Manual ANSI/ISO/ASQ Q9001-2008 Rev: 10 3/29/10

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Working together, we are continuously improving upon our ability to provide the right solution and deliver as

promised.

QUALITY MANUAL

igus Inc. 50 North Broadway Rumford, RI 02916

(401) 438-2200 / fax (401) 438-7270 igus Canada Additional Storage Facility 201 Milway Ave. Units 24 and 25 170 Greenwood Ave Concord, Ontario L4K 5K8 Rumford, RI 02916 (905) 760-8448 / (905) 760-8688

[email protected] www.igus.com

______________________________ _______________________________ QM Approved GM Approved

Date________ Date_________


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Table of Contents

Page Organizational Chart P3 Guiding Stars P4 ISO Certificate P5 1.0 Scope P6 1.1 General P6 1.2 Reduction in scope P6 2.0 Normative reference P7 3.0 Terms and definitions P7 4.0 Quality management system requirements P7 4.1 General requirements P7 4.2 Documentation requirements P8 5.0 Management responsibility 5.1 General requirements P10 5.2 Customer focus P12 5.3 Policy P12 5.4 Planning P12 5.5 Responsibility, authority and communication P13 5.6 Management review P15 6.0 Resource management 6.1 Provision of resources P16 6.2 Human resources P16 6.3 Infrastructure P17 6.4 Work environment P17 7.0 Product realization 7.1 Planning of product realization P18 7.2 Customer-related processes P19 7.3 Design and development N/A P20 7.4 Purchasing P20 7.5 Production and Service N/A P22 7.6 Control of monitoring and measuring devices P25 8.0 Measurement, analysis and improvement 8.1 General P26 8.2 Monitoring and measurement P27 8.3 Control of nonconforming product P28 8.4 Analysis of data P29 8.5 Improvement P30

P5F2


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igus Inc. Solar System (Organizational Chart)

igus, Inc. Solar Systemigus, Inc. Solar SystemVP & GM

Accounting

Quality

HR

Purchasin g

Warehouse

Collections

Technical

Support

CUSTOMER

Sales

Simple

Harnessing

Harnessing

Customer

Service

Marketing

PR

igus Inc. Solar System

System Planet = each department is designated its own planet operating within the igus Solar System.

The igus organization is structured to meet the customer’s needs, with the customer at the center of the solar system. The following key provides definition of this philosophy:

Planet


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igus Inc. GUIDING STARS (Core Values) Key to the igus Solar System Innovation Excel in developing creative customer solutions. Service Exceed our customers’ expectations. Speed Provide fast, accurate service. Aggressiveness Constantly explore new opportunities to grow and improve. Personal Development Create a desire to learn, grow and be successful. Quality Committed to excellence.

Interrelation between planets (departments) within the igus solar system.

The igus Solar System was created in such a way that all planets have the ability to interrelate between each other as well as directly with the customer, as required to meet the customer needs, igus quality

objectives, and support our quality policy.


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ISO 9001:2008

Quality Management Systems - Requirements

1. Scope The scope of igus, Inc is clearly defined within our ISO Certificate (see previous page). This scope encompasses a quality system to meet the requirements of the ANSI/ISO/ASQ/Q9001: 2008 standard, covering all locations called out on the cover page of this Quality Manual including any outside sales functions within the North American continent.

1.1 General This quality manual specifies requirements for igus Inc.’s quality management system (QMS)

It is intended that all requirements of the International Standard be applied. However, a reduction in scope has been taken in certain situations.

1.2 Reduction in scope When customer requirements, or the nature of product and/or service, do not require certain quality management system requirements for the processes specified in the International Standard, such quality management system requirements may be excluded and compliance with the remaining applicable clauses of the International Standard maintained.

igus Inc. has not reduced the scope of its quality management system to exclude any quality management system requirements that affect igus Inc.’s ability to provide conforming product and/or service. This limits such exclusions to those quality management system requirements within clause 7 products and/or service realization.

Application of reduced scope of requirements does not absolve igus Inc. of the responsibility to provide product and/or service, which meet customer requirements.

NOTE 1: Where igus Inc. applies a reduced scope; regulatory requirements are still applicable to igus Inc. and its product and/or service.

The following areas are being called out in the reduction of scope for igus Inc. o Section 7.3 of the International Standard: Design and Development

igus Inc. is primarily a distribution center for its parent company, igus, GmbH. Design and development are created and retained at that level of the operation.

○ Section 7.5 of the International Standard: Production and Service provision: Also continuing our role of a distribution center, production and service provision are also completed by our parent company, igus Inc.

2. Normative reference This quality manual contains provisions, which through reference to the text of the International Standard, constitute compliance with the standard.

3. Terms and definitions For the purposes of the International Standard, the terms and definitions given in ANSI/ISO/ASQ Q9001: 2008 quality management systems - fundamentals and vocabulary, apply to this quality manual.


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4. Quality management system requirements

4.1. General requirements igus Inc. has established a QMS that documents, implements, maintains and continually improves processes in accordance with the requirements of the international standard. igus Inc. maintains a documented quality management system designed and implemented to fulfill ISO 9001-2008 requirements. This system consists of documented procedures and instructions. These documents create a framework for clearly defining control of material processes and verification activities, thus providing our customers with confidence that the manufacture and servicing of igus Inc. products are performed in a well-defined and controlled environment. This includes:

a. Determine the processes needed for the QMS and its application throughout the organization, Procedure 1A;

b. Determination of the sequence and interaction of processes, by identifying the processes, determining how to implement control of processes Procedure 9, and monitoring the processes;

c. Ensuring the effective operation and control of processes, Procedure 1B; d. Ensuring the availability of resources and information necessary to support these processes; e. Monitoring, measure where applicable, and analyze these processes; and f. Implementing actions necessary to achieve planned results and continual improvement of

these processes. These standards are managed by igus Inc. in accordance with the requirements of the International Standard.

Where igus Inc. chooses to outsource any process that affects product conformity to requirements, igus Inc. shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system. NOTE1: Processes needed for the quality management system referred to above include processes for

management activities, provision of resources, product realization measurement, analysis and improvement.

NOTE 2: An “outsourced process” is a process that igus Inc.needs for its quality management system and which the organization chooses to have preformed by an external party.

NOTE 3: Ensuring control over outsourced processes does not absolve igus Inc. of the responsibility of conformity to all customers, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as

a) the potential impact of outsourced processes on the organizations capability to provide product that conforms to requirements,

b) the degree to which the control for the process is shared,

c) the capability of achieving the necessary control through the application of 7.4.


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4.2 Documentation Requirements

4.2.1 General All personnel who manage, perform and verify work-affecting quality are responsible for implementing the quality system. The quality manager is responsible for coordinating, monitoring, and auditing the system. Implementation of the quality system is assessed regularly by way of internal and external audits, P1AF2, and management reviews P1AF1.

The QMS documentation includes: a. a quality policy and quality objectives b. a quality manual c. documented procedures and records required by the International Standard, and d. documents, including records, determined by igus Inc. to be necessary to ensure the

effective planning, operation and control of it’s processes.

NOTE 1: Where the term “documented procedure” appears within this quality manual, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.

NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to

a) the size of organization and the type of activities, b) the complexities of processes and their interactions, and c) the competence of personnel

NOTE 3: The documentation can be in any form or type of medium.

4.2.2 Quality Manual This quality manual includes:

a. The scope of this quality management system, including all permissible exclusions; and

b. Reference to documented procedures.

igus Inc. has prepared quality management system procedures that describe the processes required to implement the quality management system. The range and extent of the system procedures are dependent upon such factors as size and type, the complexity and interaction of the processes, the methods used, and the skills and training of personnel involved in performing the work. These include: a) System level procedures that describe the activities required to implement the quality management

system; b) Procedures that describe the sequence and interactive nature of the processes necessary to ensure

the conformity of the product and/or service; and c) Instructions that describe the operating practice and control of process activities.

The following procedures require documentation per the ISO standard: a. control of documents (Procedure 5) b. control of quality records (Procedure 5) c. internal audits (Procedure 17) d. control of non-conforming product (Procedure 13) e. corrective action (Procedure 14a) f. preventive action (Procedure 14b)


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In addition, documented procedures required by contracts, ISO standards, statutory or regulatory requirements, or igus itself will be maintained. Processes are documented by various means, including in writing, by flow charts or through computer systems.

NOTE: The extent of the QMS is dependent on the size and the operations of this organization, the complexity and interactions of the processes, and the competencies of our employees. As the organization changes, the QMS will change with it.

Documents will remain legible, readily identifiable and retrievable. Applicable documents of external origin are identified and recorded.

NOTE: Documents may be in any form or any type of media.

4.2.3 Control of Documents Records are established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records will remain legible, readily identifiable, and retrievable. A documented procedure (Procedure 16) has been established to define the controls needed for the identification, storage, protection, retrieval, retention time, and disposition of records. A documented procedure (Procedure 5) has been established to control all documents and data that relate to the requirements of the International Standard. Any documents that relate to the quality of product and services are controlled per forms P5F2, P5F3, P5F4. The company's document control system provides for the approval, issue, distribution, recall, placement, and revision of all documents that relate to quality. All documents are reviewed prior to issue. Any revisions, other than ones of administrative nature, are reviewed annually to show continual compliance to the igus QMS. Obsolete documents are removed from points of use.

Documents of the QMS are controlled documents. A documented procedure (Procedure 5 Sec 1 ) has been established to:

a. Approve documents for adequacy prior to use; b. Review, update as necessary, and re-approve; c. Identify current revision status of documents; d. Ensure documents are available at points of use; e. Ensure documents are legible and identifiable; f. Ensure that documents of external origin determined by igus Inc. to be necessary for

the planning and operation of the quality management system are identified and their distribution controlled; and

g. Prevent unintended use of obsolete documents and apply suitable identification to them if they are retained for any purpose.

Prior to release, all documents are approved in accordance with the document control procedure (Procedure 5). A master list, P5F2, P5F3, P5F4 has been established and is maintained that identifies the current revision of all documents. The manager of each department is responsible for ensuring that issues of appropriate documents in his/her area are available for use, and up-to-date. Periodical reviews of files are done in order to remove all obsolete issues.

Per Procedure 5, section 1.0, uncontrolled copies of documents, as well as preliminary and obsolete documents are clearly identified to assure against their unintended use. Invalid and/or obsolete documents are to be promptly removed from all points of issue or use, or otherwise assured against unintended use.


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4.2.4 Control of quality records Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. A documented procedure (Procedure 5) has been established for:

a. identification b. storage c. retrieval d. protection e. retention times and disposition

Records will remain legible.

A documented procedure (Procedure 5) has been established and is maintained to control identification, collection, indexing, access, filing, storage, maintenance, and disposition of quality records. Quality records are maintained to demonstrate achievement of the required quality and effective operation of the quality system. The records are identified, indexed, readily retrievable, and stored in a suitable environment to prevent deterioration and loss. Pertinent vendor records are maintained. All quality records are legible. Retention periods for records are defined in section 1.0 of Procedure 16. All quality records are made accessible to customers when specified by contract. 5 Management responsibility

5.1 General requirements The GM holds ultimate responsibility for the quality of company products and services. The GM appoints a management representative as the quality manager. The appointed person has the authority and responsibility to ensure that the quality management system is maintained and its efficiency is continually improved, and that the system always complies with the requirements of the International Standard. The responsibility, authority and the interrelation of all personnel who manage, perform and verify work-affecting quality is defined throughout the quality manual, company procedures and work instructions. The quality policy provides every employee with the freedom and authority to control or stop any operation, which is not in conformance, initiate preventative actions, identify problems, recommend solutions and verify implementation of solutions.

Top management of igus Inc. provides evidence of its commitment to the development and implementation of the quality management system and is continually improving its effectiveness by: a) Communicating to the organization the importance of meeting customer as well as statutory and

regulatory requirements; through various charts, graphs, and company wide e-mails. Our organizational chart depicts our efforts to meet all of our customer’s requirements.

b) Establishing the quality policy; per procedure 1A section 1.0. c) Ensuring that quality objectives are established; per procedure 1A section 1.0.

igus Inc. is divided into several interrelated departments: (a) The Sales Departments are responsible for market research, sales, contracts, customer

relations and planning assistance, product pricing, and determining customer quality requirements and the introduction of new products to the marketplace.

(b) The Human Resource Department is responsible for recruitment, hiring, training, employee development, environmental, health and safety, benefits administration and employee welfare.

(c) The Accounting Department is responsible for all money management, credit inquiries, accounting, data processing, and joint duties of payroll with human resources.

(d) The Marketing Department is responsible for designing, developing and coordinating production of promotional marketing materials. This includes planning, public relations, advertising, purchasing incentive and promotional communication projects, including print, electronic, special events, point of purchase and direct mail.


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(e) The Purchasing Department is responsible for purchasing and inventory control of materials both foreign and domestic required for assembly; preparation and issuance of purchasing documents; provide specifications and drawings to vendors to assist in meeting igus requirements; selecting and certifying suppliers with QM, who are capable of complying with Igus Inc.’s quality requirements; and monitor and evaluate supplier performance.

(f) The Warehouse Department is responsible for all receiving, inventory control and retrieval, assembly, product modification (if applicable), inspection, packaging and shipping, as well as initiating purchasing for warehouse needs.

(g) The Harnessing Department is responsible for all value-added activities necessary for producing Energy Chain harness systems that meet customer specifications, including planning, procurement, inventory control, manufacturing, and outbound logistics.

(h) The Technical Support Department is responsible for drafting of customer and internal, assembly and component drawings, bill of material management, entry of new part numbers as well as customer assemblies and revisions.

(i) The Collections Department is responsible for retrieval all monetary debt owed to igus Inc.

(j) The Quality Department has the responsibility for quality planning, management and administration, quality procedures, measuring and test equipment, receiving inspection, quality system audits, and training in quality processes and procedures. Quality and purchasing jointly maintain the qualified supplier list.

5.2 Customer focus Top management of igus Inc. ensures that: a) Customers’ needs and expectations are determined and converted into requirements, through

Procedure 3, Contract Review with the aim of achieving customer confidence. b) Customer requirements are fully understood and met. This is achieved by:

- Sending samples to our customers to allow them to familiarize themselves with our products, drawings, and other reference material;

- Quality survey cards, with the intent of gaining information regarding the customer’s requirements; and

- Technical assistance in putting together the correct solution and products to meet the customer’s needs.

5.3 Policy igus Inc.’s management representative with executive responsibility is Carsten Blase, Vice President. The GM defines and document igus Inc.’s policy for quality including objectives for quality and igus Inc.’s commitment to quality. igus Inc.’s quality policy is relevant to igus Inc.’s organizational goals and the expectations and needs of its customers. igus Inc. ensure that this policy is understood, implemented, and maintained at all levels of the company.

Per Procedure 1B, section 1.0, top management of igus, in conjunction with the quality Manager (QM), has established a quality policy and ensures that it: a) Is appropriate for the needs of igus Inc. and its customers; b) Includes commitment to meeting requirements and continual improvement; c) Provides a framework for establishing and reviewing quality objectives; d) Is communicated, understood and implemented throughout igus Inc.; and e) Is reviewed for continuing suitability.


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5.4 Planning

5.4.1 Objectives The requirements defining how quality will be met are defined and documented in the quality system. Through these procedures, the company has given consideration as appropriate to the following activities:

a. The preparation of quality plans (Procedure 1A, 1B) b. The identification of any controls, processes, equipment (including inspection and test

equipment), fixtures, resources, and skills that may be needed to achieve the required quality. Forms P18F1 – F3 , P11F1

c. Ensuring the production process, inspection, procedures, and the applicable documentation

d. The updating, as necessary, of quality control inspection, techniques, including the development of new instrumentation

e. The identification of any measurement requirement involving capability that exceeds the

known state of the art, in sufficient time for the needed capability to be developed

igus Inc. has established quality objectives at each relevant function and level within igus Inc. The quality objectives are measurable and are consistent with the quality policy and the commitment to continual improvement.

5.4.2 Quality management system planning Top management of igus Inc. ensures that: a) The planning of the quality management system is carried out in order to meet the requirements

given in section 4.1 of the International Standard, as well as the quality objectives; and b) The integrity of the quality management system is maintained when changes to the quality

management system are planned and implemented.

igus Inc. identifies and plans the activities and resources needed to achieve quality objectives and for continual improvement. This planning is consistent with other requirements of the quality management system, procedure 2 section 4.0. The results are documented. Planning covers: a) The processes required in the quality management system (and any reduction in scope of the

International Standard); b) The resources needed, identifying quality characteristics at different stages, to achieve the desired

results; and c) The verification activities, criteria for acceptability and the quality records needed.

Planning ensures that organizational change is conducted in a controlled manner and that the quality management system is maintained during this change.

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority Roles and their interrelations, responsibilities and authorities are defined in order to facilitate effective quality management and are communicated to relevant levels of igus Inc. Organizational freedoms necessary to perform tasks that affect quality are defined.

igus Inc. reviews its quality system on a continual basis for areas where any improvements can be implemented. The GM is provided information in regards to any changes that might take place, or need his oversight on an immediate basis. Formal Management review responsibilities are ultimately up to the GM & QM. This formal review takes place annually (at a minimum), usually in the form of a report. The quality assurance (QA) manager is responsible for providing that report. Revisions to the this quality manual, quality documentation and the quality system as a whole are based on information derived from internal performance reports and reviews performed as required to guarantee the quality of the product, services and the needs of the company. At a minimum, the following information is provided & reviewed: Management objectives Market response to the quality effort Results of internal audits


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Effectiveness of corrective actions Non-conformities Assessment of the continuing suitability and effectiveness of the quality system.

Records of these reviews are maintained per Procedure 1. Procedure 1A and 1B, describe in detail, the process for reviewing the igus QMS.

igus Inc. has established a quality management system as a means of meeting its quality policy, achieving its quality objectives, and ensuring that the product and/or service conforms to customer requirements. 5.5.2 Management representative Top management of igus Inc. has appointed a member(s) of the organization’s management who, irrespective of other responsibilities, has defined authority that includes: a) Ensuring that the processes needed for the quality management system are implemented and

maintained in accordance with the requirements of the International Standard; b) Reporting to top management on the performance of quality management system, including needs for

improvement; and c) Ensuring awareness of customer requirements throughout igus Inc.

NOTE: The responsibility of management representative includes liaison with external parties in assisting dept managers on matters relating to the quality management system and the quality of our suppliers.

The general manager appoints a quality manager, who irrespective of other responsibilities has defined authority for ensuring that a quality system is established, implemented, and maintained and for reporting on the performance of the quality system to igus Inc.’s top management for review and as a basis for improvement of the quality system.

5.5.3 Internal communication igus Inc. has established and maintains processes for internal communication between the various functions regarding the quality management system and its effectiveness.

5.6 Management review

5.6.1 General igus Inc. has established a quality management system. Top management, at planned intervals (once annually), reviews the quality management system to ensure its continuing suitability, adequacy, and effectiveness. The review includes assessing opportunities for improvement and evaluates the need for changes to igus Inc.’s quality management system, including the quality policy and any company objectives.

5.6.2 Review input Management review includes review of current performance and improvement opportunities related to ( at a minimum):

a) results of audits (if required to show any critical issues that needed to be addressed); b) customer feedback (if other than general acceptance should arise); a) process performance and product conformance analyses;( if issues should arise that require attention

or corrective actions) b) status of preventative and corrective actions; (open –pending- or closed) c) follow-up actions from earlier management reviews; (if applicable) d) changing circumstances that could affect the quality management system; e) any recommendations for improvement to the QMS.


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A strategic system of planned audits (both internal and external) has been implemented to verify compliance with all aspects of the quality system and to verify whether quality activities comply with planned arrangements. A documented procedure, (Procedure 17) has been created and is maintained which outlines all audit activities and frequency.

Audits may be scheduled on the basis of the status and importance of the activity. At a minimum each quality procedure will be audited at least once every other year (1 time within a 24 month period) to ensure compliance. Unexpected circumstances or customer demands might dictate minor modifications in this schedule. Should an item not fall within the 24-month scope, it will be added to the beginning of the next cycle for completion. This will be reflected on the revised internal audit schedule and posted through out the company.

Igus internal auditors may only audit employees in their department if the audit does not pertain to their actual job related functions. Example: A Sales employee cannot audit another sales employee on sales related procedures, but could audit them on another procedure such as Corrective Action.

All audit results are recorded. The management personnel responsible for the area being audited might be recruited to assist in the addressing of discrepancies found during an audit. Audit results where negative impact or improvements are needed are submitted for management review.

Implementation and effectiveness of any corrective action taken as a result of an audit are verified by the follow-up audit or review of that audits results, the next time that procedure is audited by an internal auditor. If the applied corrective action is not affective, the issue is brought back to Quality management for review and further modifications to the process.

5.6.3 Review output The outputs from the management reviews include any decisions and actions that may be related to:

a) Improvement of the effectiveness of the quality management system and its processes; b) Improvement of product related to customer requirements; c) Process, product and/or service audits; and d) Resource needs.

The record of the management review is the action report prepared and addressed to top management. The QM retains a copy of this report via either hard or electronic copy.

6 Resource management

6.1 Provision of resources igus Inc. determines and provides all necessary resources needed to implement and maintain continual improvement of the quality management system. These resources are to be used to enhance customer satisfaction by meeting their requirements. These resources are defined below.

6.2 Human Resources

6.2.1 General igus Inc. assigns personnel to ensure that those who have responsibilities defined in the quality management system are competent on the basis of applicable education, training, skills, and experience.

NOTE: Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system.


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6.2.2 Competence, training and awareness igus Inc. has established and maintains a system level procedure (Procedure18) to:

a) Determine the necessary competence for personnel performing work affecting conformity to product requirements;

b) Where applicable, provide training or take other actions to achieve the necessary competence; c) Evaluate the effectiveness of training or actions at defined intervals; d) Make its employees at each relevant function and level aware of:

1. The importance of conformance with the quality policy, and with the requirements of the quality management system;

2. The significant impact of their work activities on quality, actual or potential; 3. The benefits of improved personal performance;

4. Their roles and responsibilities in achieving conformance with the quality policy and quality objectives and procedures and with the requirements of the quality management system;

5. The potential consequences of departure from specified procedures; 6. Maintain appropriate records of education, training, skills, and experience; and

e) Maintain training records.

Verification of Resources and Personnel: All new personnel are required to become familiar with the quality manual, policies, procedures, and work instructions relating to their job function. This is documented per Procedure 18:

(a) All personnel are required to complete training per procedure 18 for assistance in performing quality related job duties;

(b) Training descriptions and requirements are documented and maintained per Procedure 18; (c) Personnel training records are maintained per procedure 18; and (d) Personnel performing work affecting product quality are selected based on their appropriate

education, training (internal or external) and/or experience.

6.3 Infrastructure igus Inc. determines, provides, and maintains the infrastructure needed to achieve the conformity of product and/or services. This is done by the Facilities Manager in conjunction with various managers, including top management, and steering committee of the 5s program.

This includes (but is not limited too):

a) buildings, workspace and associated utilities b) process equipment, hardware and software, assembly tools c) suitable maintenance d) supporting technical services, such as our internal internet (igusnet) with product and application data e) improvements to any existing program.

6.4 Work environment igus Inc. determines and manages those human and physical factors of the work environment needed to achieve conformity of product and/or service.

This includes:

a) health and safety conditions b) work methods c) work ethics d) ambient working conditions (including noise, temperature, humidity, lighting or weather)


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7 Product Realization

7.1 Planning of product realization Processes that are necessary to realize the required product and their sequence and interaction have been determined planned and implemented. In determining such processes, igus Inc. considers the outputs from quality planning.

igus Inc. has planned and developed the processes needed for product realization. Planning for product realization are consistent with the requirements of the other processes of the quality management system.

In planning product realization, igus Inc. has determined the following as appropriate:

a) Quality objectives and requirements for the product; b) The need to establish processes and documents, and to provide resources specific to the product; c) Required verification, validation, monitoring, measurement, inspection and test activities specific to

the product and the criteria for product acceptance; and d) Records needed to provide evidence that the realization processes and resulting product meet

requirements.

igus Inc. ensures these processes are carried out under controlled conditions and produce outputs that meet customer requirements. igus Inc. determines how each process affects the ability to meet product and/or service requirements and has:

a) Established methods and practices relevant to these processes, and to the extent necessary, to achieve consistent operation;

b) Determined and implemented the criteria and methods to control processes, to the extent necessary, to achieve product and/or service conformity with the customer requirements;

c) Verified that processes can be operated to achieve product and/or service conformity with customer requirements; and

d) Determined and implemented arrangements for measurement, monitoring and follow-up actions, to ensure processes continue to operate to achieve planned results and outputs:

A documented procedure (Procedure12 ) has been established and maintained for inspection activities in order to verify that the specified requirements for the product are met. Release of product or material to the next production area does not occur until all inspections are completed. No final product is released until all inspection activities are complete. Records of inspections are established and maintained as evidence that materials, components, and all inspections have been completed and comply with specified requirements;

e) Ensure the availability of the information and data necessary to support the effective operation and monitoring of the processes;

f) Maintain as quality records the results of the process control measures, to provide evidence of effective operation and monitoring of the processes.

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product igus Inc. has established a process (Procedure 3 – Contract Review) for identifying customer requirements.

igus Inc. determines: a) Requirements specified by the customer, including their requirements for delivery and post-delivery

activities; b) Requirements not stated by the customer but necessary for specified or intended use, where known; c) Statutory and regulatory requirements applicable to the product; d) Completeness of the customer’s product and/or service requirements; e) Requirements not specified by the customer but necessary for fitness or purpose; and f) Any additional requirements considered necessary by the organization.


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NOTE: Post delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

7.2.2 Review of requirements related to the product The customer requirements, including any requested changes, are reviewed before a commitment to supply a product and/or service is provided to the customer (e.g. submission of a proposal, acceptance of a contract or order) to ensure that:

a) Customer requirements are clearly defined for product and/or service; b) Where the customer provides no written statement of requirement, the customer requirements are

confirmed before acceptance; c) Contract or order requirements differing from those previously expressed, e.g. in a proposal or

quotation, are resolved; and d) igus Inc. has the ability to meet the customer requirements for the product and/or service.

Responsibility The Customer Service / Sales departments are responsible for receiving and processing all customer orders. Orders for products are reviewed and further processed by the sales representative. Production and quality personnel may be called to assist with the review of orders for custom products.

Contract Review (Procedure3) cont. The order (contract) review comprises verification that the customer's requirements are adequately defined, documented, and have been well understood; and that the company has the capability to meet the contracts requirements. When no written statement or requirement is available for an order received by verbal means, igus Inc. ensures that the order requirements are agreed to before their acceptance. Any differences between the accepted order and the customers’ request are resolved before acceptance of the order.

Amendment to Contract Change orders are received and reviewed by the same function that is responsible for the review of initial orders. Change orders are communicated to all functions within the organization that may be affected by the change of customer requirements.

Record Order reviews are recorded and maintained. Once the order is accepted in On-Line Order, by choosing “Y”, the record is maintained electronically in the database program, On-Line Order. The results of the review and subsequent follow-up actions are recorded.

7.2.3 Customer communication igus Inc. determines and implements effective arrangements for communication with customers, to strengthen the bond between, and ensure the meeting of that customer’s requirements.

igus Inc. has defined communication requirements relating to:

a) product b) enquiry and order handling, including amendments c) customer feedback including customer complaints and actions relating to nonconforming product

and/or service d) customer responses relating to performance of product


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7.3 Design and development N/A (see reduction of scope, section 1.2 for description)

7.4 Purchasing

7.4.1 Purchasing process (Procedure 6) igus Inc. controls its purchasing processes to ensure purchased product and/or service conforms to specified purchase requirement guidelines. The type and extent of control applied to the supplier and the purchased product is dependent on the effect of the purchased product, on subsequent product realization, and on the final product.

Igus Inc. does evaluate and select suppliers based on their ability to supply product and/or services in accordance with igus Inc.’s requirements. An evaluation, re-evaluation, and selection criteria for suppliers has been established. The results of evaluations and subsequent follow-up actions are recorded and maintained in the qualified suppliers list (QSL).

Assessment of suppliers a. Suppliers are assessed by the quality manager, in conjunction with any department

heads and purchasing representative requesting the approval of a new vendor/supplier. Assessment and selection of suppliers is based partially on their ability to meet contractual requirements including the quality system and any specific quality assurance requirements. Assessment may include evaluation of one or more of the following: audits, performance history, and product appraisal. Quality system records of the assessment are maintained by domestic purchasing agent.

b. Supplier conformance to igus requirements is monitored. Methods of monitoring may include, but are not limited to, receiving inspection, testing, product appraisal, and audits.

c. Suppliers that meet requirements are placed on the qualified supplier list. Purchasing and quality will maintain this list.

7.4.2 Purchasing information Purchasing documents do contain information clearly describing the product and/or service ordered, including where appropriate: a) Requirements for approval or qualification of product and/or service, procedures, processes,

equipment and personnel; and b) Any quality management system requirements.

igus Inc. ensures the adequacy of specified purchasing requirements prior to communication with the supplier.

7.4.3 Verification of purchased product and/or services Igus Inc. establishes and implements the arrangements necessary for verification to ensure purchased products and/or services meet specified purchase requirements.

Igus or igus’ customer, when specified in the purchasing documents and or the contract may perform verification of purchased product at the suppliers’ premises. The supplier does not use such verification as evidence of effective quality control, nor does it release the vendor/supplier from the responsibility of providing quality products or from subsequent rejection.

Where igus Inc. or its customer proposes to perform verification activities at the supplier’s premises, igus Inc. specifies the required verification arrangements and method of product and/or service release in the purchasing documents.

7.5 Production and service provision (Reduction in Scope) Production and service provision is taken as a reduction in scope by igus Inc. Primary role of igus, Inc is a distribution center for our parent company, igus, GmbH. They perform all aspects of our production, and any servicing performed by igus, Inc is strictly a value-added benefit to the customer.


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7.5.1 Process Control (Procedure 9) igus Inc. plans and carries out process operations under controlled conditions, including those undertaken after initial delivery, through: a) The availability of specifications that define the characteristics of the products and/or services that are

to be achieved; b) The availability of clearly understandable work instructions for those activities where they are

necessary for the achievement of conformity of products and/or services; c) The use and maintenance of suitable production, installation, and equipment; d) The provision of suitable working environments; e) The availability and use of suitable measuring and monitoring equipment; f) The implementation of suitable monitoring and measuring activities; and g) Suitable methods for release, delivery, and/or post delivery of product and/or service.

7.5.2 Validation of processes igus Inc. validates any process where the resulting output cannot be readily or economically verified by subsequent monitoring, inspection and/or testing; and, as a consequence, deficiencies may become apparent only after the product is in use or has been delivered.

These processes are validated to demonstrate the ability of these processes to achieve planned results.

igus Inc. has established arrangements for these processes including, as applicable: a) defined criteria for review and approval of the processes b) approval of equipment and qualification of personnel c) use of specific methods and procedures d) requirements for records e) revalidation

Evidence of validated processes, qualified equipment, and/or personnel are recorded and maintained.

7.5.3 Identification and traceability Product Identification and traceability Procedure 8 A documented procedure (Procedure 8) has been established and is maintained for the identification of all products from receipt through delivery. Product identification numbers molded onto the part or stock locations controls all material that is processed into a finished assembly, from receipt through delivery. When traceability is required, this system will provide for unique identification and recording of individual products.

The company maintains a documented procedure (Procedure10) for identifying the inspection status of products. Parts are to be identified by a part number that is traceable to the packing list.

Where traceability is a requirement, igus Inc. controls and records the unique identification of product.

igus Inc. has made provision for identifying status of product with respect to required measurement and verification activities and, where applicable, identifies the product by suitable means throughout all processes. This applies to the component parts of the product where their interaction affects conformity with requirements

Inspection and test status Identification of inspection and test status is reviewed according to a documented procedure (Procedure12). The inspection statuses of all products are positively identified. The methods used to positively identify product has been defined. Only those products that have passed all required inspections are used in production or shipped to customers.

All products that have passed receiving inspection are identified and released to active inventory.

Individual products are identified and traceable during the assembly process. The inspector signing or stamping the packing list makes record of satisfactory inspection, during in-process inspection.


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Personnel performing final inspection by stamping the packing list, positively identify products that meet specifications and have passed all required inspections. Products failing inspection are positively identified and segregated where practical. 7.5.4 Customer property (Procedures 15 Handling, Storage, Packaging, Preservation, and Delivery &

Procedure 7 Control of Customer Supplied Product ) Documented procedures have been established and maintained for the control of identification, verification, protection, storage, and maintenance of customer supplied product. Material supplied by the customer is handled in the same manner as other products purchased for incorporation into the final product. When specified, special handling instructions will take precedence over igus procedures. Any lost, damaged, or defective customer supplied material is recorded and the customer notified with the proper records maintained. Verification by the company does not release the customer from its responsibility to provide acceptable product.

igus Inc. exercises care with customer property while it is under igus Inc.’s supervision or being used by igus Inc. igus Inc. ensures identification, verification, storage and maintenance of customer property provided for use or in igus Inc.

Any customer property that is lost, damaged, or otherwise found to be unsuitable for use is recorded and reported to the customer.

NOTE: Customer property may include intellectual property e.g. information provided in confidence.

7.5.5 Preservation of product igus Inc. ensures that during internal processing and final delivery of product to the indented destination that the identification, packaging, storage, protection, and handling do not affect conformity with product requirements. Preservation also applies to parts or components of a product.

Product release does not proceed until all the specified activities have been satisfactorily completed and the related documentation is available and authorized.

A documented procedure (Procedure 15 ) has been established and is maintained for the handling of materials and products from receiving through shipment to ensure that materials and products are protected from damage contamination, and deterioration.

Handling Methods have been established to prevent damage or deterioration to product.

Storage Materials are not released into storage areas until they have passed all required inspections. Warehouse personnel are responsible for ensuring that materials and products are stored in a manner that prevents damage, contamination, and deterioration. Authorized personnel release material for use in production only. Product in storage is periodically assessed for conformance to product technical specifications.

Packaging Packaging is done in a manner that conforms to established guidelines and standards, and will protect the product during storage and shipment to its final destination.

Preservation All products are identified and packaged to the extent necessary to ensure conformance to product technical specifications from receipt through final inspection.

Delivery Measures have been defined in procedure 15, that depict how the product will be packaged to ensure protection after final inspection, prior to shipping. When the customer specifies special requirements, products will be specially packaged and protected from damage during delivery to final destination.


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7.6 Control of measuring and monitoring equipment A documented procedure (Procedure 11) has been established and is maintained that defines the process used for calibration, inspection, and maintenance of all measuring equipment. Measuring equipment is used in a manner, which ensures that the measurement uncertainty is known and consistent with the required measurement capability. Per P11F1, all equipment used for inspection and measuring is checked for accuracy on a predetermined schedule. All equipment is identified with a serial number that is traceable to its calibration history. All calibration and certification records are maintained and controlled. Where the availability of technical data pertaining to the measurement equipment is a specified requirement, such data is made available when required by the customer for verification that the measuring equipment is functionally adequate.

igus Inc. controls, calibrates and maintains those measuring and monitoring devices used to demonstrate conformance of product to specified requirements.

Controls a. All inspection and measuring equipment is capable of the accuracy and precision required to

discern conforming from non-conforming product. b. All inspection and measuring equipment is identified with a serial number. All equipment is

calibrated prior to issue and at prescribed intervals. Equipment is calibrated against certified equipment having a known valid relationship to nationally recognized standards.

c. Calibration is maintained in accordance with a documented procedure (Procedure11) that defines the methods used for calibration of inspection and measuring equipment. When inspection and measuring equipment is found to be out of calibration, management will assess and document the validity of previous inspection results. Based on this assessment, management may issue a product recall and/or adjust calibration intervals.

d. The inspection status of all inspection and measuring equipment is indicated or noted. e. Calibration records are maintained for all inspection and measuring equipment. These

records include, but are not limited to equipment type, identification number, issue location, calibration status, calibration interval and acceptance criteria.

f. The environment where inspection, measuring, and test equipment are to be calibrated will be controlled to the extent necessary to assure required accuracy.

g. Inspection and measuring equipment is stored in areas where the environmental conditions cause no damage and the accuracy and fitness for use are maintained.

h. To safeguard inspection and measuring equipment from adjustments that would invalidate the calibration setting, only qualified personnel are authorized to make adjustments to inspection and measuring equipment.

igus Inc. provides methods of handling, preservation, and storage that protect measuring devices from damage and deterioration.

Measuring and monitoring devices are used in a manner that ensures that measurement uncertainty including accuracy and precision is known and is consistent with the required measurement capability.

To ensure valid results from measuring equipment, igus Inc.: a) Calibrates and adjust measuring and monitoring devices at specified intervals P11F1 or prior to use,

against measuring standards traceable to international or national standards. Where no such standards exist, the basis used for calibration is recorded;

b) Identifies measuring and monitoring devices with a suitable indicator or approved identification record to show calibration status;

c) Determines the method for calibration of measuring and monitoring devices; d) Records and maintains the results of calibration; e) Ensures environmental conditions are suitable for calibrations, measurements, inspections and tests; f) Safeguards measuring and monitoring devices from adjustments that would invalidate the calibration; g) Assesses the validity of previous inspection and test results when a device is found to be out of

calibration and take appropriate actions on the equipment and any product affected; and h) Be protected from damage and deterioration during handling, maintenance and storage.

NOTE: Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.


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8. Measurement, analysis and improvement

8.1 General Documented procedures (Procedures 9 &15) have been established and are maintained to ensure that processes that directly affect quality are carried out under controlled conditions. The warehouse assures that basic and special production operations of any type are accomplished under controlled conditions to produce a quality product. These operations will include documented procedures, adequate production equipment, and suitable and special working environments.

igus Inc. has defined, planed, and implemented measurement, monitoring, analysis, and improvement processes to ensure that the quality management system, processes and products conform to the product requirements, and to continually improve the effectiveness of the quality management system.

Controlled conditions (Procedure; all) a. Documented procedures that define the manner of production have been established and

maintained where the absence of such procedures could adversely affect product quality. b. Suitable production, servicing equipment and a suitable working environment is provided. c. Compliance with reference standards/codes, quality plans, and/or documented procedures is

controlled. d. Process parameters and product characteristics are monitored and controlled. e. As appropriate, processes and equipment are approved. Records are maintained of qualified

processes, equipment, and personnel as appropriate. f. Criteria for workmanship are stipulated in the clearest practical manner. g. Ensure continuing process capability, suitable maintenance of equipment is performed.

The type, location, timing and frequency of measurements and the requirements for records are defined (Procedure 11).

The effectiveness of measures implemented are periodically evaluated at QT meeting as well as management reviews.

The quality manager per (Procedure 20), compiles and breaks down information to create bar charts depicting customer complaint/compliments, corrective/preventive action, and non-conforming products. These visuals are presented at a QT Meeting and the ISO management review meeting to detect and analyze trends.

The results of data analysis and improvement activities are an input to the management review process.

8.2 Monitoring and measurement

8.2.1 Customer satisfaction igus Inc. uses many forms of information to monitor customer perception as to how well igus is meeting its customer’s requirements. The methods of obtaining, measurement and utilization of such information are as follows:

Quality Surveys: Included with each order, allow the customer the option to provide feedback on many different levels of the operation, from packaging to delivery to Customer Service knowledge.

Follow up to samples: Often Sales will perform “follow up” calls with recent customers on orders or samples to evaluate perception feedback on the product or service.

Outside Sales: Continuously receives feedback or Customer Perception, performing duel functions - Positive feedback is shared with inside sales as to where negative feedback often turns into a customer complaint or e-mail to quality


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8.2.2 Internal audit (Procedure17) igus Inc. carries out objective audits in order to determine if the quality management system has been effectively implemented and maintained and conforms to this International Standard. In addition, igus Inc. may carry out audits to identify potential opportunities for improvement.

The audit process, including the schedule, (P17F3 Internal Audit Schedule) is based on the status and importance of the activities and/or areas to be audited and the results of previous audits. The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process.

The system level procedure (Procedure17) for internal audit covers the audit scope, frequency and methodologies, as well as the responsibilities, requirements for conducting audits, recording, and reporting results to management. See forms P17F1, and P17F3 for further information.

Personnel other than those who performed the work being audited will perform those audits.

The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate nonconformities and their causes.

NOTE: See ISO 19011 for guidance.

8.2.3 Monitoring and measurement of processes (Procedure 9) Measurement results are used to maintain and/or improve those processes and planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate.

NOTE: When determining suitable methods, it is advisable that the organization considers the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality system.

8.2.4 Monitoring and measurement of product and/or service igus, Gmbh & igus, Inc. applies suitable methods for measurement and monitoring of the characteristics of the product to verify that requirements for the product are met. This will be carried out at appropriate stages of the manufacturing and product realization process in accordance with the planned arrangements.

Evidence of implementation of required measurement and monitoring conformance with the acceptance criteria used is recorded and maintained. Records indicate the authority responsible for release of product for delivery to the customer.

The release of product and delivery of service to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority, or igus Inc and where applicable, by the customer.

8.3 Control of non-conforming product (Procedure 13) A documented procedure (Procedure13) has been established and is maintained to ensure non-conforming product is not inadvertently used or installed. This control is to provide for identification, documentation, evaluation, segregation, disposition of non-conforming product, and for notification to the functions concerned. The customer or the customer's representative is notified when specified in the contract.

igus Inc. ensures that product that does not conform to requirements is identified and controlled to prevent unintended use or delivery.

igus Inc. provides for identifying, recording, and reviewing the nature and extent of any non-conformities encountered.

Arrangements for ensuring that non-conforming product is controlled are defined in a system level procedure (Procedure 13).


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Re-inspection of reworked product is done in accordance with criteria established in the QMS. When specified by the contract, concessions from the customer/purchaser are documented. Description of the non-conformity to be accepted and repaired nonconforming product is recorded and reported. All products repaired or reworked are re-inspected in accordance with documented procedures (Procedure 13).

igus Inc. reviews nonconformities and determines the action to be taken.

These nonconformities are: a) Corrected or adjusted to conform to requirements b) Accepted under concession, with or without correction or adjustment c) Reassigned for alternative valid application d) Rejected as unsuitable e) Returned to Vendor for rework

The QM is responsible for the review and resolving of such non-conformities.

When required by the contract, the proposed use or repair of non-conforming product is reported for concession to the customer. The description of any such correction or adjustment, accepted non-conformity, product repair or service modification is recorded.

Where it is necessary to repair or rework product, re-verification of requirements are determined and implemented.

When non-conforming product is detected after delivery or use has started, igus Inc. will take action appropriate to the effects, or any potential effects, of the non-conformity.

8.4 Analysis of data (Procedure 20) A system level procedure (Procedure 20) for the analysis of applicable data has been established to determine the suitability and effectiveness of the quality management system and for identifying where continual improvements of the effectiveness of the quality management system can be made. Igus Inc. collects data generated by measuring and monitoring activities and any other relevant sources.

igus Inc. analyzes applicable data to provide information on: a) The suitability, effectiveness and adequacy of the quality management system; b) Process operation trends; c) Customer satisfaction and/or dissatisfaction; d) Conformance to customer requirements; and e) Characteristics of processes, and products and/or services, including opportunities for preventive

action.

8.5 Improvement

8.5.1 Continual improvement igus Inc. continually improves the effectiveness of the quality management system. igus Inc. has established a system level procedure (Procedure20) that describes the use of quality policy, quality objectives, internal audit results, analysis of data, corrective and preventive action, and management review to facilitate continual improvement.

8.5.2 Corrective action (Procedure 14a) igus Inc. has established a process for reducing and eliminating the causes of non-conformity in order to prevent recurrence.

The system level procedure (Procedure 14a) for the corrective action process defines the requirements for: a) Identification and reviewing non-conformities (including customer complaints); b) Determination of causes of non-conformities; c) Evaluation of the need for actions to ensure that non-conformities do not recur; d) Implementation of any actions determined necessary to ensure that non-conformities do not recur; e) Recording the results of actions taken; and f) Reviewing that corrective action taken is effective and recorded.


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8.5.3 Preventive action (Procedure 14b) igus Inc. has established a process for reducing and eliminating the causes of potential nonconformities to prevent their occurrence. Quality management system records and results from the analysis of data are used as inputs for preventive action, as applicable.

The system level procedure (Procedure14b) for the preventive action process addresses: a) Identification of potential non-conformities; b) Determination of the causes of the identified potential non-conformities and recording the results; c) Determination of preventive action needed to prevent occurrence and to eliminate causes of potential

nonconformities; d) Implementation of preventive action; and e) Reviewing that preventive action taken is effective and recorded.


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Annex

Igus Procedures in relation to sections of the ISO standard

Procedure 1.0 Scope 1.1 General 1.2 Reduction in scope 2.0 Normative reference 3.0 Terms and definitions 4.0 Quality management system requirements 4.1 General requirements P1 4.2 Documentation requirements P2, 5, 16 5.0 Management responsibility 5.1 General requirements P1 5.2 Customer focus P1 5.3 Policy P1 5.4 Planning P1 5.5 Responsibility, authority and communication P1 5.6 Management review P1 6.0 Resource management P18 6.1 Provision of resources P1 6.2 Human resources P1 6.3 Infrastructure P1 6.4 Work environment P9 7.0 Product realization 7.1 Planning of product realization P2 7.2 Customer-related processes P3 7.3 Design and development N/A ALL 7.4 Purchasing P6 7.5 Production and Service N/A Service portion P7, 8, 9, 15 7.6 Control of monitoring and measuring devices P11 8.0 Measurement, analysis and improvement P12 8.1 General P10 8.2 Monitoring and measurement P10, 17, 20 8.3 Control of nonconforming product P13 8.4 Analysis of data P20

8.5 Improvement P14a, 14b, 21 Definitions of terms and abbreviations GM= General Manager iCAR= igus Corrective Action Report Igus GmbH = Manufacturing Koln, Germany Igus Solar System = Organizational Chart

QAM = Quality Assurance Manager (one and the same) QM = Quality Manager QMS = Quality Management System QSL = Qualified Suppliers List

SCAR = Supplier Corrective Action Report

Top Management = Vice President and Or General Manager

VP= Vice President