Section 1: Scope

1.1 General

The quality manual outlines the policies, procedures and requirements of the Quality Management System. The Quality Management system is designed to achieve Nanmac’s quality Visions and Goals with regards to production at Nanmac HQ, situated within Pope industrial park, 1657 Washington Street, Bldg # 3, Holliston, MA. The system is structured to comply with the conditions set forth in the International Standard ISO 9001:2008.

1.2 Application

Nanmac Corp. has determined that the following requirements are not applicable to the operations at this site and are documented as exclusions:

• A portion of 7.3 Design procedure P-730 Product Customization does not apply, no new product design occurs. Nanmac only customizes current products to accommodate unique customer requirements.

Section 2: Normative Reference

2.1 Quality Management System References

The following documents were used as reference during the preparation of the Quality Management System:

• ISO 9000-2005, Quality Management Systems - Vocabulary
• ISO 9001-2008, Quality Management Systems – Requirements
• ISO 9004-2009, Quality Management Systems – Guidelines for Performance Improvements

Section 3: Definitions

3.1 Quality Management System Definitions

Nanmac uses standard industry and quality management terminology. See Nanmac representative for any unique terminology communicated.

Section 4: General Requirements

4.1 General Requirements

Nanmac Corp. has established, documented and implemented a Quality Management System (QMS) in accordance with the requirements of ISO 9001:2008. The system is maintained and continually improved through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive action and management review. To design and implement the QMS Nanmac Corp. has:

• Identified the processes needed for the QMS and their application throughout the organization.
• Determined the sequence and interaction of these processes, and illustrated them on the Process Flow Diagram
• Determined criteria and methods needed to ensure that the operation and control of the processes are effective, and documented them in quality plans, work instructions and the Measuring, Monitoring and Analysis Table.
• Ensured the continuing availability of resources and information necessary to achieve planned results and continual improvement of these processes
• Established systems to monitor, measure, and analyze these processes.
• Established processes to identify and implement actions necessary to achieve planned results and continual improvement of these processes
• Nanmac Corp. manages these processed in accordance with the requirements of ISO 9001:2008.
• Where Nanmac Corp. chooses to outsource any process that affects product conformity, Nanmac Corp. ensures conformity to product specifications by implementing, where possible, the requirements of our QMS.

4.2 Documentation Requirements

The QMS documentation includes Nanmac’s:

• Documented Quality Policy and Quality Objectives
• Quality Manual
• Documented Procedures
• Documents identified as needed for the effective planning, operation and control of our processes, and
• Quality Records

This Quality Manual has been prepared to describe Nanmac Corp.’s QMS. The scope and permissible exclusions of the QMS are described in Section One of this manual. Each section of the manual references documented QMS Procedures relating to the requirements outlined in that section. The Process Flow Diagram at the end of section 4 provides a description of the interaction between the processes of the QMS system. 4.2.3 Control of Documents

All of the QMS documents are controlled according to the Document Control Procedure (P-423). This procedure defines the process for:

• Approving documents for adequacy prior to issue
• Reviewing and updating as necessary and re-approving documents
• Ensuring that changes and current revision status of documents are properly revised and updated
• Ensuring that relevant versions of applicable documents are available at points of use and that older, no longer to be used documents are recalled/replaced
• Ensuring that documents remain legible and readily identifiable
• Ensuring that documents of external origin are identified and their distribution controlled, and
• Preventing the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose

Quality records are maintained to provide evidence of conformity to requirements and of the effective operation of the QMS. The records are maintained according to the Control of Quality Records Procedure (P-424). This procedure requires that quality records remain legible, readily identifiable and retrievable. The procedure defines the controls needed for identification, storage, protection, retrieval, retention time and disposition of quality records

Section 5: Management Responsibility

5.1 Management Commitment

The Management Council has been actively involved in implementing the quality management system (QMS). It has provided the vision and strategic direction for the growth of the QMS, and established quality objectives and the quality policy.

To continue to provide leadership and show commitment to the improvement of the QMS, management will do the following.

• Communicate the importance of meeting customer, statutory, and regulatory requirements.
• Establish quality objectives
• Establish the quality policy.
• Conduct monthly management reviews
• Ensure the availability of resources.

5.2 Customer Focus

Our company strives to identify current and future customer needs, to meet customer requirements and exceed customer expectations.

The Management Council ensures that customer requirements are understood and met, by requiring compliance with documented customer communication procedures. Customer requirements are determined, converted into internal requirements, and communicated to the appropriate people in our organization (P-720-2).

5.3 Quality Policy

The management council ensures that the quality policy is communicated to all employees. It is included in new employee training and training on the QMS. It is posted in prominent places throughout the facility to maintain high standards within our organization.

Management reviews the quality policy at each management review meeting to determine the policy’s continuing suitability for our organization. The Quality Policy is documented on A-500-001, Quality Policy.

5.4 Planning

Quality objectives are established to support our organization’s efforts in achieving our quality policy and reviewed annually for suitability. Measurable objectives have been established for the following:

• Shipments – 100% on time
• Quality in production – Final Inspection > 90% acceptance
• Continuous effort to increase quality and consistency of product.
• Sourcing of suppliers for quality, cost & delivery that allows us to meet our customers’ requirements

Quality objectives are measurable, and reviewed against performance goals at management review meetings. (These are also listed in the Quality Policy document A-500-001)

The quality system has been planned and implemented to meet our quality objectives and the requirements of 4.1 of the ISO 9001 standard. Quality planning takes place as changes that affect the quality system are planned and implemented.

5.5 Responsibility, Authority and Communication

An organizational chart has been established to show the interrelation of personnel in the organization. Job descriptions define the responsibilities and authorities of each of the positions on the organizational chart. Job descriptions and the organizational chart are reviewed and approved by top management for adequacy. These documents are available throughout the organization to help employees understand responsibilities and authorities. An organizational chart, attachment A550-001 is located on page 6 of this manual.

The Document Control Manager has been appointed by the Management Council as Management Representative. As Management Representative, he has the following responsibility and authority:

• Ensure that processes needed for the quality management system are established and implemented.
• Report to top management on the performance of the quality management system, and note needed improvements.
• Promote awareness of customer requirements throughout the organization.
• Act as a liaison with external parties such as customers or auditors on matters relating to the QMS.

Processes are established for communication within the organization. Methods of communicating the effectiveness of the QMS include management meetings, management reviews, posted materials, Internal Audit Closing meetings, and other routine business communication.

5.6 Management Review

Senior Management l reviews the QMS monthly at management review meetings. This review assesses the continuing QMS suitability, adequacy and effectiveness, identifying opportunities for improvement and needed changes. Records are maintained for each management review meeting.

Assessment of the QMS is based on a review of information inputs to management review. These inputs are identified on the Management Review Meeting Minutes Form (F560-004).

During these review meetings, management will identify appropriate actions to be taken regarding the following issues:

• Improvement of the effectiveness of the quality management system and its processes
• Improvement of product related to customer requirements
• Resource needs

Responsibilities for required actions are assigned to members of the Management Council. Any decisions made during the meeting, assigned actions, and their due dates are recorded in the minutes of management review.

Section 6: Resource Management

Nanmac Corp. has implemented a Quality Management System that complies with the ISO 9000:2008 standard. This implementation was achieved with management commitment and with sufficient resources for the implementation. To effectively maintain and continually improve the system, management determines and provides necessary resources.

6.2 Human Resources

To ensure competence of our personnel, job descriptions have been prepared identifying the qualifications required for each position that affects product quality. Qualifications include requirements for education, skills and experience. Appropriate qualifications, along with required training, provide the competence required for each position.

Qualifications are reviewed upon hire, when an employee changes positions or the requirements for a position change. Human Resources maintain records of employee qualifications. If any differences between the employee’s qualifications and the requirements for the job are found, training or other action is taken to provide the employee with the necessary competence for the job. The results are then evaluated to determine if they were effective. Training and evaluation are conducted according to the Training procedure. (P-622)

All employees are trained on the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.

6.3 Infrastructure

To meet quality objectives and product requirements Nanmac Corp. has determined the infrastructure needed (P-630). The infrastructure has been provided, and includes buildings, workspace, utilities, equipment, and supporting services. As new infrastructure requirements arise, they will be documented in quality plans. Existing infrastructure is maintained to ensure product conformity. Maintenance requirements are documented.

6.4 Work Environment

A work environment suitable for achieving product conformance is maintained. Requirements are determined during quality planning. The work environment is managed for continuing suitability. Data from the quality system is evaluated to determine if the work environment is sufficient for achieving product conformance, or if preventive or corrective action related to the work environment is required.

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Section 7: Product Realization

7.1 Planning of Product Realization

Quality planning is required before new products or processes are implemented. The quality planning may take place as a customization project, or according to the Planning of Product Realization procedure (P-710). During this planning, management or assigned personnel identify:

• The quality objectives and requirements for the product,
• Processes, documentation and resources required
• Verification, validation, monitoring, inspection and test requirements,
• Criteria for product acceptance and performance

The output of quality planning includes documented quality plans, processes, procedures and design outputs.

7.2 Customer Related Processes

Nanmac Corp. determines customer requirements before acceptance of an order. Customer requirements include those:

• Requested by the customer
• Required for delivery and post-delivery activities
• Not stated by the customer but necessary for specified use or known and intended use
• Statutory and regulatory requirements applicable to the product

Customer requirements are determined according to the Customer Related Processes Procedure. (P-720-1 , P720-2).

Nanmac Corp. has a process in place for the review of requirements related to the product (P-720-1, P720-2). The review is conducted before the order is accepted. The process ensures that:

• Product requirements are defined.
• Order requirements differing from those previously expressed in a quotation are resolved.
• Nanmac Corp. has the ability to meet the defined requirements.
• Records are maintained showing the results of the review and any actions arising from the review.
• Where a customer does not provide a documented statement of requirement, the customer requirements are confirmed before acceptance.
• When product requirements are changed, Nanmac Corp. communicates changes to relevant personnel and amends relevant documents.

Nanmac Corp. has implemented effective procedures (P-720-1, P720-2,P720-3,P720-4,P-821)) for communicating with customers in relation to:

• Product Information
• Enquiries, purchase orders and order handling, including amendments
• Customer Feedback, including customer complaints

7.3 Design

The Product Customization procedure (P-730) outlines the process for controlling the product customization process. Engineering plans customization according to this procedure. NOTE: Nanmac only tailors previously existing designs and does not develop new products outside those previously delivered. The customization plan includes:

• Required customization reviews
• Verification and validation methods appropriate to each customization
• Responsibilities and authorities for the customization
• Identification of the technical interfaces required for the project
• Updating of the customization documentation as the project progresses

Inputs relating to product requirements are determined and documented according to the Product Customization Procedure (P-730). All inputs are reviewed for adequacy and completeness, and to resolve any ambiguous inputs. Inputs include:

• Functional and performance requirements
• Applicable statutory and regulatory requirements
• Where applicable, information derived from previous similar designs
• Other requirements essential for customization

Outputs of product customizations are documented according to the Product Customization Procedure (P-730). They are documented in a format that enables verification against the inputs, and are approved prior to release. Outputs:

• Meet the input requirements
• Provide appropriate information for purchasing, production and for service provision
• Contain or reference product acceptance criteria
• Identify the characteristics of the product for its safe and proper use.

Product Customization takes place in accordance with the Product Customization Procedure (P-730). The Resulting Sign off of the MOP documents, by both Sales & Applications Engineering Manager and Manufacturing serves as customized product verification

Note: Due to product’s variety in applications, and inability to replicate many different environments, Nanmac would have a difficult time developing validation procedures for each individual application.

Product Customization validation is performed according to the customization plan to ensure that the resulting product is capable of fulfilling the requirements for the specified or known intended use or application. Validation includes prescribed Calibration lab testing and Final QC activities. Validation is completed prior to delivery whenever practicable. Records of the validation activities are maintained according to the customization procedure.

The Product Customization procedure defines a process for identifying, recording, verifying, validating and approving customization changes.

7.4 Purchasing

A documented procedure (P-740) is followed to ensure that purchased product conforms to the specified purchase requirements. The procedure outlines the extent of control required for suppliers. Suppliers are evaluated and selected based on their ability to supply product in accordance with requirements as outlined in the procedure. Criteria for selection, evaluation and re-evaluation are documented in the procedure. Records of the evaluation and any necessary actions are maintained as quality records.

Purchasing information describes the product to be purchased, including where appropriate:

• Requirements for approval of product, processes and equipment
• Quality management system requirements
• Any certifications (CofC, CofA)
• Drawings and specifications

The purchasing documents are reviewed to ensure the adequacy of requirements before orders are placed with the supplier.

The Purchasing procedure (P-740) describes the process used to verify that purchased product meets specified purchase requirements. If Nanmac Corp. or the customer will perform verification at the supplier’s premises, the verification arrangements and method of product release are documented in the purchasing information.

7.5 Production and Service Provision

controlled conditions according to documented procedure (P-750). Controlled conditions include, as applicable:

• The availability of information that describes the characteristics of the product
• The availability of work instructions
• The use of suitable equipment
• The availability and use of monitoring and measuring devices
• The implementation of release, production and delivery activities
• Environment

Nanmac Corp. validates processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation demonstrates the ability of these processes to achieve planned results.
Nanmac Corp. documents the process for validation including as applicable:

• Defined criteria for review and approval of the processes
• Approval of equipment and qualification of personnel
• Use of specific methods and procedures
• Requirements for records
• Revalidation
• Similarity to other products already shipped & in use 1 year or more

Nanmac Corp. identifies the product throughout product realization according to the Identification and Traceability procedure (P-753). Product is identified with respect to monitoring and measurement requirements. Nanmac Corp. controls and records the unique identification of the product where ever traceability is a specified requirement.

Nanmac Corp. exercises care with customer property while it is under the organization's control or being used. A procedure (P-754) outlines the Identification, verification, protection and safeguarding of customer property provided for use. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this is reported to the customer and records maintained.

7.6 Control of Monitoring and Measuring Equipment

Nanmac Corp. has determined the monitoring and measurement to be undertaken and identified the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements. A documented procedure (P760) outlines the process used to ensure that monitoring and measurement can be carried out in a manner that is consistent with the monitoring and measurement requirements.
Where necessary to ensure valid results, measuring equipment is:

• Calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards
• Adjusted or re-adjusted as necessary (only by qualified and authorized personnel);
• Identified to enable the calibration status to be determined;
• Safeguarded from adjustments that would invalidate the measurement result;
• Protected from damage and deterioration during handling, maintenance and storage.

In addition, Quality Control assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements. Nanmac Corp. takes appropriate action on the equipment and any product affected. Records of the results of calibration and verification are maintained
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary by the software supplier, Nanmac will rely upon that validation process by the supplier.

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