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ISO 9001:2008
Quality Management System

QMS Manual

The information contained in this document is LND, Inc. proprietary information and is disclosed in confidence. It is the property of LND, Inc. and shall not be used, disclosed to others or reproduced without the express written consent of LND, Inc. If consent is given for reproduction in whole or in part, this notice shall appear in any such reproduction.

LND # 1-911-0043-05

12 February 2013

Quality System Manual - Section 00
Issued by: Quality Assurance Eff. Date: 2/11/13 Rev.: F Pg. 2 of 39

SECTION 0 - INDEX AND REVISION STATUS SECTION 1 - SCOPE 1.1 1.2 1.3 1.4 Quality Policy Introduction Application Exclusions Rev. F Rev. B Rev. C Rev. F Rev. C


4.1.1 Quality System Processes 4.2 Documentation Required Rev. C

SECTION 5 - MANAGEMENT RESPONSIBILITY 5.1 5.2 5.3 5.4 5.5 5.6 Management Commitment Customer Focus Quality Policy Planning Responsibility, Authority and Communication Management Review

SECTION 6 - RESOURCE MANAGEMENT 6.1 6.2 6.3 6.4 Provision of Resources Human Resources Infrastructure Work Environment

Rev. D

SECTION 7 - PRODUCT REALIZATION 7.1 Planning of Product Realization

Rev. B

Approved by/date:

Spencer Neyland

26 February 2013

Quality System Manual Section 00 Rev.: F Pg. 3 of 39

7.2 7.3 7.4 7.5 7.6

Customer-related Processes Design and Development Purchasing Production Provision Control of Monitoring and Measuring Equipment Rev. C

SECTION 8 - MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 8.2 8.3 8.4 8.5 General Monitoring and Measurement Control of Nonconforming Product Analysis of Data Improvement

SECTION APP – ISO 9001:2008 to 10CFR50 App. B Matrix

Rev. B

QOP-41-01 QOP-42-01 QOP-42-02 QOP-56-01 QOP-62-01 QOP-63-01 QOP-74-01 QOP-74-03 QOP-75-05 QOP-76-01 QOP-82-01 QOP-82-02 QOP-82-03 QOP-82-04 QOP-83-01 QOP-84-01 Production Processes Control of Documents Control of Records Management Review Competence, Awareness and Training Equipment Maintenance Supplier Evaluation and Monitoring Verification of Purchased Product Storage, Handling and Preservation Measuring and Monitoring Equipment Customer Satisfaction Internal Quality Audits In-Process Inspection Final Inspection Control of Nonconforming Product Analysis of Data Rev. A Rev. F Rev. E Rev. A Rev. C Rev. B Rev. D Rev. D Rev. C Rev. D Rev. A Rev. E Rev. C Rev. B Rev. D Rev. A

00 Rev.01 Rev. Report of Defects and Noncompliance – 10CFR21 Customer Returns Production Job Folder Shipping .02 Rev. D Rev.00 Rev.01 1-909-0002 1-911-0036 1-912-0001 1-913-0005 1-914-0005 1-945-0001 Test Control Control of Property Not Owned By LND. Communication With Suppliers Rev. 4 of 39 QOP-85-02 QOP-85-03 1-900-0010 1-900-0007 1-900-0008 1-901-0005 1-901-0010 Customer Complaints Corrective and Preventive Action Design Control Engineering Changes Customer Order Supplier Manual Engineering Review of Purchasing Dept.INDEX AND REVISION STATUS Quality System Manual Section 00 Rev.00 Rev.00 Rev.02 Rev.03 Rev.05 Rev. Inc. D Rev.06 Rev.: F Pg.

INDEX AND REVISION STATUS Quality System Manual Section 00 Rev.: F Pg. 5 of 39 QUALITY SYSTEM FORMS 1-900-0012 1-900-0017 1-901-0001 1-901-0003 1-901-0007 1-904-0004 1-911-0004 1-911-0005 1-911-0006 1-911-0008 1-911-0009 1-911-0028 1-911-0032 1-911-0033 1-911-0034 1-911-0038 1-911-0039 1-911-0040 1-911-0064 1-913-0004 1-914-0004 1-915-0013 1-511-0069 1-511-0062 QF-85-02-1 Re-graded Tube Assemblies Design Specification Sheet Plant Maintenance Work Order Scrap-Do Not Salvage Supplier Certification Customer Property Inventory Material Rejection Report (MRR) Supplier Corrective Action Request (SCAR) Engineering Change Request (ECR) Calibration Record Card Employee Qualifications Engineering Change Order (ECO) Audit Nonconformity Report (QF-82-02-2) Supplier Quality System Survey Corrective Action Request (QF-85-03-1) Conditional Acceptance Authorization and Validation Internal Audit Checklist (QF-82-02-3) Internal Audit Plan (QF-82-02-1) Quality Audit of LND Suppliers Customer Return Disposition Log WIP Output Log Training Record Initial Electrical Test Card NCR Tag Customer Complaint .

Neyland 01 Changed Shipping procedure from 1-296-0082 to 1-945-0001. Neyland 05 ECR 1739 2/12/13 S. Updated reference documents. Added EU TPED and Low Voltage (CE) directive to list in Section 2.INDEX AND REVISION STATUS Quality System Manual Section 00 Rev. Neyland 04 ECR 1530 11/30/11 S.6. Added QOP-55-01. Management Review in sub-section 5. Added removal of hazardous waste and updated location of PICS server Revised TPED directive. Added and deleted Quality System forms on page 5. Neyland 03 ECR 1338 2/11/11 S.1. ECR 852 8/21/09 S.: F Pg.1. Updated revision level of MIL-PRF-1 and various QOPs.1.1.5. Updated organizational chart in Section 5. Neyland 02 ECR 1260 11/1/10 S. Neyland . deleted CE directive. added IATA in Section 02 Added EU PED Directive and ISO 11118. 6 of 39 Quality System Manual Revisions REV. Initial Release 10/18/07 S. Updated Process Map. Updated standards listing. PAGES CHANGE REQUEST # DATE AUTHORIZED BY 00 All Incorporated ISO9001:2008. Reviewed entire manual and made grammatical corrections as necessary.

Operations Quality – QA Office Copies of this manual are available online at the LND.INDEX AND REVISION STATUS Quality System Manual Section 00 for downloading and also on the LND intranet PICS system affording access to all LND employees. Printed copies of this manual are considered to be uncontrolled and the information obsolete immediately upon being printed. . website (www.: F Pg. Inc. 7 of 39 Quality System Manual Distribution Printed copies of the Quality System Manual shall be distributed to the following: Manual Number 1 2 3 Location President. LND Quality Management Rep .lndinc.

developed and implemented a quality management system to demonstrate its ability to provide products that consistently meet customer. Inc. and MIL-PRF-1N.” 1. The quality system complies with the international standard ISO 9001:2008.1 QUALITY POLICY QUALITY POLICY “LND.3.1 INTRODUCTION LND. Date: 11/30/2011 Rev.: C Pg. Approved by/date: Spencer Neyland 12 December 2011 . is committed to the continual improvement of the effectiveness of our quality management system and to providing products that satisfy customer and regulatory requirements. 10CFR50 Appendix B.3 1.2.2 1.Quality System Manual .2. APPLICATION The quality management system defined in this manual applies to the design. Inc. statutory and regulatory requirements.2 1. 8 of 39 1. including continual improvement and the prevention of nonconformities. and to address customer satisfaction through the effective application of the quality management system. EXCLUSIONS 1. manufacture and distribution of gas-filled nuclear radiation detectors offered by LND.Section 01 SCOPE Issued by: Quality Assurance Eff. Inc.4 CLAIMED EXCLUSIONS No exclusions taken.1 1.

Appendix B: Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants 15CFR Parts 730 – 774: Export Administration Regulations (EAR) MIL-PRF-1: Performance Specification. Department of Transportation International Civil Aviation Organization (ICAO) – Technical Instructions for the Safe Transport of Dangerous Goods International Maritime Dangerous Goods Code (IMDG) ADR/RID Transportation Regulations (EU) IATA Dangerous Goods Regulations EU Directive 97/23/EC (PED) 2.2 STANDARDS AND GUIDELINES American National Standard ANSI/ISO/ASQ Q9001-2008. General Specifications for 49CFR Parts 106. 9 of 39 2.: F Pg.Customer Satisfaction – Guidelines for complaint handling in organization ISO 11118-1999: Gas cylinders – Non-refillable metallic gas cylinders-Specification and test method Approved by/date: Spencer Neyland 26 February 2013 . Date: 2/12/13 Rev. Electron Tubes. Quality Management system requirements American National Standard ANSI/ISO/ ASQ Q9000-2005: Quality management systemsFundamentals and vocabulary American National Standard ANSI/ISO/ ASQ Q9004-2009: A quality management approachManaging for the sustained success of an organization ISO 10002-2004: Quality Management .1 REGULATORY REQUIREMENTS 10CFR50.Section 02 REFERENCE DOCUMENTS Issued by: Quality Assurance Eff.Quality System Manual . 107 and 171 – 180: Pipeline and Hazardous Materials Administration.

10 of 39 3.3 3. Audit evidence: records.15 3. Audit Criteria: set of policies. fixture. accessories. Quality: Degree to which a set of inherent characteristics fulfills requirements. Customer satisfaction: Customer’s perception of the degree to which the customer’s requirements have been fulfilled.2 3. shipping containers that belong to a customer. Corrective action: Action to eliminate the cause of a detected nonconformity or other undesirable situation.Quality System Manual .12 3.14 3.10 3. procedures or requirements. drawings.11 3. statements of fact or other information.13 3. Continual improvement: Recurring activity to increase the ability to fulfill requirements.16 Approved by/date: Spencer Neyland 6 January 2010 .8 3. Quality management: Coordinated activities to direct and control an organization with regard to quality. computers. Quality assurance: Part of quality management focused on providing confidence that quality requirements will be fulfilled. which are relevant to the audit criteria and verifiable (audit evidence may be qualitative or quantitative). manuals. 3. Quality improvement: Part of quality management focused on increasing the ability to fulfill quality requirements. Competence: demonstrated personal attributes and demonstrated ability to apply knowledge and skills. Date: 12/11/09 Rev.Section 03 TERMS AND DEFINITIONS Issued by: Quality Assurance Eff. sub-assembly.1 Audit: systematic. Product: The end item of meeting all contract terms and conditions. Preventive action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.5 3.4 3. independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.7 3. software. Customer owned property: Any type of part. Quality control: Part of quality management focused on fulfilling quality requirements.: B Pg. 6 3.9 3. Quality policy: Overall intentions and direction of an organization related to quality as formally expressed by top management.

However. Inc. Refer to the LND.Quality System Manual . Inc. analysis of data. at times. nondestructive testing. 1-901-0005 for information pertaining to outsourced processes. audit results. These processes include. and Established processes to identify and implement actions necessary to achieve planned results and continual improvement of these process      4.2 Approved by/date: Spencer Neyland 26 February 2013 . documented and implemented a Quality Management System (QMS) in accordance with the requirements of ISO 9001:2008. EB welding. supplier responsibilities. Inc.: C Pg.1. corrective and preventive action and management review. To design and implement the QMS LND. and illustrated them on the Process Map Diagram Determined criteria and methods needed to ensure that the operation and control of the processes are effective.1 4. the risk involved. machining. has established. and analyze these processes. 11 of 39 4. outsourced to previously approved suppliers. has several processes that can be.1. The nature of the controls depends on the importance of the outsourced process. but are not limited to. Inc.1. materials analysis. Established systems to monitor. The processes that affect product conformity to requirements are controlled by LND.1 GENERAL REQUIREMENTS LND. evaluation of suppliers and quality program requirements. Date: 2/12/13 Rev. 4. The system is maintained and continually improved through the use of the quality policy.Section 04 QUALITY MANAGEMENT SYSTEM Issued by: Quality Assurance Eff. and plating. Inc.1. quality objectives. and the competence of the supplier to meet the process requirements. the controls in place shall not inhibit the supplier’s from proposing innovations to the outsourced process.1 Outsourced Processes LND. Supplier Manual.1. has:  Determined the processes needed for the QMS and their application throughout the organization and documented them on the Process Flow Diagram in this section of the Quality Manual Determined the sequence and interaction of these processes. and documented them in quality plans and work instructions. measure where applicable. Ensured the continuing availability of resources and information necessary to achieve planned results and continual improvement of these processes.

3 The Quality Management System (QMS) Process Flow Diagram .2.1. All main activities of the system are defined as Quality System Processes (QSPs) and are grouped into the following four categories (refer to the Process Matrix and Process Map in this section of the Quality Manual):    Product Realization Processes (PRP).1. instructions on how to carry out (or operate) the process. Quality system documentation also defines criteria and methods needed to ensure that the operation and control of quality system processes are effective.2.: C Pg. Measurement.2.1. 4.1. including key process indicators.QUALITY MANAGEMENT SYSTEM Quality System Manual Section 04 Rev. For a detailed illustration of sequence and interaction production processes. Management Responsibility Processes (MRP).1 Quality system processes The quality management system is designed as a system of interrelated processes. refer to Operational Procedure QOP-41-01. 4. and  Resource Management Processes (RMP) These processes are organized as Plan-Do-Check-Act (PDCA) loops.2 4.2 The sequence and interrelation between the four groups and individual QSPs are illustrated in the Processes Map diagram. 12 of 39 4. and definition of methods for monitoring and/or measuring the effectiveness of the process. This includes assignment of responsibilities and allocation of resources for the process. Analysis and Improvement Processes (MIP). Production Processes.

Quotes. Test & Metrology Continual Improvement Planning & Objectives MRP02 Management Review Policies & Directions PRP04 PRP05 QMS Performance Data Material Inventory Management Production Measurement.QUALITY MANAGEMENT SYSTEM Quality System Manual Section 04 Rev.: C Pg. 13 of 39 Customer RFQs. Audit & Analysis of Data MIP04 Corr. Action Customer Complaints/ Satisfaction Customer . / Prev. Analysis and Improvement Processes (MIP) MIP01 PRP06 Control of NC Product MIP02 Product/ Process Data MIP03 Shipping Int. Control & Information Management Facilities. Orders PROCESS MAP RMP01 Market Research Personnel Competence and Skills Resources RMP02 RMP03 PRP01 PRP09 Order Processing Product Design Doc. Equipment & Work Envirmnt Resource Mngmnt Processes (RMP) PRP08 PRP02 Purchasing Product Realization Processes (PRP) Production / Quality Planning Resource Needs Policies & Directions Mngmnt Responsibility Processes (MRP) MRP01 MRP03 PRP07 PRP03 Receiving Inspection.

bids and tenders Entering orders (or signing contracts) Receiving. tooling specifications.QUALITY MANAGEMENT SYSTEM Quality System Manual Section 04 Rev. and take orders from. components. 14 of 39 PROCESS MAP MATRIX PRODUCT REALIZATION PROCESSES (PRPs) Order Processing Purpose Process Owner Sub-Processes To determine customer requirements. visually verify their conformity. etc. or enter into contracts with. prepare bids and quotations. reviewing and issuing purchasing documents Communicating with suppliers regarding their quality performance (notifications. tests. Purchasing Purpose Process Owners Sub-Processes Purchasing / Quality     Evaluating and selecting suppliers and subcontractors Maintaining a list of approved suppliers Preparing. etc. submit tenders. etc) To select qualified vendors and to purchase from them materials. and services necessary for the manufacture and delivery of the product (for full scope of application refer to 1-901-0005.) Receiving Purpose To receive purchased products. Engineering  Determining quality objectives and requirements for products  Developing. operator instructions. customers. Sales        Determining product requirements Determining customer requirements Evaluating capability and capacity to meet requirements Preparing quotations.: C Pg. equipment setup instructions. inspections. LND Supplier Manual). Engineering        Planning and scheduling design projects Reviewing and controlling design input Performing design activities Conducting design reviews Establishing design output documents Verifying and validating product designs Controlling design changes Production/Quality Planning Purpose Process Owner Sub-Processes To plan and develop processes needed for manufacturing and verification of product. and mark/label products with . requests for corrective actions. entering and processing change orders Providing product information Product Design Purpose Process Owner Sub-Processes To design products meeting the design input requirements.)  Establishing product acceptance criteria and product verification requirements (measuring. validating and documenting production processes (process sheets.

Production      Carrying out manufacturing processes Monitoring and controlling manufacturing processes Establishing and maintaining production records Training process operators and technicians (on-the-job) Maintaining production equipment and tooling Delivery Purpose Process Owner Sub-Processes To deliver product to customers and distributors. Quality        Monitoring quality performance of suppliers Verifying purchased product (QC inspection) Monitoring. and testing products (in-process and final) Verifying inspection status identification Releasing products Identifying nonconforming products Selecting. measuring. store and issue materials. Test and Metrology Purpose Process Owner Sub-Processes To verify conformity of products. control and disposition nonconforming products. calibrating and controlling the monitoring and measuring equipment MEASUREMENT AND IMPROVEMENT PROCESSES (MIPs) Control of Nonconforming Product Purpose To identify. . Process Owner Sub-Processes Receiving  Receiving purchased products  Visually inspecting incoming products  Applying and/or recording product identification and traceability of incoming products To receive. components and parts to be incorporated into finished products. Material Inventory Management Purpose Process Owner Sub-Processes Stock Room     Operating and maintaining storage areas Identifying and protecting product in storage Maintaining special storage conditions/environment Operating and maintaining the inventory management system Production Purpose Process Owner Sub-Processes To manufacture products conforming to applicable requirements.: C Pg. and identification and calibration of monitoring and measuring equipment.QUALITY MANAGEMENT SYSTEM Quality System Manual Section 04 Rev. Shipping     Processing shipping orders Packaging and labeling product for shipping Dispatching or shipping product Establishing and maintaining shipping and distribution records Inspection. as applicable. 15 of 39 their identification and/or acceptance status.

implement and follow up corrective and preventive (C&P) actions. and to implement management commitments. etc) MANAGEMENT RESPONSIBILITY PROCESSES (MRPs) Planning and Objectives Purpose Process Owner Sub-Processes and Procedures To define the quality policy and quality objectives. Management     Establishing quality policy Establishing and monitoring of quality objectives Planning the quality management system Defining responsibilities and authorities  Appointing Management Representative To review the suitability and effectiveness of the quality system. holding meetings. third-party and customer audits  Collecting and analyzing quality performance data To request. and to identify opportunities for improvement. Internal Audits and Analysis of Data Purpose Process Owner Sub-Processes and Procedures Quality  Conducting internal audits of the quality system  Analyzing and evaluating results of internal. to plan the quality management system (QMS). and to evaluate its effectiveness and efficiency. discussion and evaluation of review input information  Determining changes required (if any) for the quality policy.QUALITY MANAGEMENT SYSTEM Quality System Manual Process Owners Sub-Processes and Procedures Section 04 Rev. quality policy and quality objectives. Corrective and Preventive Action Purpose Process Owner Sub-Processes and Procedures Quality  Evaluating the need for corrective and preventive (C&P) actions  Requesting and implementing C&P actions  Verifying the implementation and effectiveness of C&P actions To process customer feedback and complaints and to measure customer satisfaction. Management Review Purpose Process Owner Sub-Processes and Procedures Management  Presentation.: C Pg. quality objectives and the quality management system . plotting charts. documenting and segregating (where applicable) nonconforming products  Making nonconforming product disposition decisions  Reworking and verifying nonconforming products To verify conformity of the quality management system. to consider changes to the quality system. 16 of 39 Quality / Engineering  Identifying. reporting and presenting customer satisfaction information and data (preparing reports. Customer Complaints & Satisfaction Purpose Process Owner Sub-Processes and Procedures Customer Service     Receiving and logging customer feedback and complaints Processing and responding to customer complaints Gathering of information and data about customer satisfaction Analyzing.

1. Operations  Plant. Equipment and Work Environment Purpose Process Owner Sub-Processes and Procedures To ensure appropriate and adequate facilities.QUALITY MANAGEMENT SYSTEM Quality System Manual Section 04 Rev. processes and products. facility and equipment planning  Maintaining plant. and to control quality records. reviewing and updating the quality policy Establishing. storage. Operations / Quality     Determining competency requirements for jobs/positions affecting product quality Providing training and/or taking other actions to satisfy competency requirements Evaluating the effectiveness of training Providing awareness programs to ensure employee motivation.2. manufacturing processes and the quality system.: C Pg. Inc. Tech Comm     Establishing documents needed by the organization Reviewing and approving documents Controlling document revisions and distribution (availability) Managing retention. 17 of 39  Identifying opportunities for improvement and establishing quality objectives Continual Improvement Purpose Process Owner Sub-Processes and Procedures To continually improve the quality management system.1 DOCUMENTATION REQUIRED General LND. Work instructions. production equipment and supporting services. . provide training. and knowledge of quality-related issues Document Control and Information Management Purpose Process Owner Sub-Processes and Procedures To control documents related to products.1 4. Management      Monitoring performance of the quality management system Requesting and implementing corrective and preventive actions Establishing. and disposition of records Facilities. facilities and manufacturing process equipment 4. quality system documentation comprises the following categories:      A documented Quality Policy and quality objectives. Quality Manual. implementing and monitoring quality objectives Improving the Quality Management System RESOURCE MANAGEMENT PROCESSES (RMPs) Personnel Competence and Skills Purpose Process Owner Sub-Processes and Procedures To define competency requirements. Quality system operational procedures and records. and ensure awareness about qualityrelated issues.2. empowerment. Quality system forms.2 4.

new categories of documents are transferred from paper to electronic document control system.2. Operational Procedure QOP-42-02 Control of Records defines specifically what records are maintained in each category and designates their storage locations. to include their current revision status and changes. and are available at locations where they are used. Documents remain legible and readily identifiable. The Process Flow Diagram at the end of Section 04 provides a description of the interaction between the processes of the QMS system.’s QMS.2. Each section of the manual references documented QMS procedures relating to the requirement outlined in that section. and Obsolete documents are withdrawn from points of use. and revised documents are re-approved. These categories are further defined in Operational Procedure QOP-42-01 Control of Documents. to be necessary for the planning and operation of the QMS are identified and their distribution controlled.1 Control of records Records are established and controlled providing evidence of conformity to requirements and of the effective operation of the quality management system.2  4. Inc.4 4. 4. Documents are identified. The scope and permissible exclusions (if any) of the QMS are described in Section 01 of this manual. Quality assurance/control procedures. Inc. records and specifications. 18 of 39      Product labeling and packaging specifications. 4. Inc.2.3. Documents are distributed to. Standards and codes. It also defines the process for ensuring that records are . As this transition progresses.3. and  Regulatory specifications and standards.: C Pg. retention periods and disposal. Manufacturing specifications.2 Quality Manual This Quality Manual has been prepared to describe LND.2. is transitioning from paper to electronic documentation. Document of external origin determined by LND. and/or are clearly identified to prevent their unintended use.4. 4. Documents are reviewed and updated as necessary.3 4. Both systems are currently used. Government specifications and standards.1 Control of documents LND.2.QUALITY MANAGEMENT SYSTEM Quality System Manual Section 04 Rev.2. The document control system defined in Operational Procedure QOP-42-01 Control of Documents ensures that:       Documents are reviewed for adequacy and are approved prior to release. and are defined in Operational Procedure QOP-42-01 Control of Documents.

19 of 39 legible. are stored in appropriate locations and conditions.: C Pg. readily identified. are adequately protected.QUALITY MANAGEMENT SYSTEM Quality System Manual Section 04 Rev. . and are easily retrievable.

1 CUSTOMER FOCUS The principal objective of the quality management system is to focus our organization on the customer.2.1 MANAGEMENT COMMITMENT Top management has been actively involved in implementing the quality management system (QMS).2. and established quality objectives and the quality policy.1 Determination of Requirements Related to the Product and QM Section 7. To continue to provide leadership and show commitment to the improvement of the QMS.2. 20 of 39 5. Date: 2/12/13 Rev. top management shall do the following. 5. statutory and regulatory requirements. on enhancing customer satisfaction. Conduct annual management reviews. This is done through the process of order and contract review.2 5.Quality System Manual .1 5.2. and in associated operational procedures. Top management has provided the vision and strategic direction for growth of the QMS.2.: C Pg. and in associated operational procedures.2 Review of Requirements Related to the Product.2. This process is defined in this manual in QM Section 8. Ensuring that quality objectives are established.4 Monitoring and Measurement of Product. as defined in this manual in QM Section 8.      Communicate the importance of meeting customer. and in the associated operational procedure. Management ensures that customer satisfaction is systematically monitored as a measure of performance in determining and meeting customer requirements. Establish a quality policy. Management ensures that customer requirements are met by inspecting and testing products at various stages of production and upon completion.4 Approved by/date: Spencer Neyland 26 February 2013 .1. and in particular. and Ensure the availability of resources.3 5. as defined in this manual in QM Section 7.2 5.2. Top management ensures that customer requirements are determined and are well understood.Section 05 MANAGEMENT RESPONSIBILITY Issued by: Quality Assurance Eff. 5.2.1 Customer Satisfaction. The key to achieving high customer satisfaction is an accurate determination of customer requirements and an effective verification that the requirements are met.

and provides direction for the continual improvement effort. Para. Quality policy is periodically reviewed within the framework of management reviews of the quality system.3. Quality policy provides a framework for establishing specific quality objectives.1.3 5.1 Quality Policy. The use of the quality policy in setting quality objectives is addressed in this manual in QM Section 05.5. 1. authority and communication Responsibility and authority Interrelation of all personnel who manage. In formulating the quality policy. Quality policy is established by top management.3. to meet requirements for products and processes.4.3.5 5. and reviewed against performance goals at each management review meeting. and its role is explained and discussed at the general orientation training provided to all employees.2 5.1 General Requirements and the integrity of the quality management system are maintained when changes to the QMS are planned and implemented.2 5.5 5. and includes a commitment to comply with the requirements and continually improve the effectiveness of the quality management system.4. 5.1 Quality Objectives.2 QUALITY POLICY Quality policy is documented in this manual in QM Section 01.1.5. This is to ensure its continual relevance and suitability.4. 4. 21 of 39 5. Para.3.1 .5.1. and to improve quality system and quality performance. 5.1 5. 5.1 5.1 5.4. Para.1. Responsibility. top management ensures that the policy is appropriate to the purpose of the company. consumers and other interested parties.1 5. Para. it is displayed in the reception area and posted on the company's internet site.4 5.1 5. The quality policy is also communicated to customers. For this purpose.4.3 5.: C Pg. Quality objectives are measurable.2.4 5. perform and verify work affecting quality is identified in the Organizational Chart enclosed at the end of QM Section 05.3. PLANNING Quality objectives Top management ensures that quality objectives are established throughout the organization to implement the quality policy. Quality management system planning Top management shall ensure that quality management system processes are planned and implemented to meet the company’s quality objectives and the requirements of QM Section 04.4. Quality policy is posted throughout the company.MANAGEMENT RESPONSIBILITY Quality System Manual Section 05 Rev.

1 Ensure that processes needed for the quality management system are established. Para.2.1 Management Representative Top management has appointed the Vice President of Operations as the Management Representative for the quality management system. Management Representative has the authority and responsibility to:     5.1. and Coordinate communication with external parties on matters relating to the quality management system and ISO 9001 registration. ORGANIZATIONAL CHART 5.5. Internal communication Processes are established for communication within the organization.5.3. Report to the top management on the performance of the quality management system and any need for improvement. Methods of communicating the effectiveness of the QMS include weekly department leadperson .MANAGEMENT RESPONSIBILITY Quality System Manual Section 05 Rev.5.1. Promote awareness of customer requirements throughout the organization.1 ( as Process Owners). 4.2 Top management shall ensure that authorities and responsibilities for specific processes of the quality management system are defined and communicated:    Throughout this quality manual and in every operational procedure where the specific quality system process or activity is documented.: C Pg.2 5. INC. 22 of 39 5. LND. and In job descriptions.5. implemented and maintained.3 5.5. In Quality System Process Matrix sheets in QM Section 04.

and their due dates are recorded in the minutes of the management review.6 5. management will identify appropriate actions to be taken regarding the following issues. 5. identifying opportunities for improvement and needed changes (including the quality policy and quality objectives).2. and other routine business communication.1. 23 of 39 meetings and daily (management) production meetings.1 Management review General Top management reviews the QMS at the management review meetings. Review input Input into the management reviews consists of information and data related to quality performance of the organization. Refer to Operational Procedure QOP-56-01.MANAGEMENT RESPONSIBILITY Quality System Manual Section 05 Rev.2 5. Any decisions made during the meeting. 5. management reviews. and Resource needs.1 Follow-up actions from earlier management reviews.    Improvement of the effectiveness of the QMS and its processes Improvement of product related to customer requirements. This review assesses the continuing QMS suitability. Results of audits. Process performance and product conformity data. Changes that could affect the quality management system. assigned actions.2 Responsibility for required actions is assigned to members of the management review team. Management Review.6. .6.6.3 5.6.6. circulation of minutes of management review meetings. Status of quality objectives. this includes:         5. internal audit closing meetings. and Recommendations for improvement. Records are maintained for each management review meeting. Status of preventive and corrective actions.1 5.: C Pg.3.1 Review output During the review meetings. Customer feedback and complaints. adequacy and effectiveness.6. At a minimum.6.3. 5.

1 PROVISION OF RESOURCES LND.Section 06 RESOURCE MANAGEMENT Issued by: Quality Assurance Eff. HUMAN RESOURCES General Personnel performing work affecting conformity to product requirements are competent.1.2. Operations is responsible for training and awareness programs for company-wide participation. Identifying training needs.2 6. Conformity to product requirements may be affected by personnel who are directly or indirectly responsible for tasks within the quality management system.1. and the relevance of individual contributions towards meeting these requirements and achieving the quality policy and objectives. rules and regulations. awareness and training The objective of the company’s training program is to ensure that employees possess the required knowledge and skills for performing their jobs. Processes for ensuring adequate competency and awareness of personnel are defined in Operational Procedure QOP-62-01 Competence. Competence.2.Quality System Manual .2. such as: general orientation.2. skills and experience.1.2. Date: 2/12/13 Rev.2.2. Competency training is primarily focused on increasing the level of skills in operating equipment and processes.1. The procedure addresses issues related to:    Determining competency requirements.1 6. Providing training.2. Management determines and provides necessary resources.2. and other company-wide systems and issues.: D Pg.1 6.2 6. quality system. and other such skills as appropriate for particular positions and jobs. 6.2 6. This implementation was achieved with top management commitment and with sufficient resources for the implementation to effectively maintain and continually improve the system.1 6.2. has implemented a Quality Management System that complies with the ISO 9001:2008 standard and enhances customer satisfaction by meeting customer requirements. safety. Awareness and Training.3 6. 24 of 39 6. computerized data entry. Competency is determined on the basis of appropriate education. and that they are familiar with relevant requirements of the quality system pertaining to their job functions. Awareness programs focus on understanding the importance of customer requirements.2. Department managers and leadpersons are responsible for identifying competency requirements and for providing training in their areas. training. conducting inspections and testing.1 6.2 6.3 Approved by/date: Spencer Neyland 26 February 2013 . Inc.

2 6.1 6.1.1 Evaluating the effectiveness of training. This includes regularly scheduled maintenance of lighting systems. and internet access companies.3. 6.. and some IT services:  Transportation services are purchased from parcel delivery and courier services. wireless. Normal day-to-day operations of the IT systems are controlled and maintained by the President (AS400). LND Supplier Manual. personnel assigned to facility and maintenance departments. and/or modification or repair of existing infrastructure and facilities in their departments. and/or modification of existing process equipment (both hardware and software) are planned in conjunction with development of manufacturing processes. Transportation and hazardous waste removal services are purchased in accordance with Operational Procedure QOP-74-01 Supplier Evaluation and Monitoring. These services are purchased in accordance with Operational Procedure QOP-74-01 Supplier Evaluation and Monitoring. and 1-901-0005. Purchasing is responsible for coordinating and managing maintenance contracts. Process equipment Procurement of new. Purchasing is responsible for administrating and coordinating these contracts.3.3 6. Supporting services Supporting services required by LND. and 1-901-0005.2 6. INFRASTRUCTURE Buildings. Communication services are provided by various telephone. include transportation.RESOURCE MANAGEMENT Quality System Manual Section 06 Rev. Normal maintenance of buildings and facilities is performed by LND. workspace and associated utilities Infrastructure and facilities. Requests for changes and/or expansions of facilities are submitted to the Vice President of Operations and then to the President for review and approval. Testing (PICS System) and Draftsman (Design/Drafting). air conditioning and heating systems. 25 of 39    6. are appropriate and are properly maintained to achieve conformity to product requirements.3.3. etc. such as buildings. and cleaning.3 Department managers are responsible for identifying the need and requirements for new.1   . IT systems are designed and implemented by external consultants. Extensive repairs of buildings and other such facilities are contracted as needed. as required.3.3 6.: D Pg.2. Ensuring quality awareness.3. and from trucking or other transportation companies or consolidators.3. and Maintaining training records. LND Supplier Manual. Inc.1 6.3. hazardous waste removal. communication. workspaces and associated utilities. Inc.

4. WORK ENVIRONMENT Human factors Operations and departmental managers are responsible for ensuring suitable social and psychological conditions in the workplace. Where appropriate. limits of exposure and/or mitigating measures shall be defined and implemented for these operations.3.4.4. employee harassment.4 6.1 6. conflict resolution.4. This is to include such aspects as interaction and communication between employees. 26 of 39 6.4 6.4. Awareness and Training.1.3.1 .: D Pg.) Physical factors Production. machines. Relevant workplace policies are implemented mainly through training and awareness programs and. Requirements for the maintenance of production equipment are specified in Operational Procedure QOP-6301 Equipment Maintenance.2.1 6.4. and so forth.RESOURCE MANAGEMENT Quality System Manual Section 06 Rev.2 6.3 6.1 Equipment Maintenance Key process equipment. It is administrated by Operations and is documented in the Health and Safety (H&S) manual. where necessary. disciplinary actions.3. 6.1 6. hardware. (Refer to Operational Procedure QOP-62-01 Competence.4. and software are regularly maintained in accordance with maintenance plans specified by equipment manufacturers or department managers responsible for the equipment. Health and safety Health and safety management system is independent from the quality management system. Operations and Quality are responsible for identifying those operations where extreme environmental conditions could impact quality performance of personnel and result in product nonconformities.

establish process specifications. and the criteria for product acceptance. actions under warranty.1 Review of requirements related to the product Prior to the commitment to supply a product to the customer. monitoring.1 7. and   7. The need to develop production processes and documents.2. orders are reviewed to ensure that:   Product requirements are defined. contractual obligations such as maintenance services.2.2 7. inspection and test activities.2.2 7. validation.1. Refer Approved by/date: Spencer Neyland 6 January 2010 .1. including delivery and post-delivery (e.Quality System Manual . but necessary for specified use or intended use.1 PLANNING OF PRODUCT REALIZATION Production and quality planning Quality planning is required before new products or processes are implemented.2. Statutory and regulatory requirements applicable to the product. Date: 12/11/09 Rev. determines customer requirements before acceptance of an order. Any ambiguities and conflicts in contract or order requirements are resolved. measurement. CUSTOMER-RELATED PROCESSES Determination of requirements related to the product LND. and supplementary services such as recycling or final disposal) activities.2. where known.1.2. Required product verification. Inc.1 7. The planning includes the determination of:   Requirements and quality objectives for products and processes.g. Requirements not stated by the customer. and provide training to process operators.2  The company is able to meet customer requirements.    7.Section 07 PRODUCT REALIZATION Issued by: Quality Assurance Eff. Records of the results of the review and any associated actions are maintained. 27 of 39 7.1 7.: B Pg.1.1 Records needed to provide evidence that the realization process and resulting product and processes meet requirements.1.2 7. and 7. Customer requirements include:  Requirements specified by the customer.2.1. and Any additional requirements considered necessary by the company. Results of production and quality planning are documented on the AS400 computer system. operator instructions and other such documentation. and in the form of dated and signed drawings/work instructions.

1. assignment of qualified personnel. Inc.2.2. review. Design and development inputs Design input requirements are developed by Engineering from product concepts.3.PRODUCT REALIZATION Quality System Manual Section 07 Rev. Customer communication LND.2. 7.5 7. 28 of 39 to QM Section 4.3. Design inputs are reviewed and approved before they are used in design. Design Control. When a formal review is deemed impractical for orders.   Functional and performance requirements.3. and control of organizational and technical interfaces.3 7.2 7. Applicable statutory and regulatory requirements. contracts and order handling. models. scheduling the project. Enquiries.1 Arrangements for communicating with customers regarding enquiries and order handling are defined in flowchart 1-900-0008. Inc. Control of Records. Engineering is responsible for design. verification and validation activities. such as product briefs.3 Product information.2.2.1 7.1 7.2 7.2.2. DESIGN AND DEVELOPMENT Design and development planning LND.: B Pg. Change orders are communicated to all functions within the company that may be affected by the change of customer requirements. the review shall cover relevant product information such as catalogs or advertising material. etc. including customer complaints.3. Inputs shall include. including the identification of design. .3 7. has implemented an effective procedure for communicating with customers in relation to:    7. Customer Order.1.3. The quality system for design and development is defined in flowchart 1-900-0010.4 When the customer provides no documented statement of requirements (as with verbal orders). sketches.3 7. 7. rough prototypes. designs its own standard catalog products as well as customer-specified products and modifications.2.2.2. Engineering is responsible for the planning of design projects. the customer requirements are confirmed before acceptance.2. Change orders and amendments are processed and reviewed using the same procedures that apply to the processing of initial orders. and Customer feedback. such as internet sales. Arrangements for communicating with customers regarding customer feedback and complaints are defined in Operational Procedures QOP-82-01 Customer Satisfaction and QOP-85-02 Customer Complaints.3.2 7. 7. including amendments.

and Specify the characteristics of the product that are essential for safe and proper use.4. and approved before they are released for production. checked and verified against design and development inputs.2. Control of Records.3.3. are maintained in accordance with QM Section 4. when practical. Contain or reference product acceptance criteria.1 Information derived from previous similar designs (when applicable).3.6 7.2.6. The purpose is to ensure that the design and development outputs have met the design and development input requirements. and any necessary actions. Validation is completed prior to the delivery or implementation of the product.2 . Control of Records. 29 of 39   7.3. Requirements are complete.4.5. Records of the results of product design verification.3. and Other requirements essential for design and development.3 7. Design and development verification Product designs are verified in accordance with planned arrangements (design and development project plan). where known. Design and development validation Product designs and development are validated in accordance with planned arrangements (design and development project plan) and that the resulting product is capable of meeting the requirements for specified application or intended use. The purpose of the design reviews is to evaluate the ability of the design to meet design input requirements.4 7.6.2 7.2.3. Design and development outputs. Design and development outputs Design and development outputs are documented.4. as well as other specialist personnel.1 7.3 7.2 7.1 7. Records are maintained in accordance with QM Section 4.2.: B Pg.3 7.PRODUCT REALIZATION Quality System Manual Section 07 Rev.3.4. Records of the results of the review and any necessary actions are maintained in accordance with QM Section 4.5.2 7.     Meet the design and development input requirements. and to identify any problems and propose necessary actions. 7.3.4. Participants in design reviews include representatives of functions concerned with the design stage being reviewed. well defined and do not conflict with each other.3. Control of Records.3.1 Design and development reviews Design reviews are carried out at appropriate stages in accordance with the design project plan.3. Provide appropriate information for purchasing and production. 7. Design inputs are reviewed for adequacy.3. 7.

1 Purchasing documents are reviewed for adequacy of requirements and approved prior to orders being placed with suppliers.4.4. procedures.PRODUCT REALIZATION Quality System Manual Section 07 Rev.4.4.3 7.4.2.    Requirements for approval of product.2 7. including.7 7. Purchasing information Purchasing documents clearly and completely describe the ordered products. Control of design and development changes Design and development changes are initiated. verified and validated as appropriate.3. processed and controlled using the Engineering Change Request (ECR) system defined in Operational Procedure 1-9000007. Verification of purchased product Purchased products are verified prior to use in production and/or dispatch to customers. Review of design and development changes include an evaluation of the change on constituent parts and products already delivered.4.4. 30 of 39 7. and Quality management system requirements. Requirements for qualification of personnel. Operational Procedure QOP-74-03 Verification of Purchased Product defines the processes for verifying.2 7. Engineering Changes.1.3.3. processes and equipment.4 7. Inc. 7.2 7.3. Engineering and Quality are responsible for selecting appropriate methods for purchased product verification and acceptance. has developed a Supplier Manual (1-901-0005) that outlines the extent of control and responsibilities required by the suppliers. Records of the results of review of changes.4. Supplier Evaluation and Monitoring.3 7. Design changes are reviewed.2. LND.1 7.7.1 7.4. Verification of Purchased Product QOP-74-03.2 7. and any necessary actions.7.1. is followed to ensure that purchased product conforms to the specified purchase requirements.3. Criteria for selection. identifying and releasing purchased products. and any necessary actions.4. and approved before implementation.3 7. Suppliers are evaluated and selected based on their ability to supply product in accordance with the requirements outlined in the Supplier Manual.1 Records of the results of product design validation. .2 PURCHASING Purchasing process A documented procedure.2. evaluation and re-evaluation are documented in the Operational Procedure QOP-74-01. are maintained in accordance with QM Section 4. are maintained in accordance with QM Section 4. Control of Records. Control of Records. Records of the evaluation and any necessary actions are maintained as quality records.: B Pg.3.6.1 7.2.

and Revalidation.2 . Inc. The availability and use of monitoring and measuring equipment.3. Requirement for records.       Defined criteria for review and approval of the processes.3 7. Validation demonstrates the ability of these processes to achieve planned results. components and finished products. PRODUCTION PROVISION Control of production Product manufacturing is carried out under controlled conditions.5. 7.5 7. with unique control numbers.1 Identification and traceability Identification: Materials. are identified throughout all stages of product realization and when in storage. The implementation of monitoring and measurement.4. The controlled conditions include the control of.: B Pg.2 7. Qualification of personnel. Traceability: Traceability is maintained when required by applicable laws and regulations.5. The use of suitable equipment. or when specified internally to facilitate corrective actions.1 Validation of processes for production provision LND. Activities related to maintaining and recording traceability are addressed in 7.3. 31 of 39 7. including inspection and test status.5. as applicable:       The availability of information that describes the characteristics of the product. and The implementation of release. Traceability is based on identifying the finished products.PRODUCT REALIZATION Quality System Manual Section 07 Rev. purchasing documents specify the intended verification arrangements and method of product release. delivery and post-delivery activities. The system and methods for identifying products are explained in Operational Procedure QOP-74-03 Verification of Purchased Product. The availability of work instructions (PICS system procedures).2 If verification of purchased product is ever performed at the supplier's facility.5. This includes any processes where deficiencies become apparent only after the product is in use.1 7. validates any special processes where the resulting output cannot be verified by subsequent measurement or monitoring. Use of specific methods and procedures. Approval of equipment. or batches. The process for validation includes. 7.

verification.4 7.5.1 7. Records of the results . QOP-76-01 Measuring and Monitoring Equipment.6. This is to prevent nonconforming product from being used or dispatched.6 7. Preservation also applies to the constituent parts of the product. measuring equipment is. Preservation of product Departments and functions manufacturing. Handling and Preservation define how these policies are implemented. transporting.1.5.1 7. and when in storage.1 7. The procedure.3 Product status: Throughout product realization. 32 of 39 Operational Procedures QOP-74-03 Verification of Purchase Product.5..6. e. has determined the monitoring and measurements to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements. Safeguarded from adjustments that would invalidate the measurement results. maintenance and storage. storing or otherwise handling products are responsible for developing appropriate handling techniques and procedures. protection and safeguarding of customer property. products are identified with respect to their status.1 Quality Assurance assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements. When necessary to ensure valid results. takes appropriate action on the equipment and any product affected. Customer property The company exercises care with customer property while it is under the organization’s control or being used. Operational Procedure QOP-75-05 Storage. and Protected from damage and deterioration during handling. outlines the identification.3.PRODUCT REALIZATION Quality System Manual Section 07 Rev. Identified to enable the calibration status to be determined. Adjusted or re-adjusted as necessary. LND. Work Instruction 1-911-0036.5.5.2 Calibrated or verified at specific intervals.5.1. If any customer property is lost. 7. 7. to indicate whether they have passed or failed the specified inspections and/or tests. against measurement standards traceable to international or national measurement standards. Inc. Inc. CONTROL OF MONITORING AND MEASURING EQUIPMENT LND. General requirements for status identification are defined in Operational Procedure QOP-74-03 Verification of Purchased Product.g. this is reported to the customer and records maintained. and for protecting and preserving the product while in their custody.. outlines the process used to ensure that monitoring and measurements to be complied with are carried out in a manner that is consistent with our monitoring and measurement requirements.6.5 7. or prior to use.4. damaged or otherwise found to be unsuitable for use. Control of Property Not Owned By LND Inc.: B Pg.      7.

This shall be undertaken prior to initial use and reconfirmed as necessary. 7. Confirmation of software includes verification and configuration to maintain its suitability for use. 33 of 39 of calibration and verification are maintained.6.PRODUCT REALIZATION Quality System Manual Section 07 Rev. the ability of computer software to satisfy the intended application is confirmed.1.3 When used in the monitoring and measurement of specified requirements.: B Pg. .

2. ANALYSIS AND IMPROVEMENT Issued by: Quality Assurance Eff.1 The above listed processes are identified in documented procedures and include determination of applicable methods. Customer satisfaction information is reported to. Internal audit Quality is responsible for coordinating the internal audits of the quality management system at planned intervals to determine whether the quality system:  Conforms to planned arrangements (refer to QM Section 7. 8. Planning of Product Realization).Quality System Manual . LND Inc. Internal audits are conducted in accordance with a planned program.2 8.: C Pg.2.1 GENERAL LND.2.1.2 8.2.1 8.3 Approved by/date: Spencer Neyland 17 December 2010 . and evaluated by the management review of the quality system. To ensure conformity of the quality management system. Operational Procedure QOP-82-01 Customer Satisfaction defines the responsibilities and methods for collecting the information.3 8.2 8. 8. Necessary corrections and corrective actions are taken without undue delay by management personnel responsible for the areas where nonconforming processes and/or practices are identified by the audit.1 8. as well as the results of the previous audits.1. to the quality management system requirements as defined in this quality manual and operational procedures. monitors information relating to customer perception as to whether the company has met customer requirements.2 MONITORING AND MEASUREMENT Customer satisfaction As one of the measurements of the performance of the quality management system. analysis and improvement processes needed. as defined in Operational Procedure QOP-56-01 Management Review. plans and implements the monitoring. and to the requirements of the ISO 9001 standard. 8.    To demonstrate conformity to product requirements. Inc. Auditors follow up to ensure that the actions taken are fully implemented and are effective.2. and the extent of their use.Section 08 MEASUREMENT.2.2  Is effectively implemented and maintained. 34 of 39 8. measurement. Date: 12/17/10 Rev. 8.1. and To continually improve the effectiveness of the quality management system. taking into consideration the status and importance of the processes and areas to be audited.

4.1 8.2.2 . Records indicate the person authorizing release of product.1 8.1 8. These methods demonstrate the ability of the processes to achieve planned results. Quality initiates a corrective action request to address the problem. where applicable. release or acceptance under concession by a relevant authority and.3.2. considers the type and extent of monitoring or measurement appropriate to each process in relation to their impact on the conformity of product requirements and on the effectiveness of the quality management system.2. CONTROL OF NONCONFORMING PRODUCT Identification and documentation LND. 8. The controls and related responsibilities and authorities for dealing with nonconforming product are defined in Operational Procedure QOP-83-01 Control of Nonconforming Product. The process for requesting and implementing corrective actions is defined in Operational Procedure QOP-85-03 Corrective and Preventive Action.2.3 of this manual.4. Inc.MEASUREMENT. deals with nonconforming product by one or more of the following ways.   By taking action to eliminate the detected nonconformity.3. When considering suitable methods. Monitoring and measurement of product LND. Inc. applies suitable methods for monitoring and. By authorizing its use.3 8.4. Evidence of conformity with the acceptance criteria is maintained. 8. Inc. 35 of 39 8. where applicable. Section 4. Inc. ANALYSIS AND IMPROVEMENT Quality System Manual Section 08 Rev.2 8. ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.4 8. Product release to the customer does not proceed until all the planned arrangements have been satisfactorily completed. LND.2. unless otherwise approved by a relevant authority and.2.2. monitors and measures the characteristics of the product to verify that product requirements are fulfilled. 8. Inc. Refer to Operational Procedure QOP-4202.2. This is carried out at appropriate stages of the product realization process identified in the Production Process flowchart. by the customer.2.5 Records of the audit and its results shall be maintained in accordance with QM Section 4.2 8. as well as taking corrective actions and follow-ups. conducting and reporting internal audits. where applicable. Control of Records.1 8. Monitoring and measurement of processes LND. measurement of the quality management system processes.4. LND.3.3. When a quality system process does not conform to requirements.1.3 8. Control of Records.: C Pg.2. by the customer. Operational Procedure QOP-82-02 Internal Quality Audits defines the responsibilities and requirements for planning.

1.2 8. Conformance to product requirements. and Suppliers. analysis of data. continually improves the effectiveness of the quality management system through the use of the quality policy. audit results. including concessions obtained. customer survey results.2. When nonconforming product is corrected it is subject to re-verification to demonstrate conformity to the planned requirements.5. The analysis of data provides information relating to. quality objectives.1.4 8.3 .1 8. 8. and By taking action appropriate to the effects.4. Corrective and preventive action Corrective actions are taken to eliminate causes of nonconformities in order to prevent their recurrence. 36 of 39   By taking action to preclude its original intended use or application.1 8. Inc.3. collecting and analyzing this data is defined in the Operational Procedure QOP-84-01 Analysis of Data.5. Appropriate data includes data generated as a result of monitoring and measurement and from other relevant sources. corrective and preventive actions and management review.1 IMPROVEMENT Continual improvement LND.3 8. ANALYSIS OF DATA General Data and information recorded in quality records are compiled and analyzed periodically to determine trends in the performance and effectiveness of the quality management system and to identify opportunities for improvement.2 8. or potential effects.1.1 8.4.4 8.5 8.5. Preventive actions are implemented to eliminate causes of potential nonconformities in order to prevent their occurrence. shall be maintained in accordance with Operational Procedure QOP-42-02.1.2 8. The process for taking corrective and preventive actions includes requirements for: 8.2. Control of Records. customer complaint forms.3.3 Records of the nature of nonconformities and any subsequent actions taken. Characteristics and trends of processes and products including opportunities for preventive action.5.5. of the nonconformity when nonconforming product is detected after delivery or use has started.1. 8.MEASUREMENT.: C Pg.     Customer satisfaction. The process for determining.4. ANALYSIS AND IMPROVEMENT Quality System Manual Section 08 Rev.5.

Recording the results of any investigations and of actions taken. .5. Evaluating the need for action to ensure that nonconformities do not recur and that potential nonconformities are prevented.MEASUREMENT. This process is defined in Operational Procedure QOP-85-03 Corrective and Preventive Action. ANALYSIS AND IMPROVEMENT Quality System Manual Section 08 Rev. including. if appropriate.4 Reviewing nonconformities and determining potential nonconformities.2.: C Pg. 37 of 39      8. and  Reviewing the corrective or preventive action taken and its effectiveness. Determining and implementing actions needed. Determining causes for nonconformities and potential nonconformities. updating documentation.

B Issued by: Quality Assurance Eff.Quality System Manual .Appendix ISO 9001:2008 TO 10CFR50 APP. Date: 12/11/09 Rev. 38 of 39 Approved by/date: Spencer Neyland 6 January 2010 .: B Pg.

: B Pg.ISO 9001:2008 TO 10CFR50 APP. 39 of 39 . B Quality System Manual Section 00 Rev.