QUALITY MANUAL

ISO-9001
Submitted by:Pushkar kumar 29 (B) Saurabh Skukla 42 (B) Smita Chauhan 47 (B) Vineet Krishna 53 (B)

Submitted to:Prof. Jag Mohan

EMPI B School
NEW DELHI

Submission Year - 2001

QM-9001
Quality Manual ISO/9001-1994
Table of Contents
QM-9001

2.1 Introduction -----------------------------------------------------------------------3 3.1 Mission Statement----------------------------------------------------------------4 3.2 Vision Statement -----------------------------------------------------------------4 4.1 Management Responsibility----------------------------------------------------5 4.1.1 Quality Policy ------------------------------------------------------------------5 4.1.2 Organization --------------------------------------------------------------------5 4.1.2.1 Responsibility and Authority ----------------------------------------------6 4.1.2.2 Resources---------------------------------------------------------------------8 4.1.2.3 Management Representative-----------------------------------------------8 4.1.3 Management Representative -------------------------------------------------8 4.2 Quality System -------------------------------------------------------------------9 4.2.1 General --------------------------------------------------------------------------9 4.2.2 Quality System Procedures --------------------------------------------------9 4.2.3 Quality Planning --------------------------------------------------------------10 4.3 Contract Review-----------------------------------------------------------------10 4.3.1 General -------------------------------------------------------------------------10 4.3.2 Review -------------------------------------------------------------------------10 4.3.3 Amendment to a Contract ---------------------------------------------------10 4.3.4 Records ---------------------------------------------------------------------10 4.4 Design Control-------------------------------------------------------------------11 4.4.1 General -------------------------------------------------------------------------11 4.4.2 Design and Development Planning-----------------------------------------11 4.4.3 Organizational and Technical Interfaces-----------------------------------11 4.4.4 Design Input -------------------------------------------------------------------11 4.4.5 Design Output------------------------------------------------------------------12 4.4.6 Design Review-----------------------------------------------------------------12 4.4.7 Design Verification-----------------------------------------------------------12 4.4.8 Design Validation ------------------------------------------------------------12 4.4.9 Design Changes ---------------------------------------------------------------12 4.5 Document and Data Control ---------------------------------------------------13 4.5.1 General -------------------------------------------------------------------------13 4.5.2 Document and Data Approval and Issue-----------------------------------13 4.5.3 Document and Data Changes -----------------------------------------------13 4.6 Purchasing -----------------------------------------------------------------------14 4.6.1 General -------------------------------------------------------------------------14 4.6.2 Evaluation of Subcontractors -----------------------------------------------14

4.6.3 Purchasing Data---------------------------------------------------------------- 14 4.6.4 Verification of Purchased Product--------------------------------------------14 4.7 Control of Customer Supplied Product ----------------------------------------15 4.8 Product Identification and Traceability ---------------------------------------16 4.9 Process Control--------------------------------------------------------------------17 4.10 Inspection and Testing----------------------------------------------------------18 4.10.1 General -------------------------------------------------------------------------18 4.10.2 Receiving Inspection and Testing-------------------------------------------18 4.10.3 In-Process Inspection and Testing -----------------------------------------18 4.10.4 Final Inspection and Testing-------------------------------------------------18 4.10.5 Inspection and Test Records-------------------------------------------------19 4.11 Control of Inspection, Measuring, and Test Equipment-------------------20 4.11.1 General -------------------------------------------------------------------------20 4.11.2 Control Procedure-------------------------------------------------------------20 4.12 Inspection and Test Status -----------------------------------------------------21 4.13 Control of Nonconforming Product ------------------------------------------22 4.13.1 General -------------------------------------------------------------------------22 4.13.2 Review and Disposition of Nonconforming Product --------------------22 4.14 Corrective and Preventive Action --------------------------------------------23 4.14.1 General -------------------------------------------------------------------------23 4.14.2 Corrective Action--------------------------------------------------------------23 4.14.3 Preventive Action-------------------------------------------------------------23 4.15 Handling, Storage, Packaging, Preservation, and Delivery----------------24 4.15.1 General -------------------------------------------------------------------------24 4.15.2 Handling------------------------------------------------------------------------24 4.15.3 Storage--------------------------------------------------------------------------24 4.15.4 Packaging ----------------------------------------------------------------------24 4.15.5 Preservation--------------------------------------------------------------------24 4.15.6 Delivery-------------------------------------------------------------------------24 4.16 Control of Quality Records-----------------------------------------------------25 4.17 Internal Quality Audits----------------------------------------------------------26 4.18 Training --------------------------------------------------------------------------27 4.19 Servicing--------------------------------------------------------------------------28 4.20 Statistical Techniques-----------------------------------------------------------29 4.20.1 Identification of Need-------------------------------------------------------------29
4.20.2 Procedures-----------------------------------------------------------------------------29

INTRODUCTION
2.1 Introduction
This manual describes the quality system in operation CONCORDE MEDICAL EQUIPMENTS MANUFACTURERS in Chanakya Puri, New Delhi. This quality manual includes Concorde medical equipments quality policy, a description of the operational systems to ensure product quality, and the policies that support the ISO 9001 quality system elements. Concorde medical equipments works with its suppliers, internal resources, and customers to provide medical products and equipments that are best in term of application and performance. Customers (hospitals, private nursing homes, etc) often use Concorde medical equipments products to give the best service to their patients that cannot be provided with alternative products. The cost and performance of our sensor technology create high expectations in the minds of our customers. It is essential that we provide the highest quality products in order to earn and maintain the confidence of our customers. The president of Concorde medical equipments approves this quality manual. Quality system documents are controlled as described in PROC 4.5 Document and Data Control. PROC 4.15 includes instructions to have controlled. copies uniquely and have locations identified on a maintained document. This manual and all supporting documents support the ISO 9001 International Quality Standards 9001:1994.

MISSION STATEMENT, VISION STATEMENT 3.1 Mission Statement

To provide quality medical equipments, within a positive work environment, at a profit.

3.2 Vision Statement

We are a customer-orientated company. We provide the highest quality products to help The Medical Professionals giving the best possible treatment. We provide easiest solutions by using the most advanced technical knowledge. We Support our customer, before and after the purchase. The customer will always be our first priority. Employees are recognized as the strength of the company. Concorde medical equipments offer a challenging, regarding, and safe work environment where innovation, mutual respect, and personal growth are expected. Employees are encouraged and provided with the opportunity to develop both personally and professionally. Concorde shares the financial success of the company with its employees. Management has the freedom and responsibility to develop, present, and communicate the company plan. Management has the obligation to provide the support necessary to achieve the company plan. Concorde medical equipments is an ethical, responsible organization that provides quality employment opportunities in our community. We believe in and support education at all ages and levels.

4.1 MANAGEMENT RESPONSIBILITY 4.1 Management Responsibility

4.1.1 Quality Policy
The Quality Policy at Concorde is: Customer Satisfaction results from a Motivated Workforce and Innovative Products The quality policy is supported with the following objectives: At Concorde medical equipments Customer Satisfaction means: * Perfect and accurate delivery rates Products are reliable. At Concorde medical equipments A Motivated Workforce means: Recognition that it is necessary for departments to communicate effectively to coordinate the conversion of customer requirements into deliverable products The Company shares success through bonus, profit sharing, and pension programs Each person working at Concorde medical equipments takes part in a written survey to evaluate various aspects of the company. At Concorde medical equipments Innovative Products means: Listening to customers for input and output driven design changes Constant research & development. Continuous refinement of existing products and processes where opportunity exists Monitoring of and reducing scrap The above Quality Policy is communicated to all management participating in the Management Review Meetings and to all employees as a part of workforce training.

4.1.1 The Quality Policy

The quality policy should be relevant to the suppliers organizational goal and expectations and needs of the customers. We as organization maintain that the suppliers shall understood, implement and maintained this policy at all levels of the organization.

4.1.2 Organization
Concorde pharmaceuticals is organized along traditional lines. There are departments for Sales and Marketing, Engineering, Accounting, Material Control/Production Planning, Quality, and Production. In order for the company to meet its objectives, it is imperative that all departments maintain a team-oriented attitude, where the team is the entire company. An organization chart (Appendix QM-APP 1) is included as an appendix to this Quality Manual and is posted to show responsibilities and relationships. The ISO Coordinator updates the organizational chart when changes occur.

4.1.2.1 Responsibility and Authority

It is the philosophy of Concorde medical equipments that quality is an attitude adopted individually by each person. The purpose of policies and procedures is to enable and encourage each individual to make quality decisions. It is the responsibility of the president to encourage and support each individual in his or her quest to make quality decisions. Key responsibilities, authorities, and interfaces regarding the quality system have been assigned to the management Representative, Quality Coordinator, and Nonconforming Product Coordinator. Individuals and lines of authority are defined on the organizational chart. Lines of communication are cross-functional and open at Concorde pharmaceuticals. The organizational chart is posted for all employees to see all individuals have the freedom and authority to suggest changes for a product, process, or the quality. Our system including: To initiate action that prevents the occurrence of nonconformance To identify and record product, process, and quality system problems To initiate, recommend, or provide solutions through designated channels To verify the implementation of solutions To control further processing, delivery, or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected There are three formal methods of implementing change at Concorde pharmaceuticals: 1. Organization plans, objectives, and goals 2. Preventive/Corrective Actions 3. ECOs Based on the organizational plan, department supervisors work with management and their Departments to develop project plans using 4.02.3 project plan. Plans contain measurable objectives and goals. All employees are involved in this process. The formal input and feedback instrument for the quality system is the corrective and preventive action procedure explained in PROC 4.14 Corrective and Preventive Action. All employees are trained in the use of this procedure and are authorized to use it. The corrective and preventive action procedure provides mechanisms for routing to corrective department, verification of solutions, and control of any nonconforming product. The Quality Coordinator tracks each preventive/corrective action from its initiation to its final conclusion. The final way to make changes to product, processes, or the quality system is through ECOs. The procedure is described in PROC 4.05 Documentation and Data Control. All employees are encouraged to find areas of improvement and submit ECOs when appropriate.

Job Descriptions
President: The President is to provide leadership and guidance for the acceptance, maintenance, and enforcement of the Quality System and is also the Management Representative. In addition, the President helps develop and monitor progress toward company objectives and goals and maintains the Quality Manual.

ISO Coordinator: The ISO Coordinator is responsible for scheduling management review meetings, recording and distributing meeting minutes, scheduling and monitoring audits, and maintaining the ISO cross reference chart (Appendix QM-APP2). The ISO Coordinator maintains the organization chart, job descriptions, training requirements, and training records. In addition, the ISO Coordinator reviews proposals for statistical techniques, summarize and presents statistical data for management review. Control of quality system documentation is also included in the duties. Quality Coordinator: The Quality Coordinator provides organization-wide quality system Monitoring and reporting, coordinates the corrective and preventive action, controls test and measurement equipment, and maintains the list of internal quality records. Nonconforming Product Coordinator: The Nonconforming Product Coordinator logs and tracks all incidents of nonconforming products. Sales Manager: The Sales Manager is responsible for return procedures, demo procedures, the sales order form, and follow up concerning customer satisfaction. Product Manager: The Product Manager is responsible for customer quotation review, incoming purchase order review, internal sales order review, and follow up concerning customer satisfaction. Engineering Manager: The Engineering manager is responsible for the control of design and development of new products and for the control of product modifications. This includes confirming customer requirements, providing design validation, verification, and support and training of manufacturing on new product designs and changes to existing products. Engineering Documentation: Engineering Documentation is responsible for control of engineering documentation. Buyer: The Buyer is responsible for subcontractor selection, subcontractor evaluation, review of purchase orders, and the conduit for communication between subcontractor sand departments within the company. Operations Manager: The Operations Manager is responsible for manufacturing processes, in process evaluation and testing, inspection and test status, and nonconforming product. Inventory Control: Inventory Control is responsible for control of customer-supplied product as well as handling, storage, packaging, preservation, and delivery of materials. Technical Support: Technical Support is responsible for final inspection and testing as well as repair of customer owned product. In addition to job descriptions, specific responsibilities are also identified within procedures.

4.1.2.2 Resources
Documented procedures have been established to ensure employees are provided with the proper training, equipment, and skills. Personnel requirements to accomplish management, work, and verification activities are determined from product sales forecasts and from organizational goals and objectives developed from the annual business plan.

4.1.2.3 Management Representative

At Concorde pharmaceuticals, the Management Representative is the company President. The President has overall authority for implementation of the quality system. These responsibilities include but are not limited to the following: Development of quality plans and strategies to implement and manage quality improvement. Lead the quality integration effort in all aspects of the organization to ensure systemic deployment. Ensure compliance to ISO 9001 through scheduled audits, management reviews, and preventive/corrective actions. Ensure adequate resources, training, and tools are available.

4.1.3 Management Review

The ISO Coordinator schedules management review meetings twice per year, or as determined by the management representative. The management representative determines the attendance at these meetings based on the material to be reviewed and assigns action items and follow-up meetings as determined during the meeting. Records of the Management Review are completed and maintained by the ISO Coordinator. Agenda items for the management review shall include, but are not limited to: Audits performed since the last management review Quality Policy Open Corrective and Preventive Actions Corrective and Preventive Actions to be closed New Preventive Action possibilities Customer concerns Product performance Process performance Subcontractor performance Training activities Project plans Overall quality summary The above items are discussed and used to assess the overall effectiveness of the quality system. Where inadequate progress toward objectives or goals is found, project plans or corrective actions are initiated to assure the situation remains visible for management.

4.2 QUALITY SYSTEM

4.2 QUALITY SYSTEM 4.2.1 General
Concorde medical equipments have one facility. All aspects of Concorde medical equipments business concerned with the design, sale, production, and delivery of products are under the scope of ISO 9001. Concorde pharmaceuticals quality system is implemented in accordance with the ISO 9001 quality standard. The Concorde medical equipments quality system is organized parallel to the ISO 9001 quality standard. The quality element identification generally follows the numbering structure of the ISO 9001 quality standard. The following documents describe how the Concorde medical equipments quality system is integrated into company operations:

4.2.2 Quality System Procedures

Documented procedures are prepared and are consistent with the ISO 9001 standard and the Concorde Precision Quality Policy. These procedures are implemented throughout the organization. Concorde medical equipments quality system is documented in four levels: Level 1: Quality Manual Level 2: Procedures and Plans Level 3: Instructions and Methods (Work Instructions) Level 4: Quality Records The level of documentation to support the quality system is based on customer requirements, and the skills, methods, and training required by the personnel responsible for the performed work. The person responsible for reviewing, maintaining, and ensuring the effectiveness of a procedure, works instructions, or other quality document is considered the owner. It is the owners responsibility to create and submit a document in its final form to the ISO Coordinator. It is the responsibility of the ISO Coordinator to provide revision control and organization of the master and controlled copies of all Level 1, 2 and 3 quality system documents. Quality records (level 4 documents) are maintained and controlled as described in Control of Quality Records. As we are a medical equipment manufacturing company. Thus we dont need to comply with the 4.3 i.e. contract review.

4.3 CONTRACT REVIEW

4.3.1 General
Documented procedures are established and maintained at Concorde for contract review and the coordination of all these activities.

4.3.2 Review
At Concorde, before submission of a tender, or the acceptance of a contract or order, the tender, contract or order are reviewed. The purpose is to ensure that; A) The requirements of the customer is adequately defined and documented. In case of a verbal statement of the requirements and orders, Concorde ensures the agreement before its acceptance. B) Any differences between the contract or order requirements and the tender are resolved timely. C) The capacity and the capability to serve the order is also essential for the supplier. At Concorde we take care of this aspect.

4.3.2 Amendment To a Contract

At Concorde, the procedure of amendment to a contract is made and correctly being transferred to the functions concerned within our organization.

4.3.4 Records
Records of all the contract reviews are been maintained at Concorde.

4.4 DESIGN CONTROL

4.4.1 General
Design Control ensures that customer requirements are fully understood and communicated to the Engineering Department, and a documented procedure is maintained and followed for the same.

4.4.2 Design and Development Planning

Concorde medical equipments create plans for equipment design and development. The plans include tasks and who will be responsible for the tasks. The person responsible for the task will be qualified for the task or they will be trained. Product plans are updated as the design evolves. Planning procedures include, but are not limited to the following: Identify and record design inputs. Product design outputs. Have design reviews. Evaluate designs for design verification and validation. Evaluate for equipment safety and other regulatory requirements.

4.4.3 Organizational and Technical Interfaces

Organizational and Technical Interfaces between different groups which input into the design process shall be defined as follows: Identification of groups involved in the design-input process and their responsibility and authority. Interfaces between groups Cross-functional meetings to review progress functionality, and coordination

4.4.4 Design Input

There are two distinct methods for capturing design requirements. The first is when a design is being developed for a particular hospital and the second is when a general product is being developed. For customer driven designs (i.e. a designed equipments for a particular hospital), input requirements are captured during the contract review process. These requirements are confirmed with the Engineering Department and are entered into a sales contract. The design process begins upon customer, sales, and engineering review and acceptance of the product requirements. Any time it is determined requirements cannot be met, or there are incomplete, ambiguous, or conflicting requirements, sales will be notified. It will be sales responsibility to resolve all conflicts and other issues with the customer. For non-customer driven designs, input requirements are negotiated between sales and engineering, agreed upon, and recorded. Incomplete, ambiguous, or conflicting requirements will be resolved between sales and engineering as events occur during the design process. Applicable regulatory requirements are considered in the Design Input stage.

4.4.5 Design Output

The design process produces documentation that describes the end product. The documentation is created by engineering and is reviewed by documentation control. The final design documents must: Demonstrate that design-input requirements have been met Ensure Design Output documents adequately describe the product so that it can be produced Include or refer to acceptance criteria (test/inspection procedures) Create product specifications and operating manuals that includes instructions on proper handling and operating directions of product. A review of the design output documents occurs before product release.

4.4.6 Design Review

At appropriate stages of design, formal documentation reviews of the design results is planned and conducted. Records of such reviews are also maintained. Design reviews are conducted by the Engineering Department and any other parties determined by Engineering. Design reviews are documented and maintained as records.

4.4.7 Design Verification

Design verification activities are performed as in the Concept Development and Initial Design Process of 4.4 Design Control to ensure the design output requirements meet the design input requirements. Engineering shall determine the proper verification methods to use during the review. Design verification may include the following activities: Performing alternative calculations Undertaking tests and demonstrations. Design verification measurements are documented and maintained as records.

4.4.8 Design Validation

The customer performs design validation, as described. Design validation is performed during the design process and before final release of the product. Engineering is to decide if additional test procedures for product validation are required.

4.4.9 Design Changes

The Engineering Department approves changes to designs. Changes to designs are made directly on the schematics or drawings if the product is being produced for a one-time use. If the product will have on going sales, an ECO is generated as described in procedure PROC 4.5 Document and Data Control and a new document is created. Engineering Change Orders ensure that all the technical data is adequately captured and distributed to the appropriate areas.

4.5 DOCUMENT AND DATA CONTROL

4.5 Document and Data Control 4.5.1 General
Concorde medical equipments has established and maintained documented procedures to control all documents and data supporting the quality system including external documents

4.5.2 Document and Data Approval and Issue

Documents and data are reviewed and approved for adequacy by authorized personnel before issue. A master list of documents is on Concordes information system identifying the current revision status and is readily available to ensure correct documents are used. Documents are available where needed, as determined by management or area supervisors, to ensure quality system operations. Invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use. Any obsolete documents that are preserved are identified and archived.

4.5.3 Document and Data Changes

Changes to documents and data are reviewed and approved by the same authority group of the originals, unless otherwise designated by management. Background information is available to those who review and approve changes. The authorizing person/group determines when and where the nature of the change will be recorded.

4.6 PURCHASING
4.6 Purchasing
4.6.1 General
Documented and maintained procedures are used to ensure purchased products meet agreed upon specifications and requirements. Concorde medical equipments use the terms subcontractor and vendor interchangeably.

4.6.2 Evaluation of Subcontractors

Concorde medical equipments evaluate and select subcontractors on their ability to meet specifications and requirements. Subcontractor performance is monitored and recorded to ensure quality. The degree of control exercised over subcontractors is determined by the critical quality factors involved in the purchased product. This determination is based on the purchased product significance in meeting customer requirements.

4.6.3 Purchasing Data

Procedures are developed and maintained to ensure all pertinent product information is communicated to a subcontractor. Engineering is responsible for establishing and maintaining specifications to properly identify product. Purchasing is responsible to provide the vendor with drawings and specifications to ensure conformance to requirements. The purchasing organization has the responsibility for reviewing and approving purchasing documents.

4.6.4 Verification of Purchased Product

When verification of purchased product is performed at the subcontractors site, the purchasing documentation will identify the verification methods and the requirements for product release. When stated by contract the customer or a representative may verify product release at Concorde medical equipments or at the subcontractors facility. Verification by the customer shall not absolve Concorde medical equipments of the responsibility to provide acceptable product, nor shall it preclude subsequent rejection by the customer. The customer maintains the right to product rejection upon final delivery if the product does not perform to contracted specifications and requirements. Additionally, verification of product at a subcontractors facility cannot be used by Concorde medical equipments as evidence of an effective control for quality by the subcontractor. Concorde medical equipments does not allow urgent release of product, instead, the normal receiving process is expedited when necessary.

4.7 CONTROL OF CUSTOMER-SUPPLIED PRODUCT

4.7 Customer Supplied Product
Control of Customer Supplied Product ensures customer supplied product is properly verified, handled, stored, and maintained. Customer supplied product includes tools, gauging, packaging, and product. Inadvertent damage to, or loss of customer-supplied product is immediately recorded and communicated to the customer for resolution. Verification of customer supplied product does not absolved the customer from supplying acceptable products. Customer supplied product unsuitable for use is recorded and communicated to the customer for resolution.

4.8 PRODUCT IDENTIFICATION AND TRACEABILITY

4.8 Product Identification and Traceability
Documented procedures are established to identify products from receipt at Concorde medical equipments through production to delivery and acceptance by the customer. When traceability is required, unique coding is used and recorded to track products whether individually or in batches.

4.9 PROCESS CONTROL

4.9 Process Control
Concorde medical equipments has documented and maintained procedures to ensure product quality throughout the production process. Manufacturing does production planning with input from sales forecasting, customer orders, engineering requirements, and other material planning activities. Processes are identified and test procedures are developed by Engineering to ensure product quality. These processes are monitored by Production and improved upon when appropriate. Concorde medical equipments provide state of the art equipment, in an excellent facility, to ensure an environment where trained employees are motivated to produce quality products. Documented procedures and quality plans support process training. Concorde medical equipments is able to verify process performance through inspection and testing of product. Highly skilled employees that are specialists in their occupations perform in-process monitoring to support process control.

4.10 INSPECTION AND TESTING

4.10.1 General
At Concorde, we establish and maintain documented procedures for testing activities and inspection to ensure that the specified requirements for the products are met. All these requirements of inspection and testing and their documentation, is detailed in the quality plan or documented procedures.

4.10.2 Receiving Inspection And Testing

4.10.2.1 Concorde ensures that incoming product is not used or processed until it has been inspected or verified as conforming to specified requirements, in accordance with the quality plan and documented procedures.

4.10.2.2 To determine the amount and nature of receiving inspection, the amount of
control exercised at the subcontractors premises and the recorded evidence of conformance is considered.

4.10.2.3 in case of incoming product getting released for urgent production purposes
prior to verification, the product is positively identified and recorded so that its immediate recall and replacement in the event of nonconformity to specified requirements is possible.

4.10.3 In-Process Inspection And Testing

At Concorde, we Inspect and test the product as per the requirements of quality plan and documented procedures. do not release any product until the require inspection and tests hve been completed and necessary documentation is received and verified except when the product is released under positive-recall procedures (refer to 4.10.2.3).

4.10.4 Final Inspection And Testing

At Concorde, all final inspection and testing is done in accordance with the quality plan and documented procedures so as to maintain the evidence of conformance of finished products as per specified requirements All specified inspection and tests including those specified either on receipt of product or in process is ensured to have been carried out and that the results meet specified requirements as per the quality and documented procedures for final inspection and testing. It is also ensured that no product is dispatched until all the activities specified in the quality plan and documented procedures are satisfactorily completed and associated data and documentation are made available and also authorized.

4.10.5 Inspection And Test Records

At Concorde, the records which provide evidence of the product been inspected and tested are established and maintained these records very clearly show whether the product has passed or failed the inspections and tests according to defined acceptance criteria. In case of the failure, procedures for control of nonconforming products are applied. Records for the identification of the inspection authority responsible for the release of product are also maintained.

4.11 CONTROL OF INSPECTION, MEASURING AND TEST EQUIPMENT

4.11.1 General
At Concorde, documented procedures to control, calibrate and maintain inspection, measuring and test equipment including test software used by the us to demonstrate the conformance of the product to specified requirements are established and maintained. Inspection, measuring and test equipments are used in the manner so as to ensure full knowledge of measurement uncertainty and to maintain the consistency with the required measurement capability. Whenever the test software or comparative references such as test hardware are used as suitable forms of inspection, they are checked to prove that they are capable of verifying the acceptability of product, prior to release for use during production, installation or servicing and are rechecked at prescribed intervals. Also, the records to establish the extent and frequency of these checks and evidence of control are maintained. Availability of technical data related to inspection, measuring and test equipment is ensured whenever required by the customer or customers representative for the purpose of verification of the inspection, measuring and test equipment.

4.11.2 Control Procedures

At Concorde, we Determine the measurements to be made and the accuracy required and also the appropriate inspection, measuring and test equipment that is capable of the necessary accuracy and precision. Identify all inspection, measuring and test equipments affecting product quality and their calibration and adjustment at prescribed intervals and prior to use against nationally / internationally recognized standard equipments. Besides, all these standards and the basis used for calibration is documented. Define the process employed for the calibration of inspection, measuring and test equipments including the details of their type, unique identification, location, frequency of checks, check method, acceptance criteria and steps to be taken in case of any non-conformity. Identify inspection, measuring and test equipment with a suitable indicator or approved identification records to show calibration status. Maintain calibration records for inspection, measuring and test equipment. Assess and documentation of validity of previously done inspection and test results and also, the out-of-calibration status of the test equipment if any. Ensure the suitability of the environmental conditions for calibration, inspections, measurements and tests completed. Ensure the proper handling, preservation and storage of inspection, measuring and test equipment is done to maintain their accuracy and fitness for use.

 Safeguarding inspection, measuring and test facilities, both hardware and software, from adjustments which would invalidate the calibration setting.

4.12 INSPECTION AND TEST STATUS

4.12 Inspection and Test Status
Inspection and Test Status describes how Concorde medical equipments identify the inspection and test status of product throughout the production process. Additionally, procedures are documented and maintained to ensure only conforming product is used in the production process. Records are maintained describing the authority to release conforming product. The identification of inspection and test status shall be maintained, through production, installation and tests (or released under an authorized concession) is dispatched, used or installed.

4.13 CONTROL OF NONCONFORMING PRODUCT

4.13 Control of Nonconforming Product

4.13.1 General
Control of Nonconforming Product ensures nonconforming product is not used in the production process. The nonconforming product is segregated and dispositioned according to documented procedures. Nonconforming product identified in final inspection and test is segregated until the problem is properly resolved and the product meets specified requirements. Documented procedures provide decision criteria on communication about nonconformance and who is to be notified.

4.13.2 Review and Disposition of Nonconforming Product

Procedures are documented and maintained describing the responsibility for review and authority for the disposition of nonconforming product. Nonconforming product may be reworked, regraded, rejected, scrapped, or accepted with or without repair. Any nonconformance to specified requirements in a contract is reported to the customer. The customer has the final decision in accepting the product. Should the customer accept the nonconforming product, the product is identified as such and records are established to document the actual condition. Any product that requires rework is tested and inspected according to documented procedures or the quality plan before it is released.

4.14 CORRECTIVE AND PREVENTIVE ACTION

4.14 Corrective and Preventive Action

4.14.1 General
Corrective and Preventive Action Discrepancy Report describes the corrective and preventive action feedback mechanism at Concorde pharmaceuticals. The degree of investigation into potential or identified problems is directly related to the magnitude of this situation and the potential of the problem surfacing at the customers site. All employees are responsible for ensuring quality; including initiating corrective action, preventive action, or discrepancy reports.

4.14.2 Corrective Action

Corrective action procedures include the following actions: The capturing and proper handling of all customer complaints and nonconformities. Root cause analysis and recording of nonconformities in process, product, or any are of the quality system. Determination process for the actions required to eliminate the cause of nonconformities. Controls to ensure the corrective action have taken place and are effective.

4.14.3 PREVENTIVE ACTION

Procedures are documented and maintained for preventive action. All employees are responsible for implementing preventive action. Preventive action procedures include the following activities: Determination of the problem-solving process for preventive action. Implementation of a problem-solving process with matrices for measuring the programs effectiveness. Actions taken based on the results of preventive actions are submitted to the management representative for review during the management review meeting. Data collection form: Processes Work Operations Concessions Audit results Quality Records Service Reports Customer Complaints

4.15 HANDLING, STORAGE, PACKAGING, PRESERVATION, AND DELIVERY

4.15 Handling, Storage, Packaging, Preservation, and Delivery

4.15.1 General
Procedures are documented and maintained for handling, storage, packaging, preservation, and delivery of product.

4.15.2 Handling
Procedures are established to ensure the proper handling of product throughout the production and delivery process.

4.15.3 Storage
Designated areas are used to store product before use or delivery. These areas ensure the product will not be damaged or deteriorated. Procedures are established for authorizing transportation to and from designated storage areas. Inspection intervals are established to ensure products are reviewed for possible deterioration.

4.15.4 Packaging
Packaging and labeling processes are controlled to ensure conformance to the specified requirements of the product being shipped.

4.15.5 Preservation
Concorde medical equipments ensure products are properly stored, segregated, and preserved when under the organizations control. Incoming products are dated as they are received. This allows for a FIFO inventory system and also allows for product to be evaluated for usability. All products with a restricted shelf life are clearly labeled and personnel are trained to scrap material when it is beyond shelf life.

4.15.6 Delivery
Concorde medical equipments ensure proper preservation of product after final inspection and test. When contract specified, Concorde medical equipments ensures product preservation during delivery to the customer. Concorde pharmaceuticals shipping personnel are trained to package product for shipment without damage.

4.16 CONTROL OF QUALITY RECORDS

4.16 Control of Quality Records
Procedures are documented and maintained for identification, collection, indexing, access filing, storage, maintenance, and disposition of quality records. Quality records define the conformance to specified requirements and effectiveness of the quality system. Quality records received from subcontractors will be included in this element. Quality records are legible and stored in secure locations to prevent loss or damage. Quality records are maintained. Contractually stipulated, customers have access to quality records. Quality records may be in the form of electronic or hard copy.

4.17 INTERNAL QUALITY AUDITS

4.17 Internal Quality Audits
Procedures are documented and maintained for planning and implementing internal quality audits. Audits are conducted a minimum of semiannually on each element and schedule based on the status and importance of activity to be audited. If criticality of the work being performed deems necessary, audit intervals will be increased. The ISO coordinator and/or Management Representative has authority to adjust audit intervals. Audits ensure the quality system including processes, procedures, and work instructions, are effective and that quality objectives are being addressed. The audit process includes evaluation of objective evidence to determine the effectiveness of the quality system. Auditees are the people within a department to be audited. Auditors are persons performing the audit and are independent of the work being performed. A minimum of one auditor on the internal audit team has form Internal Auditor Training. Audit results are recorded and shared with the personnel responsible for the area being audited and copied to the management representative. The audit team leader initiates corrective actions on audit findings. The person identified as responsible will resolve corrective actions according to the corrective action procedure. The follow-up audit activities will verify and record the actions taken and to ensure the effectiveness of the corrective action.

4.18 TRAINING
4.18 Training
Training describes the methods for identifying skills, experience, training, and education. Needs and methods for tracking training and education activities for all employees. Employee competency requirements are documented in Concorde medical equipments job descriptions. Job descriptions are updated, stored, and maintained for all employees. Training is required to ensure competency in the areas listed in the job descriptions. The ISO Coordinator is responsible for the maintenance of job descriptions and training records. Job descriptions are electronically stored in Job Descriptions and are also posted. Training schedules and records for all employees are maintained in a database file. Employee skills, education, and experience are matched to the job to be performed. At a minimum, training needs are reviewed on an annual basis by the supervisor. This review process occurs during the employee annual review. The employer and supervisor as needed and submitted to the ISO Coordinator update Job descriptions. If it is determined that an employee needs additional skills to perform a task, the supervisor and training coordinator will assist the employee in obtaining the proper training or development. Training records are updated upon completion of training activities.

4.19 SERVICING
4.19 Servicing
Concorde medical equipments does not provide service contracts. However, Concorde medical equipments does perform service on equipment it sells on an order by order basis.

4.20 STATISTICAL TECHNIQUES

4.20 Statistical Techniques
Statistical Techniques is used to ensure Concorde medical equipments has the capability and structure to use statistical techniques to improve products and processes.

4.20.1 Identification of Need

All employees are authorized to suggest statistical techniques for tracking process capability and product characteristics through the Corrective and Preventive Action procedure. The ISO Coordinator and Management Representative are responsible for the evaluation and selection of appropriate statistical techniques to be used, based on the type of data collected (attribute or variable) and ho w to meet the need of evaluating the process capability or product characteristic. Quality plans indicate testing and data collection requirements for new and existing products and projects. The quality planning process considers statistical techniques when establishing quality related goals.

4.20.2 Procedures
The series of forms listed for Statistical Techniques are used to collect, evaluate, and report the results of data collection. The completed forms are stored as quality records. Each data collection requirement will be reviewed as a part of the Management Review. Statistical Techniques is a recognized competency. If a persons job description includes competency in statistical techniques, then training will be included in his/her individual training plan.