quality manual -iso 900

7/29/2019 Quality Manual -IsO 900

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QUALITY MANUAL

ISO-9001

Submitted by:- Submitted to:-Prof. Jag Mohan

Pushkar kumar 29 (B) EMPI B SchoolSaurabh Skukla 42 (B) NEW DELHI

Smita Chauhan 47 (B)

Vineet Krishna 53 (B)

Submission Year - 2001


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QM-9001

Quality Manual

ISO/9001-1994

Table of ContentsQM-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-----------------------------------------------84.1.3 Management Representative -------------------------------------------------8

4.2 Quality System -------------------------------------------------------------------9

4.2.1 General --------------------------------------------------------------------------94.2.2 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 ---------------------------------------------------------------------104.4 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 -------------------------------------------------------------------114.4.5 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 ---------------------------------------------------------------124.5 Document and Data Control ---------------------------------------------------134.5.1 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


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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 -------------------------------------------------------------------------184.10.2 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 -------------------------------------------------------------------------224.13.2 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----------------244.15.1 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-------------------------------------------------------------------------244.16 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-------------------------------------------------------------294.20.2 Procedures-----------------------------------------------------------------------------29


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INTRODUCTION

2.1 Introduction

This manual describes the quality system in operation CONCORDE MEDICAL

EQUIPMENTS MANUFACTURERSin Chanakya Puri, New Delhi.This quality manual includes Concorde medical equipments quality policy, a descriptionof 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 andperformance. 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.


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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 andafter 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, mutualrespect, 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 toachieve 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.


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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 Satisfactionmeans:* Perfect and accurate delivery rates

Products are reliable.

At Concorde medical equipments A Motivated Workforcemeans:

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 forSales 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 entirecompany.

An organization chart (Appendix QM-APP 1) is included as an appendix to this QualityManual and is posted to show responsibilities and relationships. The ISO Coordinator

updates the organizational chart when changes occur.


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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 andencourage 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 qualitydecisions. Key responsibilities, authorities, and interfaces regarding the quality system

have been assigned to the management Representative, Quality Coordinator, andNonconforming 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 individualshave 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 andfeedback 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 andpreventive 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 isthrough 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 towardcompany objectives and goals and maintains the Quality Manual.


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ISO Coordinator: The ISO Coordinator is responsible for scheduling management reviewmeetings, 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, andtraining 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 testand measurement equipment, and maintains the list of internal quality records.

Nonconforming Product Coordinator: The Nonconforming Product Coordinator logsand tracks all incidents of nonconforming products.

Sales Manager: The Sales Manager is responsible for return procedures, demoprocedures, 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, andsupport and training of manufacturing on new product designs and changes to existing

products.

Engineering Documentation: Engineering Documentation is responsible for control ofengineering 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.


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4.1.2.2 Resources

Documented procedures have been established to ensure employees are provided with theproper 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 asdetermined 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 determinedduring 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 qualitysystem. Where inadequate progress toward objectives or goals is found, project plans or

corrective actions are initiated to assure the situation remains visible for management.


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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 productsare 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. Thequality 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 andthe Concorde Precision Quality Policy. These procedures are implemented throughout the

organization.

Concorde medical equipments quality system is documented in four levels:

Level 1: Quality ManualLevel 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 customerrequirements, and the skills, methods, and training required by the personnel responsiblefor 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 inits 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.


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4.3 CONTRACT REVIEW

4.3.1 General

Documented procedures are established and maintained at Concorde for contract reviewand 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 agreementbefore 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 beingtransferred to the functions concerned within our organization.

4.3.4 Records

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


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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 maintainedand 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 groupsCross-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 adesign 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 cannotbe 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 Inputstage.


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4.4.5 Design Output

The design process produces documentation that describes the end product. Thedocumentation 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 beproduced

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 documentsoccurs 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 partiesdetermined 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 InitialDesign Process of4.4 Design Controlto 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 performedduring 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 madedirectly 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 procedurePROC 4.5 Document and Data Control and a new document is created. EngineeringChange Orders ensure that all the technical data is adequately captured and distributed to

the appropriate areas.


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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.


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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 toensure 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 c

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 toprovide 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 verifyproduct 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 ifthe 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 normalreceiving process is expedited when necessary.


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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 andcommunicated 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 tothe customer for resolution.


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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. Whentraceability is required, unique coding is used and recorded to track products whetherindividually or in batches.


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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 aredeveloped 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 occupationsperform in-process monitoring to support process control.


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4.10 INSPECTION AND TESTING

4.10.1 General

At Concorde, we establish and maintain documented procedures for testing activities andinspection 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 ofcontrol 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 purposesprior 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 completedand necessary documentation is received and verified except when the product isreleased 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 finishedproducts 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 specifiedrequirements 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 associateddata and documentation are made available and also authorized.


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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 fullknowledge 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 orservicing 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 thesestandards 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.


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Safeguarding inspection, measuring and test facilities, both hardware and software,

from adjustments which would invalidate the calibration setting.


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4.12 INSPECTION AND TEST STATUS

4.12 Inspection and Test Status

Inspection and Test Status describes how Concorde medical equipments identify theinspection 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.


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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 theproduction process. The nonconforming product is segregated and dispositioned accordingto 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 aboutnonconformance 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 reportedto 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.


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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 ofinvestigation 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 areresponsible 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 resultsQuality Records

Service ReportsCustomer Complaints


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4.15 HANDLING, STORAGE, PACKAGING, PRESERVATION,

AND DELIVERY

4.15 Handling, Storage, Packaging, Preservation, and Delivery

4.15.1 GeneralProcedures 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 theproduct will not be damaged or deteriorated. Procedures are established for authorizing

transportation to and from designated storage areas. Inspection intervals are established toensure 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 beevaluated 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 inspectionand 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.


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4.16 CONTROL OF QUALITY RECORDS

4.16 Control of Quality Records

Procedures are documented and maintained for identification, collection, indexing, accessfiling, storage, maintenance, and disposition of quality records.

Quality records define the conformance to specified requirements and effectiveness of thequality system. Quality records received from subcontractors will be included in thiselement. 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.


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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 schedulebased 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 includesevaluation 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 onthe internal audit team has form Internal Auditor Training.

Audit results are recorded and shared with the personnel responsible for the area beingaudited 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 thecorrective action.


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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 jobdescriptions. 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 Descriptionsand 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 reviewprocess occurs during the employee annual review.

The employer and supervisor as needed and submitted to the ISO Coordinator update Jobdescriptions. 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.


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4.19 SERVICING

4.19 Servicing

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


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4.20 STATISTICAL TECHNIQUES

4.20 Statistical Techniques

Statistical Techniques is used to ensure Concorde medical equipments has the capabilityand 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 Actionprocedure. 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 processcapability 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 competencyin statistical techniques, then training will be included in his/her individual training plan.