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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.