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ISO-9001
Submitted by:Pushkar kumar 29 (B) Saurabh Skukla 42 (B) Smita Chauhan 47 (B) Vineet Krishna 53 (B)
QM-9001
Quality Manual ISO/9001-1994
Table of Contents
QM-9001
2.1 Introduction -----------------------------------------------------------------------3 3.1 Mission Statement----------------------------------------------------------------4 3.2 Vision Statement -----------------------------------------------------------------4 4.1 Management Responsibility----------------------------------------------------5 4.1.1 Quality Policy ------------------------------------------------------------------5 4.1.2 Organization --------------------------------------------------------------------5 4.1.2.1 Responsibility and Authority ----------------------------------------------6 4.1.2.2 Resources---------------------------------------------------------------------8 4.1.2.3 Management Representative-----------------------------------------------8 4.1.3 Management Representative -------------------------------------------------8 4.2 Quality System -------------------------------------------------------------------9 4.2.1 General --------------------------------------------------------------------------9 4.2.2 Quality System Procedures --------------------------------------------------9 4.2.3 Quality Planning --------------------------------------------------------------10 4.3 Contract Review-----------------------------------------------------------------10 4.3.1 General -------------------------------------------------------------------------10 4.3.2 Review -------------------------------------------------------------------------10 4.3.3 Amendment to a Contract ---------------------------------------------------10 4.3.4 Records ---------------------------------------------------------------------10 4.4 Design Control-------------------------------------------------------------------11 4.4.1 General -------------------------------------------------------------------------11 4.4.2 Design and Development Planning-----------------------------------------11 4.4.3 Organizational and Technical Interfaces-----------------------------------11 4.4.4 Design Input -------------------------------------------------------------------11 4.4.5 Design Output------------------------------------------------------------------12 4.4.6 Design Review-----------------------------------------------------------------12 4.4.7 Design Verification-----------------------------------------------------------12 4.4.8 Design Validation ------------------------------------------------------------12 4.4.9 Design Changes ---------------------------------------------------------------12 4.5 Document and Data Control ---------------------------------------------------13 4.5.1 General -------------------------------------------------------------------------13 4.5.2 Document and Data Approval and Issue-----------------------------------13 4.5.3 Document and Data Changes -----------------------------------------------13 4.6 Purchasing -----------------------------------------------------------------------14 4.6.1 General -------------------------------------------------------------------------14 4.6.2 Evaluation of Subcontractors -----------------------------------------------14
4.6.3 Purchasing Data---------------------------------------------------------------- 14 4.6.4 Verification of Purchased Product--------------------------------------------14 4.7 Control of Customer Supplied Product ----------------------------------------15 4.8 Product Identification and Traceability ---------------------------------------16 4.9 Process Control--------------------------------------------------------------------17 4.10 Inspection and Testing----------------------------------------------------------18 4.10.1 General -------------------------------------------------------------------------18 4.10.2 Receiving Inspection and Testing-------------------------------------------18 4.10.3 In-Process Inspection and Testing -----------------------------------------18 4.10.4 Final Inspection and Testing-------------------------------------------------18 4.10.5 Inspection and Test Records-------------------------------------------------19 4.11 Control of Inspection, Measuring, and Test Equipment-------------------20 4.11.1 General -------------------------------------------------------------------------20 4.11.2 Control Procedure-------------------------------------------------------------20 4.12 Inspection and Test Status -----------------------------------------------------21 4.13 Control of Nonconforming Product ------------------------------------------22 4.13.1 General -------------------------------------------------------------------------22 4.13.2 Review and Disposition of Nonconforming Product --------------------22 4.14 Corrective and Preventive Action --------------------------------------------23 4.14.1 General -------------------------------------------------------------------------23 4.14.2 Corrective Action--------------------------------------------------------------23 4.14.3 Preventive Action-------------------------------------------------------------23 4.15 Handling, Storage, Packaging, Preservation, and Delivery----------------24 4.15.1 General -------------------------------------------------------------------------24 4.15.2 Handling------------------------------------------------------------------------24 4.15.3 Storage--------------------------------------------------------------------------24 4.15.4 Packaging ----------------------------------------------------------------------24 4.15.5 Preservation--------------------------------------------------------------------24 4.15.6 Delivery-------------------------------------------------------------------------24 4.16 Control of Quality Records-----------------------------------------------------25 4.17 Internal Quality Audits----------------------------------------------------------26 4.18 Training --------------------------------------------------------------------------27 4.19 Servicing--------------------------------------------------------------------------28 4.20 Statistical Techniques-----------------------------------------------------------29 4.20.1 Identification of Need-------------------------------------------------------------29
4.20.2 Procedures-----------------------------------------------------------------------------29
INTRODUCTION
2.1 Introduction
This manual describes the quality system in operation CONCORDE MEDICAL EQUIPMENTS MANUFACTURERS in Chanakya Puri, New Delhi. This quality manual includes Concorde medical equipments quality policy, a description of the operational systems to ensure product quality, and the policies that support the ISO 9001 quality system elements. Concorde medical equipments works with its suppliers, internal resources, and customers to provide medical products and equipments that are best in term of application and performance. Customers (hospitals, private nursing homes, etc) often use Concorde medical equipments products to give the best service to their patients that cannot be provided with alternative products. The cost and performance of our sensor technology create high expectations in the minds of our customers. It is essential that we provide the highest quality products in order to earn and maintain the confidence of our customers. The president of Concorde medical equipments approves this quality manual. Quality system documents are controlled as described in PROC 4.5 Document and Data Control. PROC 4.15 includes instructions to have controlled. copies uniquely and have locations identified on a maintained document. This manual and all supporting documents support the ISO 9001 International Quality Standards 9001:1994.
4.1.2 Organization
Concorde pharmaceuticals is organized along traditional lines. There are departments for Sales and Marketing, Engineering, Accounting, Material Control/Production Planning, Quality, and Production. In order for the company to meet its objectives, it is imperative that all departments maintain a team-oriented attitude, where the team is the entire company. An organization chart (Appendix QM-APP 1) is included as an appendix to this Quality Manual and is posted to show responsibilities and relationships. The ISO Coordinator updates the organizational chart when changes occur.
Job Descriptions
President: The President is to provide leadership and guidance for the acceptance, maintenance, and enforcement of the Quality System and is also the Management Representative. In addition, the President helps develop and monitor progress toward company objectives and goals and maintains the Quality Manual.
ISO Coordinator: The ISO Coordinator is responsible for scheduling management review meetings, recording and distributing meeting minutes, scheduling and monitoring audits, and maintaining the ISO cross reference chart (Appendix QM-APP2). The ISO Coordinator maintains the organization chart, job descriptions, training requirements, and training records. In addition, the ISO Coordinator reviews proposals for statistical techniques, summarize and presents statistical data for management review. Control of quality system documentation is also included in the duties. Quality Coordinator: The Quality Coordinator provides organization-wide quality system Monitoring and reporting, coordinates the corrective and preventive action, controls test and measurement equipment, and maintains the list of internal quality records. Nonconforming Product Coordinator: The Nonconforming Product Coordinator logs and tracks all incidents of nonconforming products. Sales Manager: The Sales Manager is responsible for return procedures, demo procedures, the sales order form, and follow up concerning customer satisfaction. Product Manager: The Product Manager is responsible for customer quotation review, incoming purchase order review, internal sales order review, and follow up concerning customer satisfaction. Engineering Manager: The Engineering manager is responsible for the control of design and development of new products and for the control of product modifications. This includes confirming customer requirements, providing design validation, verification, and support and training of manufacturing on new product designs and changes to existing products. Engineering Documentation: Engineering Documentation is responsible for control of engineering documentation. Buyer: The Buyer is responsible for subcontractor selection, subcontractor evaluation, review of purchase orders, and the conduit for communication between subcontractor sand departments within the company. Operations Manager: The Operations Manager is responsible for manufacturing processes, in process evaluation and testing, inspection and test status, and nonconforming product. Inventory Control: Inventory Control is responsible for control of customer-supplied product as well as handling, storage, packaging, preservation, and delivery of materials. Technical Support: Technical Support is responsible for final inspection and testing as well as repair of customer owned product. In addition to job descriptions, specific responsibilities are also identified within procedures.
4.1.2.2 Resources
Documented procedures have been established to ensure employees are provided with the proper training, equipment, and skills. Personnel requirements to accomplish management, work, and verification activities are determined from product sales forecasts and from organizational goals and objectives developed from the annual business plan.
4.3.2 Review
At Concorde, before submission of a tender, or the acceptance of a contract or order, the tender, contract or order are reviewed. The purpose is to ensure that; A) The requirements of the customer is adequately defined and documented. In case of a verbal statement of the requirements and orders, Concorde ensures the agreement before its acceptance. B) Any differences between the contract or order requirements and the tender are resolved timely. C) The capacity and the capability to serve the order is also essential for the supplier. At Concorde we take care of this aspect.
4.3.4 Records
Records of all the contract reviews are been maintained at Concorde.
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.
Procedures are developed and maintained to ensure all pertinent product information is communicated to a subcontractor. Engineering is responsible for establishing and maintaining specifications to properly identify product. Purchasing is responsible to provide the vendor with drawings and specifications to ensure conformance to requirements. The purchasing organization has the responsibility for reviewing and approving purchasing documents.
4.10.2.2 To determine the amount and nature of receiving inspection, the amount of
control exercised at the subcontractors premises and the recorded evidence of conformance is considered.
4.10.2.3 in case of incoming product getting released for urgent production purposes
prior to verification, the product is positively identified and recorded so that its immediate recall and replacement in the event of nonconformity to specified requirements is possible.
Safeguarding inspection, measuring and test facilities, both hardware and software, from adjustments which would invalidate the calibration setting.
4.13.1 General
Control of Nonconforming Product ensures nonconforming product is not used in the production process. The nonconforming product is segregated and dispositioned according to documented procedures. Nonconforming product identified in final inspection and test is segregated until the problem is properly resolved and the product meets specified requirements. Documented procedures provide decision criteria on communication about nonconformance and who is to be notified.
4.14.1 General
Corrective and Preventive Action Discrepancy Report describes the corrective and preventive action feedback mechanism at Concorde pharmaceuticals. The degree of investigation into potential or identified problems is directly related to the magnitude of this situation and the potential of the problem surfacing at the customers site. All employees are responsible for ensuring quality; including initiating corrective action, preventive action, or discrepancy reports.
4.15.1 General
Procedures are documented and maintained for handling, storage, packaging, preservation, and delivery of product.
4.15.2 Handling
Procedures are established to ensure the proper handling of product throughout the production and delivery process.
4.15.3 Storage
Designated areas are used to store product before use or delivery. These areas ensure the product will not be damaged or deteriorated. Procedures are established for authorizing transportation to and from designated storage areas. Inspection intervals are established to ensure products are reviewed for possible deterioration.
4.15.4 Packaging
Packaging and labeling processes are controlled to ensure conformance to the specified requirements of the product being shipped.
4.15.5 Preservation
Concorde medical equipments ensure products are properly stored, segregated, and preserved when under the organizations control. Incoming products are dated as they are received. This allows for a FIFO inventory system and also allows for product to be evaluated for usability. All products with a restricted shelf life are clearly labeled and personnel are trained to scrap material when it is beyond shelf life.
4.15.6 Delivery
Concorde medical equipments ensure proper preservation of product after final inspection and test. When contract specified, Concorde medical equipments ensures product preservation during delivery to the customer. Concorde pharmaceuticals shipping personnel are trained to package product for shipment without damage.
4.18 TRAINING
4.18 Training
Training describes the methods for identifying skills, experience, training, and education. Needs and methods for tracking training and education activities for all employees. Employee competency requirements are documented in Concorde medical equipments job descriptions. Job descriptions are updated, stored, and maintained for all employees. Training is required to ensure competency in the areas listed in the job descriptions. The ISO Coordinator is responsible for the maintenance of job descriptions and training records. Job descriptions are electronically stored in Job Descriptions and are also posted. Training schedules and records for all employees are maintained in a database file. Employee skills, education, and experience are matched to the job to be performed. At a minimum, training needs are reviewed on an annual basis by the supervisor. This review process occurs during the employee annual review. The employer and supervisor as needed and submitted to the ISO Coordinator update Job descriptions. If it is determined that an employee needs additional skills to perform a task, the supervisor and training coordinator will assist the employee in obtaining the proper training or development. Training records are updated upon completion of training activities.
4.19 SERVICING
4.19 Servicing
Concorde medical equipments does not provide service contracts. However, Concorde medical equipments does perform service on equipment it sells on an order by order basis.
4.20.2 Procedures
The series of forms listed for Statistical Techniques are used to collect, evaluate, and report the results of data collection. The completed forms are stored as quality records. Each data collection requirement will be reviewed as a part of the Management Review. Statistical Techniques is a recognized competency. If a persons job description includes competency in statistical techniques, then training will be included in his/her individual training plan.