Quality system manual.

NAGALAKSHMI SOLUTIONS Quality Manual ISO 9001:2008 Introduction NAGALAKSHMI SOLUTIONS has developed and implemented a Quality Management System in order to document the company’s best business practices, better satisfy the requirements and expectations of its customers and to improve the overall management of the company. The Quality Management System of NAGALAKSHMI SOLUTIONS meets the requirements of the international standard ISO 9001:2008. This system addresses the design, development, production, installation, and servicing of the company’s products. This manual describes the Quality Management System, delineates authorities, inter relationships and responsibilities of the personnel responsible for performing within the system. The manual also provides procedures or references for all activities comprising the Quality Management System to ensure compliance to the necessary requirements of the standard. This manual is used internally to guide the company’s employees through the various requirements of the ISO standard that must be met and maintained in order to ensure customer satisfaction, continuous improvement and provide the necessary instructions that create an empowered work force. This manual is used externally to introduce our Quality Management System to our customers and other external organizations or individuals. The manual is used to familiarize them with the controls that have been implemented and to assure them that the integrity of the Quality Management System is maintained and focused on customer satisfaction and continuous improvement.

Quality Management System (QMS) Process Map

The system is structured to comply with the conditions set forth in the International Standard ISO 9001:2000. Quality management systems – Requirements ISO 9004:2000. and encompasses all operations at our facilities.7. terms. The policies within this manual detail the general requirements that NAGALAKSHMI SOLUTIONS follows. Quality management systems – Fundamentals and vocabulary ISO 9001:2008. This quality manual outlines the policies. The specific procedures and forms used to comply with these requirements are detailed in the procedures.5 Specifying how procedures and resources shall be applied Record 3.2 Application Our QMS complies with all applicable requirements contained in ISO 9001:2008.4. 2. customers. Scope 1.2 Information and its supporting medium Procedure 3.6 Document stating results achieved or evidence of activities Specification 3.7. Reference Documents The following external documents contain provisions which. 1. vocabulary and definitions unique to our organization. This manual describes the requirements and expectations with which we comply. Terms and definitions Acronyms.7.4 Document specifying the quality management system Quality Plan 3.7.3 Document stating requirements .5 Specified way to carry out an activity or a process Quality Manual 3.1. Quality management systems – Guidelines for performance improvements 3.7. procedures and requirements of the Quality Management System. industry and region and referenced throughout our QMS are contained in appendix A Terms and Definitions The following terms and definitions are taken from ISO 9000:2005: Term Clause Definition Document 3. constitute provisions of our QMS: ISO 9000:2005. covers the Design and provision of all company products. through reference in this manual.1 General This purpose of this quality manual is to describe the quality program and structure implemented by NAGALAKSHMI SOLUTIONS to provide its customers with the assurance of consistent product and service quality.

     Level 1: Policies – key system objectives Level 2: Quality Manual – approach & responsibility Level 3: Procedures – methods (Who. things we do). documented and implemented a Quality Management System (QMS) in accordance with the requirements of ISO 9001:2000. The system is structured in five levels.2. 4. by defining and managing:  Process inputs.2.2 All of the QMS documents are controlled according to the Control Procedure.e. audit results. The system is maintained and continually improved through the use of the quality policy. We have adopted the process approach advocated by iso 9001:2005. procedures and processes needed to implement our quality policy and achieve our quality objectives. Data & Records – evidence of conformance Quality manual This manual is part of our QMs that defines the scope of our QMS and documents the policy. This procedure defines the process for:  Approving documents for adequacy prior to issue  Reviewing and updating as necessary and re-approving documents  Ensuring that changes and current revision status of documents are identified  Ensuring that relevant versions of applicable documents are available at points of use . analysis of data. controls.2 Documentation requirements In order to maintain this assurance a documented quality system has been developed to ensure and demonstrate that all work undertaken conforms to specification requirements. Where & When) Level 4: Work Instructions – description of processes (How) Level 5: Forms.1 4. which are in place to meet the specific needs of our external customers. product realization process(i.4. Our core business processes are what we call Customer oriented processes or COPs. quality objectives. Control of documents 4. corrective and preventive action and management review. which directly relate to requirements contained in Clause 7 of iso 9001:2008. What. Quality management system 4.1 General requirements NAGALAKSHMI SOLUTIONS has established. and outputs t ensure desired results are achieved  Interfaces between interrelated processes to ensure system effectiveness is achieved.

Management Responsibility 5.  Communicate the importance of meeting customer. retrieval.   Ensuring that documents remain legible and readily identifiable Ensuring that documents of external origin are identified and their distribution controlled. Preventing the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose 4.  Ensure the availability of resources. and established quality objectives and the quality policy. readily identifiable and retrievable. management will do the following. retention time and disposition of quality records. The procedure defines the controls needed for identification.2.2 Customer focus . It has provided the vision and strategic direction for the growth of the QMS. This procedure requires that quality records remain legible. storage. The records are maintained according to the Control of Quality Records Procedure (QP-424-001). 5. To continue to provide leadership and show commitment to the improvement of the QMS. statutory.  Conduct quarterly management reviews. protection.3 Control of records Quality records are maintained to provide evidence of conformity to requirements and of the effective operation of the QMS.1 management Commitment Top management has been actively involved in implementing the quality management system (QMS).  Establish quality objectives  Establish the quality policy.  Final Inspection Records  Training Records  Process Instructions  Calibration Records  Corrective Action Reports  Management Review Results 5. and regulatory requirements.

Quality Policy.4 Planning 5. It is included in new employee training and training on the QMS. 5. These inputs include the following: .1 Quality Objectives Quality objectives are established to support our organization’s efforts in achieving our quality policy and reviewed annually for suitability. Quality objectives are stated within the Quality Policy (AP-500-001). by requiring compliance with documented customer communication procedures.3 Internal communications 5. Objectives have been established for the following.4. Top management ensures that customer requirements are understood and met. release of product. 5.6 Management review 5.1 of the ISO 9001 standard.2 Management representatives 5. It is posted in prominent places throughout the facility to maintain high standards within our organization. and communicated to the appropriate people in our organization. Records are maintained for each management review meeting. identifying opportunities for improvement and needed changes.1 Responsibility and authority 5.5.3 Quality policy Top management ensures that the quality policy is communicated to all employees. Customer requirements are determined. Management reviews the quality policy at each management review meeting to determine the policy’s continuing suitability for our organization. Quality planning takes place as changes that affect the quality system are planned and implemented. and to exceed customer expectations. converted into internal requirements.6.NAGALAKSHMI SOLUTIONS strives to identify current and future customer needs. Quality objectives are measurable. adequacy and effectiveness. This review assesses the continuing QMS suitability. 5. 5.2 Quality management system planning The quality system has been planned and implemented to meet our quality objectives and the requirements of 4. and customer feedback. and reviewed against performance goals at each management review meeting. supplier performance. The Quality Policy is documented on A-500-001. 5.5 *Responsibility authority and communication 5.1 General Top management reviews the QMS quarterly at management review meetings. to meet customer requirements.2 Review input Assessment of the QMS is based on a review of information inputs to management review.

Any decisions made during the meeting. This implementation was achieved with management commitment and with sufficient resources for the implementation.1 General To ensure competence of our personnel. 6.2.        Results of audits Customer feedback Process performance and product conformity Company level quality data Status of preventive and corrective actions Follow-up actions from previous management reviews Planned changes that could affect the quality management system Recommendations for improvement 5. Qualifications include requirements . Management determines and provides necessary resources to effectively maintain and continually improve the effectiveness of the quality management system and to enhance customer satisfaction by meeting customer requirements. assigned actions.2 Human resources 6. management will identify appropriate actions to be taken regarding the following issues:  Improvement of the effectiveness of the quality management system and its processes  Improvement of product related to customer requirements  Resource needs Responsibility for required actions are assigned to members of the management review team.1 Provision of resources NAGALAKSHMI SOLUTIONS has implemented a Quality Management System that complies with the ISO 9001 2000 standard. and their due dates are recorded in the minutes of management review.3 Review output During these review meetings. 6. Resource management 6. job descriptions have been prepared identifying the qualifications required for each position that affects product quality.6.

process equipment and supporting services. or contract. The results are then evaluated to determine if they were effective. training or other action is taken to provide the employee with the necessary competence for the job. 6. Existing infrastructure is maintained to ensure product conformity. As new infrastructure requirements arise. when an employee changes positions or the requirements for a position change. The infrastructure has been provided. utilities. and includes buildings. Product realization 7. equipment. and any/all applicable statutory/legal requirements.1 planning of product realization Our QMS identifies.2 Customer related processes Achieving our quality policy “to meet or exceed customer requirements” requires that we determine. Appropriate qualifications. and consistently meet or exceed our customers’ requirements and expectations. Requirements are determined during quality planning and documented in the quality plan. 7. 7. (AP-662-001) All employees are trained on the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. Training and evaluation are conducted according to the Training procedure.2. along with required training. The work environment is managed for continuing suitability.for education.2 Competence. 6. understand.3 Infrastructure To meet quality objectives and product requirements NAGALAKSHMI SOLUTIONS has determined the infrastructure needed (MP-630-001). workspace. people and materials/support services needed to achieve all desired results for a particular product. skills and experience. service. provide the competence required for each position. Human resources maintain records of employee qualifications. If any differences between the employee’s qualifications and the requirements for the job are found. The outputs of products/service realization planning include the specific methods facilities. including customer requirements and related quality objectives and requirements for specific products/services. Data from the quality system is evaluated to determine if the work environment is sufficient for achieving product conformance. plans for and documents our products and services realization process to ensure consistency with all applicable requirements.4 Work environment A work environment suitable for achieving product conformance is maintained. or if preventive or corrective action related to the work environment is required. training and awareness Qualifications are reviewed upon hire. . they will be documented in quality plans. and that we establish effective communication systems with our customers with regards to product information. 6.

In other cases. or change an existing. resolves any incomplete. 7. and we ensure that the customer’s requirements are clearly identified and confirmed prior to acceptance Product requirements specified by the customer. The Operations and Technical Director has overall responsibility for managing product design and development activities. predetermined design reviews. These efforts are described below. legal and regulatory requirements which apply . The Operations and Technical Director maintains a list of products/services for which NAGALAKSHMI SOLUTIONS has design responsibility.e. 7. before finalizing documentation of required inputs. a customer order constitutes a contract. identifies design stages. contract or order handling and related changes. processes or systems.3. i.2. and customer feedback. Requirements for most major customers are identified in contracts documented and reviewed annually. The Design Team Leader prepares all engineering requirements for product realization. The Operations and Technical Director identifies. delivery and support including any after-sales product service and/or post-delivery servicing provided as part of the customer contract or purchase order. ambiguous or conflicting requirements. product specification.1 Determination of requirements related to the product Sales personnel generate quotes and negotiate final contracts/orders. at a minimum. the authority to establish a new. this responsibility includes testing and verification of design performance within customer specified applications. including complaints. documents and reviews design inputs. scheduled verification and validation activities.inquiries.1 Design planning The Operations and Technical Director serves as the Design Team Leader for design projects for new/changed products or services. The Managing Director has overall responsibility for developing and implementing effective customer-related processes in accordance with the policies in this section 7. The Design Team Leader utilizes project management planning tools (available software etc.2 Design inputs Design inputs.3. • The functional and performance requirements as derived from customer input. including the requirements for availability. products. 7.) to establish a Design Plan that.3 Design and Development Design and development processes are employed at NAGALAKSHMI SOLUTIONS to transform Customer requirements into specifications. and.

7.3 Design review During the evolution of each design project. As applicable. 7. 7. reliability. reviewed. which may include verification or validation. Design validation is performed to ensure the product or service resulting from design efforts performs as intended for all specified or known uses/applications.4 Purchasing We work in partnership with our suppliers to ensure that purchased products and services meet all applicable requirements. Control also includes the determination of treatment required for each change. when they are not.3.3.6 Control of design changes The Operations and Technical Director ensures all design changes are identified. durability. communicated to all affected organizations and functions.3. and results and any necessary actions are recorded throughout the product program.3. Design change control includes an assessment of the impact of changes upon component parts and completed products. Design verification activities are intended to determine if design output meets design input requirements. Design reviews are intended to assure that requirements are being fulfilled. the Operations and Technical Director conducts design reviews as planned and records results and any necessary actions. 7. All functions concerned with the stage being reviewed are represented at the planned review(s). sequencing. design reviews can be a form of design verification. rework and calibration services) . the Operations and Technical Director utilizes input from those involved in the review to propose a remedy for each identified problem. acquisition and verification of all products and services that affect customer requirements (such as subassembly. life. sorting.5 Design validation The Operations and Technical Director ensures design validation is carried out as planned (per the Design Plan) and records results and any necessary actions. approved. documented. maintainability. The processes applicable to the planning. the Operations and Technical Director plans and carries out or oversees.• Useful information or experience from previous similar design efforts • Targets for product quality. including those that may have already been delivered. timing and cost 7.4 Design verification The Operations and Technical Director ensures design verification activities are carried out as planned (per the Design Plan) and records results and any necessary actions.

4. including where appropriate:  Requirements for approval of product.5 PRODUCTION 7. as well as consideration of other characteristics including: the type of product.2 Purchasing information Purchasing information describes the product to be purchased. 7. processes and equipment Requirements for qualification of personnel  Quality management system requirements The purchasing documents are reviewed to ensure the adequacy of requirements before orders are placed with the supplier. Controlled conditions include. and past performance.1 Control of production NAGALAKSHMI SOLUTIONS plans and carries out production and under controlled conditions.4. as applicable:       The availability of information that describes the characteristics of the product The availability of work instructions The use of suitable equipment The availability and use of monitoring and measuring devices The implementation of monitoring and measurement The implementation of release. or services.3 Verification of Purchased products  Top manager has overall responsibility for ensuring the quality of purchased products using one or more of the following methods: receipt and evaluation of statistical data.7. 7.1 Purchasing process The type and extent of control applied to our suppliers and purchased product is dependent upon the effect on subsequent realization processes and their output.4. products. delivery and post-delivery activities . second or third party audits of supplier sites (when coupled with records of acceptable delivered product quality). 7. the results of supplier evaluations. receiving inspection and/or testing (such as sampling based on performance). the potential impact of the product on our processes.5.

7. storage.5. Validation demonstrates the ability of these processes to achieve planned results.5. installation and delivery in accordance with procedures. NAGALAKSHMI SOLUTIONS has documented the process for validation including:  Defined criteria for review and approval of the processes  Approval of equipment and qualification of personnel  Use of specific methods and procedures  Requirements for records  Revalidation 7. production. Analysis and Improvement 8. 7. Where product traceability is a customer-specified requirement.4 Preservation of product Top management has overall responsibility for establishing and implementing a material management system to ensure product conformity is preserved during internal processing and delivery to the intended destination. to ensure: • Components and products are handled and stored in a manner that prevents damage or deterioration pending use or delivery. • Each department ensures controls are implemented to prevent mixing conforming and nonconforming materials. • Packing ensures specified or original manufacturing packaging is utilized. 8. This system includes the handling.5.5. appropriate controls and records are established and maintained. packaging. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Measurement.1 General .5 Invoice and Delivery This is the responsibility of the accounts department t to prepare and send the appropriate documentation to the customer at the time of delivery according to the purchase order terms and conditions.2 Validation of processes for production NAGALAKSHMI SOLUTIONS validates any processes for production where the resulting output cannot be verified by subsequent monitoring or measurement. 7.3 Identification and traceability Top manager has overall responsibility for establishing and maintaining product identification throughout all stages of design. delivery. and protection of final product as well as raw materials and in-process constituents of the final product.

” The Managing Director has overall responsibility for identifying and reviewing customer requirements and for monitoring and measuring customer satisfaction per procedures. When planned results are not achieved. measurement of the quality management system processes. correction and corrective action is taken. correction and corrective action is taken.2.2 Monitoring and measurement of processes NAGALAKSHMI SOLUTIONS applies suitable methods for monitoring and.1 Customer satisfaction Customers are the reason we exist and drive our quality policy “to meet or exceed customer requirements. measurement of the quality management system processes. 8.3 Monitoring and measurement of processes NAGALAKSHMI SOLUTIONS applies suitable methods for monitoring and.2.3 Control of Nonconforming product NAGALAKSHMI SOLUTIONS ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. to ensure conformity of the product.4 Monitoring and measurement of product NAGALAKSHMI SOLUTIONS monitors and measures the characteristics of the product to verify that product requirements are fulfilled.  To ensure conformity of the quality management system.2. 8. 8. This is carried out at appropriate stages of the product realization process identified in Monitoring. . At a minimum.2. Measuring and Analysis of Product Realization Processes. data is analyzed to assess achievement of the corporate level quality objectives. When planned results are not achieved. as appropriate. to ensure conformity of the product. as appropriate. 8. These methods demonstrate the ability of the processes to achieve planned results. 8.  To continually improve the effectiveness of the quality management system. analysis and improvement processes as needed:  To demonstrate conformity of the product. 8. These methods demonstrate the ability of the processes to achieve planned results. where applicable.NAGALAKSHMI SOLUTIONS has planned and implemented the monitoring. where applicable.4 Analysis of data Top Management and other officers. measurement. managers and supervisors collect and analyze data using appropriate statistical techniques to determine the suitability and effectiveness of key QMS processes applicable to their area(s) of responsibility and to identify opportunities for improvement. The controls and related responsibilities and authorities for dealing with nonconforming product are defined in the Control of Nonconforming Product procedure.

Terms and definitions contained in this manual and unique to our organization or business are listed below. the definitions given in ISO 9000:2005 apply. . Terms and definitions contained ISO 9000:2005. Customer definitions will take precedence over all other definitions. contact the Quality Manager to obtain or view copies of this document. when there is a difference.Appendix A Terms and Definitions Acronyms: QMS – Quality Management System OP – Standard Operating Procedure Terms and Definitions.

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