Quality Manual NISAN

QUALITY MANAGEMENT SYSTEM

ISO 9001:2008

NSPEPL-QM-01 Page 1 of 33 Issue No.-01 Rev.No.-00 Date: 25.02.14

Title: APEX MANUAL

Section No. 00 Title : Contents Issue No.01 Rev. No.00

SECTION TITLE PAGE

00 Introduction & Company Profile 3 of 37

01 Scope 4 of 37

02 Distribution and Manual control 5 of 37

03 Amendment Sheet 7 of 37

04 QUALITY MANAGEMENT SYSTEM (4.0) 8 of 37

General requirements (4.1) 8 of 36

Documentation requirements (4.2) 8 of 36

General (4.2.1) 8 of 36

Structure of Documentation 9 of 36

Apex Manual (4.2.2) 10 of 36

Control of Documents (4.2.3) 12 of 36

Control of Records (4.2.4) 12 of 36

05 MANAGENMENT RESPONSIBILITY (5) 13 of 36

Management Commitment5.1 13 of 36

Customer Focus 5.2 13 of 36

Quality Policy 5.3 14 of 36

Planning 5.4 15 of 36

Quality Objectives 5.4.1 15 of 36

Quality Management System Planning 5.4.2 15 of 36

Responsibility, Authority, and Communication 5.5 16 of 36

Responsibility & Authority 5.5.1 16 of 36

Management Representative 5.5.2 17 of 36

Internal Communication 5.5.3 17 of 36

Management Review 5.6 17 of 36

General 5.6.1 17 of 36

Review Input 5.6.2 18 of 36

Review Output 5.6.3 18 of 36

06 RESOURCE MANAGEMENT 6.0 19 of 36

Provision of Resources 6.1 19 of 36

Human Resources 6.2 19 of 36

General 6.2.1 19 of 36

Competency, awareness and Training 6.2.2 19 of 36

Infrastructure 6.3 20 of 36

Work Environment 6.4 20 of 36

07 PRODUCT REALIZATION 7.0 21 of 36

Planning of Product Realization 7.1 21 of 36

Customer Related Processes 7.2 21 of 36

Development of requirements related to the product 7.2.1 21 of 36


ISO 9001:2008


Title: APEX MANUAL

Section No. 00 Title : Contents Issue No.01 Rev. No.00

SECTION TITLE PAGE

Review of Requirements Related to the product 7.2.2 21 of 36

Customer Communication 7.2.3 22 of 36

Design and Development 7.3 22 of 36

Purchasing 7.4 22 of 36

Purchasing Process 7.4.1 22 of 36

Purchasing Information 7.4.2 22 of 36

Verification of Purchased Products 7.4.3 23 of 36

Production and service Provision 7.5 23 of 36

Control of Production and Service Provision 7.5.1 23 of 36

Validation of Processes for Production and Service Provision 7.5.2 24 of 36

Identification and traceability 7.5.3 24 of 36

Customer Property 7.5.4 24 of 36

Preservation of Product 7.5.5 25 of 36

Control of Measuring and Monitoring Devices 7.6 25 of 36

08 MEASUREMENT, ANALYSIS, AND IMPROVEMENT (8.0) 26 of 36

General 8.1 26 of 36

Monitoring and Measurement 8.2 26 of 36

Customer Satisfaction 8.2.1 26 of 36

Internal Audit 8.2.2 26 of 36

Monitoring and Measurement 8.2.3 27 of 36

Monitoring & Measurement of Product 8.2.4 27 of 36

Control of Non-conforming Product 8.3 27 of 36

Analysis of Data 8.4 28 of 36

Improvement 8.5 28 of 36

Continual Improvement 8.5.1 28 of 36

Corrective Action 8.5.2 28 of 36

Preventive Action 8.5.3 28 of 36

Annexure I Process Model 29 of 36

Annexure II Process Interaction 30-31 of 36

Annexure III Organization Chart 6 of 36

Annexure IV Quality Objective 32 of 36

Annexure V Authority & Responsibility 33 of 36


ISO 9001:2008


Title: APEX MANUAL

Section No. 00 Title : INTRODUCTION Issue No.01 Rev. No.00

COMPANY PROFILE

INTRODUCTION

Nisan Scientific Process Equipments Pvt. Ltd. is promoted by Mr. NITIN S. NIKAM,

the Managing Director of this Organization. The company manufactures different kind of

scientific process equipments; these are likes liquid level gauges, instrument control

equipments, TEMPERATURE INSTRUMENTS, SYPHON, PRESSURE GAUGE VALVE & SNUBER etc. The

Organization has got some Statutory Approvals likes S.S.I., Municipal, BSES, Pollution

Control Board, Factory Licence, Shop& Establishment, Metal Cutting, Power Permit, and

NSIC. The S.S.I. unit cum office is located at 587/1, MIDC Rabale, T.T.C Industrial Area,

Thane-Belapur Road, Navi-Mumbai Mumbai - 400 701, Maharashtra, India. self The

Organization itself engaged in Design & Development activities which is derived by market

requirements. The major customer of this company likes KSB Pumps India Ltd. ,Excel

Hydro Pneumatics, Williams Petrochemicals, Gujarat Mill Stores, M.E. Energy Pvt. Ltd.,

SV SSK Ltd. Sulzer Pumps, GAIL (I) Ltd., HCPL, CPCL, BPCL, HOCL, Wipro, Uttam

Galva Metalic & VSP etc.

Company is implementing Quality Management System under the guidelines of ISO

9001:2008 for improved performance and enhanced customer satisfaction.


ISO 9001:2008


Title: APEX MANUAL

Section No. 00 Title : Scope of ISO 9001:2008 Issue No.01 Rev. No.00

SCOPE & EXCLUSIONS

Scope of ISO 9001: 2008 The design, manufacture & supply of flow & level instruments, level gauges, level switch,

valves, flow indicator, condensate pot, Strainer & fabricated process equipments by NISAN

SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD.

Exclusion

Nil


ISO 9001:2008


Title: APEX MANUAL

Section No. 00 Title : Manual Distribution Issue No.01 Rev. No.00

DISTRIBUTION CONTROL ISSUE NO. 01 IS THIS A CONTROLLED COPY? YES /NO YES

COPY NO. DISTRIBUTED TO

01 Managing Director

Master Copy Management Representative

Certification body On returnable basis

COPY APPROVED BY: MANAGING DIRECTOR Signature: Date: 16-09-09 COPY ISSUED BY: Management Representative Signature: Date: 16-09-09


ISO 9001:2008


Title: APEX MANUAL

Section No. 00 Title : Organisation Chart Issue No.01 Rev. No.00

Annexure - III ORGANIZATION CHART


ISO 9001:2008


Title: APEX MANUAL

Section No. 00 Title : AMENDMENT SHEET Issue No.01 Rev. No.00

AMENDMENT SHEET

Sr. No.

Section Page Amendment details REV. NO.& Date

ISSUE NO. & Date


ISO 9001:2008


Title: APEX MANUAL

Section No. 01 Title : QUALITY MANAGEMENT SYSTEM Issue No.01 Rev. No.00

4.0 QUALITY MANAGEMENT SYSTEM: 4.1 General requirements: NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. has developed, documented and implemented its Quality Management System as per ISO 9001:2008 Standard. The Top Management has established and implemented a documented system, aimed at continual improvement. The processes needed for the Quality Management System have been identified. The sequence and interaction of processes have been determined (See Annexure II) Controlling methods and criterion are identified and established to control the processes effectively. All resources and information required for processes identified at NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. are provided and are ensured. All intended outputs are listed and considered. Following steps are taken to achieve planned results:

- All processes are determined &monitored to achieve desired results and strive towards continual improvement.

- All processes are measured to meet the documented objectives. - All processes are continually analysed to achieve desired results. - Statutory and Regulatory requirements related to the business, products & processes are

addressed. - Analysis of results over last 3 years have been carried out to identify and deal with

business risks .Job Work mitigates risk of heavy blockage of Working Capital. At present no activity is outsourced by Nisan Scientific Equipments. 4.2 Documentation requirements: 4.2.1 General Documentation hierarchy for NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. is summarized in Figure I on page no. 9 of 31 Structure of Quality Management System Documentation. Documents referenced in the Apex Manual, the System Level Procedures, or Work Instructions, Lower level procedures or work instructions are applicable only to the extent specified therein. The Management Representative (MR) verifies the activities governed by the Quality Management System and ensures that they are implemented. Wherever it is felt necessary to have documented procedures other than the essential procedures which appear as documented procedure in International Standard ISO-9001: 2000, MR ensures that they are documented. The Documentation required by NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. includes the following:

Quality Policy and Objectives. Apex Manual Documented Procedure required by ISO 9001:2008 Standard Documented procedure on processes needed by NISAN SCIENTIFIC PROCESS EQUIPMENTS

PVT.LTD. to enable conformity to the ISO 9001:2008 requirements


ISO 9001:2008


Title: APEX MANUAL

Level I

Level II

Level III

Level IV

V


The following clauses as per ISO 9001:2008 have been addressed with corresponding procedures listed under. Clause No. Procedure No. 4.2.3 SYS-P-01 4.2.4 SYS-P-02 8.2.2 SYS-P-03 8.3 SYS-P-04 8.5.2 SYS-P-05 8.5.3 SYS-P-06 4.2.1(a) STRUCTURE OF DOCUMENTATION: The Documented Quality Management System of NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. has been compiled on the basis of ISO 9001:2008. The Quality Management System comprises of four-tier structure as under:

The Apex Manual. Referenced

Quality Procedures.

Referenced

Work Instructions, Specifications etc.

Related forms and records

Figure I


ISO 9001:2008


Title: APEX MANUAL

4.2.2 APEX MANUAL: This Apex Manual describes the Quality Management System adopted by NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. The manual lists resources, processes, procedures, monitoring and measurement systems for the Quality Management System which have been formulated on the basis of ISO 9001:2008 i.e. primarily of Plan, Do, Check & Act [PDCA] Cycle. The processes needed for Quality Management System are listed and their interaction is shown in Annexure II. The Manual and the information incorporated herein is solely the property of NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. It must not be re-produced in whole or in part or otherwise disclosed without prior consent in writing from NISAN SCIENTIFIC EQUIPMENTS 4.2.2(a) STRUCTURE OF THE MANUAL:

This apex manual is structured as shown in the contents page of the manual and follows the sequence of quality management system elements according to ISO 9001:2008. Each page of apex manual contains the issue number of the manual .The issue number "01" has been given to the first issue of the section. On Front page of Master Copy of the manual bears the signatures of the MANAGING DIRECTOR (approving authority of the manual) & Management Representative (issuing authority of the manual). Front of the manual is stamped CONTROLLED COPY at a specified location on the page. Obsolete copies of the manual of previous issues are identified and stamped with red ink as OBSOLETE COPY. These obsolete copies shall be kept in archives along with records of amendments. This manual is available only in the English language. 4.2.2(b) METHOD OF ISSUE:

The MR is to carry out the activities of preparing, issuing, maintaining and updating this apex manual. The distribution of the manual and the amendment(s) are controlled and are carried out by him. Any additional copies of the manual, required for external agencies, are issued by the Management Representative and such copies of the manual issued are stamped UNCONTROLLED'. These uncontrolled copies do not come under the purview of document amendment procedure and are, thus, not updated and are not used within Nisan Scientific Equipments A distribution list of the apex manual has been provided in all controlled copies. This list is used as reference for updating the respective controlled copies. The Management Representative maintains a master copy of the manual.



ISO 9001:2008


Title: APEX MANUAL


4.2.2(c) REVISION, UPDATION AND AMENDMENT PROCEDURE: Management Representative reviews the apex manual periodically. No revision is implemented unless he has approved it. The Management Representative introduces each revision formally by issuing the revised document to all concerned as per the distribution list. When revisions take place, the revisions will be indicated by the revision number on the revised page of the section and recorded in the Amendment sheet available in the controlled copies of the Manual and indicated at 4.2.2(d) below. The bottom of the revised page will also carry the date of the revision and reference to the amendment page no. If there are more than 40 amendments in the manual the complete manual is revised to the next issue number. The insertion of additional / amended section(s) and the removal of the old section(s) in the individual controlled copies as per the distribution list of the manual is the responsibility of the person holding the individual copy. All old section(s) so removed are stamped with red ink as "OBSOLETE" and returned to the Management Representative who ensures that the same are destroyed. MR will retain obsolete copy for a minimum period of five years from the date of their revision. 4.2.2(d) AMENDMENT SHEET: Each controlled copy of apex manual contains a complete record of revision(s). All revision are recorded in the Amendment Sheet as per below mentioned format. AMENDMENT SHEET

Sr. No.

Section Page Amendment details Rev. No. Issue No.

4.2.2(e) DISTRIBUTION LIST:

Sl. No. Copy Holders Copy No.

1 MANAGING DIRECTOR 01


ISO 9001:2008


Title: APEX MANUAL


4.2.3 CONTROL OF DOCUMENTS: Description: The purpose and scope of quality management system documents is defined. All documents are reviewed and approved prior to issue. Appropriate documents are available at locations where they are intended to be used. Obsolete documents are removed from points of use and retained in accordance with procedure SYS-P-01 Responsibility: The Management Representative is responsible for coordination and enforcing the document control related activities in accordance with procedure SYS-P-01. Reference: SYS-P-01 Control of Documents 4.2.4 Control of Records: NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. maintains records as objective evidence that demonstrate conformance to the quality management system and ensure its effective operation. Description NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. requires that records be:

A list of Records are at the originating location are Identified, collected, indexed, accessed, filed, stored, maintained, and disposed according to documented procedures,

Retained for established retention times, Records shall be controlled. Legible, Stored in an appropriate environment to prevent deterioration, Readily available, and Available to customers when required by customer agreement

Responsibilities: The functional heads are responsible for maintaining record matrix of their own areas while MR ensures the record matrix of MR functions as well as management functions. References: SYS-P-02: Control of Records


ISO 9001:2008


Title: APEX MANUAL

Section No. 02 Title : MANAGEMENT RESPONSIBILITY Issue No.01 Rev. No.00

5.0 MANAGEMENT RESPONSIBILITY: 5.1 Management Commitment The management at NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. is committed to the policies set forth in this manual and supported documentation. This commitment is demonstrated by continual use of the quality policy and quality objectives as guiding principles in the conduct of daily business. The management also ensures while keeping customer satisfied, the regulatory and legal requirements are met. The means of setting objectives, providing resources, directing, monitoring, and controlling NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. in a continual improvement environment are described in this manual. A structured way of discharging above intent is shown in organization chart.-Annexure-III

5.2 CUSTOMER FOCUS: Marketing Department while accepting an assignment determines the stated and implied needs of the customers. As contract requirements evolves\ the contract is reviewed and changes are implemented. The implementation plan and resources are also continually evaluated to ensure that the customer derives maximum benefits from our services. At the completion of order execution, units ensure that all the commitments and agreed conditions between his customer and NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. are met. At this time the methodology for getting customer feedback is also identified and the feedback are taken during meeting with customer or telephonic discussions. Feedback forms are also distributed to the customer to ascertain their satisfaction level; this feedback is then analyzed and results are discussed in the management review meetings. Feedback includes evaluation of the product supplied, services rendered and the future requirements. Reference: Customer Feedback form (MKT-F-01) For further details refer Section 7.2.1. And 8.2.1.


ISO 9001:2008


Title: APEX MANUAL


QUALITY POLICY

Nisan Scientific Process Equipments (P). Ltd. recognizes that each

customer is unique. We are committed to providing enhanced

customer satisfaction for products and services supplied by

understanding requirements and meeting stated and implied needs.

This we shall aim through continual improvement in product, process

and by ensuring a high level of customer care. Will continue to

maintain its Position as a Manufacturer and Supplier of Quality

Products that built to satisfy Customer need and Thereby achieve a

high level of Customer Confidence In Companys Products.

MANAGING DIRECTOR Date: 25-003-2014

Doc. No. NSPEPL-AM-01 Page: 14 of 31 (Quality Policy is being communicated and understood with in the Organisation. The stakeholders have been communicated about the Quality Policy)


ISO 9001:2008


Title: APEX MANUAL


5.4 PLANNING: 5.4.1 QUALITY OBJECTIVES: Production Manager is directly responsible to ensure that quality objectives are part of each years strategic planning and that they are measurable and fit within the framework of the quality policy. The objectives are based on: S -SPECIFIC M -MEASUREABLE A -ATTAINABLE R -REALISTIC T -TIME BOUND

Techno Power Products- Objectives are exhibited in Annexure IV-as Q-OBJ-01. 5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING: PLANNING FOR THE QUALITY: MANAGING DIRECTOR is overall responsible for effective implementation and maintenance of Quality Management System .with delegated authorities to Production Manager and MR. The planning is carried out at all levels in a systematic way, which includes the planning for Sales and Marketing, procurement of raw material, Deployment of resources like competent Manpower, Hardware-Software, production and dispatch etc. Provision for safety, potential liabilities, are taken into consideration . The following are also considered as input to the planning:

Quality policy and objectives

Customer feedback

Needs and expectations of the customers


ISO 9001:2008


Title: APEX MANUAL


Based on above, a strategy is prepared with goals and objectives that include:

Budgetary needs

Need for additional resources

Need for process improvement

Need for documentation and records

In case any revision / update in quality management system is required, it is planned & implemented in TOP Down Approach to retain the integrity of the quality management system. 5.5 RESPONSIBILITIES, AUTHORITY AND COMMUNICATION: 5.5.1 RESPONSIBILITY AND AUTHORITY: The responsibilities of key personnel, who manage, perform and verify quality related activities are demarcated in individual documents developed for the processes identified for ISO 9001:2008. The responsibility and authority for processes and services are clearly defined in NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. documentation (see 4.2) Management ensures that responsibility and authority is commensurate with the scope of each job title. The individuals who have direct responsibility to execute a process are given the opportunity to review any documentation that relates to their function.

MANAGING DIRECTOR Over-all control of the company.

Strategic planning for the company's future.

Over all responsibility for company administration and operational functions.

Handling purchase related activity.

To chair management reviews.

Allocation of resources, assign responsibilities and delegate authority to achieve targeted goals.

To define and document quality policy.

Strategic planning for the company's future.

Review of new business line. Drawing up business plan of the company.

Handling all marketing related activities.

Ensure the customer requirements are correctly specified to the Factory Manger at the time of feeding orders.

Responsible for Quality Objective setting and monitoring and meeting requirements of Quality Management System.


ISO 9001:2008


Title: APEX MANUAL

5.5.2 Management Representative Production Manager has been assigned the job of Management Representative. His responsibility includes:

Monitor the implementation and functioning of the quality management system on a day-to-day basis and organizing internal quality audits of organization.

Report to top-level Management the status of quality management system.

Identify and analyze non-conformities and results of internal audits and report to the management for review.

Monitor implementation of corrective and preventive actions as per quality procedures and verify effectiveness.

Responsible for the distribution of all controlled documents. 5.5.3 INTERNAL COMMUNICATION:

The Management Representative ensures that the effectiveness of the quality management system is communicated throughout NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. especially regarding the QMS and customer. The internal communication is made effective by team briefings and regular interaction with individuals. Communication channel in the form of telephone is being provided to all the concerned personnel for effective communication. The Management Reviews are also considered as source of internal communication. The various notice boards, displays at various levels are indicative of the customer requirements are understood with in Nisan Scientific Equipments. 5.6 MANAGEMENT REVIEW 5.6.1 GENERAL: Responsibility: The overall responsibility for management review lies with MANAGING DIRECTOR Description: Management review of the Quality System takes place at defined intervals to ensure its continuing suitability and effectiveness. These reviews are responsible for assessing the opportunities for improvement and the need for changes to the quality management system, which includes the quality policy and quality objectives. A management review committee, which comprises of MANAGING DIRECTOR, MR, /Production Manager, is responsible for reviewing the Quality Management systems and for providing adequate resources necessary.

The quality management system has been adopted to satisfy the requirements of the International Standard ISO 9001:2008 is reviewed at least once in six months.



ISO 9001:2008


Title: APEX MANUAL


5.6.2 REVIEW INPUT: The points for discussion during the Management Review Committee shall as a minimum, include the following:

Results of audits.

Customer feedback,

Process performance and product conformity,

Status of preventive and corrective actions,

Follow-up actions from previous management reviews,

Changes that could affect the quality management system and

Recommendations for improvement. Also refer Section 8.5.1 Reference : SYS-F-01 Agenda of MRM 5.6.3 REVIEW OUTPUT: The outcome of Management Review Committee is a report on the following:

Improvement of the effectiveness of the quality management system and its processes,

Improvement of product related to customer requirements and

Resource needs, as appropriate. Reference : SYS-F-02 Minutes of MRM


ISO 9001:2008


Title: APEX MANUAL

Section No. 03 Title : RESOURCE MANAGEMENT Issue No.01 Rev. No.00

6.0 RESOURCE MANAGEMENT 6.1 PROVISION OF RESOURCES: DESCRIPTION The MANAGING DIRECTOR ensures the availability of resources needed for meeting the agreed requirements of the customers. This includes the resources needed for following:

Implementing and Maintaining the quality management system,

Improving the effectiveness of quality management system continually and

Enhancing customer satisfaction. 6.2 HUMAN RESOURCES: 6.2.1 GENERAL: DESCRIPTION Managing Director & MR is responsible for identifying personnel, who can affect directly or indirectly quality of product / services and guiding / advising them for performing any task within QMS. The personnel are selected and assigned jobs based on their competence, education, training & experience. 6.2.2 COMPETENCE, AWARENESS AND TRAINING: DESCRIPTION: The main focus is to increase the competency level of the employees within NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. to achieve the following are carried out:

Determine the required competency level of the personnel before allocating the job Provide the training specifically after identification of training needs to achieve necessary

competence. Measure the effectiveness of training over a period of time. The effectiveness of the training is

measured through onsite demonstration of the trainee on the subject for which they have trained. Ensure that the personnel are aware of the importance of their activities, relevant objectives and

targets associated with their work and the method to measure and achieve them. Ensuring the availability and maintenance of records that indicate the education, training and

experience of the personnel performing work affecting product quality. REFERENCE: HRM-P-01 Procedure for Competence, Training Need Identification


ISO 9001:2008


Title: APEX MANUAL

Section No. 03 Title : RESOURCE MANAGEMENT Issue No.01 Rev. No.00

6.3 INFRASTRUCTURE:

The infrastructure needed by organization to meet the requirements of the customer is met through construction of workspace, installation of plant and machineries, other utilities like water and fresh air provisions, Information System etc. All the equipments and machineries are maintained to ensure their smooth working and to suit the requirements of the customer. Information Systems are monitored. Reference: PROD-P-01

6.4 WORK ENVIRONMENT: Management has ensured that suitable work environment is provided to the personnel. All the work areas are clean, hygienic and free from spills. All passages are marked to ensure smooth passage for movement of material and personnel. Proper lighting, ventilations are provided in the production floor areas. Fire extinguishers are provided at key locations to keep temperature, humidity, noise under control within the production area. First aid box is kept at convenient place for ready and easy access.


ISO 9001:2008


Title: APEX MANUAL

7.0 PRODUCT REALIZATION 7.1 PLANNING OF PRODUCT REALISATION: NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. recognizes the requirement of the Customer. Planning for the product(s) needed for each product is dependent on the specific customers requirements. These processes (See Annexure I) are consistent with the quality objectives and requirements of the Quality Management System in general and the specific product in particular. While planning for the product realization organization determines the following:

Quality objectives and the requirement for the product The need to establish processes and documents and provision of resources specific to

the product Required monitoring, inspection and test activities specific to the product and other

criterion for the product acceptance. Records required by NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. for

conformity to the product realization. 7.2 CUSTOMER RELATED PROCESSES: DESCRIPTION: MANAGING DIRECTOR is overall responsible for this customer related processes. Secondary responsibility lies with MR at NISAN SCIENTIFIC EQUIPMENTS The primary responsibility includes:

Ensuring that the necessary product requirements are determined. Carrying out the contract review and for approval of all contracts. The review process for each

contract [Enquiry/Order] includes the following: 7.2.1 DETERMINATION OF REQUIREMENTS RELATED TO PRODUCTS

The product requirements are adequately defined and documented and checked whether available in the product range.

It is ensured that NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. has the capability to meet the product requirements,

The statutory and regulatory requirements related to the products are determined,

Any other additional requirements (if any) are ascertained

Post delivery activities such as warranty provisions, maintenance services, contractual obligations, and Supplementary services such as replacement, recycling and final disposal need to be considered.

7.2.2 REVIEW OF REQUIREMENTS RELATED TO PRODUCTS

Differences, if any, are suitably reviewed and are resolved/contracts and/or orders amended as agreed with the customer

Negotiated contracts are suitably communicated to all concerned

Records of all contract reviews are maintained

Feedback from customers, including Customer Complaints is suitably recorded and necessary actions are implemented

Section No. 04 Title : PRODUCT REALIZATION Issue No.01 Rev. No.00


ISO 9001:2008


Title: APEX MANUAL

7.2.3 CUSTOMER COMMUNICATION:

To ensure the above processes are effectively communicated with the customer, the MANAGING DIRECTOR makes necessary communication arrangements. The customers are communicated using emails, fax and / or on telephone promptly on their queries with regards to the order processing, product information. Order confirmations are promptly sent out to customers on receipt of orders. References: MKT-P-01: Procedure for Customer Related process

7.3 Design & Development: Kindly refer PROD-P01 Processes are designed & developed a drawing along with the technical specifications. Products are developed through different stages through adequate controls & being monitored is n design & development activity carried out by this company 7.4 PURCHASING: Responsibility: Production Manager is overall responsible for taking care of purchasing activities in NISAN SCIENTIFIC EQUIPMENTS 7.4.1 Purchasing Process: A purchasing procedure has been established on the basis of essential critical items necessary for the production. The Stores In-charge duly approves the raw material as per inspection plan PROD-P-01. Suppliers are chosen on yearly basis and every supplier has been assessed and approved with suitable controls to maintain the standards demanded. Suppliers have to be approved by the quality manager in the first instance. Suppliers thus approved are forwarded to the MANAGING DIRECTOR for commercial approval and negotiations. A list of approved suppliers is prepared and maintained, a system is being used to assess each supplier on a regular basis. Ref. PUR-P-01 7.4.2 Purchasing Information: Purchase order clearly precisely identifies the requirements, including approval requirements for product. Purchase orders also specify any other requirement if any. A list of approved suppliers is maintained and is continuously updated based on the evaluation of the performance of suppliers. The purchase orders are reviewed for adequacy of specified requirements prior to release. Full details on the various mechanisms adopted are described in the relevant procedures.



ISO 9001:2008


Title: APEX MANUAL

7.4.3 Verification of Purchased Products NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. also verifies that the purchased materials conform to specified requirements, mentioned in the purchase order. For critical Items purchased the raw material is accompanied by a test certificate. At the end of the year the suppliers are evaluated and rated on the basis of followings:

A. Quality & ranked with 1. Excellence B. Price 2. Good C. Delivery 3. Poor & under observation

For new suppliers, initial evaluation is made on the basis of the above criteria. If this evaluation is found satisfactory, a trial order is placed. Factors like supplies ordered, received, quantity accepted/rejected, replacement received and deficient past performance are considered at the time of review of the performance. D-listed Suppliers being informed & given official intimation for further improvements of their Products & services. Suppliers to whom no orders have been placed for last 2 years are again evaluated before re-regularizing as approved supplier, else they are de-listed. Records pertaining to purchase are maintained as per the defined procedures. References: PUR-P-01 Procedure for Purchase 7.5 PRODUCTIONS AND SERVICE PROVISION: 7.5.1 Control of Production & Service Provision: Responsibility: The Overall responsibility for implementation of this procedure lies with Production Manger. He is responsible for monitoring the provisions necessary for production. Components required for maintenance of machines and. planning of the preventive maintenance is carried out by MR under his guidance. Description: The procedures for process control contain detailed provisions for:

Detailed procedure for every major action in the factory during the manufacturing is being drawn and put as work instructions at appropriate levels.

Safety and Statutory regulations are adopted, wherever applicable.

Machines are maintained in working order, documented procedure is being developed for effective maintenance and tackling the breakdown conditions of the machines/equipment for obtaining optimum production and quality levels.

Records pertaining to monitoring of critical process parameters are generated and maintained.

Suitable working environment conditions are maintained, wherever required.

For release and delivery of product refer Section 8.2.4 and 7.5.5 respectively. References: PROD-P-01 Procedure for product realization. PROD-R-01 Production Log Book

Section No. 04 Title : PRODUCT REALIZATION Rev. No.00


ISO 9001:2008


Title: APEX MANUAL

7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION: The processes are validated welding, Machine calibration, Testing & Inspection. The processes & Testing are identified for Nisan. 7.5.3 IDENTIFICATION AND TRACEABILITY: Responsibility: The overall responsibility for implementation of this procedure lies with the person responsible for that particular unit operation. Description: The product is identified at all stages of manufacture: from the raw material stage to the finished product. Traceability: The customer does not normally require traceability but if specified in the contract then the product is identified at all stages of its product realization. Normally material comes with the Heat no. & it will we forwarded through different stages. Even individual Serial no. is punching on every material goes through the production to dispatch. 7.5.4 CUSTOMER PROPERTY: Customer property like drawing, sample handling by this Organization that is safeguarded against loses & any damages.



ISO 9001:2008


Title: APEX MANUAL

7.5.5 PRESERVATION OF PRODUCT: Responsibility: Production Manager is responsible for effective planning and documenting a system of receipt and storage of raw materials; semi finished products and finished products. Description: Raw materials, semi-finished products and end products are adequately preserved and protected against damage or deterioration during handling, transport and storage within the plant, and during delivery of finished product in order to maintain conformity to requirements maintain in work order sheet. Deliveries are protected from damage during shipment and storage at site by means of adequate packaging as per the customers requirement.

7.6 CONTROL OF MONITORING AND MEASURING Equipments: Responsibility: The MR is responsible for implementation of procedure related to control of Monitoring and Measuring Devices. Description: The company has identified measurements to be made and the accuracies required for measurement. Accordingly measuring and monitoring devices are selected commensurate with various activities. The MR maintains records pertaining to calibration. Verification and Configuration Management of Computer Software for its suitability to use shall be planned and necessary records kept. Although there is no such provision of software which can be configured through measuring & monitoring equipments. References: PROD-P-01; Control of Monitoring and Measuring Devices



ISO 9001:2008


Title: APEX MANUAL

8.0 Measurement Analysis and Improvement 8.1 General NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. continually monitors, measures and analyses the results of processes with a view to affect improvements wherever possible and required. The monitoring, measurement and analysis of results enables NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. to achieve the following:

a) Demonstrate conformity of product/services to specified requirements and statutory and regulatory provisions ( if any)

b) Ensure conformity of the quality management system to documented procedures and other established methods.

c) Continually improve the effectiveness of quality management system to achieve quality objectives.

Whenever required, data is collected and analysed to see the effectiveness of the implemented QMS and to investigate possibilities of further improving it. 8.2 Monitoring and Measurement 8.2.1 Customer Perception NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. obtains customer feed back on the latters perception of quality of its products/services and the level at which it meets the customer requirements in a systematic manner. The company closely monitors and controls all the activities or parameters relating to the product as desired by the customer. Additional information on customer perception can be obtained from Customer satisfaction Surveys, customer data on delivered product / service quality, user opinion Surveys. Lost business analysis, compliments, warranty claims, dealer reports etc. 8.2.2 Internal Audit NISAN SCIENTIFIC PROCESS EQUIPMENTS PVT.LTD. has established a documented procedure for planning and carrying out internal audit to determine the compliance and effectiveness of the quality management system. The internal audits are scheduled on the basis of status and importance of the activity. Trained personnel from within the Organisation carry these out. It is ensured that persons who are not directly responsible for the activity being audited carry out audits. The internal audits are planned and scheduled to ensure that every activity is audited at least once in Six months. The results of audit are recorded in the improvement data sheet and brought to the notice of the person responsible for the activity. The corrections & corrective actions for removal of the nonconformity are taken and recorded. The results of audit are also reviewed by management in management review meeting. The follow up of corrective action is carried out and implementation and effectiveness of the corrective action is verified. Reference: SYS-P-03 Internal Audit

Section No. 05 Title : Measurement ,Analysis & Improvement Issue No.01 Rev. No.00


ISO 9001:2008


Title: APEX MANUAL

8.2.3 Monitoring Measurement Responsibility: The individuals in-charge of the various departments is responsible for monitoring and measuring the processes at appropriate level of the production. Description: Statistical techniques (like cause and effect diagrams. % Why Analysis) are identified and utilized at the appropriate stages of the production. These tools are applied to achieve planned results and used for performance evaluation. All departmental heads study the critical control points of the process and provide analysis to the production department and management for enhancing the production capabilities and product improvement. Key and other processes are defined and appropriate Monitoring & Measurement methods are deployed to ensure conformity of product /service and effectiveness of QMS. 8.2.4 Monitoring and Measurement of Product: Responsibility: MANAGING DIRECTOR is responsible for implementation of this procedure. Description: Suitable measurement methods are operated to verify that the required product meets customers requirement. Evidence of acceptance criteria at various stages of production is recorded according to inspection plan. Records of these inspections are kept. Reference: PROD-P-01 Monitoring and Measurement of Product 8.3 Control of Non-Conforming Products: Responsibility: The overall responsibility for implementation lies with Production Manager. The responsibility for disposition/rectification of non-conformities lies with MR. Description: The non-conformity control involves identification, evaluation, segregation and disposition of the non-conforming products found in purchased items, during processing of the product and other Quality Management System areas. A documented procedure has been developed to deal with the non-conforming products. Records pertaining to control of non-conforming products are maintained as detailed in the relevant procedures. Organization shall take action appropriate to the effects of potential effects of the no conformity, when Non conforming product / service is detected after delivery or use has started. Reference: SYS-P-04 Control of Non-conformity



ISO 9001:2008


Title: APEX MANUAL

Section No. 05 Title : MEASUREMENT, ANALYSIS AND IMPROVEMENT Issue No.01 Rev. No.00

8.4 Analysis of Data:

The data collected is reviewed and analyzed for continual improvement of the quality management system. The data is collected from relevant management information systems including internal audits, corrective and preventive action, non-conforming product/service, customer satisfaction reports etc. by the Concerned HODs

Analysis of the data provides information on: a) Effectiveness of the quality management system. b) Process operation trends. c) Customer satisfaction. d) Conformance to customer requirement. e) Suppliers.

The analysis of data shall also be relevant to the objectives set. 8.5 Improvement: 8.5.1 Continual Improvement: There is awareness among all concerned personnel to continually improve the system to fulfill the requirements of the quality management system, to act on the recommendations of various audits, and on the basis of decisions taken in the MRM. All the data generated during the implementation of QMS is analyzed and related corrective and preventive actions are taken where necessary to improve on the existing processes, procedures and systems. 8.5.2 Corrective Action: Corrective actions are taken for non-conformities observed in function as well systems; while handling customer complaints, nonconformities found during internal audits, and in process quality deviations. Corrective actions are planned and decided after careful root cause analysis of the problem. The records of the remedial actions are maintained. Effectiveness of the corrective actions is monitored in the management reviews. Reference: SYS-P-05 8.5.3 Preventive Actions: A procedure has been established for initiating preventive actions with a view to preventing the occurrence of non- conformities. Through this procedure, it is ensured that

Potential causes of non-conformity are identified through historical customer complaints, analysis of work / operations, records, audit results;

Need of suitable action is evaluated.

Appropriate action is determined and implemented.

The action taken recorded.

The effectiveness of action taken to prevent occurrence is reviewed in management reviews. REFERENCE: SYS-P-06


ISO 9001:2008


Title: APEX MANUAL

ANNEXURE -I PROCESS MODEL AND INTERACTION

Management Review Quality Policy Planning Quality Objectives Responsibility, authority, & communication

Resource Management-Apex Manual Human Resource Infrastructure Work Environment

Customer Related processes, Purchasing, Production & service Provision, Identification and traceability, Control of monitoring & measuring devices, Preservation of Product, Customer Property

Customer Satisfaction Internal Audit Monitoring & measurement of processes Monitoring & Measurement of product Control of non-conforming product Analysis of data Corrective & preventive action

ALL Available Procedures

HRM-P-01

IC -AM-01

IC. -AM-01 SYS-P-01

SYS-P-02 SYS-P-03

SYS-P-04

SYS-P-05 SYS-P-06

SYS-P-01 Apex Manual IC. -AM-01

C U S T O M E R

R E Q U I R E M E N T

C U S T O M E R

S A T I S F C A T I O N

Process Model &

Interactions


ISO 9001:2008


Title: APEX MANUAL

SN Std. clause no. & Input Main Process Interacting process Output Responsibility

1 7.2.2 Customers LOI / Order Marketing Production, Document control, Record control

dispatch schedule , production report

MANAGING DIRECTOR

8.5.2 Customer complaints Do Do CA / PA, analysis MANAGING DIRECTOR

8.2.1, Customer feedback Do Do Quality improvement plan MANAGING DIRECTOR

8.4, Customer feedback analysis report

Do Management Review, Corrective and preventive action Process

Continual improvement in product & processes

MANAGING DIRECTOR

2 7.5.1 Customer orders , or Work or Job order / Delivery order issued by Mktg. Section

Production Purchase, Document control, Record control, Inspection

Stock list, Lab testing report MANAGING DIRECTOR

7.5.2 Validation of processes Do Inspection & Q.C process output verification report / batch report

MANAGING DIRECTOR

7.5.3 Identification & traceability Do Document control, Record control

3 7.4.1 Need for new supplier & approval

Purchase Production, document & record control, Inspection, Management review

Supplier evaluation result, approved Supplier list, evaluation criteria

MANAGING DIRECTOR

7.4.2 Material indents

Do Production Purchase order MANAGING DIRECTOR

7.4.3 Receipt inspection results Do Inspection Vendors approval record MANAGING DIRECTOR


ISO 9001:2008


Title: APEX MANUAL

4 8.2.4, 7.4.3 Drawings, product specification, incoming material specification,

Inspection Production, purchase, management review, CA & PA, document & record control, Control of NC

Receipt, in-process & final inspection report, Specification, standard and test method details, Non-conformance analysis & CA & PA report

MANAGING DIRECTOR

7.6, MMD calibration

Do Production Instrument identification & calibration record

MANAGING DIRECTOR

5 6.2.2 Competence, awareness & training need of personnel

Training Interacts with all other processes

Competency gap analysis & training need, Training schedule, maintenance of record of training & effectiveness evaluation

MANAGING DIRECTOR

6 Outsourcing Activities Outsourced

Interacts with Production & Purchase dept.

Controls of Outsourcing Agencies

MANAGING DIRECTOR

7 7.5.1, 6.3 Machine Routine maintenance schedule

Maintenance Production, Document & record control, Data Analysis processes

Machine/ equipment - requirement list

MANAGING DIRECTOR

8 IA report, Customer complaint & feedback, Quality policy, Quality objective & suppliers performance

Management review Document Control, Control of record, Internal Audit, Control of NC products, CA / PA, Production, Purchase

CA & PA, & Continual improvement

MANAGING DIRECTOR


ISO 9001:2008


Title: APEX MANUAL

Annexure IV Q-OBJ-01 (Quality Objective)

Sr. No

Objectives

Target

Frequency

Authority & Signature

1

Rejection

To minimise from 1% to o %

6 months

Managing Director

2

Delivery Compliance

To increase 90 % to 95 %

6 months

Managing Director

3 Technical Modernization Manual to Automation 6 months

Managing Director

4 Provide Safe Training Once in 6 months 6 months

Managing Director

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