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ARTHEON ELECTRONICS LTD.QUALITY SYSTEM MANUAL Doc no.: A E L/QMS
QUALITY MANAGEMENT SYSTEM
Edition No-01 Revision No-00 Dated 01/07/07
ARTHEON ELECTRONICS LTD
S 34, Okhla Industrial Area,
Phase II,
New Delhi-110020, India.
Phone No:- +91-11-40516480.
+91-11-40516479
E-mail:smf@ artheonelec.com
Standard: ISO 9001:2000QMS
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ISO-9001:2000
SECTION -.0.2 Rev. no : 00,Issue:01QUALITY MANAGEMENT SYSTEM Date :01/07/07
EDITION HISTORY Page : 1 OF 1
Date of
Rev
Rev
No
Description of changes
APPROVED BY ISSUED BY
SINGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
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ISO-9001:2000
SECTION -.0.3 Rev. no : 00, Issue:01QUALITY MANAGEMENT SYSTEM Date :01/07/07
REVISION HISTORY Page : 1 OF 1
Remove
Page No.: &
Rev No
Insert
Page No. &
Rev No.
Amendment
Date
Changes made Signature of
copy holder &
Date
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
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ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION -.0.4 Rev. no : 00,Issue:01QUALITY MANAGEMENT SYSTEM Date :01/07/07
SCOPE AND APPROVAL Page : 1 OF 1
Quality Manual StructureThe Quality Management System is structured as per the requirements of standard ISO 9001-
2000 through chapters 4.0 to 8.0 which are in line with the technical requirements of the
products, for suitable quality achievement as envisaged by the group.
SCOPE :The Quality Management System covers all aspects and facts of :
Suppliers Of SMF Batteries
Quality Management SystemThe Quality Management System is derived from the Quality Policy and objectives given in
this manual, and is customer focused & aimed at enhancing customer satisfaction and gaining
an acceptance of the product in the market. It also meets the regulatory and legal requirements
of the product. It uses the process approach, systematic identification and management of
activities / processes that are employed through, a sequential process of As documented in the
different sections
APPROVAL
MD approves this Quality Manual and is committed,
to meet and exceed customer requirements, & expectations, besides complying withrelevant statutory and legal obligations.
To practice the QMS in all sphere of working of the company and thus to serve
customers with great & prompt responsiveness
To establish, implement and review the quality policy and its objectives, with a
view to ensuring their continuous suitability through improvements as necessary to
make available all necessary resources including providing an infrastructure of facilities
for achieving this purpose.
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
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ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 1.0 Rev. no: 00,Issue:01QUALITY MANAGEMENT SYSTEM Date :01/07/07
TABLE OF CONTENT Page : 1 OF 1
Section. NO. CONTENTS REV. NO. PAGES
0.1 Cover page 00 01
0.2 Edition History 00 01
0.3 Revision History 00 01
0.4 Scope and Approval 00 01
1.0 Table of Content 00 02
2.0 Introduction of Company 00 01
2.1 Distribution 00 02
2.2 Application 00 01
3.0 Quality Policy & Quality Objectives 00 01
4.0 Quality Management System-Documentation Requirement 00 04
5.0 Management Responsibility 00 04
Annexture-I 00 03
Annexture-II 00 01
Annexture-III 00 01
6.0 Resource Management 00 03
7.0 Production Realisation 00 09
08 Measurement Analysis & Improvement 00 07
09 List of Record 00 01
10 List of Work Instruction 00
01
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
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ARTHEON ELECTRONICS LTD.
ISO-9001: 2000
QUALITY SYSTEM MANUAL Doc no.: A E L/QMS
SECTION 2.0 Rev. no: 00,Issue:01
QUALITY MANAGEMENT SYSTEM Date :01/07/07INTRODUCTION OF COMPANY Page : 1 OF 1
INTRODUCTION OF COMPANY
ARTHEON ELECTRONICS LTD. Is located in
M/S. ARTHEON ELECTRONICS LTD
S 34, Okhla Industrial Area, Phase II,
New Delhi-110020, India.
Engaged in the business of
Suppliers Of SMF Batteries.
Artheon Electronics Ltd. is a professionally managed company engaged in the supply of high
quality VRLA SMF batteries imported from various parts of the world supported with high
quality service to enhance the utility and performance of the end user requirements. The company
uses the manufacturing facility of prime units in China, Taiwan, Korea and other European
countries as well as companies located in Malaysia and Hongkong to procure their requirements
of SMF batteries -which enables it to reach global scales of production and quality. Strong
product supply base coupled with highly competent manpower provide the unit a competitiveedge in the market.
ARTHEON ELECTRONICS LTD. is rated high on the customer satisfaction index as it gives
a lot of customers focus in serving them better.
As Per CUSTOMERS REQUIREMENT .
The Company has embarked on a modernisation programme to that end it has chosen to go for
Quality Management System as per ISO 9001:2000 in its organisation.
APPROVED BY ISSUED BY
SIGNATURE
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DESIGNATION CEO / MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION -.2.1 Rev. no : 00,Issue;01QUALITY MANAGEMENTSYSTEM Date :01/07/07
DISTRIBUTION Page : 1 OF 2
1 Quality Manual is the document, which describes the Quality Management System and
procedures, established and implemented by ARTHEON ELECTRONICS LTD. to meet
the requirements of International Standard ISO 9001: 2000 and to consistently provide
product that meets customer and applicable regulatory requirements. Quality Management
System, which is customer focused, aims to enhance customer satisfaction through the
effective application of the system and the processes for its continual improvement and the
assurance of conformity to customer and applicable regulatory requirements. Manual refers
supply chain of supplier - Organization - Customer. Product refers to service provides also.
This Manual applies to all activities, which contribute to the Quality of Manufacturing of
Suppliers Of VRLA- SMF Batteries.
DISTRIBUTION
1 The Manual, its copies or extract from it, must not be passed on to any person without the
written permission of MD ofARTHEON ELECTRONICS LTD.
2 Unnumbered / Uncontrolled copies may be given to Customer / Outside agencies purely for
information purpose. UNCONTROLLED copies are not covered under change control
but are current at the time of Issue.
3 Management Representative (MR), is responsible for establishing and maintaining the
processes of the Quality Management System, for periodically reporting to the management
on the performance of the system and for promoting awareness of customer requirements
through out the organisation.
4 The CONTROLLED copies are covered by change control and are stamped in red on all
pages. The controlled copies are distributed to Functional Heads. It is the responsibility of
CONTROLLED copyholder of this Manual to maintain and incorporate all revision on
receipt and keep it up to date. Copy No. 1- ------------- MD.Copy No. 2 --------------Management Representative (Master Copy)
Copy No. 3----------------Certification Body (KVQA)
Copy No.4--------------- Quality Control
APPROVED BY ISSUED BY
SIGNATURE
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DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 2.1 Rev. no. : 00,Issue:01QUALITY MANAGEMENT SYSTEM Date :01/07/07
LIST OF ABREVATIONS Page : 2 OF 2
SR.NO. ABREVATION DESCRIPTION
1 PUR Purchase
2 STR Store
3 PRD Production
4 PDEV Product Development5 QA Quality Assurance
6 MTN Maintenance
7 DEP Despatch
8 SAL Sales
9 REV Revision
10 G.R.R. Good Receipt Register
11 ENGG Engineering
12 A E L ARTHEON ELECTRONICS LTD.
13 QMS Quality Management System
14 M.D Managing MD
15 HOD Head of the department
16 NCP Non Conforming Products
17 CAPA Corrective Action Preventive Action
18 DEV Development
19 COMM Commercial
20 P.O. Purchase order
21 MR Management Representative
22 IS International Standard
23 QMS Quality Management System
APPROVED BY ISSUED BYSIGNATURE
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DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION -.2.2 Rev. no. : 00,Issue:01QUALITY MANAGEMENT SYSTEM Date :01/07/07
APPLICATION Page : 1 OF 1
APPLICATION
The following requirements of the ISO 9001-2000 neither affect the organizations ability nor
absolve it from its responsibility, to provide product that meets customer and applicable regulatory
requirements. The exclusions are limited, depending on type of product, customer requirements
and applicable regulatory requirements.
1 . Design and Development - As product is manufactured as per Requirement of the Customerand from own design applicable Statutory And regulatory standard, Design activity is excluded in
scope of this manual. Definitions as given in ISO 9001-2000.
Following supply chain is used
Supplier Organisation Customer
The term organisation replaces previously used term supplier (1994 version), Sub contractor is
replaced by term supplier, to match vocabulary used in general
Process an activity using resources and managed to convert inputs into outputs is considered as a
process. Product results of a process; is also means Service.
APPROVED BY ISSUED BYSIGNATURE
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DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 3.0 Rev. no : 00,Issue:01
QUALITY POLICY AND QUALITY OBJECTIVES Date :01/07/07
QUALITY POLICY Page : 1 OF 1
QUALITY POLICY
WE AT ARTHEON ELECTRONICS LTD. ARE COMMITTED TO
PROVIDE SUPPLY OF PRODUCTS AS PERCUSTOMERS
REQUIREMENT IN TIME, THROUGH CONTINUAL IMPROVEMENT
IN QUALITY MANAGEMENT SYSTEMS AND
INVOLVEMENT OF ITS EMPLOYEES.
QUALITY OBJECTIVES
We, Employees ofARTHEON ELECTRONICS LTD. Shall
Approach Achieving total Customer Satisfaction, by near 100% timely
delivery of quality products.
Increase in sales per year at the rate finalised in the Board of Directors and
Executive Council meetings.
Reducing rejection every year in a proportion as changed from time to
time.
Continual Improvement in Quality Management System &
to meet timely changes and upgradation in technology.
APPROVED BY ISSUED BY
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SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 4.0 Rev. no. : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07
TITLE: Documentation Requirement Page : 1 OF 4
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1.0 Purpose:
The purpose of this chapter is to provide an overview of the companys Quality
Management System and the principles upon which it is built. (ISO 9001:2000) and. operated.
2.0 Scope :
This section applies to the whole of the companys documentation establishment,
implementation, maintenance and continual improvement of the quality management
system, as well as the preparation of quality plans for all products manufactured by the
company.
3.0 Responsibility :
The responsibility for implementation review approval and improvement lies with the
Management Representative has the overall responsibility for document control. Concern
HODs. are to maintain records in their areas.
4.0 Definition :
4.1 General Requirements
The company has developed and implemented a documented Quality Management System to
meet the requirements of ISO 9001:2000 standards. The Quality Management System, is
implemented by Processes are identified throughout the organisation including those for
management activities, resources, product realisation and measurement needed for the QMS
(refer Process flow Diagram annex. II)
a) The sequence and interaction of these processes are determined
b) The criteria and methods required to ensure the effective operation and control of these
processes are suitably determined (ref.; Quality Plans)
c) The availability of resources and information necessary to support the operation and
monitoring of these processes is determined (through; Work Instructions)
d) Measuring, monitoring and analysing these processes.
e) Implementing actions necessary to achieve planned results and continual improvement of
these processes.
f) The company plans & manages these processes in accordance with QMS.
The Quality Management system also has a provision for controlling any process/s which is / are
out sourced.
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
QUALITY SYSTEM MANUAL Doc no. : A E L/QMSSECTION 4.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07
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ISO-9001:2000TITLE: Documentation Requirement Page : 2 OF 4
4.2 Documentation Requirements
4.2.1 GeneralThe Organisation chart and responsibility and authority of the main personnel is defined and
documented. (Annexure-III and AnnexureI ) ( As per 4.2.1. of ISO 9001:2000 )
The Quality Policy & Quality Objectives provide the basis for QMS (As stated in chapter 3).
The Quality Management System together with the documented procedures as required in ISO
9001-2000 are the main framework of the system.
Documented operating procedures as required by the Organisation, such as Quality Plans, Work
Instructions, Specifications, Drawings etc,
Quality records as required by standard ISO 9001-2000 (4.2.4), for effective operation and control
of activities/processes The procedures describing the logical sequence of activities with necessary
control and responsibility, are established, documented, implemented and maintained.
NOTE:-The Documentation including procedures is apt for the size and type of our company,complexity and inter-relation of activities and competence/skill level of personnel. It can be in
any form or type of medium e.g. hard copy / Electronic media. Checklist of the key procedures
as per Annexture IV. However current status of all procedures is available in Master list of
procedures.
4.2.2 Quality Manual
The Quality Manual, (this Manual) which is established and maintained, details the scope of
the QMS, exclusions with justifications & documented procedures or reference to them. It also
describes the interaction between the processes of QMS.
4.2.3 Control of DocumentsAll Documents of the Quality Management System are controlled. A documented procedure
is established in 4.2.3.1 of the section, with 4.2.3 of ISO 9001:2000 to cover the following :
To approve all documents for adequacy prior to Issue.
To review, update and re-approve documents.
To identify the current revision status of documents.
To ensure that relevant version of documents are available at the points of use.
4.2.4 Control of Quality Records
A documented procedure is established in 4.2.4.1of the section, for the Identification, storage,
retrieval, protection, retention-period and disposition of all Quality Records. Quality records are
legible, readily identifiable and retrievable.
Records required, as evidence of conformance to requirements and for effective operation of
Quality Management System are controlled. APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
QUALITY SYSTEM MANUAL Doc no. : A E L/QMSSECTION 4.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07
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ISO-9001:2000TITLE: Documentation Requirement Page : 3 OF 4
Procedure :
4.2.3.1 Control Of Document, Review, Approval & Issue
1.0 Identify and document the procedures and work instructions2.0 Discuss with the CEO & if necessary the MD.
3.0 Document the procedures / work instructions on standard format
4.0 Decide and Issue Quality Policy and Objectives.
5.0 Document Quality Manual briefly covering the Quality Management System of the
company as per the clauses of the ISO 9001-2000.
6.0 Get approval of the document from authorised signatory
7.0 Sign all pages in the column marked Issued by.
8.0 Make required number of photocopies and stamp each page with Controlled Copy
in red ink and distribute to the holders of controlled copies as per list .
9.0 Retain copy with mark as Master Copy on backside of each page for makingfurther copies.
10.0 When ever there is a change in any document and if such copies
are preserved for reference purpose retain such copies with markObsolete Copy
in red ink.
11.0 Record the documents in Master Register. 12.0 External documents like National &International standards and statutory and legalrequirements reviewed and controlled. A list is maintained.
4.2.3.2 Document Revision & Cancellation
1.0 Discuss all changes suggested with the concerned H.O.D/MD.
2.0 Follow procedure as listed in 5.1 ensuring that the approving and the issuing is done by the
same functional authority as was in the original approval and the next rev is marked.
3.0 Put revised documents in all controlled copies through concerned H.O.D. and complete the
revision list in the copy
4.0Remove copies of the old revision from each copy.
5.0 Retain one copy of the old revision and destroy all others copies.
6.0 Update the Master Register
7.0 Retain all documents for period of one year.
------- APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 4.0 Rev. no : 00,Issue:01
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ISO-9001:2000
QUALITY MANAGEMENT SYSTEM. Date :01/07/07
TITLE: Documentation Requirement Page : 4 OF 4
4.2.4.1 Control Of Records
1.0 Maintain a list of all records
2.0 Issue relevant copy to each Head
3.0 Maintain the list of records to be available with each H.O.D. so that these are
4.0 Easily retrievable, legible and are identifiable to each operation.
5.0 Keep records in racks, other safe places to avoid damage.
6.0 Maintain the records for those years as decided three years or less.
7.0 Keep backup record in Computer/Electronic media for all records maintained as in Soft copy.
8.0 Carry out scrutiny of obsolete records after specified retention period and dispose off
unwanted records by burning, or selling as waste.
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
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ISO-9001:2000
SECTION 5.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07
TITLE: Management Responsibility Page : 1 OF 4
1.0 Purpose:The purpose of this chapter is to provide an overview of the companys Management
responsibility, Authority and Management commitments to enhance the customers satisfaction.
2.0 Scope :
This section applies for Commitment of the top management by documenting and implementing
the Quality policy and Quality objectives, Quality management system planning, Quality
planning, Responsibilities and authority and maintaining effective internal communication in
the organisation.
3.0 Responsibility :
Management is responsible for assigning the responsibility and authority to the individual
employees, deciding the Quality policy and Quality objectives and concern H.O.D. areresponsible for implementing and maintaining in there respective dept.
5.0 Definition :
5.1 Management Commitment
Top managements commitment to the development, implementation and improvement of the
Quality Management System is evidenced by:
a) Its Communication to all concerned in the organisation, the importance of meeting customer
requirements of the product as well as statutory and regulatory requirement as applicable.
b) Statement / establishing of the Quality Policy
c) Ensuring establishment of Quality Objectives
d) Conducting management review meetings.
e) Ensuring the availability of necessary resources, manpower, for all activities.
5.2 Customer Focus ( Refer 7.2.1 and 8.2.1)
Management of the organisation ensure that customer requirements are determined and are fulfilled
with the aim of enhancing Customer satisfaction.
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
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DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 5.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07TITLE: Management Responsibility Page : 2 OF 4
5.3 Quality Policy
The Quality Policy Statement (section 3.0) defines the Organisations Quality policy. Employees
are fully briefed about this policy on joining the Organisation and during planned training. All
employees are responsible to implement the Quality Policy of the Organisation. The Quality Policy
is displayed at prominent places within the Organisation and is controlled.
Top management, while defining Quality Policy, considers the following;
It is appropriate to the purpose of the Organisation.It reflects commitment to meet the requirements, and continually improve the effectiveness of
Quality Management System.
It has a framework for defining and reviewing of Quality Objectives.
It is communicated and understood by all concerned in the Organisation.
It is regularly reviewed for continuing suitability.
5.4 Planning
5.4.1 Quality Objectives (7.1a Planning of product realisation)
Management ensures, establishing Quality Objectives at relevant functions and levels within the
Organisation. These objectives are measurable, and consistent with the quality policy, commitment
to continual improvement and also for meeting the requirements of the products. These objectives
are constantly reviewed (5.6.1)
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
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DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 5.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07TITLE: Management Responsibility Page : 3 OF 4
5.4.2 Quality Management System Planning
The Quality Management System is Planned to meet the requirement of ISO 9001:2000 and also
the Quality Objectives defined by the Organisation.
The Documented Quality Management System is the result of planning and is in line with the
Quality Objective that the Management set. The requirement which the system meant to meet are
(4.1 ) :
a) Determination of the process needed for the system and application throughout the organisation.
b) Determination of the sequence and interaction of these processes.c) Determination of the criteria and method to ensure the effectiveness of the operation and control
of the processes.
d) Making available the requisite resources human as well as physical to support the operation &
monitoring of the processes.
e) Monitoring, Measuring and analysing the processes.
f) Initiating actions to achieve planned results and also for continual improvement of the
processes.
g) The Management further ensures that the integrity of the QMS is maintained wherever any
changes to the system are planned and implemented.
5.5 Responsibility, Authority & Communication5.5.1 Responsibility and Authority
Functions, responsibility and authority (Refer Annexture-I) are defined and communicated, to all
concerned for effective quality managements system.
5.5.2 Management Representative
Management Representative Mr.V.S.Giridhargopal who irrespective of other responsibilities,
is responsible and Authorised for following;
a) To establish, implement and maintain the processes of Quality Management System.
b) To report to management on the performance of the Quality Management System and also
on any need for Improvement.
c) To promote awareness of Customer requirements, throughout the Organisation and to liaisonwith external agencies on matters relating to Quality Management System, as deemed
necessary.
5.5.3 Internal Communication
Appropriate communication processes regarding Quality Management System & its effectiveness,
are established, within the Organisation. Management ensures such communication regarding
effectiveness of Quality Management System. APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
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ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 5.0 Rev. no : 00,Issue;01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07TITLE: Management Responsibility Page : 4 OF 4
5.6 Management Review
5.6.1 General
MR reviews the implementation of Quality Management System, at planned intervals to ensure its
continuing suitability, adequacy and effectiveness. The review covers, evaluation of the need for
changes, to this system, Organisations Quality Policy and Quality objectives.
For this purpose a Management Committee consisting ofMR, Incharge Production, Incharge
Quality Assurance and Incharge Marketing & sales is appointed. Records from managementreview are maintained.
5.6.2 Review Inputs
The Review inputs for the Management review include the current performance and opportunities
for improvements on the following:
Follow up Action from previous Management reviews.
a) Audit reports findings.
b) Customer feedback
c) Process conformance and product conformity
d) Status of corrective action and preventive action.
e) Review of Quality Management System such as Issues related to Quality Policy and Objectives.,f) Technological Up-gradation, Training needs, Resource profiles etc.
g) Suitability and effectiveness of Quality Management System
h) Recommendation for improvement.
I) Resources required
5.6.3 Review output
a) The Review outputs from the Management Reviews, include actions relating to:
b) Required Improvement of the effectiveness of the Quality Management System and its
processes.
3) Required Improvement of product related to the customer requirements.
4) Resources requirements/needs.5) The minute of the Management Review meetings are recorded and extracts circulated to
concern dept. Incharge for action by the MR.
APPROVED BY ISSUED BY
SIGNATUREDESIGNATION MD MR
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DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. :A E L/QMS
ANNEXURE - I Rev. no : 00,Issue:01QUALITY MANAGEMENT SYSTEM Date :01/07/07
RESPONSIBILITY AND AUTHORITY Page : 1 OF 3
1.0 CEO/MD.
Formulates all decisions and implements them
Manages the fund flow for effective functioning of entire unit.
Gives the Quality Policy and Objectives of the company.
Lays down task and targets for all.
Identifying training needs and preparation of training calendar.
To create work environment by educating and motivating employees inorganisation.
To provide infrastructure for implementing quality management system.
Interacts with the customer for all matters relating to product and services.
Responsible for Administration, office efficiency & effectiveness
Responsible for the effective operations in compliance with policies and objectives.
Chairs Management review meetings.
Ensure safety requirement are being followed and safety equipment are in order
2.0 Management Representative
CEO/MD have appointed as a Management Representative. Establishment, Implementation, Documentation and Maintenance of the Quality systems.
Planning & Conducting Internal audits.
Attend to all customer feedback
Identify the training needs of all and carryout training of people .
Provide service and technical support to all customers (If required)
Evaluating performance of Quality systems & corrective action and preventive action
Preparation of agenda for Management Review Meeting.
Preparation of Management Review Meeting Schedule.
Organising Management Review Meetings and corrective action Preparation of reports for consideration by the meeting.
Action on the recommendations of Management Review Meetings.
Co-ordination with supplier for system audits.
Co-ordination with the customer for audit.
Co-ordination with the certifying body.
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APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
ANNEXURE - I Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM Date :01/07/07
RESPONSIBILITY AND AUTHORITY Page : 2 OF 3
3.0 Incharge Quality Control
Preparation of specification for bought out and finished Components.
To arrange for receiving and final inspection of raw material and finished product.
To get feed back regarding product quality.
To keep trend of customer complaint.
Verification of records generated In process and final inspection.
To monitor Calibration of all monitoring and measuring devices.
Make decision regarding quality deviated products at incoming/ In process/ final stages.
4.0 Incharge Services
To monitor production quantity & quality as per the targeted schedule.
To get the maximum out put with available resources.
To prepare and maintain production records.
To finalise optimum processing condition for each process & components. To maintain plant, machinery & Equipments in order to achieve required productivity
Initiation of corrective & preventive action.
To maintain neat house keeping
Monitoring of Preventive & break down Maintenance of tools.
To monitor and maintain the proper house keeping in the shop floor
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5.0 Incharge Marketing & Sales
Preparation and Forwarding of Quotation for enquires received.
Follow up and finalisation of orders.
Co-ordination with customer and staff in the organisation
Co-ordination for planning of Trial / first lot production.
Follow up with customer For results of trial.
Establishing new areas of business as and when the need arises.
Incorporating new products in to the System and release of all relevant Information /
documents to the Concerned dept.
Co-ordination and follow with customer for getting the feed back on supplied product.
Taking corrective and preventive action on customer complaints for entire customer
satisfaction.
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
ANNEXURE - I Rev. no : 00,Issue:01QUALITY MANAGEMENT SYSTEM Date :01/07/07
RESPONSIBILITY AND AUTHORITY Page : 3 OF 3
6.0
6
Incharge Purchase
Procurement of materials conforming to required specification against indent - raised.
Development assessment approval of supplier
Review & verification of purchase records
Arrange for supplier Payment In time
Take appropriate action on suppliers in case of not fulfilling the specified Requirements
in the contract.
Inform / Discuss Supplier quality rating to the concern and Intimate Q.A for poor quality
rating of supplier.
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7.0 Incharge Stores
Preparation and verification of GRR.
Control & monitor of handling / storage Preservation / receipt / Issue of materials.
Arrange for dispatches as per customers schedule and preparation of necessary records
required. Issue of materials and collection of bought out off-loaded and raw materials as per
requirements.
To monitor despatches for supplier for off-loaded work.
8.0
Incharge Commercial
Updating the records of training of all personnel within the organisation in their
respective file.
Monitoring on Purchase activities.
Monitoring on Sales Activities Monitoring on payment of Customer, Supplier. And Bank Transactions.
Monitoring on Sales A/c s and Purchase A/cs activities.
Monitoring on other commercial activities.
Monitoring on Excise formalities and Excise records.
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
ANNEXURE - II Rev. no : 00,Issue;01QUALITY MANAGEMENT SYSTEM Date :01/07/07
SEQUENCE & INTRACTION OF PROCESSES Page : 1 OF 1
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APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
Annexure -III Rev. no : 00,Issue:01QUALITY MANAGEMENT SYSTEM Date :01/07/07
Annual Plan
Depar tment Plan (Quali ty Object ives)
Enquiry /Quota t ions /Purchase Orde r
Payment
S tocking
Dispa tch
Procurement P lan
Rece ip t Inspec t ion &
I s s u e
Inspec t ion .
Fina l Inspec t ion
Month ly Sa les Schedule
F ina l i sed Goods
Customer Requi rement
Cus tomer In te r face /
Enquiry & Order
Cus tomer Pe rcept ion
CA & PA
Customer Spec i f ica t ion
N CP
CA & PA
N CP
CA & PA
Analys is
Cus tomer Compla in ts
CA & PA
N CP
Stores Acceptance
Choose Agency for Ca l ibra t ion
Issue to loca t ion
Ca l ibra t ion
CA & PA
Inte rna l Audi t Schedule
In te rna l
Audi t
Improvement & CA & PA
on Non conformi t ie s
Suppl ie r s
Assessment Schedule
CA & PA / Improvement
On non conformi t ie sSuppl ie r s Audi t
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ORGANISATION CHART Page : 1 OF 1
Organisation Chart
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
Finance
HOD
Sr. VP
Marketing
Sr. VP
Material
MD
CEO
Sales Team Service
Team
Stores Accounts
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ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 6.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM Date :01/07/07TITLE: RESOURCE MANAGEMENT Page : 1 OF 3
1.0 Purpose:
The purpose of this chapter is to provide and documented procedure for maintaining the
adequate resource for smooth function of the Quality management system in the organisation.
2.0 Scope :
This section applies for provision of resources, the Identification of training needs, imparting the
training to employees, Maintenance of training record as well as to provide, maintain
infrastructure and Manage the work environment needed for achieving conformity of product.
3.0 Responsibility :
The responsibility for this lies with MD, M.R. and concerned H.O.D.
4.0 Definition :
6.0 General :
6.1 Provision of Resources
The Resources required are determined and provided in a timely manner to implement, maintain
and improve the Quality Management System and continually improve its effectiveness and to
enhance Customer satisfaction by meeting the customer requirements. of ISO 9001:2000.
The Resources covers equipment and accessories, trained personnel, monitoring and measuring
equipment. Partner ensures that personnel who are assigned responsibilities, under the QualityManagement functions, are competent and are suitably qualified on the basis of education,
training, skill and experience
6.2 Human Resources .
6.2.1General
The Management ensures that personnel who are assigned, responsibilities, under the
Quality Management functions, are competent and are suitably qualified on the basis of
education, training, skill and experience,
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
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ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 6.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07TITLE: RESOURCE MANAGEMENT Page : 2 OF 3
6.2.2 Competence, Awareness and Training
The organisation takes action to;
Lay down competence requisites for personnel performing activities affecting Products Quality.
Provide suitable training to satisfy these needs.
Evaluate the effectiveness of the training provided.
Ensure that its employees are aware of the relevance and importance of their activities and their
contribution to achieve quality objectives.
Maintain appropriate personnel records of education, skills /experience, training (4.2.4)
6.3 Infrastructure
The organisation also determines, provides and maintains the requisite infrastructure of facilities
for achieving conformity of product including
Buildings, Workspace and associated Utilities.
Process equipments, hardware and software.
Supporting services such as transport or communication.
6.4 Work EnvironmentThe organisation further identifies and manages the human and physical factors of the work
environment necessary to achieve conformity to product requirements.
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
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DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 6.0 Rev. no : 00,Issue:01QUALITY MANAGEMENT SYSTEM. Date :01/07/07
TITLE: RESOURCE MANAGEMENT Page : 3 OF 3
Procedure :
APPROVED BY ISSUED BY
Identify Training Needs
Preparation Of Training
Calendar
Selection Of Faculty
Information To Employees
Preparation Of Schedule
Conduct Training
Get Feed Back Of Training
Evaluate
Effectiveness
UnsatisfactoryResult
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SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 7.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07
TITLE: PRODUCT REALISATION Page : 1 OF 10
1.0 Purpose:
The purpose of this chapter is to provide procedure for total customer satisfaction by
understanding and meeting their requirements in specified time.
2.0 Scope :This section applies for Planning, Purchasing, Production and Inspection of material to meet
the requirement of customer Schedule with right quality of product in right time as well as it is
applicable for reviewing the requirements related to products, and maintaining customers
property in good condition.
3.0 Responsibility :
The responsibility for this lies with MD and concerned H.O.D.
4.0 Definition :
7.1 Planning Of Product RealisationThe planning for product realisation is that sequence of processes and sub-processes required
for achieving the product quality. The organisation prepares Quality Plans that describe, how
the processes of quality management system are applied in planning the processes for
realisation of product.
The organisation determines the following, as appropriate:
Quality objectives/Quality plans for the product
The need to establish processes and documentation and to provide resources specific to the
product
Verification, validation, monitoring, inspection and test activities, specific to the product and
the criteria for acceptance.
The records evidencing the realisation of the processes and conformance of the resultingproduct, fulfils requirements.
The Organisation determines product realisation processes & acceptance criteria, through
Quality Plans, of QMS for specific product.
7.2 Customer related processes
7.2.1 Determination of requirement related to the product
The Organisation determines the customer requirements, which includes the following;
Product requirements including availability, delivery and support as specified by the customer.
Product requirements necessary for intended or specified use, if not specified by the customer.
Statutory requirement and regulatory requirements of product as applicable
Additional requirements as decided by the Organisation related to the product.
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APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 7.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date : 01/07/07
TITLE: PRODUCT REALISATION Page : 2 OF 10
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7.2.2Review of Requirements related to product
The Organisation reviews, the identified customer requirements related to
Product , together with additional requirements as determined (7.2.1 )
This review is conducted prior to the commitment to supply a product to the customer( e.g. submission of tender, acceptance of a contract or order), to ensure following:
a) Product requirements are defined.
b) Where the customer does not provide any documented statement of requirements, the customer
requirements are confirmed before acceptance.
c) Contract or order requirements differing from that previously expressed are resolved.
d) The organisation has the ability to meet the defined requirements.
The results of the review and subsequent follow-up actions are recorded. (4.2.4)
It is ensured that, wherever product requirements are changed, the relevant documents are
amended and the concerned persons are made aware of the changed requirements.
7.2.3 Customer Communication
The Organisation identifies and implements, effective arrangements for communicating with the
customer relating to following;
Product information;
Enquires, contracts or order handling, including amendments.
Customer feedback including Customer complaints.
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMSSECTION 7.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date : 01/07/07
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TITLEL:DESINE AND DEVELOPMENT Page : 3 OF 10
7.3 Design and Development
7.3 Design and Development
7.3.1 Design and Development Planning
The organization has got a separate design department functioning in the guidance of
Partner named R&D. The department is responsible for the planning of design and
development activities for product and installations in consultation with the Partner.
Suitable processes for review, verification and validation of the design and development
are also established.
7.3.2Design and Development Inputs
Inputs necessary for the design ad development 1) Drawings 2) Technical requirements
3) Functional requirements are received from the customers. Drawing sketches are
prepared based on these informations. the inputs are reviewed and ambiguities are
resolved internally as well as with customer if necessary.
7.3.3 Design and Development Outputs
Is assessed to see that output meets the input requirements All departments are involved
and acceptance cri teria made known to al l Special safety and use condi t ions are made
known.
7.3.4 Design and Development Review
A formal review is done by Partner for the effective verification of the design and
development outputs against the inputs. Representative form the various related
departments like production, quality assurance, purchase, marketing and outside
specialist if required take part in the review. The decisions of such reviews are recorded.
Reviews enable to evaluate whether the design outputs are meeting the product
requirements or not. Also the problems incurred can be resolved.7.3.5 Design and Development verification
The output results of Design ad development are verified against the planned
requirements to evaluate and ascertain that they are as per the input requirements.
Records of the verification and necessary actions are recorded. Verification is carried out
by Head of design and approved by Partner
7.3.6Design and Development validation
Design and development validation is done in accordance with the plan and it is ensured that the
resulting product is capable of meeting the requirements of specified application. This is done prior
to the delivery to the customer. Functional trial is also done wherever necessary. Final validation is
done by Head of quality assurance and approved by Partner
7.3.7Control of Design and Development changesDrawing changes as found necessary during reviews or as suggested by the customer are
recorded. New specifications are established incorporating the changes. Changes shall be
reviewed before.
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
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ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 7.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date : 01/07/07TITLE: PURCHASING Page : 4 OF 10
7.4 Purchasing
7.4.1Purchasing Process
The organisation controls its purchasing processes to ensure that purchased products conform to
specified purchase requirements. The type and extent of control applied to the suppliers and
purchases product depends upon the effect on subsequent product realisation processes or the
final product.
The organisation evaluates and selects suppliers based on their ability to supply product in
accordance with Organisations requirement. Criteria for selection evaluation and periodical re-
evaluation of suppliers are established. The results of evaluations and necessary follow up actions
are recorded and maintained. (4.2.4)
7.4.2 Purchasing Information
Purchasing documents contains information describing the product to be purchased including, as
appropriate, the following:
Requirement for approval of product, procedures, processes, and equipment.
Requirement for Qualification of personnel
Quality management system requirements
The organisation ensures the adequacy of specified purchase requirements contained in the
purchasing documents, prior to their communication to the supplier.
7.4.3 Verification of Purchased ProductThe organisation establishes and implements, inspection and other activities necessary for
verification of the purchased product vis a vis the specified purchase requirements.
Where it is proposed either by the organisation or its customer, to perform verification activities
at the suppliers premises, the intended verification arrangements and method of product release,
are clearly specified in the purchasing information.
7.5 Production and Service provision
7.5.1Control of production
The Organisation plans and controls all production operations under controlled conditions
including as applicable:
a) Making available, information that describes the characteristics of the product.
b) Availability of work instructions, as necessary.c) Using and maintaining suitable plant and machinery.
d) *Availability and use of the monitoring and measuring devices
e) Implementing of monitoring and measurement.
f) The implementation of release, delivery and post-delivery activities.
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
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ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 7.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07TITLE: PRODUCT REALISATION Page : 5 OF 10
7.5.2 Validation of processes for product services
The organisation validates any processes for product and service provisions where the resulting
output cannot be verified by subsequent monitoring measurement. This includes any processes
where deficiencies may become apparent only after the product is put to use. Such validation is
carried out, to demonstrate the ability of the processes to achieve the planned results. The
organisation defines and makes all arrangements for validation of the processes which include the
following as applicable:
a) Defined criteria for approval and review of processes
b) Approval of equipment and qualification of personnel
c) Use of defined methodology and procedures
d) Requirements of records (4.2.4)
e) Revalidation
7.5.3 Identification and Traceability
The organisation identifies, where appropriate, the product by suitable means throughout product
realisation
The organisation does identify the status of the product with respect to monitoring and
measurement requirements.The organisation does control and record the unique identification of the product, where
Traceability is a requirement (4.2.4)
7.5.4 Customer Property
The organisation does exercise care with the customer property while it is under its control or
being used by it. The organisation does identify, verify, protect and safeguard customer property
provided for use or incorporation into the product. Incidence of any loss, damage or unsuitability,
of customer property is recorded and reported to the customer. Where applicable intellectual
property are included as customer property.
7.5.5 Preservation of ProductThe organisation does preserve the conformity of the products, including constituent parts, with
the customer requirements during internal processing and delivery to the intended destination.
This covers identification, handling, packaging, storage and protection.
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
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ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 7.0 Rev. no : 00,Issue:01QUALITY MANAGEMENT SYSTEM. Date :01/07/07
TITLE: PRODUCT REALISATION Page : 6 OF 10
7.6 Control of monitoring and measuring devices
The organisation determines the monitoring and measurements to be carried out and the devices
required for the purpose, to assure conformity of the product to specified and determined
requirements (7.2.1).
The organisation puts in place appropriate processes to ensure that monitoring and measurement
are carried out in a manner consistent with monitoring & measurement requirements.Where necessary, ensure valid results measuring equipments are:
Verified at specified intervals and calibrated and adjusted prior to use, against traceable international
or national measurement standards. Where no such standards exist, the basis used for calibration or
verification is recorded.
Adjusted or readjusted as necessary
Identified to enable to determine the calibration status.
Safe guarded from adjustments that would invalidate the calibrations/measurements results.
Protected from damage and deterioration during handling, maintenance and storage.
The organisation ensures that the result of calibration is recorded besides assessing and recording.
The validity of previous results are assessed and recorded if the equipment is subsequently found to be
out of calibration and taking corrective action on equipment and any product affected. Records ofresults of calibration and verifications are maintained (4.2.4).
Computer Software used if any, for measuring and monitoring of specified requirement. The
ability of computer software to satisfy the intended applications is confirmed prior to use and
reconfirmed as necessary.
APPROVED BY ISSUED BY
SIGNATURE
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DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 7.0 Rev. no : 00,Issue:01QUALITY MANAGEMENT SYSTEM. Date :01/07/07
TITLE: PRODUCT REALISATION Page : 7 OF 10
Procedure
Customer Related Processes :
APPROVED BY ISSUED BY
Enquiry From Customer
Specification
Study Of Enquiry
Raise Quotation
Receipt Of P.O
Follow Up For Feed Back
Dispatch
Amendment note
If there is any
changes
Preparation Of Schedule
Corrective And Preventive
ActionOn Complaints
Discussion And
Negotiation
Co-Ordination For
Completion Of Order
Analysis Customer
Satisfaction / Dissatisfaction
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SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMSSECTION 7.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07
TITLE: PRODUCT REALISATION Page : 8 OF 10
Purchasing :
Receipt Of Quotation
Evaluation of Supplier
Placement Of Order & Approved By CEO
Invitation of A roved Sources
Receipt Of Material
Receipt of Accepted
Material To Stores
Verification of
Purchased Product
Rejected Material Send
Back to Party
Corrective & Preventive
Supplier Rating
Send Enquirer
Indent from respective dept.
a roved b CEO / HOD
Periodical Re-Evaluation
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APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 7.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07
TITLE: PRODUCT REALISATION Page : 9 OF 10
Purchasing material Visual Proper storage of incoming goods
Incoming inspection by QA
.
Verification of filled information
. Final quality Inspection
Marking/labelling Packing
Dispatch
APPROVED BY ISSUED BY
W
H
X
X
X
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SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMSSECTION 7.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07
TITLE: PRODUCT REALISATION Page : 10 OF 10
Control of Measuring and Monitoring Devices :
APPROVED BY ISSUED BY
SIGNATURE
Documented & Coded List of &
Testing Equipment
Record of
Calibration
Calibration of Testing &
Measuring Equipment (In house
or Outside source)
Recalibration
Monitoring of
Calibration
Accuracy
Schedule for Calibration
Out of
Calibration
Scraped/
Replacement
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DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 8.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07
TITLE: MEASUREMENT ANALYSIS AND
IMPROVEMENT
Page : 1 OF 7
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1.0 Purpose:
The purpose of this chapter is to provide procedure for Monitoring, Measurement, Analysis
and Improvement of processes with help of implementation of quality management system.
2.0 Scope :This section applies for Measurement of Customers perception, Internal Audits, Monitoring
and Measurement of Processes, Monitoring and Measurement of Product, Analysis of data
and taking corrective and preventive action for Continual Improvement of product and
system.
3.0 Responsibility :
The responsibility for this lies with MD, CEO, M.R. and concerned H.O.D.
4.0 Definition :
8.1 General
The organisation does define, plan and implement the monitoring, measurement, analysis and
improvement processes needed:
To demonstrate conformity of the product
To ensure conformity of Quality Management System
To continually improve the effectiveness of quality management system. This includes the
determination of the applicable methods including statistical techniques and the extent of their
use.
8.2 Monitoring and Measurement
8.2.1Customer SatisfactionThe organisation does monitor information relating to customer satisfaction and dissatisfaction
as one of the measurements of performance of the quality management system. The organisation
also monitors information relating to customer perception for fulfilment of customer
requirement. The methodologies for obtaining and using this information are determined and
documented in 8.2.1.1 of this section.
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 8.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07
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ISO-9001:2000
TITLE: MEASUREMENT ANALYSIS AND
IMPROVEMENT
Page : 2 OF 7
8.2.2 Internal Audit
The organisation conducts periodic planned internal audits to determine whether the quality
management system Conforms to planned arrangement (7.1) of the requirements of theInternational Standard and to the Quality Management System established by the organisation
and is effectively implemented and maintained.
The organisation plans the audit program taking into consideration, the status and importance of
the processes and areas to be audited, as well as the results of the previous audits.
The audit criteria, scope, frequency and methods are defined. Selection of auditors and conduct
the audits to bring about objectivity and impartiality of the audit process. Auditors do not audit
their own work.
A documented procedure is defined in 8.2.2.1 of this section specifying the responsibilities and
requirements for planning and conducting audits, and for reporting results and maintaining
records (4.2.4).
Management takes timely corrective actions on deficiencies found and eliminate non-conformities and their causes detected, during the audit without undue delay.
Follow up activities includes the verification of the implementation of corrective actions, and
reporting of verification results.
8.2.3 Monitoring and Measurement of Processes
The Organisation applies suitable methods for monitoring & where applicable measurement of
QMS processes. These methods to demonstrate their ability to achieve planned results. When
planned results are not achieved, appropriate correction & preventive action are taken to ensure
conformity of the product.
8.2.4 Monitoring and Measurement of Product
The Organisation monitors and measures the characteristic of the product, to verify that
requirements for the product are fulfilled. This is carried out at appropriate stages of the product
realisation process according to planned arrangement (7.1).
Evidence of conformity with the acceptance criteria is documented. Records do indicate the
person(s) authorising for release of product (4.2.4)
Product release does not proceed until all the planned arrangement have been satisfactorily
completed, unless otherwise approved by the relevant authority and where applicable by the
customer.
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 8.0 Rev. no : 00,Issue01
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ISO-9001:2000
QUALITY MANAGEMENT SYSTEM. Date :01/07/07
TITLE: MEASUREMENT ANALYSIS AND
IMPROVEMENT
Page : 3 OF 7
8.3 Control of Non-Conforming product
The Organisation ensures that product which does not confirm to the requirements is identified
and controlled to prevent unintended use or delivery. The control and related responsibilities and
authorities for dealing with non-conformance product are defined in a documented procedure as
per 8.3.1 of this section.
The organisation deals with nonconforming products in one or more of the following ways:
By taking action, to eliminate the detected non-conformity during production and inspection.
Records of nature of non-conformities and subsequent action taken, including concessions
obtained, are maintained (4.2.4). Non-Conforming product is corrected; it is re-verified after
correction to demonstrate conformity to the requirements.When non-conformity is detected, after delivery or use has started the Organisation takes action
appropriate to the effects, or potential effects of the non-conformity.
It is often required that the proposed rectification of the non-conforming product is reported for
concession to the customer.
8.4 Analysis of data
The Organisation collects and analyses appropriate data to determine the suitability and
effectiveness of the Quality Management System and to evaluate where continual improvements of
the Quality Management System can be made. This includes data generated as a result of
monitoring & measurement and from other relevant sources.
The Organisation collects and analyses appropriate data to determine the suitability andeffectiveness of the Quality Management System and to evaluate where continual improvements
of the Quality Management System can be made. This includes data generated as a result of
monitoring & measurement and from other relevant sources.
The Organisation analyses this data, to provide information on:
a) Customer satisfaction (8.2.1)
b) Conformance to product requirements (7.2.1)
c) Characteristics and trends of processes and products including opportunities for
Preventive action.
d) Suppliers
APPROVED BY ISSUED BY
SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
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ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION 8.0 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07
TITLE: MEASUREMENT ANALYSIS AND
IMPROVEMENT
Page : 4 OF 7
8.5 Improvement
8.5.1Continual Improvement
The organisation plans and manages the processes necessary for the continual improvement of
the effectiveness of Quality Management System and facilitates the continual improvement of
Quality Management System through the use of Quality Policy, Quality Objectives, Audit
results, Analysis of data, corrective and preventive actions and Management Review.
8.5.2 Corrective Action
The organisation takes actions to eliminate the cause of non-conformity in order to preventrecurrence. Corrective actions are appropriate to the effect of non-conformities encountered.
The documented procedure 8.5.2.1 of this section for corrective action defines requirements for:
a) Reviewing Non-conformities (including customer complaints)
b) Determining the causes of non-conformities.
c) Evaluating the need for actions to ensure that non-conformities do not recur.
d) Determining and implementing the action needed
e) Recording results of action taken (4.2.4) and Reviewing of Corrective action taken
8.5.3 Preventive Action
The organisation determines action to eliminate the causes of potential non-conformities in
order to prevent their occurrence. Preventive action taken are appropriate to the effect of thepotential problems.
The documented procedure 8.5.3.1 of this section for preventive action defines requirements for
Determining potential non-conformities and their causes
Evaluating the need for action, to prevent occurrence of non-conformities
Determining and implementing preventive action needed.
Recording results of action taken (4.2.4)
Reviewing of preventive action taken.
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DESIGNATION MD MR
DATE- 01/07/07 01/07/07
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ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION-08 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07
PROCEDURES Page : 5 OF 7
Procedure :
8.2.1.1 Customer Satisfaction
1.0 Take customer feed back on phone, during meeting with the customer, specification sheet
with customer remarks sent by customer, customer comments on receipt of goods and customer
complaint.
2.0 Record the same in non conformance format.
3.0 Analyse the same and discuss in Management Review meetings .
4.0 Take necessary corrective and preventive actions for non-occurrence of the same.
5.0 Keep the other head of depts. Informed and inform customer on the outcome.
8.2.2.1 Internal Quality Audit
1.0 Prepare annual audit plan so that
A) All departments are covered under the Quality Management System are audited at least once
In quarter.
B) Areas having large number of non-conformities are audited more frequently than stipulated.
C) The audit covers all the requirements and clauses as specified in ISO 9001-2000.
D) The audit covers review of customer feedback complaint.
2.0 Keep a list of all trained auditors.
3.0 Prepare and circulate audit schedules for individual audit to all concerned department having
the details of departments to be covered clauses to be audited and the names of auditors.4.0 The audit team must be independent of the function being audited.
5.0 Audit must be conducted by qualified and trained internal auditors, arrange for external
auditors whenever required if necessary .
6.0 Carryout audit for compliance and effectiveness of QMS.
7.0 While conducting audit verify the non conformities found in previous audit.
8.0 Record Non conformities on nonconformity formats, observations and obtain acceptance
and proposed corrective action and time required to resolve the same and report to MR.
9.0 Get Corrective actions verified.
10.0 Conduct management review meeting and discuss the non conformities recorded during
the audit and prepare minutes of meeting.
11.0 Prepare audit summary report of Management Review.
APPROVED BY ISSUED BY
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DESIGNATION MD MR
7/27/2019 Artheon Ver 1.2
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DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION-08 Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07PROCEDURES Page : 6 OF 7
8.2.4.1 Monitoring and Measurement of Product
1.0 Carryout incoming material sampling, testing and approval as per specification for
incoming materials and products specifications.
2.0 Product not under quality must be approved by the user department
3.0 As far as practicable no materials are released for further processing without approval.
4.0 Urgently required goods if released for without approval are positively identified and
recalled if product produced is found non-conforming.
5.0 In process material are measured and monitored before release for next process anddefective are rectified / rework as per requirements.
6.0 Records of all in process materialare maintained.7.0 Finished goods are made to pass the entire customer specified / agreed tests before being
put to commercial use. Any discrepancy found at the final stage is tested as per the
original plan so that it satisfies all the customer requirements.
8.3.1 Control On Non Confirming Products
1.0 The Quality Control personnel do reporting of the non-conformance when they find
them either during production or at the final stage of monitoring and measurement.
Such items are prevented from further processing These are usually entered in anon-conformance register. With details like type of Non- Conformance The cause of
the nonconformity is recorded for root cause analysis.
2.0 Disposition of Non conforming items is done depending upon the nature of non
conformance It can be Minor or Major
a) Minor Nonconformity
Minor non-conformance are those where minor nature. In all these cases the
decision regarding rejection/rework/rectification or other use for acceptance is taken
by the Head of Production Dept. with the consultation of Quality Control Dept .
b) Non conformances Major
These are those cases where performance is effected or can cause delay in
Delivery or can result in major cost involvement due to rejection/rectification/reworkIn such case the decision is taken by the Head Production, QC and MD.
The disposition of non conforming product can be of the following types
i) Reworked to eliminate the non conformity of product.
ii) Accepted with or without repair by concession with the decision of MD
/ Customer.
iii) Re-graded for alternate use.
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DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMS
SECTION-08 Rev. no : 00,Issue:01QUALITY MANAGEMENT SYSTEM. Date :01/07/07
PROCEDURES Page : 7 OF 7
8.5.1.1 Continual Improvement
1.0 Include results of achievements in the following areas for discussions in the Management
Review Meetings.
a) Results of Audits
b) Customers feedback.
c) Process performance and product conformity
d) Status of preventive and corrective actionse) Follow-up actions from previous management reviews.
f) Changes that could affect the quality management system
g) Recommendations for improvement.
2.0 Discuss the same in the meeting so as to achieve continual improvements in process and
products.
3.0 Record the decisions as minutes of meeting clearly defining the responsibility for
implementation and the date of completion.
4.0 Implement decisions for continual improvements.
8.5.2.1 Corrective Actions
1.0 Send all customer feedback, product nonconformity and audit nonconformity to Head
Production and Quality Control.
2.0 Record the same in non-conformance report. .
3.0 Analyse the causes of nonconformity.
4.0 Record the same in the non-conformance report.
5.0 Suggest suitable corrective actions.
6.0 Implement the same and monitor the results of implementation.
7.0 Non-conformity during transportation to be taken up with he transported.
8.5.3.1 Preventive Action
1.0 Identify potential nonconformity throughDiscussion with customer during his visit or by visiting his premises.
Past experience while manufacturing similar product
Problems faced during initial stage.
2.0 Get all these feedback registered in non-conformance report.
3.0 Discuss the same in Management Review Meetings to find out necessary preventive
actions and record the same as minutes.
4.0 Implement decisions to avoid nonconformity.
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SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMSAnnexure -V Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07
List Of Work Instructions Page : 1 OF 1
List Of Work InstructionsS. No. Name of Work Instruction WI No Date /Rev No
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SIGNATURE
DESIGNATION MD MR
DATE 01/07/07 01/07/07
ARTHEON ELECTRONICS LTD.
ISO-9001:2000
QUALITY SYSTEM MANUAL Doc no. : A E L/QMSAnnexure -IV Rev. no : 00,Issue:01
QUALITY MANAGEMENT SYSTEM. Date :01/07/07
List Of Record Page : 1 OF 1
List Of RecordsS. No Records List Responsibility Retention
Period
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DESIGNATION MD MR
DATE 01/07/07 01/07/07