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Quality Management System
ISO 9001:2008
XYZ
Address
Manufacture, Supply, Export & Job Work of S.S. Baluster Railing,
Hand Railing, Interior Furniture and S.S. Fabrication
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TITLE: TABLE OF CONTENTS SECTION: QM 0.1
Sr.
No.
Description
ISO 9001 Clause
Ref.
Section No. Page Nos.
01 Table of Contents -- QM-0.1 2
02 Revision History -- QM-0.2 3
03 List of Controlled Manual Holders -- QM-0.3 4
04 Introduction -- QM-1.0 5
05 Scope of the Quality Management System -- QM-2.0 6
06 Exclusions & Justifications -- QM-3.0 7
07 Quality Management System 4.0 QM-4.0 8 -9
08 Management Responsibility 5.0 QM-5.0 10–14
09 Resource Management 6.0 QM-6.0 15
10 Product Realization 7.0 QM-7.0 16–18
11 Measurement Analysis and Improvement 8.0 QM-8.0 19–21
12 Organogram -- QM-9.0 22
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TITLE: REVISION HISTORY SECTION: QM 0.2
Sr.
No.
Brief Description of Change Rev. No. Page No.
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TITLE: LIST OF CONTROLLED MANUAL HOLDERS SECTION: QM 0.3
Sr.
No.
Manual Holders Copy No.
01 Top Management / Management Representative 01 (Master Copy)
02
Production / Stores / Quality Control /Purchase / Marketing-In-
charges
02
03 Certification Agency 03
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TITLE: INTRODUCTION SECTION: QM 1.0
Our Company is one of the leading companies in its class.
We at our company are dedicated to supply quality products with High Quality Testing Equipment, Highly
qualified technical staff, in-house tool room, checking & packing we are confident of handling customer’s
requirements.
The company is backed by the strong technical expertise. Generous and ambitions management well equipped
plant with adoption of modern technology and runs under close observation by learned technicians. Expertise to
enrich quality product by breakthrough innovative ideas. The company has devoted and hard working work
force in all field of the work.
Qualified and experienced management may able to lead and guide them for the proper way of work to be
done.
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TITLE: SCOPE OF THE QUALITY MANAGEMENT SYSTEM SECTION: QM 2.0
Scope of the Quality Management System is implemented as per ISO 9001:2008 standard.
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TITLE: EXCLUSIONS & JUSTIFICATIONS SECTION: QM 3.0
The Following Clauses of ISO 9001:2008 Standard are not applicable in purview with the Scope of the
Organization:
Clause 7.3 Design & Development
The Organization is manufacturing, as per Standard specifications hence this clause is not applicable.
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TITLE: QUALITY MANAGEMENT SYSTEM SECTION: QM 4.0
4.1 GENERAL REQUIREMENTS
Organization has established, documented, implemented and maintained a quality manag ement system to
continually improve its effectiveness in accordance with ISO 9001:2008 QMS standards The process needed
for quality management system and their applications throughout the Organization are identified.
The sequences and interaction of these processes are determined and documented in respective sections of
this manual and in respective documents. Also a Flow chart for Sequence & interaction of processes is
prepared.
The criteria and methods needed to ensure that both operation and control o f these processes are effective are
determined. Availability of resources and information necessary to support the operation and monitoring of
these processes are ensured. These processes are monitored, measured and analyzed. Action necessary to
achieve planned results and continual improvement of these processes are implemented.
These processes are managed by company in accordance with the requirements of ISO 9001:2008
Organization has not outsourced any type of job work at present Detail of outsource process.
4.2 DOCUMENTATION
4.2.1 General
The Quality Management System Documentation includes:
 Quality Policy and Quality Objectives
 Quality Manual
 Quality System Activities required by ISO 9001:2008 standards, which is identified by the Organization
for its operations to be effective.
 Work instructions, SOPs, product specifications, inspection and testing procedures, supplier provided
standards, etc.
 Quality records
4.2.2 Quality Manual
This manual is in full conformity with requirements of ISO 9001: 2008 Standards and is supported by further
levels of documentation as detailed in 4.2.1. The scope of quality management system covers activities relating
to “scope” The documented procedures established for the quality management activities under the scope are
defined in level ‘B’ documentation.
This manual and cross-reference procedures in Process Interactions Chart describe the interaction between
various processes under the scope of Quality Management System.
4.2.3 Control of Documents
Documents as described in 4.2.1 are controlled, implemented, circulated, and approved as activity flow charts,
referred as under:
4.2.4 Control of Records
It is essential that Quality Records are maintained, since the records are the objective evidence that the system
is operating effectively at all stages. The activities for Control of Records are referred as under:
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TITLE: MANAGEMENT RESPONSIBILITY SECTION: QM 5.0
5.1 MANAGEMENT COMMITMENT
Organization commits itself to the development and implementation of quality management system and
continually improves its effectiveness. Regular meetings wherein the importance of meeting customer
requirements and feedback are communicated to employees whenever necessity arises will achieve this. The
administrative personnel are briefed regularly about the statutory and regulatory requirements in meeting.
The quality policy is established and the text of the Quality Policy is given in 5.3 The Quality Policy is supported
by tangible Quality Objectives as given in 5.4.1 Management Reviews are conducted regularly to ascertain
effectiveness of QMS (refer 5.6) Organization ensures that adequate resources are made available to meet
customer requirement, Quality System requirements as well as statutory and regulatory requirements.
5.2 CUSTOMER FOCUS
Organization has belief in the philosophy that, CUSTOMER is the purpose of its business. Employees are
regularly trained on customer focus. The feedback from customer in terms of quality, delivery, quality
complaints etc. are accorded top priority and their cause and preventive measures are immediately
implemented.
Customer Satisfaction is enhanced through regular meeting with customer/representatives and fulfilling their
targets in terms of quality, delivery lead-time and price expectations. Periodically customer feedback form is
sent to ascertain their needs and expectations.
5.3 QUALITY POLICY
Considering the needs and expectations of customers and our company’s business strategy, Top Management
has formulated the quality policy:
The quality policy of Organization is defined, documented and made known to all the employees by way of
display at prominent places and emphasizing its intents in regular training at all level. The policy is regularly
reviewed in management review meeting for its continuing suitability and revised as and when necessary.
5.4.1 QUALITY OBJECTIVES
The quality objective is segmented department wise and the measures to evaluate its achievements are
defined. These objectives are periodically reviewed, updated and MR identifies actions for implementation.
5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING
The Management Representative ensures that the quality management system is planned with defined
responsibility and authorities, which is documented in Quality Activities. The system is planned to meet the
requirements of clause 4.1 and quality objectives as defined in clause 5.4.1 of the manual.
The integrity of the QMS is ensured by way of review of the system, when the scope of the system is enhanced
or when new product lines are introduced. Quality Manual and Quality Activities are reviewed for changes as
and when required. Internal audit results are reviewed and the corrective actions are standardized in the quality
system Documents.
Product configuration changes are reviewed and product related documents are updated as applicable.
Corrective and preventive actions are reviewed and the changes are standardized in appropriate documents.
The result of internal and external audit is reviewed and appropriate corrective and preventive actions are
initiated.
5.5.1 Responsibility, Authority and Communication
The Organization chart included in Section 09.0 of this manual shows the relationships between the respective
functions. All employees are responsible for the quality of their own work and for advising their responsible
Manager or supervisor of any conditions that are adverse to the quality of the work being produced or adverse
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to the satisfactory operations of the quality system. Managers and supervisors are responsible, and have the
authority within their defined areas of control for:
 the quality of work carried out
 initiating action to prevent the occurrence of nonconformance
 identifying and recording quality problems
 Initiating, recommending and providing solutions to quality problems.
The responsibilities and authorities of the Organization Chart are described as below:
TOP MANAGEMENT
Responsibility:
a) Overall business development of the Organization
b) Financial Management of the Organization
c) Recruit executives in Managerial Cadre
d) Formulate quality policy with objectives for the Organization
e) Overall responsible for implemented quality management system
Authority:
a) Make key decisions and can supercede decisions taken by others
b) Approve purchase of capital goods
c) Approve the formulated quality management system
d) Final authority in all policies of the company
HEAD OF DEPARTMENT
Responsibility:
a) Maintain Harmonic cultures in the company
b) Liaison and handling prospective customers
c) Recruitment of personnel at works
d) Handling and resolving customer complaints
e) Execution of work orders in time
Authority:
a) Approve recruitment personnel at works
b) Sanction commercial transactions at work
c) Approve the formulated quality management system
5.5.2 MANAGEMENT REPRESENTATIVE
Top Management has appointed of Management Representative. Besides his functional responsibilities he has
been given additional Responsibilities and Authorities which includes:
 Preparation, Updating and maintenance of Quality Manual
 Issue of Quality Manual. Quality Activities
 Implementation of Quality Systems.
 Review of document & data control, making current version available, precludes use of obsolete
documents, identifying nature of change.
 Control of quality records is means of identification, coll ection, and indexing, disposition and retention
time.
 Liaison with external agency for ISO 9001 certification
 Conducting the internal quality audit as per schedule, recording non-conformities, and verification of
effectiveness of corrective action against non-conformities.
 Conducting the Management Review Meeting and reporting the finding of IQA to Top Management.
 Promoting the awareness of customer requirements throughout the Organization.
5.5.3 INTERNAL COMMUNICATION
Internal communication channels are ensured as follows:
 Quality Policy: Display, Induction Program & Training
 Quality Objectives: Distribution of documents
 Customer Feed Back: Meetings, Letters, Emails, Feedback form & proactive actions
 Internal Audit, C & P Actions: Management Review Meetings
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 MR is overall responsible to maintain internal communication channels.
5.6 MANAGEMENT REVIEW
5.6.1 General
Top Management with all HODs will conduct Management Review Meeting once in every six months or as and
when required. The purpose of the meeting is to ensure that Quality System meets or exceeds the requirement
of ISO 9001: 2008 standard.
In addition it will assess the Quality System’s continued suitability with respect to achieving company’s Quality
Policy and Objectives and opportunity for improvement in quality management system, quality policy and quality
objectives.
The MR records review inputs in agenda for management review. Review outputs are recorded in minutes of
MRM and communicated to all concerned.
5.6.2 Review Input
The input to management review shall include:
a) Results of internal audit and external audit
b) Customer feedback and complaints
c) Routine Operational performance of the Organization and product conformity
d) Status of corrective and preventive actions taken
e) Pending actions from previous management reviews
f) Changes that are required/affected in QMS
g) Recommendations for improvement.
5.6.3 Review Output
The review output is recorded by MR and shall include decisions and actions, target date and responsibility
related to:
a) Improvement of effectiveness of quality management system
b) Improvement in processes to meet customer requirements
c) Requirement of resources necessary for effective overall functioning
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TITLE: RESOURCE MANAGEMENT SECTION: QM 6.0
6.1 PROVISION OF RESOURCES
Organization ensures provision of resources that are needed:-
 To implement and maintain the quality management system and continually improve its effectiveness.
 To enhance customer satisfaction by meeting customer requirements.
 The resource needs are identified through activities such as product planning, internal audit,
management reviews and review of quality objectives.
6.2 HUMAN RESOURCES
6.2.1 General
Organization ensures that personnel performing work affecting product quality are competent on the basis of
appropriate education, training, skills and experience.
6.2.2 Competence, Awareness & Training
Necessary competence needed for performing work affecting product quality are determined by the MR and
HODs and documented. The personnel are assessed on the basis of determined competence requirements.
Gaps, if any, are assessed and training is provided to personnel to meet the competence need. The training
may be in-house or external classroom training.
The effectiveness of the actions taken in terms of enhancing the competence levels is evaluated. Employees
are made known the requirement of skills and knowledge required relating to the jobs they handle and how they
contribute for attaining quality objectives. Appropriate records are maintained regarding, education, training,
skills & experience
6.3 INFRASTRUCTURE
Infrastructure needs are assessed on the basis of the resource requirement and business plan. The
infrastructure such as building and amenities for the operators are provided. Tools & Tackles, Testing
Instruments, Testing facilities are provided on the basis of quality plan. Need for supporting services such as
logistics, computer support, etc. are provided.
6.4 WORK ENVIRONMENT
Organization ensures that proper layout, adequate ventilation, lighting, house keeping systems and safety
devices maintain the work environment neatly where appropriate.
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TITLE: PRODUCT REALIZATION SECTION: QM 7.0
7.1 PLANNING OF PRODUCT REALIZATION
Organization plans the requirement of quality and identifies the controls of the process, inspection and test
methods, measurement needs and standards of acceptability, acquisition of any controls, equipment, etc.
The quality planning also includes the compatibility of product/process, establishment inspection and test
activities, development of newer measurement methods, identification of inspection and testing requirement,
identification and preparation of quality records. For each product line, such controls are defined in quality plan
and are used as a means of controlling quality. Quality Plan is prepared for final approval of equipment
7.2 CUSTOMER RELATED PROCESS
7.2.1 Development of requirements related to products
Organization identifies the requirements specified by customer though work order inputs and application details
provided by customer, delivery schedules desired by customers and feedback on products supplied.
Requirements not specified by customer, who is required for intended use are identified by Departmental Head.
Statutory and regulatory requirements related to the products are identified through customer communication.
Any additional requirements related to the products are identified based on the Organization’s experience in
supplying products to similar application
7.2.2 Review of requirements related to the product
Organization ensures to review the requirements related to the product as follows:-
Product specification/application is reviewed during the order processing and any mismatch or incompatibility is
reported to the customer. Order requirements are reviewed and recorded. Delivery requirements are reviewed
and recorded.
During this review, if any product or order requirements are deviating from those previously expressed, they are
resolved. Where the customer requirements are communicated verbally, the customer requirements are
confirmed in review documents as above, prior to acceptance. When the product requirements are changed,
the amendments are reviewed and the changes are incorporated on all relevant internal documents. The
document changes are made known and communicated to relevant functions.
7.2.2 Customer Communication
The various communication systems to customers are as follows
Product information: sales executives communicate product configuration and price information.
Order handling, queries and amendment handling are carried out by Marketing Personnel and communicated to
customers. Customer feed back and complaints are analyzed and communicated to them.
7.3 DESIGN AND DEVELOPMENT
Excluded
7.4 PURCHASING
7.4.1 Purchasing Process
The Quality System Activities ensure that products, Raw material & Packaging Material are purchased form
approved sources only. Any new source of product / make shall approve based of evaluation and/or trial
production, which shall access the ability of the source to meet the company’s quality and delivery
requirements.
The extent of control on the source of supply is based on the product criticality. This is defined in product quality
plan. The results of supplier performance in terms of adherence to quality and delivery requirements are
monitored. The data is reviewed by HOD Purchase and Top Management and the supplier are evaluated once
in a year. Records of evaluation, re-evaluation and ratings are maintained.
7.4.2 Purchasing information
Purchasing specification describes the following data. Product configuration, code, makes, size and other
unique information. Requirements of approval of product such as test certificates, need for Quality system
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Certificates and as per Raw Material Testing Plan. Organization ensures that adequacy of Purchase
requirements are reviewed prior to release.
7.4.3 Verification of purchased products
The purchased products are verified by one of the following methods.
 Verification of Test Certificates
 Product evaluation through a plan of evaluation
 Receiving inspection as per receiving inspection plan
 Where specified by customer or when required by the company, the verification may be done at
supplier’s premises by company or by Customer.
 The verification method may include product evaluation, Supplier Quality System Audit.
In such case, purchasing information shall specify the method of verification and sub-sequent product release.
7.5 PRODUCTION AND SERVICE PROVISION
7.5.1 Control of Production and Service Provision
The production activity is carried out under controlled condition. The information about the product configuration
is provided to the Technicians and Engineers. Operations are carried out as per work instruction/ purchase
order. The equipment used for Production and testing is ensured have the requisite capability through
preventive maintenance of equipments. Technicians and Engineers are provided with necessary Equipments
and Instruments. The monitoring of process and testing is as per Quality Plan. The products are released to the
next stage and delivery after due verification and recording.
7.5.2 Validation of process for production
Special process is validated and records for the same are being maintained.
7.5.3 Identification and Traceability
The constituent parts, products in-process, finished products and packed products ready for dispatch are
identified by means of status boards, displayed besides the product. The status of products after each
verification stage is clearly identified as passed or failed by way of recording on the Inspection Reports.
Traceability of constituent parts is accomplished by means of unique num
7.5.4 Customer property
We are providing after sales services.
7.5.5 Preservation of Products
The products and constituent parts of the products are preserved appropriately to avoid any damage or
deterioration during storage, handling, packaging and delivery. Suitable work instructions are issued to the
personnel carrying-out these activities.
7.6 CONTROL OF MONITORING AND MEASURING EQUIPMENT
The selection of the Instruments and test equipments is done in such a way that measurement uncertainty is
known and is consistent with accuracy required. To control, calibrate and maintain inspection, measuring and
test equipment to provide evidence of conformity of product to specified requirements the procedure for
calibration and Maintenance of Instrument is followed.
It is also ensured that monitoring and measurements are carried out and in a manner that is consistent with the
monitoring and measurement requirements. For this purpose, list of measuring and test equipment is prepared.
To ensure valid results, measuring equipment is Calibrated at specified intervals, or prior to use, against
measurement standards traceable to international or national measurement standards; where no such standard
exists, the basis used for calibration or verification is recorded.
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TITLE: MEASUREMENT ANALYSIS AND IMPROVEMENT SECTION: QM 8.0
8.1 GENERAL
Organization plans and implements the monitoring, measurement, analysis and improvement process as
follows:-
 To demonstrate that products produced conform to specification
 To ensure that quality management system requirements are conformed
 To continually improve the effectiveness of quality management system
 In order to measure, analyze and continually improve, methods including statistical methods are used.
The extent of use of statistical method are explained in 8.2.3
8.2 MEASUREMENT AND MONITORING
8.2.1 Customer Satisfaction
In addition to other method, performance of the Quality Management system is also measured by monitoring
the information related to customer perception provided by customers.
8.2.2 Internal Quality Audit
Internal audits are conducted at regular intervals in six months. The purpose of such audits is to ascertain:-
Whether the planned system as outlined in this manual, Activities and other quality system Documents as
defined in 4.2.1 are complied with and whether the documented system is in accordance with the requirements
of ISO 9001:2008 standards. Whether the implemented system is effective and maintained
An audit program is planned as follows:-
 The frequency and duration of an audit is determined based on the volume of activity, importance of
the activity.
 The area or department to be audited and
 Results of previous audits
8.2.3 Monitoring and Measurement of Processes
Methods such as analysis reports are used to demonstrate that the processes achieved or deviate from the
targets. When planned results are not achieved, appropriate plans are identified and implemented to effect
correction and corrective actions to ensure conformity of the product.
8.2.4 Monitoring and Measurement of Products
Organization ensures that the products are verified at appropriate stages viz., on receipt, various production
process stages and pre delivery stage. The requirements are verified against the receiving inspection plan, in-
process quality plans and customer purchase order.
Evidence of conformity of the products as defined above is maintained in the form of inspection reports, test
log/test report. These records indicate the persons authorizing product release for the next stage or delivery to
customer. The deliveries of products are affected only after all quality requirements are completed satisfactorily.
8.3 CONTROL OF NON-CONFORMING PRODUCT
Organization ensures that products, which do not conform to product requirements, are Identified and controlled
to avoid inadvertent use or delivery. Activity for non-conforming products describes the controls involved in
segregating non-conforming products, quarantine areas for non-conforming products, the responsibilities and
authorities for evaluation, notification and disposal of non-conforming products.
The methods of dealing with non-conforming products are :-
 Required actions such as rework, to eliminate the detected non-conformity
 By authorizing use non-conforming products, or release for dispatch or accept under authorized
concessions by the authority as defined 5.5.1, or where applicable, by customer.
 By taking action to scrap after due care that the scrapped products do not find its way to the original
intended use.
8.4 ANALYSIS OF DATA
Organization determines the data to be collected, analyzed to demonstrate suitability and effectiveness of
quality management system and to effect continual improvement.
The various data collected are:
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 Measurement data
 Defect data
 Customer feedback data
 Analysis of these data shall provide information on :
 Level of customer satisfaction
 Level of conformity to specification
 Trends of product specification compliance, opportunity for improvement
 Supplier performance
 Tools and techniques such as graphs, charts, brainstorming etc. are used in the analysis of data
8.5 IMPROVEMENT
8.5.1 Continual Improvement
Continuous improvement in the effectiveness of quality management system is achieved through the use of:
 Well defined Quality policy
 Measurable quality Objectives
 Audits that identify opportunities for improvement
 Analysis of data of product conformance and operational performance, customer satisfaction and
supplier performance
 Corrective and preventive actions
 Management review
 Improvement opportunities are tracked for effective implementation and achievement of desired results
8.5.2 Corrective Action
Organization takes appropriate action to eliminate the cause of non-conformities in order to prevent recurrence.
The corrective actions will be appropriate to the effects of non-conformities.
Activity for corrective action ensures the following requirements are defined:
 The methods followed to review non-conformities and customer complaints
 The determination of cause of non-conformities
 Develop solutions that are needed to eliminate the recurrence of non-conformity
8.5.3 Preventive Action
Organization takes appropriate action to eliminate the potential cause of non-conformities in order to prevent
occurrence. The preventive actions will be appropriate to the effects of non-conformities.
Activities for preventive action ensures the following requirements are defined:
 The determination of potential cause of non-conformities
 Recommend actions that are needed to prevent occurrence of non-conformity
 Implement the actions identified to prevent occurrence of nonconformity
 Records of the results of action taken
 Reviewing the preventive actions taken
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TITLE: ORGANAZITION CHART SECTION: QM 09.0
Executives /
Workers
Marketing In
charge
Stores
In charge
Production
In charge
Q.C
In charge
Purchase
In charge
Top Mgt/ MR
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ISO 9001:2008 PROCEDURES – SOPs
Purpose: To establish flow chart for process activities
Scope: The scope of process flow chart is applicable to MANAGEMENT activities
PRO
CED
URE
No.
PROCEDUR
E TITLE
FUNCTIONAL ACTIVITIES
ISO
CL
REF:
RESP.
MGT/
P/01
CONTROL
OF
DOCUMENT
S
1. Documents are reviewed by MR &
approved by TM.
2. MR issues documents/formats for
implementation.
3. The document numbering is done as below:
First three alphabets indicates Department.
Next alphabet indicates Procedure / Format.
Next two digit code indicates the serial
number of format/document for the
particular department.
4. In case of revisions, Doc. Change request is
filled and new no. is given and old
documents are removed & marked as
obsolete copy.
5. External documents are controlled and
listed in control of external documents with
their latest revision. The same are reviewed
for their applicability and latest versions
every six months over internet / available
resources.
6. All documents, when issued are dated for
date of issue and the first issue has revision
no. as “00”.
7. The original copy of documents is
maintained in soft copy and marked as
“Master Copy” and issue copies are
maintained in hard copies and are marked
as “Controlled Copy”.
4.2.3 M R
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ISO 9001:2008 PROCEDURES – SOPs
Purpose: To establish flow chart for process activities
Scope: The scope of process flow chart is applicable to MANAGEMENT activities
PRO
CED
URE
No.
PROCEDUR
E TITLE
FUNCTIONAL ACTIVITIES
ISO
CL
REF:
RESP.
MGT/
P/02
CONTROL
OF
RECORDS
1. The records are generated in accordance to
ISO 9001:2008 standards.
2. All records are kept till retention period with
relevant details pertaining to the nature of
records.
3. Records which are maintained in soft copies
are periodically protected with backup
facilities and virus protection. All records are
easily retrievable when needed.
4. After the retention period, the records are
removed from the point of use and are
either destroyed by crushing or stored
separately.
4.2.4 M R
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ISO 9001:2008 PROCEDURES – SOPs
Purpose: To establish flow chart for process activities
Scope: The scope of process flow chart is applicable to MANAGEMENT activities
PRO
CED
URE
No.
PROCEDUR
E TITLE
FUNCTIONAL ACTIVITIES
ISO
CL
REF:
RESP.
MGT/
P/03
INTERNAL
QUALITY
AUDITS
1. Internal audits are planned in way that all
functional areas are audited once in six
months or as & when required.
2. Audit plan is prepared, wherein date of
audit, auditor, auditee, dept. etc in noted.
3. Internal Audit is done as per plan and
evidences collected during IQA are noted in
Internal Auditor Notes.
4. Non-conformities encountered during IQA
are discussed and noted in the Corrective /
Preventive Action Report and in
Management Review Meeting.
5. For all non-conformities recorded,
necessary corrective actions are initiated by
concerned personnel.
8.2.2 M R
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ISO 9001:2008 PROCEDURES – SOPs
Purpose: To establish flow chart for process activities
Scope: The scope of process flow chart is applicable to MANAGEMENT activities
PRO
CED
URE
No.
PROCEDUR
E TITLE
FUNCTIONAL ACTIVITIES
ISO
CL
REF:
RESP.
MGT/
P/04
Control of NC
Product
1. Data generated by the organization are
collected and compiled for evaluation once
in a year.
2. Analysis of data is reported in the
management review meetings.
8.3 M R
Quality Management System Manual Page 22 of 24 - 22 -
Approved by TM Issued by MR Revision No. Effective Date Issue No.
00 01-09-2014 01
ISO 9001:2008 PROCEDURES – SOPs
Purpose: To establish flow chart for process activities
Scope: The scope of process flow chart is applicable to MANAGEMENT activities
PRO
CED
URE
No.
PROCEDUR
E TITLE
FUNCTIONAL ACTIVITIES
ISO
CL
REF:
RESP.
MGT/
P/05
CORRECTIV
E ACTIONS
1. CA are initiated upon findings through
internal & external audits, Customer Feed
backs & complaints etc.
2. Root causes are analyzed jointly by all
concerned persons.
3. CAs initiated are noted in C & P action
report.
4. Actions taken are regularly reviewed &
reported in MRM.
8.5.2 M R
Quality Management System Manual Page 23 of 24 - 23 -
Approved by TM Issued by MR Revision No. Effective Date Issue No.
00 01-09-2014 01
ISO 9001:2008 PROCEDURES – SOPs
Purpose: To establish flow chart for process activities
Scope: The scope of process flow chart is applicable to MANAGEMENT activities
PRO
CED
URE
No.
PROCEDUR
E TITLE
FUNCTIONAL ACTIVITIES
ISO
CL
REF:
RESP.
MGT/
P/06
PREVENTIV
E ACTIONS
1. Preventive measures are taken considering
the necessary CA actions taken and by
identifying probable non conformities which
may occur in future
2. Root causes are analyzed jointly by all
concerned persons
3. PA are taken after consultations with all
concerned persons
4. Actions taken are regularly reviewed &
reported in MRM
8.5.3 MR
Quality Management System Manual Page 24 of 24 - 24 -
Approved by TM Issued by MR Revision No. Effective Date Issue No.
00 01-09-2014 01
QUALITY POLICY
We are committed to meet Customer
Requirements and Satisfaction by
providing Best Quality Services &
Products.
We will always achieve and maintain
effectiveness of Quality
Management System by Employee
Motivation and bring Continual
Improvement in the System
Signature
Rev. 00

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Quality management system

  • 1. Quality Management System Manual Page 1 of 24 - 1 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 Quality Management System ISO 9001:2008 XYZ Address Manufacture, Supply, Export & Job Work of S.S. Baluster Railing, Hand Railing, Interior Furniture and S.S. Fabrication
  • 2. Quality Management System Manual Page 2 of 24 - 2 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 TITLE: TABLE OF CONTENTS SECTION: QM 0.1 Sr. No. Description ISO 9001 Clause Ref. Section No. Page Nos. 01 Table of Contents -- QM-0.1 2 02 Revision History -- QM-0.2 3 03 List of Controlled Manual Holders -- QM-0.3 4 04 Introduction -- QM-1.0 5 05 Scope of the Quality Management System -- QM-2.0 6 06 Exclusions & Justifications -- QM-3.0 7 07 Quality Management System 4.0 QM-4.0 8 -9 08 Management Responsibility 5.0 QM-5.0 10–14 09 Resource Management 6.0 QM-6.0 15 10 Product Realization 7.0 QM-7.0 16–18 11 Measurement Analysis and Improvement 8.0 QM-8.0 19–21 12 Organogram -- QM-9.0 22
  • 3. Quality Management System Manual Page 3 of 24 - 3 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 TITLE: REVISION HISTORY SECTION: QM 0.2 Sr. No. Brief Description of Change Rev. No. Page No.
  • 4. Quality Management System Manual Page 4 of 24 - 4 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 TITLE: LIST OF CONTROLLED MANUAL HOLDERS SECTION: QM 0.3 Sr. No. Manual Holders Copy No. 01 Top Management / Management Representative 01 (Master Copy) 02 Production / Stores / Quality Control /Purchase / Marketing-In- charges 02 03 Certification Agency 03
  • 5. Quality Management System Manual Page 5 of 24 - 5 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 TITLE: INTRODUCTION SECTION: QM 1.0 Our Company is one of the leading companies in its class. We at our company are dedicated to supply quality products with High Quality Testing Equipment, Highly qualified technical staff, in-house tool room, checking & packing we are confident of handling customer’s requirements. The company is backed by the strong technical expertise. Generous and ambitions management well equipped plant with adoption of modern technology and runs under close observation by learned technicians. Expertise to enrich quality product by breakthrough innovative ideas. The company has devoted and hard working work force in all field of the work. Qualified and experienced management may able to lead and guide them for the proper way of work to be done.
  • 6. Quality Management System Manual Page 6 of 24 - 6 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 TITLE: SCOPE OF THE QUALITY MANAGEMENT SYSTEM SECTION: QM 2.0 Scope of the Quality Management System is implemented as per ISO 9001:2008 standard.
  • 7. Quality Management System Manual Page 7 of 24 - 7 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 TITLE: EXCLUSIONS & JUSTIFICATIONS SECTION: QM 3.0 The Following Clauses of ISO 9001:2008 Standard are not applicable in purview with the Scope of the Organization: Clause 7.3 Design & Development The Organization is manufacturing, as per Standard specifications hence this clause is not applicable.
  • 8. Quality Management System Manual Page 8 of 24 - 8 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 TITLE: QUALITY MANAGEMENT SYSTEM SECTION: QM 4.0 4.1 GENERAL REQUIREMENTS Organization has established, documented, implemented and maintained a quality manag ement system to continually improve its effectiveness in accordance with ISO 9001:2008 QMS standards The process needed for quality management system and their applications throughout the Organization are identified. The sequences and interaction of these processes are determined and documented in respective sections of this manual and in respective documents. Also a Flow chart for Sequence & interaction of processes is prepared. The criteria and methods needed to ensure that both operation and control o f these processes are effective are determined. Availability of resources and information necessary to support the operation and monitoring of these processes are ensured. These processes are monitored, measured and analyzed. Action necessary to achieve planned results and continual improvement of these processes are implemented. These processes are managed by company in accordance with the requirements of ISO 9001:2008 Organization has not outsourced any type of job work at present Detail of outsource process. 4.2 DOCUMENTATION 4.2.1 General The Quality Management System Documentation includes:  Quality Policy and Quality Objectives  Quality Manual  Quality System Activities required by ISO 9001:2008 standards, which is identified by the Organization for its operations to be effective.  Work instructions, SOPs, product specifications, inspection and testing procedures, supplier provided standards, etc.  Quality records 4.2.2 Quality Manual This manual is in full conformity with requirements of ISO 9001: 2008 Standards and is supported by further levels of documentation as detailed in 4.2.1. The scope of quality management system covers activities relating to “scope” The documented procedures established for the quality management activities under the scope are defined in level ‘B’ documentation. This manual and cross-reference procedures in Process Interactions Chart describe the interaction between various processes under the scope of Quality Management System. 4.2.3 Control of Documents Documents as described in 4.2.1 are controlled, implemented, circulated, and approved as activity flow charts, referred as under: 4.2.4 Control of Records It is essential that Quality Records are maintained, since the records are the objective evidence that the system is operating effectively at all stages. The activities for Control of Records are referred as under:
  • 9. Quality Management System Manual Page 9 of 24 - 9 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 TITLE: MANAGEMENT RESPONSIBILITY SECTION: QM 5.0 5.1 MANAGEMENT COMMITMENT Organization commits itself to the development and implementation of quality management system and continually improves its effectiveness. Regular meetings wherein the importance of meeting customer requirements and feedback are communicated to employees whenever necessity arises will achieve this. The administrative personnel are briefed regularly about the statutory and regulatory requirements in meeting. The quality policy is established and the text of the Quality Policy is given in 5.3 The Quality Policy is supported by tangible Quality Objectives as given in 5.4.1 Management Reviews are conducted regularly to ascertain effectiveness of QMS (refer 5.6) Organization ensures that adequate resources are made available to meet customer requirement, Quality System requirements as well as statutory and regulatory requirements. 5.2 CUSTOMER FOCUS Organization has belief in the philosophy that, CUSTOMER is the purpose of its business. Employees are regularly trained on customer focus. The feedback from customer in terms of quality, delivery, quality complaints etc. are accorded top priority and their cause and preventive measures are immediately implemented. Customer Satisfaction is enhanced through regular meeting with customer/representatives and fulfilling their targets in terms of quality, delivery lead-time and price expectations. Periodically customer feedback form is sent to ascertain their needs and expectations. 5.3 QUALITY POLICY Considering the needs and expectations of customers and our company’s business strategy, Top Management has formulated the quality policy: The quality policy of Organization is defined, documented and made known to all the employees by way of display at prominent places and emphasizing its intents in regular training at all level. The policy is regularly reviewed in management review meeting for its continuing suitability and revised as and when necessary. 5.4.1 QUALITY OBJECTIVES The quality objective is segmented department wise and the measures to evaluate its achievements are defined. These objectives are periodically reviewed, updated and MR identifies actions for implementation. 5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING The Management Representative ensures that the quality management system is planned with defined responsibility and authorities, which is documented in Quality Activities. The system is planned to meet the requirements of clause 4.1 and quality objectives as defined in clause 5.4.1 of the manual. The integrity of the QMS is ensured by way of review of the system, when the scope of the system is enhanced or when new product lines are introduced. Quality Manual and Quality Activities are reviewed for changes as and when required. Internal audit results are reviewed and the corrective actions are standardized in the quality system Documents. Product configuration changes are reviewed and product related documents are updated as applicable. Corrective and preventive actions are reviewed and the changes are standardized in appropriate documents. The result of internal and external audit is reviewed and appropriate corrective and preventive actions are initiated. 5.5.1 Responsibility, Authority and Communication The Organization chart included in Section 09.0 of this manual shows the relationships between the respective functions. All employees are responsible for the quality of their own work and for advising their responsible Manager or supervisor of any conditions that are adverse to the quality of the work being produced or adverse
  • 10. Quality Management System Manual Page 10 of 24 - 10 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 to the satisfactory operations of the quality system. Managers and supervisors are responsible, and have the authority within their defined areas of control for:  the quality of work carried out  initiating action to prevent the occurrence of nonconformance  identifying and recording quality problems  Initiating, recommending and providing solutions to quality problems. The responsibilities and authorities of the Organization Chart are described as below: TOP MANAGEMENT Responsibility: a) Overall business development of the Organization b) Financial Management of the Organization c) Recruit executives in Managerial Cadre d) Formulate quality policy with objectives for the Organization e) Overall responsible for implemented quality management system Authority: a) Make key decisions and can supercede decisions taken by others b) Approve purchase of capital goods c) Approve the formulated quality management system d) Final authority in all policies of the company HEAD OF DEPARTMENT Responsibility: a) Maintain Harmonic cultures in the company b) Liaison and handling prospective customers c) Recruitment of personnel at works d) Handling and resolving customer complaints e) Execution of work orders in time Authority: a) Approve recruitment personnel at works b) Sanction commercial transactions at work c) Approve the formulated quality management system 5.5.2 MANAGEMENT REPRESENTATIVE Top Management has appointed of Management Representative. Besides his functional responsibilities he has been given additional Responsibilities and Authorities which includes:  Preparation, Updating and maintenance of Quality Manual  Issue of Quality Manual. Quality Activities  Implementation of Quality Systems.  Review of document & data control, making current version available, precludes use of obsolete documents, identifying nature of change.  Control of quality records is means of identification, coll ection, and indexing, disposition and retention time.  Liaison with external agency for ISO 9001 certification  Conducting the internal quality audit as per schedule, recording non-conformities, and verification of effectiveness of corrective action against non-conformities.  Conducting the Management Review Meeting and reporting the finding of IQA to Top Management.  Promoting the awareness of customer requirements throughout the Organization. 5.5.3 INTERNAL COMMUNICATION Internal communication channels are ensured as follows:  Quality Policy: Display, Induction Program & Training  Quality Objectives: Distribution of documents  Customer Feed Back: Meetings, Letters, Emails, Feedback form & proactive actions  Internal Audit, C & P Actions: Management Review Meetings
  • 11. Quality Management System Manual Page 11 of 24 - 11 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01  MR is overall responsible to maintain internal communication channels. 5.6 MANAGEMENT REVIEW 5.6.1 General Top Management with all HODs will conduct Management Review Meeting once in every six months or as and when required. The purpose of the meeting is to ensure that Quality System meets or exceeds the requirement of ISO 9001: 2008 standard. In addition it will assess the Quality System’s continued suitability with respect to achieving company’s Quality Policy and Objectives and opportunity for improvement in quality management system, quality policy and quality objectives. The MR records review inputs in agenda for management review. Review outputs are recorded in minutes of MRM and communicated to all concerned. 5.6.2 Review Input The input to management review shall include: a) Results of internal audit and external audit b) Customer feedback and complaints c) Routine Operational performance of the Organization and product conformity d) Status of corrective and preventive actions taken e) Pending actions from previous management reviews f) Changes that are required/affected in QMS g) Recommendations for improvement. 5.6.3 Review Output The review output is recorded by MR and shall include decisions and actions, target date and responsibility related to: a) Improvement of effectiveness of quality management system b) Improvement in processes to meet customer requirements c) Requirement of resources necessary for effective overall functioning
  • 12. Quality Management System Manual Page 12 of 24 - 12 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 TITLE: RESOURCE MANAGEMENT SECTION: QM 6.0 6.1 PROVISION OF RESOURCES Organization ensures provision of resources that are needed:-  To implement and maintain the quality management system and continually improve its effectiveness.  To enhance customer satisfaction by meeting customer requirements.  The resource needs are identified through activities such as product planning, internal audit, management reviews and review of quality objectives. 6.2 HUMAN RESOURCES 6.2.1 General Organization ensures that personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills and experience. 6.2.2 Competence, Awareness & Training Necessary competence needed for performing work affecting product quality are determined by the MR and HODs and documented. The personnel are assessed on the basis of determined competence requirements. Gaps, if any, are assessed and training is provided to personnel to meet the competence need. The training may be in-house or external classroom training. The effectiveness of the actions taken in terms of enhancing the competence levels is evaluated. Employees are made known the requirement of skills and knowledge required relating to the jobs they handle and how they contribute for attaining quality objectives. Appropriate records are maintained regarding, education, training, skills & experience 6.3 INFRASTRUCTURE Infrastructure needs are assessed on the basis of the resource requirement and business plan. The infrastructure such as building and amenities for the operators are provided. Tools & Tackles, Testing Instruments, Testing facilities are provided on the basis of quality plan. Need for supporting services such as logistics, computer support, etc. are provided. 6.4 WORK ENVIRONMENT Organization ensures that proper layout, adequate ventilation, lighting, house keeping systems and safety devices maintain the work environment neatly where appropriate.
  • 13. Quality Management System Manual Page 13 of 24 - 13 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 TITLE: PRODUCT REALIZATION SECTION: QM 7.0 7.1 PLANNING OF PRODUCT REALIZATION Organization plans the requirement of quality and identifies the controls of the process, inspection and test methods, measurement needs and standards of acceptability, acquisition of any controls, equipment, etc. The quality planning also includes the compatibility of product/process, establishment inspection and test activities, development of newer measurement methods, identification of inspection and testing requirement, identification and preparation of quality records. For each product line, such controls are defined in quality plan and are used as a means of controlling quality. Quality Plan is prepared for final approval of equipment 7.2 CUSTOMER RELATED PROCESS 7.2.1 Development of requirements related to products Organization identifies the requirements specified by customer though work order inputs and application details provided by customer, delivery schedules desired by customers and feedback on products supplied. Requirements not specified by customer, who is required for intended use are identified by Departmental Head. Statutory and regulatory requirements related to the products are identified through customer communication. Any additional requirements related to the products are identified based on the Organization’s experience in supplying products to similar application 7.2.2 Review of requirements related to the product Organization ensures to review the requirements related to the product as follows:- Product specification/application is reviewed during the order processing and any mismatch or incompatibility is reported to the customer. Order requirements are reviewed and recorded. Delivery requirements are reviewed and recorded. During this review, if any product or order requirements are deviating from those previously expressed, they are resolved. Where the customer requirements are communicated verbally, the customer requirements are confirmed in review documents as above, prior to acceptance. When the product requirements are changed, the amendments are reviewed and the changes are incorporated on all relevant internal documents. The document changes are made known and communicated to relevant functions. 7.2.2 Customer Communication The various communication systems to customers are as follows Product information: sales executives communicate product configuration and price information. Order handling, queries and amendment handling are carried out by Marketing Personnel and communicated to customers. Customer feed back and complaints are analyzed and communicated to them. 7.3 DESIGN AND DEVELOPMENT Excluded 7.4 PURCHASING 7.4.1 Purchasing Process The Quality System Activities ensure that products, Raw material & Packaging Material are purchased form approved sources only. Any new source of product / make shall approve based of evaluation and/or trial production, which shall access the ability of the source to meet the company’s quality and delivery requirements. The extent of control on the source of supply is based on the product criticality. This is defined in product quality plan. The results of supplier performance in terms of adherence to quality and delivery requirements are monitored. The data is reviewed by HOD Purchase and Top Management and the supplier are evaluated once in a year. Records of evaluation, re-evaluation and ratings are maintained. 7.4.2 Purchasing information Purchasing specification describes the following data. Product configuration, code, makes, size and other unique information. Requirements of approval of product such as test certificates, need for Quality system
  • 14. Quality Management System Manual Page 14 of 24 - 14 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 Certificates and as per Raw Material Testing Plan. Organization ensures that adequacy of Purchase requirements are reviewed prior to release. 7.4.3 Verification of purchased products The purchased products are verified by one of the following methods.  Verification of Test Certificates  Product evaluation through a plan of evaluation  Receiving inspection as per receiving inspection plan  Where specified by customer or when required by the company, the verification may be done at supplier’s premises by company or by Customer.  The verification method may include product evaluation, Supplier Quality System Audit. In such case, purchasing information shall specify the method of verification and sub-sequent product release. 7.5 PRODUCTION AND SERVICE PROVISION 7.5.1 Control of Production and Service Provision The production activity is carried out under controlled condition. The information about the product configuration is provided to the Technicians and Engineers. Operations are carried out as per work instruction/ purchase order. The equipment used for Production and testing is ensured have the requisite capability through preventive maintenance of equipments. Technicians and Engineers are provided with necessary Equipments and Instruments. The monitoring of process and testing is as per Quality Plan. The products are released to the next stage and delivery after due verification and recording. 7.5.2 Validation of process for production Special process is validated and records for the same are being maintained. 7.5.3 Identification and Traceability The constituent parts, products in-process, finished products and packed products ready for dispatch are identified by means of status boards, displayed besides the product. The status of products after each verification stage is clearly identified as passed or failed by way of recording on the Inspection Reports. Traceability of constituent parts is accomplished by means of unique num 7.5.4 Customer property We are providing after sales services. 7.5.5 Preservation of Products The products and constituent parts of the products are preserved appropriately to avoid any damage or deterioration during storage, handling, packaging and delivery. Suitable work instructions are issued to the personnel carrying-out these activities. 7.6 CONTROL OF MONITORING AND MEASURING EQUIPMENT The selection of the Instruments and test equipments is done in such a way that measurement uncertainty is known and is consistent with accuracy required. To control, calibrate and maintain inspection, measuring and test equipment to provide evidence of conformity of product to specified requirements the procedure for calibration and Maintenance of Instrument is followed. It is also ensured that monitoring and measurements are carried out and in a manner that is consistent with the monitoring and measurement requirements. For this purpose, list of measuring and test equipment is prepared. To ensure valid results, measuring equipment is Calibrated at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standard exists, the basis used for calibration or verification is recorded.
  • 15. Quality Management System Manual Page 15 of 24 - 15 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 TITLE: MEASUREMENT ANALYSIS AND IMPROVEMENT SECTION: QM 8.0 8.1 GENERAL Organization plans and implements the monitoring, measurement, analysis and improvement process as follows:-  To demonstrate that products produced conform to specification  To ensure that quality management system requirements are conformed  To continually improve the effectiveness of quality management system  In order to measure, analyze and continually improve, methods including statistical methods are used. The extent of use of statistical method are explained in 8.2.3 8.2 MEASUREMENT AND MONITORING 8.2.1 Customer Satisfaction In addition to other method, performance of the Quality Management system is also measured by monitoring the information related to customer perception provided by customers. 8.2.2 Internal Quality Audit Internal audits are conducted at regular intervals in six months. The purpose of such audits is to ascertain:- Whether the planned system as outlined in this manual, Activities and other quality system Documents as defined in 4.2.1 are complied with and whether the documented system is in accordance with the requirements of ISO 9001:2008 standards. Whether the implemented system is effective and maintained An audit program is planned as follows:-  The frequency and duration of an audit is determined based on the volume of activity, importance of the activity.  The area or department to be audited and  Results of previous audits 8.2.3 Monitoring and Measurement of Processes Methods such as analysis reports are used to demonstrate that the processes achieved or deviate from the targets. When planned results are not achieved, appropriate plans are identified and implemented to effect correction and corrective actions to ensure conformity of the product. 8.2.4 Monitoring and Measurement of Products Organization ensures that the products are verified at appropriate stages viz., on receipt, various production process stages and pre delivery stage. The requirements are verified against the receiving inspection plan, in- process quality plans and customer purchase order. Evidence of conformity of the products as defined above is maintained in the form of inspection reports, test log/test report. These records indicate the persons authorizing product release for the next stage or delivery to customer. The deliveries of products are affected only after all quality requirements are completed satisfactorily. 8.3 CONTROL OF NON-CONFORMING PRODUCT Organization ensures that products, which do not conform to product requirements, are Identified and controlled to avoid inadvertent use or delivery. Activity for non-conforming products describes the controls involved in segregating non-conforming products, quarantine areas for non-conforming products, the responsibilities and authorities for evaluation, notification and disposal of non-conforming products. The methods of dealing with non-conforming products are :-  Required actions such as rework, to eliminate the detected non-conformity  By authorizing use non-conforming products, or release for dispatch or accept under authorized concessions by the authority as defined 5.5.1, or where applicable, by customer.  By taking action to scrap after due care that the scrapped products do not find its way to the original intended use. 8.4 ANALYSIS OF DATA Organization determines the data to be collected, analyzed to demonstrate suitability and effectiveness of quality management system and to effect continual improvement. The various data collected are:
  • 16. Quality Management System Manual Page 16 of 24 - 16 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01  Measurement data  Defect data  Customer feedback data  Analysis of these data shall provide information on :  Level of customer satisfaction  Level of conformity to specification  Trends of product specification compliance, opportunity for improvement  Supplier performance  Tools and techniques such as graphs, charts, brainstorming etc. are used in the analysis of data 8.5 IMPROVEMENT 8.5.1 Continual Improvement Continuous improvement in the effectiveness of quality management system is achieved through the use of:  Well defined Quality policy  Measurable quality Objectives  Audits that identify opportunities for improvement  Analysis of data of product conformance and operational performance, customer satisfaction and supplier performance  Corrective and preventive actions  Management review  Improvement opportunities are tracked for effective implementation and achievement of desired results 8.5.2 Corrective Action Organization takes appropriate action to eliminate the cause of non-conformities in order to prevent recurrence. The corrective actions will be appropriate to the effects of non-conformities. Activity for corrective action ensures the following requirements are defined:  The methods followed to review non-conformities and customer complaints  The determination of cause of non-conformities  Develop solutions that are needed to eliminate the recurrence of non-conformity 8.5.3 Preventive Action Organization takes appropriate action to eliminate the potential cause of non-conformities in order to prevent occurrence. The preventive actions will be appropriate to the effects of non-conformities. Activities for preventive action ensures the following requirements are defined:  The determination of potential cause of non-conformities  Recommend actions that are needed to prevent occurrence of non-conformity  Implement the actions identified to prevent occurrence of nonconformity  Records of the results of action taken  Reviewing the preventive actions taken
  • 17. Quality Management System Manual Page 17 of 24 - 17 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 TITLE: ORGANAZITION CHART SECTION: QM 09.0 Executives / Workers Marketing In charge Stores In charge Production In charge Q.C In charge Purchase In charge Top Mgt/ MR
  • 18. Quality Management System Manual Page 18 of 24 - 18 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 ISO 9001:2008 PROCEDURES – SOPs Purpose: To establish flow chart for process activities Scope: The scope of process flow chart is applicable to MANAGEMENT activities PRO CED URE No. PROCEDUR E TITLE FUNCTIONAL ACTIVITIES ISO CL REF: RESP. MGT/ P/01 CONTROL OF DOCUMENT S 1. Documents are reviewed by MR & approved by TM. 2. MR issues documents/formats for implementation. 3. The document numbering is done as below: First three alphabets indicates Department. Next alphabet indicates Procedure / Format. Next two digit code indicates the serial number of format/document for the particular department. 4. In case of revisions, Doc. Change request is filled and new no. is given and old documents are removed & marked as obsolete copy. 5. External documents are controlled and listed in control of external documents with their latest revision. The same are reviewed for their applicability and latest versions every six months over internet / available resources. 6. All documents, when issued are dated for date of issue and the first issue has revision no. as “00”. 7. The original copy of documents is maintained in soft copy and marked as “Master Copy” and issue copies are maintained in hard copies and are marked as “Controlled Copy”. 4.2.3 M R
  • 19. Quality Management System Manual Page 19 of 24 - 19 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 ISO 9001:2008 PROCEDURES – SOPs Purpose: To establish flow chart for process activities Scope: The scope of process flow chart is applicable to MANAGEMENT activities PRO CED URE No. PROCEDUR E TITLE FUNCTIONAL ACTIVITIES ISO CL REF: RESP. MGT/ P/02 CONTROL OF RECORDS 1. The records are generated in accordance to ISO 9001:2008 standards. 2. All records are kept till retention period with relevant details pertaining to the nature of records. 3. Records which are maintained in soft copies are periodically protected with backup facilities and virus protection. All records are easily retrievable when needed. 4. After the retention period, the records are removed from the point of use and are either destroyed by crushing or stored separately. 4.2.4 M R
  • 20. Quality Management System Manual Page 20 of 24 - 20 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 ISO 9001:2008 PROCEDURES – SOPs Purpose: To establish flow chart for process activities Scope: The scope of process flow chart is applicable to MANAGEMENT activities PRO CED URE No. PROCEDUR E TITLE FUNCTIONAL ACTIVITIES ISO CL REF: RESP. MGT/ P/03 INTERNAL QUALITY AUDITS 1. Internal audits are planned in way that all functional areas are audited once in six months or as & when required. 2. Audit plan is prepared, wherein date of audit, auditor, auditee, dept. etc in noted. 3. Internal Audit is done as per plan and evidences collected during IQA are noted in Internal Auditor Notes. 4. Non-conformities encountered during IQA are discussed and noted in the Corrective / Preventive Action Report and in Management Review Meeting. 5. For all non-conformities recorded, necessary corrective actions are initiated by concerned personnel. 8.2.2 M R
  • 21. Quality Management System Manual Page 21 of 24 - 21 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 ISO 9001:2008 PROCEDURES – SOPs Purpose: To establish flow chart for process activities Scope: The scope of process flow chart is applicable to MANAGEMENT activities PRO CED URE No. PROCEDUR E TITLE FUNCTIONAL ACTIVITIES ISO CL REF: RESP. MGT/ P/04 Control of NC Product 1. Data generated by the organization are collected and compiled for evaluation once in a year. 2. Analysis of data is reported in the management review meetings. 8.3 M R
  • 22. Quality Management System Manual Page 22 of 24 - 22 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 ISO 9001:2008 PROCEDURES – SOPs Purpose: To establish flow chart for process activities Scope: The scope of process flow chart is applicable to MANAGEMENT activities PRO CED URE No. PROCEDUR E TITLE FUNCTIONAL ACTIVITIES ISO CL REF: RESP. MGT/ P/05 CORRECTIV E ACTIONS 1. CA are initiated upon findings through internal & external audits, Customer Feed backs & complaints etc. 2. Root causes are analyzed jointly by all concerned persons. 3. CAs initiated are noted in C & P action report. 4. Actions taken are regularly reviewed & reported in MRM. 8.5.2 M R
  • 23. Quality Management System Manual Page 23 of 24 - 23 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 ISO 9001:2008 PROCEDURES – SOPs Purpose: To establish flow chart for process activities Scope: The scope of process flow chart is applicable to MANAGEMENT activities PRO CED URE No. PROCEDUR E TITLE FUNCTIONAL ACTIVITIES ISO CL REF: RESP. MGT/ P/06 PREVENTIV E ACTIONS 1. Preventive measures are taken considering the necessary CA actions taken and by identifying probable non conformities which may occur in future 2. Root causes are analyzed jointly by all concerned persons 3. PA are taken after consultations with all concerned persons 4. Actions taken are regularly reviewed & reported in MRM 8.5.3 MR
  • 24. Quality Management System Manual Page 24 of 24 - 24 - Approved by TM Issued by MR Revision No. Effective Date Issue No. 00 01-09-2014 01 QUALITY POLICY We are committed to meet Customer Requirements and Satisfaction by providing Best Quality Services & Products. We will always achieve and maintain effectiveness of Quality Management System by Employee Motivation and bring Continual Improvement in the System Signature Rev. 00