QSM Manual 9001 2015 (24.03.2017)

Quality Management System Manual
for
INTERNATIONAL STANDARD
ISO 9001:2015
K. P. PATHROSE VAIDYAN’S
KANDAMKULATHY VAIDYASALA
GMP CERTIFIED COMPANY
Kuzhur, Mala, Thrissur (Dist), Kerala, India.
Phone: 0480-2779664. Fax: 0480-2779615,
E-mail : office@kandamkulathy.com
Prepared by Verified By Approved by

Coordinator
Chief Manager Managing Director
Issue no.: 03 Issue Date: 01.01.2020 Revision Status: 00
This document and the information contained therein is the property of KANDAMKULATHY
VAIDYASALA. It must not be reproduced in whole or part or otherwise disclosed without the prior
consent in writing from KANDAMKULATHY VAIDYASALA, Kuzhur, Mala, Thrissur (Dist), Kerala, India.
Kandamkulathy is one of the most celebrated Ayurveda families of

Kerala having 150 years tradition on Ayurvedic treatments.
Late Mr. K.P.Pathrose Vaidyan of Kandamkulathy family, who studied

Ayurveda from his ancestors was a veteran Ayurveda Physician of his
time and had cured a lot of complicated diseases. He took initiatives to
establish Kandamkulathy Vaidyasala which became a multidivisional
Institution under the effective leadership of his son Mr.K.P.Wilson the
present Managing Director of Kandamkulathy Vaidyasala.
Now Kandamkulathy is a trusted name in the Ayurvedic field of Kerala

with ISO & G.M.P Certified Manufacturing Unit, Ayurveda Hospitals in
different parts of Kerala- Mala, Aluva, Ernakulam and Chalakudy,
Ayurveda Super speciality Hospital in Trivandrum, Ayurvedic
Publications, Research & Development Division, Academy, Herbal
Division and Exports.
Strictly based on the Ayurvedic concept of Authentic Ayurveda at

Appropriate Atmosphere, recently Kandamkulathy Vaidyasala has
started “Ayursoukhyam” Ayurveda Resort at Athirappilly near
Chalakudy.
DISTRIBUTION LIST
SI
Copy Holder Copy No.
No.
1 Managing Partner Controlled Copy No. 01
2 Coordinator Master Copy
3 Certifying Body Controlled Copy No. 02
AMENDMENT RECORD
Page Issue Issue Rev Rev

Sl No. Document Details of Revision
No No Date Date Date
OUR QUALITY POLICY
Customer delight is the prime business policy of our organization

and we are committed to manufacture quality ayurvedic drugs by
combining modern technology with traditional practices that
comply the requirements of Ayurvedic Pharmacopoeia of India
and through the continual improvement of International Quality
Management Systems.
Approved by
Managing Director
Kandamkulathy Vaidyasala
Quality objectives
1 Increase interstate sales by 50%

2 Increase Kerala sales by 30%
3 Increase export sales by 20%
4 Maintain minimum 80% of customer satisfaction
5 Reduce return goods due to expiry by 50%
6 Reduce return goods due to damage by 50%
7 Reduce return goods due to manufacturing problems by 50%
8 Launch 4 new products yearly
9 Powdering lose should be less than 3%
10 Processing lose should be 0.05%
11 Increase productivity minimum 10% at filling/labeling/packing and RM cutting areas
12 Reduce packing material lose by 50%
13 Filling lose should be 0.05%
14 Reduce machine breakdown by 50%
15 Reduce energy consumption by 10%
4.0 CONTEXT OF THE ORGANIZATION

Organization K. P. Pathrose Vaidyan’s Kandamkulathy Vaidyasala
Purpose Production and Supply of Ayurvedic Medicines
External Context Legal Drugs and Cosmetics Act, State Excise Rules,
Central Excise rules, Labor laws, Pollution Control board rules
Technological New product development,
Advancement in production process
Automation in production, filling & packing,
High technology at low cost, Digital technology growth
Competitive market Advertisements, New product launching,
Introduction of new companies,
New labor wage policies by the government
Cultural Different Cultures., Festivals
Social Awareness programs, Increased literacy,
Market trends, Medias
Technological awareness and updation ,
Health consciousness
Increased per capita income
Economic Growth of banks in rural areas,
Overall economic health, Inflation,
Interest rates, High GDP growth
Political New Government rules and amendments,
Funds and schemes
Environmental Herbal medicine collection and deforestation,
Scarcity in RM
Environmental pollution, Waste disposal
Internal Context Values Humanitarian consideration among employees/workers, Decent living status,
Quality consciousness
Culture Celebrations
Knowledge About Work ,About Safety,
About health and personal hygiene
Updation latest machineries and techniques,
Skill development trainings, Customer requirements
Performance Improvement in productivity through trainings and validation
Qualification, Experience, Good working conditions
Interested parties 1.Management Directors
2.Employees Top management, Staff, workers
3.Customer Distributors, Agencies, Doctors, Hospitals
4.Supplier Suppliers of raw materials, Alcohol,
Stationary, Containers, cartons, Couriers
Requirements of Interested 1.Management Organizational growth,
parties Security of investment,
Achieve customer satisfaction
2.Employees Job satisfaction, Good remuneration,

Healthy working environment, Good insurance coverage
3.Customer Quality product, Timely delivery,
Supply of true information,
Effective communication system, Effective response
4.Supplier On time payment
Effective communication
Supply of true information
Agreement with new projects
Good transportation facility
Risk Assessment 1. Management Performance of the organization
Performance of the Employee/customer/supplier
Unskilled employees
Improper communication
Raw material scarcity
2.Employees Safety working environment
Proper work instructions
Time oriented work schedule
3.Customer Quality product
Delay in delivery
Communication lag
4.Supplier Communication lag
Delay in timely delivery
Changes implemented 1.Management Providing proper communication facility
Providing training to improve employee skill
Following a better remuneration scheme
2.Employees Providing PPE’s
Proper work instruction
Better work schedule
3.Customer Providing Quality products
Keeping regular communication
4.Supplier On time payment
Keeping regular communication
4.1 Understanding the organization and its context:

Kandamkulathy Vaidyasala determine external and internal issues that are relevant to its purpose and its strategic direction and that
affect its ability to achieve the intended result(s) of its quality management system through PESTLE and SWOT. The external and internal
issues identified through PESTLE and SWOT are continuously being monitored and reviewed by Management representative
PESTLE ANALYSIS
Political Factors (P) Economic Factors (E)

1. Increase in tax rate 1. Growth of banks in rural areas
2. Implementation of new laws by the govt. 2. Overall economic health
3. Monetary policies 3. Inflation, interest rates
4. Skill enhancement in Ayurvedic Drugs Sector 4. High GDP growth
Social Factors (S) Technology Factors (T)

1. Increased literacy, market trends 1. Advancement in production process
2. Technological awareness 2. Automation tools growth
3. Health consciousness 3. High technology at low cost
4. Increased per capita income 4. Digital technology growth
Legal Factors (L) Environmental Factors (E)
1.Government regulations and change in laws 1. Ecology related issues
2.Law changes affecting social behavior 2. Waste disposal & recycling procedures
3.National employment laws 3.Raw material availability
4. International trade regulations & restrictions 4. Pollution controlling facilities and procedures
SWOT ANALYSIS
Strength (S) Weakness (W)

1. 150 years of tradition 1. Raw material scarcity
2. More Local employees 2. All India presence
3. Quick decision making 3. Low marketing strength
4. Strong customer focus 4. Export marketing
5. Strong technology backup 5. Advertisements
Opportunity (O) Threat (T)
1. Requirement for quality products 1. Government rules and regulations
2. Flexibility in products 2. Duplicate products
3. Overseas marketing 3. Skill development velocity
4. High growth potential 4. Increased competition
4.2 Understanding the needs and expectations of interested parties

Kandamkulathy Vaidyasala has determined the interested parties who are relevant to the consumers of the Ayurvedic Drug products
manufactured by Kandamkulathy Vaidyasala.
Kandamkulathy Vaidyasala’s Quality management system and the requirement of the interested parties in order to prevent the potential
effect on the organization's ability to consistently provide Ayurvedic Drug products and services which meet the customers and applicable
statutory and regulatory requirements.
Interested parties Requirements Monitoring & Review mechanism at

Kandamkulathy Vaidyasala
Management Targeted turn over
Cost effective raw material purchase Review in management review meetings
Minimum wastages
Employee satisfaction
Defined in Documented information of
External providers
Effective communication External providers control.
Payment as agreed Review in Management review meetings
On time Supply of raw materials
Customer Quality of product & Service Defined in documented information of
Delivery of product on time Marketing & Sales process.
Response to complaint Review in Management review meetings
Proper Communication channel
Statutory & Complying with the statutory and Defined in documented information of
Regulatory Body regulatory requirements as leadership
defined from time to time. Review in Management review meetings
Bankers / Updating of changes in the
Financiers organization whenever it happened Review in Management review meetings
Employees Management Support, Payments Accounting Control of management

on time ,increment in salary per year
4.3 Determining the scope of the quality management system

The organization had determined the scope of the Quality management system by considering external and internal issues, requirement
of relevant interested parties and Product & Service of the organization.
Scope of Quality Management System
“Production and Supply of Ayurvedic Medicines”

4.4 Quality management system and its processes
Kandamkulathy Vaidyasala has determined the processes needed for the quality management system and their application throughout
the organization in Process map & Interactions of processes. It has determined the inputs required and the outputs expected from each
processes in individual process map addressed in documented information of each process.
It has determined the sequence and interaction of the processes in Process map & Interactions of processes
It has determined and applied the criteria and methods (including monitoring, measurements and related performance indicators) needed
to ensure the effective operation and control of these processes in documented information of each process.
It has determined the resources needed for these processes and ensure their availability in documented information of Support process
and assigned the responsibilities and authorities to competent individuals for each processes
Kandamkulathy Vaidyasala has addressed all the risks and opportunities of various processes and has been evaluating these processes
and implementing any changes needed to ensure that these processes achieve their intended results and improve the processes and the
quality management system Improve the processes and the quality management system
4.4.2 Kandamkulathy Vaidyasala is also maintaining documented information to support the operation of its processes and retaining
documented information to have confidence that the processes are being carried out as planned.
5.0 Leadership
5.1 Leadership and commitment
The Management has demonstrated leadership and commitment with respect to the quality management system through
a) Taking accountability for the effectiveness of the quality management system by periodical review of quality management system
through management review meeting, Quality objectives review and providing necessary resources.
b) Management has established quality policy and quality objectives for the quality management system and is compatible with the
context and strategic direction of the organization.
c) Management has determined the organizational processes and integrated with the quality management system requirement through
process map & Interaction this can be demonstrated.
d) Established procedure for promoting the use of the process approach and risk-based thinking
e) Ensuring that the resources needed for the quality management system are available, this is being periodically reviewed through
management review meeting.
f) Communicating the importance of effective quality management and of conforming to the quality management system requirements
g) Ensuring that the quality management system achieves its intended results
h) Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system by providing
trainings, conducting awareness programs and
i) Promoting improvement by introducing suggestion scheme and conducting meetings.
j) Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
5.1.2 Customer focus
The management has demonstrated leadership and commitment with respect to customer focus by ensuring:
a) Applicable statutory and regulatory requirements are determined, understood and consistently met.
b) The risks and opportunities that can affect conformity of products and services and the ability to enhance
customer satisfaction are determined and addressed
c) The focus on enhancing customer satisfaction is maintained and procedure for customer satisfaction is
addressed
5.2 Quality Policy
Kandamkulathy Vaidyasala is committed for delivering quality products with promised amenities, in time possession, which meet and
exceeds the needs & expectation of their customers.
Kandamkulathy Vaidyasala is promise their valued customers the commitment to excellence in each activity by each employee in the
organization by adopting innovative and best in class engineering and management practices with continual improvement in business and
quality management system as a part of our efforts for enhancement in customer satisfaction while assuring 100% quality and quantity.
We are also committed to serve society as a whole by generating chemically inert material.
5.2.1 Establishing the quality policy

The company management has established, implemented and maintained a quality policy that:
a) is appropriate to the purpose and context of the organization and supports its strategic direction
b) Provides a framework for setting quality objectives
c) Includes a commitment to satisfy applicable requirements
d) Includes a commitment to continual improvement of the quality management system
5.2.2 Communicating the quality policy
The quality policy is
a) Available and be maintained as documented information
b) Communicated, understood and applied within the organization through display, Training and periodical review.
c) Available to relevant interested parties, as appropriate.
5.3 Organizational roles, responsibilities and authorities
The company management has ensured that the responsibilities and authorities for relevant roles are assigned communicated and
understood within the organization. While assigning roles, responsibility and authority, top management has considered and ensured that
a) The quality management system conforms to the requirements of this International Standard
b) The processes are delivering their intended outputs
c) Reporting on the performance of the quality management system and on opportunities for improvement, in particular to top
management
d) The promotion of customer focus throughout the organization
e) The integrity of the quality management system is maintained when changes to the quality management system are planned and
implemented.
Roles, responsibility and authorities assigned are available in process & as per Organization chart wise in the annexure attached
6.0 Planning
6.1 Actions to address risks and opportunities
6.1.1 Kandamkulathy Vaidyasala has addressed the issues, requirements the risks and opportunities
a) Give assurance that the quality management system can achieve its intended result(s)
b) Enhance desirable effects
c) Prevent, or reduce, undesired effects
d) Achieve improvement
6.1.2 Kandamkulathy Vaidyasala shall plan
a) actions to address these risks and opportunities
b) how to
1) Integrate and implement the actions into its quality management system processes
2) Evaluate the effectiveness of these actions
Interested
Parties Requirements Risks and Opportunities Effectiveness of actions
External
providers Communication, Communication Gap, Communication like Emails, Phone,
Product Quality, On time Delivery Defined in documented information

Customer & service, Business Loss, Reputation of Marketing & Sales process &
Response to complaint, Down for Organization. Review in Management review
Proper Communication Channel Brand image and more sales Meetings
Statutory & Organization & product Customer is not accepting Defined in documented
Regulatory related Statutory & material or loss of business. information & Review in
Body regulatory requirements is Kept. Risk free business Management review meetings
Bankers / Funds related problems may delay in
Financiers All product & organization, Asset, day today activities. All product & organization, Asset, Bank A/c
Bank A/c related and Loan related Easy financial management and faster related and Loan related documents are kept
documents are kept implementations. and transactions are well monitoring.
Market analysis, Competent
Organization facing problems in sales,
Marketing Competitive rates, More Reputation in market. marketing team.
amenities, Prime Location, Good brand image and more business
and profit
Market analysis, Competent
Competitive rates , Good RM Shortage, Organization facing Purchase team, Supplier evaluation and re
Purchase
Quality material, Timely Finance evaluation every year.
Delivery, problems, loss in manpower Customer
Dissatisfaction, Delay in product
delivery & loss of Market Reputation.
Regular availability of RM, On time
order processing more sales more
profit. Good brand image.
6.2.2 Quality objectives and planning to achieve them

6.2.1 Kandamkulathy Vaidyasala establish quality objectives at relevant functions, levels and processes needed for the
quality management system.
The quality objectives shall
a) Be consistent with the quality policy
b) Be measurable
c) Take into account applicable requirements
d) Be relevant to conformity of products and services and to enhancement of customer satisfaction
e) Be monitored
f) Be communicated
g) Be updated as appropriate
6.2.2 Kandamkulathy Vaidyasala achieve its quality objectives,

a) What will be done?
b) What resources will be required?
c) Who will be responsible?

d) When it will be completed
e) How the results will be evaluated
QUALITY OBJECTIVES
Quality objective Dept. concerned Measurement Responsibility
frequency
1 Increase interstate sales by 50% MKT Monthly Marketing in charge
2 Increase Kerala sales by 30% MKT Monthly Marketing in charge
3 Increase export sales by 20% MKT Monthly Marketing in charge
4 Maintain minimum 80% of customer satisfaction MKT Monthly Marketing in charge
5 Reduce return goods due to expiry by 50% MKT Monthly Marketing in charge
6 Reduce return goods due to damage by 50% MKT Monthly Marketing in charge
7 Reduce return goods due to manufacturing problems by MKT Monthly Marketing in charge
50%
8 Launch 4 new products yearly R&D Annually R&D Manager
9 Powdering lose should be less than 3% PRODUCTION Monthly Production in charge
10 Processing lose should be 0.05% PRODUCTION Monthly Production in charge
11 Increase productivity minimum 10% at PRODUCTION Monthly Production in charge
filling/labeling/packing and RM cutting areas
12 Reduce packing material lose by 50% PACKING Monthly Packing in charge
13 Filling lose should be 0.05% FILLING Monthly Filling in charge
14 Reduce machine breakdown by 50% MAINTANANCE Monthly Mnt in charge
15 Reduce energy consumption by 10% MNT Monthly All Dept. Heads
16 Introduction of 25 new varieties of plants in herbal garden. HERBAL GARDEN Yearly GM & BOTANIST
6.3 Planning of changes

Kandamkulathy Vaidyasala determines the need for changes to the quality management system, the changes is carried out in a planned
manner
a) the purpose of the changes and their potential consequences
b) the integrity of the quality management system
c) the availability of resources
d) the allocation or reallocation of responsibilities and authorities
Kandamkulathy Vaidyasala has determined the processes needed for the quality management system and their application throughout
the organization in Process map & Interactions of processes
7.0 Support
7.1 Resources
7.1.1 General
Kandamkulathy Vaidyasala is determine and provide the resources needed for the establishment, implementation, maintenance and
continual improvement of the quality management system. Kandamkulathy Vaidyasala is consider
a) the capabilities of, and constraints on, existing internal resources

b) what needs to be obtained from external providers.
HR & Coordinator determine and provide the resources needed to implement and maintain the quality management system and
continually improve its effectiveness and to enhance customer satisfaction by meeting customer requirement. The resources will be in the
form of Human resources including qualified personnel.
The Required resources are identified in the event of new Process Development / Business plan review, Mfg Process Flow, also based
on the Organization performance review in MRM and monthly business reviews.
7.1.2 People
Kandamkulathy Vaidyasala determine and provide the persons necessary for the effective implementation of its quality management
system and for the operation and control of its processes.
HR along with respective process In Charges ensures that personnel performing work affecting product quality are competent and
training to given on the basis operation and control of its processes.
7.1.3 Infrastructure
Kandamkulathy Vaidyasala is determine, provide and maintain the infrastructure necessary for the operation of its processes and to
achieve conformity of products and services Infrastructure can include
a) Buildings and associated utilities b) Equipment, including hardware and software
c) transportation resources d) information and communication technology
At Kandamkulathy Vaidyasala, the management determine, provide and maintain the infrastructure needed to achieve conformity to
product requirements & in identifying the required Charges resources the Coordinator play a key role based on their day to day
interactions with respective IN and employees
7.1.4 Environment for the operation of processes
Kandamkulathy Vaidyasala has determined, provided and maintained the environment necessary for the operation of its processes and to
achieve conformity of products and services
A suitable environment can be a combination of human and physical factors
a) Social (e.g. non-discriminatory, calm, non-confrontational
b) Psychological (e.g. stress-reducing, burnout prevention, emotionally protective)
c) Physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).
Coordinator in co-ordination with respective In Charges determines and manages the work environment needed to achieve conformity to
product requirement and reviewed ongoing basis.
7.1.5 Monitoring and measuring resources
7.1.5.1 General
The company has determined and provided the resources needed to ensure valid and reliable results when monitoring or measuring is
used to verify the conformity of products and services to requirements.
The organization shall ensure that the resources provided
a) are suitable for the specific type of monitoring and measurement activities being undertaken
b) are maintained to ensure their continuing fitness for their purpose
Kandamkulathy Vaidyasala is retain appropriate documented information as evidence of fitness for purpose of the monitoring and
measurement resources
7.1.5.2 Measurement traceability
The measurement traceability is maintained requirement if applicable for the instruments, or is considered by the to be an essential part
of providing confidence in the validity of measurement results,
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or
national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as
documented information
b) identified in order to determine their status
c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement
results
Kandamkulathy Vaidyasala is determine the validity of previous measurement results has been adversely affected when measuring
equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.
Control of Monitoring & Measuring Equipments.
Measurement & Monitoring system is well equipped and the system has complete control over the monitoring and measuring
Equipments. The measurement methods used are evaluated to ensure that they are appropriate and reliable.
To ensure that the measuring equipments operate effectively and give reliable results, we have taken the following steps:
1) Equipments are maintained properly and are calibrated & adjusted as and when needed. Necessary safeguards are in place to
take care of adjustments that could lead to invalid results.
2) Calibrations are carried out as per national standards (by NABL accredited laboratories only). Where no such standard exist, the
basis used for calibration or verification are recorded. The calibration records include the last date of calibration, calibrating agency
(for external agency), calibration result, and frequency of calibration as per the process and/or instrument requirement and the next
calibration date. The required accuracy is identified and compared to the measurement that meets expectations.
3) Identification of appropriate equipment is accomplished by tagging, labeling, numbering or by including it in a calibration /
maintenance database.
4) Proper control is maintained to ensure that no faulty equipment is used, the reliability of the equipment is ensured through routine
maintenance and re-calibration.
5) Equipments are used, handled and stored under conditions that protect accuracy and prevent unauthorized adjustment. Work
environmental controls are all in place for equipment.
6) Instrument history cards are maintained for all measuring & Test instruments.
7.1.6 Organizational knowledge
Kandamkulathy Vaidyasala is determined the knowledge necessary for the operation of its processes and to achieve conformity of
products and services. This knowledge shall be maintained and be made available to the extent necessary
Organizational knowledge can be based on:
a) Internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failures and successful
projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and
services);
b) External sources (e.g. standards; academia; conferences; gathering knowledge from customers or external providers)
7.2 Competence
Kandamkulathy Vaidyasala has
a) Determined the necessary competence of person(s) doing work under its control that affects the Performance and effectiveness of
the quality management system
b) Ensure that these persons are competent on the basis of appropriate education, training, or Experience
c) Where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken
d) Retain appropriate documented information as evidence of competence for all employees
7.3 Awareness
Kandamkulathy Vaidyasala is ensured that the personnel doing work under the organization shall aware of
a) The quality policy
b) Relevant quality objectives
c) Their contribution to the effectiveness of the quality management system, including the benefits of improved performance
d) The implications of not conforming to the quality management system requirements
7.4 Communication
Kandamkulathy Vaidyasala is determine the internal and external communications relevant to the quality management system, including
a) On what it will communicate
b) When to communicate
c) With whom to communicate
d) How to communicate
e) Who Communicates
INTERNAL COMMUNICATION
What When with whom How Who

1.Quality policy Permanent All Employees / Display / Letter / Management
2.Importance of As per Training Interested parties Training Management
effective QMS plan / during All Employees Training / Display
Orientation
Training
During Management
recruitment / Employee Procedure / Oral /
3.Responsibilities Promotion / Training
and Authority Department
Change
4.Quality objectives While defining / All employees Procedure / Oral / Management
5.Customer Once in 3 months Head of the Training Proprietor
complaint / At the time of department / Meeting
Feedback Receipt Respective
process owner
EXTERNAL COMMUNICATION
What When with whom How Who
Information to external Placing purchase order / Supplier (External Purchase order / Letter / Email / Purchase I/C
providers/suppliers Quotation Collection provider) Oral
Product information Enquiry stage Customer Email / Website / Catalogue / Marketing team
Letter
Enquiry, order, Enquiry review / Customer Electronic media / Marketing team
Amendments Order review Letter/ oral
Customer feedback Once in a year / Customer Forwarding customer Marketing team

After service feedback form
Action taken for

Quality control or
Electronic media / concerned
customer Once action taken Customer Letter/ oral department
complaints
Information to As agreed with Delivery chellan /
external providers Customer Customer Letter / Email StoreS I/C
7.5 Documented information

7.5.1 General
7.5.2 Creating and updating
Kandamkulathy Vaidyasala creating and updating documented information, which ensure appropriate
a) Identification and description
b) Format (e.g. language, software version, graphics) and media (e.g. paper, electronic)
c) Review and approval for suitability and adequacy
Kandamkulathy Vaidyasala quality management system is include Quality management System documentation is established with the
following approach. A four level-documented structure is followed for the operation of Quality Management System.
Level 1 : Quality Manual (standard Requirement)
Defines the approach and responsibility, which includes a documented statement of quality policy & objectives.
Level 2: Procedures
Defines what, where, when, who & why of an activity being done as stated in ISO 9001:2015 standard.
The documented procedure activity process flow chart defines the effective planning, operation and control of processes.
Level 3: WI, Quality Plans, Check sheet etc
Defines how exactly an activity is to be done ensuring the effective planning, operation and control of processes.
Level 4 : Documented Information
Provides the evidence, which has to be established for all the activities, stated above which In turn Documented Information. A master list
of Quality Record is maintained by respective Departments / section heads as per the requirement of ISO 9001:2015.
Control of Quality System Manual (Level I).
Partner is approves the Quality Manual, procedure, WI & documented Information and its amendments. Management Representative /
Quality In charge is responsible for preparation, review, issue & control of the manual and its amendments
In case any personnel ceases to be holder of manual copy for any reason, his copy number of manual will be allocated to any new “
holder with note in amendment list to this “ effect. MASTER COPY will be stamped MASTER on the front side of all pages in BLUE color.
Photo copy will be taken for all MASTER & will be CONTROLLED stamped in RED colour. Coordinator/Quality in charge maintains the
master copy having original signatures.
Document changes.
Coordinator/Quality in charge perceive the need for amendment to this manual based on adequacy audit report, mistake / corrections
during review by any holder, system change and amendment to
reference ISO standard or any change in the organization affecting system described in this manual. Amendments to this manual are
recorded in the Amendment list (After Amendment).
The holders of Quality System Manual refer to amendment list before referring to respective amended sections to clearly understand
details / purpose of amendment. A list indicating latest revision status of each page of this manual, whenever a page of any chapter is
amended, the page and the chapter bear the latest Rev. No. The latest revision no. is indicated in the amendment sheet , and on the
cover page of the Quality Manual.
The revised version of the document pages are sent only to the holders as per the list along with updated amendment list and revision
status page.
Controlled copy holders of this manual should ensure that the obsolete pages are removed & destroyed and revised pages are inserted
in the Manual at appropriate places.
Management Representative / Quality In charge maintains one copy of obsolete version of revised pages at the time of each amendment
for reference purpose and having OBSOLETE stamp in RED colour.
When the Rev. No. Of Amendment sheet reaches 09, or in case amendment to ISO standard is released, the entire manual will be
reissued and bear next serial number of issue no. No details of amendments to earlier issue and recorded in amendment list for new
issue.
Numbering Logic of Quality System Manual:
The numbering logic of this quality system manual will be as described here:
a) The numbering logic will be SHL/QPM/A1.
b) SHL indicates Kandamkulathy Vaidyasala.
c) QSM indicates Quality System Manual of ISO 9001:2015.
d) QPM indicates Quality System Procedure Manual of ISO 9001:2015.
7.5.3 Control of documented information
7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to
ensure
a) It is available and suitable for use, where and when it is needed
b) It is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity)
7.5.3.2 For the control of documented information, Orion Battery is address the following activities, as applicable
a) Distribution, access, retrieval and use
b) Storage and preservation, including preservation of legibility
c) Control of changes (e.g. version control)
d) Retention and disposition
Documented information of external origin determined by the organization to be necessary for the Planning and operation of the quality
management system is identified as appropriate, and is controlled. Documented information retained as evidence of conformity shall be
protected from unintended alterations.
8.0 Operation
8.1 Operational planning and control
Kandamkulathy Vaidyasala is plan, implement and control the processes needed to meet the requirements for the provision of products
and services, and to implement the actions in & maintained risks and opportunities related to planning maintained in operational
planning control. Like bar chart for planning
a) Determining the requirements for the products and services
b) Establishing criteria for
1) The processes
2) The acceptance of products and services
c) Determining the resources needed to achieve conformity to the product and service requirements
d) Implementing control of the processes in accordance with the criteria
e) Determining, maintaining and retaining documented information to the extent necessary
1) To have confidence that the processes have been carried out as planned
2) To demonstrate the conformity of products and services to their requirements
Kandamkulathy Vaidyasala is control planned changes and reviews the consequences of unintended changes, taking action to mitigate
any adverse effects, as necessary.
Kandamkulathy Vaidyasala is ensure that outsourced processes are controlled
8.2 Requirements for products and services
8.2.1 Customer communication
Communication with customers is include
a) Providing information relating to products and services
b) Handling enquiries, contracts or orders, including changes
c) Obtaining customer feedback relating to products and services, including customer complaints
d) Handling or controlling customer property
e) Establishing specific requirements for contingency actions, when relevant
Customers are communicated regarding the product information though letter, verbal and/ or through phone, Fax, e-mail. If any
amendments in enquiries, purchase orders it will be communicated through Phone, letter & Email. The customer complaints are
registered in customer complaint register and the corrective action taken is communicated.
8.2.2 Determining the requirements for products and services
When determining the requirements for the products and services to be offered to customers, the Kandamkulathy Vaidyasala is ensure
that
a) The requirements for the products and services are defined, including
1) Any applicable statutory and regulatory requirements
2) Those considered necessary by the organization
b) The organization can meet the claims for the products and services it offers
At present the marketing activities are looked after by Managing Partner & Coordinator and both of them are actively involved in the
determination of customer requirements and for each enquiry he determines the
a) Requirements related to the product in contract review form with respect to requirements specified by customer, including the
requirements for delivery and post delivery activities.
b) Requirements not stated by customer but necessary for specific or intended use (where Known)
c) Statutory and Regulatory requirements related to the product
d) Any additional requirements determined by the organization.
8.2.3 Review of the requirements for products and services
8.2.3.1 Kandamkulathy Vaidyasala is ensuring that it has the ability to meet the requirements for products and services to be offered to
customers. Kandamkulathy Vaidyasala is conduct a review before committing to supply products and services to a customer, to include
a) Requirements specified by the customer, including the requirements for delivery and post delivery activities
b) Requirements not stated by the customer, but necessary for the specified or intended use, when known
c) Requirements specified by the organization
d) Statutory and regulatory requirements applicable to the products and services
e) Contract or order requirements differing from those previously expressed
Kandamkulathy Vaidyasala is before acceptance, when the customer does not provide a documented statement of their requirements
8.2.3.2 Kandamkulathy Vaidyasala is retain documented information, as applicable
a) On the results of the review
b) On any new requirements for the products and services
1) MKT In Charge shall review the requirement related to the product. This review take place as and when a new P.O or verbal
order in placed / confirmed by customer for a new part no. and prior to the commitment taken to supply the products.
2) The review ensure that
3) the product requirements are defined
4) Contract or order requirements differing from those previously expressed in the proposal or quote are resolved.
5) The organization has the ability to meet the defined requirements
8.2.4 Changes to requirements for products and services
Kandamkulathy Vaidyasala is ensure that relevant documented information is amended, and that relevant persons are made aware of the
changed requirements, when the requirements for products and services are changed
8.3 Design and development of products and services
8.3.1 General
Kandamkulathy Vaidyasala is establish, implement and maintain a design and development process that is appropriate to ensure the
subsequent provision of products and services.
8.3.2 Design and development planning
Kandamkulathy Vaidyasala is consider In determining the stages and controls for design and development, including
a) The nature, duration and complexity of the design and development activities
b) The required process stages, including applicable design and development reviews
c) The required design and development verification and validation activities
d) The responsibilities and authorities involved in the design and development process
e) The internal and external resource needs for the design and development of products and services
f) The need to control interfaces between persons involved in the design and development process
g) The need for involvement of customers and users in the design and development process
h) The requirements for subsequent provision of products and services
i) The level of control expected for the design and development process by customers and other relevant
interested parties
j) The documented information needed to demonstrate that design and development requirements have been met
8.3.3 Design and development inputs
Kandamkulathy Vaidyasala is determine the requirements essential for the specific types of products and services to be designed and
developed by the Kandamkulathy Vaidyasala is consider
a) Functional and performance requirements
b) Information derived from previous similar design and development activities
c) Statutory and regulatory requirements
d) Standards or codes of practice that the organization has committed to implement
e) Potential consequences of failure due to the nature of the products and services
Inputs shall be adequate for design and development purposes, complete and unambiguous. Conflicting design and development inputs
is resolved. Kandamkulathy Vaidyasala is retain documented information on design and development inputs
8.3.4 Design and development controls
Kandamkulathy Vaidyasala is apply controls to the design and development process to ensure that
a) The results to be achieved are defined
b) Reviews are conducted to evaluate the ability of the results of design and development to meet requirements
c) Verification activities are conducted to ensure that the design and development outputs meet the input requirements
d) Validation activities are conducted to ensure that the resulting products and services meet the requirements
for the specified application or intended use
e) Any necessary actions are taken on problems determined during the reviews, or verification and validation
activities
f) Documented information of these activities is retained
8.3.5 Design and development outputs
Kandamkulathy Vaidyasala is ensure that design and development outputs
a) meet the input requirements
b) are adequate for the subsequent processes for the provision of products and services
c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria
d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper
provision
Kandamkulathy Vaidyasala is retain documented information on design and development outputs
8.3.6 Design and development changes
Kandamkulathy Vaidyasala is identify, review and control changes made during, or subsequent to, the design and development of
products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements. Kandamkulathy
Vaidyasala is retain documented information on
a) Design and development changes

b) The results of reviews
c) The authorization of the changes
d) The actions taken to prevent adverse impacts
8.4 Control of externally provided processes, products and services (Purchase)
8.4.1 General
Kandamkulathy Vaidyasala is ensure that externally provided processes, products and services conform to requirements Kandamkulathy
Vaidyasala is determine the controls to Organizations be applied to externally owned provided and processes, products and services
when
a) Products and services from external providers are intended for incorporation into the services
b) Products and services are provided directly to the customer(s) by external providers on behalf of the organization
c) A process, or part of a process, is provided by an external provider as a result of a decision by the organization
Kandamkulathy Vaidyasala is determined and applies criteria for the evaluation, selection, monitoring of performance, and re-evaluation
of external providers, based on their ability to provide processes or products and services in accordance with requirements. The
organization shall retain documented information of these activities and any necessary actions arising from the evaluations
Purchase In Charge ensures that the purchased products are procured from Approved sources only and which conforms to specified
purchase requirement. This is done as per business process flow for procurement. The type and control to be exercised on supplier,
based on the effect of the purchased product on the process/final product, is defined in the approved Supplier list.
Purchase In Charge evaluates and select supplier based on their ability to supply product in accordance with the requirements of the
organization. Criteria for selection, evaluation and re-evaluation are described and depicted in Business Process Flow chart.
a) Selection, Evaluation and approval of suppliers
b) Periodical evaluation of Supplier
c) Approved Supplier List will be maintained by the Purchase In Charge and also the records of their periodical performance.
8.4.2 Type and extend of control
Kandamkulathy Vaidyasala has ensured that externally provided processes, products and services do not affect adversely. So the
organization shall
a) Ensure that externally provided processes remain within the control of its quality management system
b) Define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output
c) Taking into consideration
1) The potential impact of the externally provided processes, products and services on the requirements
2) The effectiveness of the controls applied by the external provider
d) Determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services
meet requirements
8.4.3 Information for external providers
Kandamkulathy Vaidyasala is ensure the adequacy of requirements prior to their communication to the external provider. Kandamkulathy
Vaidyasala is communicate to external providers its requirements for
a) The processes, products and services to be provided
b) The approval of
1) Products and services
2) Methods, processes and equipment

3) The release of Products and services
The Purchase order is describes the product to be purchased including
a) Requirement of Material Test Certificate / Dimensional report / PPAP such as Control Plan / Process Flow Chart / Process Sheets /
Process Capability studies etc.
b) Requirements for qualification of personnel
c) QMS requirements.
PO will be reviewed for adequacy of the specified requirement prior to release by PUR In Charge & Coordinator
The Purchase order released to the supplier indicates the intended verification arrangements and method of product release, whenever
the company or its customer intends to perform such verification at external providers end.
Incoming Product Quality
The control / Inspection plan for incoming be based on the control exercised on the external providers -
a) Inspection and / or testing on sampling method. The sampling size should be decided based on
1) Quality assurance certificate or test report from supplier.
2) Part evaluation by accredited laboratories.
3) Receipt and evaluation of statistical data.
4) Any of above method or Combination of any two or more from above.
Supplier Monitoring
External providers performance monitoring through the following indicators & will be carried out by Purchase In Charge as described in
Procedure for Purchase
a) Delivered Product Quality will be based on the below given parameters.
1) Delivery Performance.
2) Customer disruptions including field Returns.
3) Customer notification Related to quality Or delivery Issues
4) Premium freight.
Kandamkulathy Vaidyasala is promoting monitoring of the performance of manufacturing processes of the external as part of supplier
development.
8.5 Production and service provision
8.5.1 Control of production and service provision
Kandamkulathy Vaidyasala is implement production and service provision under controlled conditions. Controlled conditions is include, as
applicable
a) The availability of documented information that defines
1) The characteristics of the products to be produced, the services to be provided, or the activities to be performed
2) The results to be achieved
b) The availability and use of suitable monitoring and measuring resources
c) The implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or
outputs, and acceptance criteria for products and services, have been met
d) The use of suitable infrastructure and environment for the operation of processes
e) The appointment of competent persons, including any required qualification
f) The validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service
provision, where the resulting output cannot be verified by subsequent monitoring or measurement;
g) The implementation of actions to prevent human error
h) The implementation of release, delivery and post-delivery activities
Production In Charge shall plan the production as per and respective Section In charge carry out process under controlled condition as
defined in Process Flow in respective process procedures
Controlled conditions shall include:-
a) Production plans for all processes which describes the characteristics of the product and process flow chart for sequence of
operations
b) Work Instructions made available at all work stations.
c) Use of appropriate equipment for a particular process/operation
d) Use of calibrated monitoring and measuring devices
e) In process inspection/verification
f) Verification of acceptance criteria
Production Plan
Production plan for all stages of production, including receipt of material sample, pilot & regular production shall be used. These
Production plans at each stage may be amendments of production plans of earlier stage.
As described above, Marketing shall be involved in preparation of production plans where required by customer production Plans will be
submitted to customer for approval.
a) The production plan shall
1) list the controls used for the manufacturing processes
2) Include methods for monitoring of control exercised over special characteristics defined by both the c Include the
customer required information, if any
3) Initiate the specified reaction plan when the process becomes unstable or not statistically capable production plans shall be
reviewed and updated, as appropriate:
4) The product is changed.
5) The manufacturing processes are changed.
6) The processes become unstable.
7) The processes become non-capable.
8) Inspection frequency and method changes
9) Change in supply sources
10) Corrective actions based on process NC,s & customer concerns
11) Drawing changes / ECNs.
Production plans are developed for all the process involved in the manufacturing by the Cross functional team. These are identified during
the advanced product planning process. Wherever approvable.
The production plans are live documents and are reviewed and updated when change to the original product or process occurs.
Work Instructions
Respective Departmental In Charges prepares Work Instructions for all operations / process activities and for all employees having
responsibilities under them. These instructions are made accessible for use at the work station& are prepared based on trial run result
and old documents of similar product at the time of job induction into production and will be reviewed for applicable changes in event of
production Plan change(s).
Preventive Maintenance
Maintenance In Charge maintains a list of all machines / equipment used in production and designated key process equipment in the list
A plan for preventive maintenance for this key equipment shall be available developed data and implemented from manufactures to
ensure recommendations, continuing process. extent of usage, and rate of wear and tear etc., based on these details appropriate
predictive techniques are used.
Maintenance In Charge ensures that required spare-parts for replacement along with other resources for maintenance as per preventive
maintenance schedule are available in time. Appropriate records of maintenance shall be maintained by Maintenance In Charge.
A system that describes planned & predictive maintenance method is detailed in Procedure respectively.
Validation of processes for production and service Provision
All processes are validated before the start of the production through set up approval and First few sample piece Inspection.
The above processes are controlled and continually monitored through documented work instructions, process qualifications, set up
approval and worker qualification, as
Applicable to ensure that the specified requirements are met.
Appropriate records are maintained by all In Charges to demonstrate the control of these processes and equipment. Records of
personnel qualifications and re-qualifications are maintained by all In Charges. Stipulate workmanship standards to the greatest
practicable extent, where appropriate, by means of written standards, representative samples or display boards.
Ensure Handling, Storing and transporting within the production shop are carried to protect all materials / products. The details of process
controls are described in respective department procedures.
8.5.2 Identification and traceability
Kandamkulathy Vaidyasala is use suitable means to identify outputs when it is necessary to ensure the conformity of products and
services
Kandamkulathy Vaidyasala is identify the status of outputs with respect to monitoring and measurement requirements throughout
production and service provision
Kandamkulathy Vaidyasala is control the unique identification of the outputs when traceability is a requirement, and shall retain the
documented information necessary to enable traceability
All material are identified including inspection and test status in appropriate manner (paint, punch mark, labels, stickers and tagging etc.)
from receipts at stores through various stages
of production. The final product is kept on trolleys & transferred to Finished Goods area before delivery to customer as detailed in work
procedures for storage, packing & dispatch.
Traceability is provided, if required by customer or decided for some products by a particular customer to identify finished products by
providing punch mark / tag / batch code. For such products proper records are maintained also the main packages are traceable through
Bar code system
When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall
report this to the customer or external provider and retain documented information on what has occurred
1. Any arrangement of Customer Supplied raw materials, components, tooling, returnable packaging, measuring instruments etc., are
identified during the contract review by MKT In Charge and communicated to the people concerned.
2. All such products are uniquely identified after proper verification and properly stored and maintained. Any such product that is lost
damaged or is otherwise unsuitable for use shall be recorded and reported to the Customer by customer representative & Marketing
In Charge.
It shall be the responsibility of QA personnel to verify the quality of such product even if it has been supplied by the Customer
8.5.4 Preservation
Kandamkulathy Vaidyasala preserve the outputs during production and service provision, to the extent necessary to ensure conformity to
requirements
Preservation is include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection
At all stages of production, appropriate material / product handling, storage, packing of products, preservation and delivery of products
established viz..
Storage and Inventory
A suitable inventory control system is established to optimize inventory turns, assure stock rotation & minimize inventory levels. Stores
Section shall monitor stock levels and inform purchase section in time & FIFO is emphasized.
Handling and Storage of Incoming Material
At present manual method are provided for movement of brought out items and raw material respectively. In charge Stores shall ensure
safe handling of materials / items received in stores. Secured storage space with proper environmental conditions to protect the products
stored shall be provided for all items in stores. Shelf life items are identified and periodic inspection of all stored items is conducted once
in three months for fitness for use.
Store In charge has the defined responsibility to receive issue & dispatch materials from secured storages i.e., Stores & Finished Goods
Stock point.
All material in stock is periodically assessed to verify continued fitness for use. Proper material accounting shall be maintained in the
stock ledger, with the consideration for keeping stored items in usable conditions.
In process Products
Handling of In-process material is done using Trolleys and BINS. At all times the individual operator ensure safe handling of the material
to prevent damage. Storage on shop floor, for in-process products if required suitable packaging material will be used to protect the
products from any kind of damages, deterioration due to environmental conditions.
Finished Products
Finished products are handled carefully with the use of hydraulic Trolleys and packed by using BINS and Polythene bags, so as to protect
them from any kind of damage and kept in Finished goods area in duly cleaned condition. All finished products stored will be under
control of assembly in charge.
Packaging
Packaging of products carried out according to packaging instructions / drawings wherever applicable, i.e., contractually agreed or if
product nature calls for packing. Type of packaging material & its quality is ensured as per customer requirements, if mentioned in the
purchase order.
Material / packages used for packing of products are verified before packing to ensure its conformance to specified requirements as per
Purchase Order/ Customer Requirement.
Packing method employed will be adequate to protect the products fully till they reach their destination if contractually specified.
8.5.5 Post-delivery activities
Kandamkulathy Vaidyasala is meet requirements for post-delivery activities associated with the products and services. They consider In
determining the extent of post-delivery activities that are required,
a) statutory and regulatory requirements
b) the potential undesired consequences associated with its products and services
c) the nature, use and intended lifetime of its products and services
d) customer requirements
e) customer feedback
Delivery
The product quality is protected after final inspection & testing and wherever contractually specified extended from delivery to destination.
The deliveries of products are done as per contract terms / delivery schedules for customer.
8.5.6 Control of changes
Kandamkulathy Vaidyasala is review and control changes for production or service provision, to the extent necessary to ensure
continuing conformity with requirements.
Kandamkulathy Vaidyasala is retain documented information describing the results of the review of changes, the person(s) authorizing
the change, and any necessary actions arising from the review.
8.6 Release of products and services
Kandamkulathy Vaidyasala is implement planned arrangements, at appropriate stages, to verify that the product and service
requirements have been met
The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily
completed, unless otherwise approved by a relevant authority and, as applicable, by the customer
Kandamkulathy Vaidyasala is retain documented information on the release of products and services. The documented information is
include
a) Evidence of conformity with the acceptance criteria
b) Traceability to the person(s) authorizing the release
To ensure that the products manufactured meet the quality requirements of customer fully, a systematic approach for inspection and
testing at all stage viz. incoming, in process and final are demonstrated. At each stage the activity is performed according to documented
procedures.
Receiving Inspection & Testing
Inspection / Verification of incoming material is carried out according to the respective Incoming Inspection Standards & Control plans.
This is the responsibility of QA In Charge.
The control plan for incoming shall use one of the following methods
a) Inspection and / or testing on sampling method.

b) Inspection at suppliers premises with / without system audit.
c) Quality assurance certificate or test report from supplier.
The incoming materials used in production shall not be used or processed without acceptance by Receipt inspection. Store Personnel are
responsible for receipt, identification, records and storage of all incoming materials, the detailed procedure for incoming material
inspection is described
Inspection and Tests Records
Records of inspection / tests at all stages mentioned above are prepared in specific forms & maintained. The format number(s) of records
as mentioned in respective procedures / work instructions /control plans.
QA In Charge and Production In Charge will be the approving authority at each stage for disposition of non-conforming materials /
products.
8.7 Control of nonconforming outputs
Procedures are established for identifying non-conforming product at Stores and stages of production / inspection as well as at the final
inspection stage. The non-conforming materials
are identified by the production operator/ QA Personnel at these stages and suitably identified. Responsibility and authority are assigned
for segregation, review and disposition of non-conforming product.
Documented information of segregation, review and suitable disposition of non-conforming materials are maintained by QA Personnel.
Who are authorized to review non-conforming product. The decisions of review as per applicable for disposition may be
a) Action which has to be taken to eliminate the non conforming situation.
b) Use as it is under concessions (deviation) / with partial rework or without rework after approval from defined Authorization.
c) Rework to meet specifications.
d) Reject / scrap.
e) Return to supplier.
f) Regard for alternative applications.
g) Reworked / Repaired product re-verified to demonstrate conformity to requirement in accordance with the documented control plan.
Details for handling of nonconforming outputs are described in Procedure
9 Performance evaluations
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
Kandamkulathy Vaidyasala is evaluating the performance and the effectiveness of the quality management system. They are retaining
appropriate documented information as evidence of the results.
To establish measurement, analysis and improvement plan for all the process / Function defined in the Quality Management System.
To establish quality management measurement process and monitor as per planned results for achievement also establish processes to
identify non- Conformity situation and subsequently corrective & preventive actions to be taken.
QA In Charge in consultation with all respective production process heads plan and implement the monitoring, measurement, analysis
and improvement processes needed.
a) What needs to be monitored and measured
b) The methods for monitoring, measurement, analysis and evaluation needed to ensure valid results
c) When the monitoring and measuring shall be performed
d) When the results from monitoring and measurement are analyses and evaluated needs and expectations have been fulfilled.
Kandamkulathy Vaidyasala is determining the methods for obtaining, monitoring and reviewing this information.
Coordinator & MKT in Charge have primary responsibility for Customer Satisfaction as one of the measurement of the Quality
Management System and as to whether the organization has met customer requirements. Customer satisfaction shall include collection
of authentic data, frequency and validity of analysis. The trend and major elements affecting customer satisfaction and key indicators of
customer dissatisfaction will be monitored supported by objective evidence. Wherever data available, level of customer satisfaction will be
compared with those of our competitors & relevant action plan will be evolved. A customer satisfaction analysis survey will be conducted
once in 12 months. Review of customer satisfaction will be taken by top management during Management Review Meeting as described
in Procedure.
9.1.3 Analysis and evaluation
Kandamkulathy Vaidyasala is analyze and evaluate appropriate data and information arising from monitoring and measurement.
The results of analysis is used to evaluate
a) Conformity of products and services
b) The degree of customer satisfaction;
c) The performance and effectiveness of the quality management system;
d) If planning has been implemented effectively;
e) The effectiveness of actions taken to address risks and opportunities;
f) The performance of external providers;
g) The need for improvements to the quality management system
9.2 Internal audit
Procedures are established for a system of planned and documented internal quality audits to verify that the Quality Management System
conforms to the planned arrangements as per ISO 9001:2015 requirements and effectively implemented and maintained.
The Head of the Organization will assign the coordinator for
a) Planning and organizing audits at works depending on the importance and the extent of the activity concerned and the results of
the previous audits. The internal quality system audits as per schedule are to be carried out at least once in SIX Months period
and at least 02 times during a year.
b) Coordinator also ensures that the trained auditors are involved in quality system audit to ensure objectivity of the auditing
processes and are not directly responsible for the area under audit. The results of the audit are documented in specified format to
record non conformances in product / process and work practices and brought to the notice of person responsible for the area
audited, who in turn shall take appropriate corrective actions within agreed time limit and ensure removal of deficiencies observed.
Follow up the effectiveness of the corrective action taken.
c) The effectiveness of identified corrective action against any such internal audit findings are verified by the Coordinator prior to
subsequent management review meeting and recorded.
d) Coordinator is responsible for ensuring that non-conformances observed during IA are closed by appropriate corrective action
implementation in a defined period. The Coordinator identifies and marks the corrective actions needing confirmation for their
effective implementation and also arrange for the verification in subsequent audits or follow up audits will be planned.
e) Coordinator maintains appropriate records of implementation & effectiveness in the form of internal audit reports. The details of
the audit team, schedule, preparation of non-conformances reports are maintained. The follow up on the corrective actions is
detailed in the procedure.
f) The nonconformance identified during third party audits or by external agencies are handled in the same manner. The non-
conformances of IA remaining open due to delay in implementation of corrective action along with major non-conformances
recorded will be reviewed during management review meetings described in the procedure.
9.3 Management review
9.3.1 General
Top management of Kandamkulathy Vaidyasala continuing suitability, adequacy, effectiveness and alignment with the strategic direction
of the organization. Management review will be conducted and chaired by Proprietor / Co ordinator once in SIX Months
To ensure continuing suitability & effectiveness in satisfying the requirements of ISO 9001:2015 and the stated quality policy and
objectives.
The Management Review will include all elements of the entire quality system as detailed in procedure and schedule for the Management
Review is described.
Records of Management Review Meetings shall be maintained by Coordinator.
The Coordinator during review shall assess opportunities for improvement and the need for changes in Quality Management System,
including the Quality Policy and Quality Objectives.
9.3.2 Management review inputs
The management review is planned and carried out taking into consideration
a) The status of actions from previous management reviews
b) Changes in external and internal issues that are relevant to the quality management system;
c) Information on the performance and effectiveness of the QMS, including trends in:
1) customer satisfaction and feedback from relevant interested parties;
2) the extent to which quality objectives have been met;
3) process performance and conformity of products and services;
4) nonconformities and corrective actions;
5) monitoring and measurement results;
6) audit results;
7) the performance of external providers
9.3.3 Management review outputs
The outputs of the management review shall include decisions and actions related to:
a) Opportunities for improvement;
b) Any need for changes to the quality management system;
c) Resource needs.
Kandamkulathy Vaidyasala is retain documented information as evidence of the results of management reviews
10 Improvement
10.1 General
Kandamkulathy Vaidyasala is determine and select opportunities for improvement and implement any necessary actions to meet
customer requirements and enhance customer satisfaction. These include
a) Improving products and services to meet requirements as well as to address future needs and expectations
b) Correcting, preventing or reducing undesired effects;
c) Improving the performance and effectiveness of the quality management system.
Improvement is include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization
10.2 Nonconformity and corrective action
10.2.1 When nonconformity occurs, including any arising from complaints, Orion Battery is
All nonconformities relating to product, process and quality system are investigated & the results are recorded. While investigating causes
of non-conformances & deciding corrective actions, the team identifies other products / situations where same or similar nonconformance
can occur.
Corrective actions for nonconforming products and processes, detected in the organization are recorded; analyzed, reviewed and
necessary actions are taken. This will be the responsibility of QA In Charge and Production In Charge. The corrective action and
preventive measures are implemented and their effectiveness is monitored. The details are as described in the procedure.
Corrective actions are taken on customer complaints; by analyzing the causes of the complaints and taking suitable action to prevent their
reoccurrence.
The effectiveness of the identified corrective action is monitored through customer feedback and also the customers are kept aware of the
corrective actions initiated, with each identified corrective action.
10.3 Continual improvement
Kandamkulathy Vaidyasala are continually improved the suitability, adequacy and effectiveness of the quality management system.
Kandamkulathy Vaidyasala is consider the results of analysis and evaluation, and the outputs from management review, to determine if
there are needs or opportunities that shall be addressed as part of continual improvement

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Quality Management System Manual

Prepared by Verified By Approved by

Kandamkulathy is one of the most celebrated Ayurveda families of

Late Mr. K.P.Pathrose Vaidyan of Kandamkulathy family, who studied

Now Kandamkulathy is a trusted name in the Ayurvedic field of Kerala

Strictly based on the Ayurvedic concept of Authentic Ayurveda at

1 Managing Partner Controlled Copy No. 01

2 Coordinator Master Copy

3 Certifying Body Controlled Copy No. 02

Page Issue Issue Rev Rev

OUR QUALITY POLICY

Customer delight is the prime business policy of our organization

1 Increase interstate sales by 50%

4.0 CONTEXT OF THE ORGANIZATION

2.Employees Job satisfaction, Good remuneration,

4.1 Understanding the organization and its context:

Political Factors (P) Economic Factors (E)

Social Factors (S) Technology Factors (T)

Strength (S) Weakness (W)

4.2 Understanding the needs and expectations of interested parties

Interested parties Requirements Monitoring & Review mechanism at

Employees Management Support, Payments Accounting Control of management

4.3 Determining the scope of the quality management system

“Production and Supply of Ayurvedic Medicines”

5.2.1 Establishing the quality policy

Product Quality, On time Delivery Defined in documented information

6.2.2 Quality objectives and planning to achieve them

6.2.2 Kandamkulathy Vaidyasala achieve its quality objectives,

c) Who will be responsible?

6.3 Planning of changes

a) the capabilities of, and constraints on, existing internal resources

What When with whom How Who

Customer feedback Once in a year / Customer Forwarding customer Marketing team

Action taken for

7.5 Documented information

a) Design and development changes

2) Methods, processes and equipment

11) Drawing changes / ECNs.

a) Inspection and / or testing on sampling method.

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