INDIAN STATISTICAL INSTITUTE
Kolkata
Quality Management System
Exercise 5
Submitted to
Prof. Ranjan Sett
Implementation of ISO 9001:2015 Quality Management System in a
Manufacturing Organization
(Case Study: Simplastic Technologies Pvt. Ltd.)
Name - Jhilik Paul
Roll - QR2506
Table of Contents
➢ Introduction 2
➢ Business Organization 2
➢ Organisation name 2
➢ Detailed write-up about Simplastic Technologies Pvt. Ltd. 3
Overview 3
Location & Scale 3
What the company does (simple process summary) 4
Key Strengths 4
Vision 4
Mission 4
Future plans / Strategic goals (next 3–5 years) 4
➢ Details of Organisational Responsibility and Authority 5
● Organizational Structure 5
● Description of the Roles & Responsibilities 6
➢ Identified Key Processes of Simplastic Technologies Pvt. Ltd. 7
1. Leadership & Management Review Process 7
2. Customer Requirement & Contract Review Process 7
3. Resource & Competence Management Process 8
4. Purchasing & Supplier Evaluation Process 8
5. Incoming Inspection Process 9
6. Production & Process Control Process 9
7. In-Process & Final Inspection Process 10
8. Storage, Packing & Dispatch Process 10
9. Internal Audit Process 11
10. Corrective Action & Continual Improvement Process 11
➢ Detailed Process Maps 12
➢ 2 Sections of ISO 9001: 2015 12
Clause 7: Support 12
Clause 8: Operation 13
➢ Takeaway 13
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➢Introduction
This report focuses on the design and documentation of a Quality Management
System (QMS) in accordance with the requirements of ISO 9001:2015. The
exercise involves identifying and defining the key processes of a business
organization, establishing its structure, and assigning responsibilities and
authorities as per the ISO framework.
It also includes the preparation of detailed process maps covering Clauses 5 to
10 of ISO 9001:2015, along with relevant performance indicators to measure
process effectiveness and efficiency. The overall objective is to demonstrate how
a systematic, process-based approach can be used to ensure consistent quality
management and continual improvement within an organization.
➢Business Organization
Type: Medium-scale manufacturing company.
Focus: Producing plastic and lightweight metal parts for consumer appliances and
small industrial equipment.
Rationale for this Choice: Manufacturing offers clear, tangible processes for mapping
a Quality Management System (QMS). This includes steps such as purchasing,
production, inspection, delivery, and continuous improvement.
➢Organisation name
Simplastic Technologies Pvt. Ltd.
Derived from the words “Simple” and “Plastic”, reflecting the company’s focus on
creating simple, efficient, and lightweight plastic-based solutions.
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➢Detailed write-up about Simplastic Technologies Pvt. Ltd.
Overview
Simplastic Technologies Pvt. Ltd. is a medium-sized manufacturing company located
in Pune, Maharashtra. The company specializes in producing plastic and lightweight
metal components used by manufacturers of home appliances and small industrial
machines.
● Core products:
○ Switchboard panels
○ Fan and appliance covers
○ Handles and knobs
○ Small casings and enclosures
○ Simple brackets and mounting parts
● Primary customers:
○ OEMs (original equipment manufacturers) of home appliances
○ Small industrial equipment assemblers
○ Local trading houses that supply components to larger assemblers
Location & Scale
● Head office / Factory: Pune, Maharashtra (single facility)
● Employee strength: Approximately 120 employees (shop floor operators,
technicians, engineers, quality, purchase, admin & sales)
● Annual turnover: Approximately ₹35 crore
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What the company does (simple process summary)
● Receives orders from customers → plans production → procures raw
materials → manufactures parts using injection molding, basic machining, and
assembly → quality inspection → packs & dispatches → collects customer
feedback.
● The company emphasizes on-time delivery, consistent product quality, and
practical improvements to reduce waste and errors.
Key Strengths
● Practical, low-complexity products that are easy to standardize.
● Agile production suitable for medium batch sizes.
● Experienced shop floor staff and straightforward quality checks.
● Close proximity to supplier clusters in Pune for fast material sourcing.
Vision
To become a reliable and growing manufacturing partner known for quality, teamwork,
and customer satisfaction.
Mission
Deliver well-made, affordable components on time while continuously improving
processes and skills.
Future plans / Strategic goals (next 3–5 years)
● Adopt eco-friendly materials: Start using recyclable and lower-impact plastics
where feasible.
● Improve automation: Introduce targeted automation (e.g., automated inspection
jigs, basic material handling) to raise productivity.
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● Strengthen quality systems: Achieve consistent quality through improved
process controls and internal audits (aligning to ISO 9001).
● Market expansion: Begin small-scale exports to neighboring countries and
increase B2B customer partnerships.
● Workforce development: Regular training programs to improve operator skills
and reduce process variation.
➢Details of Organisational Responsibility and Authority
The organizational structure defines reporting relationships and functional
responsibilities across all departments. It ensures smooth coordination and
accountability for maintaining the company’s Quality Management System (QMS).
Below, I have added the organizational structure of Simplastic Technologies Pvt. Ltd. as
well as the description of each and every role.
● Organizational Structure
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● Description of the Roles & Responsibilities
Position Responsibilities (ISO 9001 Authority
Context)
Managing Director Provides overall direction; ensures Approve QMS documents, allocate
QMS objectives are achieved; resources, take major policy
reviews management system decisions.
performance.
Quality Manager Implements and maintains QMS; Stop production in case of quality
conducts internal audits; reports on issues, approve corrective actions,
performance to top management. report to MD.
Production Manager Plans and controls production; Assign work, approve production
ensures product conformity and plans, request maintenance
continuous improvement. support.
Purchase Officer Manages supplier evaluation and Select and approve vendors, raise
purchasing of materials as per purchase orders within budget.
specifications.
HR & Admin Officer Handles recruitment, training, and Recruit staff, recommend training
competence evaluation of programs, evaluate competence.
employees.
Stores In-Charge Controls receipt, storage, and issue Release materials as per FIFO,
of materials; maintains traceability maintain inventory records, report
records. shortages.
Maintenance Engineer Ensures upkeep of machines, Stop equipment for safety reasons,
utilities, and preventive plan maintenance shutdowns
maintenance schedules.
Design Engineer Prepares product drawings and Modify designs under approved
maintains design records; assists in change process, coordinate with
design improvements. production.
Sales Executive Handles customer communication, Negotiate with customers, finalize
order processing, and feedback small orders, handle client
monitoring. complaints.
Operator/Technician Operates machinery as per Operate equipment, report
instructions; ensures product nonconforming products, maintain
quality at every stage. work area cleanliness.
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➢Identified Key Processes of Simplastic Technologies Pvt. Ltd.
(As per ISO 9001:2015 Clauses 5 to 10)
1. Leadership & Management Review Process
● Purpose: To ensure that top management regularly reviews the Quality
Management System (QMS) and evaluates its effectiveness for continual
improvement.
● Inputs: QMS performance data, customer feedback, audit results, and previous
review actions.
● Outputs: Management review minutes, decisions taken, and improvement action
plans.
● Responsibility: Managing Director and Quality Manager.
● Related ISO Clauses: 5.1, 9.3
● Performance Indicators: Number of reviews held per year, action closure rate,
achievement of objectives.
2. Customer Requirement & Contract Review Process
● Purpose: To ensure customer requirements are clearly understood, reviewed,
and agreed before accepting any order.
● Inputs: Customer orders, specifications, technical drawings, and terms and
conditions.
● Outputs: Approved order, updated delivery plan, and customer confirmation
records.
● Responsibility: Sales Executive and Quality Manager.
● Related ISO Clauses: 5.1.2, 8.2
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● Performance Indicators: Order review completion rate, customer satisfaction
score, number of order changes.
3. Resource & Competence Management Process
● Purpose: To ensure that all employees are trained, competent, and aware of
their roles in maintaining product and process quality.
● Inputs: Training needs, skill matrix, manpower plan, and performance
appraisals.
● Outputs: Trained and competent employees, updated training records, and skill
development plans.
● Responsibility: HR & Admin Officer and Department Heads.
● Related ISO Clauses: 7.1, 7.2, 7.3
● Performance Indicators: Training hours per employee, evaluation results,
employee turnover rate.
4. Purchasing & Supplier Evaluation Process
● Purpose: To ensure that materials and services procured from suppliers meet
defined quality and delivery requirements.
● Inputs: Purchase requisitions, supplier quotations, approved vendor list, and
specifications.
● Outputs: Approved purchase orders, supplier performance evaluations, and
accepted materials.
● Responsibility: Purchase Officer and Quality Manager.
● Related ISO Clauses: 8.4, 7.1.1
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● Performance Indicators: Supplier rating, percentage of accepted materials,
supplier delivery performance.
5. Incoming Inspection Process
● Purpose: To verify that purchased materials meet the required specifications
before they are used in production.
● Inputs: Supplier delivery notes, inspection standards, material specifications,
and sampling plans.
● Outputs: Accepted or rejected materials, inspection reports, supplier feedback.
● Responsibility: Quality Inspector and Stores In-Charge.
● Related ISO Clauses: 8.4, 8.6
● Performance Indicators: Incoming rejection rate, number of NCRs
(Non-Conformance Reports), supplier quality trend.
6. Production & Process Control Process
● Purpose: To ensure that all products are manufactured according to approved
specifications and quality standards.
● Inputs: Production plan, process sheets, raw materials, and machine availability.
● Outputs: Finished components, production records, and process inspection
data.
● Responsibility: Production Manager and Operators.
● Related ISO Clauses: 8.5.1, 8.5.6
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● Performance Indicators: Production yield, scrap and rework rate, on-time
completion percentage.
7. In-Process & Final Inspection Process
● Purpose: To check and verify that all parts conform to customer requirements
during and after production.
● Inputs: Process parameters, inspection checklists, and product drawings.
● Outputs: Accepted or rejected products, inspection records, and analysis
reports.
● Responsibility: Quality Manager and Inspectors.
● Related ISO Clauses: 8.6, 9.1.1
● Performance Indicators: First-pass yield, final rejection percentage, customer
complaints received.
8. Storage, Packing & Dispatch Process
● Purpose: To ensure that all finished goods are properly stored, packed, and
dispatched without damage or delay.
● Inputs: Finished goods, packing instructions, customer delivery schedule, and
transport details.
● Outputs: Packed goods, dispatch documents, and delivery notes.
● Responsibility: Stores In-Charge and Dispatch Clerk.
● Related ISO Clauses: 8.5.4, 8.5.5
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● Performance Indicators: On-time delivery rate, packaging quality, transport
damage incidents.
9. Internal Audit Process
● Purpose: To check whether all processes conform to ISO 9001 requirements
and are effectively implemented.
● Inputs: Audit plan, previous audit reports, checklists, and QMS procedures.
● Outputs: Internal audit reports, nonconformity reports, and corrective action
requests.
● Responsibility: Quality Manager and Internal Auditors.
● Related ISO Clauses: 9.2
● Performance Indicators: Number of audits conducted, NC closure time, and
improvement actions implemented.
10. Corrective Action & Continual Improvement Process
● Purpose: To identify the causes of nonconformities, take corrective action, and
promote continual improvement throughout the organization.
● Inputs: Nonconformity reports, audit findings, customer complaints, and
performance data.
● Outputs: Corrective action records, improvement plans, and updated QMS
procedures.
● Responsibility: Quality Manager and Process Owners.
● Related ISO Clauses: 10.2, 10.3
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● Performance Indicators: Number of corrective actions closed, time taken to
close issues, improvement projects completed.
➢Detailed Process Maps
This document details the Process Maps of Simplastic Technologies Pvt. Ltd., which
have been developed to meet the requirements of ISO 9001:2015 (Clauses 5–10).
Each process map comprehensively outlines the inputs, outputs, process flow,
responsibilities, and key performance indicators. This ensures the effective
management and continuous improvement of all primary organizational operations.
Process Map - Simplastic [Link]
➢2 Sections of ISO 9001: 2015
Clause 7: Support
Simplastic Technologies recognizes that strong support functions are essential for maintaining
the effectiveness of the Quality Management System (QMS).
To ensure this:
● Resources: Adequate infrastructure, equipment, and workspace are provided to
maintain consistent product quality and safety.
● Competence: All employees are trained and evaluated for competence relevant to their
roles. Records of training and skill assessments are maintained by the HR & Admin
Officer.
● Awareness: Every employee is made aware of the company’s quality policy, customer
requirements, and their role in meeting QMS objectives.
● Communication: Internal communication regarding quality, safety, and delivery
performance is maintained through periodic review meetings.
● Documented Information: All quality records, forms, and process documents are
controlled as per the document control procedure to ensure accessibility and accuracy.
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Clause 8: Operation
Simplastic Technologies plans, implements, and controls all operational processes required for
manufacturing high-quality plastic components.
➢ Operational Planning and Control: Each process, from material procurement to final
dispatch, is executed following documented procedures and standard work instructions.
➢ Customer Communication: Customer requirements, feedback, and complaints are
handled promptly to ensure satisfaction and continual improvement.
➢ Design and Development (if applicable): Product designs are verified and validated
before production, ensuring conformance to customer specifications.
➢ Control of External Providers: Suppliers are evaluated and selected based on their
capability to deliver products meeting Simplastic’s requirements.
➢ Production and Service Provision: Production activities are carried out under
controlled conditions with in-process inspections and verification.
➢ Release of Products: Final inspection and testing are performed before dispatch to
ensure all quality standards are met.
➢ Control of Nonconforming Output: Any nonconforming material or product is
identified, segregated, and handled as per the nonconformance procedure, ensuring it
doesn’t reach the customer.
➢Takeaway
Through this exercise, I understood how the ISO 9001:2015 Quality Management
System framework is applied within an organization.
By creating process maps, defining responsibilities, and linking activities with
measurable indicators, I learned how every department contributes to overall quality
objectives.
This practical understanding helped me connect theoretical ISO concepts with
real-world operations, emphasizing the importance of process-based management,
continual improvement, and customer satisfaction.
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