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COURSE CONTENT
• What is Quality Management System
• What is the purpose of QMS
• What is ISO 9001 and related other
standards
• Basic Documentation of ISO 9001
 WHAT IS QUALITY MANAGEMENT SYSTEM?
Quality Management System is a written document which directs us
to achieve
• the companies quality policy,
• client requirements,
• regulatory requirements &
• quality product,
Through systematic approach and continual improvement in the
process, procedures and techniques,

It involves the documented guidelines , process procedures and

approved formats for processes, along with a technique for
continual improvement to achieve a better product,

Through which a customer will get belief of receiving a quality

product, on time delivery and reduced wastages .
PURPOSE OF QUALITY MANAGEMENT SYSTEM
• Achieving customer requirements
• Attaining customers confidence in our organizations activities towards
achieving the quality product
• Attracts more customers and increased sales
• Reduces the probable hurdles in the project by defining, controlling &
improving the process
• Reduce wastage of materials
• Do not allows mistakes to happen
• Saves time caused due to errors
• Encourages training activities for improved performances
• Determines the roles and responsible person for the process
• Ensure the procedures are correct and approved.
WHAT IS ISO 9001 AND RELATED OTHER
STANDARDS
ISO 9001 is the worlds most widely used Quality Management System
guidelines
It gives guidelines for a company to produce their own Quality Management
System.

Other Similar Standards

ISO 9000 Series (including ISO 9000 and ISO 9004),
ISO 14000 series (environmental management systems),
ISO 13485 (quality management systems for medical devices),
ISO 19011 (auditing management systems),
ISO/TS 16949 (quality management systems for automotive-related products).
 QUALITY MANAGEMENT SYSTEM BASICS
The process approach is the key to an effective Quality Management System. It basically
means that every operation of the company must be observed as a process, meaning
you should identify all inputs, necessary resources, documents, activities, and outputs
from each operation.
Once you set up your system based on the processes, you will be able to monitor and
measure your processes, their effectiveness, and efficiency and improve them, which
is the reason why it is emphasized at the beginning of the implementation, before
going into any other details regarding the standard requirements
In simple terms, the process approach represents the concept of observing all operations
in the company as processes. This includes breaking the company down into its
processes, and determining their sequence, interaction, inputs, and outputs; as well as
identifying the processes in the company, which processes can start before other
processes are finished, resources and information needed to start the process, and
what results we expect from the process.
The best way to start implementing the process approach is to create a process map that
will include all processes in your company and their interconnections. For example,
the delivery process cannot be done before the production and sales process, and the
production cannot be done before the purchasing of raw materials. Once you create
this global process map and identify all the processes and their interrelations, you can
start defining your processes in terms of what are necessary inputs, what controls
need to be applied, and what are the outputs of the process. But this will be done
throughout the implementation; it doesn’t have to be done at once.
SAMPLE PROCESS FLOW CHART
 PLAN-DO-CHECK-ACT CYCLE
In order to have an effective management system a Plan –do-check-act cycle is carried out
TERMS AND DEFINITION – PAGE 1
It is very important to understand the terms and detentions used in the standard in
order to understand the standard requirements

Top management – An individual or group of individuals who coordinate and control an

organization at the highest level. In cases when the scope of the management system
covers just part of an organization, then top management refers to the individuals who
direct and control that part of the organization.
Organization – A person or group of people who has their own functions with
responsibilities, authorities, and relationships to achieve the objectives.
Context of the organization – A combination of internal and external factors that can
have an effect on purpose, objectives, performance, and sustainability of the
organization. Internal factors include values, culture, knowledge, and performance of
the organization. External factors include legal, technological, competitive, market,
cultural, social, and economic environment.
Interested party (stakeholder) – A person or organization that is involved in or perceives
itself to be affected by activities and actions taken by the organization. Interested
parties can be customers, suppliers, contractors, local community, government, etc.
Process – A sequence of activities that use inputs to deliver an intended result. For
example, the production process has several steps that must be conducted in the
appropriate sequence; inputs in this process are raw materials, product specifications,
and work instructions, while the outputs are the product, quality check report, etc.
TERMS AND DEFINITION –PAGE 2

Procedure – A defined way to execute an activity or a process. Procedures can be

documented or not.
Quality – Quality is the difference between a customer’s expectations and the customer’s
perception of the product or service that he received – the higher the difference, the
better perceived quality.
Nonconformity – The failure to meet a requirement.
Risk – Risk is the “effect of uncertainty on objectives,” and an effect is a positive or
negative deviation from what is expected. For example, the company plans to deliver
its products to the customers, but there is a risk of product nonconformity due to a
poorly controlled production process.
Effectiveness – The level of success in achieving or producing a desired result. For
example, the production process is effective if it is able to produce the products.

Documented information – Information required to be controlled and maintained by an

organization, and the medium on which it is contained. For example, the documented
policies, procedures, work instructions, and records represent documented
information.
 WHICH DOCUMENTS AND RECORDS ARE
REQUIRED?

Mandatory Documents

Required Documents Reference Clause

Scope of Quality Management System 4.3

Quality Policy 5.2

Quality Objectives and Plan 6.2

These are the documents and records that are required to be

maintained for the ISO 9001 Quality
Management System, but you should also maintain any other
records that you have identified as
necessary to ensure your management system can function, be
maintained, and improve over time.
Mandatory Records Reference Clause
Record of Maintenance and Calibration of Monitoring and
Measuring Equipment 7.1.5.1
Competence Records 7.2

Product/Service Requirements Review Record 8.2.3.2

Record of New Requirements for Product or Service 8.2.3.2

Design and Development Inputs Record 8.3.3

Record of Design and Development Controls 8.3.4

Design and Development Outputs Record 8.3.5

Record of Design and Development Changes 8.3.6

Record of Evaluation of External Provider (supplier) 8.4.1

Record of Product/Service Characteristics 8.5.1
Record of Changes on Customer’s Property 8.5.3

Record of Changes in Production/Service Provision 8.5.6

Evidence of Product/Service Conformity 8.6
Record of Nonconformity 8.7.2, 10.2.2
Monitoring Performance Information 9.1.1
Internal Audit Program and Results 9.2.2
Management Review Results 9.3
Nonconformities and Corrective Action 10.2.2
 COMMONLY USED NON-MANDATORY DOCUMENTS
Non-Mandatory Procedures ISO 9001 Clause
Determining Context of the Organization and Interested
Parties 4.1, 4.2

Procedure for Addressing Risks and Opportunities 6.1.

Competence, Training and Awareness Procedure 7.2, 7.3

Procedure for Control of Documents and Records 7.5

Sales Procedure 8.2
Procedure for Design and Development 8.3

Procedure for Control of Externally Provided

Processes,Products and Services (outsourced processes) 8.4.1

Procedure for Production and Service Provision 8.5

Warehousing Procedure 8.5.4

Procedure for Measuring Customer Satisfaction 9.1.2

Procedure for Internal Audit 9.2
Procedure for Management Review 9.3
Procedure for Nonconformity and Corrective Action 10.2
SAMPLE