• Introduction

• Need for Quality Management System

• Requirements of ISO 9001:2015,
Documentation
• Benefits of ISO certification
• Management System Audit
• Standard for managing audit
• ISO 19011:2011
• Certification bodies
 QUALITY MANAGEMENT SYSTEM
• A quality management system (QMS) is
defined as a formalized system that documents
processes, procedures, and responsibilities for
achieving quality policies and objectives.
• A QMS helps coordinate and direct an
organization’s activities to meet customer and
regulatory requirements and improve its
effectiveness and efficiency on a continuous
basis.
• The International Organization for Standardization (ISO) is an
international non-governmental organization made up of
national standards bodies; it develops and publishes a wide
range of proprietary, industrial, and commercial standards and
is comprised of representatives from various national standards
organizations.

• ISO 9001:2015, the international standard specifying

requirements for quality management systems, is the most
prominent approach to quality management systems.

• While some use the term "QMS" to describe the ISO 9001
standard or the group of documents detailing the QMS, it
actually refers to the entirety of the system.
Benefits Of Quality Management System

• Meeting the customer’s requirements, which

helps to instill confidence in the organization,
in turn leading to more customers, more sales,
and more repeat business
• Meeting the organization's requirements,
which ensures compliance with regulations and
provision of products and services in the most
cost- and resource-efficient manner, creating
room for expansion, growth, and profit.
 These benefits offer additional advantages, including:

• Defining, improving, and controlling processes

• Reducing waste
• Preventing mistakes
• Lowering costs
• Facilitating and identifying training opportunities
• Engaging staff
• Setting organization-wide direction
• Communicating a readiness to produce consistent
results
Need Of a Quality Management System

• The organization’s quality policy and quality

objectives
• Quality manual
• Procedures, instructions, and records
• Data management
• Internal processes
• Customer satisfaction from product quality
• Improvement opportunities
• Quality analysis
Establishing and implementing a Quality Management System

• Design
• Build
• Deploy
• Control
• Measure
• Review
• Improve
1.1 General
1.2 Application
2 Normative Reference

3 Terms and Definitions

4 Quality Management system

4.1 General requirements
4.2 Documentation requirements
5 Management Responsibility
7 Product Realization
5.1 Management Commitment
7.1 Planning of Product Realization
5.2 Customer Focus
7.2 Customer related processes
5.3 Quality Policy
7.3 Design and Development
5.4 Planning
7.4 Purchasing
5.5 Responsibility, Authority &
7.5 Production and service Provision
Communication
7.6 control of monitoring and measurement equipment
5.6 Management Review
8 Measurement, Analysis and Improvement
6 Resource Management 8.1 General
6.1 Provision of Resources 8.2 Monitoring and Measurement
6.2 Human Resources 8.3 Control of Non-conforming Product
6.3 Infrastructure 8.4 Analysis of data
6.4 Work Environment 8.5 Improvement
Quality Management System Model
 Documentation
The QMS documentation can consist of
different types of documents.
Usually, it includes documents such as the
Quality Policy, Quality Manual, procedures,
work instructions, quality plans, and records.
The QMS documentation can be represented as
a hierarchy, as shown in the diagram below:

Define what
will be done

• Quality Policy
Why stated once • Quality Objectives
• Quality Manual
• Procedures
• Work Instructions Who
• records When
How Where

Evidence
 Benefits Of ISO 9001 Certification
• Suitable for both small and large organizations
• Better internal management
• Less wastage
• Increase in efficiency, productivity and profit
• Improved customer retention and acquisition
• Consistent outcomes, measured and monitored
• Globally recognized standard
• Compatible with other ISO standards
• Minimizes mistakes
• Improves reporting and communications
• Better quality products and service
• More reliable production scheduling and delivery
• Standards maintained by annual assessments
 Quality audit
• Quality audit is the process of systematic examination of a
quality system carried out by an internal or external quality
auditor or an audit team.

• Quality audits are typically performed at predefined time

intervals and ensure that the institution has clearly defined
internal system monitoring procedures linked to effective
action.

• This can help determine if the organization complies with

the defined quality system processes and can involve
procedural or results-based assessment criteria
 Types of Audits
• A first-party audit
– It is performed within an organization to measure its strengths and weaknesses against its own
procedures or methods and/or against external standards adopted by (voluntary) or imposed
on (mandatory) the organization.
– A first-party audit is an internal audit conducted by auditors who are employed by the
organization being audited but who have no vested interest in the audit results of the area
being audited.

• A second-party audit
– It is an external audit performed on a supplier by a customer or by a contracted organization
on behalf of a customer. A contract is in place, and the goods or services are being, or will be,
delivered. Second-party audits are subject to the rules of contract law, as they are providing
contractual direction from the customer to the supplier.
– Second-party audits tend to be more formal than first-party audits because audit results could
influence the customer’s purchasing decisions.

• A third-party audit
– It is performed by an audit organization independent of the customer-supplier relationship
and is free of any conflict of interest.
– Independence of the audit organization is a key component of a third-party audit. Third-party
audits may result in certification, registration, recognition, an award, license approval, a
citation, a fine, or a penalty issued by the third-party organization or an interested party.
 Categories of Audit
• The American Society for Quality identifies
three categories of audit: a process audit, a
product audit, and a system audit.
• Product Audit: Product audit is an evaluation and qualification
method of a product, to validate whether it is conform to all
specified requirements (both internal and customer), and
fulfilling its purpose.

• System Audit: A system audit is what most people are familiar

with because this inspection activity strives to determine
conformity or nonconformity with established standards.

• Process Audit: A process audit is a highly focused inspection

of internal systems, processes and organizations. Process
audits are more than just product tracing, sampling and
measurements. The purpose of process audits is to limit the
assessment focus to specific procedures, routines or
specifications used in a designated business area, unit or
department.
 Management System Audit
• A quality management system audit evaluates an existing quality management
program to determine its conformance to company policies, contract
commitments, and regulatory requirements.
or
• A quality management system audit evaluates an organization's existing quality
management system (QMS) to ascertain its conformance with company policies,
contract commitments, and regulatory requirements.

• Audits are part of a company’s operation and, if required, certification of a

management system. The standards to be respected during an audit are defined in
the specific requirements criteria.
 Standard for managing audit
• ISO 19011 is defined as the standard that sets forth
guidelines for auditing management systems.

• The standard contains guidance on managing an audit

program, the principles of auditing, and the evaluation of
individuals responsible for managing the audit programs.

• An audit program consists of the arrangements made to

complete all of the individual audits needed to achieve a
specific purpose.
 ISO 19011:2011
• ISO 19011:2011 provides guidance on auditing management systems,
including the principles of auditing, managing an audit programme and
conducting management system audits, as well as guidance on the
evaluation of competence of individuals involved in the audit process,
including the person managing the audit programme, auditors and audit
teams.

• ISO 19011:2011 is applicable to all organizations that need to conduct

internal or external audits of management systems or manage an audit
programme.

• The application of ISO 19011:2011 to other types of audits is possible,

provided that special consideration is given to the specific competence
needed.
 Certification bodies
• Certification bodies are organizations that provide an assessment based
around the chosen standard of an company e.g. ISO 9001, ISO 14001, ISO
45001 etc.

• The certification body will award a certificate to the organization to show that
they comply once they have achieved the requirements set out in the standard.

•Bureau Veritas.
•Tuv Nord.
•TuvSud.
•BSI (British Standards Institution)
•TuvRheinland.
•Intertek.
 Role of Certification bodies
• Certification is the process of providing assurance
that an organization complies with a set of
requirements (e.g., an ISO standard).
• A certification body is an independent third party
responsible for the process of certification.
• Organizations use certification bodies in order to
obtain independent recognition.
 Benefits of Certification
External Benefits Internal Benefits
• Logos increases the stature of the • Reduces production errors and leads to a
company an the market to enlarge reduction in the necessary rectification
work.
customer base.
• Reduced warranty work leads to product
• Satisfies the larger businesses that reliability.
results in fewer customer audit. • Give the staff the opportunity to assist with
• Reduces hurdles to entering an the production of the system.
approved supplier list run by a • Fewer areas where errors could occur.
potential customer. • Staff will be better aware of their
responsibilities and the need to satisfy
• It will open international doors. customers.
• It is used as a sales and marketing • Reduced insurance premium.
tools. • Improvement in communication.
• Promote the customer to new • Provides opportunity for the management
customers. to introduce procedures and other
requirements.
 Cost of Certification
• Cost of Certification vary from one organization to
another, depending on various factors such as the size and
complexity of the organization.
• The cost of obtaining an ISO certification depends on the
number of employees and offices that the company has.
• Consultancy, training, certification fee(includes application
fee, audit fee, certificate or license fee) would be the
major areas of expenditure besides fee for calibration of
devices.
• The same cycle of fees is repeated during renewal every
three years.
Thank You