IS0-9000

(Quality Management System- QMS)

Unit IV:Chapter 11: Quality Control:
Importance of quality; Elements of quality; Organization for quality control; Quality
assurance techniques; Documentation; Quality control circles; Total quality management;
ISO – 9000.

1. About ISO:

 International Organisation of Standardization

 Develops and Publishes standards
 Independent, Non Governmental International organization
 Has central Secretariat located in Geneva, Switzerland
 Derived from Greek ISOS meaning equal.Whatever the country, whatever the
language, we are always ISO
 Facilitate –International coordination and unification of Industrial Standards
 Published 22598 International Standards and related Documents, Covering almost
every industry, from technology to food safety, to agriculture and Healthcare
 It impact everyone,everywhere
 International Organization for standardization would have different acronyms in
different languages(IOS in English, OIN-Organisation Internationale de
normalisation- in French
 The ISO 9000 family of standards is the same across the globe even though they are
called by different names. Each member country has their own entity authorized
by ISO to manage the standards, but they are all the same exact ISO 9000 quality
documents.

 ISO story began in 1946 when delegates from 25 countries met at the Institute of Civil
Engineers in London and decided to create a new international organisation to facilitate
internation coordination
 On 23 February 1947 the new organization, ISO, officially began operations
 over the years has established itself in the global economy having been adopted in over 178
countries with over one million registrations

2. About ISO 9001

 There are several different documents in the ISO 9000 family of standards,
but ISO 9001 is the only standard in the 9000 series that requires certification

 ISO 9001 is the international standard for a quality management system

(“QMS”).  In order to be certified to the ISO 9001 standard, a company must
follow the requirements set forth in the ISO 9001 Standard.
 The current version is ISO 9001:2015, which was published in September of
2015 (thus the: 2015).
  “ISO 9001 Certified” means an organization has met the requirements in ISO
9001, which defines an ISO 9001 Quality Management System (QMS).  ISO
9001 evaluates whether your Quality Management System is appropriate and
effective, while forcing you to identify and implement improvements

3.About ISO 9001-Timeline

ISO9001-1980- Technical Committee 176 formed

IS9001-1987- First Edition

ISO9001-1994- First Minor Revision

ISO9001-2000- First Major Revision

ISO9001-2008- Second Minor Revision

ISO9001-2015-Second Major Revision

4. Salient Features of ISO 9001

a) It does NOT matter what size your organization is: 1 person or 1 million people.  ISO
9001 Implementation for Small Businesses
b) It does NOT matter what industry you are in (service or manufacturing) – it can be a
restaurant, consultancy, manufacturing company, government entity, etc. There are
other standards based upon ISO 9001 for a few specific industries.
c) It is NOT a standard for products. It does not define product quality.  This is a process-
based standard: you use it to control your processes, then your end product should
meet the desired results.
d) It is NOT a personal Standard – a person cannot get certified to ISO 9001, instead an
organization or company becomes certified. Individuals, however, CAN become an
ISO 9001 Certified Lead Auditor after a 5 days training course.  This then allows them
to audit other companies.
e) There is no such thing as “ISO Certification” or “ISO 9000 Certification”, only
ISO 9001 certification.
f) It is NOT a membership group – An organization cannot “join” ISO 9001. To become
ISO 9001 certified, Any organization must
i. Follow the steps to implement an ISO 9001 quality management system.
ii. Then a Certification Body (CB or Registrar) audits the performance of your
organization against the latest version of the ISO 9001 Requirements. If you
pass this audit, the Registrar issues an ISO 9001 Certificate demonstrating
 that your organization is Registered to ISO 9001 for a three year period.
( Who is able to grant certification)
iii. Finally, the organization must be re-certified every three years in order to
maintain their ISO 9001 certification status.
5.ISO 9000 VS. 9001
S.NO ISO 9000 ISO 9001
1 a series, or family, of quality a standard within the family
management standards
2 The ISO 9000 family of standards ISO 9001 is the only standard
also contains an individual standard within the ISO 9000 family to
named ISO 9000 which organizations can
certify is,
 6.ISO 9000 Quality Management Principles

1. Customer focus
o Understand the needs of existing and future customers
o Align organizational objectives with customer needs and expectations
o Meet customer requirements
o Measure customer satisfaction
o Manage customer relationships
o Aim to exceed customer expectations
o Learn more about the customer experience and customer satisfaction
2. Leadership
o Establish a vision and direction for the organization
o Set challenging goals
o Model organizational values
o Establish trust
o Equip and empower employees
o Recognize employee contributions
o Learn more about leadership
3. Engagement of people
o Ensure that people’s abilities are used and valued
o Make people accountable
o Enable participation in continual improvement
o Evaluate individual performance
 o Enable learning and knowledge sharing
o Enable open discussion of problems and constraints
o Learn more about employee involvement
4. Process approach
o Manage activities as processes
o Measure the capability of activities
o Identify linkages between activities
o Prioritize improvement opportunities
o Deploy resources effectively
o Learn more about a process view of work and see process analysis
tools
5. Improvement
o Improve organizational performance and capabilities
o Align improvement activities
o Empower people to make improvements
o Measure improvement consistently
o Celebrate improvements
o Learn more about approaches to continual improvement
6. Evidence-based decision making
o Ensure the accessibility of accurate and reliable data
o Use appropriate methods to analyze data
o Make decisions based on analysis
o Balance data analysis with practical experience
o See tools for decision making
7. Relationship management
o Identify and select suppliers to manage costs, optimize resources, and
create value
o Establish relationships considering both the short and long term
o Share expertise, resources, information, and plans with partners
o Collaborate on improvement and development activities
o Recognize supplier successes
o Learn more about supplier quality and see resources related
to managing the supply chain

7.Benefits of ISO 9001:2015 quality management system 

The 10 benefits of ISO 9001:2015 quality management system are:
1. Increased Efficiency: The companies have done extensive researches on
the processes they are following, how to maximize quality and efficiency before
going through the ISO 9000 series Quality Management Standards certification
process. Once they achieve certification, the processes are established. There
are guidelines which can be easily followed by anyone, making it easy to
provide training, transitions and even for troubleshooting purpose. 
2. Increased Revenue: It has been observed that ISO QMS certified companies
have shown improvements in the field of productivity, financial performance as
compared to the uncertified ones.
3. Employee Morale: The staff is more satisfied and motivated once there are
defined roles and responsibilities, accountability of management,
established training procedure and a well-defined picture of how the roles of the
employees affect quality and overall success of the company.
4. International Recognition: The International Organization for
Standardization (ISO) is recognized worldwide as the authority on quality
management.
5. Factual Approach to Decision Making: The ISO9000 QMS standard sets
out clear instructions regarding audits and process reviews. This helps in
information gathering and decision making based on data.
6. Supplier Relationships: ISO certification has been found beneficial
regarding supplier relationships. The documentation and testing procedures
help to ensure the quality of the raw materials used for production purpose. This
also helps in properly evaluating a new supplier before changing suppliers.
There is a procedure to check consistency with respect to how and where
orders are placed.
7. Documentation: Since the ISO QMS standard requires
proper documentation of all processes, and changes made, errors or
discrepancies, it helps mitigate problems, and provides stability. The staff is also
more accountable. Documentation also guarantees that traceable records are
available in case of non-compliant products or raw materials.
8. Consistency: Since all processes are documented, there is a minimum
scope of errors. Processes starting right from research and development,
covering production, shipping is well documented. Even any small change in
the process has to be documented ensuring that the changes are well planned
and implemented in the best possible way to ensure maximum efficiency.
9. Customer Satisfaction: Companies can gain the confidence of clients easily
because the ISO is a universally accepted standard. ISO9001 QMS certification
ensures efficiency, consistency and dedicated quality service by the companies
thereby ensuring the satisfaction of the customers.
10. Improvement Processes: The ISO 9000 QMS emphasizes on audit
processes, management review and improved processes based on collected
 data. Based on facts and using a system of documentation and
analysis, improvements are carefully planned and implemented. This ensures
that the best decisions are made for your company.

8.ISO 9000 family” or “ISO 9000 series

• The phrase “ISO 9000 family” or “ISO 9000 series” refers to a group of quality
management standards which are process standards (not product standards).
• ISO 9000 Quality management systems – Fundamentals and
Vocabulary, referenced in all ISO 9000 Standards.
• ISO 9001 Quality management systems – Requirements, contains
the requirements an organization must comply with to become ISO 9001
certified.
• ISO 9002 – Guidelines for the application of ISO 9001:2015
• ISO 9004 – Managing for the sustained success of an organization,
provides guidelines for sustaining QMS success through evaluation and
performance improvement.