The document discusses ISO 9000, an international standard for quality management systems that can help companies improve quality through establishing guidelines for quality assurance, control, and improvement. It provides an overview of the ISO 9000 series of standards, including the requirements for different standards, implementation steps to achieve certification, and benefits such as competitive advantage, consistency in quality, and increased productivity. Certification requires a third-party audit and registration through an approved registrar.

1. ANURAG COLLEGE OF PHARMACY WARTHI BHANDARA
Produce By
Rahul B. Rahangdale
Anurag college of Pharmacy
warthi
Guided By
Miss. Astha Yadav
Asst. prof.
Anurag College of Pharmacy

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• Quality is something every company strives for and is
often times very difficult to achieve. Complications
concerning efficiency and quality present themselves
everyday in business, whether an important document
cannot be found or a consumer finds a product not up to
their expectations. How can a company increase the
quality of its products and services?

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• ISO 9000 is set up as a collection of guidelines that help a
company establish, maintain, and improve a quality
management system. It is important to stress that ISO 9000 is
not a rigid set of requirements, and that organizations have
flexibility in how they implement their quality management
system. This freedom allows the ISO 9000 standard to be used
in a wide range of organizations, and in businesses large and
small.

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ISO stands for International Organizational for
Standardization. It is an international body which consists
of representatives from more than 90 countries. The
national standards bodies of these countries are the
member of this organization.
BIS(Bureau of Indian Standards) is the Indian
representatives to ISO.
ISO and IEC(International Electro Technical Commission)
operate jointly as a single.
These are NGO Which exist to provide common standard
on international trade of goods and services.
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ISO 9000 series has five international standards on quality
management which are listed below:
1. ISO 9000 - Guidelines for selection and use.
3. ISO 9002 - Quality system model for QA in Design,devl.
4. ISO 9003 -QSM for QA in final inspection .
5. ISO 10011 –Guidelines for auditing systems.
6. ISO 10012 – QA requirement for measuring equipment.
7. ISO 10013- Guidelines for developing quality manuals.

6. • QMP 1 - customer force
• QMP 2 - Leadership
• QMP 3- Engagement of people
• QMP 4 - Process approach
• QMP 5 - Improvement
• QMP 6 -Evidence based decision making
• QMP 7 – Relationship management

7. • Management Responsibility
• Quality system
• Order Entry
• Design Development
• Document and data control
• Purchasing
• Control of customer supplied
products
• Product Identification &
Tractability
• Process control
• Inspection & Testing control of
Inspection, Measuring &Test
Equipment
• Inspection & Test Status
• Control of Nonconforming pro.
• Corrective and Preventive action
• Handling storage, packaging, &
Delivery
• Quality control Record
• Internal Quality Audit
• Training
• Servicing
• Statistical Technique

8. • ISO 9001 – specifies various operating requirements in
such areas as product design and development,
production, and Installation stages.
• ISO 9002 – Concern with quality assurance at production
and installation stage.
• ISO 9003 – Testing and Inspection.

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Leadership demonstrates commitment to customer
requirements.
Policy and measurable quality objectives are set and
renewed.
Processes are identified, analyzed, and managed.
Customer satisfaction is measured.
Data are collected, analyzed, and used.
System effectiveness is continually improved.

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• The following are the steps in ISO 9000 registration:
1. Selection of appropriate standards from ISO 9001, ISO 9002, and ISO 9003
using guideline given is ISO 9000.
2. Preparation of quality manual to cover all the element in the selected
model.
3. Preparation of procedures and shop floor instruction which are used at
the time of implement the system. Also document these items.
4. Self-auditing to check compliance of the selected model.
5. Selection of a registrar and making application to obtain certificate for the
selected model.

11. • A registrar is an independent body with knowledge and
experience to evaluate any one of the three models of the
company’s quality system(ISO 9001, ISO 9002, ISO
9003). Registrars are approved and certified by
accreditors. As an example, RAB(Registrar Accreditation
Board) of USA is an accreditor of registrar in U.K.
• The registrar, on successful verification and assessment
will register the company before selecting a registrar,
• one should know the following:
1. Accreditors of the registrar.
2. Background and credibility of the registrar.
3. Cost of registration through the proposed registrar.
4. Expected harmony between the company and the 11
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• ISO 9000 series provides several tangible and intangible
benefits which are listed below:
a) This gives competitive advantage in the global market.
b) Consistency in quality, since ISO helps in detecting non-
conformity early which makes it possible to take corrective
action.
c) Document of quality procedures adds clarity to quality
system.
d) ISO 9000 ensures adequate and regular quality training for all
member of the organization.

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e) ISO helps the customer to have cost effective purchase
procedure.
f) The customer while making purchase from companies with
ISO certificate, need not spend much on inspection and
testing. This will reduce the quality cost and lead time.
g) This will help in increasing productivity.
h) This will aid to improved morale and involvement of
workers.
i) The level of job satisfaction would be more.

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