B.

PHARM- 6th semester

Quality Assurance- BP606T
ISO 9000 & ISO 14000

Harshita Mathur
ISF College of Pharmacy, MOGA

2/3/2022 ISF College of Pharmacy, MOGA 1

CONTENTS
1. Definition of ISO
2. ISO 9000
3. ISO 9000 Goals
4. ISO 9000 Registration Process

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 Introduction
• ISO 9000 is defined as a set of international
standards on quality management and
quality assurance developed to help
companies effectively document the quality
system elements needed to maintain an
efficient quality system. They are not
specific to any one industry and can be
applied to organizations of any size.

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 Contd..
• ISO 9000 can help a company satisfy its
customers, meet regulatory requirements,
and achieve continual improvement. It
should be considered to be a first step or the
base level of a quality system.
• ISO is a non governmental organization for
standardization establish in 1946 in Geneva.

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 ISO 9000
History
• ISO 9000 was first published in 1987 by the
International Organization for Standardization
(ISO). The standards underwent major
revisions in 2000 and 2008.
• The most recent versions of the standard, ISO
9000:2015 and ISO 9001:2015, were
published in September 2015.

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 Objective
• Achieve, maintain and seek to continuously
improvement in product quality.
• Provide confidence to internal management.
• Improve quality of operation.
• Provide confidence to customers.
• Provide confidence that quality system
requirement fulfilled.

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 Benefits
• Increased marketability.
• Reduced operational expenses.
• Better management control.
• Increased customer satisfaction.
• Improved internal communication.
• Improved customer service.
• Improved health, safety and reduction of
waste.

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 The ISO 9000:2000 revision had
five goals:
• Meet stakeholder needs
• Be usable by all sizes of organizations
• Be usable by all sectors
• Be simple and clearly understood
• Connect quality management system to
business processes

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Principles of Quality Management

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 ISO 9000:2015 principles of Quality
Management
• ISO 9000:2015 principles of Quality
Management
1. Customer focus:
• Understand the needs of existing and future
customers
• Align organizational objectives with customer
needs and expectations
• Meet customer requirements

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

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 ISO 9000 Series
• ISO 9000: Explains fundamental quality
concepts and provides guidelines for the
selection and application of each standard.
• ISO 9001: Model for quality assurance in
design, development, production, installation
and servicing.
• ISO 9002: Model for quality assurance in the
production and installation of manufacturing
system.

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 Contd..
• ISO 9003: Quality assurance in final inspection
and testing.
• ISO 9004: Guidelines for applications of
standard in quality management and quality
system.

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 Steps in ISO 9000 Registration
Process
1. Identification of Key drivers:
• First step involves formal identification and
review of key drivers at a senior management
level for implementing a QMS.
• Such drivers should include improved
awareness of the performance of your key
processes and the need for continual
improvement.

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 Contd..
2. Obtaining the standard:
• Purchase a copy of the standard, search the
web for links to ISO 9000 relating to your
particular sector.
• Make sure you know the facts from the myth.
For example ISO 9000 is applicable to any
organization in any industry.

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 Contd..
3. Defining Strategy:
• For successful implementation of QMS,
commitment is required from senior
management on defining the strategy.
• Start from formal documents, quality policy
and then objective following the requirements
given in ISO 9000.
• Ensure the requirements of quality policy are
measurable to be able to demonstrate
continuous improvement.
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 Contd..
4. Planning and availability of resource for
developing the QMS:
• The required resource need to be made
available and realistic timelines allocated
ensuring that responsibilities are shared
within the organization and not just allocated
to the quality manager.
• As the system is developed, this plan should
be reviewed by the senior management and
kept updated.
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 Contd..
5. Understanding the Processes:
• It involves formally describing the interaction
between the processes within the
management system.
• This can be achieved by a simple process map
specific to organization.
• This map should identify the key processes
and also indicate the resources, controls,
documentation and records needed to meet
customer requirements.
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 Contd..
• Ensure that the process map is validated
throughout your business also ensure that
area or interactions are missed.
• As the system is developed this process map
should be used, reviewed and updated for its
eventual inclusion in the quality manual.

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 Contd..
6. Determining the training needs:
• ISO 9000 requires proper identification of
competence requirements for employees
coming within the scope of QMS.
• Team leaders, employees and internal auditors
will all need to meet the requirements of
competence, sometimes requiring external
training.
• Workshops and seminars should be available
there to meet these needs.
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 Contd..
7. Developing management system
documentation:
• ISO 9000 requires controlled documentation
of a policy, manual and procedure as well as
certain records.
• Certification requires documented procedure,
there are 6 documented procedures
specifically required by ISO 9000 as well as
those needed and identified by the
organization.
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 8. Implementing QMS
• Proper implementation of the requirements of
your QMS should be measured and recorded
by internal audits.
• A management review must also be
conducted to ensure the system’s continuing
suitability, adequacy and suitability.
• Any corrective and preventive actions should
be identified, progressed and recorded.

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 9. Pre-Assessment Audit
• A pre-assessment audit or gap analysis by
intended certification body will help in
identifying any gaps that exit between the
requirement of the standard and organization
existing process.
• The audit can be carried out any stage and is
independent of the certification process.

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 10. Certification
• Initial certification is 2 stage process.
• The stage 1 process is on site documentation
and readiness review at head office and
accreditation certificate will be awarded on
stage 2 audit.
• Forward planning and early dialogue with
certification body is important.

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 ISO 14000
• ISO 14000 is defined as a series of
international environmental management
standards, guides, and technical reports. The
standards specify requirements for
establishing an environmental management
policy, determining environmental impacts of
products or services, planning environmental
objectives, implementing programs to meet
objectives, and conducting corrective action
and management review.
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 History
• The first environmental management system
standard, BS 7750, was published in 1992 by
the BSI group.
• In 1996, the International Organization for
Standardization (ISO) created the ISO 14000
family of standards.
• ISO 14001 underwent revision in 2004.
• The current revision of ISO 14001 was
published in September 2015.

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 ISO 14000 Series
• ISO 14001: Environmental Management System –
Specification with guidance for use.
• ISO 14004: Environmental Management System –
General guidance on Principles, system and
supporting technique
• ISO 14010: Guidelines for environmental Auditing –
General principles of environmental auditing
• ISO 14011: Guidelines for environmental Auditing –
Audit procedure- Part 1: Auditing of Environmental
Management System
• ISO 14012: Guidelines for environmental Auditing –
Qualification criteria for auditor
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