Quality Assurance and Quality Management concepts

BP606T
Unit-1
Part-V
(ISO9000 &ISO14000: OVERVIEW, BENEFITS, ELEMENTS STEPS FOR
REGISTRATION)

Snigdha Rani Behera

Associate Professor
ARKA JAIN UNIVERSITY
 ISO9000 &ISO14000
Definition:
 The International Organization of Standardization (ISO) is a worldwide federation
consisting of member bodies from127countries, which promotes the development of
international manufacturing, trade and communication standards.
 The ISO 9000 family of standards is related to quality management systems and
designed to help organizations ensure that they meet the needs of customers and
other stakeholders while meeting statutory and regulatory requirements.
 The first ISO Standards were published in 1987, which were revised in 1994 as ISO
9000:1994.
 The next and latest revision of ISO standards was released in 9000 & is therefore
referred as “ISO 9000:2000 STANDARDS”.

ARKA JAIN University, Jamshedpur, Jharkhand

Objective of ISO:
 The main objective of ISO is to facilitate international trade by providing a single
internationally accepted set of standards for everybody’s references.
 ISO 9000 currently has three quality standards
1. ISO 9000:2005
2. ISO 9001:2015
3. ISO 9004:2000
Benefits of ISO:
 It is only a base line model for quality assurance, it raises the confidence of the
third party dealing with the registered unit.
 Provides senior management with an efficient management process.
 Suitable for both small and large organizations.
 Communicates a positive message to staff and customers.

ARKA JAIN University, Jamshedpur, Jharkhand

Cont…..
 Identifies and encourages more efficient and time saving processes.
 Better internal management.
 Less wastage.
 Increase in efficiency, productivity and profit.
 Improved customer retention and acquisition.
 Consistent outcomes, measured and monitored.
 Globally recognized standard, marketing opportunities.
 Marketing opportunities.

ARKA JAIN University, Jamshedpur, Jharkhand

Elements of ISO 9000:
1. Management Responsibility: Management sets the company quality policy
and implements it by providing resources, personnel and training.
2. Quality System: A Quality System comprised of a Quality Manual and
supporting procedures is created and maintained.
3. Contract Review: Contracts reflect the customer’s needs and expectations.
Products and services provided must comply with those requirements.
4. Design Control: Engineering drawings and design changes are carefully
documented to ensure that changes have been fully coordinated and approved
internally.
5. Document Control: The creation and modification of documents supporting
the quality system is strictly controlled by ISO 9001 procedures.
6. Purchasing: Purchasing procedures describe supplier requirements and the
system for ensuring compliance to these standards.

ARKA JAIN University, Jamshedpur, Jharkhand

7. Handling of Purchaser: Purchasing procedures describe supplier requirements
and the system for ensuring compliance to these standards.
8. Product identification and Traceability: Methods of tracking date and lot
codes of product and raw materials from start to finish.
9. Process Control: Work instructions, quality plans and workmanship standards
verify that each job is being done correctly.
10. Inspection and Testing: Inspection and Testing at receiving of raw materials, in
process and final inspection areas ensures quality.
Test and inspection records are preserved as part of the quality system.
11. Inspection measuring and Test equipment: Instruments and measuring tools
are calibrated regularly and records maintains.
12. Inspection and Test Status: Inspected materials may be used or process further.
13. Control of Nonconforming Product: Materials or products that fail to meet
specifications are rejected and separated from normal production.
ARKA JAIN University, Jamshedpur, Jharkhand
14. Corrective action: The corrective action system focuses on identifying the root
cause of quality concerns and any corrective action required.
15. Handling, Storage, Packaging and Delivery: Procedures outline practices that
protect products from damage during manufacturing and shipping.
16. Quality Records: Quality records provide an audit trail for internal and external
auditors.
17. Internal Quality Audits: Specially trained teams verify that the Quality System is
working by evaluating the same 20 elements required by the external auditors, on
an on-going basis.
18. Training: Training records are maintained for every employee showing their levels
of expertise.
19. Servicing: Servicing is specified in the contract, procedures are established to
verify that servicing meets the indicated requirements.
20. Statistical Techniques: Control charts, graphs and other methods of analysis
determine how well a process is working and facilitate continuous improvement.
ARKA JAIN University, Jamshedpur, Jharkhand
Steps for ISO Certification:
 Pre-Requisite to ISO Certification process
a. Choosing the type of ISO Certification.
 Various types of ISO certification available such as
1. ISO 9001 2008– Quality Management
2. ISO 14001-- Environmental Management
3. ISO 27001 -- Information security Management
4. ISO 22008 – Food Safety Management and so on.
b. Choosing an ISO Certification Body
 It is very important to choose recognized and credible certification body
 When choosing the ISO registrar, should follow following points
1. Evaluate several ISO certification service providers.
2. Check if they are following the CASCO standards.(CASCO is the ISO committee)
3. Check weather it is accredited or not.

ARKA JAIN University, Jamshedpur, Jharkhand

Process for ISO Certification in India
a. Create an application/ contract:
 The applicant and the registrar should agree on a contract.
 This contract usually defines rights and obligations of both parties and includes
liability issues, confidentiality, and access rights.
b. Quality Documents Review:
 The ISO auditor will view all the quality manuals and documents related to
various policies and procedures being followed in the organization.
 ISO auditor to identify the possible gaps against the requirements stipulated in
the ISO standards.
c. Make an action Plan:
 After the ISO auditor communicates the existing gaps in the organization, then
the organization should prepare an action plan to eliminate these gaps.

ARKA JAIN University, Jamshedpur, Jharkhand

d. Initial Certification Audit:
 The initial certification audit is divided in to Two categories
1. Stage1 2. Stage 2
Stage-1:
 The ISO auditor will audit the changes made by the organization.
 Then they will try to identify the possible non-conformities in the systems and
procedures to the desired quality management system.
Stage 2
 After all the required changes are done in the organization, the ISO auditor does
the final auditing.
 The auditor will check whether all the non-conformities have been eliminated
or not as per ISO quality standards, if the ISO auditor is satisfied, they will
prepare the final ISO audit report and forward it to registrar.
e. Completing the ISO Certification:
 After all non-conformities are addressed and all the findings are put in the ISO
audit report, the registrar will grant you the ISO certification.
ARKA JAIN University, Jamshedpur, Jharkhand
f. Surveillance Audits:
 Surveillance audit is basically conducted to ensure that ISO quality standards are
being maintained by the organization
 It is conducted from time to time.

ARKA JAIN University, Jamshedpur, Jharkhand

 ISO14000
Definition:
 ISO 14000 is a family of standards related to environmental management that
exists to help organizations
 (a) Minimize how their operations (processes, etc.) negatively affect the
environment (i.e. cause adverse changes to air, water, or land).
 (b) Comply with applicable laws, regulations, and other environmentally
oriented requirements.
 (c) Continually improve in the above.
 The ISO 14000 series of standards was introduced in 1996 by the ISO and most
recently revised in 2015.

ARKA JAIN University, Jamshedpur, Jharkhand

 The ISO 14000 family of standards is developed by ISO Technical Committee
ISO/TC207 and its various subcommittees.
 ISO 14000: standards and practices can be applied to any organization, regardless
of size or industry.
 ISO 14001: 2015 Environmental management systems - Requirements with
guidance for use.
 ISO 14004: 2016 Environmental management systems - General guidelines on
implementation.
 ISO 14005: Environmental management systems - Guidelines for a flexible
approach to phased implementation.
 ISO 14006: 2011 Environmental management systems - Guidelines for
incorporating eco-design.
 ISO 14015: 2001 Environmental management - Environmental assessment of sites
and organizations (EASO).

ARKA JAIN University, Jamshedpur, Jharkhand

 ISO 14020:2000 to 14025: 2000 Environmental labels and declarations- General
Principles
 ISO/NP 14030: Green bonds -- Environmental performance of nominated projects
and assets; discusses post-production environmental assessment
 ISO 14031: 2013: Environmental management - Environmental performance
evaluation - Guidelines
 ISO 14040: 2006 to 14049: 2006: Environmental management - Life cycle
assessment discusses pre-productive planning and environment goal setting
 ISO 14050: 2009: Environmental management - Vocabulary; terms and definitions
 ISO/TR 14062: Environmental management - Integrating environmental aspects into
product design and development
 ISO 14063: 2006: Environmental management - Environmental communication -
Guidelines and examples

ARKA JAIN University, Jamshedpur, Jharkhand

 ISO 14064: 2006:Greenhouse gases; measuring, quantifying, and reducing green
house gas emissions.
 ISO 14090: 2019: Adaptation to climate change — Principles, requirements and
guidelines.
Benefits of ISO 14000:
 It is sign of a commitment to the environment, which can be used as a marketing
tool for companies.
 It also help companies meet certain environmental regulations.
 To sell products to companies that use ISO 14000- certified suppliers.
 Companies and customers may also pay more for products that are considered
environmentally friendly.
 Satisfies investor criteria.
 Improve industry- government relations.
ARKA JAIN University, Jamshedpur, Jharkhand
Elements of ISO 14000:
1. Environmental policy: Develop a statement of organization’s commitment to
the environment. Use this policy as a framework for planning and action.
2. Environmental aspects: Identify environmental attributes of the products,
activities and services.
3. Legal and other requirements: Identify and ensure access to relevant laws
and regulations.
4. Objectives and Targets: Establish environmental goals for the organization,
in line with the policy, environmental impacts, views of interested parties and
other factors.
5. Environmental management program: Plan actions to achieve objectives
and targets.
6. Structure and responsibility: Establish roles and responsibilities and provide
resources.

ARKA JAIN University, Jamshedpur, Jharkhand

6. Training, awareness and competence: Ensure that the employees of the
organization are trained and capable of carrying out their environmental
responsibilities.
7. Communication: Establish processes for internal and external communications
on environmental management issues.
8. EMS documentation: Maintain information on your EMS and related
documents.
9. Document control: Ensure effective management to procedures and other
system.

ARKA JAIN University, Jamshedpur, Jharkhand

 THANK YOU
STAY SAFE
&
STAY HEALTHY
ARKA JAIN University, Jamshedpur, Jharkhand