AN OVERVIEW OF ISO
ISO is the International organization for
standardization founded in 1946 to promote
the development of the standards and related
activities to facilitate exchange of goods and
services worldwide.
ISO is composed of member body from over
130 countries including Indian member body
being Bureau of Indian Standards (BIS).
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AN OVERVIEW OF ISO 9001
Published in 1987
Current Version is ISO 9001:2008
Generic In Nature
Applicable to All Types of Business
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AN OVERVIEW OF ISO 9001
ISO 9000 Family
ISO 9000:
Quality Management Systems
ISO 9001:
Quality Management Systems-Requirements
ISO 9004:
Quality Management Systems Guidelines for
performance improvements.
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ISO 9001:2008- AN OVERVIEW
Points to Consider
ISO 9001 does not say how to do, it only says What
to do
Activities to be viewed from the Assurance point
of view.
Assurance should be felt by the internal / external
customer.
Look at the system adopted by you and verify whether
assurance is provided.
Any system should provide consistency, level of
performance and integration.
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ISO 9001:2008- AN OVERVIEW
ISO 9001:2008 has adopted process
approach and has a focus on
Customer Satisfaction
Measurement and Analysis
Resource Management
Continual Improvement
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ISO 9001:2008- AN OVERVIEW
Quality Management Principles
1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to Management
6. Continual Improvement
7. Factual Approach to decision making
8. Mutual beneficial supplier relationship
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AN OVERVIEW OF ISO 9001
ISO 9001 has adopted process approach and
has a focus on:
PDCA Cycle
Management Commitment
Customer Satisfaction
Monitoring and Measurement Analysis
Resource Management
Corrective & Preventive Action
Continual Improvement
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ISO 9001:2008 STANDARD
PDCA MODEL APPLIED TO QMS PROCESSES
PLAN
Establish the
QMS
Customer Customer
Requirem Satisfacti
ents Implement Development , Maintain on
DO & Operate
the QMS
Maintenance &
Improvement
&
improve ACT
Cycle QMS
Inputs Monitor & Products / Services
Review QMS
CHECK
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AN OVERVIEW OF ISO 9001
PLAN
Develop a plan for each activity
Establish Policy
Define Objectives
Identify and provide resources
Define Organization Structure & Responsibilities
DO
Show commitment
Communicate the importance of customer requirements
Deploy policy throughout Organization
Define measurable objectives
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AN OVERVIEW OF ISO 9001
CHECK
Is the system working for the Organization?
Are the set objectives are being met?
Do the people are following the framed policy?
Are the customers satisfied?
What is performance of the business?
Is there any plan that could affect the system?
ACT
Identify areas for continual improvement
Identify and provide any resources, if required
Re-organize
Convert non-believers / non-performers
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AN OVERVIEW OF ISO 9001
Process approach implementation
Identify the processes
Identify the input & output
Identify the process owner
Identify the customer
Identify the customers & business requirements and expectations
Identify the measurable for the process in line with the above
steps
Identify the interlinking processes
Reference any current documentation available for the process
Document the process (Process mapping recommended for
clarity)
Focus on continual improvement of the process
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BENEFITS OF SYSTEM IMPLEMENTATION
It ensures that only the right quality material / service will enter in the
premises to undergo full quality operation cycle and leaves the premises
with right quality parameters.
It gives due emphasis to controlled conditions including skills needed, good
maintenance of process equipments, utilities, work environment and
calibration of control equipments
It provides a sound base for creating a system, which builds the most
appropriate work methods and work norms.
It ensures that qualities ascribed to finished products do not become
accidental or incidental to the process but are conscientiously built by the
following a systematically streamlined process
Prevention of occurrence of non-conformances and elimination of cause of
errors
Continual improvement in the effectiveness of the system
Better alignment of activities towards achieving customer satisfaction
Consideration of compliance on statutory and regulatory requirements
Professional quality image and excellent chances for participating in tenders
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ISO 9001:2008-
Quality management System -
REQUIREMENTS
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ISO 9001:2008 STANDARDS REQUIREMENTS
4. QUALITY MANAGEMENT SYSTEM
4.1 General Requirements
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of documents
4.2.4 Control of Records
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ISO 9001:2008 STANDARDS REQUIREMENTS
5. MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
5.2 Customer focus
5.3 Quality Policy
5. 4 Planning
5.5 Responsibility , Authority & Communication
5.6 Management Review Control of Records
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ISO 9001:2008 STANDARDS REQUIREMENTS
6. RESOURCE MANAGEMENT
6.1 Provision of Resources
6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment
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ISO 9001:2008 STANDARDS REQUIREMENTS
7. PRODUCT REALIZATION
7.1 Planning of product realization
7.2 Customer related processes
7.3 Design & development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of measuring & monitoring devices
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ISO 9001:2008 STANDARDS REQUIREMENTS
8. MEASUREMENT, ANALYSIS & IMPROVEMENT
8.1 General
8.2 Monitoring & Measurement
8.3 Control of non-conforming product
8.4 Analysis of data
8.5 Improvement
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ISO 9001:2008 STANDARDS REQUIREMENTS
MANDATORY DOCUMENTED PROCEDURES
4.2.3 Control of documents
4.2.4 Control of records
8.2.2 Internal Audits
8.3 Control of nonconforming product
8.5.2 Corrective action
8.5.3 Preventive action
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ISO 9001:2008- DOCUMENTATION
4.2.1 DOCUMENTATION REQUIREMENTS - GENERAL
Documentation must include :
Quality policy & quality objectives
Quality manual
Documented procedures required by the standard
Documents needed by the organization to ensure
effective planning, operation & control of processes
Quality records
Extent of documentation may vary from
organization to organization
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ISO 9001:2008- DOCUMENTATION
4.2.2 QUALITY MANUAL
Must be established, maintained & include :
Scope of QMS
Details of exclusions claimed by the organization
Justification for the above exclusion
Documented procedures or reference to them
Description of the interaction between the QMS
processes
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ISO 9001:2008- DOCUMENTATION
4.2.3 CONTROL OF DOCUMENTS
Documented procedure to define controls needed:
During approval of documents for adequacy prior to issue
To review, update & re-approve the documents
To ensure that the changes & current revision status is
identified
To ensure that relevant versions are available at points of use
To ensure that the documents remain legible & identifiable
To ensure that documents of external origin identified & their
distribution controlled
To prevent unintended use of obsolete documents & to apply
suitable identification to them
All documents required by QMS must be controlled
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ISO 9001:2008- DOCUMENTATION
4.2.4 CONTROL OF RECORDS
The procedure must be documented for :
Identification,
Storage,
Retrieval,
Protection,
Retention time,
Disposition of quality records
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ISO 9001:2008- DOCUMENTATION
4.2.4 CONTROL OF RECORDS
The procedure must be documented for:
Identification,
Storage,
Retrieval,
Protection,
Retention time,
Disposition of quality records
The records must be :
Legible,
Readily identifiable,
Retrievable
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ISO 9001:2008- DOCUMENTATION
8.2.2 INTERNAL AUDIT
The organization to conduct internal audits at planned
intervals to determine whether the QMS conforms :
To the planned arrangements,
To the requirements of international standard,
To the QMS requirements established
To ensure QMS is effectively implemented & maintained
Audit Programme to be planned based on status & importance
of the processes & previous audit results
Audit criteria, scope, frequency & methods to be defined
Selection of auditors to ensure objectivity & impartiality
Documented procedure to define responsibility & requirement
for planning, conducting audits, reporting audit results &
maintaining records
Actions on detected NCs without undue delay
Follow-up audits to be conducted
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ISO 9001:2008- DOCUMENTATION
8.3 CONTROL OF NON-CONFORMING PRODUCTS
When non conforming product and or service is detected after
delivery, or use has started, the organization is expected to
take actions appropriate to the consequences of the N.C.
Records of nature of N.C., subsequent action and concession
obtained
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ISO 9001:2008- DOCUMENTATION
8.5.1 CONTINUAL IMPROVEMENT
The organization is expected to have a formal
system for continual improvement of the QMS
through the use of:
Quality Policy
Management Reviews
Quality Objectives
Audit results
Data Analysis
Corrective actions
Customer Feedback
Preventive actions
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ISO 9001:2008- DOCUMENTATION
8.5.2 CORRECTIVE ACTION
Action taken to eliminate cause of a detected non-
conformity or other undesirable situation
There can be more than one cause of potential non-conformity
Corrective action is taken to prevent recurrences
There is a distinction between correction and corrective action
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ISO 9001:2008- DOCUMENTATION
8.5.2 PREVENTIVE ACTION
Action to eliminate the cause of a potential non-
conformity or other undesirable potential situation
There can be more than one cause of potential non-
conformity
Preventive action is taken to prevent occurrences
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THANK YOU
FOR
YOUR ATTENTION
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