ISO – AWARENESS PROGRAM

18-08-2010

ISO Awarenes program

Expansion of ISO

 INTERNATIONAL ORGANISATION
FOR STANDARDIZATION

ISO Awarenes program

ROLE OF ISO

 ISO develops standards and guides

to encourage good practice in
accreditation and certification.

ISO Awarenes program

ISO is a network of the national standards institutes of
158 countries, one member per country, with a
Central Secretariat in Geneva, Switzerland, that
coordinates the system.

ISO Awarenes program

Why adopt ISO 9000?

 To comply with customers who require ISO

9000
 To sell in the European Union market
 To compete in domestic markets
 To improve the quality system
 To minimize repetitive auditing by similar and
different customers
 To improve subcontractors’ performance

ISO Awarenes program

DEFINITIONS:
 PRODUCT: Any intended output
resulting from the product realization

 Process: An activity or set or activities

using resources, and managed in order
to enable transformation of inputs into
outputs

ISO Awarenes program

Process approach
 Application of processes together with
identification and interactions of these
processes and their management to
produce desired outcome called process
approach.

ISO Awarenes program

Advantages of Process approach
 Understanding and meeting
requirements
 Need to consider process interms of
added value
 Obtaining results of process
performance and effectiveness
 Continual improvement of the process

ISO Awarenes program

ISO 9001:2008
 QUALITY MANAGEMENT SYSTEMS –
REQUIREMENTS
 PROCESS STANDARD (NOT PRODUCT
STANDARD)
 AIMS TO ENHANCE CUSTOMER
SATISFACTION

ISO Awarenes program

CLAUSES:

 1. SCOPE
 2. NORMATIVE REFERENCES
 3. TERMS AND DEFINITIONS
 4. QUALITY MANAGEMENT SYSTEMS
 5. MANAGEMENT RESPONSIBILITY
 6. RESOURSE MANAGEMENT
 7. PRODUCT REALISATION
 8. MEASUREMENT ANALYSIS AND IMPROVEMENT

ISO Awarenes program

PDCA
 Plan – establish processes and
objectives
 Do – Implement the process
 Check – Monitor and measure the
processes
 Act – Take action to continually improve
the process performance

ISO Awarenes program

4.1 General requirements
 Determine the processes needed
 Determine the sequence and interaction
 Determine the Criteria and method for
operation and control
 Ensure availability of resources
 Monitor, measure and analyze the process
 Implement the action for continual
improvement

ISO Awarenes program

4.2 Documentation requirements
 4.2.1 – General
 Quality policy and objectives
 Quality Manual
 Procedures and records required by the
standard
 Documents determined by the
organization
ISO Awarenes program
4.2 Documentation requirements
 4.2.2 - Quality Manual
 Scope
 Procedure and reference
 Interaction of the processes

ISO Awarenes program

4.2 Documentation requirements
 4.2.3 – Control of documents
 Approval prior to issue
 Review and update
 Change identification
 Relevant version at the point of use
 Legible and readable
 Prevent unintended use
 Control of external documents
ISO Awarenes program
4.2 Documentation requirements
 4.2.4 – Control of Records
 Provide evidence of conformity
requirements
 Identification, storage, protection,
retrieval, retention
 Legible, readily identifiable, retrievable

ISO Awarenes program

5. Management responsibility
 5.1 - Management commitment
The management shall provide
evidence of its commitment to the
development and implementation of the
QMS.

ISO Awarenes program

5. Management responsibility
 5.1 - Management commitment
 Communicate to the organization the
importance
 Establish Quality Policy
 Ensure quality objectives are
established
 Conduct MRM
 Ensure availability of resources
ISO Awarenes program
5. Management responsibility
 5.2 - Customer focus
 Ensure customer requirements are
determined and are met to ensure
customer satisfaction

ISO Awarenes program

5. Management responsibility
 5.3 – Quality Policy
 Appropriate for the purpose
 Commitment to comply the requirements
 Frame work for establishing and reviewing
quality objectives
 Communicated and understood within the
organization
 Reviewed for continuing suitability

ISO Awarenes program

5.4 Planning
 5.4.1 – Quality Objectives

 5.4.2 – QMS Planning

ISO Awarenes program

5.5 Responsibility, Authority and
communication
 5.5.1 – Responsibility and authority
 5.5.2 – Management representative
 5.5.3 –Internal Communication

ISO Awarenes program

5.6 Management review
 5.6.2 – Review inputs
 Results of audits
 Customer feedback
 Process performance
 Status of CA & PA
 Follow up action of previous MRMs
 Changes affecting the QMS
 Recommendation for Improvement
ISO Awarenes program
5.6 Management review
 5.6.3 – Review output
 Improvement of the QMS
 Improvement of product
 Resource needs

ISO Awarenes program

6. Resource Management
 6.1 – Provision of resources
 To Implement and maintain QMS
 To enhance customer satisfaction and
requirements

ISO Awarenes program

6. Resource Management
 6.2 – Human resources
 6.2.2 – Competence training and
awareness
 6.3 – Infrastructure (building, Utility,
Work space and Equipments)
 6.4 – Work environment (Physical and
environmental factors)

ISO Awarenes program

7. Product realization
 7.1 – Planning of product realization
 Quality objective and requirements of the
products
 Establish processes and documents and to
provide resources specific to the product
 Verification, validation, Monitoring,
measurement, inspection and test activities
and product acceptance criteria.
 Records for evidence for realization

ISO Awarenes program

7. Product realization
 7.2.1 Requirements of the products
 Requirements specified by the customer
including delivery and post delivery
requirements
 Not specified by the customer but necessary
for the product
 Statutory and regulatory requirements
 Additional requirements considered necessary
by the organization

ISO Awarenes program

7. Product realization
 7.2.2 – Review of requirements
 Define product requirements
 Contract requirements expression of
deviations are resolved
 Ability to meet the requirements

ISO Awarenes program

7. Product realization
 7.2.3 – Customer Communication
 Product information
 Enquiries, contracts or order
amendments
 Customer feed back including
complaints

ISO Awarenes program

7.3 Design and development
 7.3.1 – Design and development
planning
 Design and development stages
 Review, verification and validation
 Responsibilities and authorities

ISO Awarenes program

7.3 Design and development
 7.3.2 – Design and development inputs
 Functional and performance
requirements
 Statutory and regulatory requirements
 Information from similar previous
design
 Other essential requirement
ISO Awarenes program
7.3 Design and development
 7.3.3 – design and development outputs
 Meet the input requirements for design and
development
 Information for Purchasing, production and
service
 Reference product acceptance criteria
 Specify the characteristics of the product
essential for safe and proper use

ISO Awarenes program

7.3 Design and development
 7.3.4 – Design and development review
 Evaluate the ability of results
 Identify any problems and propose
necessary actions

ISO Awarenes program

7.3 Design and development
 7.3.5 – Design and development
verification
 7.3.6 – Design and development
validation
 7.3.7 – Control of design and
development changes

ISO Awarenes program

7.4 Purchasing
 7.4.1 – Purchasing process
 Selection of suppliers
 Criteria for selection, evaluation and re-
evaluation

ISO Awarenes program

7.4 Purchasing
 7.4.2 – Purchasing information
 Requirements of approval of Product,
procedures and processes
 Qualification of personnel
 QMS requirements

ISO Awarenes program

7.4 Purchasing
 7.4.3 – Verification of Purchased
product
 Establish and Implement system for
inspection and other activities necessary
for purchased product to meet the
requirements

ISO Awarenes program

7.5 Production and service provision
 7.5.1 - Control of production and
service provision
 7.5.2 - Validation of processes
 7.5.3 - Identification and Traceability
 7.5.4 – Customer property
 7.5.5 – Preservation of Product

ISO Awarenes program

7.6 Control of monitoring and
measuring equipment
 Calibrated and verified at regular
intervals
 Adjusted or readjusted as necessary
 Identification with calibration status
 Safeguarded from adjustments
 Protected from damage and deteriotion

ISO Awarenes program

8. Measurement, Analysis and
improvement
 8.2.1 – Customer satisfaction
 8.2.2 – Internal audit
 8.2.3 – Monitoring and measurement of
processes
 8.2.4 – Monitoring and measurement of
product

ISO Awarenes program

8. Measurement, Analysis and
improvement
 8.3 – Control of nonconforming product
 8.4 – Analysis of data
 8.5 - Improvement

ISO Awarenes program