ISO Awareness

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 What is ISO

 The ISO in ISO 9000 comes from the Greek, and means "the same as." It is the
 Nivå
same1prefix as is found in the word "isobar“.
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 The ISO standards
- Nivå are published by the International Organization for
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Standardization,
- Nivå 4 which has its offices in Geneva.
 The ISO 9000 Nivå 5
- standards were written by TC 176, which has a wide representation
from many countries including the US, and they have been adopted by the national
standards organizations of countries worldwide.

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 Why ISO ?

  ToNivå
achieve
1 consistency in customer satisfaction it requires stable processes in the
identification
- Nivå 2 of customer requirements and the conversion of those requirements
into deliverable
- Nivå 3 products and services.
Nivå 4
-
 What ISO 9001 requires is that Top management shall
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- establish such processes;
- implement them;
- monitor them at appropriate intervals;
- find ways of understanding customer perceptions of
- performance, and
- continually seek to improve the effectiveness of the system, the processes and
the products or services being supplied.

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 Why to go for ISO Certification ?

 Tangible Proof that Company’s Quality System Complies with internationally

Recognised standard
 Nivå 1
 Customer
- Nivå 2 Requirements –Customer demands Suppliers to comply with ISO
standards
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 Marketing positioning - Competing Edge with Competitors
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 Legal Requirement -Many Countries/Customers it is a Legal requirement
 Organisation Improvement –Catering organisations process and Quality improvement

Customer

Shareholders Employees Society Suppliers

Quality of
Service/Product
Return of Personal Responsible Business
Investment Development Behaviour Continuity

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 The Structure of the ISO 9000:2008 Standards

 ISO 9001:2008 contains no definitions. It refers to ISO 9000:2005.

 Nivå 1
- Nivå 2
- Nivå 3 Guidance
- Nivå 4
- Nivå 5 ISO 9004:2009 due out soon
Managing for the sustained success
of an organization — A quality
management approach

ISO 9000:2005 Application

Quality management systems —
Fundamentals and vocabulary
ISO 9001:2008
Quality management systems —
Requirements

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 Principles of ISO 9001:2008
1.Customer focus: organizations depend on their customers and therefore should understand
current and future customer needs; meet customer requirements and strive to exceed customer
expectations.
2.Leadership: leaders establish unity of purpose and direction of the organization. They should
create and maintain the internal environment in which people can become fully involved in
achieving the organization's objectives.
3. Involvement of people: people at all levels are the essence of an organization and their full
involvement enables their abilities to be used for the organization's benefit.
4. Process approach: a desired result is achieved more efficiently when related resources and
activities are managed as a process.
5. System approach to management: identifying, understanding and managing a system of
interrelated processes for a given objective improves the organization's effectiveness and
efficiency.
6. Continual Improvement: continual improvement should be a permanent objective of the
organization.
7. Factual approach to decision making: effective decisions are based on the analysis of data
and information.
8 . Mutually beneficial supplier relationships: an organization and its suppliers are
interdependent, and a mutually beneficial relationship enhances the ability of both to create value.

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 Quality Management System Concepts
 A QMS can be defined as:
“A set of co-ordinated activities to direct and control an organisation in order to
continually
Nivå 1 improve the effectiveness and efficiency of its performance.”
 A- Management
Nivå 2 system is a collection of resources comprising capital, people, processes and
procedures
- Nivåwhich
3 ensures that a customer's requirements for quality are met by the supplier
organization.
- Nivå 4
- Nivå 5

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 Why Quality Management System (QMS)
QMS provides consistency and satisfaction in terms of methods, materials,
equipment, etc, and interacts with all activities of the organisation, beginning with
the identification of customer requirements and ending with their satisfaction, at
every transaction interface.

• Organization improvement
• Improved internal transfer of know how
• Improved morale and motivation of staff
• Reduced quality costs
• Increased competitiveness
• Increased profitability
• Enhanced customer satisfaction and loyalty
• Certification of quality system to ISO 9001
• Avoidance of multiple second party audits

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 ISO 9001:2008 Structure

 Scope
 Normative reference
 Terms
Nivå 1and definitions
- Nivå
 Quality 2
management system
- Nivårequirements
- General 3
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- Documentation requirements
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 Management responsibility
- Management commitment
- Customer focus
- Quality policy
- Planning
- Responsibility, authority and communication
- Management review
 Resource management
- Provision of resources
- Human resources
- Infrastructure
- Work environment
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 ISO Structure Continued …..

 Product realisation
 -Nivå 1
Planning of product realisation
- - Customer-related
Nivå 2 processes
- Design and/or
- Nivå 3 development
- Purchasing
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- Production -andNivå 5
service operations
- Control of measuring and monitoring devices
 Measurement, analysis and improvement
- General
- Planning
- Monitoring and measurement
- Control of non-conforming product
- Analysis of data
- Improvement

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 QMS and ISO 9001 :2008

 Nivå 1
- Nivå 2
- Nivå 3
- Nivå 4
- Nivå 5

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 ISO 9001:2000 Process Approach

PROCESS EFFECTIVENESS
 Nivå 1 Extent to which planned
CONTROLS
- Nivå 2 activities are realized and
planned results achieved
- Nivå 3
- Nivå 4
- Nivå 5 PROCESS
PROCESS
“set
“setofofinterrelated
interrelatedoror
INPUT interacting activities
interacting activities
OUTPUT PRODUCT
which
whichtransforms
transforms
inputs
inputs intooutputs
into outputs
PROCESS EFFICIENCY
RESOURCES Relationship between the
result achieved and the
resources used

A desired result is achieved more efficiently when activities and related

resources are managed as a process

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 Tarento - ISO Documentation Set

 Quality Frame work

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 Quality Manual
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 Process
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 Procedures -
Nivå 5
 Templates
 Walkthrough through SVN

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 DQF & Project state

 Nivå 1 Initiate Define Plan Construct Finalize

Connecta / Tarento SE

Nivå Agreement
- Framework 2 & Work Order

Nivå 3
- Requirements
Requirements Onboarding
OnboardingProcess
Process- -Ensure
Ensurecustomer/Tarento
customer/Tarentointroduction
introduction
Analysis,
- Nivå 4
Analysis,
Staffing
StaffingRequest,
Request, Project
Project
Case Presentation
Case Presentation- Nivå
“Go”5
“Go” Evaluation/
Evaluation/
CSI*
CSI*
Sales Rough
RoughEstimates,
Estimates,
Case
CasePresentation
Presentation

Project
ProjectPlan
Plan
PM PM
PMinteraction
interactionaccording
totoagreed
according Lessons
Project agreedstandards
standards Lessons
Requirement ProjectPlan,
Plan, Learned
RequirementSpecification
Specification Quality
defined
definedininAS/PP.
AS/PP. Learned
QualityPlan
Plan QAQAwith
with“7“7Keys”
Keys”&&
Status
StatusReporting
Reporting

Project
Project
Tarento

Resource Evaluation/
Evaluation/
ResourceAnalysis
Analysis Onboarding
OnboardingProcess
Process/ /Secure
Secureresources
resources CSI*
CSI*

DH

Design
Design Code
Code Test
Test Deploy
Deploy

Project Team
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 Tarento SDLC and Work Products
Work Current
Project Phase DQF Work Product Name Responsible
Product # Scope
Initiate Assess Business Concept (P00) Project Estimation WP00.1 Y PM,DH,KAM,Customer
Initiate   Project Kick off Document WP00.2 Y PM,DH,KAM
 Nivå
Plan1 Initiate a Project (P01) Project Plan WP01.1 Y PM
Quality Planning QA Plan WP01.2
- Plan
Nivå 2 Change Management
Plan Change Management Plan WP01.3
Y
Y
PM,SQA
PM,Customer
Risk Management Risk Management Plan WP01.4
Plan- Nivå 3 Y PM
Plan Communication Management Communication Management Plan WP01.5 Y PM
Plan Nivå 4 Management
- Configuration Configuration Management Plan WP01.6 Y PM
Define NivåRequirements
- System
Specify 5 (P03) System Requirements Document WP03.1 Y PM,Team
Define   Test Plan Document WP03.3 Y PM,Test Lead/Tester
Review of Buisiness Requirement
Review WP03.4
Define Document Y Team,PM,Customer
Review of Software Requirement
Review WP03.4
Define Document Y Team,PM,Customer
Define Review Review of Project Plan WP03.4 Y PM,DH,(KAM),Customer
Define Review Review of Test Plan WP03.4 Y PM,Test Lead/Tester
Execute Specify System Design (P05) System Design Document WP05.1 Y PM,Team
Execute   System/Integration Test Case WP05.4 Y Test team
Execute   Unit Test Case WP05.6 Y Dev Team
Execute Review Review of Design Document   Y PM, Dev Team
Execute Review Review of Test Cases   Y PM,Tester,Dev
Execute Construct Software Components (P06) Unit Test Results Summary Report WP06.2 Y Dev Team
Execute Review Code Review WP06.4 Y Dev Team,Expert,PM
Execute   Release notes WP06.5 Y Dev team
  Verify System Solution (P08) System Verification Summary Report WP08.2 Y Test team,Test Lead
Followup Evaluate Project Results (P10) Project Evaluation WP10.1 Y PM,Customer
    Lessons Learned Report WP10.2 Y PM,Team

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 Questions ?

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Thank you

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