ISO is a network of the national standards institutes of 147 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.ISO occupies a special position between the public and private sectors. This is because, on the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their governement.

http://www.iso.org/

What ISO's name means
Because "International Organization for Standardization" would have different abbreviations in different languages ("IOS" in English, "OIN" in French for Organisation internationale de normalisation), it was decided at the outset to use a word derived from the Greek isos, meaning "equal". Therefore, whatever the country, whatever the language, the short form of the organization's name is always ISO.


KALITEST ACCREDIATION SCOPE FOR ISO 9001

ISO 9000 SERIES HISTORY

• 1963 : MIL-Q 9858A (US Military)
• 1969 : DEF Standards (UK MOD)
• 1974 : AQAP Defence Standards
• 1979 : BS 5750 Pt 1,2,&3
• 1987 : ISO 9000 Series
• 1994 : ISO 9000 Revised & BS 5750 became obsolete
• 1996 : ISO 14001 : 1996 was published
• 1999 : OHSAS 18001 (Occupational Health & Safety Assessment Series)
• 2000 : ISO 9000 :2000 series was published
• 2004 : ISO 14001: 2004 was published
• 2007 : OHSAS 18001 (Occupational Health & Safety Assessment Series)
• 2008 : ISO 9001: 2000 was published
 
ISO 9000 Series Family

ISO 9001: 2008
The purpose of this standard is to provide a management system framework that enables the company to establish a management system aimed at enhancing customer satisfaction, continual improvement, and the assurance of product conformity to customer and applicable regulatory requirements.
ISO 9000: 2005
This standard defines terms used throughout ISO 9001 & 9004.
ISO 9004: 2000
This standard has been developed as one part of a consistent pair of quality management system standards. The standard includes a copy of ISO 9001: 2000 with guidelines for performance improvement against each clause. The standards are designed to be used together, but can also be used independently. The standard includes guidelines for self assessment.
ISO 19011: 2002
This standard provides guidelines of the principles of auditing, managing audit
programmes, conducting quality and environmental system audits plus guidance on

 
The structure of ISO 9001:2008
1. Scope.
2. Normative reference.
3. Terms and definitions.
4. Quality Management System.
5. Management Responsibility.
6. Resource management.
7. Product realisation.
8. Measurement, analysis and improvement.

4,5,6,7,8 are mandatory requirements

ISO-9001:2008 Process Model


PDCA principle
P Plan : Establish objectives & Processes
D Do : Implement the Processes
C Check : Monitor & measure
A Act : Act to continually improve

ISO 9000 Series Key Points

1- Applicability to all product categories
2- Simple to use
3- Non Bureaucratic approach in the amount of documentation
4- Connection of QMS to the organisations processes
5- Requirement for continual improvement
6- Compatibility with ISO 14001 & OHSAS 18001
7- Process orientated structure
8- Emphasis on the role of top management
9- The concept of “permissible exclusions”
10- Requirement to monitor customer satisfaction
11- Reference to Quality Management Principles
12- Consideration of legal and regulatory requirements (related to the product or service)
13- Establishment of measurable objectives
14- Determine effectiveness of training
15- Measurement of process and product
 
BASIC CONCEPTS AND DEFINITIONS

Quality
Fitness for purpose of use (Juran 1970)
Degree to which a set of inherent characteristics fulfills requirements.
(ISO 9000 : 2005)
 
Quality Policy
The overall intentions and direction of an organisation related to quality as formally
expressed by top management.
 
Quality Management
Coordinated activities to direct and control an organisation.
 
Quality Objectives
Something sought, or aimed for, related to quality.
The Quality objectives should be SMART
S : Specified
M: Measurable
A : Achievable
R : Real
T : Timing

Quality Planning
Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfil the quality objectives.
 
Quality Control
Part of quality management focused on fulfilling quality requirements.
 
Quality Assurance
Part of quality management focused on providing confidence that quality requirements will be fulfilled.
 
Quality Management
Coordinated activities to direct and control an organisation with regard to quality.
 
Improvement
Part of quality management focused on increasing he ability to fulfil quality requirements.

Work Environment
Set of conditions under which work is performed.
 
Audit
Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled.
 
Objectivity of Auditing



Audit Criteria
Set of policies, procedures or requirements determined as a reference.

Audit Evidence
Records, statements of fact or other information which are relevant to the audit criteria and verifiable. (ISO 9000 : 2005) (ISO 19011:2002)

Audit Findings
Results of the evaluation of the collected audit evidence against audit criteria. Can indicate either conformity or nonconformity with audit criteria or opportunities for improvements. (ISO 9000 : 2005) (ISO 19011:2002)

Audit Conclusion
Outcome of an audit, provided by the audit team after consideration of the audit objectives and all audit findings. (ISO 9000 : 2005) (ISO 19011:2002)

Product
Result of processes

There are four general product category:

Hardware
Software
Services
Processed Materials or a combination of these

Requirements
Defined, legal needs and expectations or required generally may be in relation with product, system or customer defined requirements are written requirements may be defined by various sources

Corrective Action
The activities done in order to remove the main reason of determined nonconformity and to prevent it occur again.

Preventive Action
The activities done in order to remove the reason of a potential nonconformity (not occured yet).

Release
A permission given to continue next stage of the process

Review
The activities done in order to determine the conformity and effectiveness of the subjects establieshed to realize the defined objectives and targets.

Verification
The verification operation based on objective evidences that shows the defined requirements are met.

Validation
Validation of meeting the requirements that are facing to target and practice by evaluating the real evidences.

Obcektif Evidence
The informations or datas that show something exists and it is real.

Nonconformity
A deviation from specified requirement related to the product or to certification requirements defined by the certification body.

Process
A series of activities that transforms inputs to outputs and related or interacts with each other.

QUALITY MANAGEMENT PRINCIPLES

1.Customer Focus:
Organisations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

2. Leadership :
Leaders establish unity of purpose, direction and the internal environment of the organisation. They should create and maintain the internal environment in which people can become fully involved in achieving the organisations objectives.

3. Involvement of people:
Applying the principle of involvement of people leads to the following actions by the people

4. Process Approach:
A desired result is achieved more efficiently when related resources and activities are managed as a process. The Plan-Do-Check-Act cycle.

5. System Approach to Management:
Identifying, understanding and managing a system of interrelated processes for a given objective contributes to the effectiveness and efficiency of the organisation.

6. Continual improvement:
Continual improvement in the organisation’s overall performance should be a permanent objective of the organisation.

7. Factual Approach to Decision Making:
Effective decisions are based on the analysis of data and information.

8. Mutually beneficial Supplier Relationships:
An organisation and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.