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Dot Image ISO Overview
 
The objective is to provide basic knowledge of ISO 9001:2000 standards, understand how it can be integrated with the organization Management system.

  • Background
  • Core standards of ISO
  • Why ISO 9001:2000 ?
  • Benefit of ISO 9001:2000
  • Introductions to ISO 9001 Clauses
  • ISO Clause 4 - Quality Management System.
  • ISO Clause 5 - Management Responsibility
  • ISO Clause 6 - Resource Management
  • ISO Clause 7 - Product Realization
  • ISO Clause 8 - Measurement, Analysis and Improvement


Background


The ISO9000 series of standards is perhaps the most popular international standard in use today. Over 75 nations have already adopted and recognized it. Many organizations have utilized ISO9000 as a standard to create their quality systems. The purpose of ISO is to facilitate international business by providing a single set of standards that people everywhere would recognize and respect. The term ISO 9000 refers to a set of quality management standards.

A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered". Certification to an ISO 9001 standard does not guarantee any quality of end products and services; rather, it certifies that formalized business processes are being applied.

Core standards of ISO

ISO first published its quality standards in 1987, revised them in 1994, and then republished an updated version in 2000. These new standards are referred to as the "ISO 9000 2000 Series of Standards." ISO 9000 is comprises of four core standards.

These are:

  • ISO 9000:2000 ,
  • ISO 9000:2000 is the QMS fundamentals & vocabulary

  • ISO 9001:2000 and
  • ISO 9004:2000 is the guideline for performance improvement and

  • ISO 9004:2000
  • ISO 9001: 2000 specifies requirements for a quality management system. All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Why ISO 9001:2000 ?

In today's competitive business world, the clients want the quality services from their service providers. This is because the customers and buyers across the globe prefer dealing with a company which has been certified or assessed by a third party for their approach to Quality and process framework. These Quality assessment certifications could be based up on CMMI methodology, Six Sigma, or ISO etc.

ISO is and that is why standards like ISO 9001: 2000 have become popular. The ISO 9001: 2000 is one of the very common certification that organizations usually acquire worldwide, including software organizations. It helps the organization to remain competitive and to improve internal capabilities by creating and implementing a robust Quality Management System and implementing the same.

ISO Image

Benefit of ISO 9001:2000

Using ISO 9001, an organization is benefited by:

  • Having a set of procedures that cover all key processes in the business;
  • monitoring processes to ensure they are effective;
  • keeping adequate records;
  • checking output for defects, with appropriate and corrective action where necessary;
  • regularly reviewing individual processes and the quality system itself for effectiveness; and
  • Facilitating continual improvement.

ISo Image

Introductions to ISO 9001 Clauses:

ISO Clause 4 - Quality Management System.

This section contains basic requirements for establishing, documenting, implementing, maintaining and improving the QMS.

The emphasis is on the 'Process', that is:

  • Understanding and meeting (customer) requirements
  • Considering processes in terms of value added (from the customer's perspective)
  • Evaluate processes in terms of performance and effectiveness, and
  • Using objective measurements of process as the basis for continual improvement.

ISO Clause 5 - Management Responsibility

This section is about Management Responsibility and covers the following aspects:

  • Management must provide commitment to QMS and its continual improvement
  • Must satisfy requirements and enhance customer satisfaction
  • Need to establish quality policy, quality objectives, responsibilities and authorities, QMS reviews

This implies that the top management need not participate in the daily operation of the quality management system, but these individuals are required to establish the quality policy and the quality objectives, conduct management reviews, ensure availability of resources, and communicate the importance of meeting customer requirements and any applicable regulatory mandates.

ISO Clause 6 - Resource Management

This is covers the Resource Management which manages the resources required for:

  • developing, implementing, monitoring and improving the QMS
  • Addressing customer requirements and customer satisfaction.

This clause addresses the resources that are needed for the whole Quality Management System. The Resource management applies to more than just personnel; it also includes time, equipment, competence, awareness, training, infrastructure, Work Environment. This clause is further sub-divided into sub clauses. These are as follows:

6.1 Provision of resources

6.2 Human resources
6.2.1 General
6.2.2 Competence, awareness and training
6.3 Infrastructure
6.4 Work Environment

ISO Clause 7 - Product Realization

This is the largest section of the ISO 9001 standards and is subdivided into six parts. Organization will plan and develop the process needed for the product realization. Planning of the product realization will be consistent with the requirements of the other process of the Quality Management System of that organization. These are as follows:

7.1 Planning of product realization
7.2 Customer related processes,
7.3 Design and development,
7.4 Purchasing,
7.5 Production and service provision, and
7.6 Control of monitoring and measuring devices

ISO Clause 8 - Measurement, Analysis and Improvement

This section covers the measurement and analysis requirements of the process. Based on the results of monitoring and analysis of the data, the gaps are identified and bridging of such gaps is then considered as improvements. Thus, we can say that this section is used to identify and implement the process improvements. This clause is further divided into 5 sub clauses these are as follows:

8.1 General
8.2 Monitoring and measurement
8.3 Control of non-conforming product
8.4 Analysis of data
8.5 Improvement

 
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