ISO Registration Consultant, India

ISO 9001:2008

ISO 9000 stands for International Organization of Standardization, created in 1947. It is a worldwide federation of “Member Bodies” (i.e., National bodies – Government Institution or Organization incorporated by Public Law) with it’s headquarter at Geneva, Switzerland. India is represented by BIS (Bureau of Indian Standards).

ISO / TS 16949:2002

The ISO/TS 16949:2002 standard is the consensus of international quality requirements, which consists of policies and procedures that ensures worldwide consistence with the suppliers of parts, materials, or finishing services.

How do automotive manufacturers assure that the numerous parts that they receive from suppliers are of the highest quality?

How do automobile manufactures assure that suppliers provide products that manufacturers can be responsible for and are worthy of the manufacturers name?

Automotive manufacturers assure quality by requiring registration to automotive quality standards that provide quality assurance. ISO/TS 16949:2002 is the latest automotive quality standard which was developed to be a new universally accepted quality standard for automobile suppliers. The ISO/TS 16949:2002 standard was developed to be an automotive standard for the customers’ of automotive manufacturers and it is aligned with the ISO-9001: 2002 standard. The purpose of ISO/TS 16949:2002 was to create standardization in the quality management standards for automobile suppliers throughout the world. ISO/TS 16949:2002 is a process approach quality standard, which places requirements that assure consistent quality, throughout organizations that supply automobile manufacturers. By requiring ISO/TS 16949:2002 certifications, automobile manufacturers can be assured that all of their suppliers are adhering to a consistent set of quality standards that are strict and intertwined throughout the supplier’s organization.

ISO 13485:2003

ISO 13485:2003, based on the ISO 9001:2000 process model, suggests that the application and management of a system of processes is an effective way to ensure good quality management. All requirements of this International

Standard are specific to organizations providing medical devices, regardless of the type or size of the organization.

The standard strongly infers that clients should consider using ISO 9000:2000 to ensure understanding of the Process Model, definitions and other items of concern, too.

The benefits of an ISO 13485:2003 compliant quality management system to the thousands of companies worldwide include:

  1. => Recognition by regulators around the world of ISO 13485:2003 as a good basis for addressing medical device design and manufacturing regulatory requirements
  2. => Controlled consistency of manufactured products
  3. => Managed productivity and efficiency, controlling costs
  4. => Competitive advantage and increased marketing and sales opportunities.
  5. => Improved customer perception of the organization’s image, culture and performance.

Improved communications, morale and job satisfaction – staff understand what is expected of them and each other.

TL 9000

The TL-9000 is a quality management system standard (QMS) defined specifically by and for the telecommunications industry. It standardizes the quality system requirements for the design, development, delivery, installation, and maintenance of telecommunication products and services. It also defines the performance metrics required to measure the progress and results of its implementation.

The TL-9000, which was based on the ISO-9000 Standard, was conceptualized in 1996 at the Quality Excellence for Suppliers of Telecommunications (QuEST) Leadership Forum, was drafted starting in 1998, and was introduced to the industry in 1999. The goal of this entire initiative was to create a consistent set of quality system requirements that would apply to more than 10,000 telecommunications suppliers worldwide.

TL 9000 defines the telecommunications quality management system requirements for the design, development, production, delivery, installation, and maintenance of products and services. It also provides a measurement system that, when implemented, allows a company to track performance and improve results.

TL 9000 supports three distinct certifications: TL 9000-HW for hardware, TL 9000-SW for software, and TL 9000-SV for services. TL 9000 registrations can cover hardware, software, services, or any combination thereof. Registration may also include an entire company, an organizational unit, a facility, or even a specific product line as mutually agreed by the supplier and the registrar.

AS 9100

AS9100 defines additional areas within an aerospace quality management system that must be addressed when implementing an ISO 9001:2000-based quality system. Typically, these requirements are included within robust aerospace quality systems. The industry experts who wrote the standard and the representatives who approved it all agree that these additions are essential to ensure product, process and service safety and quality.

All quality systems must be designed to meet the specific needs of the users. And although AS9100 identifies areas to address within the aerospace industry, system designers are encouraged to first establish a robust quality system that’s both effective and efficient. This system should be a holistic entity with practices spanning multiple functions and processes within the business.

The AS9100 standard provides guidance for managing variation when a “key characteristic” is identified. Keys are features of a material, process or part in which the variation has a significant influence on product fit, performance, service life or manufacturability. AS9100 requires that an organization establish and document a configuration management process.

Planning product realization is essential for effective and efficient processes. The standard emphasizes planning for in-process verification when a product can’t be verified at a later point. Tooling design must also be considered when process control methodology is used to ensure that process data will be captured.

The AS9100 standard includes extensive supplementation in design-and-development functions. This isn’t surprising given the complexity of aerospace products and customers’ expectations for reliable performance during a protracted period of time.

Ozg Registration Consultant


Ozg Center, New Delhi, India

ISO 9004:2000

Quality management systems — Guidelines for performance improvements.

This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness and efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization. When compared to ISO 9001, the objectives of customer satisfaction and product quality are extended to include the satisfaction of interested parties and the performance of the organization.

This International Standard is applicable to the processes of the organization and consequently the quality management principles on which it is based can be deployed throughout the organization. The focus of this International Standard is the achievement of ongoing improvement, measured through the satisfaction of customers and other interested parties.

This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001.

ISO 10002:2004

Quality management — Customer satisfaction — Guidelines for complaints handling in organizations

ISO 10002:2004 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system.

ISO 10002:2004 is not applicable to disputes referred for resolution outside the organization or for employment-related disputes.

It is also intended for use by organizations of all sizes and in all sectors.

ISO 10002:2004 addresses the following aspects of complaints handling:

– enhancing customer satisfaction by creating a customer-focused environment that is open to feedback (including complaints), resolving any complaints received, and enhancing the organization’s ability to improve its product and customer service;

– top management involvement and commitment through adequate acquisition and deployment of resources, including personnel training;

– recognizing and addressing the needs and expectations of complainants;

– providing complainants with an open, effective and easy-to-use complaints process;

– analysing and evaluating complaints in order to improve the product and customer service quality;

– auditing of the complaints-handling process;

– reviewing the effectiveness and efficiency of the complaints-handling process.

ISO 10002:2004 is not intended to change any rights or obligations provided by applicable statutory or regulatory requirements.

ISO 10006:2003

Quality management systems — Guidelines for quality management in projects

ISO 10006:2003 gives guidance on the application of quality management in projects.

It is applicable to projects of varying complexity, small or large, of short or long duration, in different environments, and irrespective of the kind of product or process involved. This can necessitate some tailoring of the guidance to suit a particular project.

ISO 10006:2003 is not a guide to “project management” itself. Guidance on quality in project management processes is discussed in this International Standard. Guidance on quality in a project’s product-related processes, and on the “process approach”, is covered in ISO 9004.

Since ISO 10006:2003 is a guidance document, it is not intended to be used for certification/registration purposes.

ISO 10007:2003

Quality management systems — Guidelines for configuration management.

ISO 10007:2003 gives guidance on the use of configuration management within an organization. It is applicable to the support of products from concept to disposal.

It first outlines the responsibilities and authorities before describing the configuration management process that includes configuration management planning, configuration identification, change control, configuration status accounting and configuration audit.

Since ISO 10007:2003 is a guidance document, it is not intended to be used for certification/registration purposes.

ISO/IEC 90003:2004

Software engineering — Guidelines for the application of ISO 9001:2000 to computer software

ISO/IEC 90003:2004 provides guidance for organizations in the application of ISO 9001:2000 to the acquisition, supply, development, operation and maintenance of computer software and related support services. ISO/IEC 90003:2004 does not add to or otherwise change the requirements of ISO 9001:2000.

The guidelines provided in ISO/IEC 90003:2004 are not intended to be used as assessment criteria in quality management system registration/certification.

The application of ISO/IEC 90003:2004 is appropriate to software that is

  • => part of a commercial contract with another organization,
  • => a product available for a market sector,
  • => used to support the processes of an organization,
  • => embedded in a hardware product, or
  • => related to software services.

Some organizations may be involved in all the above activities; others may specialize in one area. Whatever the situation, the organization’s quality management system should cover all aspects (software related and non-software related) of the business.

ISO/IEC 90003:2004 identifies the issues which should be addressed and is independent of the technology, life cycle models, development processes, sequence of activities and organizational structure used by an organization.

IWA 1:2005

Quality management systems — Guidelines for process improvements in health service organizations

IWA 1:2005 provides additional guidance for any health service organization involved in the management, delivery, or administration of health service products or services, including training and/or research, in the life continuum process for human beings, regardless of type, size and the product or service provided.

IWA 2:2003

Quality management systems – Guidelines for the application of ISO 9001:2000 in education

International Workshop Agreement IWA 2:2003 provides guidelines for the application of ISO 9001:2000 in educational organizations providing educational products.

These guidelines do not add to, change or modify the requirements of ISO 9001:2000, and are not intended for use in contracts for compliance assessments or for certification.

Each clause of ISO 9001:2000 is included before the corresponding text of IWA 2:2003. The whole text of ISO 9004:2000 is also included to provide a complete vision of the continual performance improvement of organizations.

IWA 4:2005

Quality management systems — Guidelines for the application of ISO 9001:2000 in local government.

The objective of International Workshop Agreement IWA 4:2005 is to provide local governments with guidelines for the voluntary application of ISO 9001:2000 on an integral basis. These guidelines do not, however, add, change or modify the requirements of ISO 9001:2000.

For a local government to be considered reliable, it should guarantee minimum conditions of reliability for the processes that are necessary to provide all the services needed by its citizens in a consistent and reliable manner. All the local government’s processes, including management, core, operational and support processes, should constitute a single, integral, quality management system. The integral character of this system is important because, otherwise, although a local government could be reliable in some areas of activity, it may be unreliable in others. For a government to be considered reliable, it should guarantee minimum conditions of reliability for all key processes and services. To achieve this, it is advisable that the local government clearly identify the management, core and support processes that, together, make it reliable (see Annex A). Annex B provides a diagnostic tool for local governments to evaluate the scope and maturity of their processes and services.

Ozg Registration Consultant


Ozg Center, New Delhi, India


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