:: Quality Management
ISO 9001:2008 – Quality Management System
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 its headquarter at Geneva, Switzerland. India is represented by BIS (Bureau of Indian Standards).
ISO is important because of its systemic orientation. We think this is crucial. Many people in this field wrongly emphasize motivational and attitudinal factors. The assumption is that quality can only be created if workers are motivated and have the right attitude. This is fine, but it doesn't go far enough. Unless you institutionalize the right attitude by supporting it with the right policies, procedures, records, technologies, resources, and structures, you will never achieve the standards of quality that other organizations seem to be able to achieve. Unless you establish a quality attitude by creating a quality system, you will never achieve a world-class standard of quality.
Simply put, if you want to have a quality attitude you must have a quality system. This is what ISO recognizes, and this is why ISO 9000 is important.
TL 9000 – Quality Management System for Telecom Sector
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.
The inaugural QuEST Forum meeting in January, 1998 saw the formation of member groups tasked with the definition of the TL9000 overview, as well as the industry's requirements for hardware, software, services, hardware measurements, software measurements, and service measurements. Monthly handbook development meetings followed this inaugural forum until the completion of committee draft of the TL-9000 was announced at a press conference held at SuperCOMM '98 in June, 1998.
The result was TL-9000 Book One, which standardizes the telecommunications industry's quality system requirements. Its structure uses a 5-tier model as follows:
- Tier 1 contains the international requirements of the ISO 9001;
- Tier 2 contains the quality system requirements of the telecommunications industry that are common to all its sectors, i.e., hardware, software and services;
- Tier 3 contains quality system requirements that are specific to each of the industry's individual sectors, i.e., hardware, software and services;
- Tier 4 contains the telecommunications industry's supplier performance metrics or measurements that are common to all its sectors, i.e., hardware, software and services; and
- Tier 5 contains the telecommunications industry's supplier performance metrics or measurements that are specific to each of the industry's individual sectors, i.e., hardware, software and services.
A second handbook that deals with metrics to quantify the benefits realized from TL-9000 implementation was later created by the industry. Aside from measuring the performance of the quality system, this second handbook also assesses the progress of quality maturation of the company, identifies areas for quality process improvement, and provides comparative benchmarking capabilities for the industry. Thus, the QuEST Forum was able to produce two handbooks:
- TL 9000 Quality System Requirements
- TL 9000 Quality System Measurements
The main driving force behind the effort to come up with a quality standard for telecommunications companies is the high cost being incurred by the industry as a result of quality issues. This is why the TL-9000 standard incorporates a performance measuring system that quantifies the effects of its implementation - to allow the various telecommunications companies to document their savings and share their experiences with others in quantified terms.
AS 9100 - Quality Management System for Aerospace Sector
AS9100 defines additional areas within an aerospace quality management system that must be addressed when implementing an ISO 9001:2008-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.
ISO / TS 16949 - Quality Management System for Automobile Sector
The ISO/TS 16949:2009 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 16949:2009 is the latest automotive quality standard which was developed to be a new universally accepted quality standard for automobile suppliers. The ISO/TS 16949:2009 standard was developed to be an automotive standard for the customers’ of automotive manufacturers and it is aligned with the ISO-9001: 2009 standard. The purpose of ISO/TS 16949:2009 was to create standardization in the quality management standards for automobile suppliers throughout the world. ISO/TS 16949:2009 is a process approach quality standard, which places requirements that assure consistent quality, throughout organizations that supply automobile manufacturers. By requiring ISO/TS 16949:2009 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.
SEI CMMi – Quality Management System as per SEI for Software & Service Organizations
It is a guide for implementing development practices that continuously improve software quality. This has been created by SEI (Software Engineering Institute) – a research and development centre operated by Carnegie Mellon University.
“CMMI” refers to the integration of diverse tool sets and appraisal methods related to CMM.
CMMi builds on and extends on the best practices of the:
- Capability Maturity Model for Software (SW-CMM);
- Systems Engineering Capability Model (SECM);
- Integrated Product Development Capability Maturity Model (IPD-CMM);
- Supplier Sourcing Capability Maturity Model (SS-CMM).
CMMi will help Software and Systems Engineering Companies to Study, Define, Implement, Improve and Appraise their internal Processes to result in improvement of the Development Cycle Time, Timely deliveries to Customers, Reduction in Schedule, Effort and Cost variances, reduced Defect levels, reduced Rework, improved Productivity and Profitability.
CMMI Maturity Levels
There are 5 maturity levels viz.,
ISO 13485 - Quality Management System for Medical Equipments Sector
- Quantitatively Managed
ISO 13485:2003, based on the ISO 9001:2008 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 9000:2008 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 includes:
- Recognition by regulators around the world of ISO 13485:2003 as a good basis for addressing medical device design and manufacturing regulatory requirements
- Controlled consistency of manufactured products
- Managed productivity and efficiency, controlling costs
- Competitive advantage and increased marketing and sales opportunities.
- 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.