Case Studies Based on Adoption of ISO 9001

US Air Force Earns High Flying Results

US Air Force Programme Management Squadron adopted ISO 9001 in 1995, as a sourcing criterion in its supplier selection process. After two years, they called the management representative of each supplier and asked them to become an ASQ Certified Quality Auditor. The Air Force saved millions of dollars from these supplier contract specifications and also eliminated critical defects in supplier products and services. This also resulted in improved communication between the Air Force and its key suppliers and hence increased mission effectiveness.

ORKIN Results

This case study is based on a company, named ‘ORKIN,’ operating in pest control, which expanded its operations rapidly in the middle 1990s. With the expansion, this company faced the challenges of maintaining quality and consistency of service. As a solution to these challenges, the company decided to work to get ISO 9001 certification. To attain ISO 9001 certification, a new department, the ‘Quality Assurance Department’ was set up in the company in 2002. The whole company became ISO 9001 certified by issuing a manual detailing processes in the QA department. Then the company asked them to conduct a full audit. In the initial stage of the audit, local management opposed the audit, but the QA department kept on working to make them understand the benefits of the process. In 2005, ISO 9001 was earned by company’s quality management system. This resulted in shifting the responsibility of quality assurance to the QA department and saving nearly $125,000 per year by removing the requirement of the external ISO 9001.

Other Quality Systems

Some other quality management systems are given below:

  • • QS/TS 16949 Quality System for the Automotive Industry.
  • • ISO 13485 Quality System for Medical Devices.
  • • AS 9100 Quality System for the Aerospace Industry.
  • • ISO 14000 Environmental Management System (EMS).
  • • ISO 26000 Quality System for Ensuring Social Responsibility.

QS/TS 16949 Quality System for the Automotive Industry

The TS 16949 quality system is a refined edition of ISO 9000, which is focused on quality assurance in the automotive industry. All the top-level suppliers of automobile manufacturers require this certification. TS 16949 is aimed at developing a quality system which results in continuous improvement, reduced wastage, reduced variation, and defect prevention. This was developed to:

  • • Remove the need for multiple certification audits.
  • • Use as a common quality system for the automobile manufacturing industry and automobile service part industry.
  • • Use all through the automotive production network.

ISO 13485 Quality System for Medical Devices

ISO 13485 was first published by ISO in 1996 for assuring quality in the design and manufacture of medical devices. Accepting the FDA’s good manufacturing practices, this standard gives the definitions of various terms, such as medical device, sterile medical device, and many more.

The aim of this edition is to create easy harmonious medical device regulatory requirements for quality management systems. This standard has excluded some of the requirements of ISO 9000, as they were inappropriate for this standard. Because of this exclusion, one cannot claim conformity to ISO 9001.

AS 9100 Quality System for the Aerospace Industry

AS 9100 is a quality system specially developed for meeting the requirements of the aerospace industry. It is the highest level quality system available up to now. This quality system was developed to meet the common objective of ensuring quality within the aerospace industry.

Companies should produce reliable and safe products that match the needs of consumer and regulatory requirements. This will result in total customer satisfaction. The challenge of delivering products to consumers with varying quality expectations and requirements is also faced by aerospace suppliers and processors. Such situations can be handled wisely by adopting a quality system like AS 9100.

ISO 14000: Environmental Management System

ISO 14000, a global series of standards focused on environment management, was published in 1996 and was updated in 2004. ISO 14000 standards have been developed along with the development of the ISO 9000 quality standard. The main aim of ISO 14000 standard is to motivate the organisations to incorporate environmental concerns in their operations and product standards. The beauty of this standard is that it is not forced, but it is adopted by organisation voluntarily to control the impact of various activities on the environment. The organisations are free to adopt ISO 14000 series standards, partially or fully. ISO 14000 does not recommend any environmental performance targets; however, it equips the organisations with such tools, which helps in surveying and controlling the effect of their work, products, and services on the environment. The various aspects of environment management addressed by ISO 14000 are as follows:

  • • To investigate environment-related issues.
  • • To audit the impact of the operation of an organisation on the environment.
  • • To develop various terms and conditions for the safeguarding of the environment.
  • • To analyse the life cycles of the various products and their impact on the environment.
  • • To implement standards for controlling impacts on the environment.
  • • To evaluate the performance of standards adopted for environmental management.

Benefits for Compliance with an ISO 14000 EMS

The benefits for compliance with an ISO 14000 EMS results:

  • • Helps improve the relationship of the organisation with its customers.
  • • Helps improve the relationship of the organisation with the government.
  • • Improves the image of the organisation.
  • • Helps in establishing the organisation as a brand working with concern for the environment and society.
  • • Attracts customers as a producer of sustainable products.
  • • Results in improved value in the market and hence improves access to capital.
  • • As value increases in the market, market share also increases.
  • • High-value organisations get insurance at a reasonable cost.
  • • Wastage is minimised, which results in reduced costs.
  • • Consumption of resources and materials is reduced.
  • • As an environmentally conscious organisation, it becomes easier to get permits and authorisations.

ISO 14000 Registration

Registration is certification of an organisation that confirms that organisation has adopted an environment management standard and the organisation has a concern about sustainable development. Though an organisation can simply declare that they follow all the requirements of an EMS, most of the organisations go for registration of their EMS. Organisations register their EMS to assure their customers and other authorities that the organisation is fully concerned about the environment and society.

Principles behind the ISO 14000 Series

The key principles behind the development of ISO 14000 standards and documents are:

  • • To help in managing environmental issues in a better way.
  • • To focus on the various aspects related to the environment.
  • • To increase the applicability in all countries.
  • • To involve customers and the public by promoting the concept of environmental management.
  • • To reduce wastage and faster consumption of natural resources. It will result in reduced cost of products.
  • • EMS along with reduced product costs will also help in expanding the business worldwide.
  • • To be experimentally proven.
  • • To be practical, valuable, and usable.

Major Groups of ISO 14000 Series

The ISO 14000 series can be divided into two major groupings:

Organisation-Oriented Standards

The standard gives full guidelines required for establishing, maintaining, and evaluating an EMS. This system contains the various guidelines for environmental auditing. It is used for auditing of environmental management systems. It is also focused on environmental systems and functions of other organisations. The various organisation-oriented ISO 14000 standards are as follows:

ISO 14001:2004

This is an environmental management system. It includes various specifications with guidelines for use.

ISO 14004:2004

This is an environmental management system. It includes guidelines on principles, systems, and supporting techniques.

ISO 14010:1996

This system includes general principles and guidelines for environmental auditing.

ISO 14011:1996

This system contains the various audit procedures and guidelines for environmental auditing. It is used for auditing of the EMS.

ISO 14012:1996

This system includes guidelines for environmental auditing and qualification criteria for environmental auditors.

ISO 14031:1999

This system is used for environmental management. It contains environmental performance evaluation guidelines.

ISO/TR 14032:1999

This system is used for environmental management.

ISO/TR 14061:1998

This system contains information to assist forestry organisations in the use of an environmental management system

Product-Oriented Standards

These standards are focused on the impacts of a product on the environment throughout its life cycle. In this standard, a study is done to measure the impacts made by any product on the environment. After measuring these impacts, this information is attached to the products in the form of levels and declarations. These standards help organisations in gathering the information required for decision-making. This information can be communicated to consumers of the product so that they may understand its impact on the environment.

Benefits of Environmental Management Systems

Most of the benefits of environmental management systems are the savings made by an organisation, increased profitability, and better sales opportunities. The savings may result in millions of dollars in the form of reduced penalties and fines. Other savings can be achieved by waste reduction, resource use reduction, etc. Any organisation can measure its positive impact on the environment. Some of the benefits of an EMS are given below.

a) Better Regulatory Compliance:

Running an Environment Management System will help organisations in ensuring that it fulfils all the environmental legal responsibilities and all these responsibilities are easily managed.

b) More Effective Use of Resources:

For sustainable development, natural resources must be used very wisely. Resources should be used more effectively without wastage. EMS will help in making some policies and procedures that will ensure a reduction in wastage of resources. This reduction in wastage will also result in reduced costs.

c) Marketing:

An organisation can highlight the credibility of its business as an environmentally conscious operation, which has made a commitment to continuous environmental improvement, through advertising or annual reporting.

d) Finance:

An organisation can find it easier to get investments from banks and other financial institutions, which are increasingly keen on businesses that control their environmental impact.

e) Increased Sales Opportunities:

Running an EMS may help organisations by increasing sales opportunities, as some government departments and some large business houses may impose a condition of dealing w'ith organisations that have an EMS system.

f) Lighter Regulation:

EMS is not a regulatory requirement, but an organisation that runs an EMS shows its concern for the environment. For such environmental concerns, an organisation may get a benefit in the form of lower fees from environmental regulators.

g) Certification to Recognised Standards:

Getting certification for running an EMS through ISO 14001, BS 8555, or EMAS can help any organisation in increasing its business credibility with customers and stakeholders.

Apart from this, with increasing awareness about the environment, it is becoming essential for organisations to adopt an EMS for maintaining their position in the market.

 
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