ISO certification and Industrial compliance
ISO
What is ISO?
* International Organization for Standardization
* ISO 9000 is a series of quality management system(QMS) standards
* ISO 9000(QMS) standards are not specific to products or services, but apply to the processes that create them
* The standards are generic so that they can be used by both manufacturing and service industries
History of ISO
ISO (International Organization for Standardization) is the world’s largest developer of voluntary International Standards. ISO founded in 1947 and since then have published more than 19000 International Standards covering almost all aspects of technology and business. Today it’s have members from 164 countries and about 150 people work full time for our Central Secretariat in Geneva, Switzerland.
Popular ISO standards
* ISO 9000 Quality management
* ISO 14000 Environmental management
* ISO 3166 Country codes
* ISO 26000 Social responsibility
* ISO 50001 Energy management
* ISO 31000 Risk management
* ISO 22000 Food safety management
* ISO 4217 Currency codes
* ISO 639 Language codes
Benefits of International Standards
ISO International Standards ensure that products and services are safe, reliable and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors and increasing productivity. They help companies to access new markets, level the playing field for developing countries and facilitate free and fair global trade.
International Standards bring technological, economic and societal benefits. They help to harmonize technical specifications of products and services making industry more efficient and breaking down barriers to international trade. Conformity to International Standards helps reassure consumers that products are safe, efficient and good for the environment.
Benefit includes:
For Business
For Society
For Government
For Business
International Standards are strategic tools and guidelines to help companies tackle some of the most demanding challenges of modern business. They ensure that business operations are as efficient as possible, increase productivity and help companies access new markets.
Benefits include:
* Cost savings
* Enhanced customer satisfaction
* Access to new markets
* Increased market share
* Environmental benefits
* Taking part in the standard development process
For Society
ISO has over 19000 standards touching almost all aspects of daily life.
When products and services conform to International Standards consumers can have confidence that they are safe, reliable and of good quality. For example, ISO's standards on road safety, toy safety and secure medical packaging are just a selection of those that help make the world a safer place.
International Standards on air, water and soil quality, on emissions of gases and radiation and environmental aspects of products contribute to efforts to preserve the environment and the health of citizens.
For Government
ISO standards draw on international expertise and experience and are therefore a vital resource for governments when developing regulations.
This has a number of benefits:
Expert opinion - ISO standards are developed by experts. By integrating an ISO standard into national regulation, governments can benefit from the opinion of experts without having to call on their services directly.
Opening up world trade - ISO standards are international and adopted by many governments. By integrating ISO standards into national regulation, governments help to ensure that requirements for imports and exports are the same the world over, therefore facilitating the movement of goods, services and technologies from country to country.
What is ISO 9001
ISO 9001 is an international standard that gives requirements for an organization’s quality management system (QMS). It is part of a family of standards published by the International Organization for Standardization (ISO) often referred to collectively as the “ ISO 9000 series ” or “ ISO 9000 family ”.
For this reason, you may sometimes hear your suppliers refer to being “ ISO 9000 certified ”, or having an “ ISO 9000-compliant QMS ”. This will normally mean that they are claiming to have a QMS meeting the requirements of ISO 9001, the only standard in the ISO 9000 family that can be used for the purpose of conformity assessment.
ISO 9000 - Quality management
The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.
There are many standards in the ISO 9000 family, including:
ISO 9001:2008 - sets out the requirements of a quality management system
ISO 9000:2005 - covers the basic concepts and language
ISO 9004:2009 - focuses on how to make a quality management system more efficient and effective
ISO 19011:2011 - sets out guidance on internal and external audits of quality management systems.
What are the principles of standards?
ISO 9000 also contains 8 management principles which provide the foundation for the ISO 9000 series of standards.
1. Customer focus
2. Leadership
3. The involvement of people
4. Process approach
5. System approach to management
6. Continual improvement
7. A factual approach to decision making
8. Mutually beneficial supplier relationships
1. Customer focus ~ Organizations 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 and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.
3. Involvement of people ~ People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.
4. Process approach ~ A desired result is achieved more efficiently when activities and related resources are managed as a process.
5. Systems approach to management ~ Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.
6. Continual improvement ~ Continual improvement of the organization’s overall performance should be a permanent objective of the organization.
7. Factual approach to decision making ~ Effective decisions are based on the analysis of data and information.
8. Mutually beneficial supplier relationships ~ An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
What does the ISO 9001 contain?
There are 8 sections in ISO 9001:
1. Scope
2. Normative reference
3. Terms and definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement
It is sections 4, 5, 6, 7 & 8 which contain the requirements themselves and organizations wishing to be certified against ISO 9001:2000 will need to demonstrate that they have addressed all of these requirements.
Implementing and maintaining QMS based on the ISO 9000 standard
For a successful implementation of your QMS, these seven steps are recommended :
1. Fully engage top management to-
Define why you want to implement ISO 9000
Define your mission, vision, and values in your organization
Define your organization’s stakeholders : customers, suppliers, stockholders, employees, society etc.
Define your quality policy, and
Define and align organizational objectives and related product/ service quality objectives.
2. Identify key processes and the interactions needed to meet quality objectives.
3. Implement and manage the QMS and its processes(using process management techniques)
4. Build your ISO 9000-based QMS
* Identify ISO 9000 requirements
* Map these requirements with your implemented QMS, where applicable
* Make a gap analysis: identify where in your existing system the requirements are fulfilled, and where they are not
* Include in your QMS processes the activities, procedures and controls needed.
5. Implement the system, train company staff and verify effective operation of your processes
6. Manage your QMS
* Focus on customer satisfaction
* Monitor and measure the operation of your QMS
* Strive for continual improvement
* Consider implementing business excellence models in the company operations.
7. If necessary, seek third party certification/registration of the QMS or alternatively, issue a self-declaration of conformity
How does ISO 9001 help you in selecting Supplier?
To help in this task you may consider the following :
* What is the specific product (goods or service) you are buying ?
* What impact does this product have on your own business ?
* are the risks to your business if you experience problems with this product ?
* How can you be sure that the product you receive will actually meet your requirements ?
* What do you know about the reputation and historical performance of your supplier ?
* What level of confidence do you need in your supplier’s ability to provide you with conforming product on a consistent basis ?
* If you decide that conformity to ISO 9001 is important, (based on your assessment of the risks associated with the goods and services you are buying) how can you be sure that your supplier does have a QMS that meets ISO 9001 requirements ?
* Are the goods and services you require covered by your supplier’s QMS ? (You may need to ask for a copy of your supplier’s actual certificate or declaration of conformity to find this out !).
How does you have confidence that your supplier meets ISO 9001?
There are various ways in which your supplier can claim that its QMS meets the requirements of ISO 9001. These include :
Supplier’s declaration of conformity : A declaration by your supplier itself affirming that its QMS meets ISO 9001 requirements, usually supported by legally-binding signatures. This declaration can be based on your supplier’s internal audit system, or on second party or third party audits
Second party assessment : your supplier has been assessed directly by its customer (for example by you, or by another customer, whose reputation you respect) to check if its QMS meets ISO 9001 requirements and your own requirements – sometimes used in contractual “ business-to-business ” transactions
Third party assessment : (Often referred to as certification or registration) your supplier hires an impartial third party (a certification body or “ registrar ”) to conduct an assessment to verify conformity to ISO 9001 requirements. This third party then issues a certificate to your supplier describing the scope of its QMS, and confirming that it conforms to ISO 9001.
Additional confidence may be derived from the fact that some certification bodies (registrars) are accredited by nationally or internationally recognized accreditation bodies, who verify the certification body’s independence and competence to carry out the certification process.
Bangladesh (BSTI)
The Bangladesh Standards and Testing Institution (BSTI) was established by the Government through an Ordinance passed in July 1985. BSTI is headed by a Director General (Additional Secretary to the Government). BSTI is playing an important role in developing and Promoting industrial Standardization
The primary activities of the Bangladesh Standards and Testing Institution (BSTI) are:
# standardization of services and products (S);# introduction of the international unit system of weights and measures and promotion of metrology services (M);
# promotion of quality assurance activities; rendering testing facilities for services and products; preparation, promotion and adoption of national standards.
# The Institution is also empowered with some regulatory measures in these fields. The Institutional budget is fully supported by its own income, i.e. It is functioning as a self financing organization.
