ISO 9000, 9001, 14001, 13485, 16949, 19011, AS 9000, TL 9100, FDA, GMP Product System Certification

Provide ISO 9000, 9001, 14001, 13485, 16949, 19011, AS 9000, TL 9100, FDA, GMP certification services for product system certification, AS 9000, TL 9100, FDA, GMP for product system certification

Understanding ISO 9001 GMP Certification

When the large majority of products or services in a particular business or industry sector conform to International Standards, a state of industry-wide standardization can be said to exist. ISO standards (ISO 9000, TL 9000, AS 9100) are developed by technical committees comprising experts from the industrial, technical and business sectors which have asked for the standards, and which subsequently put them to use. This is achieved through consensus agreements between national delegations representing all the economic stakeholders concerned suppliers, users, government regulators and other interest groups, such as consumers.

They agree on specifications and criteria to be applied consistently in the classification of materials, in the manufacture and supply of products, in testing and analysis, in terminology and in the provision of services. In this way, International Standards provide a reference framework, or a common technological language, between suppliers and their customers, which facilitates trade and the transfer of technology.

ISO 9001 and GMP Certification Benefits Business

International Standards consists of an international consensus (know-how). By defining the characteristics that products and services will be expected to meet on export markets, International Standards give developing countries a basis for making the right decisions when investing their scarce resources and thus avoid squandering them. The widespread adoption of International Standards means that suppliers can base the development of their products and services on specifications that have wide acceptance in their sectors. This, in turn, means that businesses using International Standards are increasingly free to compete on many more markets around the world.

ISO 9001 and GMP Certification Customer's Benefit

For customers, the worldwide compatibility of technology which is achieved when products and services are based on International Standards brings them an increasingly wide choice of offers, and they also benefit from the effects of competition among suppliers. And, for consumers, conformity of products and services to International Standards provides assurance about their quality, safety and reliability. For everyone, International Standards can contribute to the quality of life in general by ensuring that the transport, machinery and tools we use are safe.International Standards on air, water and soil quality, and on emissions of gases and radiation, can contribute to efforts to preserve the environment.

Recognize ISO 9001 International Certification

ISO 9000 actually refers to "quality management. This means what the organization does to enhance customer satisfaction by meeting customer and applicable regulatory requirements and continually to improve its performance in this regard. ISO 14000 is primarily concerned with "environmental management". This means what the organization does to minimize harmful effects on the environment caused by its activities, and continually to improve its environmental performance. cGMP refers to the FDA's "current Good Manufacturing Practice".

Recognize GMP and OHSAS 18001 Certification

There are different GMPs for the various industries regulated by the FDA. i.e. Medical Device, Human Food, and Pharmaceuticals. The cGMP for medical devices is a set of quality system requirement very similar to the previous 1994 version of ISO 9000.  cGMP for Pharmaceuticals or Human Food set regulations, which have the force of law and an organization is required to implement processes and procedures that comply with the requirements listed in the applicable cGMP before you can release your product, you can be audited by FDA inspectors at anytime.

OHSAS 18000 refers to a series of standards for Occupational Health and Safety Management Systems. OHSAS 18001 sets requirement on occupational and health safety for employees. In addition to the OHSAS 18001 Occupational Health and Safety Management Specifications there is a guidance document known as OHSAS 18002:2000 Occupational Health and Safety Management Systems Guidelines for the implementation of OHSAS 18001.

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