ISO 9001:2008
Quality Management System:

ISO 9001: 2008 defines quality as ‘the degree to which a set of inherent characteristics fulfils requirements.’ Grade denotes a category or grade attributed to a product, and grades and categories of products having the same functional use can be widely different.
ISO 13485


ISO 13485 is the international standard recognized for medical device regulations around the world. It is intended to promote harmonisation in the medical device industry and set a basis for quality system regulations worldwide.
ISO 14001:2004
Environmental Management System:

EMS defines an effective environmental system which can be applied to all types of companies. Environmental issues have come to the forefront in recent years with greater awareness amongst legislators, insurers, financiers...
WHO-GMP

WHO-GMP is an acronym for WORLD HEALTH ORGANIZATION – GOOD MANUFACTURING PRACTICE is the specifications derived by world health organization.

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been "top-of-the-line" 20 years ago, may be less than adequate by today's standards.