ISO 13485 specifies requirements for a quality management system for its medical devices at which an organization should demonstrate its ability to provide medical devices.

Such organizations may be involved in one or more phases of their life-cycle, including design and development, manufacturing, storage and supply, installation, or servicing of a medical device, and design and development or supply of associated activities. ISO 13485:2016 is also employed by suppliers or external parties that provide merchandise, including quality management system-related services to these organizations.

ISO 13485 is designed to be used by organizations engaged with the design, manufacturing, installation, and servicing of medical devices and related services. It can also be utilized by internal and external parties, such as certification bodies, to help them with their auditing procedures.

Explaining basic requirements for suppliers of learning services from non-formal education and training.

CE Mark The Conformitè Europëenne (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods marketed in the European Economic Area (EEA) as of 1985. The CE marking signifies a manufacturer’s statement that goods comply with the EU’s New Approach Directives. All these directives not only apply to products inside the EU but also for goods that are manufactured in or designed to be sold in the EEA. This creates the CE marking recognizable worldwide even to those unfamiliar with the EEA.

There’s an EU requirement that products not in conformity with all the provisions of the directives Aren’t allowed to circulate at the lands of the member nations

CE marking does not offer any particular information to the user. It’s not a quality guarantee declaration, it doesn’t reveal evidence of third-party testing, and it should not be mistaken with any certification mark of this kind issued by international or European savvy examination bodies.

Certain directives include an option for the accountable organization to give a declaration of conformity saying that a product meets the requirements of the applicable directives.

Halal is an expression designating any object or an action that is permissible to use or participate in, according to Islamic law. It’s the reverse of haram. The term is employed to designate food viewed as permissible following Islamic law. Halal is an Arabic word meaning lawful or permitted. Concerning food, it is the dietary standard, as encouraged in the Qur’an (the Muslim scripture).

These terms are generally utilized concerning food products, meat products, cosmetics, personal care products, pharmaceuticals, food ingredients, and food contact substances. When many things are halal or haram, some items aren’t very apparent. Further information is needed to categorize them as halal or haram.

Good Manufacturing Practice (GMP) is a system for ensuring the products are consistently produced and controlled according to quality standards. It is intended to decrease the risks involved in any pharmaceutical production that may not be eliminated through testing the final product.

The SA8000 Standard is the world’s top social certification program. The SA8000 Standard and Certification System offers a platform for organizations of all types, in almost any industry, and in almost any country to conduct business in a way that is fair and decent for workers and also to demonstrate their adherence to their greatest social standards. Made by SAI in 1997 as the first respectable societal certification, it has caused the industry for over 20 years.

SA 8000 certification is a certifiable international standard that inspires an organization to apply, build and keep good social practices in the workplace.

Capability Maturity Model Integration (CMMI) is a process-level improvement training and evaluation program. Administered by the CMMI Institute, it was developed at Carnegie Mellon University (CMU). It is necessary by several U.S. Government contracts, particularly in program development.

CMMI may be used to guide process development across a project, a division, or a whole organization. CMMI defines the next maturity levels for processes: Initial, Managed, Defined, Quantitatively Managed, and Optimizing.

HACCP Hazard analysis and critical control points, or HACCP is a systematic preventative strategy to food safety from biological, chemical, bodily hazards, and more lately radiological risks in production procedures which could cause the finished product to be unsafe and designs measures to decrease the risks to a safe level. This way, HACCP attempts to avoid hazards instead of trying to inspect finished goods for the consequences of these hazards.

The HACCP system may be used in any way phases of a food series, from food manufacturing and preparation processes such as packaging, distribution, etc…

HACCP has been recognized internationally as a reasonable instrument for adapting traditional inspection methods to a modern, science-based, food safety system. Based on risk assessment, HACCP programs allow both industry and authorities to allocate their funds efficiently by building and auditing protected food production practices.

The OECD Principles of Good Laboratory Practice (GLP) ensure the creation of high-quality and reliable test data related to the safety of industrial chemical compounds and preparations.

Vulnerability Assessment and Penetration Testing (VAPT) are both security services that are devoted to identifying vulnerabilities in the network, server, and system infrastructure. Both the services serve another purpose and are carried out to achieve different but complementary goals.