ISO 9001 is a Quality Management Standard. It suits all organizations large or small and covers all sectors, including charities and the voluntary sector. It is suitable for organizations in all industry sectors and will help your organization to improve management processes to compete locally and/or globally. It aims to help organizations become structured and efficient.
ISO 13485 Medical devices — Quality management systems — Require for regulatory purposes specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
ISO 14001(EMS) Environment Management System is the internationally recognized standard for the environmental management of businesses. It prescribes controls for those activities that have an effect on the environment. These include the use of natural resources, handling and treatment of waste and energy consumption.
ISO 17025 is use for calibration and testing laboratories. It applies to any organization that wants to assure its customers of precision, accuracy and repeat ability of results. This includes in-house laboratories for which assurance of results is at a premium.
ISO/IEC 20000 certification (often referred to as just ISO 20000) is the international IT service management standard that enables IT organizations (whether in-house, outsourced or external) to make certain that their IT provider management tactics are aligned each with the desires of the business and with global excellent exercise.
ISO/IEC 20000 certification enables businesses benchmark how they supply managed services, measure provider stages and investigate their performance. It’s miles broadly aligned with, and draws strongly.
ISO 22000 is a Food Safety Management System that can be applied to any organization in the food chain, farm to fork. Becoming certified to ISO 22000 allows a company to show their customers that they have a food safety management system in place. This provides customer confidence in the product. This is becoming more and more important as customers demand safe food and food processors require that ingredients obtained from their suppliers to be safe.
ISO 27001 is the international standard for Information Security Management Systems (ISMS). It is applicable to any organization where the misuse, corruption or loss of its business or client information could result in a major commercial disaster. So 27001 sets out the requirements of information security management system. It is part of the ISO 27000 family of standards relating to information and cyber security and offers a comprehensive set of controls, based on best practice in information security.
ISO 29000 defines the great management system requirements for the layout, development, production, installation and provider of products for the petroleum, petrochemical and natural gas industries.
Developed as a direct result of a partnership between ISO and the international oil and gas industry (led by the American Petroleum Institute – API), ISO 29000 specifically focuses on the oil and gas supply chain.
The ISO 29000 general is based totally on ISO 9001 and carries supplementary necessities emphasizing defect prevention and the reduction of variant and waste from service vendors.
The Occupational Health and Safety Assessment Series, OHSAS 18000, has been developed to help organizations control and minimize occupational health and safety risks. OHSAS 18001 is a specific standard for occupational health and safety management systems designed to eliminate or minimize the risk to employees and other interested parties who may be exposed to occupational health and safety risks associated with the business activities. OHSAS 18001 is compatible with ISO 9001 and ISO 14001 management systems. OHSAS 18001 represents a progression of a management system philosophy, from quality to environmental, continuing to occupational health and safety.
Food Safety System Certification 22000 (FSSC 22000) is an ISO-based certification scheme for auditing and certification of food safety systems of the organizations in the whole food supply chain. The scheme uses FSSC 22000 uses the existing standards ISO 22000, ISO 22003 and technical specifications for sector PRPs and applies to the organizations in the food chain which process or manufacture animal products, perishable vegetal products, products with a long shelf life and (other) food ingredients like additives, vitamins and bio cultures and food packaging manufacturing. The FSSC 22000 certification scheme is fully recognized and accepted by the Global Food Safety Initiative (GFSI) and by the European co-operation for Accreditation (EA).
Hazard Analysis and Critical Central Point (HACCP) Food Safety Management System is a process control system designed to identify and prevent microbial and other hazards in food production and entire food chain. HACCP includes steps designed to prevent problems before they occur and to correct deviations through a systematic way as soon as they are detected.
Such preventive control systems with documentation and verification are widely recognized by scientific authorities and international organizations as the most effective approach available for producing safe food.
HACCP enables the producers, processors, distributors, exporters of food products to utilize technical resources efficiently and in a cost effective manner in assuring food safety.
HACCP offers continuous and systematic approaches to assure food safety. In light of recent food safety related incidents, there is a renewed interest in HACCP from a regulatory point of view. The industry will do well to adopt HACCP approaches to food safety whether or not it is required.
International Featured Standard (IFS) Standards are developed for and through all involved parties in the supply chain, which would like to use uniform standards to ensure safety and quality of food and non-food products and related services.
IFS Standards help to comply with all legal food and non-food safety and quality requirements and give common and transparent standards to all concerned suppliers and service providers as well as a concrete and strong answer to the high safety and quality expectations of customers.
HALAL “Food That Meets With Muslim Law”.
Muslims commonly use two terms to describe every subject as Halal or Haram. Halal is a Arabic word which means permitted, lawful with respect to which no restriction exists, and the doing and consuming of which the Law-giver, ALLAH has allowed.
Haram means the opposite-unlawful or forbidden that which the Lawgiver absolutely prohibited; anyone who engages in it is liable to incur the punishment of Allah in the Hereafter as well as a legal punishment in this world.
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.
British Retail Consortium (BRC) Global Standards is a leading safety and quality certification program, used by over 23,000 certificated suppliers in 123 countries, with certification issued through a worldwide network of accredited certification bodies.
The Standards guarantee the standardization of quality, safety and operational criteria and ensure that manufacturers fulfill their legal obligations and provide protection for the end consumer. BRC Global Standards are now often a fundamental requirement of leading retailers.
An integrated management system (IMS) combines all related components of a business into one system for easier management and operations. Quality (QMS), Environmental (EMS), and Safety (OHSMS) management systems are often combined and managed as an IMS.
“Kosher” is a Hebrew word that literally means “fit” or “proper.” When used in relation to food products, “kosher” means that the item in question meets the dietary requirements of Jewish law. The principles governing what is kosher and what is not, are rooted in the Written Torah (the Bible) and the Oral Torah.
GDPMD (Good Distribution Practices for Medical Devices):
GDPMD (Good Distribution Practices for Medical Devices) specifies the requirements for a Quality Management System to be established, implemented and maintained by an organization in carrying out activities in medical devices distribution to comply with the medical device regulatory requirements.
GDPMD (Good Distribution Practices for Medical Devices) requires an organization to demonstrate its ability to maintain quality, safety and performance of medical devices in compliance with the medical device regulatory requirements during distribution.
SEDEX stands for Supplier Ethical Data Exchange, it is non-profit business organization dedicated to drive ethical business practices. It provides secure online database that allows members to store, manage and share data and information on four key areas Labor standards, Health and Safety, Business Ethics and Environment. It is a fast, Cost effective way of sharing business information globally. It helps to improve ethical business practices in Global Supply chain. As a supplier, Sedex allow to fill the self-assessment form and post any certification, corrective action plans and audit reports.
SA8000 is an auditable certification standard that encourages organizations to develop, maintain, and apply socially acceptable practices in the workplace. International workplace-quality standard based on the concept of social accountability, its major objective is to ensure application of ethical practices in hiring and treatment of employees and in production of goods and services. Released in 1997 by the New York (USA) based non-profit body social accountability International (SAI), it relies on the codes-of-conduct affirmed by International Labour organization (ILO), the Universal Declaration Of Human Rights, and UN Convention On The Rights Of A Child. Founded on the principles of transparency, credibility, and verification, it is said to be the first global ethical standard and appropriate for any type of organization regardless of the country, industry, or size.
The Business Social Compliance Initiative (BSCI) Monitoring System is the European approach to improving social performance in supplier countries through a uniform social standards monitoring solution.
BSCI is an initiative of the Foreign Trade Association (FTA). All BSCI participants are also FTA members and share the FTA vision of “Free Trade, Sustainable Trade”. To fulfill this vision, BSCI has been given specific governance bodies through which BSCI companies are invited to actively take part, to develop and implement an excellent system for improved working conditions in the global supply chain.
Supply chain management system
ISO 28001 provides requirements and guidance for organizations in international supply chains to develop and implement supply chain security processes.
Establish and document a minimum level of security within a supply chain(s) or segment of a supply chain. Assist in meeting the applicable authorized economic operator (AEO) criteria set forth in the World Customs Organization Framework of Standards and conforming national supply chain security programs.
Quality management – Customer satisfaction
This document gives guidelines for the process of complaints handling related to products and services within an organization, including planning, design, development, operation, maintenance and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system.
OCCUPATIONAL HEALTH AND SAFETY
ISO 45001 is an ISO standard for management systems of occupational health and safety (OH&S), published in March 2018. The goal of ISO 45001 is the reduction of occupational injuries and diseases.
Management system for private security operations
It provides the principles and requirements for a security operations management system (SOMS).
ISO 18788 provides a business and risk management framework for organizations conducting or contracting security operations and related activities and functions while demonstrating.
ANTI-BRIBERY MANAGEMENT SYSTEMS
Prevent, detect and address bribery by adopting an anti-bribery policy, appointing a person to oversee anti-bribery compliance, training, risk assessments and due diligence on projects and business associates, implementing financial and commercial controls, and instituting reporting and investigation procedures.
Road traffic safety management systems
ISO 39001 specifies requirements for a road traffic safety (RTS) management system to enable an organization that interacts with the road traffic system to reduce death and serious injuries related to road traffic crashes which it can influence.
Asset management system
ISO 55001 specifies requirements for an asset management system within the context of the organization. ISO 55001 can be applied to all types of assets and by all types and sizes of organizations.
Good Laboratory Practices
In August 2016, the FDA published—and is currently reviewing—a revised set of proposed Good Laboratory Practices (GLP) regulations. They are currently conducting surveillance inspections of laboratories, testing sites, and CROs to ensure that facilities comply with GLP and can maintain data integrity for their studies. If a Study Director does not have the ability to ensure both GLP compliance and data integrity, they can be subject to a Form 483, other Warning Letters, and more.
Good Agricultural Practices
Good Agricultural Practices are voluntary audits that verify that fruits and vegetables are produced, packed, handled, and stored as safely as possible to minimize risks of microbial food safety hazards.
Good Agricultural Practices (GAP) and Good Handling Practices (GHP) are voluntary audits that verify that fruits and vegetables are produced, packed, handled, and stored as safely as possible to minimize risks of microbial food safety hazards. GAP & GHP audits verify adherence to the recommendations made in the U.S. Food and Drug Administration’s Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (pdf) and industry recognized food safety practices.
Restriction of Hazardous Substances Directive
RoHS stands for Restriction of Hazardous Substances. RoHS, also known as Directive 2002/95/EC, originated in the European Union and restricts the use of specific hazardous materials found in electrical and electronic products (known as EEE). All applicable products in the EU market after July 1, 2006 must pass RoHS compliance.
Worldwide Responsible Accredited Production
Created by a working group of the American Apparel & Footwear Association in 1997, WRAP became a standalone entity in 2000. While it was founded by clothing industry companies, WRAP’s charter requires that a majority of its board members come from outside the apparel industry.
CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA.
Forest Stewardship Council
The Forest Stewardship Council (FSC) is an international non-profit, multi-stakeholder organization established in 1993 to promote responsible management of the world’s forests. The FSC does this by setting standards on forest products, along with certifying and labeling them as eco-friendly.
Good Storage Practices
Good Storage Practices (GSPs) play an integral role in various Pharmaceutical, Pharma-oriented and food companies, organizations and institutions. Each one of them is required to demonstrate not only efficient management but also efficient storage of products. Such efficient storage of drugs is essential because it will that the potency and the physical integrity of medicaments are preserved and kept. What is more, GSPs are activities which generally prevent deterioration and ensure that the quality and safety of product are also maintained. All storage conditions for medical materials and food products are expected to be compliant with products’ labelling.
Good Distribution Practices for Medical Devices
GDPMD (Good Distribution Practices for Medical Devices) specifies the requirements for a Quality Management System to be established, implemented and maintained by an organization in carrying out activities in medical devices distribution to comply with the medical device egulatory requirements.
Capability Maturity Model Integration
The Capability Maturity Model Integration (CMMI) helps organizations streamline process improvement, encouraging a productive, efficient culture that decreases risks in software, product and service development.
Capability Maturity Model Integration (CMMI) is a process level improvement training and appraisal program. Administered by the CMMI Institute, a subsidiary of ISACA, it was developed at Carnegie Mellon University (CMU). CMMI defines the following maturity levels for processes: Initial, Managed, Defined, Quantitatively Managed, and Optimizing.
Version 2.0 was published in 2018. CMMI is registered in the U.S. Patent and Trademark Office by CMU.