ISO 9001:2015
ISO 9001: 2015 is an international standard that contains the requirements for a quality management system in a business organization that must meet the criteria to align its operations with internationally recognized standards. The quality system is a management system that leads to achieving set goals in terms of business quality and service delivery. This system consists of organizational structure, responsibility of the entities in the organization, processes and resources needed to manage the system… ISO 14001: 2015
ISO 14001: 2015 ISO 14001 is a family of standards related to environmental management that exists to help organizations to minimize how their operations processes, etc. negatively affect the environment (i.e. cause adverse changes to air, water, or land); comply with applicable laws, regulations, and other environmentally oriented requirements; and continually improve in the above. ISO 14000 is similar to ISO 9000 quality management in that both pertain to the process of how a product is produced, rather than to the product itself.
OHSAS 18001 OHSAS 18001, Occupational Health and Safety Assessment Series, (officially BS OHSAS 18001) is a British Standard for occupational health and safety management systems. Compliance with it enables organizations to demonstrate that they have a system in place for occupational health and safety. BS OHSAS 18001 is being replaced by ISO 45001, which was published in March 2018 by the International Organization for Standardization. Organizations which are certified to BS OHSAS 18001 should migrate to ISO 45001 by March 2021 if they want to retain a recognized certification.
ISO 45001
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. The standard is based on OHSAS 18001, conventions and guidelines of the International Labour Organization including ILO OSH 2001, and national standards. It includes elements that are additional to BS OHSAS 18001 ISO 45001 changes compared to OHSAS 18001:2007) which it is replacing over a three-year migration period from 2018 to 2021. ISO 45001 also follows the High Level Structure of other ISO standards like ISO 9001:2015 and ISO 14001:2015 which makes integration of these standards much easier.
ISO/ IEC 17025:2017
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body.
ISO 9001: 2015 is an international standard that contains the requirements for a quality management system in a business organization that must meet the criteria to align its operations with internationally recognized standards. The quality system is a management system that leads to achieving set goals in terms of business quality and service delivery. This system consists of organizational structure, responsibility of the entities in the organization, processes and resources needed to manage the system… ISO 14001: 2015
ISO 14001: 2015 ISO 14001 is a family of standards related to environmental management that exists to help organizations to minimize how their operations processes, etc. negatively affect the environment (i.e. cause adverse changes to air, water, or land); comply with applicable laws, regulations, and other environmentally oriented requirements; and continually improve in the above. ISO 14000 is similar to ISO 9000 quality management in that both pertain to the process of how a product is produced, rather than to the product itself.
OHSAS 18001 OHSAS 18001, Occupational Health and Safety Assessment Series, (officially BS OHSAS 18001) is a British Standard for occupational health and safety management systems. Compliance with it enables organizations to demonstrate that they have a system in place for occupational health and safety. BS OHSAS 18001 is being replaced by ISO 45001, which was published in March 2018 by the International Organization for Standardization. Organizations which are certified to BS OHSAS 18001 should migrate to ISO 45001 by March 2021 if they want to retain a recognized certification.
ISO 45001
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. The standard is based on OHSAS 18001, conventions and guidelines of the International Labour Organization including ILO OSH 2001, and national standards. It includes elements that are additional to BS OHSAS 18001 ISO 45001 changes compared to OHSAS 18001:2007) which it is replacing over a three-year migration period from 2018 to 2021. ISO 45001 also follows the High Level Structure of other ISO standards like ISO 9001:2015 and ISO 14001:2015 which makes integration of these standards much easier.
ISO/ IEC 17025:2017
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body.
Macedonian GMP standard
The Good Manufacturing Practice (GMP) system is international standard introduced in Macedonia that contains quality assurance requirements and a system for Good manufacturing practice for the production of medicines and products intended for the needs of pharmacy. The system is designed to provide quality that it provides confirms the medicinal product or medicinal products to be manufactured and controlled in accordance with quality standards that correspond to their target use, and to meet the requirements of the marketing authorization and the product specification to be manufactured according to standard. Legitimate body for standardization of Macedonian GMP is the Drug Agency and medical funds of the Republic of Macedonia (MALMED).
Gs1 standard for bar code
Barcodes are symbols that can be scanned electronically using laser or systems based camera. They are used to encrypt information such as numbers on products and serial numbers. Barcodes play a key role in supply chains, enabling the parties as manufacturers of medicinal products, retailers, manufacturers, transport providers and hospitals to automatically identify and get them to track the products while moving through the supply chain.
GLOBALG.A.P
GLOBALG.A.P. is a farm assurance program, translating consumer requirements into Good Agricultural Practice. EurepGAP is a common standard for farm management practice created in the late 1990s by several European supermarket chains and their major suppliers. GAP is an acronym for Good Agricultural Practices. It is now the world’s most widely implemented farm certification scheme. Most European customers for agricultural products now demand evidence of EurepGAP certification as a prerequisite for doing business. The standard was developed using the Hazard Analysis and Critical Control Points (HACCP) guidelines published by the United Nations Food and Agriculture Organization, and is governed according to the ISO Guide 65 for certifications schemes. Unlike other farm certification schemes, it has definitive rules for growers to follow, and each production unit is assessed by independent third party auditors. These auditors work for commercial certification companies who are licensed by the EurepGAP secretariat to conduct audits and award certificates where merited.
GACP (Good Agricultural and Collection Practices)
GACP (Good Agricultural and Collection Practices) is a set of guidelines covering areas of cultivation (from seeds and propagation material), collection, harvest, processing, packaging, personnel, equipment, documentation and others for the sake of satisfying the minimum required quality assurance in plant cultivation.This standard is necessary for the manufacturing plants of cannabis for medical purposes!
The Good Manufacturing Practice (GMP) system is international standard introduced in Macedonia that contains quality assurance requirements and a system for Good manufacturing practice for the production of medicines and products intended for the needs of pharmacy. The system is designed to provide quality that it provides confirms the medicinal product or medicinal products to be manufactured and controlled in accordance with quality standards that correspond to their target use, and to meet the requirements of the marketing authorization and the product specification to be manufactured according to standard. Legitimate body for standardization of Macedonian GMP is the Drug Agency and medical funds of the Republic of Macedonia (MALMED).
Gs1 standard for bar code
Barcodes are symbols that can be scanned electronically using laser or systems based camera. They are used to encrypt information such as numbers on products and serial numbers. Barcodes play a key role in supply chains, enabling the parties as manufacturers of medicinal products, retailers, manufacturers, transport providers and hospitals to automatically identify and get them to track the products while moving through the supply chain.
GLOBALG.A.P
GLOBALG.A.P. is a farm assurance program, translating consumer requirements into Good Agricultural Practice. EurepGAP is a common standard for farm management practice created in the late 1990s by several European supermarket chains and their major suppliers. GAP is an acronym for Good Agricultural Practices. It is now the world’s most widely implemented farm certification scheme. Most European customers for agricultural products now demand evidence of EurepGAP certification as a prerequisite for doing business. The standard was developed using the Hazard Analysis and Critical Control Points (HACCP) guidelines published by the United Nations Food and Agriculture Organization, and is governed according to the ISO Guide 65 for certifications schemes. Unlike other farm certification schemes, it has definitive rules for growers to follow, and each production unit is assessed by independent third party auditors. These auditors work for commercial certification companies who are licensed by the EurepGAP secretariat to conduct audits and award certificates where merited.
GACP (Good Agricultural and Collection Practices)
GACP (Good Agricultural and Collection Practices) is a set of guidelines covering areas of cultivation (from seeds and propagation material), collection, harvest, processing, packaging, personnel, equipment, documentation and others for the sake of satisfying the minimum required quality assurance in plant cultivation.This standard is necessary for the manufacturing plants of cannabis for medical purposes!
Good manufacturing practices (GMP)
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
Hazard analysis and critical control points, or HACCP
Hazard analysis and critical control points, or HACCP, is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level. In this manner, HACCP attempts to avoid hazards rather than attempting to inspect finished products for the effects of those hazards. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc.
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
Hazard analysis and critical control points, or HACCP
Hazard analysis and critical control points, or HACCP, is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level. In this manner, HACCP attempts to avoid hazards rather than attempting to inspect finished products for the effects of those hazards. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc.
ISO 22000
ISO 22000 is a standard developed by the International Organization for Standardization dealing with food safety. It is a general derivative of ISO 9000.
The ISO 22000 international standard specifies the requirements for a food safety management system that involves the following elements:
• interactive communication
• system management
• prerequisite programs
• HACCP principles
Critical reviews of the above elements have been conducted by many scientists. Communication along the food chain is essential to ensure that all relevant food safety hazards are identified and adequately controlled at each step within the food chain. This implies communication between organizations both upstream and downstream in the food chain. Communication with customers and suppliers about identified hazards and control measures will assist in clarifying customer and supplier requirements.
Recognition of the organization’s role and position within the food chain is essential to ensure effective interactive communication throughout the chain in order to deliver safe food products to the final consumer.
SMETA Audit
Sedex Members Ethical Trade Audit (SMETA) is one of the most widely used ethical audit formats in the world. SMETA is an audit methodology, providing a compilation of best practice ethical audit techniques. It is designed to help auditors conduct high quality audits that encompass all aspects of responsible business practice, covering Sedex’s four pillars of Labour, Health and Safety, Environment and Business Ethics. SMETA is designed for suppliers to share one audit with multiple customers, meeting multiple customer requirements and reducing duplication in ethical auditing. SMETA has three elements:
1. A common Best Practice Guidance on conducting ethical trade audits
2. A common Audit Report format
3. A common Corrective Action Plan format.
Nearly 20,000 SMETA audits are uploaded onto the Sedex platform every year. Each SMETA audit carries a unique reference code to ensure the SMETA audit is appropriately validated. It can be used in a regular site audit or in the Sedex Offline Audit Tool. SMETA is available in English, Spanish and Chinese.
SMETA Audit
Sedex Members Ethical Trade Audit (SMETA) is one of the most widely used ethical audit formats in the world. SMETA is an audit methodology, providing a compilation of best practice ethical audit techniques. It is designed to help auditors conduct high quality audits that encompass all aspects of responsible business practice, covering Sedex’s four pillars of Labour, Health and Safety, Environment and Business Ethics. SMETA is designed for suppliers to share one audit with multiple customers, meeting multiple customer requirements and reducing duplication in ethical auditing. SMETA has three elements:
1. A common Best Practice Guidance on conducting ethical trade audits
2. A common Audit Report format
3. A common Corrective Action Plan format.
Nearly 20,000 SMETA audits are uploaded onto the Sedex platform every year. Each SMETA audit carries a unique reference code to ensure the SMETA audit is appropriately validated. It can be used in a regular site audit or in the Sedex Offline Audit Tool. SMETA is available in English, Spanish and Chinese.