ISO 14001:2015 ENVIRONMENTAL MANAGEMENT SYSTEM

• ISO 14001:2015 specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. ISO 14001:2015 is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.
• ISO 14001:2015 helps an organization achieve the intended outcomes of its environmental management system, which provide value for the environment, the organization itself and interested parties. Consistent with the organization's environmental policy, the intended outcomes of an environmental management system include:
  • Enhancement of environmental performance.
  • Fulfillment of compliance obligations.
  • Achievement of environmental objectives.
• ISO 14001:2015 is applicable to any organization, regardless of size, type and nature, and applies to the environmental aspects of its activities, products and services that the organization determines it can either control or influence considering a life cycle perspective. ISO 14001:2015 does not state specific environmental performance criteria.

18001:2007 Occupational Health and Safety Management System

• OHSAS 1800:2007 Occupational Health and Safety Management system is an international standard which provides a framework to identify, control and decrease the risks associated with health and safety within the workplace. Implementing the standard will send a clear signal to your stakeholders that you view employee’s health and safety as a priority within your organization.
• On March 12, 2018, the new health and safety management systems standard comes into force.
• Organizations with BS OHSAS 18001 certification are granted a period of three years to make the transition to the new standard. The impact determined by the changes / innovations introduced by the ISO 45001 requirements depends on the degree of maturity and effectiveness of the current management system.
• Due to the COVID19 outbreak globally, the transition period for migrating accredited certification from OHSAS 18001:2007 to ISO 45001:2018 can be extended up to six months (11 September 2021).

ISO 45001:2018 Occupational Health and Safety Management System

• ISO 45001 is an ISO standard for management systems of occupational health and safety, published in March 2018. The goal of ISO 45001 is the reduction of occupational injuries and diseases, including promoting and protecting physical and mental health.
• SO 45001:2018 is applicable to any organization regardless of its size, type and activities. It is applicable to the OH&S risks under the organization's control, taking into account factors such as the context in which the organization operates and the needs and expectations of its workers and other interested parties.
• ISO 45001:2018 does not state specific criteria for OH&S performance, nor is it prescriptive about the design of an OH&S management system.
• ISO 45001:2018 enables an organization, through its OH&S management system, to integrate other aspects of health and safety, such as worker wellness/wellbeing.
• ISO 45001:2018 does not address issues such as product safety, property damage or environmental impacts, beyond the risks to workers and other relevant interested parties.

ISO 13485:2016 Quality Management System for Medical devices

• ISO 13485 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 and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
• Requirements of ISO 13485 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
• The processes required by ISO 13485 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.

ISO 50001 Energy Management System

• The specification requires use of an energy management system with a main purpose of using energy more efficiently. The standard is based on a management system model of continual improvement, similar to some other common ISO standards. The certification calls for a company to develop an energy policy, establish goals to meet the policy, utilize data to meet goals, measure policy effectiveness, and continually make improvements to the policy.
• ISO 50001 is not industry specific and is intended for any organization that wants to implement and maintain an energy management system.
• This ISO standard provides a practical way to improve energy use, through the development of an energy management system (EnMS).

IATF 16949:2016

• This is the global technical specification and quality management standard for the automotive industry. Based on ISO 9001:2015, it was published in October 2016 and replaces ISO/TS 16949. It is designed to be used in conjunction with ISO 9001:2015 and contains supplemental requirements specific to the automotive industry rather than being a standalone QMS.
• It brings together standards from across Europe and the US. IATF 16949:2016 outlines everything you need to know about achieving best practice when designing, developing, manufacturing, installing or servicing automotive products.

ISO 22000 / BRC / Food Safety Management System

• ISO 22000 is an international certification standard that defines the requirements of food safety management systems. It can be used by all organizations, in the supply chain - from farmers to food services, to processing, transportation, storage, retail and packaging.
• It combines and supplements the core elements of ISO 9001 and HACCP to provide an effective framework for the development, implementation and continual improvement of a Food Safety Management System (FSMS).
• Increasing consumer demand for safe food has led many companies to develop both food quality and safety management systems, based on the Hazard Analysis and Critical Control Point (HACCP). In 2001, ISO started the development on an auditable standard, which further defines HACCP’s role in food safety management systems and culminated in the newly formed ISO 22000. The ISO 22000 standard intends to define the food safety management requirements for companies that need to meet and exceed food safety regulations all over the world. One standard that encompasses all the consumer and market needs. It speeds and simplifies processes without compromising other quality or safety management systems.

ISO/IEC 27001 Security Management System

ISO/IEC 17025 (NABL) - General requirements for the competence of testing and calibration laboratories

• ISO/IEC 17025 (NABL) - General requirements for the competence of testing and calibration laboratories.
• ISO/IEC 17025 is useful for any organization that performs testing, sampling or calibration and wants reliable results. This includes all types of laboratories, whether they be owned and operated by government, industry or, in fact, any other organization.
• The standard is also useful to universities, research centers, governments, regulators, inspection bodies, product certification organizations and other conformity assessment bodies with the need to do testing, sampling or calibration.

IATF 16949 Automotive Quality Management System

This is the global technical specification and quality management standard for the automotive industry. Based on ISO 9001:2015, it was published in October 2016 and replaces ISO/TS 16949. It is designed to be used in conjunction with ISO 9001:2015 and contains supplemental requirements specific to the automotive industry rather than being a standalone QMS.

It brings together standards from across Europe and the US. IATF 16949 outlines everything you need to know about achieving best practice when designing, developing, manufacturing, installing or servicing automotive products.

AS 9100 Aerospace Quality Management System

• AS 9100 Aerospace Quality Management System.
• Safety, airworthiness, product conformity and reliability are all key aspects of AS9100, the aerospace quality standard. These quality requirements are crucial to aerospace OEMs, which maintain high levels of liability for their product standard. Because product performance can be affected by a failure to handle parts and materials correctly, AS9100 addresses the complexity and diversity of the industry's supply chain. The standard takes into consideration the complete life cycle of aerospace products.
• The US Federal Aviation Administration (FAA) defines individual manufacturing approvals through its Federal Aviation Regulations (FARs) and laws mandating compliance. Subsequently, AS9100 is rapidly becoming a prerequisite for doing production in the aerospace business, as many original equipment manufacturers (OEMs) only work with suppliers that are certified to the aerospace standard. Also, many International Aerospace Quality Group (IAQG) member companies have deployed AS9100 within their own organizations.

ISO 29001:2020

• ISO 29001:2020 Petroleum, petrochemical and natural gas industries-Sector-specific quality management systems-Requirements for product and service supply organizations.
• It is standard practice for organizations in the petroleum, petrochemical and natural gas industries (further referred to as oil and gas sector) to require their products and services suppliers to operate quality management systems that conform to standards, such as ISO 9001, ISO 29001, API Spec Q1 and API Spec Q2 . Products and service providers are often required to certify their quality management systems by recognized accredited certification bodies.
• ISO 29001:2020 supplements ISO 9001:2015 with requirements and guidance to manage risks associated with the oil and gas sector and provides a framework for aligning requirements with complementary standards employed within the sector.
• ISO 29001:2020 is designed to be technically equivalent to API Spec Q1 (9th edition) and API Spec Q2 (1st edition).
• ISO 29001:2020 provides 'minimum' requirements as agreed within the oil and gas sector to manage quality. Organizations specifying ISO 29001:2020 to their products and service providers can incorporate additional requirements related to their own and stakeholder requirements.

CE Marking

CE Marking is a ‘mark of conformity’ or ‘mark of compliance’ which states that a particular product meets requirements of European union legislation. It is a mandatory mark to place / sell a product in Europe. CE Marking is a kind of guarantee for consumers that “the product is safe for use”. CE Marking is also considered as most recognized product certification in world. CE marking is the manufacturer's declaration that the product meets the requirements of the applicable EC directives.

API SPEC Q1/Q2

API Spec Q1 is a company level certification based on the standard developed and published by the American Petroleum Institute (API) titled "Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry". This certification is intended for companies who manufacture equipment or components of equipment used in oil and natural gas production. Certifications are issued exclusively by API.

API SPEC Q2 is Specification for Quality Management System Requirements for Service Supply Organizations for the Petroleum and Natural Gas Industries.

API MONOGRAM

API Monogram is a voluntary licensing program that facilitates the consistent manufacturing of product that conforms to applicable API Specifications. Licensed manufacturers are given the authority to apply the API Monogram registered mark to equipment that meets the requirements.

Plus, the licensee demonstrates that they have a quality management system that is compliant with API Spec Q1/Q2 - an industry-leading quality management standard. API Spec Q1 meets all of the ISO 9001 requirements, in addition to requirements that are geared specifically for the oil and natural gas industry.

5S

One of the most powerful Lean Manufacturing Tools and a cornerstone of any successful implementation is that of 5S. 5S and its 5 Steps areSeiri, Seiton, Seiso, Seiketsu and Shitsuke.

5S is a simple tool for organizing your workplace in a clean, efficient and safe manner to enhance your productivity, visual management and to ensure the introduction of standardized working.

In addition to standardized working which provides you with a stable foundation to build all of your other improvements through implementing Lean Tools, you also provide a highly visual workplace. One of the most important factors of 5S is that it makes problems immediately obvious. 5S is a team run process and should be conducted by the people who work within the area in which the principles of 5S are being applied.

NABH

• National Accreditation Board for Hospitals & Healthcare Providers (NABH) is a constituent board of Quality Council of India, set up to establish and operate accreditation programme for healthcare organizations. the board is structured to cater to much desired needs of the consumers and to set benchmarks for progress of health industry. The board while being supported by all stakeholders including industry, consumers, government, have full functional autonomy in its operation.

GMP, GLP

• Merck‘s advanced GMP inorganic salts production facility in Darmstadt, Germany features state-of-the-art technology that meets the global requirements for top quality pharmaceutical salts.
• The Principles of Good Laboratory Practice (GLP) are a managerial quality control system covering the organisational process and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded, reported and retained (or archived). The OECD Principles of GLP are followed by test facilities carrying out studies to be submitted to receiving authorities for the purposes of assessing the health and environmental safety of chemicals and chemical products which may also be of natural or biological origin and, in some circumstances, may be living organisms.
• The Principles of GLP define the responsibilities of test facility management, study director, study personnel and quality assurance personnel that are operating within a GLP system, and minimum standards concerning the suitability of facilities and equipment to perform studies, the need for standard operating procedures, documentation of raw data, study reports, the archiving of records, etc.