Quality Management Systems for Medical Devices
It is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal.
Automotive Production and Relevant Service Part Organizations
ISO 16949, in conjunction with ISO 9001:2015, defines the quality management systems’ requirements for the design & development, production and, when relevant, installation and service of automotive-related products.
Petroleum, petrochemical and natural gas industries
ISO 16949, in conjunction with ISO 9001:2015, defines the quality management systems’ requirements for the design & development, production and, when relevant, installation and service of automotive-related products.
Occupational health and safety management systems
ISO 45001 is an internationally agreed-upon standard, in simple words, a set of international best practices aimed to reduce occupational injuries and diseases, thereby helping both the employers and the economy at the national level
Occupational health and safety management systems
ISO 45001 is an internationally agreed-upon standard, in simple words, a set of international best practices aimed to reduce occupational injuries and diseases, thereby helping both the employers and the economy at the national level due to losses from early retirement .
Food Safety Management Systems
ISO 22000:2018, sets the requirements for any organization in the food chain, for food safety management systems. It describes what is needed by an organization to demonstrate that it’s capable of controlling all kinds of food hazards, thereby ensuring that the food is safe for consumption.
Hazard Analysis Critical Control Points
HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.
Food Safety System Certification (FSSC)
FSSC 22000 is a certification scheme for auditing and certification of Food Safety Management Systems (FSMS), owned by a legal entity under Dutch law, called the Foundation FSSC 22000. The foundation also offers certification for combined FSMS and QMS (abbreviated as FSSC 22000-Quality).
Business Continuity Management Systems
The objective of a business continuity management system (abbreviated as BCMS) is to ensure continuity or recovery of business should it be disrupted
The BCMS comprises scope, risk assessment & evaluation, business continuity strategies, business continuity objectives, development planning, awareness & training
Anti-bribery Management Systems
Risk Management
Information Security Management Systems
SO 27001:2013 is an internationally agreed-upon set of best practices in regards to ensuring adequate controls that address requirements including confidentiality, integrity, and availability of ‘information’ pertaining to customers, employees, business partners, regulators, and society at large.
Quality Management System for Private Security Companies
ISO 18788:2015 sets requirements for organizations that conduct or contract security operations. It provides a framework for the effective conduct of security operations
Security Management Systems for the Supply Chain
Security incidents against international supply chains are threats to international trade and the economic growth of trading nations. People, goods, infrastructure and equipment including means of transport need to be protected against security incidents and their potentially devastating effects. Such protection benefits the economy and society as a whole.
Environmental Management Systems
ISO 14001 is a standard pertaining to environmental management systems that have been agreed upon internationally.
It helps organizations in many ways e.g. an increase in efficiency with regard to the use of raw materials and other resources, waste reduction, competitive edge
Quality Management System for Private Security Companies
ISO 18788:2015 sets requirements for organizations that conduct or contract security operations. It provides a framework for the effective conduct of security operations
Energy Management Systems
World energy consumption continues to rise – it has more than doubled in the last 40 years and is projected to increase a further 30 % by 2040 (International Energy Agency (IEA), World Energy Outlook 2017).
– Business Excellence’ team will conduct an initial assessment/gap analysis according to the scope of services with reference to the STANDARD including office as well as sites
– A comprehensive written report will be presented to the Top Management on the status of the compliance against standard’ requirements in order to know as to what are the gaps
– Business Excellence’s team will provide awareness training to the key process owners and relevant staff, on the requirements of the standard
– Further to this, they’ll explain how these requirements apply to their business
Business Excellence’ team will provide full assistance for the development of documentation according to the requirements
These documents will be of different types at different levels (in the order of importance) including policies, manual, system element procedures, and associated ‘forms’ including RACI matrix, process maps, risks & opportunities register, KPI’s, etc
Business Excellence’ team will extend its full support in regards to the implementation of the aforementioned documented management systems in letter and spirit
This may include SWOT analysis, process mapping, setting objectives & targets, development of RACI matrices, training need analysis, internal audit, corrective action including root cause analysis, management review meeting etc
– Finally, a mock assessment by the ‘Business Excellence’ team will be performed before third-party arrives
– The detailed report of which shall be submitted to the management and will help rectify the non-conformities & concerns
– However, management to ensure rectification of the identified concerns within the time frame, as agreed
– The selected third party to review documentation including records
– Lastly, conduct an onsite audit
To evaluate the existing systems to ascertain as to what is in compliance and what’re the gaps and submitting a comprehensive report to the client
The templates for documents of all types (at all levels) including policies, manuals, system element procedures, work instructions, RACI matrices, forms, process maps, checklist, registers, etc.
On the requirements of the international standard and how these apply in the context of the business
– Business Excellence’ team will review each & every provided document prior to finalization
– However, after review by us; the client shall also review these documents prior to approval
Business Excellence’s team will extend its full support in regards to the implementation of the documented management systems in letter & spirit. This may include SWOT analysis, process mapping, risk assessment, objectives and targets, RACI matrices, training need analysis & training plan, internal audit, corrective action, management review etc
The management systems documentation including records shall be submitted to the relevant authority for its review of documentation and on-site assessment
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