ISO 9000 is a series of International Standards for Quality Management & Quality Assurance. It is not a set of product standards nor it is specific to one industry. It is a provision of minimum system requirements which will help ensuring that items/ services are provided in accordance with a good management practice.
ISO 14001 is certification of environment management system. Implementation of ISO 14001 standard ensures that an organization has taken proper measures to reduce adverse affect of it’s activities over environment. ISO 14001 certification provides a tool to effectively manage environmental concerns of an organization. Even non polluting organization can apply for ISO 14001 certification to prepare a framework for betterment of environment. Latest version in ISO’s EMS standard is ISO 14001:2015 certification
OHSAS 45001:2018 is an internationally recognised occupational health and safety management system standard.The standard is applicable to any organization that wishes to eliminate or minimize risk to employees and other stakeholders who may be exposed to OH&S risks associated with its activities. Many organizations will have elements required by OHSAS 45001 already in place, which can be supplemented to provide a more cohesive management system to meet the requirements of the standard.
• Customer satisfaction - through delivery of products that consistently meet customer requirements whilst safeguarding their health and property.
• Reduced operating costs - by decreasing down-time through incidents and ill health and reducing costs associated with legal fees and compensation.
• Improved stakeholder relationships - by safeguarding the health and property of staff, customers and suppliers.
• Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers.
• Improved risk management - through clear identification of potential incidents and implementation of controls and measures.
• Proven business credentials - through independent verification against recognized standards.
• Ability to win more business - particularly where procurement specifications require certification as a condition to supply.
ISO/IEC 27001:2013 covers all types of organizations (e.g. commercial enterprises, government agencies, not-for profit organizations). ISO/IEC 27001:2005 specifies the requirements for establishing, implementing, operating, monitoring, reviewing, maintaining and improving a documented Information Security Management System within the context of the organization's overall business risks.
The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.