ISO 13485:2016 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).
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.
Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.
The standards place great emphasis on making quality management systems closer to the processes of organizations and on continual improvement. As a result, they direct users to the achievement of business results, including the satisfaction of customers and other interested parties.
ISO 14001:2015 was published on 15th Sept, 2015. The standard sets out the criteria for an environmental management system. It maps out a framework that a company or organization can follow to set up an effective environmental management system. It can be used by any organization, large or small, regardless of its field of activity including manufacturing, services, institutions, health or any other sector.
Using ISO 14001:2015 can provide assurance to company management and employees as well as external stakeholders that environmental impact is being measured and improved.There are more than 300,000 certifications to ISO 14001 in 171 countries around the world.
Using ISO 14001 helps in Demonstrating compliance with current and future statutory and regulatory requirements, increased leadership involvement and engagement of employees, improvement in company reputation and the confidence of stakeholders, achieving strategic business aims by incorporating environmental issues into business management, providing a competitive and financial advantage through improved efficiencies and reduced costs, encouraging better environmental performance of suppliers by integrating them into the organization’s business systems.
ISO 45001 formulates requirements for comprehensive, modern occupational health and safety. Replacing the previously, widely-used OHSAS 18001 standard, ISO 45001:2018 has been in force since March 2018 and is the only international and independent standard for operational health and safety management systems. Our experts certify your occupational health and safety management system according to ISO 45001 and consider all aspects of occupational safety – both those related to operational processes as well as those arising from work-related stress that can trigger mental illness.
Energy Management The new ISO 50001:2018 is based on the quality standard ISO 9001 and the environmental standard ISO 14001. This enables organizations to convert their existing energy and environmental management systems into a systematic energy management system:
ISO 22301 is an international framework that has been developed to help businesses identify potential threats to critical business functions and design a business continuity management plan. The standard helps companies build effective backup systems and processes to safeguard against theft, natural disasters, disease outbreaks, terrorist attacks and other extraordinary incidents. ISO 22301 specifies the requirements to plan, implement, monitor, review and improve a company’s business continuity management system, thereby minimising the impact of disruptions.
ISO 22301 certification provides formal business continuity guidelines that will keep your organisation operational during and following a disruption. It seeks to minimise the impact to critical business functions, ensuring they are still capable of being delivered or recovered promptly. The ISO 22301 standard is applicable for companies of all sizes across any industry, particularly those operating in high risk or complex environments where the ability to function without delay is of paramount importance. ISO 22301 business continuity certification also helps you avoid loss of revenue and customers should a major problem occur.
ISO 26000 is an international standard providing guidelines for social responsibility in business and other organizations. It aims to improve the conditions for workers, the natural environment and the health and welfare of society. Corporate social responsibility (CSR) is a vital part of business today. Organizations and stakeholders around the world are becoming increasingly aware of the need for and benefits of socially responsible behavior. By acting in a socially responsible way, a company gains recognition as a credible and equitable employer and business partner.
IG can support you in understanding the purpose of ISO 26000 and how you can improve the sustainable development of your company. Our experts provide ISO 26000 verification, gap assessment, training in social responsibility and translate the key principles of ISO 26000 into effective actions. Furthermore, we inform you of best practices relating to socially responsible behavior.
Implementing an information security management system will provide your organization with a system that will help to eliminate or minimize the risk of a security breach that could have legal or business continuity implications.
An effective ISO 27001 information security management system (ISMS) provides a management framework of polices and procedures that will keep your information secure, whatever the format. Following a series of high profile cases, it has proven to be very damaging to an organization if information gets into the wrong hands or into the public domain. By establishing and maintaining a documented system of controls and management, risks can be identified and reduced.
ISO 27001 certification demonstrates that you have identified the risks, assessed the implications and put in place systemized controls to limit any damage to the organization.
Accreditation is an independent assessment that ensures certification bodies have the technical competence and integrity of impartiality to deliver credible certification services. This is essential to building confidence and trust in certification.
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