Medical Devices Quality Management System

ISO 14001 Certification – Environment Management System

ISO 14000 is a family of standards related to «Environmental Management» that aims to help organizations to achieve ISO 14001 Certification:

• 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;
• Continually improve in the above.

Since; ISO 14000 is similar to ISO 9000 quality management, in what both pertain to the process of how a service or product delivered or produced rather than to the product or service quality itself for sure;

Since; as common practice; with ISO 9000 auditing process, Swiss Approval International evaluation and certification for ISO 14001.  Performed in a similar way according ISO 19011 audit standard  and when auditing, performed for both management systems, 9000 and 14000, compliance at once achieved.

Though; ISO 14001; sets out the criteria for an Environmental Management System (EMS). It does not state requirements for environmental performance. Since; maps out a framework that a company or organization can follow to set up an effective EMS. Not only it can used by any organization that wants to improve resource efficiency but also; reduce waste, and drive down costs. Therefore; using ISO 14001 can provide assurance to company management and employees as well as external stakeholders. Environmental impact measurement and improvement; indeed.

However; ISO 14001 is known as a generic management system standard, meaning that it is relevant to any organization seeking to improve and manage resources more effectively. As a result; this includes:

• Single-site to large multi-national companies.
• High-risk companies to low-risk service organizations.
• Manufacturing, process, and the service industries, including local governments.
• All industry sectors including public and private sectors.
• Original equipment manufacturers and their suppliers.

The requirements of ISO 14001 are an integral part of the European Union‘s Eco-Management and Audit Scheme (EMAS). EMAS‘s structure and material requirements are more demanding, mainly concerning performance improvement, legal compliance, and reporting duties.

ISO 14001 Environmental Management System requirements are very similar to those of EMAS. Additional requirements for EMAS include:

• Stricter requirements on the measurement and evaluation of environmental performance against objectives and targets.
• Government supervision of the environmental verifiers.
• Strong employee involvement; EMAS organisations acknowledge that active employee involvement is a driving force and a prerequisite for continuous and successful environmental improvements.
• Environmental core indicators creating multi-annual comparability within and between organisations.
• Mandatory provision of information to the general public.
• Registration by a public authority.

ISO 14001 Certification

Swiss Approval International assures an accredited certification. Therefore; giving to organizations the suitable passport for International market, ensuring with accuracy and independence the principles and rules established by the standard ISO 14001. EMAS certification is also possible, through affiliated authorized certification bodies.