ISO 14001
ISO 14001:2015 is the international standard for environmental management systems (EMS). It sets requirements for an EMS that an organisation can use to improve its environmental performance.
Core principles:
- Continual improvement of environmental performance
- Compliance with legal and other environmental obligations
- Identification and management of environmental risks and opportunities
- Life cycle perspective
Distinctions:
- ISO 14001: environmental management
- ISO 9001: quality management (general)
- EN ISO 13485: quality management for medical devices
- ISO 45001: occupational health and safety
Relevance for glove and PPE manufacturers:
- Increasingly required by major purchasers (hospital groups, industry) as a sustainability credential
- Helps minimise environmental impacts of production (water, energy, waste in glove manufacturing)
- Synergy with REACH compliance and supply chain requirements
ISO 14001 is not a legal obligation. Certification is carried out by accredited bodies. ISO 14001 and ISO 9001 can be combined in an integrated management system.
Frequently asked questions
Is ISO 14001 legally required for medical device manufacturers?
No. ISO 14001 is not a legal requirement. It is a voluntary standard. However, many large purchasers and tenders require ISO 14001 certification as a sustainability credential.
What is the difference between ISO 14001 and ISO 9001?
ISO 9001 is a quality management standard (focus: customer satisfaction, product quality). ISO 14001 is an environmental management standard (focus: environmental performance, environmental law compliance). Both can be combined in an integrated management system.
Can ISO 14001 certification help ensure REACH compliance?
Indirectly yes. A well-implemented EMS per ISO 14001 systematically identifies environmentally relevant substances in production - including SVHCs under REACH. However, it does not replace the direct REACH assessment and notification obligations.