ISO 7396-1:2016 is an international standard published by the International Organization for Standardization (ISO) that sets out requirements for the design, installation, testing and commissioning of pipeline systems for compressed medical gases and vacuum in healthcare facilities such as hospitals. It aims to achieve the highest levels of safety and efficiency in the use of medical gases in healthcare settings. It is a product and installation standard, not a management-system standard: each installation is verified against it by testing and inspection at handover and commissioning, and no management-system certificate is issued against it.
Why ISO 7396-1:2016 Matters
ISO 7396-1:2016 is one of the core standards in health and medical care. It helps improve the quality of healthcare services by ensuring that medical gas supply systems operate with the highest level of safety and efficiency. Applying the standard contributes to:
- Better patient safety: by ensuring medical gases are supplied safely and effectively.
- Greater confidence among patients and hospitals: test and verification results provide assurance about the quality of the medical gas supply system.
- Compliance with local and international regulations: applying the standard helps ensure conformity with the various health laws and regulations.
What ISO 7396-1:2016 Covers
ISO 7396-1:2016 sets out a range of essential requirements that medical gas supply systems in hospitals and healthcare facilities must meet. These include:
- System design: specifying the pipework, equipment and installation locations so that medical gas flows continuously and safely.
- Testing and inspection: tests must be carried out to confirm the system operates efficiently and safely, including checks for gas leaks and the integrity of supply pipelines.
- Documentation: the standard requires comprehensive documentation of systems and equipment to support ongoing maintenance and review.
- Maintenance and periodic testing: the standard also covers routine maintenance practices to keep the system in good condition and operating safely.
The Benefits of Applying ISO 7396-1:2016
1. Greater operational efficiency
By applying ISO 7396-1:2016, healthcare organisations can improve the performance of their medical gas supply systems, reducing unplanned downtime and increasing operational efficiency.
2. Assured compliance with international standards
Verifying installations against the standard ensures that medical gas supply systems conform to the most advanced international standards in the field, making it easier for healthcare facilities to expand internationally.
3. A stronger reputation
Applying ISO 7396-1:2016 reflects an organisation’s commitment to quality and safety in healthcare delivery, enhancing its reputation and increasing the confidence of patients and visitors.
4. Reduced health risks
Making sure medical gas supply systems operate to recognised standards reduces the risks associated with using medical gases in hospitals and improves patient safety.
How Is ISO 7396-1:2016 Applied and Verified?
Understand the requirements: read the ISO 7396-1:2016 standard in full.
Assess your current position: review your facility’s medical gas systems to identify any gaps.
Design and install to the standard: have the system designed, installed or upgraded by a qualified manufacturer or installer to meet the requirements of the standard.
Provide training: train staff on operating the system and the required safety procedures.
Test and commission: have a competent party carry out the tests in the standard before use, such as leakage, cross-connection, flow, and gas identity and purity tests.
Record the results: keep the test and verification records as evidence that the installation conforms to the standard.
Maintain and improve: maintain the system regularly to make sure it continues to conform.
Retest after changes: test and verify the system again after any modification or extension.
ISO 7396-1:2016 is a vital standard for healthcare organisations seeking to ensure the quality and safety of their medical gas supply systems. By complying with this standard, hospitals and healthcare organisations can deliver the best possible care while safeguarding patients and staff alike.
Team Quality does not issue ISO 7396-1 certificates, as installations are verified against this standard by testing and inspection. Team Quality can, however, certify the quality management system of the manufacturer or installer of these systems to ISO 13485 or ISO 9001.
Team Quality specialises in auditing and awarding international ISO certificates to institutions, factories, companies and government bodies of all kinds. It is accredited locally by the Egyptian Accreditation Council (EGAC) and internationally by the International Accreditation Service (IAS), both signatories of the International Accreditation Forum (IAF) multilateral recognition arrangement. It is also registered with the Egyptian Organization for Standardization and Quality (EOS).
Our aim at Team Quality is to help companies of all sizes and sectors achieve excellence in quality by offering a wide range of services, including:
- Certification: we audit and certify organisations against internationally recognised standards such as ISO 9001, ISO 14001 and ISO 29994.
- Training: we offer open training courses, available to all, across a range of areas of quality, such as internal auditing, risk analysis and problem solving.
- Assessment: we provide independent assessment services to measure how well companies comply with recognised quality standards.
Our Accreditations
The company is accredited locally by the Egyptian Accreditation Council (EGAC) and internationally by the International Accreditation Service (IAS).
Locally by
- the Egyptian Accreditation Council (EGAC)
International accreditation and registration:
- Internationally: International Accreditation Service (IAS), an IAF MLA signatory
- Registered with: Egyptian Organization for Standardization and Quality (EOS)
- Our certificates can be verified on IAF CertSearch
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