Industries we serve
Healthcare & Pharmaceuticals
Where the quality system and the patient outcome are the same thing.
- 5Standards commonly certified
- ISO 13485the device sector’s regulatory baseline
- SectorExperienced assessors assigned
What this sector is actually dealing with
The pressures behind the certification decision
Organisations rarely certify because they woke up wanting a management system. These are the reasons they actually give us.
Regulatory density
GMP, CDSCO, state FDA, NABH and export-market requirements overlap and occasionally conflict, and every one of them requires evidence.
Patient data protection
Digitised records, telemedicine and health apps create personal data exposure under the DPDP Act with limited historical governance.
Product traceability and recall
Batch traceability and field safety corrective action capability must be provable, not theoretical.
Supplier and material control
API sources, excipients, packaging and sterilisation services all sit inside the regulated chain and must be qualified and monitored.
Recommended standards
Standards most relevant to healthcare & pharma
Where several apply, integrating them into one management system reduces both total audit days and the risk of two parallel systems drifting apart.
Medical Devices Quality Management
Certify a medical device QMS meeting regulatory expectations for design, manufacture, sterilisation and vigilance.
Learn moreQuality Management System
Certify a quality management system that delivers consistent products and services and satisfies customers.
Learn moreInformation Security Management System
Certify an ISMS that protects the confidentiality, integrity and availability of information through assessed risk.
Learn moreOccupational Health & Safety
Certify an OH&S management system that prevents work-related injury and ill health through worker participation.
Learn moreEnvironmental Management System
Certify an environmental management system that controls impacts, meets compliance obligations and reduces waste.
Learn moreAlso serving
Other sectors we work in
Next step
Certifying in healthcare & pharma?
We will assign an assessor with genuine experience in your sector, and tell you in advance who they are and what their background is.