Quality assurance and documentation discipline
Built to support quality expectations. Altruist Diagnostics positions quality as a lifecycle activity from supplier selection and incoming inspection through production, release, feedback and improvement.
ISO 13485-aligned readiness
Quality Management System developed in accordance with ISO 13485 requirements. Certification status should be stated only when verified by controlled evidence.
Incoming quality control is supported through controlled SOPs, records, responsibilities and review criteria.
In-process quality checks is supported through controlled SOPs, records, responsibilities and review criteria.
Final quality review is supported through controlled SOPs, records, responsibilities and review criteria.
Supplier qualification is supported through controlled SOPs, records, responsibilities and review criteria.
Traceability is supported through controlled SOPs, records, responsibilities and review criteria.
Risk management is supported through controlled SOPs, records, responsibilities and review criteria.
Document control is supported through controlled SOPs, records, responsibilities and review criteria.
CAPA is supported through controlled SOPs, records, responsibilities and review criteria.
Continuous improvement is supported through controlled SOPs, records, responsibilities and review criteria.
Training is supported through controlled SOPs, records, responsibilities and review criteria.
Validation planning is supported through controlled SOPs, records, responsibilities and review criteria.