Healthcare Textiles Processing Facility Certification Scheme (HEALTEXPROF) is an initiative of AMTZ in collaboration with the Association of Indian Medical Device Industry (AiMeD) and Association of Healthcare Providers India (AHPI).

The COVID-19 pandemic has highlighted the importance of healthcare textiles and PPE in protecting healthcare workers and patients from infection. However, the quality of these products depends not only on the materials used but also on the processing facilities where they are sterilized, cleaned, and packaged.

The Healthcare Textiles Processing Facility Certification Scheme will help ensure that these facilities meet international standards for quality and safety.

Purpose

This Scheme provides mandatory requirements for the proper handling, processing, and preparation of multiple-use healthcare textiles either on-site or off-site for use in health care facilities.

This Scheme also describes a quality assurance program for the processing of multiple-use healthcare textiles, which includes processes and techniques for the preparation of clean bulk items for delivery to user sites and/or the assembly of textile packs for sterilization prior to end use.

Healthcare Textiles Processing Facility Certification Scheme - HEALTEXPROF | Medical Device Quality Management System

This scheme applies to:

  • The scheme aims to ensure the quality of healthcare textiles, including personal protective equipment (PPE), by certifying the facilities that process them.
  • This scheme covers Multiple-use healthcare Textiles only.
Quality of healthcare textiles, including PPE | Medical Device Quality Management System

This scheme can be implemented by:

  • Healthcare textiles processing facilities to undertake a rigorous evaluation process that includes site visits, documentation reviews, and testing of samples.
Healthcare textiles processing facilities to undertake a rigorous evaluation process | Medical Device Quality Management System

This Scheme shall not cover:

  • Single-use healthcare Textiles as they are not meant to be used again.
Single-use healthcare Textiles | Medical Device Quality Management System
This voluntary scheme is developed in compliance with
  • International standards ISO/IEC 17065:2012. Conformity assessment. Requirements for bodies certifying products, processes and services.
  • published International Accreditation Forum (IAF) documents and existing best practices available across the Globe.
International standard ISO/IEC 17065:2012 - Compliance | Medical Device Quality Management System

Note: Please share duly filled Application Form along with necessary documents.

Only PDF files are accepted. Each file must not exceed 500 KB.

Documents Required to submit along with the application:
1. Proof of Legal Entity *
2. Address Proof *
3. Proof of Legal Obligation/Regulatory Approvals/Licenses *
4. Quality Manual *
5. Master List of Procedure *
6. Master List of Work Instructions *
7. Master List of Formats *
8. Other Documents (If any)