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ISO 16604:2004 Certification

What is ISO 16604?

ISO 16604:2004 describes a laboratory test method for measuring the resistance of materials used in protective clothing to penetration by blood-borne pathogens. This test method uses a surrogate microbe under conditions of continuous liquid contact. Protective clothing “pass/fail” determinations are based on the detection of viral penetration at a specific hydrostatic pressure using the ISO 13994 test apparatus.

This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorb the challenge fluid.

This test method involves a sensitive assay procedure. Because of the length of time required to complete this test method, it might not be suitable for use as a material or protective clothing quality control or assurance procedure.

Benefits of ISO 16604:2004 Certification

Global recognition

Competitive advantage in the market

Enhanced reliability

Enhanced customer satisfaction

Opportunity to gain new businesses

The ability to control and manage threats within an organization

Who can be certified ISO 16604:2004?

Manufacturing Companies

Ware Housing

Hospitals

Storage

Document required for ISO 16604:2004

  • System Manual
  • System Procedure
  • Policy
  • Objectives
  • Mission & Vision
  • Standard Operating Procedure (SOP)
  • Checklist
  • Forms
  • Formats
  • Records

The extent of Documented Information differs as per:

  • Organization’s size
  • Activities performed by the organization
  • Processes undertaken by the Organization
  • Products and services offered by the organization
  • The complexity of processes undertaken
  • Competence of persons involved

Role of Shamkris and Process of ISO 16604:2004

Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain a certificate of success in addition to enhanced performance.

The implementation process is described below:

Time Frame

Task

Process

Day 1

GAP Analysis
Certification Body
Selection
Cost Estimates

  • Finding the GAP between existing system related to ISO requirements
  • Selecting the appropriate certification body
  • Based on the scope of your business & certification body you choose

Week 1

Developing Documents

  • Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
  • Review of Standard Operating Procedures (SOP)

Week 4

Implementing Management System

  • ISO Awareness training for the top management and staff
  • Implementing a well-documented management system throughout the organization

Week 8

Internal Audit
MRM
CAPA

  • Internal audits identifying nonconformities related to ISO requirements
  • Management Review Meetings
  • Corrective and Preventive Action plan for nonconformities

Week 10

Certification Body
Audit
N-C Closing

  • Shamkris acts on your behalf and assists you in the third-party audit
  • Closing of any nonconformities identified by the certification body

Week 12

Certificate Issued

  • ISO certificates issued for years
  • Surveillance Audits yearly

Year on Year

Yearly Compliance

  • Support of Yearly documentation for audit

FAQ

ISO 16604:2004 describes a laboratory test method for measuring the resistance of materials used in protective clothing to penetration by blood-borne pathogens. This test method uses a surrogate microbe under conditions of continuous liquid contact.