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
Check out the Who can be certified ISO 16604:2004 Certification Video
Document required for ISO 22612:2016
- 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 an accreditation body of success in addition to enhanced performance.
The implementation process is described below:
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
Certification Body
• ISO certificates issued for 1 years
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.