ISO 16603:2004 Certification
What is ISO 16603?
ISO 16603:2004 describes a laboratory test method for measuring the penetration resistance of clothing materials to blood and body fluids. This test method uses a synthetic blood in continuous contact with the material specimen at specified set of conditions 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 synthetic blood.
Benefits of ISO 16603:2004 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 16603:2004?
Manufacturing Companies
Ware Housing
Hospitals
Storage
Document required for ISO 16603:2004
- 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 16603:2004
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