ISO 22609:2014 Clothing for protection against infectious agents — Medical face masks — Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)
What is ISO 22609:2014 Certification?
ISO 22609:2014 describes a laboratory test method for measuring the resistance of medical face masks to penetration by a splash of synthetic blood.
ISO 22609:2014 primarily addresses the performance of materials or certain material constructions used in medical face masks. The test method does not address the performance of the medical face mask’s design, construction, interfaces, or other factors which may affect the overall protection offered by the medical face mask and its operation (such as filtration efficiency and pressure drop).
ISO 22609:2014 does not evaluate the performance of medical face masks as a protection against contamination via airborne exposure pathways or in the prevention of the penetration of aerosolized body fluids deposited on the medical face mask.
Benefits of ISO 22609:2014 Certification
Customer Satisfaction
Deliver products that consistently meet customer requirements and a service that is dependable and can be relied on.
Reduced Operating Costs
Continual improvement of processes and resulting operational efficiencies mean money saved.
Improved Stakeholder Relationship
Improve the perception of your organization with staff, customers, and suppliers.
Legal Compliance
Understand how statutory and regulatory requirements impact your organization and its customers.
Improved Risk Management
Greater consistency and traceability of products and services means problems are easier to avoid and rectify.
Proven Business Credentials
Independent verification against a globally recognized industry standard speaks volumes.
Who can be certified ISO 22609:2014?
Workers, fundamentally those in the health care profession, associated with treating and thinking about people harmed or wiped out, can be presented to natural fluids fit for transmitting malady.
Document required for ISO 22609:2014 Certification
- 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 22609:2014
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