In our last blog we have seen about CLAUSE 4 & CLAUSE 5 of ISO 13485:2016. Please check out for the link given below.
ISO 13485:2016 - QMS REQUIREMENTS
ISO 13485:2016 - MANAGEMENT RESPONSIBILITY
Today we are going to see about CLAUSE 6 of ISO 13485:2016 - RESOURCE MANAGEMENT.
Let's get into the topic with a small introduction about ISO 13485:2016.
WHY ISO 13485:2016?
ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that constantly meet customer and applicable regulatory requirements. Such organisations can be involved in Design & Development of Medical Device, Production, Storage and Distribution, Installation and Servicing of Medical Device or provision for other associated activities (eg: Technical Support).
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CLAUSE 6: RESOURCE MANAGEMENT
It is divided into following sub clauses.
CLAUSE 6.1 ALLOCATION REQUIREMENTS
1. Find out resources that organizations QMS needs.
2. Offer resources that organizations QMS needs.
3. Offer resources that are required to implement organizations QMS.
4. Offer resources that are required to fulfill
Customer requirements.
CLAUSE 6.2 PERSONNEL REQUIREMENTS
1. Recognize personnel and assess the work that could influence product quality.
2. Develop a process to look after the competence of medical device workers.
3. Employ organizations process to manage competence of companies medical device workers.
4. Choose effective methods for evaluating organizations training & awareness activities.
5. Keep records that shows the competence of medical device workers.
CLAUSE 6.3 INFRASTRUCTURE REQUIREMENTS
1. Develop organizations QMS infrastructure requirements.
2. Offer the infrastructure that companies QMS needs.
3. Recognize maintenance activities that could influence quality.
4. Keep the infrastructure that organizations QMS needs to have.
CLAUSE 6.4 ENVIRONMENT REQUIREMENTS
It is again divided into following sub clauses.
CLAUSE 6.4.1 CONTROL YOUR WORKING CONDITIONS
1. Recognize work environment required to fulfill product requirements.
2. Document organizations requirements for work environment.
3. Recognize the working conditions that affects the quality of medical devices.
4. Document procedures to monitor and control these working conditions.
5. Recognize personnel who could influence medical device safety or performance.
6. Recognize those who come into contact with products or concerning environments.
7. Develop health, cleanliness and clothing requirements for these personnel.
8. Control those who work temporarily under special environmental conditions.
CLAUSE 6.4.2 PLAN YOUR CONTAMINATION CONTROLS
1. Plan how your organization is going to control products that are or may be contaminated.
2. Plan how your organization is going to control the contamination of sterile medical devices.
Now I hope you have acquired some knowledge about CLAUSE 6 in ISO 13485:2016. We will see in detail about other clauses in next blog.
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