Thursday, June 18, 2020

ISO 13485:2016 - RESOURCE MANAGEMENT

Hi friends!!! 

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).


Image courtesy: Flickr.com
Licensed under: CC Share Alike 

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.

NOTE: Dear friends!!! ...Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

Check out for my other blogs

DON’T FORGET TO FOLLOW THIS BLOG PAGE

DROP YOUR MAIL ID TO GET IMMEDIATE UPDATES

If you find this blog post knowledgeable, comment & share it with a friend! 








7 comments:

  1. I believe there are many more pleasurable opportunities ahead for individuals that looked at your site

    ISO 13485 certification

    ReplyDelete
  2. Thanks for sharing a informative one. Know all about iso 13485: ISO 13485

    ReplyDelete
  3. This post is really nice and informative. The explanation given is really comprehensive and informative..

    ISO 13485 Certification

    ReplyDelete
  4. This post is really nice and informative. The explanation given is really comprehensive and informative..

    ce mark hong kong

    ReplyDelete
  5. We Informed you about Income Tax Return

    This tax in India since 1961 through the multiple Amendment of the Constitution of India.

    This article is really helpful to you, Every business and offices required Income Tax Return in Mumbai and Income Tax Return in Pune. We also provide professional service for tax return, tax guidanace in Income Tax Return in Chennai as well as we provide Income Tax Return in Jaipur and Income Tax Return in Noida.

    Get complete detail about income tax, tax refund status, income tax filing procedure, pan number, tax guide. Tax experts in India provided by TaxWala will assist you through the entire process. Online Income Tax Return File your return application & get your acknowledgement Online. Agents and consultanst at TaxWala help you to file income tax return done online in 3 hours without any problem.

    Our Tax Consultants also available for Income Tax Return in chandigarh, Income Tax Return in Bengaluru, Income Tax Return in Gurgaon and Income Tax Return in Hyderabad.

    We are best in taxation services, itr filing, income tax return in india etc

    Best Digital Marketing Company in India

    ReplyDelete