Hi friends!!!
In our previous blogs we have seen about CLAUSE 4, CLAUSE 5, CLAUSE 6, CLAUSE 7. Please check out for the links given below.
Today we are going to see about CLAUSE 8 of ISO 13485;2016. In order to make the learning easy we will split the CLAUSE 8 into two separate blogs.
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).
CLAUSE 8: MEASUREMENT, ANALYSIS AND IMPROVEMENT
It is divided into following sub clauses.
CLAUSE 8.1 General
CLAUSE 8.2 Monitoring and measurement
CLAUSE 8.3 Control of non-conforming product
CLAUSE 8.4 Analysis of data
CLAUSE 8.5 Improvement
We will discuss in detail about each clauses individually.
IMPORTANT TERMINOLOGIES
MEASUREMENT
Allocation of numbers to performance, events or objects.
MONITORING
Done to verify compliance or non-compliance of a process or product.
ANALYSIS
Uses data to discover patterns, relationship and trends.
CLAUSE 8.1 General
Plan processes related to monitoring, measurement and analysis.
Plan how monitoring methods will be utilized to confirm conformity and effectiveness.
Plan how measurement will be utilized to confirm conformity and effectiveness.
Plan how analysis will be utilized to confirm conformity and effectiveness.
CLAUSE 8.2 Monitoring and measurement
It is again divided into following sub clauses.
CLAUSE 8.2.1 Feedback
1. Develop feedback methods and procedures.
2. Assess the information organization has gathered.
3. Utilize feedback to measure QMS effectiveness.
4. Utilize feedback to facilitate risk management.
5. Utilize feedback to support improvement process.
6. Utilize feedback to enhance product realization.
CLAUSE 8.2.2 Complaint handling
1. Develop organizations complaint handling procedure.
2. Document organizations complaint handling procedure.
3. Implement organizations complaint handling procedure.
4. Keep organizations complaint handling procedure.
5. Maintain organizations complaint handling procedure.
CLAUSE 8.2.3 Reporting to regulatory authorities
1. Develop reporting procedures when regulators expect your organization to report to them.
2. Document reporting procedures when regulators expect your organization to report to them.
3. Implement reporting procedures when regulators expect your organization to report to them.
4. Keep reporting procedures when regulators expect your organization to report to them.
CLAUSE 8.2.4 Internal audit
1. Develop your organizations internal audit procedure.
2. Plan your organizations internal audit process.
3. Carryout your organizations internal audit process.
4. Keep your organizations internal audit process.
5. Eliminate all non conformities and its causes.
6. Follow up on measures implemented to resolve non conformities.
CLAUSE 8.2.5 Monitoring and measurement of processes
1. Find out whether process achieved intended results.
2. Develop proper methods to monitor and measure each QMS process.
3. Apply suitable methods to monitor and measure each QMS process.
CLAUSE 8.2.6 Monitoring and measurement of product
1. Monitor and measure organizations product characteristics.
2. Establish record of product monitoring and measurement activities.
3. Complete all planned arrangements before the product is released.
Now I hope you have acquired some knowledge about CLAUSE 8 in ISO 13485:2016. We will see in detail about other sub clauses of CLAUSE 8 in next blog.
NOTE: Dear friends!!! …Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.
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