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).
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
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