Hi friends!!!
In our previous blogs we have seen about CLAUSE 4, CLAUSE 5, CLAUSE 6, CLAUSE 7, CLAUSE 8. Please check out for the links given below.
Today we are going to see about CLAUSE 8.3, 8.4 and 8.5 of ISO 13485;2016.
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
In our previous blog CLAUSE 8 – PART 1 we have discussed about clause 8.1 and 8.2. Now we are going to see clause 8.3, 8.4, 8.5.
CLAUSE 8.3 Control
of non-conforming product
It is divided into
following sub clauses.
Clause 8.3.1
General
1. Discuss the
prevention of unintended delivery or use of non-conforming products.
2. Explain how you
intend to prevent unintended product delivery or use.
3. Avoid the
unintended delivery or use of your non-conforming products.
4. Keep record of
your organizations non-conforming products activities.
CLAUSE 8.3.2
Actions in response to non-conforming product detected before delivery
1. Deal with non-conforming
products before delivery.
2. Take actions to
eliminate detected non-conformities.
3. Prevent products
original intended use or application.
4. Authorize
non-conforming products use, release or acceptance.
CLAUSE 8.3.3
Actions in response to non-conforming product detected after delivery
1. Recognize
non-conforming products after delivery or after use.
2. Act as appropriate
to counter the effects that have been identified.
3. Develop and keep a
record of actions that have been taken.
4. Explain how company’s
advisory notices should be released and managed.
5. Keep a record of
actions taken when advisory notices are issued.
Clause 8.3.4 Rework
1. Explain how product
rework should be performed.
2. Clarify how product
rework should be verified.
3. Clarify how product
rework should be reviewed.
4. Clarify how product
rework should be approved.
5. Clarify how product
rework should be recorded.
CLAUSE 8.4
Analysis of data
Elaborates
analytical requirements as following
1. Plan how your
organization is going to evaluate its QMS.
2. Establish
procedures to evaluate organizations QMS.
3. Utilize analytical
results to improve organizations QMS.
CLAUSE 8.5
Improvement
It is divided into
following sub clauses.
CLAUSE 8.5.1
General
1. Recognize any
changes that are necessary for improvement.
2. Recognize any
changes that maintain QMS stability, adequacy and effectiveness.
3. Recognize any
changes that are needed to ensure medical device safety and performance.
4. Initiate changes
that must be made.
CLAUSE 8.5.2 Corrective
action
1. Document
corrective action procedure.
2. Explicate how
actual problems will be investigated.
3. Explain how
corrective actions will be developed.
4. Explain how
corrective actions will be verified.
5. Explain how
corrective actions will be taken.
6. Explain how
corrective actions will be reviewed.
7. Implement
organizations corrective action procedure.
8. Keep records of
corrective actions made.
CLAUSE 8.5.3 Preventive
action
1. Document preventive
action procedure.
2. Explicate how
actual problems will be investigated.
3. Explain how preventive
actions will be developed.
4. Explain how preventive
actions will be verified.
5. Explain how preventive
actions will be taken.
6. Explain how preventive
actions will be reviewed.
7. Implement
organizations preventive action procedure.
8. Keep records of preventive
actions made.
IMPORTANT
TERMINOLOGIES
Correction: Occurs
when you discover a problem and implement an immediate fix to allow the work to
continue.
Corrective action:
Discovers the root cause and correct it to prevent the problem from occurring again
in the future.
Preventive action:
Correct the root cause of potential non conformity. It means when a worker
judges some problem in the process and correct it before that process can create
non conformity. That problem can be a root cause for various defects.
Now I hope you have acquired some knowledge about CLAUSE 8 in ISO 13485:2016. We will see in detail about different topic related to healthcare in our 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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