Hi friends!!!
In our previous blogs we have seen about CLAUSE 4, CLAUSE 5, CLAUSE 6, CLAUSE 7 of ISO 13485:2016. Please check out for the links given below.
CLAUSE 4
CLAUSE 5
CLAUSE 6
CLAUSE 7 - PART 1
Today we are going
to see remaining sub clauses of CLAUSE 7 – 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).
Image courtesy: Flickr.com
Licensed under: CC Share Alike
CLAUSE 7 PRODUCT REALIZATION
It is divided into following sub clauses.
Clause 7.1 Planning of product realization.
Clause 7.2 Customer related process.
Clause 7.3 Design and Development.
Clause 7.4 Purchasing.
Clause 7.5 Production and service provision.
Clause 7.6 Control of monitoring and measuring equipment.
Image courtesy: Wikipedia
Licensed under: CC Share Alike
We have seen about CLAUSE 7.1, CLAUSE 7.2, CLAUSE 7.3 in previous blog. Let's discuss about remaining sub clauses.
CLAUSE 7.4 PURCHASING
It is divided into
following sub clauses.
CLAUSE 7.4.1
Purchasing process
1. Develop procedures
to control product purchases.
2. Develop supplier
evaluation and selection criteria.
3. Develop supplier
monitoring and re-evaluation.
4. Monitor
performance of company’s suppliers.
5. Act whenever
supplier fails to meet purchasing requirements.
6. Develop supplier
evaluation, selection and monitoring records.
CLAUSE 7.4.2
Purchasing information
1. Plan organizations
product purchases.
2. Review organizations
purchase requirements before sharing them.
3. Maintain
organizations purchasing documents and records.
CLAUSE 7.4.3 Verification of purchased product
1. Develop methods
and activities to verify purchased product.
2. Make arrangements to
verify purchased product.
3. Verify whether organizations
purchased product meets purchase requirements.
4. Consider what to
do when changes are made to purchased products.
5. Establish and
maintain a record of purchased product verification.
CLAUSE 7.5 Production
and service provision
It is divided into
following sub clauses.
CLAUSE 7.5.1
Control of production and service provision
1. Plan organizations
production and service provision.
2. Carry out
organizations production and service provision.
3. Monitor organizations
production and service provision.
4. Control
organizations production and service provision.
CLAUSE 7.5.2 Cleanliness of the product
1. Identify product
that organization clean prior to sterilization process.
2. Document and
maintain organizations cleanliness or contamination requirements for products
that you clean prior to sterilization or use.
3. Identify product
that organization cannot clean prior to sterilization process.
4. Document and
maintain organizations cleanliness or contamination requirements for products
that you cannot clean prior to sterilization or use.
5. Identify products
supplied non sterile to be cleaned before sterilization or use.
6. Document and
maintain organizations cleanliness or contamination requirements for products
that are supplied non sterile to be cleaned before sterilization or use.
7. Identify process
agents that must be removed from products during manufacturing.
8. Document process
agents that must be removed from products during manufacturing.
CLAUSE 7.5.3
Installation activities
1. This clause
specifies product installation and verification requirements.
2. Establish medical
device installation requirements.
3. Document organizations
medical device installation requirements.
4. Establish medical
device installation verification requirements.
5. Document
organization medical device installation verification requirements.
CLAUSE 7.5.4
Servicing activities
1. Develop medical device
servicing procedures & reference materials.
2. Document
organization procedures & materials to control medical device servicing
activities.
3. Use organization
procedures and materials to control medical device servicing activities.
4. Maintain a record
of organizations medical device servicing activities.
5. Recognize
improvement opportunities and servicing complaints.
CLAUSE 7.5.5
Particular requirements for sterile medical devices
1. Develop record of
organizations sterilization process parameters.
2. Record sterilization
parameters for each batch of medical devices.
CLAUSE 7.5.6
Validation of processes for production & service provision
1. Develop procedures
to validate production and service delivery process and software applications
that could influence products & services.
2. Validate process
and software application that could influence products and services.
3. Recognize process
that generate output that cannot be verified by subsequent monitoring and measurement
until it’s too late.
CLAUSE 7.5.7
Particular requirements for validation of process for sterilization and sterile
barrier systems
1. Develop procedures
used to validate process for sterilization and sterile barrier system.
2. Document
procedures used to validate process for sterilization and sterile barrier
system.
3. Apply procedures
used to validate process for sterilization and sterile barrier system.
4. Maintain
procedures used to validate process for sterilization and sterile barrier
system.
CLAUSE 7.5.8 Identification
1. Develop procedures
and systems to control the unique identity of medical devices.
2. Document
procedures and systems to control the unique identity of medical devices.
3. Implement
procedures and systems to control the unique identity of medical devices.
CLAUSE 7.5.9
Traceability
It is further divided
into following sub clauses.
CLAUSE 7.5.9.1
Establish suitable product traceability procedures
1. Develop
organization product traceability procedures.
2. Implement organization
product traceability procedures.
3. Maintain organization
product traceability procedures.
CLAUSE 7.5.9.2
Establish suitable records for implantable devices
1. Establish
organizations traceability records for implantable medical devices.
2. Direct suppliers
of distribution services to have distribution records.
CLAUSE 7.5.10
Customer property
1. Recognize property
supplied by customers to be utilized by medical devices.
2. Verify property
supplied by customers to be utilized by medical devices.
3. Protect property
supplied by customers to be utilized by medical devices.
4. Keep a record of
customer property that is lost, damaged or unsuitable.
5. Communicate lost,
damaged or unsuitable customer property to customers.
CLAUSE 7.5.11
Preservation of product
1. Establish
procedure to preserve conformity of products.
2. Document and
maintain procedures to preserve conformity of products.
3. Prevent medical
device damage, alteration and contamination.
4. Protect products when
exposed to hazards and expected conditions.
CLAUSE 7.6 Control
of monitoring and measuring equipment
1. Identify and
recognize monitoring and measurement requirement.
2. Choose proper monitoring
and measurement requirement.
3. Develop
organizations monitoring and measurement procedures.
4. Prepare organizations
calibration and verification plans & procedures.
5. Safeguard
organizations monitoring and measurement equipment.
6. Establish
monitoring and measurement software procedures.
Now I hope you have acquired some knowledge about CLAUSE 7 in ISO 13485:2016. We will see in detail about other 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.
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!
