Saturday, June 20, 2020

ISO 13485:2016 PRODUCT REALIZATION - PART 1

Hi friends!!!

In our previous blogs we have seen about CLAUSE 4, CLAUSE 5, CLAUSE 6 of ISO 13485:2016. Please check out for the links given below.

CLAUSE 4

CLAUSE 5

CLAUSE 6

Today we are going to see about CLAUSE 7 of ISO 13485:2016. In order to make the learning easy we are going to divide the contents of CLAUSE 7 into two separate blogs.

Let's get into the topics with a 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).


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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.


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CLAUSE 7.1 Planning requirements

1. Plan QMS processes that are required to realize products.
2. Develop QMS processes that are required to realize products. 
3. Establish risk management processes for product realization.
4. Plan how is your organisation going to realize each product.
5. Device quality objective for medical products.
6. Explain particular product realization requirement.
7. Produce product realization planning output.
8. Maintain records of product realization activities.
  
CLAUSE 7.2 Customer related process

It is again divided into following sub clauses.

CLAUSE 7.2.1 Determine product requirements

1. Recognize requirement provided by customers, products intended use, regulatory bodies, organisation itself.

CLAUSE 7.2.2 Review your product requirements

1. Assess product requirements before organisation accept orders.
2. Review product requirements before organisation supplies products.
3. Record organisation product requirement reviews .
4. Verify product requirements before organisation agrees to make orders. 
5. Confirm that product requirements can be fulfilled before organisation proceeds.

Clause 7.2.3 Communicate product requirements 

1. Plan arrangements to communicate with customers.
2. Document organisation customer communication arrangement.
3. Implement organisation customer communication arrangement.
4. Keep organisation customer communication arrangement.
5. Develop arrangement to communicate with regulatory authorities.
6. Employ organisation arrangements to communicate with regulatory authorities.

CLAUSE 7.3 Design and development 

It is again divided into following sub clauses.

CLAUSE 7.3.1 Prepare Design and Development procedures

1. Organisation required to document all the logical phases in design and development in a well structured procedure.
2. Defining responsibilities for different activities, including approving authorities.

The requirement of standard are:

1. Develop procedures for design and development.
2. Document procedures for design and development.

CLAUSE 7.3.2 Organize and plan Design and Development activities

1. Avoid unnecessary delays.
2. Prepare goals and objectives of design and development of product.
3. Breakdown of major activities includes timeline for each activity and whole project, risk management activities and allocation of resources needed in each phase of design and development.

The requirement of the standard are:

1. Plan the design and development of Organisation medical products.
2. Document the design and development of organisations medical products plan.
3. Maintain the design and development of Organisation planning document.
4. Control design and development of Organisation medical product.

CLAUSE 7.3.3 Determine Design and Development input

Design inputs can be decided based on the following factors.

1. Intended application.
2. Customer requirements.
3. Ergonomics & safety features.
4. Risk control & risk mitigation techniques.
5. Past complaints, failure reports, adverse events of similar products.
6. Usability requirements. Example: application, preservation, handling and maintenance.
7. Physical features, attributes and manufacturing feasibility.
8. Relevant regulatory, legal and statutory needs and appropriate standards.
9. Sterilization requirements and servicing needs.
10. Economic study and costing feasibility.

The requirements of the standard are:

1. List all the products design and development inputs.
2. Review all the products design and development inputs.
3. Approve all the products design and development inputs.
4. Keep a record of design and development inputs.

CLAUSE 7.3.4 Generate Design and Development output

Organisation can produce design output in the following forms

1. Raw materials, components parts, sub-assemblies and finished device specification in drawing.
2. Manufacturing process and environment specification.
3. Procedure for quality assurance that explains acceptance criteria.
4. Product identification, traceability, manufacturing, packaging and inspection procedures.
5. Documentation for submission to the regulatory authorities where devices will be marketed.
6. Design history file to demonstrate that design was verified and validated.

The requirements of this standard are same as CLAUSE 7.3.3               

CLAUSE 7.3.5 Carry out Design and Development reviews

1. Address number of manufacturing and customer concerns.
2. Check whether design meets product requirement or not.
3. Check whether device exhibits compatibility with processing capabilities or not.
4. Check whether safety concerns are addressed or not.
5. Check whether device is environment friendly or not.
6. Check whether service elements are adequate or not.
7. Minutes of meeting shall be maintained.

The requirements of the standard are:

1. Plan organizations design and development reviews.
2. Perform reviews in accordance with planned arrangements.
3. Maintain records of organisations design and development reviews.

CLAUSE 7.3.6 Perform Design and Development verification

Make sure design inputs matches the design output. Organisation can verify design with the help of lab tests, chemical analysis, substitute calculations, comparing designs, inspections & review of documents like specification records, drawings, procedures, plans & reports.

The requirements of the standard are:

1. Plan organisations design and development verification activities.
2. Document organisations design and development verification plan activities.
3. Perform verification in accordance with planned arrangements.
4. Maintain records of organizations design and development verification activities.

CLAUSE 7.3.7 Conduct Design and Development validation

Make sure medical device confirms to end user requirements. Validation is done on samples of initially produced lots. Validated in stimulated condition where its actual performance can be tested. Example: Clinical testing of medical device.

The requirements of this standard are same as CLAUSE 7.3.6.

CLAUSE 7.3.8 Manage Design and Development transfers

1. Document a procedure to transfer design and development outputs to manufacturing. Product development has to make sure that design can be translated to production and records of such transfers are maintained.

The requirements of the standard are:

1. Develop procedures.
2. Employ organisations procedures.
3. Record design and development transfer results and conclusions.

CLAUSE 7.3.9 Control Design and Development changes

Design changes can be needed at any time based on review, verification, validation, complaints, risk mitigation, manufacturing issues. Prior to change enforcement it should be reviewed, verified, validated and approved against design inputs and requirements.

The requirements of this standard are same as CLAUSE 7.3.8.

CLAUSE 7.3.10 Maintain Design and Development files

Includes reference records for conformity to design requirements, records of review, verification, validation and changes.


Now I hope you have acquired some knowledge about CLAUSE 7 in ISO 13485:2016. We will see in detail about other sub clauses of CLAUSE 7 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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