Sunday, June 14, 2020


Hi friends!!!

Today we are going to see a basic overview of ISO 13485:2016 Medical Device Quality Management System - Requirements for Regulatory Purposes.

You will get to learn and gain knowledge about different clauses and their requirements in this blog.

In order to make the learning easy we will see each clause in a separate blog.

Now we are going to see in detail about CLAUSE 4.

Let's get into the topic.

WHY WE NEED 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).

ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system related services to such organisations.

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There are totally 8 Clauses. Out of which 1st three clauses are Introductory & Non auditable and last 5 clauses are the requirements of Quality Management System.


Clause 4: General requirements for Quality Management System.
Clause 5: Management Responsibilities
Clause 6: Resource Management 
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement

Let's discuss in detail about each of the above given clauses.

Clause 4: General requirements for Quality Management System

Clause 4 has different sub clauses. Below are some of the important sub clauses.

Clause 4.1 General Requirements

It is again divided into following clauses

Clause 4.1.1 Develop a Quality Management System

Following are the requirements of Clause 4.1.1

1. Develop a organisations QMS.

2. Document organisations QMS.

3. Keep the effectiveness of QMS.

4. Identify organisations QMS document requirements.

5. Identify the documents regulators expect from organisation.

6. Figure out MDR apply to one's organisation.

7. Recognize the role that medical device regulators expect your organisation to perform.

8. List the documents, activities, management activities, procedures, requirements that ISO 13485 needs     your organisation to maintain.

CLAUSE 4.1.2 Classify roles and applications of QMS

Following are the requirements of Clause 4.1.2

1. Consider roles that regulators need your organisation to perform.

2. Determine process that QMS needs from your organisation.

3. Explain how processes are implemented.

4. State how organisations process are interrelated.

5. Employ a risk based approach to manage organisations QMS approach.

CLAUSE 4.1.3 Support Process

Following are the requirements of Clause 4.1.3

Clause related with support of QMS process 

1. Assist every QMS process.

2. Assist every QMS process Operations.

3. Assist every QMS process Monitoring.

4. Assist every QMS process Measuring.

5. Assist every QMS process Analysis.

6. Assist every QMS process Record Keeping.

Clause 4.1.4 & 4.1.5 are Manage Changes & Control Outsourcing

Clause 4.1.6 Validation of Software

Following are the requirements of Clause 4.1.6

Document procedure for validation of computer software

1. Procedure for validation of Medical Software used in manufacturing & services.

2. Procedures can include frequency of validation based on the level of risk that may affect the ability        of product to meet desired specifications.

Results of Software Validation

1. Validation Results shall be maintained along with conclusion & if needed necessary actions for               validations.

2. Validation results shall include screenshots of software inputs & outputs throughout validation testing     & resulting actions from validation results.

Clause 4.2 QMS Documentation Requirements

Documentation requirements for QMS has been addressed in five different sub clauses. They are.

Clause 4.2.1 Incorporate Information

1. Incorporate all the documents & records in organisations document management systems.

2. Incorporate all the documents & records needed by regulations.

3. Incorporate all the documents & records needed by ISO 13485.

4. Incorporate all the documents & records needed by organisations process & products.

Clause 4.2.2 Create Manual

1. Create a quality manual for organisations QMS.

2. Explain scope of organisations QMS.

3. Outline the structure of organisations QMS documentation.

4. Incorporate QMS procedures or references while discussing different elements on QMS in manual.

5. Describe how organisations QMS process interrelate with each other.

Clause 4.2.3 Develop Medical Device Files

1. Develop & keep file for each medical device type or each family of medical devices.

2. Incorporate the reference document exhibiting organisation complying with relevant regulations &        ISO 13485.

3. Incorporate documents, descriptions, procedures, specifications, records for each medical device type     or family of medical device.

Clause 4.2.4 Control Documents

1. Develop a procedure for managing QMS documents.

2. Document the procedure for organisation QMS document control.

3. Implement organisation QMS document control procedure.

4. Control organisations QMS documents.

5. Review and approve documents before use.

6. Ensure correct version of documents are in use.

7. Protect identity and legibility of organisation QMS documents.

8. Recognize and control distribution of external QMS documents.

9. Avoid unplanned or unmeant use of obsolete documents.

10.Keep obsolete documents for reference in future use.

Clause 4.2.5 Maintain records

The requirements for this clause is same like clause 4.2.4 in terms of maintaining records.

Now I hope you have acquired some knowledge about CLAUSE 4 in ISO 13485:2016. We will see in detail about other clauses 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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