Week 6 : Manufacturing Standards Focus ISO13485 and GDP

Question 1

What does the element of conformity assessment consist of?

Answer 1

• Quality management system
• Device safety and performance
• Registration

Question 2

What is under “Quality management system”

Answer 2

• Quality management system

* Post-market surveillance system

Question 3

What is under “Device safety performance”

Answer 3

• Technical documentation

* Declaration of conformity

Question 4

What is under “Registration”

Answer 4

• Registration of persons

* Registration of devices

Question 5

What is the international standard specifies requirements for a quality management system

Answer 5

ISO 13485: 2016

Question 6

Example of documentation and records control.

Answer 6

Medical device file

Question 7

Describe medical device file

Answer 7

For each medical device type or medical device family
•Company must have one or more files containing or referencing documents
•Generated to demonstrate conformity to the requirement of the ios13485 and show compliance with applicable regulatory requirements.

Question 8

Describe the content of medical file(s)

Answer 8

• General description of the medical device, intended use/purpose, and labelling, including any instructions for use
• Specification for product
• Specification or procedures for manufacturing, packaging, storage,handling and distribution
• Procedures for measuring and monitoring
• As appropriate, requirement for installation
• As appropriate, procedures for servicing

Question 9

What are the important. points in ISO 13485:2016

Answer 9

•Focus on QMS requirements, not prodcuts requirements 
•QMS requirements in the standard apply throughout the life cycle of the product
-Desgin 
-Developed
-manufactured 
•Managment responsibilities 
•Corrective and preventive actions 
•Software validation

Question 10

Describe “management responsibility” in IOS13485

Answer 10

Top managment shall ensure that responsibilities and authorities are defined, documented and communicated within the organisation.

Question 11

Describe “design and development” in IOS 13485

Answer 11

• Plan and control the desgin and development of product
• Document procedures for design and development
• Ensure that design and development outputs are suitable for manufacturing
• Verification and validation of product desgin and development

Question 12

Describe the purchasing process

Answer 12

•Documents procedures that purchased product is according to specified purchasing information
•Documents criteria for the evaluation and selection of suppliers based on
-Supplier’s ability to provide correct product required
-performance of supplier
-effect of the purchased product on the quality of the medical device
-The effect is proportionate to the risk of the medical device

Question 13

Describe the cleanliness of product

Answer 13

Company documents requirements for cleanliness of product or contamination control of the product

Question 14

Describe the installation activities

Answer 14

• Document requirements for medical device installation and acceptance criteria for verification of installation
• Including activities done by external party
• Records of installation activities must be maintained

Question 15

Describe “Servicing Activities”

Answer 15

If servicing of the MD is required, documents of

• Servicing procedures
• Reference materials and reference measurements that is necessary, for performing the servicing are given and maintained which includes verifying that product requirements are met

Question 16

Desribe indentification

Answer 16

• Document procedures for product indentification and identify product by suitable means throughout its life cycle
• Maintain identification of product status throughout production, storage, installation and servicing to ensure only product that has passed the requirement is dispatched, used or installed
• Returned products are identified and distinguished from conforming products