ISO 13485 Standards for Medical Devices Quality Management

The standard for the Quality Management System is referred for the design and manufacture of Medical Devices is known as ISO 13485. Whereas ISO 13485:2016 is an individual document and aligns with ISO 9001:2008 because it does not follow the structure of the latest version of 9001. The rules and regulations are depending upon the countries as countries have their own set of regulations. 

What is ISO Certification?

There are two types of certifications. 

1. Certification of Quality Management System of the company against the requirement of ISO certification. 

2. Certification of the individual is required to audit. 

Certification for your company requires implementing the QMS and then hires the recognized certified body to audit and approve the standards. When all the procedures are in place then you need to operate QMS for some time, by doing this you will get the necessary records to process further to audit, review, and certification.  

Let us first understand what is the purpose of ISO 13485?

Purpose

The medical device industry widely used international standards for quality management. This is issued by the ISO i.e. International Organization for Standardization. It is the standard of an effective solution to meet the requirement for the medical device industry. It also provides a practical foundation for manufacturers as well as demonstrating the commitment for the safety and quality of medical devices of EU Medical Device Directive (MDD), and EU Medical Device Regulation (MDR).  

The current version of ISO 13485

ISO latest revised on March 2016. In this latest version, they included many things. They are: 

1. A more focus on risk

2. Amplification of management responsibilities

3. Amplification of training responsibilities

4. Improvement at facility requirement

5. Design and development requirements for many regulations.

6. Improvement on control suppliers

7. Traceability procedures

8. Improvement at Complaint handling process

9. Enhancement of product cleanliness requirement

These are the improvement that the current version of ISO 13485 Certification has. These are the requirement which is acceptable on the basis of implementing a QMS.

Is ISO 13485 mandatory? 

This is the common question that every organization will face it and they even wonder to take ISO certification or not. The simple answer is NO, ISO 13485 is not mandatory. With respect to ISO, you can create QMS which best suits the needs of your organization. As long as the QMS process meets the legal and regulatory requirements for medical devices, you can manufacture and sell the product. 

Concepts Of IATF 16949:2016 Standard for the Automotive Sector

These are the standards that ascertain the need for Quality Management System (QMS), especially for the automotive sector. It had been originally created in 1999 to enrich different assessment and certification schemes. It primarily focuses on the event of a top quality Management System which provides a continual improvement, emphasizing defect prevention and therefore the reduction of variation and waste within the supply chain.

IATF 16949 was developed by the International Automotive Task Force to enhance the certification process. it had been issued by CISQ Automotive. this is often a federation of Certification Bodies that are recognized by IATF. IATF is an independent QMS system that's fully aligned with the structure and requirement and this may not work as an alone body but must be implemented as a supplement with ISO 9001:2015.

What is IATF 16949?

This standard will provide guidance and tools for the businesses and organizations who want to make sure their product consistency satisfies their customer requirement also because of the quality and consistency of the products. It actually defines the standards for automotive-based QMS. a corporation will receive the IATF 16949 certification once they provide the merchandise design-related function. Their requirements are generic and are applicable to any supplier providing design and development. It supported the seven QMS Principles which include a robust customer center, the motivation and implication of top management, and therefore the process of continual improvement.
QMS principles are defined as:
1. Customer center
2. Leadership
3. Engagement of individuals
4. Process advance
5. Improvement
6. deciding supported Evidence
7. Relationship management

When and the way to Implement IATF 16946 Standard?
This can be done at any time but mostly used when customers specify this requirement as a part of the contract and organization willing to enhance their products and customer satisfaction.
While implementing any new or improved QMS may be a strategic decision. Their main focus is to spot also as minimize the danger while meeting and exceeding customers, organizational goals, and objective requirements.

Organizations have an eye fixed on:
1. Identify the purchasers who receive value from the organization.
2. Understand the customer needs and expectations from the organization
3. Create a link in between the organization objective to customer needs and expectations
4. Communicate between customer needs and expectation from the organization
5. to satisfy the customer needs and therefore the expectation you ought to first plan, design, develops, produce, deliver and also support the system.
6. to require appropriate measures you ought to measure and monitor customer satisfaction.
7. Organization will become more socially responsible.