What is the Difference Between ISO 14971 and ISO 13485?

Do you know the difference between ISO 1497 and ISO 13485? No.Let’s understand then For manufacturers, seeking after the legitimate standards helps with following administrative requirements as well as guarantees that their instruments are protected, effective, and reliable. International norms in the clinical device sector, ISO 14971 and ISO 13485, are generally referenced. Two of these norms are fundamental for makers, they fill different needs and focus on various parts of a medical device lifecycle. 

What is ISO 14971?

ISO 14971 is an international regulation primarily known for the procedure that clarifies the risk of operating risky medical devices. It offers a selective structure for identifying, surveying, and moderating risk all through the clinical life cycle. The fundamental point is to diminish the chance of harm to patients, clients, and other people who might come into contact with the medical instrument. This standard is  concentrates on the risk management and checking that the risk from the mendical instruments are properly handled, design, and post-market phases of a medical instruments lifecycle.  

These are the fields that are covered by ISO 14971:-

1. Risk Assessment 
2. Risk Control
3. Risk Monitoring
4. Surveillance of Post-Market 

What is ISO 13485?

ISO 13485 is a quality management system (QMS) regulatory mainly created for the pharmaceutical instrument manufacturers. It gives the structure for growing, sustaining, and efficacious QMS to confirm that the device meets regulatory needs and customer prospects regularly. The main focus of ISO 13485 is on quality control throughout the planning, manufacturing, installation, and servicing of clinical devices. 

These fields are covered by this standard ISO 13485:-

1. Design Control 
2. Document Control 
3. CAPA (corrective and preventive actions)

Difference Between ISO 14971 and ISO 13485

Here are the differences between ISO 14971 and ISO 13485 listed in table below:-

S.No.	Area	ISO 14971	ISO 13485
1.	Focus Area	ISO 14971 is a risk management centre that manages the identification, assessment, and moderation of dangers all through the instrument lifecycle.	ISO 13485 is a quality management system standard that gives rules to keep up with overall item quality and guarantee consistency with administrative needs.
2.	Scope	ISO 14971 applies to all phases of a clinical instruments lifecycle, stressing on ensuring the instrument’s wellbeing by controlling the dangers associated with its utilization.	ISO 13485 covers the entire quality administration method, that contains configuration, assembling, and post-market activities, ensuring that the gadget follows clients necessities and administrative requirements.
3.	Implementation	ISO 14971 needs manufacturer to set up procedure for risk management and to keep risk management file for every instrument	ISO 13485 needs a quality management system (QMS) that is consistently audited and documented.
4.	Regulatory Compliance	ISO 14971 is crucial for meeting risk management needs that are frequently set by the regulatory authorities, for example the FDA or European Medicine Agency in short (EMA)	ISO 13485 is mostly used as a means to explain compliance with regulatory needs, specifically in condition of the quality and consistency.

Can a Company be ISO 13485 Certified Without Being ISO 14971 Compliant?

Yes, the entity can be ISO 13485 certified without being properly ISO 14971 compliant. However, major regulatory authorities need compliance with standards to confirm that product quality and associated dangers are successfully operated. 

Does ISO 13485 Cover Risk Management?

Yes, ISO 13485 needs manufacturers to apply risk management processes to safe the the future consequences. However, it does not go into the details that ISO 14971 does. Despite the fact that ISO 13485 confirms overall quality control, ISO 14971 primarily concentrates on evaluating and operating risk throughout the instrument lifecycle. 

What are the Benefits of Adopting Both ISO 14971 and ISO 13485?

Accepting both standards confirms comprehensive dangers in risk management and instrument quality. However, ISO 14971 ensures safety by effective risk control; ISO 13485 introduces a method to organise quality through the instrument lifecycle. Together, they give a sturdy structure to follow regulatory needs and improve customer trust.

How Does ISO 14971 Impact Post-Market Surveillance?

ISO 14971 focuses on the requirement for regular surveillance of danger to avoid any kind of risky situation. After the instruments enter the market. It needs manufacturers to track and examine post-market details to check more future problems and accept curative actions when needed. 

Can ISO 14971 Be Applied to All Medical Devices?

Yes, ISO 14971 can be valid for all pharmaceutical devices irrespective of their size or complexity. This standard provides a compliant approach to risk management that can be adjusted to distinct instruments and their associated risks.

Do Companies Need to Implement ISO 13485 Before ISO 14971?

ISO 13485 and ISO 14971 are frequently applied in corresponding. However, entities introduce their quality management system (ISO 13485) initially, pursued by developing a explanatory risk management system (ISO 14971) that combines with the whole QMS. 

Conclusion

In the end, ISO 14971 and ISO 13485 are equally important in ensuring the safety, quality, and compliance of medical devices. However, they have different purposes. ISO 14971 focuses basically on risk management, helping with guaranteeing the instrument meets administrative and quality necessities all through its lifecycle. For clinical instruments makers, performing both ISO 14971 and ISO 13485 can uphold in confirming that their items are secure, of top quality, and compliant with worldwide administrative guidelines. By knowing the distinction between these two norms and how they match one another, producers can improve in guiding the complicated universe of clinical device regulations.