What is the Difference Between ISO 9001 and 13485?

The International Organization for Standardization, or ISO, is a globally recognized group of representatives. Headquartered in Geneva, Switzerland, they develop and publish standards for dozens of industries. This includes the medical and medical device ISO standards put into practice daily here at Pathway NPI. Both ISO 9001 and 13485 are quality management system standards that can be used by organizations to ensure that their products and services meet customer expectations. However, there are some key differences between the two standards.

We’ll take you through the history behind the ISO, how these quality standards originated, and how they can best be applied today. These standards apply to our daily work in design and engineering, regulatory, and manufacturing. 

The History of ISO Standards

ISO standards originated in the 1940s in an effort to standardize technical drawings across different industries. In response to the devastation of World War II, representatives from 25 countries gathered together to form what is now known as the ISO.

During the 1950s, ISO focused on creating standards for mechanical engineering. In the following decade, they shifted their attention to standardizing electronic components. It was during this time that some of the most well-known standards were published, including ISO 27001 and ISO 9001.

In 1987, ISO released the first iteration of ISO 13485. This was a quality management system standard specifically for medical device manufacturers. Since then, there have been several updates to both iso 9001 and iso 13485, with the most recent versions in place today.

While ISO 9001 is a generic quality management system standard that can be applied to businesses in any industry, ISO 13485 is specific to the medical device industry.

Organizations that want to demonstrate compliance with ISO 9001 can do so by implementing a quality management system and being audited by a third-party certification body. On the other hand, ISO 13485 compliance requires a quality management system specific to the medical device industry as well as third-party audits.

Get to Know ISO 9000

The ISO 9000 family of standards is all about quality management. In fact, it is the best-known quality management standard currently in place for businesses of all sizes.

The ISO 9000 family of standards is related to quality management systems and provides guidance on how to meet customer expectations. The most recent version, ISO 9001:2015, was published in September 2015. It outlines the requirements for a quality management system and can be used by any organization, regardless of size or industry.

ISO 9000 standards originated in 1987 and were created to help businesses improve their quality management systems. The family of standards includes ISO 9000, ISO 9001, and ISO 9004.

ISO 9000 is a generic standard that provides guidance on how to establish and operate a quality management system. It’s the foundation of the ISO 9001 standard and can be used by any organization, regardless of size or industry.

ISO 9001

ISO 9001 is a generic standard that can be used by any organization, regardless of its size or type of business. Any organization that wants to certify to ISO 9001 must follow the requirements in this standard.

In order to become certified to ISO 9001, an organization must go through a certification process conducted by an external body. This usually includes an audit of the organization’s quality management system to ensure that it meets all of the requirements laid out in the standard. Once certified, the organization will need to undergo periodic surveillance audits to maintain their certification status.

ISO 9004 is a guideline for organizations that want to exceed ISO 9001 requirements and continually improve their performance.

How to Demonstrate Compliance with ISO 9001

In order to demonstrate compliance with ISO 9001, organizations must implement a quality management system and be audited by a certification body. The certification process usually includes an assessment of the organization’s quality management system to ensure that it meets all of the requirements laid out in the standard. Once certified, the organization will need to undergo periodic surveillance audits to maintain their certification status.

Organizations that are already certified to ISO 9001 can transition to the 2015 version of the standard by following the guidance laid out in Annex SL of ISO 9001:2015.

Annex SL is a new framework for all ISO management system standards that provides a high-level structure and common terminology. This makes it easier for organizations to implement multiple ISO standards as well.

3 key takeaways:

– ISO 9001 is a quality management system standard that can be used by any organization, regardless of size or industry.

– Organizations can demonstrate compliance with ISO 9001 by implementing a quality management system and being audited by a certification body.

– The Annex SL framework provides a high-level structure and common terminology for all ISO management system standards. This makes it easier for organizations to implement multiple ISO standards.

Get to Know ISO 13485

ISO 13485, on the other hand, is specific to organizations that design and manufacture medical devices. It was first created in 1996 and has been updated several times since then, with the most recent version being published in 2016.

ISO 13485 is based on the ISO 9001 quality management system requirements and provides additional guidance specifically for the medical device industry.

In order to become certified to ISO 13485, organizations must implement a quality management system that meets all of the requirements laid out in the standard. They must also be audited by a certification body to ensure compliance. Once certified, they will need to undergo periodic surveillance audits to maintain their certification status.

How to Demonstrate Compliance with 13485

Compliance with ISO 13485 can be demonstrated by implementing a quality management system that meets all of the requirements laid out in the standard. Organizations must also be audited by a certification body to ensure compliance. Once certified, they will need to undergo periodic surveillance audits to maintain their certification status.

Key takeaways:

– ISO 13485 is a quality management system standard specifically for organizations that design and manufacture medical devices.

– Compliance with ISO 13485 can be demonstrated by implementing a quality management system and being audited by a certification body.

– The requirements of ISO 13485 are based on those of ISO 9001, with additional guidance specifically for the medical device industry.

Help With ISO Standard Compliance

In order to demonstrate compliance with either ISO 9001 or 13485, organizations must implement a quality management system. This system should be designed to meet the specific needs of the organization and its customers.

The quality management system must be regularly audited by a certification body to ensure compliance with the relevant standard. Once certified, the organization will need to undergo periodic surveillance audits to maintain their certification status.

The ISO standards for medical devices are significant — and can appear overwhelming. Here at Pathway NPI, a storied medical device company in San Diego, we have had great success at guiding companies through the steps as they develop their own products. We can help you too. If you have questions about 510(k) clearance vs. approval, we can answer those questions as well!

Pathway, a medical device contract manufacturing company you can trust.

The International Organization for Standardization, or ISO, is a globally recognized group of representatives. Headquartered in Geneva, Switzerland, they develop and publish standards for dozens of industries. This includes the medical and medical device ISO standards put into practice daily here at Pathway NPI. Both ISO 9001 and 13485 are quality management system standards that can be used by organizations to ensure that their products and services meet customer expectations. However, there are some key differences between the two standards.

We’ll take you through the history behind the ISO, how these quality standards originated, and how they can best be applied today. These standards apply to our daily work in design and engineering, regulatory, and manufacturing. 

The History of ISO Standards

ISO standards originated in the 1940s in an effort to standardize technical drawings across different industries. In response to the devastation of World War II, representatives from 25 countries gathered together to form what is now known as the ISO.

During the 1950s, ISO focused on creating standards for mechanical engineering. In the following decade, they shifted their attention to standardizing electronic components. It was during this time that some of the most well-known standards were published, including ISO 27001 and ISO 9001.

In 1987, ISO released the first iteration of ISO 13485. This was a quality management system standard specifically for medical device manufacturers. Since then, there have been several updates to both iso 9001 and iso 13485, with the most recent versions in place today.

While ISO 9001 is a generic quality management system standard that can be applied to businesses in any industry, ISO 13485 is specific to the medical device industry.

Organizations that want to demonstrate compliance with ISO 9001 can do so by implementing a quality management system and being audited by a third-party certification body. On the other hand, ISO 13485 compliance requires a quality management system specific to the medical device industry as well as third-party audits.

Get to Know ISO 9000

The ISO 9000 family of standards is all about quality management. In fact, it is the best-known quality management standard currently in place for businesses of all sizes.

The ISO 9000 family of standards is related to quality management systems and provides guidance on how to meet customer expectations. The most recent version, ISO 9001:2015, was published in September 2015. It outlines the requirements for a quality management system and can be used by any organization, regardless of size or industry.

ISO 9000 standards originated in 1987 and were created to help businesses improve their quality management systems. The family of standards includes ISO 9000, ISO 9001, and ISO 9004.

ISO 9000 is a generic standard that provides guidance on how to establish and operate a quality management system. It’s the foundation of the ISO 9001 standard and can be used by any organization, regardless of size or industry.

ISO 9001

ISO 9001 is a generic standard that can be used by any organization, regardless of its size or type of business. Any organization that wants to certify to ISO 9001 must follow the requirements in this standard.

In order to become certified to ISO 9001, an organization must go through a certification process conducted by an external body. This usually includes an audit of the organization’s quality management system to ensure that it meets all of the requirements laid out in the standard. Once certified, the organization will need to undergo periodic surveillance audits to maintain their certification status.

ISO 9004 is a guideline for organizations that want to exceed ISO 9001 requirements and continually improve their performance.

How to Demonstrate Compliance with ISO 9001

In order to demonstrate compliance with ISO 9001, organizations must implement a quality management system and be audited by a certification body. The certification process usually includes an assessment of the organization’s quality management system to ensure that it meets all of the requirements laid out in the standard. Once certified, the organization will need to undergo periodic surveillance audits to maintain their certification status.

Organizations that are already certified to ISO 9001 can transition to the 2015 version of the standard by following the guidance laid out in Annex SL of ISO 9001:2015.

Annex SL is a new framework for all ISO management system standards that provides a high-level structure and common terminology. This makes it easier for organizations to implement multiple ISO standards as well.

3 key takeaways:

– ISO 9001 is a quality management system standard that can be used by any organization, regardless of size or industry.

– Organizations can demonstrate compliance with ISO 9001 by implementing a quality management system and being audited by a certification body.

– The Annex SL framework provides a high-level structure and common terminology for all ISO management system standards. This makes it easier for organizations to implement multiple ISO standards.

Get to Know ISO 13485

ISO 13485, on the other hand, is specific to organizations that design and manufacture medical devices. It was first created in 1996 and has been updated several times since then, with the most recent version being published in 2016.

ISO 13485 is based on the ISO 9001 quality management system requirements and provides additional guidance specifically for the medical device industry.

In order to become certified to ISO 13485, organizations must implement a quality management system that meets all of the requirements laid out in the standard. They must also be audited by a certification body to ensure compliance. Once certified, they will need to undergo periodic surveillance audits to maintain their certification status.

How to Demonstrate Compliance with 13485

Compliance with ISO 13485 can be demonstrated by implementing a quality management system that meets all of the requirements laid out in the standard. Organizations must also be audited by a certification body to ensure compliance. Once certified, they will need to undergo periodic surveillance audits to maintain their certification status.

Key takeaways:

– ISO 13485 is a quality management system standard specifically for organizations that design and manufacture medical devices.

– Compliance with ISO 13485 can be demonstrated by implementing a quality management system and being audited by a certification body.

– The requirements of ISO 13485 are based on those of ISO 9001, with additional guidance specifically for the medical device industry.

Help With ISO Standard Compliance

In order to demonstrate compliance with either ISO 9001 or 13485, organizations must implement a quality management system. This system should be designed to meet the specific needs of the organization and its customers.

The quality management system must be regularly audited by a certification body to ensure compliance with the relevant standard. Once certified, the organization will need to undergo periodic surveillance audits to maintain their certification status.

The ISO standards for medical devices are significant — and can appear overwhelming. Here at Pathway NPI, a storied medical device company in San Diego, we have had great success at guiding companies through the steps as they develop their own products. We can help you too. If you have questions about 510(k) clearance vs. approval, we can answer those questions as well!

Pathway, a medical device contract manufacturing company you can trust.