Introduction to ISO 13485

stendard-iso-13485-course

The ISO 13485 is an international standard that was specifically published to define the requirements of a quality management system for organisations within the medical device industry. This covers the entire lifecycle processes, including design and development, production, warehousing, distribution, installation and servicing activities. Besides ISO 13485, US FDA 21 CFR Part 820 compliance is also mandatory for companies entering the US market.

The framework of such quality management systems also focuses on the need to handle risk management, which is taken care by ISO 14971. Recently, we have also seen the trend of medical device software (both standalone and embedded ones) and these companies must also adopt the IEC 62304 framework. 

Good news: Stendard First™ is designed to include information on meeting the new ISO 13485, US FDA 21 CFR Part 820, ISO 14971 and IEC 62304 requirements. 


Roadmap to Certification

ISO 13485:2016 (First Timer)

ISO 13485:2016 (First Timer)

In early 2016, the ISO 13485 standard was revised and published, giving rise to the third edition – ISO 13485:2016. By February 2019, all organisations must already be certified to ISO 13485:2016 and the previous 2003 version will not be accepted.

We understand that the journey towards setting up your QMS can be daunting to most who are unfamiliar with the standards. Realising that many are unaware of the entire lifecycle, click on each of the 5 stages below to understand the process towards certification.

+ Stage 1: Document Generation (By Stendard First™)

Stendard First™ is a smart generator that helps your organisation create a QMS structure (Quality Manual, SOPs, Work Instruction and Forms) to meet the ISO 13485, US FDA 21 CFR Part 820, ISO 14971 and IEC 62304 requirements.

Using an intuitive Q&A interface, questions are accompanied by layman hints, explanations and guidance. From the answers that you provide, a fully customised set of documents is generated. With just a click of the 'Export' button, gain full ownership of 70+ customised documents in just an instant.

What used to take 6-8 weeks to prepare, is now generated in less than 1/2 day. We tackle the most time consuming process for you.

+ Stage 2: Training (By our Partners)

Training is supported by our selected partners, whom are certification bodies. This can include a general Standard Awareness Training or a more in-depth Internal Audit Training. We recommend at least one of your team mates to go for an Internal Audit Training, so you can be self-sufficient and able to perform your own internal audit.

+ Stage 3: Document Implementation (By you)

After you have generated your documents via Stendard First™ and have completed your training, you can finalise all the content details and get ready for implementation.

Upon implementing your QMS documents, it is time to start following the procedures and using the forms day-to-day.

+ Stage 4: Internal Audit (By you)

Based on the audit checklist generated via Stendard First™, your team will conduct an internal audit. The purpose is to make sure that everyone in your team is familiar with the documented procedures and are executing it well. Any non-conformance should be detected and recified. This is also a good exercise for everyone prior to the actual audit.

+ Stage 5: Certification (By Certification Bodies)

The final stage of this compliance journey is the actual certification audit. Every ISO 13485 audit goes in a 3-year cycle - an initial audit followed by 2 years of surveillance audits, and the cycle goes on. Upon successful completion of this audit, the ISO 13485 Certification is officially yours.


Forget about templates. Create automatic, easy and customised Medical Device QMS with only USD 2588.

 

Basic

USD 2588

Who should pick this?

  • Tutorial-based Learning
  • Intuitive Q&A Interface
  • Customised Documents
  • View Generated Documents
  • In-built Edit Features
  • Export (PDF/Word)
Recommended for SMEs

Optional Add-on

Additional Support towards Certifications
  • Introduction to Certification Bodies
  • Standard Awareness Training
  • Internal Audit Training
 
ISO 13485:2016 (Transition from ISO 13485:2003)

ISO 13485:2016 (Transition from ISO 13485:2003)

In early 2016, the ISO 13485 standard was revised and published, giving rise to the third edition – ISO 13485:2016. By February 2019, all organisations must successfully transit to the new ISO 13485:2016 and the previous 2003 version will not be accepted.

The preparation process usually takes more than 6 months due to the uncertainty. With so much time to spend on, the cost of transition escalates as well. 

Here, Stendard First™is able to help companies transit to the ISO 13485:2016 with ease, through our 1) ISO 13485:2016 Transition Checklist and 2) highlighting all documents content that met the new requirements. With this information, you can easily adopt the new content and bring them into your existing documents.

We have also broken down your transition journey into FIVE different stages below. Click on the respective stage for the details. 

+ Stage 1: Document Generation (Stendard First™)

Stendard First™ is a smart generator that helps your organisation create a QMS structure (Quality Manual, SOPs, Work Instruction and Forms) to meet the ISO 13485:2016, US FDA 21 CFR Part 820, ISO 14971:2007, EN ISO 14971:2012 and IEC 62304:2006 requirements.

Using an intuitive Q&A interface, questions are accompanied by layman hints, explanations and guidance. From the answers that you provide, a fully customised set of documents is generated. Furthermore, you can rename and number these documents according to your preference and organisational requirements.

With just a click of the 'Export' button, gain full ownership of 70+ customised documents in just an instant.

What used to take 6-8 weeks to prepare, is now generated in less than 1/2 day. We tackle the most time consuming process for you.

+ Stage 2: Gap Analysis (By You)

Using our ISO 13485:2016 Transition Checklist that's generated via Stendard First™, you can easily identify all the gaps towards meeting the new requirements of ISO 13485:2016. Our Checklist will also guide you to search for the respective document with the new content.

+ Stage 3: Document Implementation (By You)

From our ISO 13485:2016 Transition Checklist, you would be able to easily identify any gaps you have within your existing documents. With this checklist, you can also very quickly identify the new content (highlighted in blue) that is specific to meet the new ISO 13485:2016.

You can now copy and paste the new content into your existing QMS documents and immediately comply with the new standard. Now your team can review these updated documents and prepare for implementation.

+ Stage 4: Internal Audit (By You)

Based on the audit checklist generated via Stendard First™, your team can now conduct an internal audit. The purpose is to make sure that everyone in your team is familiar with the updated documented procedures and are executing it well. Any non-conformance should be detected and recified. This is also a good exercise for everyone prior to the actual audit.

+ Stage 5: Certification (By Certification Bodies)

The final stage of this compliance journey is the actual certification audit. Upon successful completion of this transition audit, the new ISO 13485:2016 Certification is officially yours.


Forget about templates. Create automatic, easy and customised Medical Device QMS with only USD 2588.

 

Basic

USD 2588

Who should pick this?

  • Tutorial-based Learning
  • Intuitive Q&A Interface
  • Customised Documents
  • View Generated Documents
  • In-built Edit Features
  • Transition Checklist
  • Transition Content Highlight
  • Export (PDF/Word)
Recommended for SMEs

Optional Add-on

Additional Support towards Certifications
  • Introduction to Certification Bodies
  • Standard Awareness Training
  • Internal Audit Training