Introduction to ISO 13485
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 processes spanning the entire product life-cycle, 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 this quality management system focuses on the need to handle risk management, in line with ISO 14971. In addition, medical device software (both standalone and embedded ones) are to comply with IEC 62304.
Good news: Stendard First™-generated documents include details that meet all the ISO 13485, US FDA 21 CFR Part 820, ISO 14971 and IEC 62304 requirements.
Roadmap to ISO 13485:2016 Certification
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 for most who are unfamiliar with the standards. Realising that many are unaware of the entire certification process, we have summarised it to 5 stages:
+ Stage 1: Document Generation (using 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. Furthermore, you can rename and number these documents according to your preference and organisational requirements.
For our transiting clients, we have included the ISO 13485:2016 Transition Checklist within 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.
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 a day. We tackle the most time-consuming process for you.
+ Stage 2: Training (online with Stendard)
Training is supported by our selected partners, who are certification bodies. This can include a general ISO 13485 Awareness Training or a more in-depth Internal Audit Training. We recommend at least one of your teammates 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 ISO 13485 documentation and get ready for implementation.
Upon implementing your QMS documents, it is time to start following the procedures and using the forms during your day-to-day operations.
+ 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 on your team is familiar with the documented procedures and are executing it well. Any non-conformance should be detected and rectified. 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.