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: Start preparing for the journey. Learn how to with Stendard.
- Gain an overview of regulatory requirements (catered to your business expansion strategy).
- Understand the requirements of the standard and know what quality practices need to be in place.
+ Stage 2: Automate the creation of your QMS documents with Stendard Solution™.
- Stendard Solution™ allows for efficient, automated document generation.
Quality Manual and SOPs customised according to ISO requirements and your company specifics.
Form templates, ready for immediate implementation.
- These documents are comprehensive, taking into account the ISO 13485, US FDA 21 CFR Part 820, ISO 14971 and IEC 62304 requirements.
- We have also included the "ISO 13485:2016 Transition Checklist", highlighting the differences between the ISO 13485:2016 and ISO 13485:2003 requirements. Within, it identifies the relevant SOPs produced by the Stendard Solution™ that addresses these requirements.
+ Stage 3: Begin putting your SOPs into practice. Digitalise this with Stendard Solution™.
- Set up your QMS with the implementation of processes.
The team at Stendard is able to support this with a step-by-step run-through of the clauses and SOPs to match your current business practices - tightening processes to be implemented, or modifying draft documents if necessary.
- With Stendard Solution™, maintain an updated, consolidated depository of your team's records, without physical limitations.
+ Stage 4: Perform your internal audit.
- Support from the team at Stendard includes:
Training on how to conduct an internal audit.
Proper diagnostic assessment before your first audit to ensure readiness.
- The Audit module within Stendard Solution™ includes a clause-by-clause checklist to ensure you have covered all the requirements of the standards.
+ Stage 5: Achieve your Certification!
(Given external audit by Certification Bodies)
- Passing your external audit would mean obtaining your ISO 13485:2016 certification!
- Every ISO 13485 audit follows a 3-year cycle: an initial audit, with surveillance audits each year for the next two years. After which, the cycle begins again.
- Maintaining your certification would require continued compliance to the standards. With Stendard Solution™, you can easily keep up with it!
Get ISO 13485:2016 Trained Online Now!
Our team at Stendard has come up with an online course to provide this training for you, at your convenience!
With this, you can schedule and enjoy learning at your own pace and space. Get trained from your desk at home or at your office, anytime possible!