Introduction to ISO 13485

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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. The ISO 13485 covers the entire lifecycle of the medical devices, including design and development, production, warehousing, distribution, installation and servicing activities.

At the same time, suppliers or service providers of raw materials, components, sterilisation, calibration, legal representatives (e.g., European Authorised Representatives) services can also adopt the ISO 13485 framework. In fact, we have seen more organisations certified to ISO 13485 because it is an outsourcing requirement set by their client (the medical device owner). Some organisations are certified to ISO 13485 voluntarily in order to raise competitiveness and give confidence to their clients for meeting international standard.

In early 2016, the ISO 13485 standard was revised and published, giving rise to the third edition – ISO 13485:2016. In the latest ISO 13485:2016, many requirements became clearer. There is greater emphasis on risk management, and is better aligned to global regulatory and US FDA 21 CFR Part 820 requirements. By now, organisations must already be moving into the new ISO 13485:2016. By 2019, all organisations must already be certified to ISO 13485:2016 and the previous 2003 version will not be accepted.

Relevance to US FDA 21 CFR Part 820

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The US has a very long history in regulating medical devices. The quality management system for organisations dealing with medical devices is based on the US FDA 21 CFR Part 820 regulations. The US FDA enforcement officers will perform audits directly on these organisations even when they are not based with US. This is different from the ISO 13485 certification process, where the auditing is performed by auditors from the appointed Certification Bodies (also known as Notified Bodies).

For organisations that would like to target the US and other markets, it is quite common to have their quality management system aligned to both US FDA 21 CFR Part 820 and ISO 13485:2016 requirements. This is a good stepping-stone to have your business scale global. This is why we have Stendard First designed to include information on meeting the ISO 13485:2016 and US FDA 21 CFR Part 820 requirements. 

Roadmap to Certification

The journey towards certification of ISO 13485 and US FDA 21 CFR Part 820 can be daunting to most who are unfamiliar with the standards' requirements. Realising that many are unaware of the entire lifecycle, Stendard has systematically broken down the whole process into just FIVE different stages below. Click on the respective stage to begin understanding the path towards compliance.

 

+ Stage 1: Gap Analysis (By Advisor)

Using our checklist, our advisors will go through the list of questions with your organisation. The objective is to bridge any gaps towards meeting the requirements of ISO 13485:2016 and/or US FDA 21 CFR Part 820.

At this stage, your organisation may also share existing information and processes with our advisors, who will also verify if these processes can remain or need to be fine-tuned.

+ Stage 2: Document Generation (Stendard First™)

Stendard First™ is a smart generator that helps your organisation create a quality management system structure (Quality Manual, SOPs, Work Instruction and Forms) to meet the ISO 13485:2016 and/or US FDA 21 CFR Part 820.

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.

+ Stage 3: Document Review (By Advisor via Stendard First™)

With the set of customised documents generated from Stendard First™, your organisation should do an initial review to have a basic understanding of the recommended processes. If you have questions regarding the documents or sections, you can request for the documents to be reviewed by our advisors.

Once your permission is given, our advisors can access and review your documents. Based on the gap analysis session and/or any questions that your organisation has raised, our advisor will recommend and amend certain sections of the documents for you. The objective here is to ensure that the set of documents is ready for your organisation's implementation.

+ Stage 4: Training, Implementation and Internal Audit (By Advisor)

In preparation for the certification audit, some organisation might opt for further assistance regarding the implementation of the processes (in accordance to the documentation) and the conduct of internal audits.

Training on implementation includes advising the roles of each department and employee as part of the quality management system and getting everyone familiar in filling up the forms during their day-to-day activities.

Our advisors can also provide internal audit training to the appointed internal auditors. An official internal audit is conducted so everyone is familiar with an audit before proceeding to the last and final stage of the compliance journey.

+ Stage 5: Certification (By Certification Bodies)

The final stage of this compliance journey is the actual certification audit. Usually conducted over multiple days, on-site audits is performed to ensure proper implementation and adherence of the organisation's documented processes.

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.


 

Stendard First™ ISO 13485:2016 Price Plan

Starter

FREE
  • Tutorial-based Learning
  • Intuitive Q&A Interface
  • Customised Documents
  • Rename Documents
  • Partially Preview Documents

Basic

USD 2588
  • Tutorial-based Learning
  • Intuitive Q&A Interface
  • Customised Documents
  • Rename Documents
  • Preview Documents
  • In-built Edit Features
  • Export (PDF)

Express

USD 4988
  • Tutorial-based Learning
  • Intuitive Q&A Interface
  • Customised Documents
  • Rename Documents
  • Preview Documents
  • In-built Edit Features
  • Export (PDF/Word)
  • Attached Advisor/Consultant
  • Gap Analysis
  • Document review
Most popular

Advanced

CUSTOMISED
  • Tutorial-based Learning
  • Intuitive Q&A Interface
  • Customised Documents
  • Rename Documents
  • Preview Documents
  • In-built Edit Features
  • Export (PDF/Word)
  • Attached Advisor/Consultant
  • Gap Analysis
  • Full document review
  • Classroom Training Package
  • Implementation of Processes
  • Guidance to Certification

Basic: Use Stendard First™ to complete Stage 2 of your compliance journey - Document Generation. We tackle the most time-consuming activity for you. 

Express: On top of using Stendard First™ to generate your documents, we have our advisors to help you through Stage 1 to 3. The final output is a set of customised documents that has been reviewed and is ready for implementation. This is the most popular plan adopted by SMEs.

Advanced: A fully customisable plan that leverages on Stendard First™and our advisors to help you through Stage 1 to 4. This can include customised training, guidance to implementation of processes, conducting of internal audits and support till certification.