Transition from ISO 13485:2003 to ISO 13485:2016

In early 2016, the ISO 13485 standard was revised and published, giving rise to the third edition – ISO 13485:2016. In this latest ISO 13485:2016, many requirements are better aligned to global regulatory and US FDA 21 CFR Part 820 requirements. We have come to the last year of the 3-year transition phase. By February 2019, all organisations must successfully transit to the new ISO 13485:2016 and the previous 2003 version will not be accepted.

What has changed?

Many new requirements were added and this new ISO 13485:2016 is now better aligned to global requirements. There is a greater focus on the application of risk management principles throughout the quality management system, not just on the product only. Software used in the quality management system, production and services have to be validated now. More obvious and specific requirements were also emphasised for handling non-conformance, corrective and preventive actions, and management review - strengthening the entire system as a whole. The rest of the changes were focused on making the existing requirements less ambiguous - setting higher expectations compared to the previous version.  

The Transition Roadmap

The transition process usually takes more than 6 months, which includes 1) identifying new requirements, 2) gap analysis, 3) creating and reviewing the documents, 4) internal audit and 5) preparation for third-party audit. With so much time to spend on, the cost of transition escalates as well. 

Hence, Stendard First™has included the much awaited extension to help companies transit to the ISO 13485:2016. In this new interface, we have specially included 1) a ISO 13485:2016 Transition Checklist and 2) highlighting all documents content that met the new requirements. In this way, your organisation can first refer to the checklist for the new clauses and tracing it to the specific documents for details. Once you access these specific documents, you will realise that the new content are clearly highlighted. With this information available for your organisation, you can easily transit to the new ISO 13485:2016. As all our documents have incorporated the industry's best practices, you may also use the other documents and content for your existing quality management system.
 

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

 

+ Stage 1: Gap Analysis (By Advisor)

Using our ISO 13485:2016 Transition Checklist, our advisors will go through the list of questions with your organisation. The objective is to identify all gaps towards meeting the new requirements of ISO 13485:2016.

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 transit to the new ISO 13485:2016.

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.

On top of receiving the exclusive ISO 13485:2016 Transit Checklist, all the documents will also have specific content that is highlighted. This highlighted information is unique to the new requirements and tells your organisation exactly how to fulfill them.

Finally, 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 transition expectation. 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. If you have an existing set of documents and prefers to use it, just extract the new content out from Stendard First™ and insert them into your documents.

+ 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 with the transition requirements.

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.

Upon successful completion of this transition audit, the new ISO 13485:2016 Certification is officially yours.


 

Stendard First™ ISO 13485:2016 Transition 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
  • Transition Checklist
  • Transition Content Highlight
  • Export (PDF)

Express

USD 4988
  • Tutorial-based Learning
  • Intuitive Q&A Interface
  • Customised Documents
  • Rename Documents
  • Preview Documents
  • In-built Edit Features
  • Transition Checklist
  • Transition Content Highlight
  • 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
  • Transition Checklist
  • Transition Content Highlight
  • 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 during this transition phase. 

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 your transition. 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 through your transition phase.