Title
Companion Guide To Completing Your ISO 13485:2016
CONTENTS
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INTRODUCTION ............................... |
3 |
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COMPLETING THE GAP ANALYSIS |
4 |
Note: This Guide 1 of 4, along with the other 3 Guide documents, are all written based on proven implementation planning steps, by Brian Newbery – Founder of Fast-Track QMS Consultants. They are designed to guide you and your team, with the Implementation and Certification of your companies ISO 13485:2016 Quality Management System. They align with each of the steps of the implementation process:
Guide 1 of 4 – Gap Analysis
Guide 2 of 4 – Implementation Planning
Guide 3 of 4 – Implementation
Guide 4 of 4 - Certification
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INTRODUCTION ................................................................................... |
3 |
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COMPLETING THE GAP ANALYSIS ..................................................... |
4 |
The Ultimate ISO 13485 QMS Implementation Kit
Page 2 of 10
Companion Guide To Completing Your ISO 13485:2016
Introduction
This Guidance Document is designed to help you complete the ISO 13485:2016 Gap Analysis Checklist.
My experience in the corporate world, leading the implementation of many quality management systems, and later as a consultant helping start-up medical device companies with their ISO 13485:2016 quality management system implementation, I have continued to be totally convinced that completing a Gap Analysis as part of the Implementation Planning step, is absolutely essential to the success of the project.
As part of the PDCA cycle, taking the time to complete the gap analysis and use the information obtained to help develop the plan for the QMS implementation, will go a long way to ensure you don’t miss any of the ISO 13485:2016 requirements. A missed gap found only at the time of the Certification audits can cause months of delays in your Certification. The gap analysis will also provide the information needed to determine the resources required to complete your QMS implementation and certification on schedule.
The Ultimate ISO 13485 QMS Implementation Kit
Page 3 of 10
Companion Guide To Completing Your ISO 13485:2016
Completing The Gap Analysis
Purchase Copy of the ISO 13485:2016 standard
Before you start your Gap Analysis you need to purchase at least one copy of the ISO 13485:2016 standard.
A copy of the standard along with the slides Introduction to ISO 13485:2016 Quality Management System, included in the Implementation Planning Kit you will have the documents you need to complete a thorough gap analysis. The slides contain a summary of the requirements included mandatory documents required. For detailed requirements however, you need to have a copy of the actual standard.
This is critical for you to clearly understand the requirements of the ISO standard, and you will not be able to conduct a meaningful gap analysis and implementation plan without having an actual controlled copy.
During the Certification audits the auditor is also going to expect you to have a controlled copy of the ISO 13485:2016 Standard on file, as well as other appropriate external documents.
These standards are available online for immediate download. Sources I can recommend are:
Techstreet and ISO Store
There are other relevant standards you should purchase i.e. ISO 14971:2019 for risk management, and other inspection and testing standards that are appropriate to your medical device. These documents in your quality management system will be considered as external documents and controlled as such.
Techstreet also offer revision for all the standards you purchase from them and will keep you informed of any updates.
The Ultimate ISO 13485 QMS Implementation Kit
Page 4 of 10
Companion Guide To Completing Your ISO 13485:2016
Training
In addition to reading your copy of the ISO 13485:2016 standard in order to understand each of the 5 element requirements, it’s also beneficial, for at least the implementation project leader to take additional formal training.
I would recommend for the project leader to take these 2 formal certification training courses:
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ISO 13485 Foundations Course - (8 hrs.)
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ISO 13485 Lead Auditor Course - (16 hrs.)
Links to sign up for these 2 courses are available on our website under Services: Click here
Major benefits of completing this training before your start your gap analysis and implementation planning include:
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Detailed understanding of the requirements and reduced risk of missing gaps;
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Able to conduct constructive internal audits during the implementation process;
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Management understanding of the overall ISO 13485:2016 requirements and the roles they play in the management of the QMS.
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Have Documented training records and Certificates to present to auditors during the Certification process.
It is also good practice for each of the implementation team members to have easy access to a copy of the standard, or even better their own copy. Also I recommend they go through the Foundations Course shown above. For Management the project leader can train using the slides provided with this implementation kit from Fast-Track QMS Consultants.
Fast-Track QMS consultants can also provide ISO 13485 introduction training to management, and the implementation team if that is a preferred option.
The Ultimate ISO 13485 QMS Implementation Kit
Page 5 of 10
Companion Guide To Completing Your ISO 13485:2016
Use of identified gaps and priority scale
Implementing a complete quality management system that fully meets the companies and ISO 13485:2016 requirements, is a major undertaking. Of course the total effort also depends on where you’re starting from. Either way you’re not going to be able to complete the entire implementation and certification in a short time frame, and typically takes a minimum of 6 to 9 months with outside expert consulting help, or 12 to 18 months if handled internally with limited resources.
This is where using a priority scale as you complete the gap analysis and build your detailed implementation plan can be very helpful. I have added this as a useful tool and is not in any way a requirement of the ISO Standard. All the requirements of the Standard need to be met but my experience shows that meeting some requirements of the standard, should have priority over other areas in your implementation plan.
For example, meeting all of the documentation and process requirements for design and development should be in place before the need for Management Review. More on all of this in the Planning Guide.
Priority indicated as shown, and definition as below.
P1: Priority 1 and based on potential impact should be given first priority.
P2: Priority 2 to be worked on after Priority 1
P3: Can be worked on later.
?: General ref. information
The Ultimate ISO 13485 QMS Implementation Kit
Page 6 of 10
Companion Guide To Completing Your ISO 13485:2016
Complete the Gap Analysis Checklist
After you have obtained a copy of the ISO 13485:2016 standard and completed the recommended training shown above you will be ready to complete the Gap Analysis Checklist. Start with entering the general background information at the beginning of the Checklist.
This information is good for you to start thinking about target completion dates, and if you’re a start-up medical device company, to be also considering the general state of your product design and manufacturing process readiness. The target completion date may certainly change after you complete the gap analysis and implementation planning but this is a starting point.
Also if you are going to work with us at Fast-Track QMS Consultants its good general information for us to have.
The Ultimate ISO 13485 QMS Implementation Kit
Page 7 of 10
ISO 13485:2016 QMS Gap Analysis Checklist
Companion Guide To Completing Your ISO 13485:2016
Next, go through each of the 5 elements, 4 through 8, and answer each of the questions, either yes or no. Add any notes as appropriate, that help explain your answer and the gap description. This can be a current document number if you have one, a procedure template you may have purchased and just needs to be customized.
If you need clarification on any of the questions refer to the ISO 13485:2016 standard. If additional help is required on any of the questions you can call me at Fast-Track QMS Consultants or send us an email. Unlimited email support is part of your implementation planning package.
Do not rush the completion of this gap analysis as it’s going to be the foundation of your implementation planning, and identifying any gaps is critical to determining a robust plan that gets you to a compliant QMS and successful certification.
The Ultimate ISO 13485 QMS Implementation Kit
Page 8 of 10
Companion Guide To Completing Your ISO 13485:2016
Examples of Gap Analysis Checklist answers
The following are just some examples for your reference, on how to complete the checklist.
Question # 1: You may currently have zero documented procedures in place, or perhaps you have some ISO 9001 procedures, or have purchased document bundles from Fast-Track QMS Consultants, and they just need customizing as shown under notes for this question.
Question # 2: Under element 4.1.1 it is required that you document the roles undertaken by the organization which can include manufacturer, authorized representative, importer or distributor. This is normally documented in the Quality Manual.
Question # 51: You may have purchased a SOP template, have an existing procedure that needs to be updated or this is a priority one gap that needs to be addressed.
Question # 52: This can be a significant gap, as all production processes that can have an effect on product quality need to have documented procedures. Here you should identify which processes are going to need such documented procedures.
The Ultimate ISO 13485 QMS Implementation Kit
Page 9 of 10
Companion Guide To Completing Your ISO 13485:2016
Congratulations, you have completed your Gap Analysis, and you have identified the gaps you need to fill as part of the next step, Implementation Planning covered in Guide 2 of 4.
The Next Step
You will take the gaps you have identified and assign the closing of each of these gaps to one of the implementation team members using the ISO 13485:2016 – Implementation Plan Assignments document, provided with this kit.
Also, and depending on your companies project approval process and if they require a formal project approval, you can complete the supplied ISO 13485:2016 – Implementation Project Proposal.