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Meet Brian Newbery the expert behind the kit, with over 25 years of industry mastery
My experience of over 25 years leading the implementation of many quality management systems, and as a consultant helping medical device companies with their ISO 13485:2016 quality management system implementation, I have continued to be totally convinced that completing a Gap Analysis and Implementation Plan before starting the actual QMS implementation, is essential to the success of the project.
The good news for all of you is that I learned this myself the hard way. My very first complete quality system implementation I did the first thing right and purchased a copy of the Standard. But then skipped the gap analysis and planning steps and dived right into the actual implementation. Result was missed gaps, underestimated implementation time and resources needed, and so missed the certification target by many months.
EXPERT INSIGHTS
Make good use of the expertise and guidance I provide in this kit and take a few days and complete the gap analysis and implementation plan. You will avoid gaps and save months on completing implementation and obtaining certification, it is well worth the effort.
What do other say about Brian's expertise
Here’s Everything You Will Receive
When You Order TODAY!
4 - ISO 13485 QMS Implementation Guides
Guide 1 of 4 - Gap Analysis
Guide 2 of 4 - Implementation Planning
Guide 3 of 4 - Implementation
Guide 4 of 4 - Certification
3 - ISO 13485 QMS Implementation Forms
Enhanced Gap Analysis Checklist
ISO 13485 Implementation Plan Assignments Form
ISO 13485 Implementation Project Proposal Form
1 - Slide Presentation
Getting Acquainted with ISO 13485:2016 - A Beginner's Guide
Bonus
1 Standard Operating Procedure ................................................. Total Value $149
1 Hour Gap Analysis Consultation ................................................. Total Value $150
100% Satisfaction
90-Day Money Back Guarantee
Get Instant Access to The Best Practices from an Industry Seasoned Expert And Achieve
ISO 13485 Implementation Success
The First Time!
75% Limited Time Discount
When you order TODAY!
Need More Information About "The Ultimate ISO 13485 Implementation Kit?"
This kit is the result of my own hard-earned lessons from my first implementation project, where I faced many challenges and setbacks.
I wasted so much time and money because
I didn't plan ahead.
The importance of the implementation planning process is crucial. Without a well-structured plan, companies can find themselves lost in a maze of compliance requirements, facing unexpected challenges, and wasting valuable time and resources.
Many medical device companies often underestimate
the ”planning phase” significance
Instead they skip the planning process altogether and immediately jump into the implementation phase. Leading them to make similar mistakes and fall into the same setbacks I had when I started.
Let Me Show You Everything You Will Receive When You Order Your Kit Now!
That's why I created this kit to help you succeed in your project the first time around without the hassle and stress.
Guide 1 of 4 - The Gap Analysis
This guide helps you assess your current situation and identify the gaps between your existing quality system and the requirements of ISO 13485:2016.
If you want to implement or update your quality management system (QMS) to comply with ISO 13485:2016, the first step is to conduct a gap analysis. A gap analysis is a systematic process of comparing your current QMS with the requirements of the standard and identifying any areas that need improvement.
A gap analysis will help you to:
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Understand the scope and impact of the changes introduced by ISO 13485:2016
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Determine the resources and actions needed to achieve compliance
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Establish a realistic timeline and budget for your QMS project
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Prioritize the most critical and urgent gaps to address
This guide will provide you with a practical approach and useful tools to conduct a gap analysis for ISO 13485:2016.
Guide 2 of 4 - Implementation Planning
This guide helps you develop a realistic and effective plan to close the gaps and prepare for certification.
To achieve certification for your organization, you need to have a clear and practical plan to address the gaps between your current situation and the requirements of the standard. This guide will help you to create such a plan, by providing you with a step-by-step process, tips and tools to identify and prioritize the actions you need to take. By following this guide, you will be able to prepare for certification in an efficient and effective way.
In this guide, you will learn how to:
- Identify the key steps and resources needed to implement the changes required by the standard.
- Estimate the time and cost of each step and prioritize them according to your needs and goals.
- Create a detailed action plan with clear responsibilities, deadlines and milestones.
- Monitor and track your progress and adjust your plan as needed.
- Communicate your plan to your stakeholders and get their support and feedback.
Guide 3 of 4 - Implementation
This guide helps you execute the plan and implement the necessary changes in your quality system, processes, documentation, and records.
In this guide, you will learn how to apply the best practices and standards for quality management to your organization.
You will also learn how to monitor and measure the effectiveness of your quality system, processes, documentation, and records. You will be able to identify and resolve any issues or gaps that may arise during the implementation phase. By following this guide, you will ensure that your quality system, processes, documentation, and records are aligned with your goals and objectives, and that they comply with the relevant regulations and requirements.
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Follow the steps in this guide to execute the plan and make the required adjustments to your quality system, processes, documentation, and records.
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Review the guide carefully and make sure you understand the objectives, scope, and expected outcomes of each step.
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Use the templates and tools provided in the guide to document your actions and results.
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Monitor and evaluate the effectiveness of the changes and report any issues or deviations to the project manager.
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Complete the implementation within the agreed timeline and budget.
Guide 4 of 4 - Certification
You have completed the previous three guides and are ready to take the final step towards ISO 13485:2016 certification. In this guide, you will learn how to prepare for the audit process, what to expect from the auditors, and how to demonstrate your compliance with the standard. You will also find tips and best practices to help you achieve a successful outcome and improve your quality management system.
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Conduct an internal audit to verify your compliance with the standard and address any nonconformities or opportunities for improvement.
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Select a certification body that is accredited by a recognized accreditation body and has experience in your industry sector.
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Prepare the necessary documentation and evidence to demonstrate your compliance with the standard, such as quality manual, procedures, records, etc.
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Schedule the certification audit with the certification body and communicate with the auditor about the scope, agenda, and logistics of the audit.
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Participate in the certification audit and provide the auditor with access to your processes, personnel, and documentation.
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Respond to any findings or observations from the auditor and implement corrective actions as needed.
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Receive the certification decision and certificate from the certification body and celebrate your achievement.
Getting Acquainted with ISO 13485:2016
ISO 13485:2016 is an international standard that specifies the requirements for a quality management system (QMS) for medical devices. It is designed to help organizations ensure that they meet the regulatory and customer expectations for the safety and effectiveness of their products and services.
ISO 13485:2016 applies to all stages of the life cycle of a medical device, from design and development to production, installation, servicing and disposal. It also covers aspects such as risk management, documentation, training, auditing and corrective actions.
By implementing ISO 13485:2016, organizations can demonstrate their commitment to quality and compliance, as well as improve their processes and performance.
If you are new to ISO 13485:2016, you may wonder what it means for your organization and how to implement it. This guide will provide you with a brief overview of the main features and benefits of the standard, as well as some tips and resources to help you get started.
Enhanced Gap Analysis Checklist
An enhanced gap analysis checklist is a tool that helps to identify the strengths and weaknesses of an organization, process, or system. It compares the current state with the desired state and provides recommendations for improvement.
An enhanced gap analysis checklist can be used for various purposes, such as:
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Assessing the compliance with standards, regulations, or best practices
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Evaluating the performance, efficiency, or effectiveness of an operation
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Identifying the gaps, risks, or opportunities for innovation
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Developing an action plan, roadmap, or strategy for change
An enhanced gap analysis checklist typically consists of four steps:
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Define the scope and objectives of the analysis
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Collect and analyze data on the current and desired state
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Identify and prioritize the gaps and their root causes
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Recommend and implement solutions to close the gaps
Implementation Plan Assignments Form
The Implementation Plan Assignments Form is a document that specifies the roles and responsibilities of each team member for the execution of a project.
The form include the following information:
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The name and contact details of the project manager and the project sponsor
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The scope, objectives, deliverables, and timeline of the project
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The list of tasks, subtasks, and milestones for each phase of the project
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The name, role, and skills of each team member assigned to each task
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The estimated effort, duration, and dependencies of each task
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The risk assessment and mitigation strategies for the project
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The communication and reporting plan for the project
The Implementation Plan Assignments Form should be completed and approved by the project manager and the project sponsor before the start of the project. The form should be updated regularly to reflect any changes in the project status, scope, or resources. The form should be shared with all the team members and stakeholders involved in the project
Implementation Project Proposal Form
The Implementation Plan Assignments Form is a document that specifies the roles and responsibilities of each team member for the execution of a project.
The form include the following information:
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The name and contact details of the project manager and the project sponsor
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The scope, objectives, deliverables, and timeline of the project
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The list of tasks, subtasks, and milestones for each phase of the project
-
The name, role, and skills of each team member assigned to each task
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The estimated effort, duration, and dependencies of each task
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The risk assessment and mitigation strategies for the project
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The communication and reporting plan for the project
The Implementation Plan Assignments Form should be completed and approved by the project manager and the project sponsor before the start of the project. The form should be updated regularly to reflect any changes in the project status, scope, or resources. The form should be shared with all the team members and stakeholders involved in the project
Bonus #1: Standard Operation Procedure
As a special offer, we are giving you an extra SOP of your choice at no cost when you order “The Ultimate ISO 13485 Implementation Kit” today. This kit contains everything you need to implement the ISO 13485 standard in your organization, from templates and checklists to training and guidance. Don’t miss this opportunity to get a free SOP that will help you improve your quality management system and comply with the requirements of ISO 13485.
Bonus #2: One Hour Gap Analysis Consultation
In this consultation, we will review your gap analysis for your business situation, challenges, and objectives and assess the strengths and weaknesses of your current approach and identify the areas where you can improve.
Based on this analysis, we will provide you with a customized report that outlines the best practices, recommendations, and solutions for your specific needs.
This consultation is a great way to get a clear picture of where you are, where you want to be, and how we can help you get there.
Get Instant Access to The Best Practices from an Industry Seasoned Expert And Achieve
ISO 13485 Implementation Success
The First Time!
75% Limited Time Discount
When you order TODAY!
100% Satisfaction
90-Day Money Back Guarantee