Gap Analysis For Standard 1, Learning Form Experience: Fill & Download for Free

The following checklist will guide you through ISO 13485-2016 implementation steps, on where to start, and what to do first.Classification of the medical device - review the characteristics of your device and determine its classification. Determine if it is a class I, II or III device according to the risk associated with the product.Select an appropriate QMS manager - The QMS manager can be self-trained or a certified QMS manager. In most of the cases the QMS manager has been selected from the existing team members, and the assigned employee is generally working in another position as well. The point is that they must be properly trained in order to provide QMS oversight in an appropriate manner.Performing a GAP analysis for QMS - The purpose of the GAP analysis is to show the difference between what you are currently doing and what the Standard is expecting.Prepare Quality policy - The Quality policy is a statement that includes the company’s primary goals and the strategy to achieve them.Determine the Quality objectives - The Quality policy sets the route to Quality objectives that are more concrete goals related to certain processes.Organizational structure - The Organizational chart should include the positions (with or without concrete names or avatars) and the relationships (hierarchy) between those positions.Establish the Quality plan - The Quality plan is a common table or sheet that should include:- QMS activities- Start and due dates- Responsible person for certain activities- Impact on other processes- Means of proofs for effective implementation of certain activities- Resources required for that activities, etc.Establish the Quality manual - This document should include :- Process interaction diagram- Statements of the applicable processes and their implementation- List of excluded processes and the reason of exclusion- Organizational chart- Quality objectives- Quality policy- References to relevant documents such as Work instructions, process descriptions and formsEstablish processes for Document and Record Control - These processes should be among the first to define and implement; and should be approved before implementation.Performing training related to processes of Document and Record control - All employees should have training to learn how to use properly the QM system.Establishing the remaining QMS processes - All the applicable processes have to be properly documented in the company. These process definitions and rules should be available for relevant employees.Work Instructions for quality management activities - Work Instructions should be prepared where they are necessary for an effective accomplishment of a concrete process or activity. Examples of Work Instructions may include directions for using a certain computer software or performing a task on an assembly line.Job Descriptions for each position - The job description concerns only for a position not for an employee, therefore employees for a certain position can be changed but the description and requirements for that position remains the same (Position title, position requirements, necessary experience, education and skills to perform tasks related to the particular position, relationships with other positions, reporting requirements, etc.)Appoint the Management Representative - The Management Representative is a person who oversees the whole QMS system and serves as an interface for external parties.Employee list with positions and other details - This list should be available only for senior management, it includes details from employees. With all the contact information it makes easier to reach people; group people for a project, etc. This list can be part of a QMS software as separate function.Employee CVs - All the employees’ CVs should be stored in the Company’s system.Document training on the procedures comprising the quality system - Training records should include evidence of effectiveness of training, and you should be able to demonstrate competency of the people performing those procedures.Purchasing - The Management has to decide whether there are certain processes that should be outsourced. The outsourced processes should be controlled by the Company.Implementation of the core processes - The implementation can be paper based or using electronic document formats in a QMS software environment. The core processes might include design and development processes, customer related processes and production related processes.Full quality system internal audit - Timing of the internal audit should be late enough in the quality plan. If the internal auditor(s) have been heavily involved in the implementation of the quality system, the Company may decide to hire an external consultant to perform the first internal audit.CAPA - Corrective and Preventive actions. All the CAPA findings and proposals for taking certain corrective actions should be reviewed and approved by the Management. The implementation of each corrective action should be verified to prove their effectiveness. Preventive actions can be implemented in almost any case after the Corrective action.Performing Management Review - Management review should be performed on a regular basis, after each internal audit, design change or when some nonconformance appears, as well as when a product has been returned or complaint has been received.Management of the suppliers - This may involve identifying the Company’s suppliers, ranking them according to type and risk, qualifying or disqualifying them and executing supplier quality agreements.Updating the Quality Plan as the project proceeds - The constant monitoring and update of the Quality Plan will be required throughout the project implementation or product manufacture.Involve a Consultant for the next internal audit - It is recommended to involve a consultant company or person for the internal audit, before submitting request for the external auditors or certification bodies.CAPA - This CAPA is intended to correct all the deficiencies discovered by the Consultant organization during the internal audit.Performing Management review - The Management should review the CAPA findings and make decisions related to appropriate Corrective actions.Getting certified! - Select an appropriate Certification body and submit your request for ISO 13485:2016 certification.Hope this guide will help you. I’m ready to answer any additional question you may have.

At the beginning of 2017, I wanted to experience as much as possible on a personal front. My ultimate goal is to give back and help others achieve their goals. To do so, I would need to experience things myself, so I could be in a better place to offer advice and guidance.Coming into this post, I honestly don’t know how many job responsibilities (hustles) I performed over the past year. Let’s count them up:Statistician/ProgrammerBloggerStatistical ConsultantLandlordSmall Business OwnerCertified Food ManagerSocial Media MarketerAccountantCustomer Service RepresentativeWeb DesignerWarehouse WorkerJob #1: Statistician/Programmer (Day Job)Each week, I head to the office for 40 hours a week of my day job. It’s not glamorous, but it’s a great job at a great company. I love building things and always have. I used to play with Legos all day when I was a kid. Now, it’s building programs and statistical models at work on a daily basis.I really enjoy my job, and have no plans of leaving in the near future. My boss is great, and I’m learning a lot about the financial industry, but also exploring many new technologies in the programming world. Automation and programming is incredibly powerful – I’m excited to continue to learn about this in the future.Job #2: BloggerThe Mastermind Within was created at the very end of 2016 on a cold winter day. I love blogging – I love writing, connecting with other bloggers, sharing my thoughts, and helping others.I spend 10-20 hours each week writing, marketing, tweaking things on my site, and answering emails from readers. My main motivation is to share with you what I’m learning in my life, so you can go out and become more successful. If you ever have any questions for me, feel free to reach out via my contact form.Job #3: Statistical ConsultantLast February, I was approached by a friend to help him and his bio-statistical consulting business out. For the most part, it is relatively straightforward statistics: comparing the distributions of different populations and drawing conclusions through standard parametric and non-parametric tests. I enjoy it because it pays well, I can grow my statistical skills, but also, I’m now a published author in the field of bio-statistics. Pretty cool, right?Job #4: LandlordFor the first 10 months of 2017, I had 2 roommates who were paying me rent. I needed to ensure that the sidewalks were shoveled, the utilities paid on time, and any things needing to be fixed were fixed in an appropriate time frame.Before 2015, I’d never owned a house or been a landlord. It was a great learning experience for the past 2.5 years, as I got an experience as a landlord through my house hacking. I’m looking forward to buying a rental property in the coming years to become a landlord once again.Job #5: Small Business OwnerIn May, I started a business with a business partner which would focus on making money two different ways. The first, a kombucha tea subscription kit where our company sends out flavoring and starter kits to our customers each month. The second income stream is dropshipping t-shirts through Shopify and print on demand. I’ve learned a ton about business through creating this.There is so much that goes into starting a business. It’s not enough just to have an idea. Then there’s the paperwork, opening various accounts, coming up with more ideas, implementing a plan, executing, staying consistent. I’m going to write a post on my recommended path for starting a business in the future, but just know, there’s so much to do and a lot to consider.Job #6: Certified Food Safety ManagerTo package dried fruits, sugar, and tea, I needed to get in to a commercial kitchen. To get in to a commercial kitchen, I needed to become a Certified Food Safety Manager. For $85 and 20 hours of my time, I was able to get certified and now can create safety plans for food handling.After never working in a kitchen before, this was quite an interesting learning experience. The test wasn’t too difficult, and it was cheap – if you are interested in the food industry, this is probably a solid resume booster. Here’s my full post on it from last summer: Becoming a Food Safety Manager.Job #7: Social Media MarketerOver the past 12 months, I’ve learned a ton about marketing. As a math major, I have no background in marketing. Pinterest, Twitter, Facebook, Quora, oh my! I don’t really like doing social media, but it’s an essential task in today’s business environment.I’m really excited to keep getting in to Pinterest and Quora in 2018 – both of these platforms are fantastic and have a huge reach.Job #8: AccountantIn college, I was a bookkeeper and spent 3 years doing cash flow analysis, accounts receivable, bank reconciliations, and your standard bookkeeping. All of this has paid off since I’m the chief accountant for my self, but also my business. It’s not too complicated, but there’s definitely a lot to learn.I’m still learning more about taxes and financial statements. These skills will pay off no matter what I do in the future.Job #9: Customer Service RepresentativeOver the holiday season, I got a lot of emails and messages from customers. Where’s my shirt?!!? Why does my package only have this and not that? Your site is misleading, I want my money back!While frustrating, it’s a necessary part of business and very valuable feedback for what to change and edit on the sites.Job #10: Web DesignerBefore 2017, I didn’t know too much about web design. I had a website back in 2015, but it looked unprofessional. No images, poor color scheme, etc.Now, I’ve learned a lot about web design, to the point where my boss is trusting me to build out web applications for the team and department! Over the past 12 months, I’ve taken most of the Code Academy courses (which I’d highly recommend), learned about user experience, as well as the consequences of picking an appropriate color scheme for your business.This site has been tweaked and re-tweaked many times, and I still have ideas to improve the user experience. I re-did the business website 3-5 times in October/November in an effort to prepare for Christmas, and that pushed me to a higher level.There’s so much to learn for design – I’m at the very tip of the iceberg – and I love it!Job #11: Warehouse WorkerAt the end of each month, it’s time to pack up the subscription kits and send them off to our customers. Spending a 10 hours at the end of the month is a tough task, and managing what does in which kit is always fun. Eventually, this could be outsourced, but for now, it’s all on me!The Power of FocusI think I put too much on my plate in 2017, but it was a great learning experience. My recommendation for you is to look to expand your knowledge, but do it in a way which complements your passion and your daily job.For example, my side hustle of statistical consulting complements my day job in a very direct way. Flipping the switch from day job to side hustle doesn’t require too much on my part. My business does not, so I struggled for at least 2-3 months getting in to that mindset where my brain was comfortable thinking in that way.Learning, Applying, and Providing Value to Increase Your IncomeI love writing because I love how I’m able to inspire others to do more with their lives through my actions. I could be the most successful person in the world, but unless I share my experiences with you, none of my successes will matter.For you, focusing on learning something new, applying it, and providing value to others will help you increase your value to others, which in the future, will allow you to increase your income.I want to learn all of these different things so I can have a more complete world view, and have experience in many different areas. For me, my main strengths are programming, mathematics and statistics, and basic finance and accounting.Some of the areas I’m improving in are writing, business, marketing, and project management. I definitely have some weaknesses, but if I keep learning, applying, and providing value to others, I know I’ll be able to fill in those gaps.Take some time out of your day and spend it on yourself. Remember my favorite quote, and take action:“Your level of success will rarely exceed your level of personal development, because success is something you attract by the person you become.” – The Miracle Morning

FOCUS IS INCREDIBLY IMPORTANT FOR SUCCESS.At the beginning of 2017, I wanted to experience as much as possible on a personal front. My ultimate goal is to give back and help others achieve their goals. To do so, I would need to experience things myself, so I could be in a better place to offer advice and guidance.Coming into this post, I honestly don’t know how many job responsibilities I performed over the past year. Let’s count them up:Statistician/ProgrammerBloggerStatistical ConsultantLandlordSmall Business OwnerCertified Food ManagerSocial Media MarketerAccountantCustomer Service RepresentativeWeb DesignerWarehouse WorkerJob #1: Statistician/Programmer (Day Job)Each week, I head to the office for 40 hours a week of my day job. It’s not glamorous, but it’s a great job at a great company. I love building things and always have. I used to play with Legos all day when I was a kid. Now, it’s building programs and statistical models at work on a daily basis.I really enjoy my job, and have no plans of leaving in the near future. My boss is great, and I’m learning a lot about the financial industry, but also exploring many new technologies in the programming world. Automation and programming is incredibly powerful – I’m excited to continue to learn about this in the future.Job #2: BloggerThe Mastermind Within was created at the very end of 2016 on a cold winter day. I love blogging – I love writing, connecting with other bloggers, sharing my thoughts, and helping others.I spend 10-20 hours each week writing, marketing, tweaking things on my site, and answering emails from readers. My main motivation is to share with you what I’m learning in my life, so you can go out and become more successful. If you ever have any questions for me, feel free to reach out via my contact form.Job #3: Statistical ConsultantLast February, I was approached by a friend to help him and his bio-statistical consulting business out. For the most part, it is relatively straightforward statistics: comparing the distributions of different populations and drawing conclusions through standard parametric and non-parametric tests. I enjoy it because it pays well, I can grow my statistical skills, but also, I’m now a published author in the field of bio-statistics. Pretty cool, right?Job #4: LandlordFor the first 10 months of 2017, I had 2 roommates who were paying me rent. I needed to ensure that the sidewalks were shoveled, the utilities paid on time, and any things needing to be fixed were fixed in an appropriate time frame.Before 2015, I’d never owned a house or been a landlord. It was a great learning experience for the past 2.5 years, as I got an experience as a landlord through my house hacking. I’m looking forward to buying a rental property in the coming years to become a landlord once again.Job #5: Small Business OwnerIn May, I started a business with a business partner which would focus on making money two different ways. The first, a kombucha tea subscription kit where our company sends out flavoring and starter kits to our customers each month. The second income stream is dropshipping t-shirts through Shopify and print on demand. I’ve learned a ton about business through creating this.There is so much that goes into starting a business. It’s not enough just to have an idea. Then there’s the paperwork, opening various accounts, coming up with more ideas, implementing a plan, executing, staying consistent. I’m going to write a post on my recommended path for starting a business in the future, but just know, there’s so much to do and a lot to consider.Job #6: Certified Food Safety ManagerTo package dried fruits, sugar, and tea, I needed to get in to a commercial kitchen. To get in to a commercial kitchen, I needed to become a Certified Food Safety Manager. For $85 and 20 hours of my time, I was able to get certified and now can create safety plans for food handling.After never working in a kitchen before, this was quite an interesting learning experience. The test wasn’t too difficult, and it was cheap – if you are interested in the food industry, this is probably a solid resume booster. Here’s my full post on it from last summer: Becoming a Food Safety Manager.Job #7: Social Media MarketerOver the past 12 months, I’ve learned a ton about marketing. As a math major, I have no background in marketing. Pinterest, Twitter, Facebook, Quora, oh my! I don’t really like doing social media, but it’s an essential task in today’s business environment.I’m really excited to keep getting in to Pinterest and Quora in 2018 – both of these platforms are fantastic and have a huge reach.Job #8: AccountantIn college, I was a bookkeeper and spent 3 years doing cash flow analysis, accounts receivable, bank reconciliations, and your standard bookkeeping. All of this has paid off since I’m the chief accountant for my self, but also my business. It’s not too complicated, but there’s definitely a lot to learn.I’m still learning more about taxes and financial statements. These skills will pay off no matter what I do in the future.Job #9: Customer Service RepresentativeOver the holiday season, I got a lot of emails and messages from customers. Where’s my shirt?!!? Why does my package only have this and not that? Your site is misleading, I want my money back!While frustrating, it’s a necessary part of business and very valuable feedback for what to change and edit on the sites.Job #10: Web DesignerBefore 2017, I didn’t know too much about web design. I had a website back in 2015, but it looked unprofessional. No images, poor color scheme, etc.Now, I’ve learned a lot about web design, to the point where my boss is trusting me to build out web applications for the team and department! Over the past 12 months, I’ve taken most of the Code Academy courses (which I’d highly recommend), learned about user experience, as well as the consequences of picking an appropriate color scheme for your business.This site has been tweaked and re-tweaked many times, and I still have ideas to improve the user experience. I re-did the business website 3-5 times in October/November in an effort to prepare for Christmas, and that pushed me to a higher level.There’s so much to learn for design – I’m at the very tip of the iceberg – and I love it!Job #11: Warehouse WorkerAt the end of each month, it’s time to pack up the subscription kits and send them off to our customers. Spending a 10 hours at the end of the month is a tough task, and managing what does in which kit is always fun. Eventually, this could be outsourced, but for now, it’s all on me!The Power of FocusI think I put too much on my plate in 2017, but it was a great learning experience. My recommendation for you is to look to expand your knowledge, but do it in a way which complements your passion and your daily job.For example, my side hustle of statistical consulting complements my day job in a very direct way. Flipping the switch from day job to side hustle doesn’t require too much on my part. My business does not, so I struggled for at least 2-3 months getting in to that mindset where my brain was comfortable thinking in that way.Learning, Applying, and Providing Value to Increase Your IncomeI love blogging and writing because I love how I’m able to inspire others to do more with their lives through my actions. I could be the most successful person in the world, but unless I share my experiences with you, none of my successes with matter.I want to learn all of these different things so I can have a more complete world view, and have experience in many different areas. For me, my main strengths are programming, mathematics and statistics, and basic finance and accounting.Some of the areas I’m improving in are writing, business, marketing, and project management. I definitely have some weaknesses, but if I keep learning, applying, and providing value to others, I know I’ll be able to fill in those gaps.Take some time out of your day and spend it on yourself. Remember my favorite quote, and take action:“Your level of success will rarely exceed your level of personal development, because success is something you attract by the person you become.” – The Miracle Morning