ISO 9001 & ISO 13485 Certification: A Professional’s Future

ISO 9001 & ISO 13485 Certification: A Professional’s Future

ISO 9001 & ISO 13485 Certification: A Professional’s Future

ISO 9001 and ISO 13485 certification both offer significant benefits to an individual. We’ve covered ISO 9001 certification in great detail on our blog before. ISO 13485 certification, according to the International Organization for standardization, covers quality management for medical devices. It’s immediately apparent that these certifications may be linked. ISO 13485 certification can trace its roots back to the ISO 9001 standard, but the processes used within the standard are defined specifically for medical devices. If someone were to be qualified with both ISO 9001 and ISO 13485 certification, they would be an asset to their business. But what would their future be if they leave the company?

Trained Staff Is Crucial for ISO Certification

If a business is trying to achieve ISO certification, it needs to start with qualified personnel. Several companies have put a lot of time and effort into educating and training their employees to take up positions as internal auditors. These auditors are a crucial part of the certification process. In ISO 13485 certification, a business must constantly inspect its products to ensure they meet a certain minimum standard. As with most ISO certification processes, the idea is to establish a system of self-improvement within the manufacturing process. Most individuals who have had experience with the ISO certification system would have immediately spotted the process flow of the Plan-Do-Check-Act (PDCA) cycle. Unfortunately, this isn’t immediately obvious to a new trainee.

A professional with both ISO 9001 and ISO 13485 certification can be a priceless addition to any business seeking its own accreditation. Aside from being a pillar of the business’s certification push, the expert can guide others to becoming auditors themselves. It’s crucial to have someone who understands the process of ISO certification within a company’s hierarchy. Without this intimate knowledge of the standard, a business risks making mistakes. While this might not seem like a massive deal in the grander scheme of things, these mistakes can take a toll on a company. Minor errors in implementing a standard could have severe knock-on effects in terms of cost and time. Achieving certification can take a lot longer if the business isn’t sure what it’s doing.

ISO 13485 Certification Requires Constant Monitoring

Both ISO 9001 and ISO 13485 certification have self-improvement as a core function of the standard. Trained personnel know how to best apply the tenets of the standards towards improving the business’s processes regarding quality. ISO 9001 helps develop a quality management system (QMS) that the company can rely on in a general sense. ISO 13485 certification focuses on medical device production specifically. In tandem, they could make a business globally competitive, but only if it has a qualified person to guide them towards achieving this goal.

Constant monitoring forms a core part of all ISO standards. Self-improvement and internal audits are helpful in determining where the company’s shortcomings are. With skilled, trained personnel dedicated to performing audits, a business can reliably find its weaknesses and shore them up. The goal of implementing and ISO standard is to allow a business to be competitive globally. To maintain this competitiveness over the long term and retain certification requires trained staff. But internal personnel need to have support from consultants. There’s such a thing as being too close to the forest to see the trees, after all.

External Help Can Be Useful

As with most certifications, it may be impossible to achieve relying entirely on internal personnel. ISO 9001 and ISO 13485 certification requires external auditors to verify the business’s attempts before becoming certified. SyncResource has been offering support to businesses on the road to ISO certification for years. Contact us today to get professional guidance on achieving the elusive goal of ISO 13485 certification.

ISO 13485 Consultants : Can They Jumpstart Your Certification

ISO 13485 Consultants : Can They Jumpstart Your Certification

ISO 13485 Consultants will help you get certified faster and make sure that you’re actually compliant with standards.

You may be toying with the idea of building an in-house team to get you certified. You think this will be a wise and cost-effective decision. Why pay someone else to do what you can do yourself?

Here are 4 Reasons ISO 13485 Consultants will get your certified faster.

Looking to get ISO 13485 certification for your business?

ISO 13485 Consultants are Specialists

Take a look at your company. You are a team of specialists. That’s why people pay you to do the work you do. Think about the kinds of simple mistakes amateurs make in your industry—and all the extra work that makes for you.

How much time and pain do customers save themselves when they come to you first?

That’s why consultants are an important part of the business ecosystem. We use them to fill in gaps whenever we don’t have the internal resources or skill set to accomplish a goal.

ISO 13485 consultants will come to your business to do one specific thing which they are very good at. They understand how to put implement quality management systems regardless of the industry.

…So they Make Fewer Mistakes

Since ISO 13485 consultants are specialists, they make fewer mistakes. An in-house team will be learning on the job and trying to master new information. They don’t know what the Global Harmonization Task Force recommends.

That doesn’t mean they’ll fail.

But you rest assured, mistakes will be made.

Paying your employees to learn makes sense when you are trying to break into a new market or build up their skills to suit your needs. But does bankrolling these failures make sense to get ISO 13485 certified? Ask yourself whether the time and effort your team will invest in learning the ropes will be worth any potential savings.

ISO 13485 Consultants Can Focus

If you want your company to successfully implement ISO 13485, you are going to have to divert employee time and resources. They’ll need to stop focusing on other projects in order to learn about and then implement standards.

Ask yourself what will suffer when your team members are working on ISO compliance.. Will customer satisfaction decrease? Will targets that you expected to hit in March move to September? How accurate of a timeline can your inexperienced in-house team give you?

Your ISO 13485 consultants will have clear priorities. They will be able to keep their eye on the prize and give you accurate timelines.

What questions do you have and how can we help?

ISO 13485 Consultants Don’t Have Competing Interests

Even with the best of intentions, your in-house team is not going to be impartial when looking at your organization. They have ties to people and projects which will cloud their vision.

ISO 13485 consultants are going to walk into your company with fresh eyes. They won’t have allegiances to any departments or individuals. There will be no need for them to cover up a job poorly done in the past to protect themselves.

Because they’re an objective third-party, ISO 13485 consultants will be great at seeing the flaws and loopholes in your system.

Can an In-House Team Get the Job Done?

Companies have put together successful in-house teams. That is an option. If you want to do that, take a look at our cheat sheet to get your team started. You can even give us a call and we’d be happy to answer any questions you have.


How to Overcome the Challenges of ISO 13485 Implementation 

How to Overcome the Challenges of ISO 13485 Implementation 

What are the biggest challenges of  ISO 13485 implementation in your business?

These challenges can be separated into two broad categories:

(1) Hurdles faced by building Quality Management Systems in general; and
(2) Challenges in ISO 13485 implementation in specific. These are troubles you face if you’re involved in any stage of the medical device life cycle

Challenges of QMS Implementation

Here are three of the biggest challenges in ISO 13485 implementation no matter which Quality Management System you wish to conform to.


Management needs to have a clear understanding of requirements. Leaders will set the tone for how the rest of the organization approaches changes.

Leaders need to understand that QMS is not a side project. Focusing solely on certification to meet the requirements of a customer is a bad idea. If your view remains narrow, your effort to conform to standards will stall and ultimately fail.

Instead, leaders need to view their QMS as an essential part of the business process. Focusing on standardization, improvements, and customer satisfaction will benefit your company in the long run.

Rumors and Gossip

Most workplaces experience an uptick in rumors and gossip when they implement a QMS. The primary concern for most of your employees is that they will lose their job. Upper management should communicate the purpose of the changes to their workforce to quickly allay fears. Bringing in specialists can help to clear up popular misconceptions.

Too Much Theory and Documentation

In an attempt to be perfect, organizations will go overboard with details. They’ll focus on theory over practice, stalling successful implementation. They will create documentation processes that don’t facilitate communication, improve operations, or make proof of compliance easier.

Don’t let perfect be the enemy of good, or good the enemy of done. You are building your QMS to improve over time and use resources more efficiently. Don’t allow perfectionism and useless paperwork to become challenges in ISO 13485 implementation.

Contact us to get a specialist’s opinion.

Challenges of ISO 13485 Implementation

Maybe you head an organization that is already ISO 9001 certified. Maybe you have already dealt with those problems. So you are more interested in the particulars of compliance within the medical device industry.

Here are two of the biggest challenges for ISO 13485 Implementation.

Risk-Based Decision Making: One of the Biggest Challenges of ISO 13485 Implementation

In our personal and professional lives, we constantly perform risk-based decision making. What can go wrong? How likely are those events to happen? Is this level of risk tolerable?

One of the challenges in ISO 13485 implementation is that you have to standardize this process. You know that your organization has responsibility for the safety of product/service realization. But you also need to monitor and ensure control  the process throughout the entire product life cycle.

Are your suppliers certified? What are the risks associated with employee’s misinterpretation of processes? How will you gather feedback from users and stakeholders to ensure continued improvement?

You should put a Failure Modes and Effects Analysis into place. If you have one, expanding it to include the entire product/service life cycle will help you deal with safety issues head-on.

Have questions about implementation? Ask us!

High Standards

One of the challenges in ISO 13485 implementation is meeting more rigid standards. These standards exist in the medical device industry due to the international regulatory environment. Recent revisions to these standards force companies to devote a lot of time and resources to evaluating their supply chain.

To meet standards, hire a consultant, get a in-depth gap analysis conducted.

Overcoming these hurdles will be easier for you than the average person. Maybe you are already asking yourself, “Where problems can arise and how can I prevent them?”

Looking to get ISO 13485 certification for your business?

What questions do you have and how can we help?


Why ISO 13485 Certification is an Amazing Idea

Why ISO 13485 Certification is an Amazing Idea

Why ISO 13485 Certification is an Amazing Idea

Imagine you are a small start-up specializing in the design and development of medical devices. Your team has engineered a rubber medical examination glove that has greater sensitivity than a latex glove. You want to hit the ground running when you bring your product to market.

  • What can you do to ensure quality consistently?
  • How can you get your team all on the same page for processes and standards?
  • What can you do to convince prospects that you are producing a high quality product?

You need ISO 13485.

Imagine you are an international company who sells raw material to a wide range of producers and are trying to become a supplier to the medical device industry.

  • How do you persuade potential new customers of your company’s commitment to quality?
  • What can you tell prospects that gives them confidence in your organization?
  • What can you tell prospects that gives them confidence in your products?

You need ISO 13485.

(Get your ISO 13485 cheat sheet here.)

ISO 13485 Certification Improves Internal Operation

Your quality management system (QMS) defines a set of internal rules that every level of your organization adheres to. A streamlined set of policies, processes, documented procedures and records assures that your company reliably and consistently creates and delivers quality products and services to your customers. Everyone follows set standards and knows what to expect. Your staff  is cross trained in ISO so that each member can review other team member’s results. This greatly increases adherence and your success.

Continuous Improvements

The routine measurement and analysis built into your ISO 13485 allows you to create a culture of continual improvement. You can look at individual processes in your organization and how separate elements interact. Then you can easily target the best areas for improvement and savings. You can make evidence-based decisions through the use of standardized documentation and procedures.

Engaged Workforce with ISO 13485 Certification

Your QMS clearly define policies and procedures so that each person in your workforce knows exactly what they’re responsible for. You put team members directly in control of the management and improvement of their processes. This allows each member to take responsibility for his or her output. They’ll invest more deeply in the outcomes of the organization. When employees feel empowered and more vested in a project, a team or the company, studies have shown their focus, dedication, and productivity all increase.

(Ready for a consultation? Click here.)

Image, and Market

When you become ISO 13485 certified, you show your commitment to producing quality medical devices to your customers and  regulatory bodies. Your prospects know you are a  professional organization dedicated to quality. Your marketing department and sales personnel get an advantage they can use in attracting and selling your products and or services.

Market Access

Getting ISO 13485 certified can increase your available markets. To access most major markets worldwide, you need to be ISO 13485 compliant. Certification is the first step to achieving compliance with any countries regulatory requirements.

Customers and Credibility

When you get certified, you signal your dedication to quality and customer satisfaction to the world. On the open market, you may even find customers who refuse to work with you without certification in place. Certification by a recognized certification body will improve your credibility and give you a competitive advantage over those who have chosen to forego certification.

One of the foundation principles of ISO 13485 Certification is improving customer satisfaction. Certification will allow you to meet and exceed customer expectations and continually identify new requirements.

Looking to get ISO 13485 certification for your business?

What questions do you have and how can we help?


Remarkable Benefits: Guide to ISO 13485 Sterilization Requirements

Remarkable Benefits: Guide to ISO 13485 Sterilization Requirements

Remarkable Benefits: Guide to ISO 13485 Sterilization Requirements

What is ISO 13485 sterilization requirement? One of the must-haves for medical device industries is to have an established set up for sterilization of medical devices. Improper sterilization can become life-threatening for patients as it may result in the transfer of pathogens between contaminated and non-contaminated locations. Improper sterilization can lead to infection after surgery, making it much more dangerous to undergo an operation.

A medical device can be described as an instrument, apparatus, machine, or implant that is intended to be used to diagnose, prevent, or treat any disease or be used in any other condition prescribed by the physician.

Definition of ISO 13485 Sterilization requirements

Sterilization requirement is a core functionality in medical professions. By performing this process, medical personnel ensures that the apparatus used in any medical procedure is free of contaminations and pathogens that may introduce complications. Sterilization is an in-depth cleaning methodology that goes deeper than conventional cleaning processes. The requirements for sterilization are covered in ISO 13485:2016.

Many medical devices and surgical instruments are often used more than once during numerous surgeries and occasionally with several patients. To limit the transfer of pathogens from one person to another, it is essential to sterilize the surgical instruments after being used in any surgery to avoid contamination by micro-organisms. Numerous methods have been used to sterilize medical surgical instruments, including:

  • Autoclaving radiation
  • Ethylene Oxide (ETO) Sterilization
  • Chlorine Dioxide Sterilization
  • Hydrogen Peroxide Sterilization
  • And other ways.

Is it Necessary to Sterilize Surgical Instruments?

As ISO 13485 Sterilization requirements emphasize, it is important to ensure patients’ safe medical conditions during any surgery. The whole purpose of providing this sterilization is to eliminate any possible chance of surgery-induced diseases and other related medical issues.

A patient’s safety during any medical procedure is of tantamount importance. There are several reasons why sterilization is so vital to achieving this end goal:

  1. The sterilization process stops the reproduction of pathogens on the surface of medical equipment. This cessation of growth of the colony lowers the number of organisms and makes it less likely to spread diseases between theaters of operation.
  2. Lethal diseases can be stopped outright by destroying the disease-causing organisms through sterilization.
  3. Sterilization reduces the chances of complications and the need for more surgeries to achieve the desired results.

How to Follow ISO 13485 to Comply with Sterilization Requirements

The requirements for sterilization can be found within the ISO 13485:2016 standard. The clauses that cover the sterilization of equipment include:

  • Clause 3.20: Sterile Medical Device

Most authorities provide detailed guidelines about the levels of sterility they accept. The regulatory authorities that form the bodies that oversee your intended market will inform you of the required standards for your sterilization procedure to follow.

ISO 13485 6.4.2 clearly outlines how to prevent contamination after devices are sterilized. This preventative procedure is done with engineering controls like dust collectors and ventilation systems by monitoring air quality at a defined frequency. The results can be recorded before and after sterilization.

  • Clause 7.5.5: Particular Requirements for Sterile Medical Devices

Clause 7.5.5 states requirements in the form of two sets, which are:

  • All the records of sterilization process parameters for every batch have to be maintained and recorded. The sterilization process parameters can include various constraints to be registered, like temperature, pressure, gas flow, humidity level, and environmental conditions. The personnel in charge of sterilization may also need to be noted since the human factor may significantly affect the result.
  • Every batch of sterilization needs to be traceable, which means getting back the information where it was packed, shipped with complete sterilization records.
  • Clause 7.5.7: Sterilization Process Validation and Sterile Barrier Systems

Clause 7.5.7 declares two sets of requirements, which are:

  • Sterilization Process Validation: It’s not sufficient to only carry out the sterilization process. It is equally important to validate the sterilization method. The review of the validation process will further highlight any need to change the process or product.
  • Sterile Barrier System‘s Validation: A Sterile Barrier System has one requirement in its installation – it should have sufficient enough barrier to prevent recontamination of previously sterilized equipment. A sterile barrier can be engineered in a control room containing bio-sensors for medical devices’ packaging with appropriate alarms indicating any signs of bio-contamination. Furthermore, it should be able to prevent any cross-contamination about to happen. Such Sterile Barrier Systems need to be validated if an amendment is required for the design change, or any parameter control has to be changed.

Benefits of Implementing Rock Solid Sterilization Process

All the clauses of ISO 13485 have numerous benefits of implementing and deeply involved in the life cycle of medical devices:

  • Sterilization Strengthens Customers’ Trust

Those medical devices that are being sterilized ensure the prevention of many health risks. Compromised medical equipment can result in fatalities, specifically when it comes to micro-organisms that can badly infect the human body.

  • Easy Traceability

If any non-conformity occurred within the system, it could be corrected right away if the sterilization process is adequately documented. Non-conformities can be traced along the route of documentation to find the problem within the process. If a non-conformity shows up during manufacture, the accepted response is to stop manufacture until a complete investigation is undertaken.

  • Management of Risks

By reliable traceability, the medical device industry can effectively manage the risks. It can demonstrate compliance to the highest level possible, fulfilling all the authority’s legal and regulatory requirements that oversee each market.

  • Competitive Advantage of ISO 13485 Sterilization

Businesses that conform to the standard have a competitive edge over other companies. By demonstrating compliance with ISO 13485 sterilization, a business’s products become more attractive to potential buyers, especially those that pay close attention to international standard testing.

Looking to get ISO 13485 certification for your business?

What questions do you have, and how can we help?


Ultimate Beginner’s Guide to ISO 13485 Design Control MDQMS

Ultimate Beginner’s Guide to ISO 13485 Design Control MDQMS

Ultimate Beginner’s Guide to ISO 13485 Design Control MDQMS

ISO 13485 Design Control is considered the Bible for Medical Device industries. It comprehensively explains the ideal management system for designing and manufacturing medical devices, also known as MDQMS (Medical Devices Quality Management System).

Compliance with ISO 13485 enables any medical business to fulfill all the legal requirements of regulatory bodies. To be ISO 13485 certified, a business must have high competency levels to satisfy mandatory requirements.  The company will also meet end consumers’ expectations for high-quality medical devices by conforming to the standard.

ISO 13485 is also fully integrated with ISO 9001, making it simple to comply with US FDA and EU CE requirements, leading to a stronger brand image for the business as a whole.

Brief Intro of ISO 13485 Design Control MD-QMS

As mentioned earlier, ISO 13485 Design Control specifies the QMS for medical industries and fully demonstrates the ability to provide medical devices with excellent quality outcomes capable of satisfying consumers’ needs. It doesn’t matter if the medical device industry is related to any one of the operations like design and development, production, storage of the raw material or final product, distribution, erecting installation, or periodic services of a medical device in the form of remote technical assistance or regular visits to provide hands-on technical support.

Moreover, ISO 13485 can be used by suppliers and third parties that need a QMS specifically for medical device industries.

ISO 13485 Design Control in terms of ISO 13485

ISO 13485 Clause 8.3 provides a full package of guidelines allowing a business to conform to the standard when designing a medical product. The mandatory requirements of design and development in the light of ISO 13485 are:

  • Documentation of Each Design and Development Phase

Each level of design and development must be recorded meticulously. This process allows the company to outline precisely how the product was developed as well as any trials conducted and the responsibilities of each team member per phase.

  • Planning

Detailed planning of design and development can prevent unnecessary delays.  Initially, the business must identify goals and objectives regarding product design and development. The company should also break down the activities into milestones, with each window being documented and defined before the process continues.

The business should have the proper allocation of budget and resources to meet the needs of the project. It is essential not to forget the periodic review of the project of design and development so that if one department needs support to be provided on time, to avoid delaying the project deadline.

  • ISO 13485 Design Control Inputs

The design input is the most crucial step, as the whole outcome is dependent on the quality of information. The design input should include:

  • Top requirements and reasons for developing the product
  • The demands or needs from the end-user
  • Physical features (tangible and intangible)
  • Feasibility of manufacturing
  • Safety factors and Ergonomic study
  • Risk control and Risk analysis
  • Servicing needs depending on the importance of the product
  • Costing feasibility


  • Design Outputs

The outputs of design and development can be done in the following forms:

  • Inventory of raw materials, spare parts or sub-assemblies
  • Manufacturing process specifications
  • Environmental assessment and specifications
  • Identification, traceability, manufacturing, packaging, inspection, and distribution of the product
  • Submission of documents for regulatory authorities
  • History records of designs and trials if conducted on a pilot-scale or plant-scale and their outcomes
  • Product Validation
  • Design Review

The finalization of the design isn’t the end. On the contrary, it’s just the beginning. It is essential to review the plan from time to time as the market is continuously evolving, and there is a constant need to make products better and better to stay ahead of the competition. Additionally, one must review the design to satisfy safety concerns if they get arise over time. In keeping with the standard’s requirements, design reviews should be documented extensively.

  • Design Verification

Does the product live up to its purpose? The design should be verified so that the business knows that it works for what it was intended for.

  • Product Transfer from R&D Scale to Plant Manufacturing Scale

Product transfer relies on moving the designed product over to the plant. It allows for scale production of the product. Additionally, R&D personnel from the lab can inform plant managers and operators about problems they should look for during the manufacturing process.

  • Change Management of New Product

As with most standard, perfection is iterative. If there are production issues, the design may need to be revamped to deal with them. Changes that occur will also need to be fully documented to adhere to the standards.

Advantages of ISO 13485 Design Control Effective Process

In ISO 13485 Design Control, specific requirements are mentioned for new product design and the development process. Conforming to these guidelines makes new products more reliable and safer for the end consumer to use. However, periodic reviews will strengthen product attributes to the best level possible by minimizing design flaws and defects. Using reviews in this way results in higher quality products.

Design control guidelines in ISO 13485 play a significant role in the medical device industry, which is more sensitive to the end consumer. Patients in hospitals and clinics worldwide depend on the standard of medical devices to ensure that they have a safe stay in these institutions.