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.

The Link Between ISO 9001 Certification And Service/Product Reliability

The Link Between ISO 9001 Certification And Service/Product Reliability

The Link Between ISO 9001 Certification And Service/Product Reliability

Businesses may have heard about ISO 9001 certification and might have even considered becoming certified in the past. For whatever reason, these businesses might have decided against certification. In most cases, it’s because they don’t see the tangible evidence for ISO 9001 certification making a difference to a business’s products or services. While it can be difficult for the non-specialist to spot, ISO certification does help businesses a lot. Despite the claims, is there any objective evidence that shows a positive link between business performance and ISO 9001 certification?

What Is ISO 9001 Certification?

We’ve already covered ISO 9001 in our previous blogs. To recap, the International Organization for Standardization  (ISO) mentions that ISO 9001 certification sets the criteria for establishing a quality management system within the company. The establishment of this system, it is claimed, will help a business be surer of its products and services. At its heart, it focuses on the business’s responsibility to the consumer. The certification process allows the company to examine its processes and products to ensure that its quality remains constant throughout the business’s lifetime. Achieving certification doesn’t mean the enterprise can relax, however. The ISO certification needs to be renewed ever so often to ensure that the business doesn’t lapse in its responsibility to the end-user.

Does It Make Any Difference?

Over the years, companies have applied to and achieved ISO 9001 certification but have not felt any difference in their business processes. They may have seen better customer acceptance of their products and a more substantial market presence, but they might have overlooked these apparent benefits without anything to compare them to.

The January 2021 issue of the journal Heliyon addresses this in a study that examines the relationship between ISO 9001:2015 certification and business performance for a manufacturing company in the developing world. The paper mentions a noticeable lack of research into ISO 9001 certification in this particular industry and its ability to make a business more competitive. In undertaking the study, they covered fifty (50) companies and used them as a representative sample size.

The results showed a significant and noticeable improvement in companies’ operational and business performance that had implemented the certification against those that hadn’t. However, it did note that, in this particular locale, the most significant hurdle businesses faced was finding competent staff that could implement the guidelines of ISO 9001 effectively. Inadequate training and a lack of qualified personnel is a genuine hurdle to overcome. These issues were further exacerbated by a lack of commitment from upper management towards establishing and improving the QMS.

Why Establish a QMS?

A typical question that businesses ask is why they should even bother to set up a QMS system. The ISO 9001 standard helps a business put together an infrastructure for ensuring quality in their products and services. Aside from making a business competitive internationally, it allows a company to gauge itself based on the performance of other businesses in the industry worldwide. Locally, a company that states it’s ISO 9001 certified shows that it is as good as any international company when it comes to its products or services. This distinction shouldn’t be underplayed, since it grants an edge against the competition.

What Is The Solution?

Developing ISO 9001 certification is laudable, but only if properly implemented. Finding the proper process towards reaching ISO 9001 certification is not something that happens overnight. Luckily, Sync Resource has been in the business of securing ISO 9001 certification for clients for years. We know what works and what doesn’t and can even help a company define its problems and overcome them through dedicated effort. If your business is seeking ISO 9001 certification, contact Sync Resource today to access trained and qualified professionals to help you in your journey.

3 Ways ISO Certification Wins More Business

3 Ways ISO Certification Wins More Business

ISO Certification Helps You Keep Customers


More business means more money. And ISO certification wins business, and here’s how:

ISO certification wins more business by putting customers first. Your QMS (Quality Management System) lets potential clients know that their satisfaction is your number one priority. Being certified is like slapping a giant sticker on your company that says: Internationally recognized. Internationally approved.

Clients need some way to filter all the companies striving for their attention. They do this by looking for referrals and third-party certifications.

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 ISO Certification Helps You Keep Customers

Keeping a customer is cheaper than winning a new one. Customer retention is the centerpiece of any successful company’s business plan. How do you keep them coming back for more?

ISO certification wins more business by keeping your customers happy. Implementing an ISO approved quality management system allows you to consistently provide high-quality products and services. Continual improvement keeps customers engaged with your business. Exceeding expectations makes them loyal and more likely to refer you to someone they know.

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ISO Accreditation Wins More Business by Opening Doors

ISO is a requirement for public contracts both nationally and worldwide. Want to work with the US Federal Government? You’ll probably need ISO. Do you want to win contracts in China or Japan? ISO accreditation will help.

ISO accreditation wins more business in the private sector, too. If you want to become part of a supply chain and a contractor upstream of you has ISO accreditation, you may need it, too.

Whatever line of work you’re in, ISO accreditation wins more business.

When Does a Business Need ISO 9001 Internal Auditor Training

When Does a Business Need ISO 9001 Internal Auditor Training

Internal audits are the most critical part of the ISO 9001 quality management system (QMS). Having someone with ISO 9001 internal auditor training can be valuable to a business seeking to achieve and maintain the certification. According to the International Standards Organization (ISO), it is recommended that institutions seeking ISO 9001 certification have regular internal audits to ensure that all the parts of the system are working well. ISO 9001 certification depends on internal audits as part of its continual improvement process, as mentioned before. Here, we delve into when a business should have an ISO 9001 internal auditor training and what this entails.

What Does Internal Auditor Training Involve?

It’s not a requirement for businesses undertaking the ISO 9001 certification to get training from external organizations. However, businesses that offer external auditing services may also provide training for ISO 9001 internal audits. Companies that want their internal auditors to be trained appropriately would be wise to enroll them in either these supplemental courses or in a lead auditor training course. Typically, these training courses include information that auditors ought to know, including:

  • Understanding the structure and function of the ISO 9001 certification and the entire listing of the Requirements and Structure of the standard.
  • Utilizing the ISO 9001 guidelines for auditing management systems, allowing them to assess how well the company’s processes measure up against the requirements.
  • Real-world scenarios to help auditors understand what they may encounter during their new role as internal auditors.

Company-Specific Topics

ISO 9001 internal auditor training will give individuals the chance to learn about the intricacies of applying the standard. Additionally, it will allow them insight to understand what they should learn from their own institutions. Every QMS system tends to have its own needs and functions. While the standard provides a generalized overview of how the system should function, it’s up to the internal auditors to pinpoint the specific topics within the company they need to focus on. These include:

  • QMS Specifics for the Institution: To properly audit a company’s QMS, an auditor needs to be aware of the processes, policies, procedures, and how these interact to get a complete idea of how the QMS functions. Asking people involved in the process can help the auditor develop a roadmap that they can use to speed up their auditing.
  • Checklists: Audit checklists are useful tools in helping auditors get and stay on track with their audit. It also helps them to underscore the elements of the QMS that they think need improvement.

Auditing With a Purpose

Anyone involved in ISO 9001 internal training should be aware of the reason for their practice. Auditing plays a crucial role in helping institutions achieve their ISO 9001 certification. An internal auditor must ensure that their audits are done thoroughly and comply with the ISO 9001 rules. Additionally, any suggestions they present to the company should help to improve its QMS. We’ve touched on how essential employee training is to the success of an ISO 9001 certification. It might be tempting to consider internal audits as a way to force change into the system, but doing so can lead to unforeseen problems. It’s much better to use the standards as a guideline for your own suggestions for improving the company’s QMS.

Planning For Success

Enterprises that establish a QMS already have the right idea in mind. However, without constant auditing, there are many places where the QMS can falter. Internal auditors are the best way to avoid having the institution slip back into an uncoordinated mess. Interested in learning more about ISO 9001 internal auditor training? Send Sync Resource a message today! We can help you with your ISO 9001 internal auditor training program.

Wondering What To Do For ISO 9001 For Small Business? Best Practices For Certification

Wondering What To Do For ISO 9001 For Small Business? Best Practices For Certification

You may be wondering exactly what to do for ISO 9001 for small business. Keep in mind that ISO Certification is a significant step for a small business to raise its reputation. Indeed notes that ISO certification allows a company to establish its credibility among consumers, business partners, and other stakeholders. For small businesses, ISO 9001 certification can make them stand out in a crowded field. The International Organization for Standardization (ISO) informs us that ISO 9001 deals with the establishment and maintenance of a quality management system (QMS). Unfortunately, the road to certification is complicated. Most companies need to delve into what to do for ISO 9001 for small business. Luckily, we can break down the process in an easy-to-understand way.

The Overview Of the Process

We’ve covered a simplified method of getting ISO 9001 certification before, but for small businesses we’ve condensed the process into a few appropriate steps:

  • Adopt the standard: Buy the standards publication, read it, and decide that you want to achieve certification.
  • Find a consultant: Ideally, a company that knows how to help small businesses meet the needs of the standard would be what you’re looking for.
  • Examine existing processes: See what your existing processes are and how they compare to the standard.
  • Make necessary adjustments: If your systems are already functioning in compliance with the standard, there’s nothing to do. If they aren’t up to standard, then you need to make changes and re-examine.
  • Select a registrar: This body will perform an external audit to ensure that you conform to the standard.
  • Deal with issues: After the audit finishes, you should address the shortcomings that the registrar found to achieve your certification.

The process seems simplistic when laid out like this, but each one of these steps has many smaller parts involved. Achieving certification is an ongoing process. Even after the certification, you will need to renew it every few years, which requires the systems you put in place to remain operational. Luckily, the ISO 9001 process has something designed just for this purpose.

The PDCA Cycle

If you want to know what to do for ISO 9001 for small businesses, the core of the continuous improvement process hinges on the PDCA cycle. PDCA stands for Plan-Do-Check-Act. It describes how a company should deal with meeting and maintaining the standards prescribed by the ISO 9001. Each of these steps has its own responsibilities:

  • Plan:

The planning stage defines the aims of the component, and the material and personnel needed to achieve those aims in line with the business policy.

  • Do:

Once the plan is finalized, the business proceeds to work to meet the previously outlined plan’s goals.

  • Check:

The process is monitored and compared to the plan. This step is usually where documentation happens, and corrective measures are suggested to ensure that the process conforms to the plan.

  • Act:

Suggestions proposed in the previous step are tested for viability, and if they are workable solutions, the business can then implement them.

A Wholistic Alignment: Understanding What To Do For ISO 9001 For Small Business

The ISO 9001 standard is unique in its approach since it allows businesses to align their business objectives with the implementation of their QMS. Part of the process requires that companies look inward and define their strengths and weaknesses, as well as external threats that could impact their industry. Additionally, the inclusion of employee awareness as an integral part of the process keeps everyone on the same page. It helps promote buy-in at the employee level to establish and maintain the ISO 9001 standard.

Interested in seeing what ISO 9001 can do for your small business? Contact Sync Resource today to find out what to do for ISO 9001 for small business.

What You Need to Know About ISO 9001 Awareness Training

What You Need to Know About ISO 9001 Awareness Training

We’ve previously covered management commitment to ISO 9001 certification, but ISO 9001 awareness training should also be top of mind. For a business to succeed in implementing their ISO 9001 standards, the employees must also buy into the vision. As The Houston Chronicle notes, if you don’t communicate how your QMS works or which aspects of quality you’re focusing on, your program will fail. In the case of ISO 9001, awareness training is how businesses can seek to inform their employees about the QMS and what constitutes “quality” in the company’s terms. But what defines quality, and how can you communicate that to employees effectively?

Understanding ISO Quality Awareness

An employee does not need to know all the details of the ISO standard. In fact, adding that information to their plate can overwhelm them and make them less likely to support the standard’s implementation. ISO quality awareness has a much smaller scope. For ISO 9001 awareness training can help employees understand their role in the QMS, and how their specific duties impact its functioning. Therefore, awareness training allows employees to learn how their actions play a critical part in the implementation of the ISO 9001 standard. Quality awareness doesn’t mean the employee knows the ISO standards definition inside and out. It means that they are aware of how their contribution affects the company’s push towards compliance.

Employee Engagement and ISO 9001 Awareness Training

We covered in a previous blog post how managers who want to engage their employees properly should approach implementing the ISO 9001 standard. Employee engagement goes hand in hand with awareness training. To properly engage an employee, management must understand their competencies. What are those particular employees good at? Once you determine the roles they are best suited for, you can engage them by showing them how their actions impact the larger picture. ISO compliance requires all hands to be on deck. ISO 9001 awareness training allows employees to judge whether their actions are compliant with the standard. Employees can then take corrective action, with the end goal of being compliant in line with the business’s goals.

Knowledge Fosters Self-Correction

Employee buy-in, combined with the knowledge of the employee’s specific role, can help develop a self-correcting positive feedback loop. Employees within a company should demonstrate autonomy for certain things. Internal audits form a part of the ISO certification process, but if an employee can self-audit the company benefits. An employee who can determine his or her compliance makes the internal auditor’s overall job much more manageable. When the business gets to the point of external auditing in anticipation of certification, each employee’s self-auditing nature ensures that the company remains compliant. Whether the company can rely on employees to self-audit comes back to ISO 9001 awareness training.

What Employees Should Know

The standard has a series of requirements that employees need to know:

  • The company’s quality policy
  • The quality objectives for the employee’s department
  • The employee’s specific contribution to the success of the QMS
  • What benefits improved performance will bring to the company
  • What non-compliance means and the consequences of failing to meet the standard

These key points offer employees the motivation and the knowledge to contribute to the QMS in a meaningful way. It serves to empower and inform the workers so that they can align themselves with the company’s vision. By offering employees this level of knowledge, management shares the burden of responsibility and makes the employee feel like an integral part of the company. This feeling is crucial to achieving employee buy-in and raising engagement.

If you’re looking for a professional consultant to help you develop tools for your ISO 9001 awareness training, Sync Resource remains dedicated to helping our clients achieve their certification goals. Call us today, and let us help you train your workforce to self-correct!