ISO 13485 Injection Molding

Certified to Keep People Safe

PreciKam’s mission is to make parts that are important to people’s health and safety, it, therefore, flows logically that we would have the external audited proof that we mean this statement. This is why we are ISO 13485 Certified. PreciKam has scored zero nonconformities in the last four consecutive annual external audits conducted by Intertek. When Risk Management is at the forefront of your business, trust an ISO 13485 injection molding manufacturer.

About ISO 13485

ISO 13485 is the international standard for Quality Management Systems, specifically within the medical device industry. Though implementing this standard is not required to produce medical and health-type devices and parts, it should be!

If you care about your devices, select an ISO 13485 facility that can provide a solid foundation for quality throughout your product’s full life cycle. ISO 13485 is a Quality Management System for ensuring that medical devices are designed, manufactured, and distributed in a way that ensures your specific requirements are always met.

PreciKam’s ISO 13485:2016 Certification provides peace of mind to its medical industry customers. If user safety is one of your core values and if Risk Management is a strategy to achieve safety, ensure your manufacturer is ISO 13485 injection molding Certified before contacting them.

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Did You know?

Although ISO 13485 is the international standard for Quality Management Systems, it is not currently a Certification required by law. Remember to always inquire about this Certification when vetting manufacturers!

About ISO 13485

ISO 13485 is the international standard for Quality Management Systems, specifically within the medical device industry. Though implementing this standard is not required to produce medical and health-type devices and parts, it should be!

If you care about your devices, select an ISO 13485 facility that can provide a solid foundation for quality throughout your product’s full life cycle. ISO 13485 is a Quality Management System for ensuring that medical devices are designed, manufactured, and distributed in a way that ensures your specific requirements are always met.

PreciKam’s ISO 13485:2016 Certification provides peace of mind to its medical industry customers. If user safety is one of your core values and if Risk Management is a strategy to achieve safety, ensure your manufacturer is ISO 13485 injection molding Certified before contacting them.

Did You know?

Although ISO 13485 is the international standard for Quality Management Systems, it is not currently a Certification required by law. Remember to always inquire about this Certification when vetting manufacturers!

About ISO 13485

ISO 13485 is the international standard for Quality Management Systems, specifically within the medical device industry. Though implementing this standard is not required to produce medical and health-type devices and parts, it should be!

If you care about your devices, select an ISO 13485 facility that can provide a solid foundation for quality throughout your product’s full life cycle. ISO 13485 is a Quality Management System for ensuring that medical devices are designed, manufactured, and distributed in a way that ensures your specific requirements are always met.

PreciKam’s ISO 13485:2016 Certification provides peace of mind to its medical industry customers. If user safety is one of your core values and if Risk Management is a strategy to achieve safety, ensure your manufacturer is ISO 13485 injection molding Certified before contacting them.

Did You know?

Although ISO 13485 is the international standard for Quality Management Systems, it is not currently a Certification required by law. Remember to always inquire about this Certification when vetting manufacturers!

Important Questions Asked ISO 13485:2016

ISO 13485 injection molding is a highly rigorous external auditing process used to ensure producers of medical device components strictly and consistently follow and meet their clients’ specific requirements. Patient health and safety are largely dependant on a molder’s credentials. ISO 13485 certifies that this manufacturer has a well-established Quality Management System to ensure product quality, safety, and compliance with regulatory requirements, including good documentation processes (GDP) and good manufacturing practices (GMP). PreciKam spends thousands of hours on training, internal as well as external audits and procedures every year to manage the risk of defects or failures in a final product. Before choosing a contract manufacturer, make sure you ask them how much they invest in quality and safety!

Keeping an ISO 13485:2016 Certification can be just as difficult as earning one. A highly rigorous process, this Certification validates PreciKam’s Quality Management System, ensuring that we do what we say we are doing. The entire company strives for excellence on a consistent basis. This comes with thousands of hours of training per year, tens of thousands of dollars invested to conduct audits, and team development. PreciKam likes to set the bar higher because of our unwavering commitment to making significant parts that keep people safe. Find out about our four major Certifications.

When health and safety is at the forefront, ensuring compliance through ISO 13485 is necessary. This widely recognized standard for medical device Quality Management Systems meets regulatory board requirements. PreciKam understands and meets all ISO 13485 requirements, ensuring that products are designed and manufactured in compliance with this standard. Engineers can appreciate that this is a necessary step for obtaining regulatory approval to introduce a medical device into the market.

ISO 13485 is a very rigorous standard for medical device quality that requires consistency of mastery. Mastery does not only mean excelling at a specific point in time, rather, excelling and improving continuously as processes change. Understanding the requirements of this standard can help engineers identify areas for improvement in product development and monitor the manufacturing processes as a whole.

The Risks of not Contracting an ISO 13485 Injection Molding Manufacturer

Quality & Safety

Just as trust is earned, so is an ISO 13485 Certification. Many manufacturers may choose to not certify because it is a very expensive and demanding Certification to get – and to keep. This monetary and intellectual investment is like an ongoing pledge to quality and safety. One of the biggest risks of not contracting an ISO 13485 Certified facility is that it might indicate a supplier that is not willing to invest in quality or lacks confidence in their ability to follow their internal procedures. This lack of commitment should be reason enough to be concerned with how this may pose significant risks to patient safety and product quality. ISO 13485 is a critical manufacturing Certification for medical devices that should be a prerequisite for all manufacturers.

Delays & Additional Costs

Resources such as time and budget are valuable, but few people realize that working with an ISO 13485 Certified facility saves you time and money. Medical device manufacturers that contract non-ISO 13485 Certified injection molders may need to invest additional time and budget to ensure that the components produced meet quality and safety standards. This often incurs unexpected costs and delays.

Lack of Controls

PreciKam has built a great reputation in the medical sector, in part, because of our well-defined process controls and Risk Management systems. ISO 13485 injection molding and assembly assures that we have robust process controls in place, which guarantee the consistency of components produced. This level of control enables us to meet even the strictest requirements of medical and scientific equipment plastics.

Oversight

ISO 13485 comes together with external auditors who regularly visit our facilities. Their rigorousness ensures that your device is being manufactured exactly to your specific requirements and based on your documentation needs. The very nature of having rigorous quality procedures that are being meticulously followed minimizes the risk of oversight. Internal audits are something PreciKam prides itself on. In fact, for four consecutive years, we achieved zero nonconformities in our ISO13485:2016 audits.

Documentation

ISO 13485 is most rigorous around documentation. For this reason, PreciKam provides documentation that is often better than what most customers require. As a result, all our customers benefit from our ISO 13485 injection molding facility.

Non-compliance

ISO 13485 is often a key requirement for obtaining regulatory approval across the globe. Contracting a manufacturer that is not ISO 13485 Certified increases the probability you may not be able to demonstrate compliance within regulatory requirements.

ISO 13485, in conjunction with our other Certifications, ensures that you are contracting a manufacturer that takes safety as seriously as you do. PreciKam’s well-established Quality Management System always means that the highest product quality, safety, and compliance with regulatory requirements are met.