Certifications such as the International Organization for Standardization (ISO) are essential in today’s global markets: They signal to buyers and trade partners that a vendor’s product, service, and documentation are consistent with specified quality and process improvement standards.

To help ensure our micromachining capabilities meet your expectations for quality, precision, and performance, Laser Light Technologies holds both ISO 9001:2015 certification for quality management and quality products and services and ISO 13485:2016 certification for quality in producing medical devices.

ISO 9001:2015 ISO 13485:2016

Laser Light Certifications FAQ

  • What is vendor or industry certification?
  • Why should customers know about Laser Light’s (or any other manufacturers) certifications?
  • What is ISO 9001 certification?
  • What is the ISO 9001 certification process?
  • What is ISO 13485 certification?
  • Who needs ISO 13485 certification?
  • What certifications does Laser Light have? And what do they mean?

What is vendor or industry certification?

Vendor certification is a process that ensures a vendor meets all industry and regulatory standards so that the vendor’s products are produced in a consistent manner, and so that purchasers can expect that products achieve certain levels of quality and documentation.

Why should customers know about Laser Light’s (or any other manufacturers) certifications?

ISO certification is an indication of an organization’s dedication to quality and quality management. When a company is ISO certified, it demonstrates that the organization…

  • is committed to performance and productivity through system and procedure documentation as well as active staff training and development.
  • is actively working to reduce waste and improve efficiency through proactive efforts that avoid wasteful issues using continuous improvement strategies.
  • provides a superior customer experience by creating higher standards for and greater value in the products it delivers.

What is ISO 9001 certification?

ISO 9001 is the international standard for an organization’s quality management system. It is used by manufacturers to demonstrate that they provide products and services that are consistent and meet regulatory requirements in an environment of continuous improvement.

These standards are based on seven quality management principles that an organization’s management can apply to promote organizational improvement:

  • Customer focus, to understand the needs of customers and incorporate their perspective into company decision-making
  • Leadership, to establish a vision and set goals
  • Engagement of people, to ensure that staff’s abilities are developed and used, and all are held accountable for their roles
  • Process approach, to manage all activities as processes to understand their interconnectivity and deploy resources effectively
  • Improvement, to better performance across the organization
  • Evidence-based decision making, to ensure the use of accessible and accurate data for analysis and decision-making
  • Relationship management, to identify suppliers and partners to maximize efficiency, resources, and value

Together, these values create an environment of continuous improvement for consistency, reliability, and increased value.

What is the ISO 9001 certification process?

To achieve ISO 9001 certification, a company’s quality management standards and processes must align with the ISO 9001 Standard.

To do this, a company must

  • Learn the ISO standards.
  • Implement the quality standards in the business and document how they are applied.
  • Undergo an audit by an ISO auditor.
  • Receive the certification.

What is ISO 13485 certification?

ISO 13485:2016 is the medical industry business standard for a quality management system that is used to design and manufacture medical devices.

Although it aligns with the ISO 9000 standard, ISO 13485 maintains a higher standard for documentation and safety, while also focusing more on customer satisfaction.

Who needs ISO 13485 certification?

Although ISO 13485 certification is voluntary, this international standard is recognized for ensuring the design, development, production, installation, and delivery of medical devices. Worldwide, the market identifies this certification as an indication of quality.

Laser Light has earned ISO 13485 certification, making us a premiere choice for medical device manufacturers. Our specialty is laser micromachining, which we use to manufacture microscopic components for medical device companies, many of which are Fortune 500 companies. We have the cleanrooms, processes, and experience to do a quality job.

What certifications does Laser Light have? And what do they mean?

Laser Light is both ISO 9001:2015– and ISO 13485:2016-certified.

ISO 9001 is the international standard for an organization’s quality management system. It is used by manufacturers to demonstrate that they provide products and services that are consistent and meet regulatory requirements in an environment of continuous improvement.

ISO 13485:2016 is the international standard recognized for ensuring the design, development, production, installation, and delivery of medical devices. Worldwide, the market identifies this certification as an indication of quality.

These industry certifications ensure that our micromachining capabilities meet your expectations for quality, precision and performance.

What these certifications mean for our customers is that Laser Light Technologies is focused on quality. And toward that goal, we have dedicated resources throughout our organization to work constantly toward greater efficiency by increasing productivity, reducing unnecessary costs, to ensure quality and increase customer satisfaction.

Are there further certifications or safety standards having to do with laser machinery?

In short, yes.

There are a number of certifying bodies and standards boards that outline laser safety practices and procedures. The U.S. Occupational Safety and Health Administration keeps a list of laser hazards and safety standards, of which manufacturers using laser equipment should be aware. (Curious readers can also read more about the history of laser safety standards here.)

There is also an ISO standard. ISO 11553-1:2020 specifically addresses “laser radiation” hazards arising in laser processing machines, as well as safety requirements relating to them. It also pertains to information that needs to be supplied by the manufacturers of such equipment.

At Laser Light, we take safety very seriously. We take many steps to ensure that our working environments are safe both for employees and for the delicate materials in our workspaces.

Do you have further questions about our certifications? Visit our contact page.