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Quality Management System Coverage

Life Science Outsourcing provides robust quality management system coverage to meet our clients’ various medical device needs.

Technician reviewing accelerated aging test data on a computer in a controlled laboratory environment.

Leveraging Our eQMS for
Consistent Compliance and Superior Quality

At LSO, we take full advantage of our state-of-the-art eQMS supported by expert staff with decades of experience. For startups, we provide a robust foundation for scaling operations while ensuring FDA and ISO 13485 compliance. OEMs benefit from streamlined processes, reduced risks, and consistent product quality—all backed by our advanced facilities and a team dedicated to your success.

What is a quality management system?

A quality management system (QMS) encompasses all processes, procedures, and responsibilities that are needed for consistent product quality. It can cover a variety of medical device manufacturing aspects, including:

  • Design controls
  • Risk management
  • Supplier management
  • Production controls
  • Complaint handling
  • Corrective and preventive actions (CAPA)
Medical Package Testing: Anatomy of a Protocol

Who needs quality management system coverage?

A QMS helps manufacturing staff follow production controls and standard operating procedures, support regulatory affairs teams to meet compliance requirements, enables quality assurance and quality control teams to oversee and conduct inspections, and gives design and development teams the necessary tools for design controls, risk management, and validation of products.

Quality management systems are important to the medical device manufacturing process for several reasons:

  • Ensures compliance
  • Enhances product quality
  • Reduces risk
  • Supports customer satisfaction
  • Provides continuous improvement

How does quality management system coverage work?

A QMS has many different layers to provide full capabilities and scope to achieve quality objectives.

Documentation and procedures

A QMS can establish clear procedures, work instructions, and records that guide all quality-related activities.

Risk management

QMS can identify, analyze, and mitigate risks throughout the product lifecycle.

Design controls

Manufacturers rely on a QMS to determine if the product design meets the user needs as well as regulatory requirements through the validation and verification process.

Production and process controls

A QMS helps to maintain consistent product quality through SOPs, training, equipment maintenance, and in-process inspections.

Nonconformance and CAPA

QMS tools can identify quality standard deviations and implement corrective actions to prevent a recurrence of the deviations.

Internal audits and management review

QMS can identify areas for improvement and supports effective compliance.

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What standards apply?

A quality management system is mandatory for medical device manufacturers in the United States.

  • A QMS meets the FDA requirements for the Quality System Regulation (QSR), outlined in 21 CFR Part 820, which specifies necessary quality system requirements.
  • A QMS is also compliant with ISO 13485, which is often required for global market access.

Why LSO?

As an FDA-registered and ISO 13485-certified contract manufacturing organization, Life Science Outsourcing (LSO) offers assembly, packaging, sterilization, and specialized capabilities in diagnostics packaging and design. Our unique business model combines comprehensive in-house services and extensive regulatory expertise, allowing us to provide the agility and flexibility needed to expedite market launches while standardizing the supply chain and minimizing risks.

Full EtO Validation

Comprehensive packages for regulatory compliance.

Flexible Sterilization Cycles

From fractional to full cycles with EtO residual testing.

Robust Qualification

Secure with 2X qualification.

Choice of PCDs

Tailored to your sterilization needs.

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