Quality standards in manufacturing are essential. They apply to all industries, ensuring customers receive finished products that conform exactly to the original design. Manufacturers who meet more stringent regulatory standards experience a significant advantage over the competition, and it’s important for customers to know how to vet a company’s quality control system.
COMCO understands the importance of quality – utilizing our many years of experience, along with following suit with the latest quality standards, certifications and leading in innovative growth and industry improvements we are recognized for delivering our orders to spec and we have achieved an average of 98% on-time delivery. Our organization strives to deliver high quality production and manufacturing, along with white glove customer service to all our clients.
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What Is the ISO 9001 Certification?
Obtaining a copy of an organization’s current ISO 9001 certificate is a reliable way to determine if it will provide consistent quality. ISO 9001 manufacturing and general quality guidelines define the requirements of a Quality Management System (QMS). It includes 10 clauses outlining the design, implementation, and refinement of the QMS. Most importantly, it includes seven mandatory provisions:
- Context of the organization: The basis of a manufacturer’s QMS depends on identifying the expectations of interested parties, including the company’s internal and external factors affecting those interests.
- Leadership: Leaders must ensure success by establishing their company’s quality policy and assigning duties for its implementation, all while encouraging consistent focus on the customers’ needs.
- Planning: This entails identifying objectives and assessing risks and opportunities involved in quality improvement plans.
- Support: For manufacturers, ISO 9001 requires that a QMS integrates the following into their overarching quality improvement efforts: business infrastructure, facility conditions, human resources, monitoring processes and tools, records-keeping, knowledge bases, and communications systems.
- Operation: Manufacturers must set numerous requirements for product specifications, design, and planning, along with how supplier relationships and variables not yet conforming to the QMS may impact production.
- Performance evaluation: To evaluate the effectiveness of their QMS, manufacturers must assess customer satisfaction, monitor processes (using internal audits), and conduct management reviews.
- Improvement: Continual adjustments to the QMS involves identifying and correcting nonconforming factors wherever possible.
- Promoting awareness of regulatory standards
- Controls over work environments to maintain product safety
- Risk management and design-control protocols during product development
- Standards for implantable device traceability and inspection
- Documentation and validation procedures to maintain sterile materials, equipment, and work environments
- Verification processes for preventing and correcting QMS issues
- Standards for maintaining product cleanliness
What is the ISO 13485 Certification?
Based on ISO 9001, ISO 13485 manufacturing standards apply to medical devices. It’s the most widely used international protocol for ensuring medical device manufacturers have an effective QMS according to stringent medical standards for hygiene and safety.
After passing an initial ISO 13485 audit, manufacturing companies continue to receive yearly audits as part of the three-year recertification process. For manufacturers, ISO 13485 certification entails:
Learn More About COMCO Plastics’ Commitment to Quality
It’s important for clients to determine whether a potential manufacturing partner has up-to-date ISO certifications in the relevant field(s). COMCO is fully committed to quality throughout our plastic manufacturing processes, and our QMS fully conforms to ISO 9001 and 13485. Manufacturing standards at our facility must adhere to stringent quality controls.
For over half a century, we’ve pioneered various thermoplastics and precision machining for custom plastic components. We continue that legacy by constantly refining our QMS to ensure customers receive the highest-quality plastic products on the market. Contact us to inform us about your plastic fabrication needs, or with any questions related to our quality standards in manufacturing, design, and support processes.