QC 080000 Introduction
QC 080000 is an international IECQ (International Electrotechnical Commission Quality Assessment System for Electronic Components) technical specification for hazardous substance process management. It is a proactive, effective, and cost-efficient approach to managing, minimizing, and eliminating hazardous substances in electronic and electrical products and their production processes.
QC 080000 provides a foundation for the comprehensive, systematic, and transparent management and control of the processes designed to meet customer, statutory, and regulatory HSF (Hazardous Substance Free) requirements. It ensures the value-added management of HSPM processes from concept through product realization to product end-of-life.
By providing a comprehensive process management specification, QC 080000 allows for better management of all hazardous substance processes, regardless of the exact HSF requirements a company is trying to meet. The specification is designed to help you:
- satisfy both customer HSF requirements and international HSF regulatory requirements,
- determine and document the technical aspects of the hazardous- or restricted substance levels in products and processes,
- develop procedures and process controls to ensure technical compliance with hazardous substance restriction requirements, and
- provide the necessary training, process tools, and infrastructure to ensure sustainability.
QC 080000 and ISO 9001
QC 080000 was written to correspond to the framework of ISO 9001:2000, the international standard for quality management systems. While ISO 9001 provides a basis for the optimization of business systems, QC 080000 takes it a step further to emphasize the management of hazardous substances.
Certification: benefits and process
IECQ-recognized, third-party certification to QC 080000 can indicate to regulators that a manufacturer’s processes are effectively controlling hazardous substances. It indicates that the organization has processes in place to properly manage product realization specifically for HSF. In addition, third-party certification:
- Ensures uninterrupted access to global markets
- Ensures a sustained competitive advantage
- Provides a strong showing of compliance with applicable laws
- Assists in driving business integration and continuity of process control throughout the supply chain
Prior to seeking certification to QC 080000, your organization must be certified to ISO 9001 or one of its derivatives (such as ISO/TS 16949, ISO 13485, TL 9000, or AS9100). Both standards may be assessed concurrently.
The audit process for QC 080000 is very similar to that of ISO 9001, with annual assessments and a certificate validity of three years. However, there are a few minor differences:
- There can be no Opportunities For Improvement (OFIs), only major or minor nonconformities.
- All requirements and functions shall be covered during the annual surveillance audit. No sampling assessments are allowed; all sites must be assessed during every audit.
- Technical product and process factors shall be evaluated, such as: material/product risk analysis, testing reports, supply chain management, risk control, or calculations for conformity.
The scope statement on the certificate will cover applicable legal and other requirements (RoHS, WEEE, Batteries, Packaging, etc.) in addition to a product scope (such as “design and manufacture of…”) such as what would be shown on an ISO 9001 certificate.
Once your organization is certified, the certificate will be posted on IECQ’s website at www.iecq.org.