QC 080000 Made Practical

If you build or source electronics, you already live with a alphabet soup of rules—RoHS, REACH, Prop 65, TSCA-PBT, ELV, battery and packaging directives, and more. Each one asks a version of the same question: What’s in your product, and how do you know? The IECQ QC 080000 Hazardous Substance Process Management (HSPM) standard turns that question into a repeatable management system—so compliance becomes a controlled process, not a last-minute scramble.

This article breaks down what QC 080000 is, how it ties into your day-to-day work, and what it looks like to implement it with support from Enviropass.

What is QC 080000?

QC 080000 is an IECQ certification framework that integrates with your quality system (often ISO 9001) to manage hazardous substances across the product lifecycle. Instead of treating each regulation as a one-off request, it gives you a process map for:

• Understanding legal and customer requirements
• Controlling supplier inputs and material data
• Verifying evidence (declarations, test reports)
• Managing changes, nonconformities, and continuous improvement

Think of it as the operating system for RoHS/REACH and related chemical restrictions. Where ISO 9001 tells you to make a consistent product, QC 080000 tells you to make a product consistent with substance restrictions.

Who benefits most?

• OEMs and brand owners supplying global markets who must prove due diligence
• EMS/contract manufacturers who sit between multiple customers and suppliers
• Component distributors who need standardized declarations and traceability
• Startups and scale-ups that want to institutionalize compliance early (before growth multiplies complexity)

If you are repeatedly asked for Article 33 declarations, IEC 63000 technical documentation, or SCIP data, QC 080000 is a natural fit.

What QC 080000 requires (in plain language)

• Policy & legal mapping

Document the substance laws you must meet (RoHS, REACH SVHCs, Annex XVII, customer lists) and how they apply to your parts and articles.

• Risk assessment at article/assembly level

Identify parts and materials with higher risk (e.g., solders, plating, plastics, adhesives, paints, cables, batteries).

• Supplier control & material declarations

Standardize what you ask for (declara­tions, test reports, SDS). Require updates when laws change or parts change.

• Verification & testing rules

Define when to accept documentation, when to screen (e.g., XRF), and when to order targeted lab tests per IEC 62321.

• Change management

Engineering changes, supplier substitutions, or location moves must trigger a re-check of hazardous-substance evidence.

• Training & roles

Make sure purchasing, engineering, and quality each know their part of the process.

• Records & traceability

Keep a living record of compliance decisions and evidence—so you can demonstrate due diligence during audits or customer reviews.

• Internal audit & management review

Audit your own process, fix gaps, and continuously improve.

How this connects to RoHS, REACH, and IEC 63000

• RoHS sets the limits (Pb, Cd, Hg, Cr(VI), PBB, PBDE, and phthalates).
• REACH adds SVHC communication (Article 33), possible SCIP submissions, and Annex XVII restrictions.
• IEC 63000 describes how to compile technical documentation for restricted substances.
• QC 080000 is the umbrella process that ensures you consistently gather, evaluate, and maintain the documentation those laws expect.

A practical implementation roadmap

Step 1 — Gap assessment

Map your current practices against QC 080000. Where are the risks—supplier data, change control, or test strategy?

Step 2 — Scope and responsibilities

Define which products, sites, and teams are in scope. Assign clear roles for engineering, purchasing, quality, and compliance.

Step 3 — Standardize supplier requests

Adopt a single set of forms and expectations (e.g., EPEC style supplier questionnaires, material declarations, SDS sanity checks). Set refresh cadences for SVHC updates.

Step 4 — Verification plan

Decide when documentation is enough, when to XRF screen, and when to order targeted lab tests. Choose accredited labs and archive their reports.

Step 5 — Build the evidence library

Create article-level folders or a database. Keep: supplier declarations, test reports, exemption rationales, change logs, and communications.

Step 6 — Train & pilot

Run a pilot on one product line. Adjust templates and work instructions based on real supplier responses.

Step 7 — Internal audit & corrective actions

Audit your workflow, fix gaps, then scale to other product lines.

Optional Step 8 — Certification

If desired, apply for IECQ QC 080000 certification with a recognized certification body to validate the system externally.

Common pitfalls—and how to avoid them

Over-relying on generic statements. Ask for article-level declarations aligned to your actual parts and BOMs.

No change trigger. Make substitutions and ECOs automatically prompt substance re-checks.

Testing everything, always. Testing is valuable—but targeted testing is smarter. Let risk drive your test plan.

Scattered records. Centralize documents; use consistent filenames and versioning so audits are simple.

Ignoring language/locale. If you serve Canada/EU, plan for EN/FR documentation and hreflang on customer-facing pages.

What Enviropass brings

Gap analysis & implementation plan tailored to your products and supply chain

Templates: supplier requests, checklists, work instructions, and record structures that match QC 080000 expectations

Training (EN/FR) for engineering, purchasing, and quality teams

Verification strategy: when to rely on docs, when to XRF, when to test at accredited labs

Pre-assessment support before you invite an IECQ certification body

Ongoing maintenance for SVHC updates, exemptions, and new regulations

Why it’s worth it

Beyond “passing audits,” QC 080000 reduces launch delays, cuts repetitive supplier chasing, and gives customers the confidence that your declarations are defensible. In many sectors—medical, automotive, industrial—it’s a tangible differentiator in bids and supplier onboarding.