Food and product assurance

CE Marking Compliance Assessment

Understand the conformity route, technical evidence and declarations required before placing applicable products on the European market.

Standard reference

CE

Certification and readiness guide
What it is

A management decision—not only a certificate.

CE marking is a manufacturer’s declaration that an applicable product meets relevant European requirements. The required assessment route depends on the product and legislation.

A clearly defined compliance route supported by applicable requirements, technical documentation, testing evidence and the correct declaration.
Business value

What a well-used system can improve

01

Clearer identification of applicable legislation

02

Structured technical documentation

03

Better control of product evidence

04

Reduced risk of incomplete declarations

05

Improved market-access preparation

06

Defined responsibilities across the supply chain

Who it suits

Designed around operating context, not company size.

  • Machinery manufacturers
  • Electrical and electronic products
  • Medical-device businesses
  • Importers and exporters
  • Product designers
  • Manufacturers entering European markets
Assessment focus

What the system needs to control.

  1. 01Applicable directives or regulations
  2. 02Conformity-assessment route
  3. 03Technical file
  4. 04Risk assessment
  5. 05Testing evidence
  6. 06Declaration of Conformity
  7. 07Marking and traceability
Readiness evidence

Before requesting assessment

This is a practical starting list, not a substitute for the applicable standard or scheme rules.

Product and intended use defined
Applicable legislation identified
Standards selected
Technical evidence assembled
Economic-operator roles confirmed
Declaration prepared
Certification pathway

From defined scope to maintained certificate

  1. Step 01

    Application and scope

    Confirm the organization, sites, activities and standard to be assessed.

  2. Step 02

    Readiness and assessment

    Review documented arrangements and evidence that the system operates in practice.

  3. Step 03

    Decision and issue

    Close applicable findings before an independent certification decision and issue.

  4. Step 04

    Surveillance and renewal

    Maintain the system, complete surveillance activities and renew within the certification cycle.

Related guides

Standards often work together.

RoHS

Restricted substances compliance

Build evidence that applicable electrical and electronic products meet restricted-substance requirements.

ISO 13485:2016

Medical-device quality

Control medical-device quality across design, production, supplier management and regulatory activities.

Define your certification record

Tell us what your organization does and what the certificate should cover.

A clear scope helps align the standard, assessment and final certificate record from the beginning.