Key takeaways
- 1The EU importer must ensure, before placing the product on the market, that the appropriate conformity assessment procedure was carried out, the technical documentation has been drawn up, and the product carries the required marking and documents.
- 2A market surveillance authority can ask for the declaration of conformity and the technical documentation. The Commission's Blue Guide states that voluntary initiatives, such as product certification or a quality management system, "cannot be put on the same footing" as market surveillance.
- 3A notified body, where the legislation requires one, issues its own certificate or approval. Where it is involved in the production control phase, its identification number follows the CE marking.
An accredited ISO certificate answers a buyer's question about how your organization is run. It does not answer the legal question of whether a product may be placed on the EU market. The first is voluntary and set by the buyer. The second is set by EU legislation, product by product, and is met only by the procedure that legislation prescribes.
The costly mistake is sending the right document to the wrong question.
Who wrote the requirement
A buyer wrote it. A purchase specification, tender or supplier questionnaire asks for ISO 9001, ISO 14001 or ISO 22000 certification, often from an accredited certification body. The buyer chose that requirement and can change it or drop it.
EU legislation wrote it. For products covered by EU harmonisation legislation, the legislation sets the essential requirements and the conformity assessment procedure, usually chosen from a standard set of modules. No buyer can waive it, and no certificate the two parties agree on replaces it.
Both can apply to the same shipment.
What management system certification covers
Certification of a management system gives independent demonstration that the system conforms to specified requirements, is capable of consistently achieving its stated policy and objectives, and is effectively implemented. It is about the system, not a product. ISO/IEC 17021-1 makes the point in its rules on marks: a management system certification mark may not appear on a product or its packaging, or be used in any way that could be read as denoting product conformity.
IAF MLA recognition works on this voluntary side. EGAC is a signatory, and its IAF MLA scope covers five of the six standards listed below.
What the regulated side asks for
Under the EU's reference provisions for product legislation, the manufacturer draws up the technical documentation, carries out the applicable conformity assessment procedure or has it carried out, draws up a declaration of conformity and affixes the CE marking. By affixing it, the manufacturer takes responsibility for the product's conformity.
Each party asks for something specific:
- The EU importer must ensure, before placing the product on the market, that the appropriate conformity assessment procedure was carried out, the technical documentation has been drawn up, and the product carries the required marking and documents.
- A market surveillance authority can ask for the declaration of conformity and the technical documentation. The Commission's Blue Guide states that voluntary initiatives, such as product certification or a quality management system, "cannot be put on the same footing" as market surveillance.
- A notified body, where the legislation requires one, issues its own certificate or approval. Where it is involved in the production control phase, its identification number follows the CE marking.
A management system certificate is not on any of these lists.
Where a notified body comes in, and where it does not
A notified body is an organisation designated by an EU country to assess the conformity of certain products before they are placed on the market, where the legislation requires a third party. Whether one is required depends on the act:
- Electrical equipment under the Low Voltage Directive 2014/35/EU is assessed by internal production control. The Directive states that none of its procedures requires a notified body.
- Lifts under the Lifts Directive 2014/33/EU follow one of the procedures in Article 16(1), and every one of them involves a notified body.
The Commission lists notified bodies in its NANDO database; they may serve manufacturers inside or outside the EU. The Blue Guide calls accreditation the preferred way to assess their competence; that accreditation is issued by a national accreditation body under Regulation (EC) No 765/2008, peer-evaluated through the European co-operation for Accreditation (EA).
A quality system close to ISO 9001, but not a certificate
Under Modules D, E and H, the manufacturer operates a quality system that a notified body assesses and approves. The Blue Guide says a quality system based on EN ISO 9001 gives a presumption of conformity with these modules for the provisions the standard covers, provided the system takes the specific features of the products into account. For Module D, the audit team includes at least one member with experience of evaluation in the product field and knowledge of the applicable legislation.
So an ISO 9001 system can be the starting point, but the approval comes from the notified body, against the legislation. An accredited ISO 9001 certificate is not that approval.
The European position on accreditation from outside the EU
Chapter II of Regulation (EC) No 765/2008 applies to accreditation "used on a compulsory or voluntary basis", and several of its requirements are tied to Member States, starting with the single national accreditation body each one appoints. The Blue Guide sets out what follows for attestations issued under accreditation by non-European accreditation bodies that do not meet those requirements: they can be used on the European market "but only in the voluntary sphere". Where conformity assessment is required by regulation, Member State authorities may refuse them, even when the accreditation body is an IAF MLA signatory. The Blue Guide's exception is a government-to-government mutual recognition agreement between the EU and a third country, for the sectors it covers.
CAS's position
CAS's accreditation covers management system certification against the six standards listed below. CAS is not a notified body and does not carry out conformity assessment under EU harmonisation legislation.
What this means for you
If you are an exporter: place each requirement before you answer it. A buyer's requirement is met by a certificate; a legal one, by the procedure the legislation sets.
If you are an EU buyer or importer: ask for the two separately. The management system certificate tells you about the supplier; the declaration of conformity and, where required, the notified body's certificate tell you about the product.
If you are certified to ISO 9001:2015: its clause 8.2.2 already requires the organization to define the applicable statutory and regulatory requirements for its products. Certification confirms that the system conforms to the standard; it does not confirm that a product meets those requirements.
This is generic information about the requirement, not advice on any particular management system.
CAS — An EGAC accredited MS certification body No. 012418. Accredited scope: ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 50001 and ISO 22301. Certificates accredited for ISO 9001, 14001, 45001, 22000 and 50001 fall within EGAC's IAF MLA scope; ISO 22301 is accredited by EGAC and sits outside that scope.
Verify any certificate: cas.com.eg/certsearch
Read next