What is a quality systems registrar

What is a quality systems registrar

A registrar, or registration body (the preferred term), is sometimes called a certification body. (Accreditation bodies are entirely different—they are the entities that audit/approve registration bodies.)

There are some 573 registration bodies in operation worldwide, including
52 in the United States.

The registrar is the organization that checks your quality system and confirms that it meets ISO 9000 requirements for a prescribed and agreed period of time.

To do this, the registrar:
a. Audits your organization’s quality system to determine the degree of conformity to ISO 9000 standards. The audit is carried out:
— On paper (desktop study).
— On site (throughout your facility).
b. Registers your quality system, assuming it conforms, to ISO 9000.
c. Monitors conformity on an ongoing basis by means of regular reaudits
and other methods.
All quality system registrars perform these functions, with certain
variations. Registrars differ in two principal ways:
a. Accreditation status.
b. Scope of accreditation

Reputable ISO 9000 registrars are accredited by international accreditation
bodies. These enforce a standard, EN 45012 (European Standard for Bodies Certificating Suppliers’ Quality Systems), that governs the processes that registrars follow. This standard is quite strict:
a. Registrars must make their services available to all qualified suppliers
without imposing undue financial or other conditions, and
must administer their regulations in a nondiscriminatory manner.
b. The registrar’s organization must not engage in activities that may
affect its impartiality. For example:
— It must not provide consulting services “on matters to which
its certificates are related” (i.e., quality systems). This requirement
is superseded by the ISO 9000 restriction noted earlier.
— It must not directly engage in commerce with firms that it has
assessed and/or registered.
— Individuals involved in the registration process must not have
provided consulting services to registration clients, or any related
firms, within the previous two years.
— Its employees and agents must not engage in business activities
that would cause others to question the firm’s impartiality.
— The registrar may not market consultancy and registration
services together, and may not recommend consulting services
to clients.
— Auditors may not give advice as part of registration audits.
— The registrar must provide the accreditation body with documentation
of its employees’ qualifications.
— The registrar must have appropriate facilities for carrying out
its activities.
— The registrar must have a quality manual and documented
procedures. (Curiously, EN 45012 does not require that registrars
register to ISO 9000!)
— Registrars may not grant or renew certificates of registration until all major noncompliances are eliminated.

Another point of differentiation is scope of accreditation. All registrars
are not accredited, or approved, to register firms in any line of business. Each registrar is accredited to operate within the business or industrial sectors about which it has documented expertise. This is generically referred to as the registrar’s scope.