S3: Module D 2012-10-311

Physikalisch-Technische Bundesanstalt

Session 3:

Conformity AssessmentModule D

Peter Ulbig, Harry Stolz

Belgrade, 31 October 2012

S3: Module D 2012-10-312

Structure of the Measuring Instruments Directive

MIDAnnexes

MI-001...MI-010

Requirements, specific to measuring instrument categories

Annexes MI-001...MI-010

Requirements, specific to measuring instrument categories

Articles1 to 23

Articles1 to 23

Annexes I and A-H1

Conformity assessmentprocedures

Annexes I and A-H1

Conformity assessmentprocedures

Annex IBasic

Require-ments

Annex IBasic

Require-ments

General descriptionof the „modules“

possible „modules“

S3: Module D 2012-10-313

Conformity assessment by module D

ANNEX D

DECLARATION OF CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION

PROCESS

1. ‘Declaration of conformity to type based on quality assurance of the production process’ is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned are in conformity with the type as described in the EC-type examination certificate and satisfy the appropriate requirements of this Directive.

S3: Module D 2012-10-314

Combination of conf. assessment modules

Module

B(type

examination)

Module

F(product

verification)

+

Module

B(type

examination)

Module

D(quality

approval)+

(= assessment

of every single

product)

(= assessment

of QM of the

production line)

S3: Module D 2012-10-315

Combination of conf. assessment modules

one notified body for module D instead of several notified bodies for module F could be cheaper

S3: Module D 2012-10-316

Combination of conf. assessment modules

however, if there are several production sites, it could get very expensive with module D

every production site has to be visited

S3: Module D 2012-10-317

Requirements according to Module D

The manufacturer shall operate an approved

quality system for:

- production,

- final product inspection and

- testing of the measuring instrument concerned

as specified in paragraph 3 and shall be subject

to surveillance as specified in paragraph 4.

S3: Module D 2012-10-318

Requirements according to Module D

The manufacturer shall lodge an application for assessment of the quality system with a notified body of his choice.

The application shall include:

- all relevant information for the instrument category envisaged;

- the documentation concerning the quality system;

- the technical documentation of the approved type and a copy of the EC-type examination certificate.

S3: Module D 2012-10-319

Requirements according to Module D

Which information about the QMS is necessary?

S3: Module D 2012-10-3110

Requirements according to Module D

How is the assessment carried out?

In addition to experience in quality management systems, the auditing team shall possess appropriate

- experience in the relevant field of metrology and instrument technology, and

- knowledge of the applicable requirements of this Directive.

The evaluation procedure shall include an inspection visit to the manufacturer's premises.

S3: Module D 2012-10-3111

Requirements according to Module D

What are the tasks of the manufacturer?

The manufacturer has

- to fulfil the obligations arising out of the quality system as approved and

- to maintain it so that it remains adequate and efficient.

- to keep the notified body informed of any intended change of the quality system

S3: Module D 2012-10-3112

Requirements according to Module D

How shall surveillance be carried out?

The notified body

- shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system.

- may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, to verify that the quality system is functioning correctly.

S3: Module D 2012-10-3113

Requirements according to Module D

What about the metrology marking?

The manufacturer shall affix

- the ‘CE’ marking,

- the supplementary metrology marking and

- the notified body‘s identification number

to each measuring instrument

M 06 0102

S3: Module D 2012-10-3114

Module D and ISO 9001

ISO 9001-Certification

Compliance with customer requirementsDecrease of failure costsContinuous improvement

Get customer confidence

All processes and products of an organisation

Application / audit / evaluation / decision / surveillance

3 years

Annual surveillance visits

Purpose of QM-Systems

Purpose of certificates

Scope of certificate

Typical procedure

Validity period

Surveillance period

QM-Approval

Securing of the compliance of measuring instruments with legal requirements

Authorisation of conformity declaration

Measures of quality assurance for certain product categories (includes if necessary further organisations – i.E. subcontractors)

Application / audit / evaluation / decision / surveillance

3 years

Annual surveillance visits + unexpected visits

S3: Module D 2012-10-3115

Module D and ISO 9001

• An present ISO 9001-Certificate does not replace the approval audit by the notified body

• ISO 9001-Certification is not a requirement for the approval of the quality system, but helpful (lower costs, audit of notified body is restricted to the „technical delta“)

• Some notified bodies offer ISO 9001-Certification in addition to the approval of the quality system (not PTB)

Useful WELMEC-Guide for Measuring Instrument Manufacturers:WELMEC Guide 8.6 „Measuring Instruments Directive 2004/22/EC

Presumption of Conformity of the Quality System of Manufacturers with Module D or H 1 when EN ISO 9001:2000 is applied“

http://www.welmec.org/publications/8-6.asp

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Module D procedure

Provision of information

Application

Order confirmation

Nomination of the audit team

Stage 1 Audit

Evaluation of the quality system

Decision about QM-Approval

Updating the certificates database

Evaluation of notifications on changes of the quality system

Annual surveillance visits + spot check, where appropriate

Reassessment (after 3 years)

Stage 2 Audit

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Application for Module D

• Filled and signed application form + list of preliminary questions

• Acceptance of / agreement on the General Terms and Conditions of the certification body

• Copies of existing QM-Certificates (e.g. ISO 9001 certificates, accreditation certificates)

• List of the measuring instrument types which are designated for the Conformity Declaration with regard to the quality system approval applied(with number of design examination certificates / type examination certificates if existing)

• Copies of type-examination-certificates

• Technical documentation of the measuring instruments

• Quality plans for several measuring instrument types, (i.e. short description of the key elements of production to make sure that the requirements of the MID will be met, e.g. quality system approval of suppliers, 100% final inspection including calibration, justification and sealing or placing into operation on site by own service technicians)

• Quality Management Manual of the company

• List of all documents subordinated to the QMM and relevant to the quality system approval

Further documents will be requested by the audit teamduring the approval procedure

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Requirements according to Module D

Final tasks of the manufacturer:

The manufacturer shall

- supply a copy of the declaration of conformity with each measuring instrument,

- keep all relevant information for 10 years after the last instrument has been manufactured, including all decisions and reports of the notified body.

S3: Module D 2012-10-3119

Summary

More and more manufacturers choose Module D

instead of Module F:

- you can calculate what is cheaper:

n times the fee for mod. F or one time the fee for mod. D

- module D offers more flexibility you can produce any number of measuring instruments and you save the costs for the transport of the measuring instruments to the notified bodies for module F

- you have to pay special attention to the user interface, if you sell to other countries (due to the language!), a notified body for module F finds out your errors!

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Finally …

… and finally if you choose module D, then often you can get the service for module B and D fromone notified body, what makes it very simple, because this notified body already knows yourinstrument

… and if this notified body speaks your language, then it is the easiest way

… but this notified body has to provide you with quality,otherwise you could run into trouble with the marketsurveillance authorities!!!