12 Acorn Industrial Park, Crayford Road, Crayford, Dartford, Kent, DA1 4AL Tel: +44 (0)1322 520500 Fax:

+44 (0)1322 520501 e-mail: mcerts@sira.co.uk

www.sira.co.uk/MCERTS

A Guide to the Certification of Products under the Environment Agencys MCERTS Scheme

MCERTS activities other than certification are delivered through Sira Environmental Limited, an operating company owned by Volvere plc; certification is undertaken by Sira Certification Service (SCS).

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Sira Certification Service

Sira Certification Service

Sira Certification Service is a company limited by guarantee and operates internationally providing certification of management systems, personnel and products. Sira is accredited for these activities by the United Kingdom Accreditation Service (UKAS) and is appointed as a notified body by the UK Government under European Directives. MCERTS is the Environment Agencys Monitoring Certification Scheme. The scheme provides a framework within which environmental measurements can be made in accordance with the Agencys quality requirements. The product certification scheme covers a range of monitoring and sampling products including: continuous emissions monitoring systems automatic isokinetic samplers ambient air monitoring systems portable equipment for emissions monitoring instruments and sampling systems for water monitoring portable water monitoring systems

The MCERTS scheme

Sira operates the MCERTS scheme on behalf of the Environment Agency. MCERTS Performance Standards and related documents can be downloaded from the Environment Agency website www.mcerts.net This document provides guidance to organisations that wish to apply for MCERTS product certification and describes the evaluation and certification process. Evaluation of a product consists of laboratory testing where performance (accuracy, repeatability, cross-sensitivity, etc) is determined, and (where specified) a field-test where the performance of the product is determined whilst installed on a process over a three month period. Products that can be certified Application for certification continuous emission monitoring systems for gaseous emissions, particulates, temperature, pressure and flow automatic isokinetic samplers continuous ambient air quality monitoring systems for SO2, Nox, CO, O3, particulates, metals, benzene and certain polycyclic aromatic hydrocarbons open-path ambient air monitoring systems continuous water monitoring equipment including turbidity and pH meters; ammonia, COD, TOC, dissolved O2, total P, NO3 and TON analysers water flowmeters automatic wastewater sampling equipment portable systems for emission monitoring portable systems for water monitoring

An application pack is available from Sira, which includes information on the certification process, including an application form and test plan template. The applicant will need to submit a completed application form and proposed test plan to proceed. Applications are accepted from product manufacturers. If the manufacturer is not based in the UK, a local representative or agent can apply where appropriate.

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Sira Certification Service

The application for which certification is required (where applicable) shall be stated on the application form. If the product is to be used on a variety of processes, then the applicant is advised to state the most rigorous process. This will allow the certification to be extended to the less severe processes with minimum cost and time. The applicant specifies the measurement ranges for which the product is to be certified, in line with the performance standards published by the Environment Agency. The applicant is required to provide evidence that an appropriate quality management system controls manufacture of the product. If the manufacturer has an ISO 9001 certificate from an accredited certification body, details should be supplied with the application. MCERTS performance standards require that an audit of the manufacturing process is undertaken by the certification body to confirm that the manufacturer has implemented procedures to ensure manufacturing reproducibility and control of any design changes so that they do not degrade performance below the MCERTS standard. Sira is happy to assist the applicant in completing the Application Form, but the applicant must sign it. Quotation Once an application form and test plan is received Sira will supply a quotation for the cost of certification which excludes the cost of testing. The applicant has the option of choosing which organisations perform the laboratory or field testing, providing they are qualified to do so (generally this means they are accredited to ISO/IEC 17025). The applicant can also submit existing test reports, which will normally have to be from a suitably accredited laboratory. Following the quotation stage, a Technical Liaison Officer (TLO) will be assigned who has the appropriate expertise on the type of product submitted for certification. The TLO will provide technical support and will assess the proposed test plan to ensure it meets the MCERTS requirements. Certification of a product is overseen by an impartial technical expert(s) (TLO) and Sira who will review the test programme(s) and evaluate the results. Laboratory tests The applicant will place an order for the test work direct with the test laboratory and will supply the product direct. The product will be operated according to its instruction manual. If the product should fail any performance test, then the programme will be halted and the applicant asked to comment. The applicant will place an order for the test work direct with the test laboratory. Sira has some standard test sites available for field tests. Manufacturers can propose alternative sites provided that it is acceptable to the test laboratory and that the product is essentially identical to the product undergoing laboratory tests, though this may increase costs. To shorten certification time, field and laboratory tests may be conducted simultaneously if the applicant can supply the correct number of instruments. During the field test, only the laboratory will have access to the product under test, although the site operator may log the output
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Field tests

readings for his own monitoring purposes. The manufacturer will have access for normal repair/servicing activities as necessary. Typically, the applicant will commission the instrument under the supervision of the test laboratory. The applicant will be asked to provide a commissioning timescale. Since commissioning is supervised, excessive over run of timescale may incur additional costs. If the applicant does not install the product, the applicant will have the opportunity to inspect the installation and request changes if it does not comply with the instruction manual. If other changes are made that are not included in the manual, then these will be reported to Sira and may affect the granting of a certificate. If the product should clearly fail any performance test, then the programme will be halted and the applicant asked to comment. The instrument may need to be removed and/or the test period may require to be extended to compensate. The applicant can comment on the reports from both the laboratory and field tests before the Certification Committee considers them. Recognition agreement with UBA A type-approval scheme for Continuous Emission Monitoring Systems, operated by the Umweltbundesamt (UBA) in Germany has many similarities with the MCERTS scheme. To minimise the burden on manufacturers seeking both UBA and MCERTS approval The Environment Agency and UBA have an agreement, which provides for the mutual recognition of laboratory and field test data. Therefore, manufacturers with UBA type-approval certificates may apply to Sira for MCERTS certification. Sira will review the UBA test data before recommending certification in accordance with its established procedures. Further information on the Environment Agency/UBA recognition agreement is available from Sira. Granting of a certificate Modifications to certified products Sira with technical support from the TLO will recommend whether a certificate should be granted, specifying the wording on the certificate and any special conditions. Manufacturers shall establish and maintain a procedure to assess whether a design change, a change of component or a different manufacturing procedure may affect the certified performance of the product. All such assessments shall be documented and approved by an appropriate specified representative of the certificate holder. If the assessment indicates that performance will be unchanged, or improved, then Sira need not be notified of the change until the annual audit of the manufacturing process. If the assessment indicates that the certified performance may be worse than stated on the certificate, then the change shall not be implemented without first consulting Sira. It is the manufacturers responsibility to conduct an assessment and provide the results to Sira. Results should be supported by any test data that is available and details of any changes required to the certificate or documentation referred to in the certificate (for example, drawings listed in the design schedule). Sira shall then evaluate whether the manufacturer has adequately assessed the effect of the proposed modification. The modification shall not be implemented without authority from Sira who may require further independent testing to verify the assessment.
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Initial Audit of the of manufacturing process

The purpose of the audit is to confirm that the manufacturer has provisions to ensure manufacturing reproducibility and to control any design changes that may degrade product performance. The audit is not duplicating an ISO9000 audit and is focused on the technical aspects of the product(s) to be certified. Sira conducts an initial audit of the manufacturing process prior to the certification of the product. Certification cannot be granted until the initial audit has been successfully completed. Applicants with more than one manufacturing site may have sites audited on a sampling basis if there is a common quality system controlling all the sites. Manufacturers with an accredited ISO9000 system A typical audit will normally include, but not be restricted to, the following:

Review of the quality management system if the company has a quality management system that is certified to ISO 9001 by an appropriately accredited certification body the MCERTS audit will take account of this certification and will focus principally on reviewing the certification bodys audit reports and any relevant outstanding non-compliances. Review of purchasing process in respect of performance-critical components. This will include processes for ensuring the suitability of Suppliers QA, quality control and handling of delivered items and stock control, especially of components having limited shelf life. Review of design status & changes the process for controlling design change will be audited, and all design changes affecting MCERTS-certified products since the previous MCERTS surveillance audit will be reviewed. In particular, evidence will be sought of how the effect was assessed of the design change on the MCERTScertified performance. Examination of final inspection and calibration the procedures for validating that individual production instruments are compliant with MCERTS criteria will be reviewed. Evidence will be sought that any calibration facilities are fit for purpose and that the traceability of the measurements and the associated measurement uncertainty is acceptable. Review of feedback from users opportunities for improvement identified as a result of field use of certified equipment will be reviewed during the audit, typically through monitoring of complaints and through service department records Examination of a sample of the product when possible, samples of certified products will be examined during manufacture or after assembly to check compliance with the design originally certified and the manufacturing controls on components critical to the certified performance Checking compliance with conditions of certification compliance with the `Regulations Applicable to holders of Sira Certification Service Certificates, and with any special conditions specified on the specific MCERTS product certificate will be checked during the audit. This includes checking that certification marks are not being
Page 5 of 7 Sira Certification Service

Form 1177 Issue 10 July 2006

used in a misleading manner on products or in publicity material

Monitoring of compliance with performance specifications manufacturers will be invited to provide evidence that ongoing production instruments continue to comply with MCERTS performance criteria. Provision of test data, whether generated by the manufacturer or from third parties, and the level of assurance it provides, will be taken into account when assessing the frequency of manufacturing audits and the extent of the performance checks required when conducting the five year review. Data need not be from tests that are fully compliant with MCERTS test procedures to be useful. Data from routine production checks may provide useful assurance of consistent performance.

Manufacturers with no accredited quality management system Sira will perform an initial audit and will also perform an additional day of auditing to perform an assessment of the quality management system.

Surveillance audits

Sira will conduct an annual surveillance audit which will entail the manufacturer completing a questionnaire and supplying specific information. Manufacturers with an accredited ISO9000 system

Review of the quality management system Manufacturer to provide a copy of the current ISO 9000 certificate and a copy of the last ISO9000 summary report including any non-compliance. The manufacturer is required to indicate what non compliances are still outstanding. Review of design status & changes Manufacturer to confirm in writing that no changes to the design schedule document e.g. drawing listed. If changes have been performed the manufacturer shall provide evidence of how the change on the certified performance was assessed, the conclusions of the assessment and confirm the design change was authorised by the appropriate person. If the change was assessed by test then a copy of the test results shall be provided as evidence. Review of feedback from users Manufacturer to provide details of any complaints affecting the certified product(s).Manufacturer to provide any returns under warranty affecting the certified product. Examination of a sample of the product Manufacturer to confirm
that the product is still manufactured at the same site and provide approximate number manufactured since last audit. Manufacturer shall report any design changes that are being considered to be implemented in next 12 months. the manufacturers website

Checking compliance with conditions of certification - Sira reviews Monitoring of compliance with performance specifications

Manufacturer to state any routine in-house testing performed to ensure on-going compliance of product(s).

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Sira Certification Service

Manufacturers with no accredited quality management system Sira will perform an annual surveillance audit and will also perform an additional assessment/review of the quality system. This may necessitate annual visits depending on the individual circumstances. Sira reserves the right to perform an annual surveillance audit visit if required. This is at the discretion of Sira and will be dependent on the evidence submitted. Certificate validity
MCERTS certificates are valid for five years.

The MCERTS scheme requires that certificates shall only be renewed if the product complies with the version of the MCERTS standard that is then current. This may require additional assessment or testing. Any such testing may be performed either in an appropriately accredited laboratory or possibly through tests performed by the manufacturer and witnessed by Sira. In addition, Sira shall require reasonable evidence that the performance of current production of the certified product continues to comply with the MCERTS standard and the performance data stated on the certificate. This shall normally be demonstrated by repeating certain tests in an accredited laboratory. Sira shall take account of any appropriate test data from an accredited laboratory that is already available, and possibly any routine monitoring data already available from the manufacturer.

Certification Marks

Holders of Sira certificates are licensed to use the Sira Certification Mark on certified products and on literature or documentation directly associated with the certified product(s). Full details are available from Sira.

Sira Certificate No. MC030026/02

Sira MC030026/02

Withdrawal of certificates Appeals

Sira may suspend, withdraw or cancel certificates if the certificate is no longer valid. The certificate holder will be informed in the event of pending withdrawal, cancellation or suspension. Prospective and current certificate holders have the right to appeal against certification decisions taken by Sira. An appeal is initiated by submitting details in writing to the Managing Director of Sira Certification Service. Sira maintains a register of all MCERTS certificates. The register can be viewed and copies of certificates downloaded at: www.sira.co.uk/MCERTS/MCERTSCertifiedProducts.pdf

Certificate register

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Sira Certification Service