annex 1 check list for the performance of the audit …

WP3NA2_0027 Annex No. 1 to Doc. No. WP3NA2_0017

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Institution ………………………………………………. Location Country …....…………………………… of 63

ANNEX 1

CHECK LIST FOR THE PERFORMANCE OF THE AUDIT TO THE RESEARCH TESTING FACILITIES


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CONTENTS

1. GENERAL REMARKS 4

1.1 Introduction 4

1.2 Glossary 6

1.3 The Check List 7

1.3 General Information 8

2. AUDIT 9

2.1 Audit start up 9

2.2 Audit closure 10

3. PRELIMINARY VERIFICATIONS 11

3.1 State of certification 11

3.2 State of accreditation 11

3.3 State of procedures 12

3.4 Standards 12

4. GENERAL MANAGEMENT REQUIREMENTS 15

4.1 Organization 15

4.2 Management system 20

4.3 Document control 22

4.4 Review of requests, tenders and contracts 23

4.5 Subcontracting of tests and calibrations 24

4.6 Purchasing services and supplies 25

4.7 Service to the customer 25

4.8 Complaints 26

4.9 Control of nonconforming testing and/or calibration work 26


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4.10 Improvement 27

4.11 Corrective action 27

4.12 Preventive action 27

4.13 Control of records 28

4.14 Internal audits 29

4.15 Management reviews 29

5.1 General 30

5.2 Personnel 31

5.3 Accommodation and environmental conditions 33

5.4 Test and calibration methods and method validation 34

5.5 Equipment 37

5.6 Measurement traceability 41

5.7 Sampling 43

5.8 Handling of test and calibration results 43

5.9 Assuring the quality of test and calibration results 45

5.10 Reporting the results 45

6. SPECIFIC TECHNICAL REQUIREMENTS 49

6.1 Identification of the test 49

6.2 Personnel in charge of the test 50

6.3 Test methods 51

6.4 Test performance 52

6.5 Test equipment 57

6.6 Maintenance 58

6.7 Calibration 58

6.8 Test report 60

7. REMARKS 63


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1. GENERAL REMARKS

1.1 Introduction

Seismic Engineering Research Infrastructures for European Synergies, SERIES, is a project funded by the European Community in the 7th Framework Programme –

Infrastructures (FP7/2007-2013) under grant agreement n° 227887. Its aims were twofold. Firstly, to bring Europe into line with the current state of earthquake engineering and structural dynamics Research and Technological Development (RTD) in the United States and Japan. Second, to bridge the gap between European countries with high seismicity but less advanced RTD infrastructures on one hand and some more technologically advanced Member States with low seismicity on the other.

Networking Activity No.2 of the SERIES Project addressed the qualification (in the form of mutual accreditation) of European laboratories specialising in earthquake engineering and equipped for structural testing at large scales. The ultimate aim of qualification is to provide reliability. Experimental activities should be repeatable, i.e. replicate tests on the same specimen in the same laboratory should lead to the same results, and reproducible, i.e. replicate tests on the same specimen in different laboratories should lead to the same results.

Moreover in the realm of globalization of economic activities the adoption of International Standards to conduct the experimental activities serves as comparison between various enterprises around the world and they are applicable to the manufacturing and services industries and are a necessary tool for mutual recognition.

It is expected that the accreditation of European earthquake engineering infrastructures will enhance their standing with respect to their American or Japanese counterparts by promoting a unified EU policy on acceptance criteria for products and techniques.

As far as the accreditation of the research infrastructures the following obstacles should be pointed out:

• In the framework of the European Directives about the free circulation of products, persons and services in the EC Countries the Conformity Assessment Bodies (CAB) play a role which is covered by European Standards and Regulations. Whereas the qualification of CAB’s laboratories which are performing structural tests on products for the civil structures industry is covered by the EC Regulation 765, there is not any European or International standard devoted to the qualification of the research and technological development (RTD) infrastructures in earthquake engineering;

• The existing International or European Standards dealing with certification or accreditation are not specifically devoted to the RTD laboratories;

• There is not any International or European standard or regulation requesting the qualification of RTD infrastructures neither dealing with general structural testing nor with specific seismic engineering testing;


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• There is lack of specific Standards covering RTD seismic testing;

• There is lack of specific Standards covering special seismic testing with multi-axial large shaking tables, quasi-static and pseudo-dynamic techniques or hybrid experimental & mathematical modeling techniques;

In order to overcome those obstacles, it was recognized that:

• the general management requirements of EN ISO/IEC 17025 are suitable also for the management of RTD infrastructures, and

• the same conclusion was drawn for the suitability of the general technical requirements of EN ISO/IEC 17025 for the RTD infrastructures, but not for the requirements of clause 5.4.2 - Selection of methods.

As far as the last point, as it is above stated, there is a lack of specific Standards covering RTD seismic testing and special seismic testing with multi-axial large shaking tables, quasi-static and pseudo-dynamic techniques or hybrid experimental & mathematical modeling techniques; moreover the taking in of the testing approach, as a consequence of too rigid accreditation requirements and procedures, is often unpractical, due to the complexity of the tests and to the hazardous character of the specimen response: in many situations, testing procedures may require real-time adjustments suggested by engineering judgments based on the acquired results of the experiments.

As discussed in the Common Protocol fo the qualification of RTD infrastructures it was therefore identified the need to include additional activities in their scope of accreditation on the basis that their competence should be evaluated not only to carry out activities in accordance with previously evaluated procedures, but also for the development and validation of their procedures in accordance with a pre-established system. This kind of scope is defined “flexible scope” by EA 2/15.

To lead to the qualification with “flexible scope” of the RTD infrastructures, in accordance with EA 2/15, Specific Technical Requirements for the RTD seismic testing were identified with reference to the requirements of clauses 5.4.3, 5.4.4 and 5.4.5 of EN ISO/IEC 17025.

The adoption of technical annexes to the Common Protocol dealing with Specific Technical Requirements will account for the need to cover the special requirements for the performance of research tests.

Last but not least issue is that the present National Accreditation Bodies are awarded of the accreditation of Conformity Assessment Bodies and not of Research Facilities.


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1.2 Glossary

The glossary below is introduced for the sake of clarity.

Certification The formal procedure by which an accredited or authorized person or agency assesses and verifies (and attests in writing by issuing a certificate) the attributes, characteristics, quality, qualification, or status of individuals or organizations, goods or services, procedures or processes, or events or situations, in accordance with established requirements or standards.

Accreditation Accreditation is the third party attestation related to a conformity assessment body (CAB) conveying formal demonstration of its competence to carry out specific conformity assessment tasks (ISO/IEC 17000:2004).

Qualification The process to demonstrate the ability to fulfill specified requirements (ISO 9000).

Standard A technical specification approved by a recognised standardisation body for repeated or continuous application, with which compliance is not compulsory (Directive 98/34/CE).

Facility/Facilities The research laboratory/laboratories dealing with seismic testing and/or monitoring of structures.

Research Activity The carrying out of observations/tests on a research object, based on a research plan, and the interpretation of the results thereof. (RvA – T031)

Research and Development Activity The research, within the field of competence which in its design and/or execution is not of a repetitive nature, and the relevant research techniques in which the body has proven experience and the required expertise. The field of research is primarily determined by the problem with which the body has experience of and is faced with. The research field must be based on the research methods/techniques or on the inspection methods/techniques as specified in the list of already recognized activities, applied standard methods within the body. The development of new research techniques, within the research field, may form a part of the research. (RvA – T031)


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1.3 The Check List

The present check list is based upon the Common Protocol for the Qualification of Research Infrastructures.

The present check list may be used by the research facility as self evaluation tool.

The check list reports in the second column the questions to which the Facility has to answer and in the third column the rationale of the relevant question as it is derived from the reference EN ISO/IEC 17025 Standard or from the Common Protocol; in the forth column the number of the relevant clause is indicated; where needed to avoid misunderstanding, clauses of the Common Protocol are identified by the abbreviation CP.

This check list comprises six sections.

Section 1 addresses the issues and the remarks relevant to the qualification of the Research Infrastructures and a guide to the check list is given. Moreover the Facility identification is reported.

Section 2 addresses the audit performance.

Section 3 addresses the current state of certification, accreditation, and management procedures within the Facility.

Section 4 addresses the current state of the Facility’s managerial procedures

Section 5 addresses the current state of the Facility’s general technical procedures focusing on the issues surrounding laboratory equipment (calibration, utilisation, and management), and the test data that the equipment produces.

Section 6 aims to identify the specific test procedures that are applied at the Facility.


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1.3 General Information

RESEARCH FACILITY:

SITE

AUDIT DATE:

TEAM: SIGNATURE

FACILITY STAFF: SIGNATURE


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2. AUDIT

2.1 Audit start up

2.1.1 Meeting of the inspectors team before the visit - To remind to the inspectors the general criteria for the performance of the audit. - To identify the type of test which shall be performed by the Facility and for which the Facility should be accredited. - To plan the audit by taking into account the availability of the personnel and equipment. - To verify the answers preliminary given to the check list in order to taylor the audit on the effective situation of the Facility. - To assign the duties to each inspector of the team. Notes:

2.1.2 Preliminary meeting with the Facility Specify starting time, end time, presents list (names and functions).

2.1.3 Introduction of the inspectors. 2.1.4 To present the scope of the audit, the procedures for the performance of the audit, for the recording of the issues, for the

final discussion.

2.1.5 Request of a room for the meetings of the inspecting team. 2.1.6 To confirm the confidentiality obligation of the inspectors.


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2.1.7 To define the behaviour of third party persons. 2.1.8 To decide the test to be conducted. 2.1.9 To approve the test planning and to assign the operators. 2.1.10 To communicate the request of a test report including the estimate of the uncertainty of the measurements. 2.1.11 To approve the programme for the system management audit and the needed staff. 2.1.12 To agreed upon the work time, the breaks, the time for the final meeting and the attending personnel.

2.2 Audit closure

2.2.1 Meeting of the inspectors team before the audit closure 2,2.1.1 Assessment of the findings from each inspector. 2.2.1.2 Assessment of the test report.

2.2.2 Final meeting with the Facility Specify starting time, end time, presents list (names and functions).

2.2.2.1 To remind to the Facility the performed controls and that they were performed on a sampling basis. 2.2.2.2 Specify that the audit is a way to collect information about the Facility’s fulfilment of the requirements of the Common

Protocol and that the accreditation is given by an official Accreditation Body.

2.2.2.3 To give the Facility the rationale of the findings.


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3. PRELIMINARY VERIFICATIONS

§ QUESTIONS RATIONALE § ANSWERS R

3.1 State of certification

03.01.01 Does the Facility use quality system management?

Should the Facility already use a quality system management a reduced check list could be adopted.

4

03.01.02 If you have answered ‘yes’ to 02.01.01, does the Facility have any certification of the quality system management? Please specify the certification body.

Should the quality system management of the Facility be already certified a reduced check list could be adopted.

4

03.01.03 Does the Facility have any certification for the performance of experimental tests?

Should the Facility be already certified for the performance of experimental tests a reduced check list could be adopted.

5

03.01.04 If you have answered ‘yes’ to 02.01.03, please list the certified tests.

Should the Facility be already certified for the performance of any experimental tests a reduced check list could be adopted.

5


3.2 State of accreditation

03.02.01 Does the Facility have any accreditation for the performance of experimental tests? If so, please specify the accreditation body.

Should the Facility be already accredited for the performance of experimental tests a reduced check list could be adopted.

5


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03.02.02 Does the Facility have accreditation for the performance of any experimental tests? If so, please list the accredited tests.

Should the Facility be already accredited for the performance of any experimental tests a reduced check list could be adopted.

5


3.3 State of procedures

03.03.01 Does the Facility utilise defined procedures to which assure the performance of experimental tests? If so, please list the test procedures.

Should the Facility already use defined procedures for the performance of experimental tests a reduced check list could be adopted.

5.4

03.03.02 Does the Facility utilise defined procedures for managing personnel? If so, please list the personnel management procedures.

Should the Facility already use defined procedures for managing personnel a reduced check list could be adopted.

5.2

03.03.03 Does the Facility utilise defined procedures for instrumentation management? If so, please list the instrumentation management procedures.

Should the Facility already use defined procedures for managing instrumentation a reduced check list could be adopted.

5.6

03.03.04 Does the Facility utilise defined procedures for equipment management? Please list the equipment management procedures.

Should the Facility already use defined procedures for managing equipment a reduced check list could be adopted.

5.5


3.4 Standards

03.04.01 Does the Facility adopt Standards for the performance of experimental seismic testing?

Should the Facility already use Standards for the performance of experimental seismic testing a taylored check list could be adopted.

5.4


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03.04.02 If the Facility adopts Standards for the performance of experimental seismic testing, please list the adopted Standards.

Should the Facility already use Standards for the performance of experimental seismic testing a taylored check list could be adopted.

5.4

03.04.03 Does the Facility adopt Standards for the management of experimental facilities (shaking table, actuators, pipelines, servo-controllers, pumps, power supply units)?

Should the Facility already use Standards for the management of experimental facilities a taylored check list could be adopted.

5.5

03.04.04 If the Facility adopts Standards for the management of experimental facilities, please list the adopted Standards.

Should the Facility already use Standards for the management of experimental facilities a taylored check list could be adopted.

5.5

03.04.05 Does the Facility adopt Standards for the management of measuring equipment (measurement transducers, cables, signal conditioners and amplifiers, filters)?

Should the Facility already use Standards for the management of measuring equipment a taylored check list could be adopted.

5.6

03.04.06 If the Facility adopts Standards for the management of measuring equipment, please list the adopted Standards.

Should the Facility already use Standards for the management of measuring equipment a taylored check list could be adopted.

5.6

03.04.07 Does the Facility adopt Standards for the management of data acquisition systems?

Should the Facility already use Standards for the management of data acquisition systems a taylored check list could be adopted.

5.6

03.04.08 If the Facility adopts Standards for the management of data acquisition systems, please list the adopted Standards.

Should the Facility already use Standards for the management of data acquisition systems a taylored check list could be adopted.

5.6


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03.04.09 Does the Facility adopt Standards for data acquisition, recording and storage?

Should the Facility already use Standards for data acquisition, recording and storage a taylored check list could be adopted.

5.4.7

03.04.10 If the Facility adopts Standards for the management of data acquisition, recording and storage, please list the adopted Standards.

Should the Facility already use Standards for data acquisition, recording and storage a taylored check list could be adopted.

5.4.7

03.04.11 Does the Facility adopt Standards for data processing, including frequency analysis, statistics, and modal analysis?

Should the Facility already use Standards for data processing a taylored check list could be adopted.

5.4.7

03.04.12 If the Facility adopts Standards for data processing, please list the adopted Standards.

Should the Facility already use Standards for data processing a taylored check list could be adopted.

5.4.7


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4. GENERAL MANAGEMENT REQUIREMENTS


4.1 Organization

04.01.01 Is the Facility legally independent or is it a part of an independent institution?

The Facility or the Organization of which it is part shall be an entity that can be held legally responsible.

4.1.1

04.01.02 Can the Facility be held legally responsible? The person entitled to legally represent the laboratory should be appointed by an authoritative body or by a legal document. This person will carry out functions to manage the tests in order:

• To satisfy the requirements of the Standard;

• To satisfy the demand of customers, of the laws and of the controlling authorities;

• To avoid conflict of interests.

4.1.1


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04.01.03 Does the Facility have the freedom to carry out its activities (e.g. testing, reporting) without seeking the approval of other parties (e.g. holding companies)?

It is responsibility of the laboratori to carry out its testing and calibration activities in such a way as to meet the requirements of IEC/ISO 17025 STD and to satisfy the needs of the customer, the regulatory authorities or organization providing recognition.

4.1.2

04.01.04 In the manual or in the procedures do responsibilities and management/technical procedures be defined for testing: a) in the laboratory permanent facilities; b) at sites away from its permanent facilities; c) in mobile facilities?

The management system shall cover work carried out in the laboratory’s permanent facilities, at sites away from its permanent facilities, or in associated temporary or mobile facilities.

4.1.3

04.01.05 Are the managerial and technical personnel free from any undue internal and external commercial, financial and other pressures and influences?

If the laboratory is part of an organization performing other activities other than testing, the responsibilities of key personnel in the organization that have an involvement or influence on the testing activities of the laboratory shall be defined in order to identify potential conflicts of interest.

4.1.4

04.01.06 Do the managerial and technical personnel have the authority and resources needed to carry out their duties?

The laboratory shall have managerial and technical personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties …….

4.1.5 a)


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04.01.07 Does the Facility have policies and procedures to ensure the protection of its customer’s confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results?

The laboratory shall have policies and procedures to ensure the protection of its customers’ confidential information and proprietary rights, …….

4.1.5 c)

04.01.08 Does the Facility have policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgement or operational integrity?

The laboratory shall have policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgement or operational integrity.

4.1.5 d)

04.01.09 Does the Facility have defined the organization and management structure of the laboratory, its place in any parent organization, and the relationships between quality management, technical operations and support services?

The laboratory shall define the organization and management structure of the laboratory, its place in any parent organization, and the relationships between quality management, technical operations and support services.

4.1.5 e)


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04.01.10 Has the Facility specified the responsibility, authority and interrelationships of all personnel?

The laboratory shall specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work affecting the quality of the tests. The Laboratory should produce a functional block scheme and a short job description of the main functions. An document is necessary to demonstrate the technical competence of the person entitled for a specific role. This document could be separate from the Management Manual in order to allow an easy and frequent updating.

4.1.5 f)

04.01.11 Does the Facility provide adequate supervision of testing staff, including trainees?

The laboratory shall provide adequate supervision of testing staff, including trainees, by persons familiar with methods and procedures, purpose of each test, and with the assessment of the test results.

4.1.5 g)

04.01.12 Does the technical management have overall responsibility for the technical operations and the provision of the resources?

The laboratory shall have technical management which has the overall responsibility for the technical operations and the provision of the resources needed to ensure the required quality of laboratory operations.

4.1.5 h)


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04.01.13 Does the Facility have a quality manager who, irrespective of other duties and responsibilities, has defined responsibility and authority for ensuring that the management system is implemented and followed at all times? Were the quality manager a consultant, does the assignement contract request enough time to manage the quality system?

The laboratory shall appoint a member of staff as quality manager who, irrespective of other duties and responsibilities, shall have defined responsibility and authority for ensuring that the management system related to quality is implemented and followed at all times; the quality manager shall have direct access to the highest level of management at which decisions are made on laboratory policy or resources.

4.1.5 i)

04.01.14 Has the Facility appointed deputies for the key managerial functions?

The laboratory shall appoint deputies for key managerial personnel; individuals may have more than one function.

4.1.5 j)

04.01.15 Does the Facility ensure that its personnel are aware of the relevance and importance of their activities?

The laboratory shall ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system.

4.1.5 k)

04.01.16 Does the Facility ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system?

Top management shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system.

4.1.6


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4.2 Management system

04.02.01 Does the Facility have a quality management system manual?

The laboratory shall establish, implement and maintain a management system appropriate to the scope of its activities. The laboratory shall document its policies, systems, programmes, procedures and instructions to the extent necessary to assure the quality of the test results. The system’s documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel.

4.2.1

04.02.02 Has the top management of the Facility issued a quality policy statement?

The laboratory’s management system policies related to quality, including a quality policy statement, shall be defined in a quality manual. The overall objectives shall be established, and shall be reviewed during management review. The quality policy statement shall be issued under the authority of top management. It shall include at least the following: …….

4.2.2

04.02.03 Has top management provided evidence of commitment to the development and implementation of the management system and to continually improving the effectiveness?

Top management shall provide evidence of commitment to the development and implementation of the management system and to continually improving the effectiveness.

4.2.3


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04.02.04 Does top management communicate to the organization the importance of meeting customer requirements?

Top management shall communicate to the organization the importance of meeting customer requirements as weel as statutory and regulatory requirements.

4.2.4

04.02.05 Does the quality manual include or make reference to the supporting procedures including technical procedures?

The quality manual shall include or make reference to the supporting procedures including technical procedures. It shall outline the structure of the documentation used in the management system.

4.2.5

04.02.06 Are the roles and responsibilities of the technical management and the quality manager defined in the quality manual or in another system document?

The roles and responsibilities of technical management and the quality manager, including their responsibility for ensuring compliance with ISO17025 Standard, shall be defined in the quality manual.

4.2.6

04.02.07 Does top management ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented? Does a specific document exist to define procedures and responsibilities to apply when changing the management system?

Top management shall ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented.

4.2.7


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4.3 Document control

04.03.01 Does the Facility have procedures to control all documents that are part of its management system?

The laboratory shall establish and maintain procedures to control all documents that form part of its management system (internally generated or from external sources), such as regulations, standards, other normative documents, test methods, as well as drawings, software, specifications, instructions and manuals.

4.3.1

04.03.02 Has the Facility defined the responsibilities for the issue, review and approval of the documents?

All documents issued to personnel in the laboratory as part of the management system shall be reviewed and approved for use by authorized personnel prior to issue. A master list or an equivalent document control procedure identifying the current revision status and distribution of documents in the management system shall be established and shall be ready available to preclude the use of invalid and obsolete documents.

4.3.2.1

04.03.03 Does the Facility uniquely identify a document’s: Date of issue Revision identification Page numbering Total number of pages Issuing authorities?

Management system documents generated by the laboratory shall be uniquely identified. ……..

4.3.2.3


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04.03.04 Do the changes to the documents be reviewed and approved by the same function that performed the original review?

Changes to the documents shall be reviewed and approved by the same function that performed the original review unless specifically designated otherwise. The designated personnel shall have access to pertinent background information upon which to base their review and approval.

4.3.3.1


4.4 Review of requests, tenders and contracts

04.04.01 Does the Facility have a procedure for the review of requests, tenders and contracts?

The laboratory shall establish and maintain procedures for the review of requests, tenders and contracts. The policies and procedures for these reviews leading to a contract for testing shall ensure ……. . Any differences between the request or tender and the contract shall be resolved before any work commences. Each contract shall be acceptable both to the laboratory and the customer.

4.4.1


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04.04.02 Does the Facility assure that: The requirements of the customer are adequately defined, documented and understood? It has the capability and resources to meet the requirements? The appropriate test method is selected and that the Facility is capable of meeting the customer’s requirements?

See above. 4.4.1


4.5 Subcontracting of tests and calibrations

04.05.01 Does the Facility subcontract work? When a laboratory subcontracts work, whether because of unforeseen reasons or on a continuing basis, this work shall be placed with a competent subcontractor. A competent subcontractor is one that, for example, complies with ISO/IEC 17025 STD for the work in question. ILAC and EA agreed upon that systematic subcontracting under accreditation is not possible. Accreditation is only possible for an operation for which a laboratory itself is competent to perform and does indeed perform.

4.5.1


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04.05.02 Does the Facility advise the customer of the subcontract and does it obtain the approval of the customer?

The laboratory shall advise the customer of the arrangement in writing and, when appropriate, gain the approval of the customer, preferably in writing.

4.5.2


4.6 Purchasing services and supplies

04.06.01 Does the Facility have procedures for the purchasing and acceptance of: Equipment and instrumentation? Consumable materials? Services such as maintenance, calibration, consultancy?

The laboratory shall have a policy and procedures for the selection and purchasing of services and supplies it uses that affect the quality of the tests.

4.6.1


4.7 Service to the customer

04.07.01 Is access allowed by the Facility to the customer during the tests?

The laboratory shall be willing to cooperate with customers or their representatives in clarifying the customer’s request and in monitoring the laboratory’s performance in relation to the work performed.

4.7.1

04.07.02 Does the Facility seek feedback from the customers to improve the management system, testing and calibration activities and customer service?

The laboratory shall seek feedback, both positive and negative, from its customers.

4.7.2


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4.8 Complaints

04.08.01 Does the Facility have a policy and procedures for the resolution of complaints received by the customers or other parties?

The laboratory shall have a policy and procedure for the resolution of complaints received from customers or other parties.

4.8

04.08.02 How many complaints were received by the Facility since the last audit?

See above. 4.8


4.9 Control of nonconforming testing and/or

calibration work

04.09.01 Does the Facility have the policy and procedures to deal with any aspect of its testing work that does not conform to the Facility’s procedures or the agreed requirements of the customer?

The laboratory shall have a policy and procedures that shall be implemented when any aspect of its testing work, or the results of this work, do not conform to its own procedures or the agreed requirements of the customer. …… .

4.9.1

04.09.02 Does the Facility have the policy and procedures to deal with anomalies, unexpected events and non-conformities of its testing work that does not conform to the Facility’s procedures or the agreed requirements of the customer?

See above CP - 2.9.1


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4.10 Improvement

04.10.01 Does the Facility continually improve the effectiveness of its management system?

The laboratory shall continually improve the effectiveness of its management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actons and management review.

4.10


4.11 Corrective action

04.11.01 Does the Facility have a procedure for implementing corrective actions?

The laboratory shall establish a policy and a procedure and shall designate appropriate authorities for implementing corrective action when nonconforming work or departures from the policies and procedures in the management system or technical operations have been identified.

4.11.1


4.12 Preventive action

04.12.01 Does the Facility have a plan to monitor test quality to allow corrective actions to be taken in advance when necessary?

Needed improvements and potential sources of nonconformities, either technical or concerning the management system, shall be identified. ….. .

4.12.1


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4.13 Control of records

04.13.01 Does the Facility have procedures for: Identification Collection Indexing Access Filing Storage Maintenance and Disposal of quality and technical records?

The laboratory shal establish and maintain procedures for Identification, Collection, Indexing, Access, Filing, Storage, Maintenance and Disposal of quality and technical records. ….. .

4.13.1.1

04.13.02 Does the Facility have a procedure such that documents and recordings of the test activities allow traceability of equipment, materials, personnel, environmental conditions and performed controls?

The laboratory shall retain records of the original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each test report issued, for a defined period. ….. . The customer should be protected by assuring that the recorded data are well managed in order to guarantee possible repetition of the tests.

4.13.2.1

04.13.03 Are observations, data and calculations recorded at the time they are made?

Observations, data and calculations shall be recorded at the time they are made and shall be identifiable to the specific task.

4.13.2.2


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4.14 Internal audits

04.14.01 Does the Facility conduct internal audits of its activities to verify the compliance with the requirements of the management system?

The laboratory shall periodically, and in accordance with a predetermined schedule and procedure, conduct internal audits of its activities to verify that its operations continue to comply with the requirements of the management system and ISO/IEC 17025 STD.

4.14.1


4.15 Management reviews

04.15.01 Does the top management of the Facility conduct a periodic review of the management system and of the testing activities?

In accordance with a predetermined schedule and procedure, the laboratory’s top management shall periodically conduct a review of the laboratory’s management system and testing activities to ensure their continuing suitability and effectiveness, and to introduce necessary changes or improvements. …. .

4.15.1


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5. GENERAL TECHNICAL REQUIREMENTS


5.1 General

05.01.01 Has the Facility taken into account the following factors in developing test and calibration methods and procedures, in training and qualification of personnel and in the selection and calibration of the equipment it uses:

• Human factors

• Accommodation and environmental conditions

• Test and calibration methods and method validation

• Equipment

• Measurement traceability

• Sampling

• The handling of test and calibration items?

Many factors determine the correctness and reliability of the tests and calibration performed by a laboratory. These factors include contributions from:

• Human factors (5.2)

• Accommodation and environmental conditions (5.3)

• Test and calibration methods and method validation (5.4)

• Equipment (5.5)

• Measurement traceability (5.6)

• Sampling (5.7)

• The handling of test and calibration items (5.8).

5.1.1


Rev.01



05.01.02 Does the Facility have and apply procedures for estimating repeatability of tests? Does the Facility have and apply procedures for estimating repeatability of tests during time?

See above. Common Protocol – General criteria

• From a technical point of view the mutual accreditation is a tool to guarantee the reliability of testing laboratories: reliability is translated in practice into

o Repeatability, the principle that experimental activities repeated on the same specimen in the same laboratory lead to the same results, and

o Reproducibility, the principle that experimental activities repeated on the same specimen in different laboratories lead to the same results.

5.1.1


5.2 Personnel

05.02.01 Has the management of the Facility formulated the goals with respect to education, training and skills of the Facility personnel?

The laboratory management shall ensure the competence of all who operate specific equipment, perfom tests and calibrations, evaluate results, and sign test reports.

5.2.1


Rev.01



05.02.02 Does the Facility ensure that contracted personnel are supervised and competent and that they work in accordance with the Facility’s management system?

The laboratory shall use personnel who are employed by, or under contract to, the laboratory. Where contracted and additional technical and key support personnel are used, the laboratory shall ensure that such personnel are supervised and competent and that they work in accordance with the laboratory’s management system.

5.2.3

05.02.03 Are the minimum requirements for the personnel qualification defined.?

The laboratory shall maintain current job descriptions for managerial, technical and key support personnel involved in tests..

5.2.4

05.02.04 Does the Facility have records of the authorization, competence, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel?

The laboratory shall maintain records of the relevant authorizations, competence, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel. This information shall be readly available and shall include the date on which authorization and competence is confirmed.

5.2.5


Rev.01



5.3 Accommodation and environmental

conditions

05.03.01 Are the testing and calibration, lighting and environmental conditions appropriate for the correct performance of the tests?

Laboratory facilities for testing and calibration, including but not limited to energy sources, lighting and environmental conditions, shall be such as to facilitate correct performance of the tests.

5.3.1

05.03.02 Does the Facility monitor, control and record environmental conditions?

The laboratory shall monitor, control and record environmental conditions as required by the relevant specifications, methods and procedures or where they influence the quality of the results.

5.3.2

05.03.03 Does the Facility control the access to and use of test and calibration areas?

Access to and use of areas affecting the quality of the tests shall be controlled.

5.3.4

05.03.04 Does the Facility have procedures to clean the laboratory?

Measures shall be taken to ensure good housekeeping in the laboratory. Special procedures shall be prepared where necessary.

5.3.5


Rev.01



5.4 Test and calibration methods and method

validation

05.04.01 Does the Facility have test and calibration methods?

The laboratory shall use appropriate methods and procedures for all tests within its scope. These include sampling, handling, transport, storage and preparation of items to be tested, and, where appropriate, an estimation of the measurement uncertainty as well as statistical techniques for analysis of test data. Accreditation may only take place in respect of operations that have been formally reported.

5.4.1

05.04.02 Does the Facility have technical procedures on the use and operation of all relevant equipment, and on the handling and preparation of items for testing and calibration?

The laboratory shall have instructions on the use and operation of all relevant equipment, and on the handling and preparation of items for testing, ….. .

5.4.1

05.04.03 Are readly available to personnel all instructions, standards, manuals and reference data relevant to the work of the laboratory? Are all those documents kept up to date?

All instructions, standards, manuals and reference data relevant to the work of the laboratory shall be kept up to date and shall be made readly available to personnel.

5.4.1


Rev.01



05.04.04 Are standardized test and calibration methods used in preference to other test methods?

The laboratory shall use test methods which meet the needs of the customer and which are appropriate for the tests it undertakes. Methods published in international, regional or national standards shall preferably be used.

5.4.2

05.04.05 Are non-standard, Facility-developed methods validated?

When the customer does not specify the method to be used, the laboratory shall select appropriate methods that have been published either in international, regional or national standards, or by reputable technical organizations, or in relevant scientific texts or journals, or as specified by the manufacturer of the equipment. Laboratory-developed methods or methods adopted by the laboratory may also be used if they are appropriate for the intended use and if they are validated. Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled.

5.4.2 5.4.5.1

05.04.06 Is the development of internal testing methods a planned activity and is it assigned to qualified personnel?

The introduction of test methods developed by the laboratory for its own use shall be a planned activity and shall be assigned to qualified personnel equipped with adequate resources.

5.4.3


Rev.01



05.04.07 Does the Facility have and apply procedures for estimating uncertainty of measurement?

Testing laboratories shall have and shall apply procedures for estimating uncertainty of measurement.

5.4.6.2

05.04.08 Are calculations and data transfers subject to appropriate checks in a systematic manner?

Calculations and data transfers shall be subject to appropriate checks in a systematic manner.

5.4.7.1

05.04.09 Is the computer software developed by the user documented in sufficient detail and is it suitably validated?

When computers or automated equipment are used for the acquisition, processing, reading, reporting, storage or retrieval of test data, the laboratory shall ensure that:

• Computer software developed by the user is documented in sufficient detail and is suitably validated as being adequate for use;

5.4.7.2

05.04.10 Are procedures established and implemented for protecting the data?

• Procedures are established and implemented for protecting the data;

5.4.7.2

05.04.11 Are computers and automated equipment maintained to ensure proper functioning and are provided with the environmental and operating conditions necessary to maintain the integrity of test data?

• Computers and automated equipment are maintained to ensure proper functioning and are provided with the environmental and operating conditions necessary to maintain the integrity of test data.

5.4.7.2


Rev.01



5.5 Equipment

05.05.01 Is the measurement and test equipment appropriate for the type of tests the Facility is conducting?

The laboratory shall be furnished with all items of sampling, measurement and test equipment required for the correct performance of the tests.

5.5.1

05.05.02 Does the Facility ensure that all test equipment: - complies with the test specification? - is calibrated? - allows for the correct performance of the test?

Equipment and its software used for testing, calibration and sampling shall be capable of achieving the accuracy required and shall comply with specification relevant to the tests concerned. Calibration programmes shall be established for key quantities or values of the instruments where these properties have a significant effect on the results. Before being placed into service, equipment shall be calibrated or checked to establish that it meets the laboratory’s specification requirements and complies with the relevant standard specifications. It shall be checked and calibrated before use.

5.5.2


Rev.01



05.05.03 Is the maintenance of all the employed equipment specified as follows:

• Manufacturer’s instructions

• The maintenance plan and maintenance carried out to date

• Frequency of maintenance

• Log of damage, malfunction, modification or repair?

Equipment shall be operated by authorized personnel. Up-to-date instructions on the use and maintenance of equipment (including any relevant manuals provided by the manufacturer of the equipment) shall be readily available for the use by the appropriate laboratory personnel.

5.5.3


Rev.01



05.05.04 Is the deployed equipment uniquely identified as follows:

• Name and description of the equipment and its software

• Name of the manufacturer; model number and serial number

• Initial check in with respect to the purchasing requirements

• Date of receipt and date of start up

• The current location, where appropriate

Records shall be maintained of each item of equipment and its software significant to the tests performed. The records shall include at least the following:

a) The identity of the item of equipment and its software;

b) The manufacturer’s name, type identification, serial number or other unique identification;

c) Checks that the equipment complies with the specifications

d) The current location, where appropriate

e) The manufacturer’s instructions, if available, or reference to their location;

f) Dates, results and copies of reports and certificates of all calibrations, adjustments, acceptance criteria, and the due date of next calibration;

g) The maintenance plan, where appropriate, and maitainance carried out to date;

h) Any damage, malfunction, modification or repair to the equipment.

5.5.5


Rev.01



05.05.05 Is the maintenance of all the employed equipment specified as follows:

• Manufacturer’s instructions

• The maintenance plan and maintenance carried out to date

• Frequency of maintenance

• Log of damage, malfunction, modification or repair?

The laboratory shall have procedures for the safe handling, transport, storage, use and planned maintenance of measuring equipment to ensure proper functioning and in order to prevent contaminaton or deterioration. Note – Additional procedures may be necessary when measuring equipment is used outside the permanent laboratory for tests.

5.5.6

05.05.06 Is the calibration of all the employed equipment recorded as follows:

• Dates

• Results

• Copies of reports

• Certificates of all calibrations

• Due date of next calibration

Whenever practicable, all equipment under the control of the laboratory and requiring calibration shall be labelled, coded or otherwise identified to indicate the status of calibration, including the date when last calibrated and the date or expiration crieteria when recalibration is due.

5.5.8


Rev.01



5.6 Measurement traceability

05.06.01 Are all equipment calibrated before being put into service?

All equipment used for tests, including equipment for subsidiary measurements (e.g. for environmental conditions) having a significant effect on the accuracy or validity of the result of the test, calibration or sampling shall be calibrated before being put into service. Tha laboratory shall have an established programme and procedure for the calibration of its equipment.

5.6.1


Rev.01



05.06.02 Are all the calibrations and measurements made by the laboratory traceable to the International System of Units (SI)?

5.6.2.1 – For calibration laboratories, the programme for calibration of equipment shall be designed and operated so as to ensure that calibrations and measurements made by the laboratory are traceable to the International System of Units (SI). 5.6.2.2.1 – For testing laboratories, the requirements given in 5.6.2.1 apply for measuring and test equipment with measuring functions used, unless it has been established that the associated contribution from the calibration contributes little to the total uncertainty of the test results. When this situation arises, the laboratory shall ensure that the equipment used can provide the uncertainty of measurement needed. Note – The extent to which the requirements in 5.6.2.1 should be followed depends on the relative contribution of the calibration uncertainty. If calibration is the dominant factor, the requirements should be strictly followed.

5.6.2.1 & 5.6.2.2


Rev.01



5.7 Sampling

05.07.01 Are defined procedures employed by the Facility when sampling test specimen?

The laboratory shall have a sampling plan and procedures for sampling when it carries out sampling of substances, materials or products for subsequent testing. In case of prototype testing, the laboratory should provide the description of the specimen in the Test Report.

5.7.1


5.8 Handling of test and calibration results

05.08.01 Does the Facility have procedures for the transportation, receipt, handling, protection, storage, retention and disposal of test items?

The laboratory shall have procedures for the transportation, receipt, handling, protection, storage, retention and disposal of test items, including all provisions necessary to protect the integrity of the test item, and to protect the interests of the laboratory and the customer.

5.8.1


Rev.01



05.08.02 Does the Facility have procedures for the recording of abnormalities of test items?

Upon receipt of the test item, abnormalities or departures from normal or specified conditions, as described in the test method, shall be recorded. When there is doubt as to the suitability of an item for test, or when an item does not conform to the description provided, or the test required is not specified in sufficient detail, the laboratory shall consult the customer for further instructions before proceeding and shall record the discussion.

5.8.3

05.08.03 Does the Facility have procedures for avoiding deterioration, loss or damage to the test item during storage, handling and preparation?

The laboratory shall have procedures and appropriate facilities for avoiding deterioration, loss or damage to the test item during storage, handling and preparation. Handling instructions provided with the item shall be followed. When items have to be stored or conditioned under specified environmental conditions, these conditions shall be maintained, monitored and recorded.

5.8.4


Rev.01



5.9 Assuring the quality of test and calibration

results

05.09.01 Does the Facility have quality control procedures for monitoring the validity of tests undertaken?

The laboratory shall have quality control procedures for monitoring the validity of tests undertaken. Participation in proficiency comparisons is becoming an increasingly important element of the assessment and accreditation of laboratories.

5.9.1


5.10 Reporting the results

05.10.01 Does the Facility report the results of each test in accordance with specific instructions of the test method?

The results of each test, or series of tests carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the test methods.

5.10.1


Rev.01



05.10.02 Does the test report include the following information?

a) A title (e.g. “Test report”) b) Name and address of the Facility c) Unique identification of the test report d) Name and address of the customer e) Identification of the methodology

employed in testing f) Description and unambiguous

identification of the tested item g) Date of receipt of the test item and date of

performance of the test h) Reference to the sampling plan and

procedures i) Test results with the units of

measurement j) Name, function and signature of person

authorizing the test report k) A statement that the results relate only to

the tested items l) Page number and total number of pages.

Each test report shall include at least the following information, unless the laboratory has valid reasons for not doing so:

a) A title (e.g. “Test report”); b) The name and address of the

laboratory, and the location where the tests were carried out, if different from the address of the laboratory;

c) Unique identification of the test report, and on each page an identification in order to ensure that the page is recognized as a part of the test report, and a clear identification of the end of the test report;

d) Name and address of the customer; e) Identification of the method used; f) A description of, the condition of, and

unambiguous identification of the item tested;

g) The date of receipt of the test item where this is critical to the validity and application of the results, and the date of performance of the test

h) Reference to the sampling plan and procedures …… ;

i) The test results with, where appropriate, the units of measurement;

j) The name, function and signature or equivalent identification of person authorizing the test report;

k) Where relevant, a statement to the effect that the results relate only to

the items tested.

5.10.2


Rev.01



05.10.03 Does the test report include a statement that the test report shall not be reproduced except in full, without written approval of the Facility?

Note 2 – It is recommended that laboratories include a statement specifying that the test report shall not be reproduced except in full, without written approval of the laboratory.

5.10.2

05.10.04 Does the test report include the additional information such as deviations from the test method, compliance with specifications, the estimated uncertainty of measurement, opinions and interpretations?

In addition to the requirements listed in 5.10.2, test reports shall, where necessary for interpretation of the test results, include the following:

a) Deviations from, additions to, or exclusions from the test method, and information specific test conditions, such as environmental conditions;

b) Where relevant, a statement of compliance/non-compliance with requirements and/or specifications;

c) Where applicable, a statement on the estimated uncertainty of measurement; …… ;

d) Where appropriate and needed, opinions and interpretations (see 5.10.5);

e) Additional information which may be required by specific methods, customers or groups of customers.

5.10.3.1


Rev.01



05.10.05 Does the test report include opinions and interpretations and are opinions and interpretations clearly marked as such?

When opinions and interpretations are included, the laboratory shall document the basis upon which the opinions and interpretations have been made. Opinions and interpretations shall be clearly marked as such in the test report.

5.10.5

05.10.06 Does the Facility have procedures for the storage of the test reports?

The laboratory shall retain records of the original observations, derived data ………. and a copy of each test report issued, for a defined period. ….. .

4.13.2.1

05.10.07 Does the Facility have procedures for data storage, data transmission and data processing?

In the case of transmission of test results by electronic or electromagnetic means, the requirements of ISO/IEC 17025 STD shall be met (see also 5.4.7)

5.10.7


Rev.01


6. SPECIFIC TECHNICAL REQUIREMENTS


6.1 Identification of the test

06.01.01 What types of items are typically tested? Each test report shall include a description of, the condition of, and unambiguous identification of the item tested.

5.10.2

06.01.02 What test method is typically employed? Methods published in international, regional or national standards, or by reputable technical organizations, or in relevant scientific texts or journals, or as specified by the manufacturer of the equipment shall preferably be used. The Technical Annexes to the Common Protocol should be referred to.

5.4.2

06.01.03 What type of test is typically performed (static test, pseudo-dynamic test, sinusoidal vibrations, multi-frequency vibrations, etc.)?

The test report shall include the identification of the method used.

5.10.2

06.01.04 What is typically measured? See above. 5.10.2

06.01.05 What is the typical measurement range? See above. 5.10.2

06.01.06 Date, time and place of the test performed. The test report shall include the name and address of the laboratory, and the location where the tests were carried out, if different from the address of the laboratory.

5.10.2


Rev.01



06.01.07 Test report identification. The test report shall include unique identification of the test report, and on each page an identification in order to ensure that the page is recognized as a part of the test report, and a clear identification of the end of the test report.

5.10.2


6.2 Personnel in charge of the test

06.02.01 Christian and family name of the operator. The laboratory shall maintain current job descriptions for managerial, technical and key support personnel involved in tests..

5.2.4

06.02.02 Qualification of the operator, study degree. Personnel performing specific tasks shall be qualified on the basis of appropriate education, training, experience and/or demonstrated skills, as required.

5.2.1

06.02.03 Does the operator have appropriate education and experience?

See above. 5.2.1

06.02.04 Was the operator trained and qualified for the test conduct? Does the facility maintain records of the personnel qualification and of the continuous education and training?

The laboratory shall maintain records of the relevant authorizations, competence, educational and professional qualifications, training, skills and experience of all technical personnel.

5.2.5


Rev.01



6.3 Test methods

06.03.01 Is the test method a Standard? Methods published in international, regional or national standards shall preferably be used. The Technical Annexes to the Common Protocol should be referred to.

5.4.2

06.03.02 Does the Facility have its own test procedures? When necessary, the standard shall be supplemented with additional details to ensure consistent application. To cover specific test requirements a test specification could be supplied by the research engineer to the testing Laboratory.

5.4.2

06.03.03 Is the test method readily available to personnel?

All instructions, standards, manuals and reference data relevant to the work of the laboratory shall be kept up to date and shall be made readily available to personnel.

5.4.1

06.03.04 Does the Facility verify its own tests repeatability?

The adoption of international standard test methods is only a necessary condition to guarantee test repeatability. The Technical Annexes to the Common Protocol should be applied and the requirements there specified should be fulfilled.

5.4.2


Rev.01



06.03.05 Does the Facility have a procedure for the evaluation of the measurements uncertainty according to ENV 13005?

Testing laboratories shall have and shall apply procedures for estimating uncertainty of measurement. The Technical Annexes to the Common Protocol should be applied and the requirements there specified should be fulfilled.

5.4.6.2


6.4 Test performance

06.04.01 Was the test item appropriately stored and retained after the laboratory acceptance?

The laboratory shall have procedures for the transportation, receipt, handling, protection, storage, retention and disposal of test items, including all provisions necessary to protect the integrity of the test item, and to protect the interests of the laboratory and the customer.

5.8.1

06.04.02 Does the Facility have procedures to verify the suitability of test items?

When there is doubt as to the suitability of an item for test, or when an item does not conform to the description provided, or the test required is not specified in sufficient detail, the laboratory shall consult the customer for further instructions before proceeding and shall record the discussion.

5.8.3


Rev.01



06.04.03 Are defined sampling plans and procedures available when sampling test specimen?

The laboratory shall have a sampling plan and procedures for sampling when it carries out sampling of substances, materials or products for subsequent testing.

5.7.1

06.04.04 Are the records of the sampling procedure used available, with the identification of the sampler, and the environmental conditions? Are the conservation and transportation requirements fulfilled?

The laboratory shall have procedures for recording relevant data and operations relating to sampling that forms part of testing that is undertaken. These records shall include the sampling procedure used, the identification of the sampler, environmental conditions and diagrams or other equivalent means to identify the sampling location as necessary and, if appropriate, the statistics the sampling procedures are based upon.

5.7.3

06.04.05 Is the identification of the test item retained throughout its life in the laboratory?

The laboratory shall have a system for identifying test items. The identification shall be retained throughout the life of the item in the laboratory.

5.8.2

06.04.06 When items have to be stored or conditioned under specified environmental conditions, are these conditions maintained, monitored and recorded?

When items have to be stored or conditioned under specified environmental conditions, these conditions shall be maintained, monitored and recorded.

5.8.4


Rev.01



06.04.07 Does the Facility monitor, control and record environmental conditions?

Due attention shall be paid, for example, to biological sterility, dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, and sound and vibration levels, as appropriate to the technical activities concerned. Tests shall be stopped when the environmental conditions jeopardize the results of the tests.

5.3.2

06.04.08 Does the testing equipment comply with the requirements of the test standard or method?


5.5.1

06.04.09 Are up-to-date instructions on the use of equipment readily available for the use by the appropriate laboratory personnel?

Up-to-date instructions on the use and maintenance of equipment (including any relevant manuals provided by the manufacturer of the equipment) shall be readily available for the use by the appropriate laboratory personnel.

5.5.3

06.04.10 Does the Facility have specific procedures for the management of measuring equipment when it is used outside the permanent laboratory for tests?

The laboratory shall have procedures for the safe handling, transport, storage, use and planned maintenance of measuring equipment to ensure proper functioning and in order to prevent contaminaton or deterioration. Note – Additional procedures may be necessary when measuring equipment is used outside the permanent laboratory for tests.

5.5.6


Rev.01



06.04.11 Was the test performed after the specified test method?

Methods published in international, regional or national standards, or by reputable technical organizations, or in relevant scientific texts or journals, or as specified by the manufacturer of the equipment shall preferably be used. The Technical Annexes to the Common Protocol should be referred to.

5.4.2

06.04.12 Are the raw data traceable starting from the test report?

Calculations and data transfers shall be subject to appropriate checks in a systematic manner.

5.4.7

06.04.13 In case of data processing by authomatic system such as database and statistical programmes of off-the-shelf software, are the results of the worksheets validated?

Commercial off-the-shelf software (e.g. wordprocessing, database and statistical programmes) in general use within their designed application range may be considered to be sufficiently validated. However, laboratory software configuration/modifications should be validated as in 5.4.7.2.a).

5.4.7.2


Rev.01



06.04.14 Are the rounding and the number of decimal digits managed in a correct way?

See above and EA 4/16 punto 7.6 - The number of decimal digits in a reported uncertainty should always reflect practical measurement capability. In view of the process for evaluating uncertainties, it is rarely justified to report more than two significant digits. Often a single significant digit is appropriate. Similarly, the numerical value of the result should be rounded so that the last decimal digit corresponds to the last digit of the uncertainty. The normal rules of rounding can be applied in both cases. For example, if a result of 123.456 units is obtained, and an uncertainty of 2.27 units has resulted from the evaluation, the use of two significant decimal digits would give the rounded values 123.5 units ± 2.3 units..

5.4.7.2

06.04.15 Does the Facility have quality control records for monitoring the validity of the present test (e.g. interlaboratory comparisons or proficiency testing programmes)?

The laboratory shall have quality control procedures for monitoring the validity of tests undertaken. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to the reviewing of the results.

5.9.1


Rev.01



6.5 Test equipment

06.05.01 Does the test equipment meet the requirements of the test?


5.5.1

06.05.02 Verify that records are maintained of each item of equipment and its software significant to the tests performed. The records shall include at least the following:




d) The current location, where appropriate e) The manufacturer’s instructions, if available,

or reference to their location; f) Dates, results and copies of reports and

certificates of all calibrations, adjustments, acceptance criteria, and the due date of next calibration;



Records shall be maintained of each item of equipment and its software significant to the tests performed. The records shall include at least the following:




d) The current location, where appropriate e) The manufacturer’s instructions, if

available, or reference to their location; f) Dates, results and copies of reports and

certificates of all calibrations, adjustments, acceptance criteria, and the due date of next calibration;



5.5.5


Rev.01



6.6 Maintenance

06.06.01 Does the Facility have procedures for the maintenance of the test equipment?

The laboratory shall have procedures for the safe handling, transport, storage, use and planned maintenance of measuring equipment to ensure proper functioning and in order to prevent contaminaton or deterioration.

5.5.6

06.06.02 Where applicable, does the Facility have procedures for the management of calibration correction factors?

Where calibrations give rise to a set of correction factors, the laboratory shall have procedures to ensure that copies (e.g. in computer software) are correctly updated.

5.5.11

06.06.03 Does the Facility have safeguards against anomalous adjustments of the test equipment?

Test equipment, including both hardware and software, shall be safeguarded from adjustments which would invalidate the test results.

5.5.12


6.7 Calibration

06.07.01 Does the Facility have calibration procedures stating responsibilities and calibration time intervals?

Whenever practicable, all equipment under the control of the laboratory and requiring calibration shall be labelled, coded or otherwise identified to indicate the status of calibration, including the date when last calibrated and the date or expiration crieteria when recalibration is due.

5.5.8


Rev.01



06.07.02 In case of internal calibration procedure verify: a. The limits of acceptability of the calibration

results and the characteristics of the reference primary standard;

b. The internal calibration reports, the completeness and acceptability of the calibartion results;

c. The estimate of the calibration uncertainty shall be done after the International UNI CEI ENV 13005 STD;

d. The traceability of the calibration primary standards to the International System of Units (SI);

e. The programme for the calibration of the primary and secondary standards;

f. The reference standard shall be used only for calibration

g. The internal calibration reports for the secondary calibration standard.

Take note of the serial number, calibration certificate of the primary standard, name of the external Body for calibration.

5.6.2.1 – For calibration laboratories, the programme for calibration of equipment shall be designed and operated so as to ensure that calibrations and measurements made by the laboratory are traceable to the International System of Units (SI). 5.6.2.2.1 – For testing laboratories, the requirements given in 5.6.2.1 apply for measuring and test equipment with measuring functions used, unless it has been established that the associated contribution from the calibration contributes little to the total uncertainty of the test results. When this situation arises, the laboratory shall ensure that the equipment used can provide the uncertainty of measurement needed. Note – The extent to which the requirements in 5.6.2.1 should be followed depends on the relative contribution of the calibration uncertainty. If calibration is the dominant factor, the requirements should be strictly followed.

5.6.2.2


Rev.01



06.07.03 Has the Facility validated the internal calibration procedures?

When it is necessary to use methods not covered by standard methods, these shall be subject to agreement with the customer and shall include a clear specification of the customer’s requirements and the purpose of the calibration. The method developed shall have been validated appropriately before use.

5.4.4

06.07.04 Does the Facility perform intermediate controls between two calibration dates? Does the Facility have adequate procedures?

When intermediate checks are needed to maintain confidence in the calibration status of the equipment, these checks shall be carried out according to a defined procedure.

5.5.10


6.8 Test report

06.08.01 Verify the conformity of the test report to the requirements of the ISO/IEC 17025.

The results of each test, or series of tests carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the test methods

5.10.1


Rev.01



06.08.02 Does the test report include a statement on the estimated uncertainty of measurement, where applicable? Is the estimated uncertainty of measurement reported as expanded uncertainty in the same unity of the measurement?

In addition to the requirements listed in 5.10.2, test reports shall, where necessary for interpretation of the test results, include the following:

a) ………….; b) ………….; c) Where applicable, a statement on

the estimated uncertainty of measurement; information on uncertainty is needed in the test reports when it is relevant to the validity or application of the test results, when a customer’s instruction so requires, or when the uncertainty affects compliance to a specification limit;

……...

5.10.3.1

06.08.03 Does the test report include a statement of confidence specifying the level of confidence and the coverage interval?

See above. EA 4/16 – clause 7.1 - Once the expanded uncertainty has been calculated for a specified level of confidence (typically 95%), the test result y and the expanded uncertainty U should be reported as y ± U and accompanied by a statement of confidence. This statement will depend on the nature of the probability distribution; some examples are presented below.

5.10.3.1


Rev.01



06.08.04 Does the test report include the identification of the method used?

Each test report shall include at least the following information, unless the laboratory has valid reasons for not doing so:

a) ……..; b) ……..; c) ……..; d) ……..; e) Identification of the method used;

5.10.2


Rev.01


7. REMARKS

R number Remark

Please add additional sheets as required

annex 1 check list for the performance of the audit …

Documents