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Quality Management Manual Classif. MGQ of 21

Rev. 4

Quality Management

Manual

UNI EN ISO 9001:2008

REV. REASON FOR MODIFICATION DRAWN UP CHECKED APPROVED DATE 2 English Translation version of the

Italian manual rev. 2 (trad. M. Walters) L. Malafronte L. Malafronte P. Gasparini 30/06/2010

3 Review and updating of the Italian manual rev. 3 (trad. M. Walters) L. Malafronte L. Malafronte P. Gasparini 20/06/2011

4 Review and updating of the Italian manual rev. 4 (trad. M. Walters) L. Malafronte P. Gasparini G. Manfredi 03/09/2012

Checked copy no. 1 - recipient RSGQ company function/external authority Copy not checked

Warning: The release of this Manual, as an unchecked copy, does not oblige the Company to keep the document updated. A reproduction of this document, even partial, is forbidden without the authorisation of AMRA Scarl.


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INDEX

1. PURPOSE AND SCOPE 4 1.1 GENERAL INFORMATION 1.2 APPLICATION

2. NORMATIVE REFERENCES 6

3. TERMS AND DEFINITIONS 6 4. QUALITY MANAGEMENT SYSTEM 7 4.1 GENERAL REQUIREMENTS 4.2 DOCUMENTATION REQUIREMENTS 4.2.1 GENERAL INFORMATION 4.2.2 QUALITY MANAGEMENT MANUAL 4.2.3 CONTROL OF DOCUMENTS 4.2.4 CONTROL OF REGISTERS 5. MANAGEMENT RESPONSIBILITIES 9 5.1 MANAGEMENT UNDERTAKING 5.2 CUSTOMER FOCUS 5.3 QUALITY POLICY 5.4 PLANNING 5.4.1 QUALITY OBJECTIVES 5.4.2 MANAGEMENT SYSTEM PLANNING FOR QUALITY 5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION 5.5.1 RESPONSIBILITY AND AUTHORITY 5.5.2 MANAGEMENT REPRESENTATIVE 5.5.3 INTERNAL COMMUNICATION 5.6 MANAGEMENT REVIEW 5.6.1 GENERAL INFORMATION 5.6.2 REVIEW INPUT 5.6.3 REVIEW OUTPUT 6. RESOURCE MANAGEMENT 12 6.1 RESOURCE AVAILABILITY 6.2 HUMAN RESOURCES 6.2.1 GENERAL INFORMATION 6.2.2 SKILLS, AWARENESS AND TRAINING 6.3 INFRASTRUCTURES 6.4 WORKING ENVIRONMENT 7. PRODUCT/SERVICE REALIZATION 13 7.1 PLANNING OF PRODUCT/SERVICE REALIZATION


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7.2 CUSTOMER-RELATED PROCESSES 7.2.1 DETERMINATION OF PRODUCT/SERVICE REQUIREMENTS 7.2.2 REVIEW OF PRODUCT/SERVICE REQUIREMENTS 7.2.3 CUSTOMER COMMUNICATION 7.3 DESIGN AND DEVELOPMENT 7.4 PURCHASING 7.4.1 PURCHASING PROCESS 7.4.2 PURCHASING INFORMATION 7.4.3 CONTROL OF PURCHASED PRODUCTS/SERVICES 7.5 PRODUCTION AND SUPPLY OF SERVICES 7.5.1 CONTROL OF PRODUCTION AND SERVICES SUPPLY 7.5.2 VALIDATION OF PRODUCTION PROCESSES AND SERVICES SUPPLY 7.5.3 IDENTIFICATION AND TRACEABILITY 7.5.4 CUSTOMER PROPERTY 7.5.5 PRODUCT/SERVICE PRESERVATION 7.6 CONTROL OF MONITORING AND MEASUREMENT DEVICES 8. MEASUREMENTS, ANALYSIS AND IMPROVEMENT 16 8.1 GENERAL INFORMATION 8.2 MONITORING AND MEASUREMENT 8.2.1 CUSTOMER SATISFACTION 8.2.2 INTERNAL AUDITS 8.2.3 PROCESS MONITORING AND MEASUREMENT 8.2.4 PRODUCT/SERVICE MONITORING AND MEASUREMENT 8.3 CONTROL OF NON-CONFORMING PRODUCTS/SERVICES 8.4 DATA ANALYSIS 8.5 IMPROVEMENT 8.5.1 CONTINUOUS IMPROVEMENT 8.5.2 CORRECTIVE ACTIONS 8.5.3 PREVENTIVE ACTIONS 9. CORRELATION TABLE 19 10. ANNEXES 21 11. REGISTRATIONS 21


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1. PURPOSE AND APPLICATION FIELD 1.1 GENERAL INFORMATION This Manual describes the Quality Management System of AMRA S.c.a r.l. in relation to the international standards ISO 9001 Edition 2008. The purpose of this manual is to describe: 1. the application field of the Quality Management System, as well as any exclusions with the relative

evaluations of admissability; 2. the documented procedures laid down for the Quality Management System or references to the same; 3. interactions between the Quality Management System processes; 4. management responsibilities in defining the Business Quality Policy; 5. responsibilities in the choice of objectives and in all the activities concerning the Company Management

according to the requirements dictated by the international standard ISO 9001:2008 to be followed; 6. the way in which the Management checks the handling of the set objectives.

Company history

AMRA S.c.a r.l. is a non-profit company which chiefly undertakes researches in the sector of natural and man-made risks. AMRA S.c.a r.l. is the end result of a project, approved with the resolution of the Campania Regional Government G.R. no. 647 of 13 February 2001 and financed with the European Funds of the Campania Regional Authority, for the creation of the Regional Centre of Competence about "Analysis and Monitoring of Environmental Risk" (CRdC-AMRA) headed by the University of Naples "Federico II". AMRA “Analysis and Monitoring of Environmental Risk” S.c.a r.l. is a limited liability non-profit consortium, with entirely public capital whose shareholders are:

Università degli Studi di Napoli Federico II (majority shareholder); Seconda Università degli Studi di Napoli; Università degli Studi di Salerno; Università degli Studi di Napoli Parthenope; Università degli Studi del Sannio; Consiglio Nazionale delle Ricerche (CNR); Istituto Nazionale di Geofisica e Vulcanologia (INGV); Stazione Zoologica Anton Dohrn.

AMRA groups together the five universities in Campania and three public research institutes active in the region in the sector of environmental risk. AMRA thus constitutes the largest regional aggregation of scientific competence skilled in the various aspects of analysis and monitoring of environmental risk.

One of the Centre’s main characteristics is that of being a permanent research structure for developing innovative methodologies applied to environmental issues, created through a synergy of various high-level skills present in the various structure in Campania by aggregating strategic researches. AMRA thus taps the best expertise existing in the Southern Italy in the field of analysis and management of environmental risk and given the public selection methods, the quantity of resources invested and the scientific excellence continually verified by an ad hoc International Committee set up by the Campania Regional Authority, AMRA is well placed at the absolute forefront in its field. AMRA is capable of managing projects with a European dimension and it is involved in several projects financed by European Union.


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Company Information

• Name: AMRA S.c.a r.l • Head Office and Operations Centre: Via Nuova Agnano 11, Naples, Italy • tel. +39 081/7685124/25 fax +39 081/7685144 • e-mail: [email protected] - web: www.amracenter.com • P.IVA: 05155871212 • President: Prof. Gaetano Manfredi • Managing Director: Prof. Paolo Gasparini 1.2 APPLICATION The Quality Management System is applied to the following activities:

Design and supply of activities for the analysis and monitoring of environmental risks. Design and supply of professional training

Exclusions: No requirement of the ISO 9001:2008 standard is excluded in the QMS of AMRA S.c.a r.l


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2. NORMATIVE REFERENCES ISO 9001:2008 Quality Management System – Requirements. For all other Normative References see Form EN-05 “List of Documents of an outside source/Standards/Laws”.

3. TERMS AND DEFINITIONS In the QMM the terms and definitions reported in ISO 9001:2008 are applied, as below: N° ABBREVIATION

(original) ABBREVIATION DEFINIZIONE DEFINITION

1 A.B. A.B. Advisory Board Advisory Board 2 AD CEO Amministratore Delegato Chief Executive Officer 3 ASS. DIR. DIR.ASS Assistente di Direzione Director’s assistant 4 CDA BoD Consiglio di Amministrazione Board of directors 5 CE EXC Comitato Esecutivo Executive committee 6 COMM. EDIT. CM Comitato Editoriale Editorial Board 7 CONSUL CONSUL Consulente Consultant 8 CS BSA Collegio Sindacale Board of statutory auditors

9 DT TD Direttore Tecnico Technical Director 10 PO PO Project Officer Project Officer 11 PRE PRE Presidente President 12 C. FIN F. CONSUL Consulente Finanziario Finance Consultant 13 R. AMM. ADM. DIR. Responsabile Amministrativo Administrative Director 14 R. COMM. AC. MAN. Responsabile Commerciale Account manager 15 R.ACQ P.MAN. Responsabile Acquisti Purchasing manager 16 R.FORM TDF Responsabile Formazione Training Director 17 RAQ/RSGQ QAM Responsabile della Gestione Qualità Quality Assurance Manager 18 RC PC Responsabile di Commessa/Progetto Project Coordinator 19 RSPP PPSM Responsabile del Servizio di

Prevenzione e Protezione Prevention and Protection Service Manager

20 RUP RUP Responsabile del Procedimento Procedure’s responsible 21 SEGR.AMM. ADM. SEC. Segreteria Amministrativa Administrative Secretary 22 SORV.SAN. SS Sorveglianza Sanitaria Sanitary Surveillance 23 WEB WEB Webmaster Webmaster 24 Doc DOC Documento Document 25 MGQ QMM Manuale di Gestione per la Qualità Quality Management Manual 26 Mod FORM Modello Form 27 PdQ QP Piano della Qualità Quality Plan 28 PGL WMP Piano Gestione Lavori Work Management Plan 29 PR MP Procedura Gestionale Management Procedure 30 SGQ QMS Sistema di Gestione della Qualità Quality Management System 31 IST WIST Istruzioni Lavoro Work instructions

4. QUALITY MANAGEMENT SYSTEM 4.1 GENERAL REQUIREMENTS So as to increase customer satisfaction through compliance with the requirements demanded, the Company has promoted the adoption of a process approach in the development, implementation and improvement of the effectiveness of the Quality Management System.


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By “PROCESS” we mean any activity that uses resources and that is managed to allow the transformation of input elements into output ones (often, the output from one process directly constitutes the input from another). AMRA S.c.a r.l has decided to adopt the process approach because the dentification and management of various inter-connected business activities allows to maintain a control over the links between the individual processes, and also over their combinations and interactions. As this approach is used in the context of a Quality Management System, the Top Management undertakes to: • establish objectives and determine processes needed to provide results in agreement with customer

requirements and with the policies of the organisation; • implement processes; • monitor and measure the processes and products/services vis-à-vis the policies, objectives and requirements

for products/services and report their results; • adopt actions to continually improve processes’ performance. AMRA S.c.a r.l. has decided on the following internal processes: • Management System for Quality, Planning and Improvement (Doc. MGQ 02); • Design of analysis and monitoring of environmental risk – Design and supply of training (Doc. MGQ 03); • Purchasing (Doc. MGQ 04); • Commercial Process (Doc. MGQ 05). All the other active processes are intended as a support for the primary processes. For each process a document was developed that uses a flow-chart to describe the input, the output, the documents and resources involved. Interactions between processes are identified, and the intermediate activity phases of the individual process are indicated. So as to be able to monitor, measure and subsequently analyze the processes’ performance, one or more indicators are established for each process, as well as the person responsible and the way the indicators are recorded. The identification of the indicators is carried out by management during the quality system review in collaboration with other managers of the company. During the review, the Managing Director together with the Quality Assurance Manager and the other company’s managers carry out an analysis of the above indicators so as to ensure the effective working and control of such processes, as well as implement necessary action to achieve the planned results and the continual improvement of such processes. The identified indicators, the limit values, the responsibles for process management and monitoring methods are reported in Document Doc. MGQ 08 “Process Indicators”. The relevant records will be drawn up by the QAM on Form. MGQ 08.1 “Process Monitoring”. Outsourcing Activities entrusted to third parties:

Scientific partners Labour consultancy Accounting Safety Medical Surveillance Publishing and web sites

Scientific Partners: some aspects, of a purely technical-operational nature, of the Design and Supply Processes activities of the analysis and monitoring of environmental risk may be entrusted to external partners (members or otherwise of AMRA’s team) whose activity is monitored by the Project Officer according to the methods envisaged under Procedure PGL02. Labour consultancy, Accounting, Safety, Medical Surveillance, Publishing and web sites: activities falling within these categories are monitored through instruments implied in the same characteristics of the performed services.


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4.2 DOCUMENTATION REQUIREMENTS 4.2.1 GENERAL Documentation of the QMS used by AMRA S.c.a r.l. includes:

documented statements on quality policy and objectives, a quality management manual, documented procedures namely: - PR 01 Directors’ activities - PR 02 Control of documents and records on quality - PR 03 Internal audits - PR 04 Control of non-conforming products - PR 05 Corrective, preventive and improvement action - PR 06 Training - PR 07 Customer processes - PR 08 Activities of traineeships and internships - PR09 Procedure for the verification of the used softwares - PR10 Procedure for the evaluation and qualification of suppliers and supply patterns - PGL01 Training Design and Supply of Activities of Environmental Analysis and Monitoring - PGL02A Design and Supply of Activities of Environmental Analysis and Monitoring in Europe - PGL02B Design and Supply of Activities of Environmental Analysis and Monitoring at national and Regional level - IST Tutor Job training - Instructions for Active and Passive Billing - Instructions for Payments Management jobs - Instructions for Cash.Flow traceability jobs - Instructions Entrustment of Under-treshold calls jobs - Missions’ regulation

4.2.2 QUALITY MANAGEMENT MANUAL The Company has drawn up the current Quality Manual (also issued in Italian and Spanish) and undertakes to keep it constantly updated. It includes: a. the scope of the Quality Management System, as well as details on any exclusions and relative justifications; b. documented procedures laid down for the Quality Management System or references to the same (see the

correlation table at the end of this manual); c. a description of interactions among Quality Management System processes. 4.2.3 CONTROL OF DOCUMENTS The documents required by the quality management system are controlled according to the responsibilities and methods reported in procedure PR 02 “Control of quality documents and records”. The records are a special type of document and are controlled in accordance with what it is described in the section below. In particular, in procedure PR 02 the necessary methods are established to: a. approve documents, concerning compliance, before releasing them; b. review, update (when necessary) and re-approve the same documents; c. ensure that amendments are identified, as well as the current state of document review; d. ensure that the relevant versions of applicable documents are available in the workplace;


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e. ensure that the documents are and remain readable and easily identifiable; f. ensure that the documents are converted into electronic format and stored on the server of the Company, disk

drive and transferred to Icloud and remain legible and readily identifiable; g. ensure that the documents of an external source are identified and their distribution is controlled; h. prevent the involuntary use of obsolete documents and adopt their proper identification in the case they should

be kept for any purpose. 4.2.4 CONTROL OF RECORDS The records have been established to provide evidence of conformity to requirements, and the effective operation of the quality management system. Records will remain readable, identifiable, and traceable. The Company has set up procedure PR 02 “Control of quality documents and records” to establish the necessary methods to identify, store, protect, retrieve and define the duration of storage, and how items may be deleted from records. 5. MANAGEMENT RESPONSIBILITIES 5.1 MANAGEMENT COMMITMENT The Top Management is committed to the development and implementation of the Quality Management System and continually improves its effectiveness by:

• communicating to the organisation, through their “quality policy”, the importance of both meeting express customer needs and the respect of statutory and regulatory requirements;

• assuming the responsibility of determining the quality policy and the guidelines required for its implementation, according to the methods reported in the document “Quality Policy” (Doc. MGQ 07);

• defining and planning measurable quality objectives in the documents “Quality Policy” (Doc. MGQ 07), and “Quality Objective Planning” (Doc. MGQ 09)

• conducting periodic management reviews as described in PR 01; • ensuring the availability and suitability of resources used, as described in PR06; • ensuring that customer requirements are defined and satisfied so as to increase customer satisfaction

(PR07 Customer processes). 5.2 CUSTOMER ORIENTATION The Top Management ensures that customer requirements are determined and are met with the aim of enhancing the customer satisfaction, according to the responsibilities and operating modes reported in procedure PR. 07 “Customer-related Processes” and in the Work Management Plan (PGL 01 and PGL 02). The client’s satisfaction is monitored this way: for projects and calls:

• number of projects committed by the same Customer /renewal of Contracts and Conventions • number of publications, study, researches, work in which Amra projects are mentioned. • utilization of Amra’s data/results in publications, studies, researches conducted by third • call re-financing

For training-Area • number of partecipation requests to training courses organized by Amra • number of publications, studies, researches produced by courses’ frequenters

5.3 QUALITY POLICY In the "Quality Policy" document (Doc. MGQ 07) attached to this quality management manual, the CEO has laid down his own quality policy directives and established relative strategic objectives and consequent commitments, better specified in Doc. MGQ 09 “Planning of Quality Objectives”.


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In particular, in the "Quality Policy" document, the CEO shall undertake to ensure that the Company’s quality policy: is appropriate to the purposes of the organisation; is geared to total Customer satisfaction in terms of service; includes the commitment to meeting requirements and continual improvement in the Quality

Management System; envisages top management’s commitment to defining and periodically reviewing quality objectives; envisages the involvement of the entire Company’s staff in the objectives listed in the previous points

and the commitment to adopting suitable methods and instruments so as to ensure that it is understood, implemented and maintained at each company level.

The Management’s responsibility is to translate such commitments into concrete objectives to be pursued within each company area. The CEO also undertakes to review the continual suitability of the quality policy through periodic analysis of the application and adequacy of the Quality System. The "Quality Policy document” and the other documents and records required are available in the Company’s intranet. 5.4 PLANNING 5.4.1 OBJECTIVES FOR QUALITY The CEO has the responsibility to define, for the relevant levels and functions of the organisation, the quality objectives and ensure that they are achieved in the schedules set by the same CEO. In the Doc. MGQ 09 "Planning Quality Objectives", the CEO has defined the guidelines for setting the objectives, methods, responsibilities and the terms to achieve them, the times to monitor the state of things. It is the CEO’s responsibility to translate such guidelines into concrete objectives to be pursued within each company area. The CEO also undertakes to exercise control over the application and conformity of the quality management system set up to ensure the achievement of the objectives indicated. Under the review of the system, having analyzed the collected data and the level of achievement of the set objectives, the CEO shall identify new company objectives and assign relative responsibilities to achieve them. 5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING Top management ensures that the planning of the Quality Management System is done so as to meet the requirements reported in point 1.1 of this manual and achieve the quality objectives. It also ensures that the integrity of the Quality Management System is preserved when amendments are planned and implemented to the same system. 5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION 5.5.1 RESPONSIBILITY AND AUTHORITY The Company’s organisational structure is summarised in the organisational chart attached to the management procedure PR 01 “Management Activity”. The document specifies the hierarchical lines, the responsibilities and relative authorities characterising the Company’s organisational structure. In particular, it specifies the staff that have the organisational freedom and necessary authority: a) to promote action required to prevent the occurrence of non-conformity in the service, process and quality

management system; b) to identify any problem related to products, process and quality management system; c) launch, propose or supply solutions through the established channels;


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d) verify the implementation of solutions as indicated in PGL1, PGL2A and PGL2B, in PR 04 “Management of non-conformity”, and in PR 05 “Corrective and Preventive Action”.

The structure of responsibilities, authorities, and reciprocal relations between staff that directs, executes and verifies activities affecting quality, is given by the indications contained in this quality management system and it has been summarised in Form. PR 1.1 “Organisational Chart”. For each activity the following are envisaged: • responsibilities; • communication. The Company’s organisational structure is functional and is described in detail in PR 01 “Management Activity”.

5.5.2 MANAGEMENT REPRESENTATIVE The top management has issued the Doc. MGQ 06 “Management representative”, with which it appoints, as Management Representative, a member of the management structure and defines his/her tasks and responsibilities. 5.5.3 INTERNAL COMMUNICATION Acknowledging the key role of internal communication for system functioning, for quality of the service supplied, for the staff motivation and the prevention of errors and inefficiencies, top management has defined the methods of communication, dissemination of documents and relative responsibilities. The Communication is managed, not only through system documentation, but also through: • periodic meetings; • training sessions; • dissemination of information concerning organisational aspects, introduction of innovative technologies, legal

updates; • written communication; • Intranet – mail service. In particular, the CEO has established that: • Quality objectives and results achieved are made known to all the operators during the biannual meeting

and/or after the management review (annual). • Knowings activities concerning compliance with procedures and any implementational difficulties are

promoted within the staff; in this context suggestions can be gathered from employees. 5.6 MANAGEMENT REVIEW 5.6.1 GENERAL The PRE and CEO, on an annual basis, will carry out a review of the Company’s quality management system to ensure its continual suitability, adequacy and effectiveness. This review includes assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews are maintained according to the methods under the procedure PR 02 “Control of quality-related documents and records”. 5.6.2 REVIEW INPUT The input to the management review will include the information below: • results of audits; • customer feedback;


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• process performance and product conformity; • status of corrective and preventive action; • follow-up action from previous management reviews; • changes that could affect the quality management system; • recommendations for improvement. 5.6.3 REVIEW OUTPUT The output from the management review will include any decisions and actions related to: • improvement in the effectiveness of the quality management system and its processes; • improvement of products related to customer requirements; • resources’ needs. 6. RESOURCE MANAGEMENT 6.1 PROVISION OF RESOURCES The Company determines and provides the resources needed: a. to implement and maintain the Quality Management System and continually improve its effectiveness; b. to enhance customer satisfaction by meeting customer requirements. 6.2 HUMAN RESOURCES 6.2.1 GENERAL The Company shall ensure that the staff conducting activities affecting product/service quality, are competent on the basis of a suitable degree of education, training, skill and expertise. 6.2.2 COMPETENCE, AWARENESS AND TRAINING The Company undertakes to: • determine the necessary competence for staff performing work that directly affects the quality of the service; • provide training or take other action to achieve the necessary competences; • evaluates the effectiveness of the actions taken; • ensure that its personnel is aware of the relevance and importance of their activities and how they contribute

to the achievement of the quality objectives; • maintain appropriate records of staff education, training, skills and experience. This undertaking is highlighted under the procedure PR 06 “Training” and its annexes. 6.3 INFRASTRUCTURES AMRA S.c.a r.l. undertakes to determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable: a) buildings, workspace and associated utilities; b) process equipment (hardware and software); c) support services. The Company aims to ensure that the work spaces are suitable and equipped. For each activity necessary conditions both in relation to legal standards (safety in the workplace) and service quality have been laid down. In particular, spaces for performing various activities or technical spaces have been identified.


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6.4 WORK ENVIRONMENT The Company undertakes to determine and manage the work environment needed to achieve conformity to product requirements. Internal arrangements, procedures and a work management plan have been stipulated to ensure: 1. the conditions required for performing the work properly; 2. safe working conditions; 3. conflict reduction through:

• definition of responsibility and roles; • staff involvement in drawing up procedures; • improvement in communication; • employee training and information on safety, accident prevention and the use of personal protection

devices; • involvement of all the staff to make them aware of their own contribution to achieving objectives.

The company monitors the health and work-related stress of employees by the Sanitary Surveillance. .

7. PRODUCT/SERVICE REALIZATION 7.1 PLANNING OF SERVICE REALIZATION

The Company plans and develops the processes needed to realize the research project/service/study. The planning of the product/service realization is also consistent with the requirements of the other processes of the Quality Management System. In planning products realization, the Company determines the following, as appropriate: a) quality objectives and requirements for the product/service; b) the need to establish processes and documents, and provide resources specific to the product/service; c) required verification, validation, monitoring, inspection and testing specific to the product/service and the criteria

for product acceptance; d) records needed to provide evidence that the realization processes and resulting products/services meet the

requirements. The results of this planning are presented in a way that is suitable for the Company’s modus operandi. In particular, for experimental research projects AMRA S.c.a r.l. plans the order so that the technical and economic situation can be is kept under control at any moment. Such planning is used as the basis, for each order, for the trend in costs, for each working phase in terms of controls, for the resources involved and the list of the equipment used. 7.2 CUSTOMER-RELATED PROCESSES AMRA S.c.a r.l takes measures to ensure that, before supplying a service, the work requirements have been determined, customer requirements have been understood and it has been verified that the terms and conditions of the service can be met. 7.2.1 DETERMINATION OF PRODUCT/SERVICE-RELATED REQUIREMENTS The Company determines requirements of the service (public or private), in relation to: 1. requirements specified by the customer; 2. compulsory compliance requirements; 3. any other requirement established by the Company itself.


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7.2.2 REVIEW OF SERVICE/PRODUCT REQUIREMENTS The Company undertakes to review the requirements related to the project/service. This review is conducted prior to AMRA’s commitment to supply a service to the customer (e.g. feasibility study – partner search) and ensures that: 1) the requirements of the project/study/service are defined; 2) possible divergences between the requisites of a call and of a programme, have been resolved; 3) the Company has the capacity to satisfy the requisites defined. Records of the results of the review and actions arising from the review are suitably maintained. Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the Company before acceptance. Where the requirements of an order are changed, the Company shall ensure that relevant documents are amended and that the staff involved are made aware of the changed requirements. 7.2.3 CUSTOMER COMMUNICATION The Company has determined and implemented effective arrangements for communicating with customers in relation to: 1) information on the state of supply of the service; 2) enquiries, contracts or order handling, including amendments; 3) Customer feedback, including complaints. This commitment is elucidated in the management procedure PR 07 “Customer-related Processes” and its appendices. 7.3 DESIGN AND DEVELOPMENT AMRA S.c.a r.l carries out design activities for environmental analysis and monitoring, and design and provision of training. In any case, downstream of commercial activities or publicly-advertised calls, the project is carried out in a controlled fashion. All the project activities are planned and carried out in conformity with the legal requisites concerned. Design verification and review are planned and carried out in the appropriate phases of the design process. Detailed methods are reported under the appropriate controlled procedure. 7.4 PURCHASING 7.4.1 PURCHASING PROCESS The Company shall ensure that the purchased products/services conform to specified purchase requirements. The type and extent of the control applied on the supplier and the purchased product/service should be correlated to the possible effect of the purchased product/service upon subsequent product/service creation or upon the final product/service. AMRA S.c.a r.l. assesses and chooses suppliers according to their ability to supply products in conformity with the requirements of the Company itself and has established criteria for selection, assessment and re-assessment of suppliers. The records of the evaluation results and of all the necessary actions arising from the evaluation are stored. The supply and assessment activities of the suppliers is detailed in PR10, 7.4.2 PURCHASING INFORMATION The purchasing information must describe the products that will be purchased (materials, components, services, etc.) including, where appropriate: 1) Definition of criteria and procedures of the approval procedures of products/services, of the realized

processes and used equipment;


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2) specification of necessary qualifications prerequisites for the staff involved in supply process; 3) definition of requirements of the supplier’s Quality Management System. The Company undertakes to ensure the respect of the requirements specified for provision prior to notifying the supplier. 7.4.3 VERIFICATION OF PURCHASED PRODUCTS/SERVICES AMRA S.c.a r.l establishes and implements the inspection or other activities necessary for ensuring that the purchased products/services meet the specified purchase requirements. If the Company or its customer wants to perform a verification at the supplier’s premises, the Company shall specify, in the purchasing information, the ways about this verification and the ways to release the product/service. 7.5 PRODUCTION AND SERVICE PROVISION 7.5.1 OVER-TIME CONTROL OF PRODUCTION AND SERVICE PROVISION The Company plans and implements the supply of services and research projects under controlled conditions. Such conditions include: a) the availability of information that describes the characteristics of the project/service; b) the availability of work instructions, if necessary; c) the use of suitable equipment; d) the availability and use of monitoring and measuring equipment; e) the implementation of monitoring and measurement activities; f) the implementation of activities related to the release and delivery of results/reports (project output), and

potential subsequent activities. 7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION The Company validates all the production and service-provision processes whose final result cannot be verified by subsequent monitoring or measurement. In this category, there are those processes for which deficiencies become evident only after the product is used or the service has been delivered. The validation has to demonstrate the capacity of such processes to achieve the planned results. As applicable, the Company establishes arrangements for these processes about: a) defined criteria for the review and the approval of the processes; b) the approval of equipment and qualification of personnel; c) the use of specific methods and procedures; d) the requirements for records; e) the revalidation. 7.5.3 IDENTIFICATION AND TRACEABILITY The Company, where appropriated, identifies the services/projects through suitable instruments over all the phases of the project. The Company identifies status progress of the project in relation to monitoring and measuring requirements. 7.5.4 CUSTOMER PROPERTY The Company exercises care with the Customer properties (material and intellectual) when these are under its control or used by the Company itself, and it will take care of any management of the customer’s installation, laboratories or facilities during the execution of the project/service at the Customer. AMRA S.c.a r.l. undertakes to identify, verify, protect and safeguard the Customer’s property placed at their disposal. In the case that the Customer’s property is lost, damaged or found unfit for use, the customer will be promptly


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notified of such circumstances and the relative records preserved. All the activities concerning the management of projects/drawings/reports/previous studies supplied by the customer, are reported in procedure PR 07 “Customer-related Processes”. 7.5.5 PRODUCT/SERVICE PRESERVATION The Company keeps the conformity of the products (data/reports/studies/projects) unchanged throughout the entire project execution until the final delivery to the customer. This reservation includes identification, management and protection of documents and papers.

7.6 CONTROL OF MONITORING AND MEASURING EQUIPMENT The Company determines the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of the conformity of the projects/studies to certain requirements. The Company has established processes to ensure that the monitoring and measurement can be carried out, in a manner that is consistent with the monitoring and measurement requirements. Where it is necessary to ensure valid results, the measuring equipment has: a) to be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to

international or national measurement standards; where such standards do not exist, the criteria used for calibration or verification shall be recorded,

b) to be adjusted or re-adjusted as necessary; c) to be identified in order to determine its calibration status; d) to be protected from adjustments that could invalidate the measurement results; e) to be protected from damage and deterioration during handling, maintenance and storage. In addition, the Company assesses and records the validity of the previous measuring results if it is found that the equipment does not meet the requirements. The Company takes appropriate action on the equipment and any involved product. Records of the results of calibration and verification are retained. When a software is used to monitor and measure specific requirements, its suitability to run the expected applications will be confirmed. Such confirmation shall precede the initial use and shall be repeated when necessary. 8. MEASUREMENTS, ANALYSIS AND IMPROVEMENT 8.1 GENERAL INFORMATION The Company has planned and implemented the monitoring, measurement, analysis and improvement processes needed: a) to demonstrate the conformity of the projects/studies; b) to ensure conformity of the Quality Management System; c) to continually improve the effectiveness of the Quality Management System. This includes the determination of applicable methods, including statistical techniques, and the scope of their use. This treatment is managed under PR 01 “Management Activity”. 8.2 MONITORING AND MEASUREMENT 8.2.1 CUSTOMER SATISFACTION AMRA S.c.a .r.l monitors the information relating to customer perception as to whether the Company has satisfied customer requirements, such monitoring representing one of the performance measures of the Quality Management System. The Company has also determined methods to obtain and use such information.


Rev. 4

The operative methods are reported in procedure PR 07 “Customer-related Processes”. 8.2.2 INTERNAL AUDITS The Company conducts internal audits at planned intervals of time (internal inspection checks) to determine whether the Quality Management System is consistent to the planned arrangements, to the requirements of ISO 9001:2008 and to the Quality Management System requirements established by the Company, that is effectively implemented and kept updated. The Company has also planned a programme of audits that takes account of the state and importance of the processes and of the areas subject to audits, and also the results of previous Inspection Audits. The audit criteria, scope, frequency and methods have been defined. The selection of auditors and the conduction of audits ensure objectivity and impartiality of the audit process. The auditors will not be albe to audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records have been defined in the documented procedure PR 03 “Internal Audits”. The people responsible for the activities that will be audited have to ensure that any necessary correction and corrective actions are taken without undue delay to eliminate detected non-conformities and their causes. Follow-up activities have to include the verification of the fulfilment of the actions taken and the communication of the results of the inspection audit. 8.2.3 PROCESS MONITORING AND MEASUREMENT The Company has adopted suitable methods for monitoring and, where applicable, measuring the Quality Management System processes. These methods aim to demonstrate the ability of the processes to achieve the planned results. If these results are not achieved, corrective actions are taken, as appropriate, to ensure the product’s conformity. Such activities are reported in procedure PR 04 “Control of non-conforming products”, as regards the treatment of non-conformities, and in procedure PR 05 “Corrective, Preventive and Improvement Action”, to adopt measures to eliminate the causes that generated non-conformities.

8.2.4 PRODUCT/SERVICE MONITORING AND MEASUREMENT 8.2.5

The Company monitors and measures the characteristics of the services to supply, to verify that the requirements have been met. This is carried out at appropriate stages of the supply process in accordance with the planned arrangements. Evidence of conformity with the acceptance criteria is documented; the records indicate the person(s) authorizing the release of certain phases. The company estabilished that the release of certain project phases and the delivery of the service to the customer will not take place until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and where applicable, by the customer. As for processes, such activities are reported in procedure PR 04 “Control of non-conforming products”, as regards the treatment of non-conforming products/services, and in procedure PR 05 “Corrective, Preventive and Improvement Action”, to adopt measures to eliminate the causes that have generated non-conformities.

8.3 CONTROL OF NON-CONFORMING PRODUCTS

The Company ensures that the products/services which do not conform to product requirements are identified and controlled to prevent its unintended use or delivery. The documented procedure, PR 04 “Control of non-conforming products” establishes the modalities and related responsibilities and authorities that have to deal with non-conforming products.


Rev. 4

The Company deals with non-conformities in one or more of the following ways: a) by taking action to eliminate the detected non-conformity; b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable,

by the customer; c) by taking action to preclude the original intended use or application of the product service. Records about the nature of nonconformities and any subsequent actions taken, including concessions obtained, are maintained. When the non-conforming product is corrected, the product is subject to re-verification to demonstrate conformity to the requirements. When the non-conforming product is detected after delivery or use, the Company adopts appropriate actions about the effects, or potential effects, of the non-conformity, and subsequently implements appropriate corrective measures. Moreover, the effectiveness of action taken vis-à-vis the non-conformity is analyzed. 8.4 DATA ANALYSIS The Company periodically determines, collects and analyzes appropriate data to show the suitability and effectiveness of the Quality Management System to evaluate where improvements in effectiveness of the System itself may be made. This includes data from monitoring and measurement and from other relevant sources. The data analysis supplies information concerning: a) customer satisfaction; b) conformity with product/service requirements; c) characteristics and trends of processes and products including opportunities for preventive action; d) suppliers. This analysis is made both during the System Review and during periodical meetings held by QUAM with the managers of the affected areas. 8.5 IMPROVEMENT 8.5.1 CONTINUOUS IMPROVEMENT The Company has undertaken that the effectiveness of the Quality Management System will be continuously improved, using the Quality Policy, Quality Objectives, the results of Inspections, data analysis, corrective and Preventive Action and Management Reviews. 8.5.2 CORRECTIVE ACTION The Company has estabilished that it will implement actions to eliminate the causes of non-conformity so as to prevent their recurrence. The Corrective Actions must be appropriate to the effects of the non-conformity encountered. The documented procedure PR 05 “Corrective, Preventive and Improving Action” has been laid down. It points out the requirements for: a) the review of non-conformity (including customer complaints); b) the identification of the causes of non-conformity; c) the evaluation of the need to adopt action to avoid the recurrence of non-conformity; d) the identification and implementation of the necessary action; e) the recording of the results of the actions implemented, f) the review of the corrective action implemented. 8.5.3 PREVENTIVE ACTION The Company has undertaken to identify the actions to eliminate the causes of potential non-conformities, so as to prevent this from occurring. The Preventive Actions implemented must be appropriate to the effects of the potential problems.


Rev. 4

The documented procedure PR 05 “Corrective, Preventive and Improving Actions” has been laid down and it points out the requirements for: a) identifying potential non-comnformity and its causes; b) assessing the need to implement action to prevent the occurrence of non-conformity; c) identifying and implementing the necessary actions; d) recording the results of the actions implemented; e) review of the implemented Preventive Actions.


Rev. 4

9. CORRELATION TABLE The following correlation table reports, for each point of ISO 9001:2008, the relative applicational documentation of the Quality Management System.

Standard Applicational documentation 4.1 General requirements Quality Management Manual 4.2 Documentation requirements PR 02 Check of quality documents and records 5.1 Management undertaking

PR 01 Management activities 5.2 Customer-focused attention 5.3 Quality policy 5.4 Planning

5.5 Responsibility, authority and communication Mod. PR1 001

Company’s organization chart with job descriptions

5.6 Management review PR 01 Management activities 6.1 Resource availability PR 06 Training 6.2 Human resources 6.3 Infrastructures

PGL01 PGL02_A PGL02_B

PGL01 - Design and supply of training Activities of Environmental Analysis and Monitoring Activities of Environmental Analysis and Monitoring PGL02_A - Design and Supply of Environmental Risk Analysis and Monitoring Activities in Europe PGL02_B -Design and Supply of Activities of Environmental Analysis and Monitoring at national and regional leve

6.4 Working environment

7.1 Planning of product/service creation PGL01 PGL02_A PGL02_B

PGL01 - Design and supply of training Activities of Environmental Analysis and Monitoring Activities of Environmental Analysis and Monitoring PGL02_A - Design and Supply of Environmental Risk Analysis and Monitoring Activities in Europe PGL02_B -Design and Supply of Activities of Environmental Analysis and Monitoring at national and regional level

7.2 Customer-related processes PR 07 Customer processes

7.3 Design and development PGL01 PGL02_A PGL02_B

PGL01 - Design and supply of training Activities of Environmental Analysis and Monitoring PGL02_A - Design and Supply of Environmental Risk Analysis and Monitoring Activities in Europe PGL02_B -Design and Supply of Activities of Environmental Analysis and Monitoring at national and regional level

7.4 Purchasing PR10 Procedure for the evaluation and qualification of suppliers and supply patterns

7.5 Production and supply of services PGL01 PGL02_A PGL02_B

PGL01 - Design and supply of training Activities of Environmental Analysis and Monitoring Activities of Environmental Analysis and Monitoring


Rev. 4

PGL02_A - Design and Supply of Environmental Risk Analysis and Monitoring Activities in Europe PGL02_B -Design and Supply of Activities of Environmental Analysis and Monitoring at national and regional level

7.6 Control of monitoring and measurement devices PR09 Procedure for the verification of the used softwares

8.2 Monitoring and measurement

PR 03 PR 01 PGL01 PGL02_A PGL02_B

In-house inspections Management Activities PGL01 - Design and supply of training Activities of Environmental Analysis and Monitoring Activities of Environmental Analysis and Monitoring PGL02_A - Design and Supply of Environmental Risk Analysis and Monitoring Activities in Europe PGL02_B -Design and Supply of Activities of Environmental Analysis and Monitoring at national and regional level

8.3 Control of non-conforming products/services PR 04 PGL01 PGL02_A PGL02_B

Control of non-standard products PGL 1 – Training Design and Supply PGL02_A - Design and Supply of Environmental Risk Analysis and Monitoring Activities in Europe PGL02_B -Design and Supply of Activities of Environmental Analysis and Monitoring at national and regional leve

8.4 Data Analysis PR 01 Management activities

8.5 Improvement PR 05 Corrective, Preventive and Improving Actions

10. ANNEXES • Mod. PR 001 Company’s organization chart • Doc. MGQ 01 Processes’ Summary Scheme • Doc. MGQ 02 Management System for Quality, Planning and Improvement • Doc. MGQ 03 Training Design and Supply

Design and Supply of Environmental Risk Analysis and Monitoring Activities • Doc. MGQ 04 Purchasing • Doc. MGQ 05 Commercial Activity • Doc. MGQ 06 Management Representative • Doc. MGQ 07 Quality Policy • Doc. MGQ 08 Process Indicators

• Doc. MGQ 09 Planning of Quality Objectives

SGQ procedures cited in Par. 4.2.1 11. REGISTRATIONS List of documents reported in Form RRQ-16 “Quality Registration Documents”.