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Quality Management Manual Amra S.c.a r.l. Rev.6 – 2015.12.30 1

Quality Management Manual UNI EN ISO 9001:2008

REV. REASON FOR MODIFICATION DRAWNUP CHECKED APPROVED DATE

2

English Translation version of

L. Malafronte

L. Malafronte

P. Gasparini

30/06/2010Italian manual rev. 2 (trad. M.

Walters)

3

Review and updating of the

L. Malafronte

L. Malafronte

P. Gasparini

20/06/2011manual rev. 3 (trad. M.

Walters)

4


L. Malafronte P. Gasparini

P. Gasparini


Walters)

5

Review and updating of the L. Malafronte P. Gasparini

P. Gasparini


Walters)

6


L. Malafronte P. Gasparini

P. Salatino


Walters)

X 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.


SISTEMA DI GESTIONE: ISO 9001:2008 Amra has obtained in March 2007 by RINA UNI EN ISO 9001: 2008 for:

design and provision of analysis and monitoring of environmental risks;

design and provision of vocational training activities.


INDEX

1. PURPOSE AND SCOPE 7

1.1 GENERAL INFORMATION

1.1.1 Company History

1.1.2 Training Activities

1.1.3 Company Information

1.2 APPLICATION 2. NORMATIVE REFERENCES 12

3. TERMS AND DEFINITIONS 12

4. QUALITY MANAGEMENT SYSTEM 13

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 15

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


5.6.2 REVIEW INPUT

5.6.3 REVIEW OUTPUT


6. RESOURCE MANAGEMENT 19

6.1 RESOURCE AVAILABILITY

6.2 HUMAN RESOURCES


6.2.2 SKILLS, AWARENESS AND TRAINING

6.3 INFRASTRUCTURES

6.4 WORKING ENVIRONMENT

7. PRODUCT/SERVICE REALIZATION 21

7.1 PLANNING OF PRODUCT/SERVICE REALIZATION

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 25


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 28 10. ANNEXES 30 11. REGISTRATIONS 30


1. PURPOSE AND APPLICATION FIELD


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 2. the procedures laid down for the Quality Management System or references to them; 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. 1.1.1. Company history

2002: 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".

2005: 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.

AMRA LINES OF ACTIVITIES:


Several European institutions and universities cooperate with AMRA:

GFZ Helmholtz‐Zentrum Potsdam Deutsches GeoForschungsZentrum, Germania

ETHZ Eidgenössische Technische Hochschule Zürich, Svizzera

BRGM Bureau De Recherches Geologiques et Minieres, Francia

AUTH Aristotelio Panepistimio Thessaloniki, Grecia

KIT Karlsruher Institut fuer Technologie, Germania

CMCC Centro Euro‐Mediterraneo sui Cambiamenti Climatici, Italia

CIRCE Centro de investigación de recursos y consumos energéticos, Spagna

IIASA International Institute for Applied Systems Analysis, Austria

EUCENTRE European Centre for Training and Research in Earthquake Engineering, Italia

NIEP Institutul National de Cercetare‐Dezvoltare Pentru Fizica Pamantului, Romania

SCEC Southern California Earthquake Center, USA

AMRA carries out a range of outreach activities with several funding institutions such as the World Bank and the International Development Bank. AMRA is also a member of the European Plate Observing System (EPOS) approved by the European Strategy Forum on Research Infrastructures (ESFRI).

1.1.2 Training activities

Since the time of the Competence Centre, AMRA has carried out training activities. The Campania Region has designed and delivered:

Training of High Personnel Qualification in the Analysis, Environmental Risk Monitoring and Management "(2004‐2005);

Training of highly qualified personnel for the development of innovative technologies and managerial skills in the field of Environmental Risk (2006‐2007). In Europe, the activities have been planned within the Project:

NERA ‐ "Network of European Research Infrastructures for Earthquake Risk Assessment and Mitigation" (EC‐FP7) were made internships for post‐docs and PhD students from across Europe with activities in the field of Early Warning for seismic protection of structures and infrastructure.

CLUVA ‐ Climate Change and Urban Vulnerability in Africa (EC‐FP7) was held at the headquarters AMRA a


course "training on the job" on the Multi‐risk rating. The course was addressed to ten students from five African universities and included themes addressed in particular the vulnerability of the structures and infrastructures to hydrogeological events. National level, the activities have been planned within the Project:

TeMASAV ‐ "Technology and environmental monitoring for the sustainability of the vast" areas have been established fellowships, whose activities have involved the study of sustainable technologies, in various scientific fields linked to the construction and development of urban areas.

VINCES ‐ "Evaluation of Integrated Life Cycle for Sustainable Building" was held at the headquarters AMRA a course "training on the job" to "sustainable building environmental assessment tools".

Strit ‐ Tools and Technologies for Risk Management of Transport Infrastructure were awarded 10 scholarships for the training of technical expert in structural diagnostics and integrated monitoring (lasting 1020 hours) as part of the "Training for operators and technicians research to engage in the management of maintenance and safety of the transport infrastructure ", authorized and funded by the Ministry of Education, University and research within the National Operational Programme and Competitiveness 2007‐2013 by Decree Executive of the Ministry of Education n.1770 / Ric. of 01/10/2013 (Cod. ID PON01_02366).

CSSC ‐ Experimental Centre for Skills Development in the Area of Construction, the project led by CFME‐Center for Training of Construction and Allied Craftsmen of Naples and Province Integrated Systems.

1.1.3 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. PieroSalatino

• Managing Director: Prof. Paolo Gasparini 1.2 APPLICATION

The Quality Management System is applied to the following activities:

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


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 assistant4 CDA BoD Consiglio di Amministrazione Board of Directors

5 COMM. EDIT. EB Comitato Editoriale Editorial Board

6 CONSUL CONSUL Consulente Consultant

7 CS BSA Collegio Sindacale Board of Statutory auditors

8 DT TD Direttore Tecnico Technical Director

9 PO/LEAR PO/LEAR Project Officer, Legal Entity Appointed Representative

Project Officer

10 PRE PRE Presidente President

11 C. FIN F. CONSUL Consulente Finanziario Finance Consultant

12 RIC. RIC. Ricercatore Researcher

13 R.FORM TD Responsabile Formazione Training Director

14 RAQ/RSGQ QAM Responsabile della Gestione Qualità

Quality Assurance Manager

15 RC PC Responsabile diCommessa/Progetto

Project Coordinator

16 R. AMM. ADM. DIR. Responsabile Amministrativo Administrative Director

17 R. CONTA R. CONTA Responsabile Contabilità Account Manager

18 R. PAGA R. PAY Responsabile dei Pagamenti Payments responsible

19 R.ACQ PUO Responsabile Acquisti Purchasing office

20 RSPP PPSM Responsabile del Servizio diPrevenzione e Protezione

Prevention and ProtectionService Manager

21 RUP RUP Responsabile del Procedimento Person in charge ofthe P d22 SEGR. SEGR. Segreteria Secretary

23 SEGR.AMM. ADM. SEC. Segreteria Amministrativa Administrative Secretary


24 SORV.SAN. SS Sorveglianza Sanitaria Sanitary Surveillance

25 WEB WEB Webmaster Webmaster

26 VEC COMO Responsabile Visibilità e Comunicazione

Communication Officer

27 RSO RSO Research Support Office Research Support Office

28 Doc DOC Documento Document

29 MGQ QMM Manuale di Gestione per la Qualità Quality Management Manual

30 Mod FORM Modello Form

31 PdQ QP Piano della Qualità Quality Plan

32 PGL WMP Piano Gestione Lavori Work Management Plan

33 PR MP Procedura Gestionale Management Procedure34 SGQ QMS Sistema di Gestione della Qualità Quality Management System

35 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. The processes should be CONSTANTLY improved to provide better service to customers, to reduce costs and timescales, and to become more competitive. AMRA S.c.a r.l has decided to adopt the process approach because the identification 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 organization; • 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 Chief Executive Officer 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 person in charge of the 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:

ƒ Scientific partners ƒ Labour consultancy ƒ Accounting ƒ Safety ƒ Medical Surveillance ƒ 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 Survelillance, Publishing and web sites: activities falling within these categories are monitored through instruments implied in the same characteristics of the performed services.

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:

‐ 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 –

H2020 ‐ PGL02B Design and Supply of Activities of Environmental Analysis and Monitoring ‐ 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; 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).

Customer satisfaction is monitored as well: for Projects and Contracts: • analysis of project evaluation; • number of projects entrusted by the Client / renewal of agreements and contracts; • number of deliverables approved per project • use of data / results AMRA in publications, studies, research and work carried out by third parties. • number of projects entrusted by the Client / renewal of agreements and contracts; • number of publications, studies, research, jobs that are cited AMRA projects and construction contracts; • use of data / results AMRA in publications, studies, research and work carried out by third parties. for the Training Area: direct mode • the satisfaction of the course evaluation form, relatively Training Area, administered to students at the end of the teaching activities. and others in indirect mode, such as: • number of other requests for participation in training courses organized by the company; • number of publications, studies, research, works produced by the students 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”. 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;


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;

• 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.

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 by the Head of Security and the Head of the Health Surveillance monitors the health of employees and work related stress. .


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.

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;

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 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


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. The operative methods are reported in procedure PR 07 “Customer‐related Processes”. The operative methods are reported in procedure PR07 “Cutomer 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 in charge 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

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.

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 product7service.

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.

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.

Manuale per la Gestione della Qualità della Amra S.c.a r.l. Rev.6 del 30.12.2015 28

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

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


PGL02_A ‐ Design and Supply of Environmental Risk Analysis and




7.2 Customer‐related processes PR 07 Customer processes

7.3

Design and development

PGL01

PGL02_A

PGL02_B


Activities of Environmental Analysis and

Monitoring

PGL02_A ‐ Design and Supply of Environmental Risk

Analysis and Monitoring Activities in Europe



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


Activities of Environmental Analysis and

Monitoring Activities of Environmental


PGL02_A ‐ Design and Supply of Environmental Risk

Analysis and Monitoring Activities in Europe



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






PGL02_B ‐Design and Supply of Activities o


8.3

Control of non‐conforming products/services PR 04

PGL01

PGL02_A

PGL02_B

Control of non‐standard products








8.4 Data Analysis PR 01

Management activities

8.5

Improvement

PR 05 Corrective, Preventive and Improving

Actions


10. ANNEXES

• Mod.

• Doc.

• Doc.

• Doc.

PR 001

MGQ 01

MGQ 02

MGQ 03

Company’s organization chart

Processes’ Summary Scheme

Management System for Quality, Planning and Improvement

Training Design and Supply Design and Supply of Environmental Risk Analysis and Monitoring• 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”.