GESTIONE DELLA DOCUMENTAZIONE:

diritti digitali di accesso e definizione dei sw in uso

Riferimenti

– UNI CEI EN ISO/IEC 17025:2018

– UNI CEI EN ISO/IEC 17065:2012

– Prescrizioni Integrative ACCREDIA – RT08

Redatto

D. Grandesso

Verificato e Approvato

M. Meyer

 

Note di modifica rev14: aggiornamento nomi del personale, sw e cartelle

Note di modifica rev15: aggiornamento norme

  1. Diritti di accesso alla documentazione digitale

i diritti di accesso alla documentazione digitale in rete sono stabiliti dal Resp ITC (Direzione) in base al gruppo di appartenenza dell’utente che accede al server:

    1. Direzione

    2. Administrators

    3. Amministrazione

    4. qualità

    5. certificazione

    6. commerciale

    7. tecnici

  1. Software in uso con influenza sul sistema di garanzia della qualità

La definizione di configurazione dei software che in uso per soddisfare i requisiti della norma UNI CEI EN ISO/IEC 17025 e quindi hanno influenza sul sistema di garanzia della qualità.

Sul Manuale si trovano dettagli sui singoli documenti riguardanti identificazione, codice, redazione, approvazione, mantenimento dell’elenco di validità, distribuzione e contenuto minimo e le modalità di gestione (digitale o cartacea) e distribuzione.

Tabella di identificazione dei software

REQUISITO

SOFTWARE IN USO

1 SCOPO E CAMPO DI APPLICAZIONE

2 RIFERIMENTI NORMATIVI

3 TERMINI E DEFINIZIONI

4 REQUISITI GENERALI

4.1 Imparzialità

4.2 Riservatezza

5 REQUISITI STRUTTURALI

6 REQUISITI RELATIVI ALLE RISORSE

6.1 Generalità

6.2 Personale

6.3 Strutture e condizioni ambientali

6.4 Dotazioni

6.5 Riferibilità metrologica

6.6 Prodotti e servizi forniti dall’esterno

7 REQUISITI DI PROCESSO

7.1 Riesame delle richieste, delle offerte e dei contratti

7.2 Selezione, verifica e validazione dei metodi

7.3 Campionamento

7.4 Manipolazione degli oggetti da sottoporre a prova o taratura

7.5 Registrazioni tecniche

7.6 Valutazione dell’incertezza di misura

7.7 Assicurazione della validità dei risultati

7.8 Presentazione dei risultati

7.9 Reclami

7.10 Attività non conformi

7.11 Controllo dei dati e gestione delle informazioni

8 REQUISITI DEL SISTEMA DI GESTIONE

8.1 Opzioni

8.1.1 Generalità

8.1.2 Opzione A

8.2 Documentazione del sistema di gestione (Opzione A)

8.3 Controllo dei documenti del sistema di gestione (Opzione A)

8.4 Controllo delle registrazioni (Opzione A)

8.5 Azioni per affrontare i rischi e le opportunità (Opzione A)

8.6 Miglioramento (Opzione A)

8.7 Azioni correttive (Opzione A)

8.8 Audit interni (Opzione A)

8.9 Riesami di direzione (opzione A)

  • Microsoft Word, Excel 2016

  • Microsoft win server 2016

  • Google G-Mail

  • Trendmicro vers. “WORRY FREE BUSINESS SECURITY”

  • Zywall USG100

  • Secure Soft PDF Signer 5.5

  • PDF Acrobat reader

  • Gamma Sprint Team System rev 7

  • Newsteo Rf monitor premium rel. 4.4.1.1

  • white: shared documents

  • blue: LAB-specific documents

  • pink: specific documents ON

  • (*) collaborative verification (see 8.2.3.1)

Type

Identification

Document abbreviation

Drafting

Verification / Approval

Distribution

Minimum content

1

Description of the reference standards application

QAM

Quality staff

Management

on network server

Requirements 17025, 17065 and reference to application documents in Ricotest

2

Docs. of regulatory institutions

Of the issuing regulatory institution

Of the issuing institution

Management if widespread

on network server

n.a.

Customer documents

n.a.

Customer

Lab Technician

UKCA Assessor

on network server

n.a.

Documentation of installations and instruments

n.a.

manufacturer

Technician responsible for instruments and calibrations

Digital or on paper PR-GAP

n.a.

3

Updated list of EN names and harmonised standards, Designated Standards

Update list

CEN CENELEC OJEU, BS

Quality staff

Management

on network server

List of standards updated in the last 15 days

Standards Application Sheets

SAN

Quality staff

Management

on network server

Concise description of the interpretation and application of requirements in RCT

Management procedures

PR QUA

Quality staff

Management

on network server

Additional detailed description to SAN

Test procedures

PR PRO

Laboratory technicians

Management

on network server

Supplementary descriptions or translations concerning test standards, without any change in method;

Calibration procedures

Confirmation procedures

PR TAR

PR CON

Laboratory technicians;

Quality Staff

Management

on network server

Description of internal methods for calibration of instruments and confirmation of equipment

Procedures for calculating uncertainty

PR INC

Laboratory technicians;

Quality Staff

Management

on network server

Description of test uncertainty calculation procedure

Equipment management procedures

PR GAP

Laboratory technicians;

Quality Staff

Management

Paper-based at the Laboratory + on network server

Collection of documentation on acquisition records, input verification, instructions, maintenance, calibration, metrological confirmation, dismantling of instruments and equipment

General list of equipment

equipment list

Laboratory Technicians

Not applicable

Digital, internal, on the network server

database of data concerning incoming verification, instructions, maintenance, calibration, metrological confirmation, decommissioning of instruments and equipment

Maintenance procedures

PR MAN

Laboratory Technicians

Quality Staff

on the network server

instructions for the preventive maintenance of an instrument

Intermediate verification procedures

PR VER

Laboratory Technicians

Quality Staff

on the network server

Instructions dedicated to an instrument or family of instruments for instrument verification within a calibration interval

3

Contracts

General conditions RICOTEST

Management

Management (*)

on the network server

Description of the contractual clauses for the provision of the test service

contracts of Test subscription

Management

Management (*)

on the network server

Description of the elements governing the contract involving cost advantages

Conditions for CE / UKCA certification of PPE

Management

Management (*)

on the network server, web link for customers

Description of the contractual clauses governing the affixing of the CE marking (also with reference to legal requirements)

Price lists

(*)

List of certification services

Management

Management

on the network server

List of certification services and their prices

List of tests

Management

Management

on the network server

List of tests and their prices

Directories

List of Standards

Laboratory Mng

Management

on the network server

List of valid standards

Order list

Sales and Customer Service

Not applicable

on the network server

List of orders complete with information and management data

List of CE / UKCA applications

Personnel certification office

Not applicable

on the network server

List of proceedings complete with management information and data

List of CE / UKCA certificates

Personnel certification office

Not applicable

on the network server

List of valid, revoked, suspended certificates

Laboratory order tracking list

Lab. Coord.

Not applicable

on the network server

List of orders in progress with record of processing dates and technicians in charge

4

Forms

QS forms

M_#progressive or title

Various

Not applicable

on the network server

Orderly structure for data collection

Manuscript: MS_#norma_year

Laboratory technicians

Management

on the network server

Structure for collecting data defined by the test standard

Forms of the NAO descriptive title revision date

Various

Management

on the network server

Orderly structure for data collection

5

advertising information

None

Management

Management

Web only

n.a.