La norma ISO 9001:2015 è in vigore
Ottobre 12, 2015
ISO 9001:2015 – L’approccio basato sui rischi
Ottobre 26, 2015
Nel post del 12 ottobre abbiamo dato notizia della pubblicazione della norma ISO 9001:2015 ed un cenno alle principali novità rispetto alla versione 2008.
Affrontiamo ora la nuova struttura della norma: la HLS, High Level Structure, costituita da 10 punti, che viene proposta per tutte le norme che riguardano i Sistemi di Gestione (MMS – Management System Standards), struttura usata anche per la nuova norma relativa al sistema di gestione ambientale ISO 14001: 2015, pubblicata il 15 settembre 2015, sostitutiva della ISO 14001:2004.
Nel 2012, infatti, la ISO (International Organization for Standardization), ha definito una struttura, comune ed obbligatoria per tutti i sistemi di gestione, la HLS appunto, inserendola nelle direttive operative ISO /IEC, più precisamente nell’Allegato SL (ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2013, Annex SL, Appendix 2).
Il fine è quello di garantire compatibilità tra le norme per i sistemi di gestione, uniformarne il linguaggio, facilitarne la comprensione dei requisiti ed evidenziarne maggiormente gli elementi sostanziali, evitando così di trovarsi in situazioni contraddittorie, come definire processi comuni con termini diversi e gestire manuali riferiti a strutture normative diverse fa loro.
Nella tabella sottostante viene confrontata la struttura HLS della ISO 9001: 2015 con quella a 8 punti della versione precedente:
| PUNTO | Titolo ISO 9001:2015 | Titolo ISO 9001:2008 |
| 1 | Scopo | Scopo |
| 2 | Riferimenti normativi | Riferimenti normativi |
| 3 | Termini e definizioni | Termini e definizioni |
| 4 | Contesto dell’Organizzazione | Sistema di gestione della Qualità |
| 5 | Leadership | Responsabilità della Direzione |
| 6 | Pianificazione | Gestione delle risorse |
| 7 | Supporto | Realizzazione di prodotto |
| 8 | Attività operative | Misurazione, analisi e miglioramento |
| 9 | Valutazione delle performance | – |
| 10 | Miglioramento | – |
Mentre la tabella seguente invece, estratto del documento ISO/TC 176/SC2/N1293, riporta la correlazione tra i punti della norma ISO 9001:2015 e della 2008:
| ISO 9001:2008 | ISO 9001:2015 |
| 1 Scope | 1 Scope |
| 1.1 General | 1 Scope |
| 1.2 Application | 4.3 Determining the scope of the quality management system |
| 4 Quality management system | 4 Context of the organization
4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.4 Quality management system and its processes |
| 4.1 General requirements | 4.4 Quality management system and its processes
8.4 Control of externally provided processes, products and services |
| 4.2 Documentation requirements | 7.5 Documented information |
| 4.2.1 General | 7.5.1 General |
| 4.2.2 Quality manual | 4.3 Determining the scope of the quality management system
7.5.1 General 4.4 Quality management system and its Processes |
| 4.2.3 Control of documents | 7.5.2 Creating and updating
7.5.3 Control of documented Information |
| 4.2.4 Control of records | 7.5.2 Creating and updating
7.5.3 Control of documented Information |
| 5 Management responsibility | 5 Leadership |
| 5.1 Management commitment | 5.1 Leadership and commitment
5.1.1 General |
| 5.2 Customer focus | 5.1.2 Customer focus |
| 5.3 Quality policy | 5.2 Policy
5.2.1 Establishing the Quality policy 5.2.2 Communicating the Quality policy |
| 5.4 Planning | 6 Planning |
| 5.4.1 Quality objectives | 6.2 Quality objectives and planning to achieve them |
| 5.4.2 Quality management system planning | 5.3 Organizational roles, responsibilities and authorities
6 Planning 6.1 Actions to address risks and opportunities 6.3 Planning of changes |
| 5.5 Responsibility, authority and communication | 5 Leadership |
| 5.5.1 Responsibility and authority | 5.3 Organizational roles, responsibilities and authorities |
| 5.5.2 Management representative | 5.3 Organizational roles, responsibilities and authorities |
| 5.5.3 Internal communication | 7.4 Communication |
| 5.6 Management review | 4 Quality management system
4.1 Understanding the organization and its 4.2 Understanding the needs and expectations of interested parties 9.3 Management review |
| 5.6.1 General | 9.3.1 General |
| 5.6.2 Review input | 9.3.2 Management review input |
| 5.6.3 Review output | 9.3.3 Management review output |
| 6 Resource management | 7 Support
7.1 Resources |
| 6.1 Provision of resources | 7.1.1 General
7.1.2 People |
| 6.2 Human resources | 7.2 Competence |
| 6.2.1 General | 7.2 Competence |
| 6.2.2 Competence, training and awareness | 7.2 Competence
7.3 Awareness |
| 6.3 Infrastructure | 7.1.3 Infrastructure |
| 6.4 Work environment | 7.1.4 Environment for the operation of processes |
| 7 Product realization | 8 Operation |
| 7.1 Planning of product realization | 8.1 Operational planning and control |
| 7.2 Customer-related processes | 8.2 Requirements for products and services |
| 7.2.1 Determination of requirements related to the product | 8.2.2 Determination of requirements for products and services |
| 7.2.2 Review of requirements related to the product | 8.2.3 Review of the requirements for products and services
8.2.4 Changes to requirements for products and services |
| 7.2.3 Customer communication | 8.2.1 Customer communication |
| 7.3 Design and development | 8.3 Design and development of products and services |
| 7.3.1 Design and development planning | 8.3.1 General
8.3.2 Design and development planning |
| 7.3.2 Design and development inputs | 8.3.3 Design and development Inputs |
| 7.3.3 Design and development outputs | 8.3.5 Design and development outputs |
| 7.3.4 Design and development review | 8.3.4 Design and development controls |
| 7.3.5 Design and development verification | 8.3.4 Design and development controls |
| 7.3.6 Design and development validation | 8.3.4 Design and development controls |
| 7.3.7 Control of design and development changes | 8.3.6 Design and development changes
8.5.6 Control of changes |
| 7.4 Purchasing | 8.4 Control of externally provided processes, products and services |
| 7.4.1 Purchasing process | 8.4 Control of externally provided processes, products and services
8.4.1 General 8.4.2 Type and extent of control |
| 7.4.2 Purchasing information | 8.4.3 Information for external providers |
| 7.4.3 Verification of purchased product | 8.4.2 Type and extent of control
8.4.3 Information for external providers 8.6 Release of products and services |
| 7.5 Production and service provision | 8.5 Production and service provision |
| 7.5.1 Control of production and service provision | 8.5.1 Control of production and service provision
8.5.5 Post-delivery activities |
| 7.5.2 Validation of processes for production and service provision | 8.5.1 Control of production and service provision |
| 7.5.3 Identification and traceability | 8.5.2 Identification and traceability |
| 7.5.4 Customer property | 8.5.3 Property belonging to customers or external providers |
| 7.5.5 Preservation of product | 8.5.4 Preservation |
| 7.6 Control of monitoring and measuring equipment | 7.1.5 Monitoring and measuring resources
7.1.5.1 General 7.1.5.2 Measurement traceability |
| 8 Measurement, analysis and improvement | 9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation |
| 8.1 General | 9.1.1 General |
| 8.2 Monitoring and measurement | 9.1 Monitoring, measurement, analysis and evaluation |
| 8.2.1 Customer satisfaction | 9.1.2 Customer satisfaction |
| 8.2.2 Internal audit | 9.2 Internal audit |
| 8.2.3 Monitoring and measurement of processes | 9.1.1 General |
| 8.2.4 Monitoring and measurement of product | 8.6 Release of products and services |
| 8.3 Control of nonconforming product | 8.7 Control of nonconforming outputs
10.2 Nonconformity and corrective action |
| 8.4 Analysis of data | 9.1.3 Analysis and evaluation |
| 8.5 Improvement | 10 Improvement |
| 8.5.1 Continual improvement | 10.1 General
10.3 Continual Improvement |
| 8.5.2 Corrective action | 10.2 Nonconformity and corrective action |
| 8.5.3 Preventive action | 6.1 Actions to address risks and opportunities (see 6.1.1, 6.1.2)
10.3 Continual Improvement |
Avremo modo, in seguito, di discutere novità e differenze principali…
