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ISO 9001-2015 - Apresentação Orientativa PDF
ISO 9001-2015 - Apresentação Orientativa PDF
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Atuais Novos
Introduo
1. Escopo
2. Referncias Normativas
3. Termos e Definies
4. Contexto da organizao
1. Entendendo a organizao e seu contexto
2. Entendendo as necessidades e expectativas das partes
interessadas
3. Determinando o escopo do sistema de gesto da qualidade
4. Sistema de gesto da qualidade
1. Generalidades
2. Abordagem de processos
5. Liderana
1. Liderana e comprometimento
1. Liderana e comprometimento com respeito ao sistema
de gesto da qualidade
2. Liderana e comprometimento com respeito s
necessidades e expectativas dos clientes
2. Poltica da qualidade
3. Funes organizacionais, responsabilidades e autoridades
6. Planejamento
1. Aes para lidar com riscos e oportunidades
2. Objetivos da qualidade e planos para alcan-los
3. Planejamento de mudanas
7. Apoio
1. Recursos
1. Generalidades
2. Infraestrutura
3. Ambiente de processo
4. Dispositivos de monitoramento e medio
5. Conhecimento
2. Competncia
3. Conscientizao
4. Comunicao
5. Informao documentada
1. Generalidades
2. Criao e atualizao
3. Controle de informao documentada
9. Avaliao de desempenho
1. Monitoramento, medio, anlise e avaliao
1. Generalidades
2. Satisfao do cliente
3. Anlise e avaliao de dados
2. Auditoria interna
3. Anlise crtica pela direo
10. Melhoria
1. No conformidade e ao corretiva
2. Melhoria
4 Contexto da Organizao
5 Liderana
6 Planejamento
7 Suporte
8 Operao
9 Avaliao do desempenho
10 Melhoria
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CD ISO 9001:2015
Risk
effect of uncertainty
Note 1: An effect is a deviation from the expected positive or negative.
Note 2: Uncertainty is the state, even partial, of efficiency of information related to,
understanding or knowledge of, an event, its consequence, or likelihood.
Note 3: Risk is often characterized by reference to potential events (ISO Guide 73,
3.5.1.3) and consequences (ISO Guide 73, 3.6.1.3), or a combination of these.
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CD ISO 9001:2015
The organization shall determine external and internal issues, that are relevant to its
purpose and its strategic direction and that affect its ability to achieve the intended
outcome(s) of its quality management system, updating when needed .
The organisation shall update such determinations when needed.
When determining relevant external and internal issues, the organization shall consider
those arising from:
changing needs and trends which can have an impact on the objectives of the
organization;
relationships with, and perceptions and values and expectations of relevant external
interested parties;
governance issues, strategic priorities, internal policies and commitments
resource availability and priorities and technological change
Note 2 When understanding the internal context the organization could consider those
related to perceptions, values and culture of the organization.
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CD ISO 9001:2015
Note Addressing current and anticipated future needs can lead to the identification of
improvement and innovation opportunities.
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CD ISO 9001:2015
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CD ISO 9001:2015
When planning for the quality management system, the organization shall
consider the issues referred to in 4.1 and the requirements referred to in 4.2 and
determine the risks and opportunities that need to be addressed to assure the
quality management system can achieve its intended outcome(s) assure that the
organization can consistently deliver product conformity and customer
satisfaction prevent, or reduce, undesired effects achieve continual
improvement.
The organization shall plan:
actions to address these risks and opportunities, and how to integrate and
implement the actions into its quality management system processes (see 4.4)
evaluate the effectiveness of these actions.
any actions taken to address risks and opportunities shall be proportionate to
the potential effects on conformity of goods and services and customer
satisfaction.
Note Options to address risks can include for example risk avoidance, risk
mitigation or risk acceptance
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CD ISO 9001:2015
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CD ISO 9001:2015
9.1.1 General
The organization shall take into consideration the determined risks and opportunities and shall:
etermine what needs to be monitored and measured in order to:
- demonstrate conformity to product requirements,
- evaluate the performance of processes (see 4.4),
- ensure conformity and effectiveness of the quality management system, and
- evaluate customer satisfaction and
evaluate supplier and external party issues performance of external provider(s);
determine the methods for monitoring, measurement, analysis and evaluation, as applicable,
to ensure valid results;
determine when the monitoring and measuring shall be performed ;
determine when the results from monitoring and measurement shall be analysed and
evaluated;
determine what performance indicators of the quality management system are needed.
The organization shall establish processes to ensure that monitoring and measurement can be
carried out and are carried out in a manner that is consistent with the monitoring and
measurement requirements.
The organization shall retain appropriate documented information as evidence of the results.
The organization shall evaluate the quality performance and the effectiveness of the quality
management system.
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CD ISO 9001:2015
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CD ISO 9001:2015
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CD ISO 9001:2015
8 Operation
_
+
10.1 Nonconformity and
corrective action 10.2 Improvement
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ISO 9001:2008 ISO CD 9001:2015
1 Scope 4 Context of the organization
1.2 Application 4.2 Understand needs and expect of interest parties
4.3 Determining the scope of the QMS
4.4.2 Process approach
4 Quality management system
4.1 General requirements
4.2 Documentation requirements 6 Planning
Jun 2012 Nov 2012 Jun 2013 Jan 2014 Set 2014 Jan 2015 Set2015
Atividades de
verificao
e validao
Diretivas ISO
Anexo SL
Pesquisa com
usurios
Interaes com Interaes com
Reviso dos SC1 (ISO 9000) IAF & ISO/CASCO
QMPs sobre questes de sobre transio
terminologia
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