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ISO 9001:2015 Introduction (English)

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Bianet Camacho

on 8 April 2016

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Transcript of ISO 9001:2015 Introduction (English)

Act
Do
Check
Plan
ISO 9001:2015
Introduction

DOCUMENTARY STRUCTURE
Resources
Identify, Explain, measure, control, and keep improving your process.
The adoption of QMS is a strategic decision.
HOSPITAL
COMPATIBILITY BETWEN ISO 9001:2008 &
ISO 9001:2015
ISO-9001:2015
ISO-9001:2008
QUALITY MANAGEMENT SYSTEM
QUALITY MANAGEMENT SYSTEM
0.- Introduction
1.- Scope
2.- Normative References
3.-Terms and Definitions
4.-Quality Management System
5.-Management Responsibility
6.-Resource Management
7.-Product Realization
8.-Measurement, analysis and improvement
Risk-based thinking
ISO 9001 STANDARD
SCOPE DOCUMENT
(QUALITY MANUAL)
PROCEDURES
MANDATORY
DOCUMENTARY STRUCTURE
STANDARD
SPECIFIC
a)Documentary Control
b)Records Control
c)Limpieza de infraestructura
d)Monitoreo de la salud del personal en contacto con el producto
e)Vestimenta del personal
f)Monitoreo y control del entorno de trabajo
g)Gestión de riesgos
h)Diseño y desarrollo (En caso de aplicar)
i)Inspección del producto comprado
j)Limpieza del producto antes de su entrega
k)Servicio al cliente
l)Instalación del producto
m)Verificación del servicio
n)Identificación del producto
o)Identificación del producto no conforme
p)Rastreabilidad
q)Preservación del producto
r)Verificación del cumplimiento de los requisitos del cliente
s)Auditorías internas
t)Control del producto / servicio no conforme
u)Análisis de datos
v)Notas de aviso
w)Acciones correctivas
x)Acciones preventivas
Son algunos ejemplos de procedimientos

Mejora continua
Revisiones por la dirección
Detección de necesidades de capacitación
Capacitación
Competencia laboral
Rastreabilidad
Calibración
Comunicación interna
Evaluación de proveedores
Análisis de datos
Compras
Estos procedimientos van de acuerdo con el tipo de producto sanitario manufacturado, comercializado y/o instalado por la organización y establecen la diferencia entre la forma de operar de organizaciones dedicadas a lo mismo.
The scope document shall:

• Describe the boundaries of
your organization's QMS and to explain what it applies to.
• Identify the types of products
and services that will be included in your organization's QMS.
• Explain that every ISO 9001 requirement.
RECORDS
• “shall” indicates a requirement;
• “should” indicates a recommendation;
• “may” indicates a permission;
• “can” indicates a possibility or a capability:

For an organization to function effectively, it has to determine and manage numerous linked activities. The identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the "process approach".

|
RECORDS
Son las evidencias de que se hizo lo estipulado en los procedimientos. Normalmente los registros son los formatos del sistema, una vez que han sido llenados.
RECORDS
Son las evidencias de que se hizo lo estipulado en los procedimientos. Normalmente los registros son los formatos del sistema, una vez que han sido llenados.
Thank You!
MANAGING FOR THE SUSTAINED SUCCESS OF AN ORGANIZATION- A QUALITY MANAGEMENT APPROACH
ISO 9000:2015
ISO-9004:2009
ISO-9001:2015
SPECIFIC REQUIREMENTS
QUALITY MANAGEMENT SYSTEMS- FUNDAMENTALS AND VOCABULARY
QUALITY MANAGEMENT SYSTEMS REQUIREMENTS
THE STATE OF ART

CIVIL ENGINEERING REQUIREMENTS


0.-Introduction
1.-Scope
2.-Normative References
3.-Terms and Definitions
4.-Context
5.-Leadership
6.-Planning
7.-Support
8.-Operations
9.-Evaluation
10.-Improvement
In this International Standard, the following verbal forms are used:
when the term documented procedure appears, it means that the procedure is established, documented, implemented and maintained.
A document that states the achieved results.
By correlating this definition with definition of a document, results that a record may be on paper or in electronic format.
Demonstrate ability to provide services that meet customer and applicable statutory and regulatory requirements.

Aims to enhance customer satisfaction through the effective application of the system.

Why ISO?
Leadership
Planning
Support
Operations
Performance Evaluation
Improvement
• Maintain documents needed to support process operations.
• Control documents which support process operations.
• Retain records which show that plans are being followed.
• Control records which show that plans are being followed.
4.1 Understand your organization and its unique context
4.2 Understanding the needs and expectations of interested parties
4.3 Define the scope of your quality management system
4.4 Develop a QMS and establish documented information
Maintain and control documents which support process operations.Retain and control records which show that plans are being followed.


Context of the organization
5.1 Provide leadership by encouraging and focusing on quality and customers

5.2 Provide leadership by formulating, establishing and implementing a suitable quality policy


5.3 Provide leadership by defining roles and responsibilities

7.1 Support your QMS by providing the necessary resources
7.1.1 Provide internal and external resources for your QMS
7.1.2 Provide suitable people for your QMS and your processes
7.1.3 Provide the infrastructure that your processes must have
7.1.4 Provide the appropriate environment for your processes
7.1.5 Provide monitoring, measuring, and traceability resources
7.1.5.1 Provide suitable monitoring and measuring resources
7.1.5.2 Provide suitable measurement traceability resources
7.1.6 Provide knowledge to facilitate process operations
7.2 Support your QMS by ensuring that people are competent

7.3 Support your QMS by explaining how people can help
7.4 Support your QMS by managing your communications
7.5 Support your QMS by controlling documented information
7.5.1 Include the documented information that your QMS needs

7.5.2 Manage the creation and revision of documented information
7.5.3 Control the management and use of documented information
7.5.3.1 Control your organization's QMS documents and records
7.5.3.2 Control how QMS documents and records are controlled

6.1 Define actions to manage risks and address opportunities
6.1.1 Consider risks and opportunities when you plan your QMS
6.1.2 Plan how you’re going to manage risks and opportunities
6.2 Set quality objectives and develop plans to achieve them
6.2.1 Establish quality objectives for all relevant areas
6.2.2 Develop plans to achieve objectives and evaluate results
6.3 Plan changes to your quality management system

8.1 Develop, implement, and control your operational processes
8.2 Determine and document product and service requirements
8.2.1 Communicate with customers and manage customer property
8.2.2 Clarify all product and service requirements and capabilities
8.2.3 Review product and service requirements and record results
8.2.3.1 Verify requirements before you accept orders from customers
8.2.3.2 Document your review of product and service requirements

8.2.4 Amend documents when product and service requirements change
8.3 Establish a process to design and develop products and services
8.3.1 Create an appropriate design and development process
8.3.2 Plan product and service design and development activities
8.3.3 Determine product and service design and development inputs

8.3.4 Specify how design and development process will be controlled
8.3.5 Clarify how design and development outputs will be produced
8.3.6 Review and control all design and development changes
8.4 Monitor and control external processes, products, and services
8.4.1 Confirm that external products and services meet requirements

8.4.2 Develop controls for externally provided products and services
8.4.3 Discuss your organization’s requirements with external providers
8.5 Manage and control production and service provision activities
8.5.1 Establish controls for production and service provision

8.5.2 Identify your outputs and control their unique identity
8.5.3 Protect property owned by customers and external providers
8.5.4 Preserve outputs during production and service provision
8.5.5 Clarify and comply with all post-delivery requirements

8.5.6 Control changes for production and service provision
8.7 Control nonconforming outputs and document actions taken
8.7.1 Identify and control nonconforming output to prevent unintended use
8.7.2 Document nonconforming outputs and the actions that are taken

9.1 Monitor, measure, analyze, and evaluate QMS performance
9.1.1 Plan how to monitor, measure, analyze, and evaluate

9.1.2 Find out how well customer needs and expectations are being met
9.1.3 Evaluate performance, effectiveness, conformity, and satisfaction
9.2 Use internal audits to examine conformance and performance
9.2.1 Audit your quality management system at planned intervals

9.2.2 Develop an internal audit program for your organization
9.3 Carry out management reviews and document your results
9.3.1 Review suitability, adequacy, effectiveness, and direction
9.3.2 Plan and perform management reviews at planned intervals
9.3.3 Generate management review outputs and document results

10.1 Determine improvement opportunities and make improvements
10.2 Control nonconformities and take appropriate corrective action
10.2.1 Correct nonconformities and address causes and consequences
10.2.2 Document your nonconformities and the actions that are taken
10.3 Enhance the suitability, adequacy, and effectiveness of your QMS

Enables an organization to determine the factors that could cause its processes and their its quality management system to deviate from the planned results.

Risk-based thinking
It is the auditable standard
Full transcript