NTC ISO 9001:2015

PRINCIPALES CAMBIOS
 Ya no se habla de “producto”, se habla de “bienes y servicios”
 No se utiliza “Exclusiones”
 No se utiliza “Representante de la dirección)
 Se habla de Información Documentada
 No se utiliza Proveedor, es Proveedor Externo.
 Ambiente de trabajo cambia a Ambiente para la Operación de los procesos
 NO se utiliza Equipo de seguimiento y medición, ahora es Recursos de seguimiento y
medición.
 El termino Productos Comprados cambia a Productos y servicios suministrados externamente
 Se incluyen dos clausulas respecto al contexto de la organización.
 Se habla de pensamiento basado en riesgos
 Se incluye una clausula sobre el enfoque basado en procesos.
 Formas verbales (Debe - Requisito, Debería - Recomendación y puede – Permiso, Posibilidad
o Capacidad)
 El estándar pasa de 8 Capítulos a 10 Capítulos.
 PENSAMIENTO BASADO EN RIESGOS

El Riesgo es el efecto de la incertidumbre y dicha incertidumbre

puede tener efectos positivos o negativos. Una desviación
positiva que surge de un riesgo puede proporcionar una
oportunidad. Pero no todos los efectos positivos del riesgo
tienen como resultado oportunidades.

Fuente: NTC ISO 9001:2015

 CONTENIDO

0. Introducción 3. Términos y Definiciones

0.1 Generalidades 4. Contexto de la Organización
0.2 Principios de la Gestión de 5. liderazgo
Calidad
6. Planificación
0.3 Enfoque a Procesos
7. Apoyo
0.4 Relación con otras Normas de
8. Operación
Sistemas de Gestión
9. Evaluación del Desempeño
1. Objeto y Campo de Aplicación
10. Mejora
2. Referencias Normativas
0. INTRODUCCIÓN
 CONTEXTO DE LA ORGANIZACIÒN

• External issues This is not a natural comfort zone for many auditors and
• Internal issues management systems professionals and ISO 9001 recognizes this;
• Interested parties it provides three guidance notes to understanding context:
 Note 1 confirms that positive and negative factors should be
considered, which directly ties to the concept of Risk and
Opportunity
 Note 2 provides some starting considerations for external analysis
 Note 3 provides limited guidance for considering internal
factors such as organizational culture
 https://www.nqa.com/en-gb/resources/blog/march-2016/defining-context?utm_medium=email&utm_campaign=6909701_InTouch%20-%
20March%202016&utm_content=Guide%20to%20Context&utm_source=NQA%20Certification%20Ltd&dm_i=8TF,443K5,JNZK2H,EXIDU,1
 CONTEXT = SCOPE OF MANAGEMENT SYSTEM

7S Model = internal issues.  Used for internal analysis PESTEL Model = external issues. Used as a framework
including harder elements such as systems and structures and for reviewing the macro and micro operating environment
intangible elements such as management style and of the organization, including legal compliance obligations
organizational culture.

                                                                                                 
• 6 Markets Model = interested parties. Used to identify the range of
stakeholders and interested parties which should be ranked in terms of their
interest and influence. There is a some cross over with 7S model for staff.
METHOD 1: SIMPLE CONTEXT REVIEW MATRIX
The Context Review Matrix provides a simple framework
for reviewing the external and internal factors that create
the Context of the Organization.

It is a relatively low-intensity method to start thinking about

and capturing contextual information. It can be used to
present your process to different stakeholders (interested
parties).

Bearing in mind the above factors, you

should consider:
• What are the risks and
opportunities?
• Which risks and opportunities
should be prioritized?
METHOD 2: STRUCTURED CONTEXT ANALYSIS
FRAMEWORK
Moving to a more detailed methodology is the Context
Analysis Framework.

The Context Analysis Framework

links context with policy and objectives of a management
system. It achieves this through strategic, tactical and
operational analyses distilled into the Key Issues of the
organisation.

The Key Issues define the aspects of context that

influence the organisations purpose, objectives and
sustainability. They also provide the input to policy making
and objective setting – which may be quality,
environmental, energy, safety or security objectives
depending on the management system.
 CONTEXT ANALYSIS PROCESS

• Analyse and Evaluate Internal and External Issues. Use models including PESTEL, 6
Market Model, and 7S models to identify compliance obligations, interested parties,
environmental and market factors.
Tip: Tabulate the headings from each model to create a bespoke matrix of identification, evaluation and
prioritization based on positive and negative impact (risk and opportunity).
• SWOT analysis. Distil external factors into Strengths, Weaknesses, Opportunities and Threats
(Risks and Opportunities)
Tip: refer to Section 6 of the standard for requirements on actions to address risks and opportunities.
• Key Issues: From the SWOT, identify the key issues facing the organisation i.e. the high priority
issues that must be addressed in strategy, policy and objectives
Tip: Key issues can be distilled into a single sided document for reference and policy and objective setting.
• Create Policy. Document, communicate and make available a policy that addresses the key
issues and commits the organization to continual improvement.
Tip: Policy is a requirement of leadership – see Section 5 of the standard for specific requirements.
• Set Objectives. Set objectives consistent with policy that are measurable, monitored and
communicated. SMART objectives, quality objectives, environmental objectives etc.
Tip: Objectives are a requirement of Section 6 Planning and should meet the specific requirements stated by the
standard