ISO 9001:2015 Flashcards
1
Q
In ISO 9001:2015,
_________ -> Plan -> Hacer -> __________
A
Actuar -> Plan -> Hacer -> Verificar
2
Q
Dentro de Plan, nosotros …..
A
Plan la estrategia
3
Q
Dentro del Hacer, nosotros …
A
Carry Out the strategy from the planning phase
4
Q
Dentro del Verificar, nosotros …
A
Relay the necessary information to clients
5
Q
Actualmente la calidad se ha convertido en un factor ____________ para la expansión o de las
empresas.
A
estratégico
supervivencia
6
Q
Poseer un sistema de gestión es una herramienta que permite ____________.
A
trabajar según unos estándares
documentados
7
Q
UNE en ISO 9001:2015 “Es un modelo de Sistema de Gestión con reconocimiento
internacional, basado en establecer una metodología de trabajo”
A
True
8
Q
Las ventajas de la certificación son:
** HINT
FERMPIM^2DV
A
- Ventajas competitivas
- Facilita la mejora continua
- Es un elemento diferenciador
- Reconocimiento Internacional
- Mejora la imagen de la empresa
- Permite optar a mercados restringidos (restricted)
- Mejora el acceso a contratación pública
- Inspira confianza y fidelidad en los clientes
- Mejora las buenas relaciones públicas y con la comunidad
- Demuestra (shows) a los clientes y proveedores el compromiso de una buena gestión
9
Q
Steps for initial certification of ISO 9001 are:
A
Solicitud Certificación -> Planificación -> Fase 1 -> Fase 2 -> Emisión certificado
10
Q
Pasos para mantener el certificado son:
A
Seguimiento anual 1 -> Seguimiento anual 2 -> Recertificación
11
Q
Los objetivos del paso de planificación son:
A
- Acordar un calendario de certificación
- Asegurar la existencia de actividad significativa.
- Confirmar datos para una adecuada selección del equipo auditor
12
Q
Los aspectos críticos del paso de planificación son:
A
- Planificar con antelación (advance)
- Actividades realizadas en cliente (on the client)
- Actividades estacionales (seasonal activities)
- Interlocutores (middle men)
- Horarios
13
Q
Los objetivos de Fase 1 son:
A
- Comprobar que los datos de la solicitud son adecuados
- Conocer el grado de desarrollo del SGC (Sistema de Gestión de la Calidad)
- Asegurar que se contemplan (contemplate) los requisitos más relevantes
- Dar viabilidad a la Fase 2
- Planificar la Fase 2
14
Q
En Fase 1, el cliente envía documentación y el órgano haciendo el auditorio lo hace in situ (on site) y da un reportaje. Luego, el cliente envía su Plan de Aseguramiento y Control de la Calidad (PAC) y si todo esta bien, pasa a Fase 2.
A
True
15
Q
Los aspectos críticos en Fase 1 son:
A
- Determinar el alcance (scope)
- Identificación de requisitos legales y de cliente y cómo se traslada al SGC
- Identificación de mecanismos de seguimiento y medición.
- Mejora Continua
16
Q
El objetivo de Fase 2 es:
A
Comprobar la implantación del SGC de acuerdo a los requisitos de la Norma correspondiente.
17
Q
En Fase 2, el órgano haciendo el auditorio comprueba que todo está bien y da un reportaje después de otro auditoría in situ. Si todo esta bien, luego, el cliente envía su nueva PAC y pasa al EMISIÓN
CERTIFICADO.
A
True
18
Q
Los aspectos críticos del Fase 2 son:
A
- Conocimiento del SGC
- Registro de lo que se hace
- Uniformidad de criterios
- Acciones de mejora
19
Q
Los objetivos de EMISIÓN CERTIFICADO son:
A
- Comprobar que el proceso de certificación se ha realizado:
Independiente
Con tiempo suficiente
Con competencia técnica
Según lo solicitado - Comprobar que hay evidencias suficientes de cumplimiento
20
Q
En la fase de EMISIÓN CERTIFICADO, si todo esta bien, hay un Comité Certificación desde el órgano emitir el certificado, y si todo está bien con ellos, el cliente da su último PAC y recibe su certificación.
A
True
21
Q
Los aspectos críticos del fase de emisión certificado son:
A
- Alcance (scope) definido en el informe de auditoría
2. Claridad y contenido del PAC
22
Q
Los objetivos de AUDITORIA SEGUIMIENTO (parcial) son:
A
- Asegurar que la organización mantiene implantado y actualizado el SGC.
- Comprobar la eficacia del PAC de la auditoría anterior.
- Comprobar que se hace un uso correcto de la marca de certificación.
23
Q
In AUDITORIA SEGUIMIENTO (parcial) , the client and evaluating body agree to the planning of the audit, and the first audit is done on site. A report is then issued, and if everything is fine, the client sends its first PAC and the evaluating body issues a letter.
A
True
24
Q
Los aspectos críticos de AUDITORIA SEGUIMIENTO (parcial) son:
A
- Cumplir calendario.
- Informar de cambios importantes:
Nuevas actividades
Nuevos centros
Variaciones en nº de trabajadores
25
Los objetivos de recertificación son:
1. Asegurar que la organización mantiene implantado y actualizado el SGC.
2. Comprobar la eficacia del PAC de la auditoría anterior.
3. Comprobar que se hace un uso correcto de la marca de certificación.
4. Valoración global del SGC en el ciclo de tres años: mejoras y desviaciones crónicas.
26
In the recertification phase, the client and the evaluating body go through the planning phase again, and another evaluation is done on site and a report issued. If everything is fine, the client gives its final PAC, and the evaluating body issues the ISO renewal.
True
27
Los aspecto críticos del fase recertificación son:
1. Cumplir calendario (Margen).
2. Informar de cambios importantes:
Nuevas actividades
Nuevos centros
Variaciones en nº de trabajadores
28
It takes 5 – 6 meses, desde que la empresa entrega la Solicitud de Certificación hasta la consecución del certificado. Entonces, es mejor que se solicite la certificación con 3 meses sobre la fecha prevista
de inicio del proceso.
True
29
Una empresa puede garantizar éxito en su proceso de certificación por:
1. Reconocer que la Gestión de la Calidad están entre las prioridades más altas de la organización
2. Establecer comunicaciones y relaciones con las partes interesadas, internas y externas
3. Asegurar el compromiso de la dirección y de todo el personal
4. Realizar un diagnóstico de la situación de partida de la organización
5. Establecer la política y los objetivos de la calidad
6. Identificar los requisitos legales y otros requisitos suscritos (sign and accept liability under (an insurance policy), thus guaranteeing payment in case loss or damage occurs - underwritten)
7. Establecer objetivos y metas exigentes pero alcanzables
8. Establecer un proceso de gestión que permita la mejora continua del sistema
30
ISO 9001 es la norma de calidad más extendida del mundo y su estructura forma la base de otras
normas de referencia en determinados sectores.
True
31
Puede acometer la implantación de la ISO 9001
| con otras normas de calidad, dependiendo de su sector.
True
32
The ISO 9001: 2015 standard is structured in ten chapters that facilitate integration with other management system standards such as ISO 14001: 2015 on environmental management or ISO 45001: 2018 on occupational health and safety management.
True
33
In chapter 0. Introduction of the ISO 9001:2015 standard, the reasons for the implementation of a quality management system and the resulting benefits are:
1. Increase the ability to generate products and provide services on a regular basis that meet customer and regulatory requirements
2. Increase customer satisfaction
3. Address the risks and opportunities related to the organization, its context and its performance
4. Demonstrate, by obtaining a certificate, the existence of a quality management system in the organization
34
Chapter 1 of the ISO 9001:2015 standard is Purpose and field of application.
True
35
The purpose of the ISO 9001 standard is to define the requirements that a company must meet in order to have a quality management system.
True
36
The ISO 9001: 2015 standard is a generic standard that allows it to be applied in all types of organizations, regardless of their size, activity or geographic location.
True
37
In chapter 4 of the ISO 9001:2015 standard, "context of the organization", to define the scope and the quality management system itself and its processes, the organization has to take into account the following factors:
1. Understanding of the organization and its context
2. Identification of the factors that can influence the performance of the quality management system.
Needs and expectations of interested parties such as customers, employees, suppliers, shareholders, etc.
38
In chapter 5 of the ISO 9001:2015 standard, "Leadership", the top management of the organization _______________. Among other issues, this leadership must be demonstrated by ________________.
must assume and demonstrate leadership in relation to the quality management system
approving a quality policy and defining the different roles, responsibilities and authorities in the organization
39
In chapter 6 of the ISO 9001:2015 standard, "Planning", the organization, taking into account the factors analyzed in section 4 (_____________) and the ____________, must identify the ___________ and ___________ that affect it and _____________. These actions may be part of the necessary plan for the fulfillment of quality objectives .
```
context and interested parties
performance of the processes
risks
opportunities
define actions to reduce risks or take advantage of opportunities
```
40
In chapter 7 of the ISO 9001:2015 standard, "Support", the _________________ will be supported by _____________ and by the people of the organization. The company must ensure _______________. The system is also supported by a set of documents that the organization must keep updated and preserve.
performance of the quality management system
infrastructures or work teams
the good condition of the work teams and the competence of the personnel involved in the management system
41
In chapter 8 of the ISO 9001:2015 standard, "Organization", the requirements regarding operational processes: ______________ , __________ , ___________ , ________, or ________ and their corresponding control are addressed.
```
commercial
design
purchasing
production
service provision
```
42
In chapter 9 of the ISO 9001:2015 standard, "Performance Evaluation", the organization must monitor its performance to ____________. The company must have ________ to monitor the system indicators and the degree of customer satisfaction , as well as ____________.
detect non-compliance with requirements or expected results
processes
to carry out internal audits and reviews of the system by management
43
In chapter 10 of the ISO 9001:2015 standard, "Improvement", the organization must have__________ for ____________, as well as for the opening and analysis of corrective and improvement actions.
a defined methodology
| the detection and treatment of non-conformities
44
In chapter 4.1, Understanding the organization and its context, the organization must establish _____________, and that may affect its ability to achieve the intended results of its Quality Management System.
both external and internal issues that are relevant to its purpose and strategic direction
45
In chapter 4.1, the organization has the obligation to __________ on external and internal issues.
monitor and review information
46
Questions in chapter 4.1. can address positive and negative factors or conditions for the company's consideration.
True
47
Understanding the external context in chapter 4.1. can be facilitated by considering issues relating to ____, _______, ______, ______, ______, social and economic environments, whether _____, ____, regional or local.
```
the legal
technological
competitive
market
cultural
international
national
```
48
Understanding the internal context for chapter 4.1 can be facilitated by considering ___________ of the organization.
issues related to the values, culture, knowledge and performance
49
There are ___________ issues to the organization that may affect its _____________, and therefore must be taken into account in the Quality Management System. These are aspects that can ____________.
external and internal
purpose and its strategic direction
intervene in the organization's ability to achieve the desired results
50
To meet the requirements of chapter 4.1, we can use:
1. 5 fuerzas de Porter
2. Análisis PEST/PESTE/PESTEL
3. Matriz de Perfil Competitivo (MPC)
4. Matriz de Evaluación de Factores Externos (MEFE)
5. Matriz de Evaluación de Factores Internos (MEFI)
6. Benchmarking
7. Matriz FODA (Fortalezas, Oportunidades, Debilidades y Amenazas).
51
La cadena de valor de Porter constituye una herramienta de gestión que se usa para realizar un análisis interno a través la disgregación de la organización en actividades productoras de valor.
True
52
La cadena de valor de Porter aborda (addresses) las principales actividades de una organización como eslabones (links) de una cadena de actividades que van añadiendo valía (value) al producto conforme va pasando por cada una de ellas. Estas actividades van desde el diseño del producto y obtención de insumos (supplies) hasta su distribución y servicio post-venta.
True
53
The fact of breaking down the organization into activities facilitates the identification of strengths and weaknesses.
True
54
In chapter 4.1, each activity will be assigned a value and the associated cost. In those values and costs, the strengths and weaknesses that may mean a competitive advantage or disadvantage will be sought.
True
55
The SWOT (DAFO en español) can be defined as a strategic analysis based on the detection of internal elements (strengths and weaknesses) and external (opportunities and threats) that are diagnostic for the competitiveness of the organization.
True
56
SWOT is based on indicators that justify each of the elements that compose it, being able to quantify them to define, in the development of the strategic plan, the company's objectives.
True
57
In chapter 4.2, "Understanding the needs and expectations of stakeholders", due to its effect or potential effect on the organization's ability to regularly provide products and services that satisfy customer and applicable legal and regulatory requirements, the organization must determine:
1. interested parties that are relevant to the quality management system
2. the relevant requirements of these interested parties for the quality management system.
58
The organization monitors and reviews the information on interested parties and their relevant requirements.
True
59
Stakeholders and their requirements are ___________ of the Quality Management System to provide ____________ that meet those requirements.
key factors
| products and services
60
in chapter 4.2, both ___________ change over time and are therefore subject to _________, for example in management review.
stakeholders and their requirements
| periodic review
61
When we speak of interested parties we are referring to ___________.
clients, users, partners, people in the organization, external suppliers, unions, governments ...
62
Typical stakeholders in an organization are:
1. Customers
2. Shareholders
3. Providers
4. Personal
5. Competitors
6. Society
63
When looking at customers as stakeholders, we must __________.
take care of the quality of our products and / or services, loyalty and their satisfaction
64
When looking at shareholders as stakeholders of an organization, it is essential to _______________ of our organization.
pay attention to the productivity, costs, profitability and growth
65
When looking at Providers as stakeholders, the most relevant issues to be discussed with them are ____________.
strategic alliances and concerted quality
66
When looking at Personal as stakeholders, we are looking at ________________.
job security, personal and professional development, and staff satisfaction
67
When looking at our competition as stakeholders, it is very important to ______________ and ______________.
do an investigation of the competition to avoid being displaced
to be alert in terms of innovation and development, brand image and positioning
68
When looking at society as stakeholders, we must take care of aspects such as ___________, the ____________ and ___________ so as not to cause social unrest.
respect for the environment
impact of our activity on society
our corporate image
69
Chapter 6.1 is titled ____________.
Actions to address risks and opportunities
70
In chapter 6.1.1, "When planning the Quality Management System", the organization must consider the ____________, the ___________, and determine the risks and opportunities that must be addressed in order to:
issues referred to in section 4.1
requirements referred to in section 4.2
1. Ensure that the Quality Management System can achieve its expected results
2. Increase the desirable effects
3. Prevent or reduce unwanted effects
4. Achieve improvement
71
In chapter 6.1.2, the organization plans:
a) Actions to address identified risks and opportunities
b) The form of:
1. Integrating and implementing the actions in the processes of the Quality Management System (see 4.4.)
2. The evaluation of the effectiveness of these actions
72
Actions taken to address risks and opportunities must correspond to the potential impact on the conformity of products and services.
True
73
Options for dealing with risks may include:
1. avoiding risks
2. taking risks to pursue an opportunity
3. eliminating the source of risk
4. changing the probability or consequences
5. sharing the risk
6. maintaining risks through informed decisions
74
Opportunities can lead to the adoption of new practices, _________, opening new markets, ______________, establishing partnerships, using new technologies and other desirable and feasible possibilities to address the needs of the organization or those of your customers.
launching new products
| contacting new customers
75
Chapter 6.1 reflects a large part of what the ISO 9001: 2015 standard wants to convey. It is a very novel part, so it is the one that can have the most impact on current Quality Management Systems.
True
76
The objective of chapter 6.1 is to ___________ and that all the expected results are obtained in addition to ____________.
ensure that the Quality Management System works correctly
| a planning of the actions that will address all the risks and opportunities must be carried out.
77
The ISO 9001: 2015 standard does not establish the risk management methodology that must be used to identify, analyze and evaluate all the risks linked to processes, to reduce or eliminate all the failures that derive from the risks and to manage the risks of a proactively.
True
78
The risks spoken of in chapter 6.1 are __________, that is, risks that are closely related to the processes, activities or operations carried out by the company.
of an operational nature
79
In chapter 6.1, there is no talk of occupational hazards or risks that occur in emergency situations.
True
80
Some methodology that can be used to manage risks are:
1. COSO
2. AMFE
3. IRM
4. ISO 31000
81
ISO 31000 is _____________.
a series of standards that are established by the design and implementation principles to maintain risk management in a systematic and transparent way of any form of risk or any context.
82
El método AMFE o AMEF es ___________.
a widely used tool in risk management and is used to plan quality.
83
El método AMFE se caracteriza por:
1. Preventive nature
2. Systematization
3. Participation
84
In prevention, the company anticipates the failure to occur and has the possibility of acting preventively as soon as possible.
True
85
In systematization, the company guarantees that all the possibilities of failure have been taken into account
True
86
In participation, the company must keep in mind that developing an AMFE is a team effort and requires that it be put into operation thanks to the common knowledge of all the affected areas.
True
87
Chapter 6.2 is called _____________.
Objetivos de calidad y planificación
88
In chapter 6.2.1, the organization establishes ___________ for the corresponding functions and levels, as well as the _____________.
quality objectives
| processes necessary for the Quality Management System
89
The quality objectives of chapter 6.2.1 must:
1. Be in line with the quality policy
2. Be measurable
3. Consider the applicable requirements
4. Be successful for the conformity of products and services and for the increase of customer satisfaction
5. Be subject to monitoring
6. Be communicated
7. Be updated, as appropriate
90
In chapter 6.2, the organization retains documented information on the quality objectives.
True
91
In chapter 6.2.2, when planning how to achieve its quality objectives, the organization shall establish:
1. What is going to be done
2. What resources will be needed
3. Who will be responsible
4. The way in which the results will be evaluated
92
In chapter 6.2, all the characteristics that the company's quality objectives must meet are included and must be ____________, and they must _________.
coherent and measurable
| address how it is going to be carried out and who will be responsible
93
In section 6.2.1, the company must establish the _____________ to carry out all the pertinent functions and processes within the Quality Management System.
quality objectives
94
In section 6.2.1, the company has to decide the ___________. The quality objectives have to be ___________ and be _______, in addition to the improvement in customer satisfaction.
functions, levels and processes
consistent with the quality policy of the company
conspicuous to establish the conformity of the products and services
95
Quality objectives have to be ________, and have the customer and legal requirements monitored to ___________. _____________ should be made from time to time and be updated as the need arises.
measured
determine whether the objectives are met or not
Communications
96
In section 6.2.2, the company has to establish a ______ to determine how all the quality objectives are achieved.
plan
97
The organization must plan in order to determine how the quality objectives will be achieved.
True
98
stakeholder
person or organization that can affect, be affected by, or perceive themselves to be affected by a decision or activity
99
The term “___________” can be used as an alternative to “stakeholder”.
interested party
100
risk source
element which alone or in combination has the potential to give rise to risk
101
event
occurrence or change of a particular set of circumstances
102
An event can have one or more occurrences, and can have several causes and several consequences.
True
103
An event can be something that is expected which does not happen, or something that is not expected which does happen.
True
104
An event can be a risk source
True
105
consequence
outcome of an event affecting objectives
106
A consequence can be ___________ and can have positive or negative direct or indirect effects on objectives.
Consequences can be expressed _______________.
certain or uncertain
qualitatively or quantitatively
107
Any consequence can escalate through cascading and cumulative effects.
True
108
control
measure that maintains and/or modifies risk
109
Controls include, but are not limited to, _____________.
any process, policy, device, practice, or other conditions and/or actions which maintain and/or modify risk
110
Controls may not always exert the intended or assumed modifying effect.
True
111
The purpose of risk identification is to _____________. ______________ information is important in identifying risks.
find, recognize and describe risks that might help or prevent an organization achieving its objectives
Relevant, appropriate and up-to-date
112
Tangible Risk
A threat or opportunity that is by nature quantifiable or can be quantified using typical risk management tools and analysis
113
Examples of tangible risk include production risk, product risk, finance risk, and accounting risk
True
114
Production risk arises from a variety of causes such as ____________, etc. Causes for product risk may include ______________, and so on.
property damage, environmental damage, supply chain problems, dematerialization of risk
error in design and manufacture, product recall, low customer loyalty
115
Tangible risks can be easily quantified, meaning the benefits and costs _______________.
can be expressed in dollar terms
116
Intangible risks are ______________ and require a greater degree of subjectivity and intuition.
difficult to define in concrete and dollar terms
117
Schedule slippages, personnel unavailability and budget shortfalls are examples of ________________ risk
tangible
118
If not managed properly, tangible risks can lead to business risks such as lost customer sales.
True
119
Rising raw material and energy costs represent a ____________ for most companies because they ____________. A related risk is pricing pressure -- the inability of companies to increase prices because of competition from low-cost overseas suppliers and aggressive discounting by competitors.
tangible risk
| directly impact profitability
120
System failures or cyberattacks could cause serious disruptions throughout the supply chain, which could hurt production and sales for several companies simultaneously. This is an example of _________.
Tangible risk
121
Regulations, including environmental regulations such as carbon-trading schemes, and related compliance costs is one of the top __________ risks. This is an __________, because regulatory actions by governments worldwide cannot be reasonably predicted or quantified. Companies should use industry associations and lobby elected officials to anticipate and possibly shape regulatory changes rather than wait for them to happen
intangible
intangible risk
122
Economic and political volatility also are ___________ risks, both in emerging and developed markets. Rising protectionism sentiments, especially during downturns, represent a serious risk for global businesses.
intangible
123
Emerging technologies and the ability to constantly innovate are other_________ risks. Companies must not only ____________, they also must integrate new technologies -- such as social media and enterprise resource planning -- in their business processes to avoid being rendered obsolete by their competitors.
intangible
keep pace with the competition in terms of leading-edge products
124
10 no conformidades de calidad más comunes identificadas por ISO 9001 son:
1. Falta de documentación
2. Registro de los errores
3. Clientes infelices, negocios perdidos
4. Fallas en la capacitación del personal
5. No contar con un procedimiento de inspección final
6. Ausencia de verificaciones regulares de los procesos
7. Falta de participación de las personas
8. Ausencia de métodos que cubran las actividades y la planificación
9. La falta de calidad en las instrucciones de funcionamiento
10. Falta de un procedimiento de calibración
125
Si una empresa tiene una Falta de documentación, this means that ______________ and therefore _________________.
critical processes and procedures within the organization are not properly documented
the ability to look back and thus solve problems and improve efficiency in the product life cycle are limited
126
La inconformidad (incumple) de falta de documentación está corregido por la medida ________________.
documentar todos los procesos y procedimientos
127
Si una empresa no se registra sus errores, eso significa que ________________. Esa inconformidad está corregido por _________________ y tiene la ventaja de ________________.
Mistakes (Errores) are made but are not recorded in a timely manner, so Senior Management. doesn't know about them.
the timely and correct recording of errors
allowing the business to review and control (revisar y controlar) non-conformities and solve small problems before they become larger (antes de que adquieran mayores dimensiones).
128
La inconformidad de Clientes infelices y negocios perdidos significa que ________________.
communication mechanisms that allow the opinions, complaints or congratulations (mecanismos de comunicación que permiten conocer las opiniones, las quejas o las felicitaciones) of customers to be known is not present and the company only knows what the customers want but cannot predict their expectations based on trends that change every day
129
The needs of the customers should be the most important thing for the organization .
True
130
Communication mechanisms that allow the opinions, complaints or congratulations of customers to be known is essential for the success of the Quality Management System.
True
131
La incumple de Clientes infelices y negocios perdidos esta corrigido por _______________.
communication mechanisms that allow the opinions, complaints or congratulations (mecanismos de comunicación que permiten conocer las opiniones, las quejas o las felicitaciones) of customers should be put in place so the company can try to predecir (predict) sus expectativas con base en las tendencias que cambian todos los días
132
Fallas en la capacitación del personal (Failures in staff training) significa que _______________, y esto resulta en _________
el personal no fue capacitado adecuadamente
decrease in proactivity (disminución en la proactividad), incompetent workforce on jobs (mano de obra incompetente en los puestos de trabajo), and weak evidence of education and qualification when required (una evidencia débil de educación y calificación cuando es necesario).
133
No contar con un procedimiento de inspección final (Not having a final inspection procedure) significa que ________________.
The company does not know what is delivered and how it is delivered and therefore cannot effectively verify quality and compliance in the business.
134
No contar con un procedimiento de inspección final está corregido por las medidas ______________ y tiene las ventajas de _________________.
of carrying out inspections of the processes and procedures related to the deliveries of products and services to the end customer. (realizando inspecciones a los procesos y procedimientos relacionados con las entregas de sus productos y servicios al cliente final)
detecting the need to implement corrective actions in the future, thus helping to optimize processes and reduce future costs (detectando la necesidad de implementar acciones correctivas en adelante, ayudando así a optimizar sus procesos y reducir costes futuros)
135
Ausencia de verificaciones regulares de los procesos (Lack of regular process checks) significa que _________________.
regular checks on the different production processes, supervised by Senior Management are not carried out to verify that everything is in accordance with the requirements of ISO 9001 (controles regulares a los diferentes procesos de producción, supervisados por la Alta Dirección, para verificar que todo está conforme con los requisitos de ISO 9001 no se llevan a cabo)
136
Ausencia de verificaciones regulares de los procesos (Lack of regular process checks) esta corregido por _________________ y tiene la ventaja de _______________.
carry out regular checks on the different production processes, supervised by Senior Management , to verify that everything is in accordance with the requirements of ISO 9001 (practicando controles regulares a los diferentes procesos de producción, supervisados por la Alta Dirección, para verificar que todo está conforme con los requisitos de ISO 9001)
The company implements corrective actions that help fulfill the requirement of continuous improvement demanded by the standard (La empresa implementa acciones correctivas que ayudan a cumplir con el requisito de mejora continua que exige la norma.).
137
Falta de participación de las personas significa que _______________ y está corregido por ________________.
there is non- participation of employees , clients or other interested parties
identifying the most competent employees to be part of leading the work team in the SGC (identificando los empleados más competentes para integrar liderar el equipo de trabajo en el SGC.).
138
Ausencia de métodos que cubran las actividades y la planificación (Absence of methods covering activities and planning) significa que _______________ y está corregido por _______________.
The importance of planning activities and its influence on the QMS is not recognized and causes many ineffective actions to be implemented, which leads to invested time and resources in tasks that do not produce any results, leaving aside things that really matter .
139
La falta de calidad en las instrucciones de funcionamiento (Lack of quality in operating instructions) significa que ________________.
The instructions on the development and execution of tasks are not clear, so production and waiting times are impaired due to interruptions caused by the need to restart after writing clear and objective instructions .
140
Falta de un procedimiento de calibración (Lack of a calibration procedure) significa que _______________ y está corregido por __________________. Una ventaja de la corrección es ________________.
inadequate instruments and tools for verification of conformity are present in the company.
ensuring that calibration procedures for measuring, control, and verification instruments are in accordance with what is required by the manufacturer of those tools and that they follow the applicable legal guidelines and requirements.
The company is protected from unnecessary fines and value is added to its reputation.
