U4 Flashcards
Quality has always been a concern; in fact, the origin of systematic quality assurance lies in guilds (professional associations). Master craftsmen and journeymen were responsible for producing quality themselves. If they did not meet the quality requirements of customers, they were thrown out of the guild. Today, many firms seek to develop a competitive advantage.
One way of establishing a competitive advantage is to?
offer the best quality.
Closely linked to customer satisfaction, quality is of utmost importance for many firms. Satisfying a customer with a product or service is——————————-.
their core process
Even if a firm is performing very well in terms of quality, how does it maintain the standard or ensure that the standard is improved?
Just as people do not become successful overnight, neither do firms.
Successful firms need to understand their stakeholders, the market, and the external environment
They need to be creative and improve processes for achieving goals?
Because products and services are becoming increasingly complex so that people from different disciplines work on them together, a standardized approach is necessary.
To do so, firms need to define and understand?
quality and systematically assess it in their organization, e.g., with the help of a quality management system.
A quality management system (QMS) comprises of :
“the organizational structures,
responsibilities,
procedures,
processes,
and resources for implementing quality management”.
In other words, a QMS consists of:
a methodology for ensuring that a manufacturer produces to the required specifications.
The main reason for setting up a quality management system is to ?
reach the quality goals of a firm in a timely and transparent way and to secure the intended quality standard permanently.
The quality management system ensures that?
a firm fulfills the expectations of interested parties.
These can be internal parties like————————————-.
employees and managers or owners.
Employees, for example,
value transparency and job security.
Managers and owners appreciate?
the transparent organization and coordination of a QMS.
The fact that a QMS assures quality and saves time is valued by?
external parties like customers, shareholders, and suppliers.
Their expectations are fulfilled, their risks reduced, and they become more trusting of the firm.
A certified quality management system does not only increase trust, but can be?
the prerequisite for a contract?
In short, a “QMS indicates that?
there is control, auditing becomes possible and it increases the transparency of the operations”
There are several operational aspects that need to be considered when setting one up?
Because There are several demands on a QMS.
The figure below shows that a QMS exists within an integrated management system of a firm, ?
because it must also take into account quality requirements concerning, e.g., risk, facility, or environmental management.
image
Norm?
A norm is a document from a recognized institution that offers rules, guidelines, or requirements for an activity or their results for voluntary use.
A norm is a document from a recognized institution that offers?
rules,
guidelines,
or requirements for an activity or their results for voluntary use.
Management (EFQM) voluntarily to stay:
competitive
and improve their performance
Several types of norms exist on national, regional, or international levels, e.g.,?
ISO-norms on the internationa
l and EU-norms on the European level.
These regional or international norms are trade barriers because?
firms are expected to comply with them, while promoting world trade because they assure a certain quality standard.
Moreover, they represent a clear means of
—————- for all partners of the economic life and —————–protection; ———————-protection and employee protection would not be possible without ——————-.
communication
consumer
environmental
norms
ISO 9000 is a bundle of ?
international quality management standards.
These were developed to make sure that firms meet ?
customers’ needs
or needs of clients and partners while meeting legal and administrative requirements associated with a product or service.
In the USA, firms were required to assure their quality when?
supplying government procurement agencies or to win a contract.
This turned out to be difficult because ?
there were several different quality management frameworks.
The implementation of ISO 9000 reduced the difficulty of using ?
different quality standards and administrative procedures
The seven principles of quality management are specified in ISO 9000 and serve as?
the basis for the requirements of a quality management system.
These seven principles of quality management are the following:
==Customer focus. Because a firm is dependent on customers, it aims to meet and exceed customer requirements.
==Leadership. Managers should create conditions that facilitate reaching goals and quality objectives.
==Engagement of people. Everyone in an organization is competent, authorized, and committed to improving the organization and its value.
==Process approach. Quality management systems should follow a controlled process-oriented approach.
==Improvement. Successful companies improve continuously.
==Evidence-based decision-making. Decisions are based on the analysis of data and information.
==Relationship management. Organizations construct relationships to create value for all involved parties.
ISO 9000 thus lays?
the groundwork for further ISO norms.
It includes the ISO 9001 requirements on quality management systems for certification, as outlined in
the figure below, as well as the ISO 9004 norm.
image
image
ISO 9004 provides guidance on quality self-assessment methods in a wider context by including ?
provides guidance for systematic and continuous improvement of the overall performance of the firm
all relevant and interested stakeholders.
It is not a guideline for using ISO 9001, but?
provides guidance for systematic and continuous improvement of the overall performance of the firm.
ISO 9001:2015 consists of———————————- that specify requirements for quality standards
seven clauses
The first standard, ISO 9001:
1987 was revised several times
The date of the introduction of the norm is placed
behind the colon.
In 2021, the current standard is
ISO 9001:2015
Today, ISO 9001 is?
the most widely used quality management system
with 1.2 million certificates worldwide
The main idea of ISO 9001 is ?
“that good products can only come from good processes and these can only be effective in a system” .
Customers should be able to rely on?
an expert third party to certify compliance with minimum requirements.
image
The numbers in parentheses refer to seven clauses in the standard. These are explained below:
–Clause 4 specifies internal and external topics in the context of the organization and specifies the requirements on a QMS in an organization.
–Clause 5 concerns leadership issues and is thus placed in the middle of the PDCA cycle, as it deals with roles, responsibilities, and authorization in the organization.
–Clause 6 deals with planning issues, like the identification of risk and chances, and the definition of measurable quality goals.
–Clause 7 deals with requirements of how the QMS can be supported by providing resources, competences, consciousness, and communication, and dealing with documentation.
–Clause 8 regulates the requirements for the provision of operations, e.g., how processes are broken down into sub-processes and which requirements are demanded for products and services in the development, production, sales, and after-sales phase.
–Clause 9 explains how requirements are evaluated, e.g., customer satisfaction and internal audits.
–Clause 10 emphasizes the need for continuous improvement for products and services. If there is non-conformity (an error), it should be corrected, and a repetition should be prevented.
Although it is not formally required, many firms seek to find a registrar for formal documentation, because?
firms often require their suppliers to be ISO 9001-certified.
This process can be difficult because there is no —————————–, but several registrars have agreements with —————————————– or other authorities. It is challenging to find a registrar that can be used in several of the ———————————— where a firm conducts international ————-.
central authority
chambers of commerce
desired countries
trade
Although many firms that have introduced ISO 9001 have been very successful financially, there are also some drawbacks. One of the main obstacles with ISO 9001 is?
that it focuses on the delivery. In other words, if it is applied mindlessly by following “say what you do—do what you say,” procedures are only blindly followed and there is little room left for creativity
Further obstacles of ISO 9001 lie in overdocumentation, management reviews without:
influence or consequence,
internal auditing simply for compliance,
corrective and preventive action at a low level,
and failure to involve and engage employees in the QMS.
To overcome these obstacles and to succeed in innovation?
an agile management framework is required. Firms need to ensure that they stay innovative, especially when implementing a QMS.
Most firms treat the implementation of a QMS as a project that is?
planned one to two years in advance.
When introducing a QMS, it might be necessary to abandon all current documentation because?
it has become redundant. Each document needs to be checked to stay lean and flexible.
The following steps are conducted during a project timeline of 18 to 24 months:
1-The project starts when the decision is made.
First, top management needs to be dedicated and follow up on the project because awareness of top management closely relates to their knowledge about the purpose of a QMS and organizational culture.
Thus, after the project start, a situation analysis and an assessment of the organizational culture is usually conducted
