CHAPTER 5 : ISO 9000 Flashcards
a specialized agency for
standardization, the International Organization for Standardization (ISO), founded in 1946 adopted a series of written quality standards in ______ .
1987
. It is an independent, non-governmental international organization with a membership of 169 national standards bodies.
International Organization for Standards
ISO is a scientific term for _______ (as in isotherm lines on a weather map, which show equal temperatures).
equal
documented agreements that include technical specifications or other precise
criteria to be used consistently as rules, guidelines, or definitions to ensure that materials, products processes, and services are fit for their purpose.
Standard
ISO standards are internationally agreed by experts. Think of them as a _______ that describes the best way of doing something.
formula
The standards required __________ for all processes affecting quality and suggest that
compliance through auditing leads to continuous improvement.
documentation
A company could comply with the standards and still produce a poor-quality product as long as it did so consistently!
True
family standards
focus on developing, documenting, and implementing procedures to ensure consistency of operations and
performance in production and service delivery processes, with the aim of continual improvement, and
supported by fundamental principles of total quality
ISO 9000
standards originally were intended to be advisory in nature and to be used for two-party contractual situations (between a customer and supplier) and for internal auditing.
ISO 9000
Recertification is required every ______ years
three
ISO 9000 has three principal benefits
- It provides discipline.
- It contains the basics of a good quality system
- It offers a marketing program
help businesses of any size and sector reduce costs, increase
productivity, and access new markets.
ISO International Standards
provide specifications to ensure products and services work the way you expect them to.
ISO standards
ISO and policy makers
Consistent, transparent, targeted
SO standards help policy makers to:
- Open up world trade
- Stimulate solutions to national and international issues
- Save money
- Provide solutions to policy issues
” A third-party company called a _________ is the only authorized entity that can award ISO 9001 certification.
They are accredited by an authoritative national body and are
contracted by companies to evaluate their quality management system to see if it meets the ISO 9001 standards
Registrar
measures how effectively management determines the company’s overall quality policy, its objectives, and its responsibilities, as well as its quality policy
implementation.
Quality management
an explicit requirement.
Customer Satisfaction
few final steps worth taking before booking your certification audit:
- Get the QMS running (present schedule)
- Gap analysis (prove that customers are satisfied)
- Pre-certification audit (internal audit - if requirements are met)
Do I have to certify?
If you’re happy simply gaining these benefits and are not too terribly worried about being able to demonstrate your credentials, then conformance may be
enough.
Certification is an expensive disruption.
the length of the certification audit scales with the size of your organization,
There’s so much documentation involved.
No, just make sure you have enough documentation to tell people how
the process works (a work instruction for the product/ service and for checking the product/service) where
it is needed and to check that they’re doing it correctly (such as a log or checklist).
Certification won’t guarantee quality
Yes, because it focuses on compliance rather than improvement.
What certification does guarantee is that your organization is doing everything it can to ensure quality and
minimize customer dissatisfaction.
Can’t my customers audit my quality processes instead of paying for a certification body?
if you have several customers who all want
validation of your quality credentials, then repeated audits by your customers is likely to become a significant burden and disruption
The certification auditor is just looking for problems.
This is only true if you have a very bad auditor. Certification Body auditors are passionate about quality management and, like anyone passionate about something, they want to see it done right.
Maintaining quality
Although a certification to ISO 9001:2015 is proof that your organization has implemented a
management system that conforms to the specification, it is not proof that your organization continues to
follow best practice.
select an appropriate process approach
You should be sure that it has a cyclical structure
* Plan-Do-Check-Act Cycle
* DMAIC
“The quality of an organization’s products and services is determined by the ability to satisfy customers and the intended and unintended impact on relevant interested parties”, which makes it a function of the
organization’s ability to do business with its customers and other interested parties.
Quality
This is a broad idea,
encompassing the organization’s business environment, industry, major partners and suppliers, legal
requirements and so on.
Also consider the organization itself - want to achieve
Context of the organization
comprises all forms of documentation:
policies, procedures, work instructions, records and so on.
Documented information
As such, the
documented information you choose to develop (or where your organization’s‘context’ requires it) should
be an accurate ___________ of the actual quality processes you have in place
reflection
By staying aware of the importance of inputs and outputs when designing or formalizing your QMS processes, it is much simpler to make sure that they are appropriately
identified, measured, and tracked.
Inputs and outputs
people and organizations
with some interest in your organization and its activities. By default, this will include customers and suppliers, regulatory bodies and so on.
Interested parties
effect of uncertainty
risk
represents potential events that have consequences for the organization, which should either be planned
for (to limit the effect and/or compensate when they occur) or prevented.
Risk
The Standard comprises ten clauses of which
seven (Clauses 4–10) specify the requirements for a QMS
- Context of the organization
- Leadership
- Planning
- Support
- Operation
- Performance evaluation
- Improvement
directed almost solely at “top management”, which is the “person or group of people
who directs and controls an organization at the highest level”.
This focus makes sure that the QMS is led
by individuals able to provide the resources and authority to establish, implement, maintain, and improve
the management system.
Clause 5 – Leadership
which declares the organization’s dedication
to and perspective on quality.
quality policy
required to assign appropriate roles, responsibilities, and authorities
relating to quality and the QMS.
top management
focused on risk, quality objectives and change, which are interrelated functions within the QMS
Clause 6 – Planning
Supporting the QMS by providing the necessary resources and organizational structures is critical to the success of any management system.
Support
The Standard broadly divides support into
resources,
competence,
awareness, communication, and documented information.
covering people,
infrastructure, environment in which the processes are operated, measuring and organizational
knowledge.
resource
The organization
should establish methods of identifying the actual requirements, assessing whether the appropriate
individuals meet those requirements, and how to develop the necessary ____________
competence
“ability to apply knowledge and skills to achieve intended results
Competence
apply to all persons doing work under the organization’s control,
which can include people who are not ordinary employees of the organization, such as contractors, suppliers’ employees and so on.
awareness
both internal and external communications,
communication procedures should not be difficult
communication
This is one of the more
demanding parts of the Standard because many organizations do not document their processes or take
the time to properly manage what documentation they do keep.
documented information
the organization needs to make sure that
any QMS documents describe what you actually do, and that what you are actually doing is sufficient to
meet your quality objectives
responsibility for quality largely resides in the organization’s day-to- day operations
Clause 8 – Operation
The subclause e 8.5.5 requires the organization to preserve outputs during production and service provision, which
makes sure that there is an ____________ following the product/service through its production lifecycle.
auditable trail
There are three core practices involved in performance evaluation:
- monitoring, measurement, analysis, and evaluation
- internal audit
- management review
planned assessments that focus on the functioning of the QMS, its conformity with the organization’s own
requirements and those of ISO 9001.
internal audits
process by which the organization’s top management formally
assesses the QMS and determines any necessary changes.
management review
improving the processes that govern quality management will naturally improve the quality of products and services
means that it recurs regularly; it is something that is repeated frequently
- Continual
means that it occurs without interruption
- Continuous
organization must make sure that it continually
examines opportunities for improvement (to both the QMS and to quality in general) and implements
those that are viable
