Quality Control and Assurance

Is a global association consisting of national

standardization bodies that support the
development of related standardization to help
international trade, and also to help develop global 1. Increase Company Credibility
cooperation in the fields of science, technology and 2. Increase Consumer Confidence
to set international economic activities. produce international 3. Quality Assurance In Accordance With
standards in the industrial agreements which are then published as International Standards
and commercial fields. international standards 4. Optimizing Employee Performance
5. Save Cost

Goal
Definition Advantage

Types

-ISO 9001 (quality management system)

-ISO 14001 (environmental management system)
-ISO 22000 (food safety management system)
-ISP 27001 (information security management system)
-ISO 16949 (automotive quality management system)
Clouse separate provisions of an agreement that
-ISO 17025 (standard testing institute or laboratory)
has been made by ISO, which one of the
-ISO 28000 (high-risk enterprise supply chain security system)
principal or the article is to support the ISO
-ISO 5001 (energy management system)

ISO 9001

Quality Management
System, or quality assurance
system, which is a standard
mechanism that is prepared,
agreed upon, and implemented
by an organization in carrying
out the activities of a company.
-How the company operates
-How work flows from one activity to
another.
-Handling jobs, inputs, processes,
outputs
-Physical parameters of the work
to prevent temporary errors in the
project and to prevent mistakes after
the product is delivered to the
customer. organizations that embrace /
run the quality management system,
DIMAS MAHENDRA
strive more in improving the quality of PUTRA/1411800054
management.
Quality Control and Assurance
ISO 9001:1987
Procedure
The ISO standard on the 1987
version of QMS has the same
structure as BS 5750, with 3
(three) QMS models:
for quality assurance in
design,
for QA in production, and
for QA in final testing and
inspection only.
ISO 9000: 1987 is influenced
by military standards in the
United States in particular,
but is also suitable for
manufacturing
ISO 9001:1994
Praventive action
Because the need for
guaranty quality is not only
in the final inspection
aspect, but also
emphasized the need for
preventive action
processes to avoid
mistakes in the process
that causes incompatibility
in the product
In ISO 9000: 1994 there are
3 versions, namely 9001
about design, 9002 about
production process and
9003 about services.
ISO 9001:2000
Process Approach
& PDCA
the smallest organization
can implement an ISO
9001: 2000 system with
various exceptions to its
business processes. ISO
9001: 2000 still requires 6
procedures that must be
documented, namely
Procedure Control of
Document, Control of
Record, Control of Non
Conforming Product,
Internal Audit, Corrective
Action and Preventive
Action
ISO 9001:2008
Process Approach
& PDCA
was born as a form of
refinement of the 2000
revision. The 2008 version
stipulates that the
corrective and preventive
action processes
undertaken must
effectively have a positive
impact on the process
changes that occur within
the organization. In
addition, the emphasis on
outsourcing process
control is highlighted in
this latest ISO 9001
version.
ISO 9001:2015
Risk &
Opportunities
Also the application of Risk
Management in each line of
business enables the
company to always calculate
the risks that will be faced
from every action or decision
taken. The application of
High Level Structure makes it
easy to integrate one
management system with
another management
system. It is expected that
this ISO 9001: 2015 can
encourage the application of
other management systems
to the company.
Quality Control and Assurance
NORMATIVE REFERENCE
There is nothing special about this clause
SCOPE
There were not many significant
changes between clause 1 of 2008
and 2015 other than adding "Service"
after "Product" because in the ISO
9001: 2015 version, the terms
product and service were clearly
differentiated to avoid confusion.
IMPROVEMENT
Clause 10 contains the efforts for
continuous improvement that must be
done by the organization
The concept is more or less the same as
the concept of corrective action and non-
confirmity at ISO 9001: 2008
It's just that the approach used is a risk
management approach where there are
no more preventive action breaks but
there are risks and opportunities
PERFORMANCE EVALUATION
Clause 9 again shows that ISO 9001: 2015 is neater
in grouping clauses
All matters relating to evaluation are collected in
this clause such as internal audit, process
measurement and monitoring and customer
satisfaction, process analysis and evaluation, to
management review meetings.
TERMS AND DEFINITIONS
There is nothing special about this clause
CONTEXT OF THE
ORGANIZATION
Clause 4 in ISO 9001: 2008 directly
explains the requirements of ISO
9001 documents. As for ISO 9001:
2015, it is limited to discussing the
organizational context.
LEADERSHIP
In general, the contents of clause 5
of ISO 9001: 2015 are no different
from ISO 9001: 2008 which discusses
the obligations that must be carried
out by top management
PLANNING
This is a completely new clause
compared to ISO 9001: 2008. The
emphasis of clause 6 of ISO 9001:
2015 is to ask each organization to
recognize risks and opportunities;
strive to seize opportunities and
prevent, reduce and manage risk
OPERATION SUPPORT
All matters relating to the organization's operations are ISO 9001: 2015 is neater in grouping clauses.
discussed in this ISO 9001: 2015 clause 8. discuss all Everything related to support is supported in clause
aspects of operations ranging from product or service 7.
planning, production or service delivery, relationships Clauses on documents, infrastructure, human
with customers and third parties, storage and protection resources, competencies, outreach and
of products or services to handling problems during the communication, to measuring tools, are all
operational process. collected in this clause