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Quality Introduction By Maya

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Title: Quality Introduction By Maya


1
Quality Systems Introduction" by Maya S.
2
INTRODUCTION TO QUALITY SYSTEMS
3
INTRO TO QUALITY
  • Quality systems are methodologies in which a
    manufacturer must establish and follow a system
    to help ensure that their products consistently
    meet applicable requirements and specifications.
  • If your customer does not require or specify any
    quality standard, you need to ask your self a few
    questions.
  • What benefits will a quality system give my
    company?
  • What quality systems are out there?
  • Which one will fit our companies needs?

4
IN THE PAST FEW YEARS THERE ARE TWO QUALITY
SYSTEM STANDARDS THAT ARE TALKED ABOUT.
GENERAL STANDARDS
ISO
Military
5
ISO 9000
It is now adopted as a world-wide standard. The
ISO 9000 family is a series of documents that
define requirements for the Quality Management
System Standard.
International Standards Organization (ISO) is
the International quality standard.
ISO 90002005
First developed in Europe to standardize between
separate country systems.
Fundamentals and Vocabulary used in the ISO 9000
Standards.
6
ISO 90012008 contains the actual requirements an
organization must comply with to become ISO 9001
Registered.
People often say "ISO 9000" certified, but what
they mean is they have met the requirements of
the ISO 9001 standard.
ISO 90012008
  • Past (Obsolete) versions of ISO 9000 include
  • ISO 90012000 was revised in the year 2008.
  • ISO 90012000 replaced the 1994 versions
  • ISO 90011994 - Manufacturing with Design
    Development
  • ISO 90021994 - Production and Installation (No
    Design)

7
ISO TS 16949
  • This quality system is an enhanced version of ISO
    9000 that reflects the needs of the automotive
    industry.
  • This certification is required for all
  • first- tier suppliers of the Big Three
  • automakers.
  • The goal of ISO TS 16949 is the development of a
    quality management system.

8
ISO TS 16949
  • Avoid multiple certification audits.
  • Provide a common approach to a quality management
    system for automotive production and relevant
    service part organizations.
  • Be applied throughout the automotive supply chain.

9
What is the most important reason you would like
to implement ISO / IATF 16949 Certification?
  • Improve your image and credibility  When
    customers see that you are certified by a
    recognized certification body,
  • They will understand that you have implemented a
    system that is focused on meeting customer
    requirements and improvement.
  • This improves their trust that you will deliver
    what you have promised.

10
  • Qualify to supply the automotive industry  This
    is one of the main drives for companies to get
    certified against IATF 16949. In order to get big
    customers from the automotive industry.
  • Improve customer satisfaction  One of the key
    principles of the IATF 16949 QMS is the focus on
    improving customer satisfaction by identifying
    and meeting customer requirements and needs.

11
  • Fully integrated processes  By using the process
    approach of IATF 16949, you not only look at the
    individual processes in your organization, but
    also at the interactions of those processes.
  • Use evidence-based decision making  Ensuring
    that you are making decisions based on good
    evidence is a key to the success of an IATF 16949
    QMS.

12
  • Create a culture of continual improvement  With
    continual improvement as the main output of the
    QMS, you can attain ever-increasing gains in
    savings of time, money, and other resources.
  • Engage your people  Who better than the people
    working within a process to help find the best
    solutions for improving that process?

13
ISO 13485
  • Is the ISO 9000 for medical device manufacturers.
  • Embracing the FDAs good manufacturing practices,
    this standard defines terms such as.
  • Medical device, active medical device, active
    implanted medical device, sterile medical device,
    and more.

14
ISO 13485
  • The primary objective of this standard is to
    facilitate harmonized medical device regulatory
    requirements for quality management systems.
  • Due to these exclusions, you will not be able to
    claim conformity to ISO 9001.

15
AS 9100
  • Aerospace Standard
  • Is a requirement that is above ISO90012008, used
    in the aerospace industry.
  • Currently the highest level of quality system
    possible.

16
ISO 14001
  • It deals with environmental management system
    requirements such as
  • Documentation, training, auditing, defining
    environmental aspects and their impact,
    performance evaluation, life cycle assessments,
    leadership, and continuous improvement.

17
ISO 14001
  • What are the benefits of implementing an
    Environmental Management System (EMS)?
  • Can positively affect your company's bottom line.
    Potential savings can amount to millions of
    dollars in reduced fines and penalties alone.

18
THANK
YOU
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