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WHAT IS THE ISO 9000 FAMILY? ISO 9000 is a family of standards for
quality management systems. It is maintained by ISO, the International
Organization for Standardization A set of rules in which to be followed in order
to meet needs (i.e. consumer) A standard in which to conduct business IOS?? - ISO was derived from the greek word
isos meaning equal
ISO 9000 FAMILY ISO 9004:2000 Quality management
systems - Guidelines for performance improvements.
ISO 9000:2005: Quality management systems - Fundamentals and vocabulary.
ISO 9000 FAMILY ISO 9001:2008
First Published in 1987 Revised in 1994 Revised in 2000 Current revision in the 11/15/2008
Hence it’s called ISO 9001:2008
ISO 9001-2008 SECTIONS 8 Sections total – req. found in 4-8
1.0 Scope 2.0 Normative referenced 3.0 Terms and definitions - ISO
9000:2005
ISO 9001-2008 SECTIONS
4.0 Scope (the way we run our business – structure)
5.0 Management Responsibility (management supports the structure)
6.0 Resource Management (people, buildings, machines, software)
7.0 Product Realization (the way we make our product)
8.0 Measurement, Analysis, & Improvement (product & process)
WHY ISO 9000? Ensures that a company has a quality
system in place and is using that system
Creates a competitive edge Increases Customer Confidence Foster employee confidence
ISO 9001 ELEMENTSISO 9001 Elements
1. Management Responsibilities
2. Quality System
3. Contract Review
4. Design Control
5. Document Control
6. Purchasing
7. Control of Customer Supplied Product
8. Product Identification and Traceability
9. Process Control
10. Inspection and Testing
11. Inspection Measuring and Test Equipment
12. Nonconforming Product
13. Corrective and Preventative Action
14. Handling, Storage, Packaging…
15. Control of Quality Records
16. Internal Audits
17. Training
18. Servicing
19. Statistical Techniques
CERTIFICATION
The International Organization of Standardization does not itself certify companies. Authorized accreditation bodies give
certification by auditing. Accreditation body members must declare their
common intention to join the IAF. International Accreditation Forum has the full
list of accreditors. Fees are involved for this service.
CERTIFICATION
The applying organization is reviewed based on an extensive appraisal of its sites, functions, products, services, and processes.
A list of problems is made known to the management.
ISO 9001:2008 certificate is issued If the problems are minor, Corrective plan is produced by the management.
An ISO certificate renewal is every three years.
CERTIFICATION
A company or organization may publicly state its conformance with ISO 9001:2008. DOs
Certified or Registered DON’Ts
ISO 9000 Accredited
Certification to the ISO 9001:2008 standard applies to the process not the product.
PROCESS FOR CERTIFICATION
Applying organization is reviewed based on appraisal of its sites, functions, products,
services, and processes
A list of problems is
made known to the
management
ISO 9001:2008 certification is
awardedIf problems are minor, a resolution plan must be
set in place pre certification
HOW POPULAR IS A CERTIFICATION
Rank Country Number of Certificates
1 China 297,037
2 Italy 138,892
3 Russian Federation 62,265
4 Spain 59,854
5 Japan 59,287
6 Germany 50,583
7 United Kingdom 44,849
8 India 33,250
9 United States 25,101
10 Korea, Republic of 24,778
AUDITING Two types required:
external certification body internal staff trained in ISO certification
The aim is a continual process of review and assessment in order to: verify the system is working as it should find out where it can improve and to correct or
prevent problems identified.
Internal auditors should audit outside their usual management line, so their judgments are not biased.
AUDITING The 2000 standard uses the process
approach. Auditors are expected to decide what is effective,
rather than what was formally prescribed.
Under the 1994 version, the question was broadly "Are you doing what the manual says you should be doing?“
The 2000 version, the question is more "Will this process help you achieve your stated objectives or is there a better way?
ACCORDING TO ISO.ORG“Without the international agreement contained in ISO standards on metric quantities and units, shopping and trade would be haphazard, science would be unscientific and technological development would be handicapped.”
ACCORDING TO ISO.ORG“Standards ensure desirable characteristics of products and services such as quality, environmental friendliness, safety, reliability, efficiency and interchangeability ”
When things work well we tend not to notice…
WHEN STANDARDS ARE ABSENT, WE SOON NOTICE
Products Poor qualityLack of fit Incompatibility with equipment that we
already haveUnreliabilityDanger!
SOME SPECIFIC EXAMPLES… Screw Threads
Helps assembly of productsSolves repair and maintenance problems
SymbolsProvide danger warnings and information
across language barriersCan you match the symbol to the meaning?
ISO 9001 - ADVANTAGES
Creates a more efficient & effective operation
Raises customer satisfaction & retention Enhances marketing Improves employee motivation,
awareness, and morale Promotes international trade Increases profit & productivity Reduces waste
PROBLEMS WITH ISO 9001
Time and Money
Prone to failure when a company is interested in certification before quality
Customer contractual requirements force certifications rather than a desire to improve quality
Certification by an independent auditor is often a problem ISO actually advises ISO 9001 implementation
without certification, simply for the quality benefits that can be achieved
ISO 13485:2003 – MEDICAL DEVICES ISO 13485:2003 - quality management system
for the design and manufacture of medical devices. Seen as first step in achieving European regulatory
requirements. In general ISO 13485:2003 is very similar to ISO
9001 but there is one significant difference ISO 9001 requires organizations to demonstrate
continuous improvement ISO 13485 requires the quality system only
demonstrate that it is implemented and maintained.
CURRENT GOOD MANUFACTURING PRACTICES (CGMP) Applied to Medical Devices in 1978 by the FDA GMP governs
Methods Facilities Controls
Used in Medical Device Design Manufacture Packaging Labeling Storage Installation Servicing
CURRENT GMP VERSUS ISO 9001
Medical device manufactures must comply with the quality system requirements laid down in Current Good Manufacturing Practice (cGMP)
GMP modifications were made by the FDA (in 1997) to bring the standard closer to ISO 9001/13485 requirements but did not exactly mirror it.
FUTURE OF ISO 9000 Next version is expected to be published
December 2015. Committee will vote to approve in March
2015.
QUESTIONS?????? NCR video www.youtube.com/watch?v=G8WI2Mgy
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Quality & ISO video http://www.youtube.com/watch?v=y4iIO
9Db5rk&feature=channel http://www.youtube.com/watch?v=0YAy
79hyJII&feature=channel