Session 2: ISO 9000/ISO 14000 Standards & Registration Process

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Session 2

Overview
ISO 9000/ISO 14000 Standards &
Registration Process
ISO 9000/ISO 14000 Standards
• ISO 9000 is a family of standards which
address Quality Management Systems
• ISO 14000 is a family of standards which
address Environmental Management
Systems
• Each management system is intended for
the Organization to achieve a recognized
level of competency, so as to be
recommended for Registration.
Goals of ISO 9001 Standard
• Increase Customer Satisfaction
• Reduce Organization Non-Conformity
• Ensure continual improvement of the Organization’s
quality management system and its product/service
effectiveness
• Serve as a recognized Aerospace Industry Quality
Standard
• Reduce individual customer audits
• Organization to “walk the talk” making these standards a
normal part of their daily operation.

Bottom Line: Enhanced customer satisfaction, more


business and improved financials, better job
advancement opportunities
Goals of the ISO 14001 Standard
• Help organizations achieve their
environmental and economic goals
• Meet legal requirements and other
requirements
• Help our Planet Go Green!
Focus of these Standards
• Top Management buy-in and involvement
• Process-oriented/process approach
• Data-driven
• Emphasis on continual improvement of
both management systems, and on the
effectiveness of the processes used to
provide the final product or service.
Why should a company want to
be registered?
• Major customers are demanding registration.
• Allows the Organization to conduct business outside of
the United States
• It is becoming an industry norm.
• Some customers accept the third-party audit report in
lieu of conducting their own on-site audits.
• It helps the Organization improve its processes so as to
be more efficient and effective.
• These standards drive improvements in quality,
schedule, continual process improvements, and use of
best practices
What is Registration?
• Registration is a process whereby a third-party
organization verifies the Organization’s compliance to
the requirements of the standard and determines that
their processes are effective, so as to recommend them
for registration.

• The Organization receives a registration certificate good


for 3 years.

• During this 3 year period, the third-party organization will


conduct regularly scheduled on-site surveillance audits
to confirm continued compliance and to assess the
effectiveness of their processes. At the end of the 3 year
cycle a Re-assessment audit will be conducted and the
cycle continues.
Levels Of Auditing
• First Party Audit - is any audit by an
organization on itself, i.e. an internal audit.
• Second Party Audit - is an audit by one
organization, working on behalf of another;
example is auditing a supplier
• Third Party Audit- is an audit by an
external independent organization; such
as ISO9001 or ISO 14001.
Who conducts the Registration and
Surveillance Audits?
• A third party organization (referred to as a Registrar) has
a pool of trained and certified subcontract auditors who
are sent to the Organization to conduct the on-site
registration and subsequent surveillance audits.
• Audits are conducted by the subcontract auditor(s) to the
requirements of the respective management system
standard.
• The scope of the organization is defined. They are
required to provide justification for that clause(s) of the
Standard that the Organization determines is not
applicable to scope of their quality management system.
Example: An Organization who only builds to a
customer’s print would not have design as part of their
scope (In earlier revisions of the QMS standard they
clauses use to be called an exclusion).
Who conducts Registration and
Surveillance Audits Continued…?
• Audit reports are issued by the subcontract
auditor and evaluated by an independent
experienced Registrar auditor (CB) to verify the
completeness and accuracy of the report, its
contents and recommendation.

• The focus of these audits is to assess


Organization compliance to requirements, and to
assess the effectiveness of the Organization’s
processes.
Registration Process Steps
1. On-Site Readiness Review (Stage 1)- Review their
documentation, tour the Organization’s facility, and
conduct a top level process/documentation readiness
assessment.

2. Registration Audit (Stage 2) - Verify compliance to all


the requirements of the management standard and
assess core process effectiveness.

Surveillance Audit- Surveillance audit frequency is


mutually established. During a surveillance audit a
sample of requirements from the standard are selected
and the Organization is audited to verify sustained
compliance to requirements and for process
effectiveness.
Documenting Findings
• Audit findings (non-conformances*) are
classified as “major” or “minor” and are
documented for resolution by the Organization.
Generally speaking -Isolated occurrence vs. a
systemic (wide spread) problem
• The Organization is required to investigate each
non-conformance to achieve its root cause, to
ensure full containment, and to identify and
implement corrective action(s), and as
applicable, preventive action(s). Transistor
Story-
• *Non-fulfillment of a requirement
What is Corrective Action?
• Positive action(s) are defined and
implemented to ensure that the root cause
for the non-conformance does not repeat.
• Corrective action prevents recurrence!
What is Preventive Action?
• When a potential problem is recognized,
actions are taken to prevent its
occurrence.
• These actions are called Preventive
Actions.
• Potential problems can be found by
identifying a data trend, by observation, by
control charts, etc.
Corrective/Preventive Action
Story

True story used to help remember the


difference between both terms.
“Going to the show”
How to become a subcontract
auditor.
• Contact Exemplar Global (formerly known as
RABQSA).
• Requires taking an Exemplar Global approved
lead auditor training course, obtaining on-site
auditing oversight experience, related
experience if possible, and some written
recommendations.
• Benefits: Attractive auditor fees, paid travel
expenses, work with lots of companies, identify
best practices.

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