Registration Process Steps
The Registration Process at
International Quality Registrars (IQR) Corporation involves the following
steps:
A – DOCUMENT REVIEW
B – PRE-ASSESSMENT (OPTIONAL)
C – REGISTRATION AUDIT
D – SURVEILLANCE AUDITS
E - VALIDITY OF REGISTRATION
CERTIFICATES
A - DOCUMENT REVIEW
Purpose
The document review addresses
the recorded description of the methods selected by the company for
meeting the quality system requirements (such as the quality manual). It
provides a basis for the company and the lead auditor to determine that
the system, as described, is complete and that the audit objectives for
registration are achievable.
Process
Prior to the pre-assessment
and/or registration audit, the quality manual and applicable procedures
are submitted to International Quality Registrars (IQR) Corporation for
review*. The revision status is verified and the contents are compared
with the requirements of the selected standard. Any requirements that are
not or do not appear to be covered will be identified and a request will
be made for either clarification or for action to expand the system
description. A summary of these items is sent to the company and the
process is continued until it is determined that the system description is
complete.
*
- The document
review can also be initiated at the time of the pre-assessment if so
desired. Determination of the timing of the document review is completely
at the discretion of the company as long as it is completed prior to the
registration audit.
Results
Upon completion of the document
review, plans are finalized for the registration audit. Any revisions made
to the reviewed documentation by the company are communicated to
International Quality Registrars (IQR) Corporation to ensure continuing
validity of that plan.
B – PRE-ASSESSMENT (OPTIONAL)
Purpose
The pre-assessment is conducted
to assist the company in determining the status of its implementation of
the quality system. It will allow the company to determine the timeframe
for full implementation and schedule its registration assessment.
Time
The size and complexity of the
operation defined by the quality system documentation will determine the
amount of time needed to perform the pre-assessment. Typically, one to two
days is sufficient to assess those activities that significantly impact
the overall effectiveness of the system. Additional time can be scheduled
depending on the extent of the pre-assessment up to and including a full
system evaluation.
Process
The company representative and
International Quality Registrars (IQR) Corporation will establish a lead
auditor, determine the amount of time needed to perform the pre-assessment
and decide the elements/activities to be addressed. The company
representative will then notify the personnel who operate the quality
system of the agreed upon schedule.
The pre-assessment begins with
an opening meeting where the audit and registration guidelines are
presented, the plan for elements/activities to be covered is updated and a
decision on the reporting method is made based on the needs of the
company. An audit format is followed which includes documentation review,
observation of activities, interviews with personnel and quality record
review. This will continue throughout the duration of the pre-assessment.
Any changes made to the areas that are covered will be submitted to the
company representative for approval.
Outcome
The lead auditor presents the
results of the pre-assessment at the closing meeting. These results are
for the company use only and are not used during the registration
assessment.
C - REGISTRATION AUDIT
Registration Audit Team
The audit team is introduced,
in writing to the client. The client shall review the audit team and, if
any concerns exist, contact International Quality Registrars (IQR)
Corporation The client can request a replacement for another team without
giving a reason.
Registration Audit Schedule
The client has 2 days prior to
the initial scheduled audit to change the date. A registration audit
schedule and checklist are sent to the client within two (2) days prior to
the registration audit.
Registration Audit Progress
Reports
Daily meetings are held by the
audit team with the client to discuss audit progress as well as any
non-conformities discovered or concerns that have arisen.
Registration Audit Completion
Upon completion of the audit, a
closing meeting will be held to discuss any non-conformances discovered.
During this meeting, the client will have the opportunity to propose
corrective action to the audit team for approval. The client must confirm,
in writing, the implementation of any corrective actions taken. The
effectiveness of corrective actions taken is verified during the
subsequent surveillance audit.
D - SURVEILLANCE AUDIT
General
International Quality
Registrars (IQR) Corporation will propose surveillance audit dates at
least four to six weeks prior to the audit. The client is requested to
confirm these dates or propose alternative dates.
A surveillance audit schedule
including the elements to be audited will be sent to the client so that
all personnel/departments can make arrangements for the audit.
Upon completion of the
surveillance audit, a meeting is held with the client to discuss any
non-conformances found. The client has the opportunity to propose
corrective actions and establish a timeframe for implementation of these
actions.
E - VALIDITY OF REGISTRATION
CERTIFICATES
The client has two types of
certificates to choose from:
Three Year Validity
Registration Certificate
- this certificate is valid for three
years. Annual surveillance visits are carried during the validity period.
One Year Certificate of
Compliance
- this certificate is issued with a 1 year validity
period. Optionally, Surveillance visits maybe conducted every six months.
It is mandatory that all elements of the appropriate standard(s) are
audited within a one year period.