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DOCUMENT REVIEW
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Prior to the pre-assessment and/or registration audit, you must submit your
quality manual to AMTec for review. Its contents will be compared with the
requirements of the ISO 9001:2000 standard. Any requirements that do not appear
to be covered will be identified and AMTec will request either clarification or an
action to expand the system description. A summary of these items will be sent
to you and the process will continue until it is determined that your system
description is complete. On completion of the document review, plans will be
finalized for the registration audit.
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PRE-ASSESSMENT (OPTIONAL)
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Your company may choose to go through an optional pre-assessment to assist in
determining the implementation status of your quality system.
Pre-assessment helps your company to determine:
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the steps necessary for full implementation. |
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an appropriate schedule for your registration assessment. |
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A pre-assessment follows an audit format including document review, observation
of activities, interviews with personnel and quality record review. At a
closing meeting, results of the pre-assessment will be presented and an
evaluation of the implementation status of the quality system will be made by
the lead auditor. These results are for your company’s use and are not used
during the registration assessment.
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REGISTRATION ASSESSMENT
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The principal purpose of the Registration Assessment is to assess your company’s
Quality Management System to the ISO 9001:2000 standard and to ensure that
policies and procedures are effectively implemented and your Quality Management
System is suitable and effective in supporting the company’s quality policy and objectives.
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During the audit, daily meetings will be held by the audit team with your management team to
discuss audit progress and any nonconformities as they are discovered or concerns that have arisen.
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To achieve Registration, your company must: |
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Provide the audit team with sufficient objective evidence for them ultimately to
conclude that your management system has been fully documented and effectively
implemented in accordance with ISO 9001:2000.
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Provide the audit team with the appropriate records, so they may review records within
the system as they provide vital evidence of the effectiveness of the program.
Records of customer complaints, including changes in procedures and work
instructions resulting from corrective actions, should be readily available.
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Provide the audit team with the appropriate records, so they may review records within
the system as they provide vital evidence of the effectiveness of the program.
Records of customer complaints, including changes in procedures and work
instructions resulting from corrective actions, should be readily available.
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Allow the audit team access to facilities, personnel and records in order that they
can verify that your company’s Quality Management System has been implemented
and is being maintained.
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Cooperate fully in the resolution of any non-conformances.
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On completion of the audit, a meeting will be held with management to review any
nonconformities discovered. During this meeting, you will have the opportunity
to propose corrective action to the audit team for approval. You must provide,
in writing, the implementation plan for any corrective actions taken. The
effectiveness of corrective actions taken will be verified during the
subsequent surveillance audit.
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You can help |
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As part of the registration process you can assist us in the following ways: |
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Provide an escort for each of our auditors during on site activity.
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It is important that your Management Representative be available during all phases
of the Registration Assessment.
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Provide a room or work area for the audit team to use during on site activity with a telephone.
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Confidentiality
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Any and all information that comes into possession of AMTec, its employees and
agents, throughout the entire registration process described herein, except as
required by the Law of the Land, and the relevant Accreditation Authorities,
will be treated as strictly confidential. AMTec will not share any information
with a third party without prior written consent of the Client.
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SURVEILLANCE
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AMTec will notify you no less than 30 days in advance of the proposed Surveillance
Visit. Surveillance Visits will take broadly the same structure as the
Registration Audit, but on a smaller scale.
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Semi-annual Surveillance option |
Five surveillance audits are conducted approximately six months apart. AMTec
auditors will minimally review 1/3 of your system at each visit. A benefit of
this option is greater assurance of continued maintenance of the management
system due to the frequent surveillance audits. Clients that successfully
complete this surveillance program without any major findings may be eligible for
a reduced re-registration audit.
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Annual Surveillance option |
Two surveillance audits are conducted approximately twelve months apart. AMTec
auditors will minimally review 1/2 of your system at each visit.
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At a minimum, customer complaints and your organization’s response, internal audit
review, planning and results, management review results and actions, and
progress made towards continual improvement targets will be reviewed at each
surveillance audit.
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Special Surveillance Audits |
Should circumstances dictate the necessity, AMTec will conduct a Special Surveillance
Visit in the course of maintaining the registration. Circumstances may include
the customer wishing to extend the Scope of Registration, a significant change
in the Customer’s Management System or Organizational structure, after a merger
or acquisition, as required in response to a sanction by your customer, or due to the
issuance of a major non-conformance.
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Corrective Action(s) arising from Assessment or Audit Visit(s) |
Corrective Action Requests (CAR) arise when there is a lapse in the implementation of your
system. During a Registration Assessment or a Surveillance Visit, your AMTec
audit team may issue a Corrective Action Request. You are required to close
these corrective actions (both minor and major). Minor corrective actions are
minor lapses in the implementation of your system and are not considered
critical. Major corrective actions are typically systemic in nature and could
materially affect the system.
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RE-REGISTRATION
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| Accreditation
requires that the entire system be assessed at a minimum of once every three
years. Each surveillance audit will re-examine part of the system and a
re-assessment will be conducted at the beginning of each three year cycle based
on current published requirements of the ISO 9001:2000 standard. AMTec will
issue a new Certificate of Registration, upon successfully conducting an
assessment visit at the end of your re-registration. AMTec reserves the right
to conduct a re-assessment of your system at a length of time less than the
standard’s minimum requirements if (in the opinion of your Lead Auditor) your
system has been maintained in a marginal state of implementation.
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