1.0 Types and Schemes of Certification
Purpose of Management System Certification
: Certification of
management systems provides assurance that an organization has implemented a
system for managing relevant aspects of its activities, products, and services
in line with its policy and international management system standards. This
certification demonstrates that the organization’s management system:
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Conforms to specified requirements.
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It is capable of consistently achieving its
stated policy and objectives.
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It is effectively implemented​​.
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Quality Management System (ISO 9001)
: Focuses on
meeting customer requirements and improving customer satisfaction.
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Environmental Management System (ISO 14001)
: Aimed at
managing environmental aspects, ensuring compliance with environmental
laws, and continually improving environmental performance.
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Occupational Health and Safety Management
System (ISO 45001)
: Ensures a safe and healthy working
environment by preventing work-related injury and ill health.
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Food Safety Management System (ISO 22000)
: Addresses
food safety through the control of food safety hazards.
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Medical Devices Quality Management System (ISO
13485)
: Pertains to quality management systems
specific to the medical devices industry.
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Energy Management System (ISO 50001)
: Involves the
development and implementation of an energy policy, setting targets for
energy use, and designing action plans to reach these targets.
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Information Security Management System
(ISO/IEC 27001)
: Focuses on keeping sensitive information
secure, ensuring the confidentiality, integrity, and availability of
information.
1.1 Criteria for Granting Certification:
AMY may grant and issue the certificate to the
client under the following criterion:
(a) The client has a documented Management
system that is laid in accordance with its scope of certification and that it
conforms to the requirements of the applicable Management System Standard as
mentioned above.
(b) The Client has completed at least one cycle
of internal audit and management review of the management system established.
(c) Both internal audit and management review
have been found effective as assessed by AMY auditors.
(d) The client has paid all the dues including
the certification fee.
(e) The client shall keep a record of all
complaints and actions taken and the same shall be submitted to AMY auditors
for verification when requested.
(f) The client has undergone the stage 1 and
stage 2 audit satisfactory, and the recommendation of the audit team is
favorable.
2.0 Certification Process
2.1 Certification Agreement
On acceptance of the Quotation, this
certification agreement is signed between AMY and the client for providing
certification of the client’s management system by AMY to the applicable
international standard.
2.2 Stage 1 Audit & Documentation Review
AMY shall conduct a stage 1 audit at client site
to verify the adequacy of documentation with respect to the requirements of the
applicable standard and also to understand and gather further information on
the client activities and processes including applicable statues, to plan for
the stage 2 audit .The client shall satisfactorily resolve all the observations
raised in document review along with other concerns / issues highlighted during
the audit and the same confirmed to AMY before planning the stage –2 audit . AMY shall submit a formal
report to the client.
Note: for multi-site organizations Procedure
P-4-1-2 – Certification process procedure to be followed.
2.3 Stage 2 Audit
AMY’s audit team shall visit the client’s
premises, as per an agreed plan, to verify the effectiveness of the client’s
management system in meeting the requirements of the applicable ISO standard.
AMY shall submit a formal report to the client.
2.4 Non-Conformity Report
If a non-conformance is detected during the
audit, a Nonconformity Report shall be issued to the client. For the
non-conformities raised during the audit client shall submit the correction and
the corrective action plan (based on root cause) to AMY office within 10
working days from the last day of the audit. AMY shall verify the submitted
correction and the corrective action and confirm the acceptance of the same to
the client. Clients shall take the correction and corrective action within the
stipulated date and submit the documentary evidence to AMY to verify the
effectiveness of action taken and accordingly to close the non-conformances.
In the event of certification audit (fresh
client) AMY shall cancel the audit under the following conditions:
(a) Client does not submit Corrective Action
Plan for the Non-Conformity raised within 10 working days as stipulated above.
(b) In case of major non-conformity, the
verification of effective corrective action is not completed within 90 days.
(c) In case of minor non-conformity, the
verification of effective corrective action is not completed within 30 days.
In the event of certified clients AMY shall
suspend the certificate under the following conditions:
(a) Client does not submit a Corrective Action
Plan for the non-conformity raised within 10 working days as stipulated above.
(b) In case of major non-conformity, the
verification of effective of corrective action is not completed within 90 days
as stipulated above.
(c) In case of minor non-conformity, the
verification of effective corrective action is not completed within 30 days.
2.5 Recommendation for Certification
AMY shall recommend certification of the
client’s management system, based on the following:
(a) AMY has reviewed the audit reports and has
accepted the recommendations of the audit team.
(b) The client has submitted the correction and
corrective action for the non-conformities raised within the stipulated time
and AMY has accepted the same.
(c) In case of a major non-conformance, the
effectiveness of correction and corrective action is verified by AMY's auditors
as agreed and the non-conformity either closed or downgraded to minor.
If the client is not recommended for
certification AMY shall accordingly inform the client.
2.6 Issue of certificate
AMY shall issue the certificate against the
applicable standard to the client only after the closure of all the
non-conformances as stated in section 2.5 of this agreement.
The Certificate is the property of AMY and shall
be produced to AMY as and when requested.
The certification will be valid for a period of
three years from the date of approval of certification, subject to the
satisfactory maintenance of the Management System as confirmed through agreed
surveillance audits.
2.7 Surveillance Audit
Surveillance audits shall be conducted regularly
at the client site at least once a year to confirm that the Client’s Management
System continues to conform to the requirements of the standard to which it is
certified.
The date of the first surveillance audit following
initial certification shall not be more than 12 Months from the certification
decision date and failure to comply with this requirement will lead to
suspension and subsequently withdrawal of certification.
For the non-conformity raised during the
surveillance audit the conditions stipulated in section 2.5 of this agreement
shall be applicable.
If a surveillance audit cannot be carried out
because the client’s operations are affected owing to factors outside its
control, e.g.: employee union strike, natural calamity, etc. the case shall be
presented to AMY for a decision.
AMY shall submit a formal report to the client.
2.8 Re-certification Audit
The purpose of the recertification audit is to
confirm the continued conformity and effectiveness of the client’s management
system as a whole and its continued relevance and applicability for the scope
of certification.
The recertification audit shall include a site
audit and shall consider the performance of the management system over the
period of certification and shall also include a review of previous
surveillance audit reports. The recertification audit may have a stage –1 audit
in situations where there have been significant changes to the management
system, the client or changes to legislation.
AMY shall conduct the recertification audit at
least 60 days in advance to the expiration of certification so that the client
has time to implement corrective actions before the expiry of the certification
For non-conformities raised during the audit,
the conditions specified in section 2.5 of this agreement become
applicable. AMY shall submit a formal
report to the client.
2.9 Special Audit
AMY shall conduct special audits under the
following conditions,
(a) Extension to the scope of certification
already granted, on the request of client. This could be clubbed with routine
surveillance audit.
(b) To investigate complaints received by AMY
about the client.
(c) Follow up audit in case of suspension or
major non-conformity raised in any audit.
(d) Changes to AMY’s certification requirements.
For non-conformities raised during the audit the
conditions identified in section 2.5 of this agreement shall become applicable.
AMY shall submit a formal report to the client.
2.10 Notice of Changes by AMY
AMY shall inform the client in advance of any
changes to its requirements for certification and shall subsequently verify
that each client comply with this requirement. It shall necessitate a special
audit in certain cases.
2.11 Notice of Changes by the client
The client shall inform AMY, without delay, of
matters that may affect the capability of management system to continue to
fulfill the requirements of the standard used for certification. These may
include changes related to:
(a) The legal, commercial, organizational status
or ownership.
(b) Organization and management (e.g. change in
key managerial, decision making or technical staff).
(c) Contact address and sites.
(d) Scope of operation under the certified
management system.
(e) Major changes to the management system and
processes.
AMY shall review the changes and accordingly
discuss with client for an early verification to ensure that the capability of
the management system continues to fulfill the requirements of the applicable
standard.
2.12 Maintaining Certifications
The Certification is maintained for a period of
3 years under the following conditions.
(a) The Surveillance Audits are conducted as
planned and the client has demonstrated that they continue to satisfy the
requirements of the management system standard as confirmed by AMY.
(b) All the non-conformances raised during
previous surveillance are closed within the time frame agreed and correction
and corrective actions for the non-conformities raised during the current audit
are identified and accepted by AMY as per conditions specified in the section
2.5.
(c) The Internal Audit and the management
reviews are conducted as scheduled and there are no issues pending.
(d) The client shall maintain suitable records
of customer complaints and keep the records of investigation and remedial
actions taken with respect to such complaints for verification by the AMY
auditors.
(e) All outstanding dues to AMY are paid.
2.13 Suspending, Withdrawing or reducing the
scope of certification
(a) Suspension
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AMY shall suspend certification in cases
wherein:
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The client’s certified management system
has persistently or seriously failed to meet certification requirements,
including requirements for the effectiveness of the management system.
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The client does not allow surveillance and
recertification audits to be conducted at the required frequencies.
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Wishful misuse of logo & reference to
certification.
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Noncompliance with submission of Corrective
action as stated in section 2.5 of the agreement.
The suspension shall be for a period of a
maximum of six months, and the suspended status of the client shall be publicly
made available in the register of certified clients being maintained by AMY at
its registered office. During this period the client shall discontinue the use
of the logo or any reference for certification in advertising matters, as
directed by AMY, at the time of giving notice of suspension.
(b) Withdrawal
AMY shall withdraw the certificate under the
following circumstances:
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Failure of the client to resolve the issue
of suspension within six months shall result in the withdrawal of
certification.
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Other reasons like major legal complaints,
companies involved in malpractice, AMY loses accreditation etc.
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Client voluntarily requested for a
withdrawal.
Upon withdrawal of the certificate the client
ceases to enjoy the certification status and shall accordingly return the
certificate as directed by AMY at the time of withdrawal notice.
(c) Reduction in scope of certification
AMY shall decide to reduce the client’s scope of
certification by excluding the parts not meeting the requirements, when the
client has persistently and seriously failed to meet the certification
requirements for those parts of the scope of certification. Such exclusions
shall be consistent with the certification standard.
Upon request from any party, AMY shall provide
information related to the validity of a given certificate.
2.14 Certification and Use of Logo
The certificates issued by AMY remain the
property of AMY and must be returned when requested. The client is authorized
to use the certificate mark or its logo in advertising matter as per the
instruction given by AMY at the time of issuing the certificate.
The client, while using its certification, shall
ensure that it:
(a) Conforms to requirements of AMY when
referring to its certification status in communication media such as Internet,
brochures or advertising or other documents.
(b) Does not make or permit any misleading
statement regarding its certification.
(c) Does not use or permit the use of the
certification document or any part thereof in a misleading manner.
(d) Upon suspension or withdrawal of its
certification, discontinues its use of all advertising matters that contains a
reference to certification, as directed by AMY.
(e) Amends all advertising matter when the scope
of certification has been reduced.
(f) Shall not use the certification information
in a manner to imply that the product or service is certified. The
certification mark or logo shall not be used on a product or product packaging
as this could be interpreted as denoting product conformity.
(g) Does not imply that certification applies to
activities that are outside the scope of its certification.
(h) Shall not use the certification in such a
manner that would bring AMY and /or the certification system into disrepute and
lose public trust.
(i) Logos shall also
not to be applied on visiting cards.
(j) Use of CB logo will be following Logo
regulations as mentioned AMY website:
www.amyinternational.org
2.15 Accessible Information
AMY shall make the following information
publicly accessible through its web site in
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Management Systems Certification Rules and
Regulations.
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Policy on personnel.
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Quality policy.
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Impartiality policy.
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Confidentiality Policy.
All other information shall be treated as
confidential.
2.16 Obligations of the applicant / certified
organization
The applicant / certified organization shall
commit to fulfill continually the requirements of certification set by AMY for
the scope for which certification has been granted including adapting changes
in requirements for certification as and when communicated.
(a) When requested the applicant / certified
organization shall cooperate with AMY in the fulfillment of the requirements
for certification. This shall apply to all locations included in the
certification.
(b) In the case where there are multiple offices
of a certification body (AMY) or multiple sites of a client, then on that case
this agreement should be considered as a legally enforceable agreement between
the certification body (AMY) granting certification and the client that covers
all the sites within the scope of the certification.
(c) The applicant / certified organization shall
provide access to information, documents and records as necessary for granting
certification and maintaining certification.
(d) Certified organizations shall allow the
personnel from the accreditation body access to their sites and shall provide
access to information, documents and records when requested by AMY.
(e) The certified client shall claim
certification only with respect to the scope for which certification has been
granted.
(f) The certified organization shall not use its
certification in such a manner as to bring AMY into disrepute.
(g) The applicant / certified organization shall
pay fees as determined by AMY.
(h) The certified client informs the AMY,
without delay, of the occurrence of a serious incident or breach of regulation
necessitating the involvement of the competent regulatory authority.
(i) The applicant /
certified organization shall inform without delay of any significant changes
relevant to the certification in respect of its status or its operation
related:
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It’s legal, commercial or ownership status.
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The organization, top management & key
personnel.
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Resources and premises.
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Scope of certification.
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Other such matters that might affect the
ability of the certified organization to fulfill requirements of
certification.
2.17 Obligations of AMY
(a) AMY shall make publicly available
information about the status of certification that it has granted the certified
organization. The information should be updated regularly. The information
shall include the following:
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Geographical areas in which it operates.
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The status of a given certification.
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The name, related normative document, scope
and geographical location (city and country) for a Specific certified
client.
AMY shall give due notice of any changes to its
requirements for certification. It shall consider the views expressed by
interested parties before deciding on the precise form and the effective date
of the changes. Following a decision on, and publication of, the changed
requirements it shall verify that each certified client carries out necessary
adjustments.
3.0. General Terms and Conditions
(a) Termination-The client and AMY shall have
the right to terminate this agreement at any time giving 30 days of written
notice of such termination. The client shall, in case of termination, reimburse
to AMY all the dues up to date of termination. AMY, if it so wishes, shall also
charge a termination fee to be negotiated at the time of termination and this
is in addition to the dues that are payable to AMY. In no case shall such a
termination fee not exceed 15% of the value of the agreement. All reimbursable
are payable at the end of said 30-day period.
(b) Confidentiality- AMY shall not disclose any
information about the client or individual to a third party without the written
consent of the client or the individual concerned. If AMY is required by law to
release confidential information to a third party, the client or the individual
concerned shall, unless regulated by law, be notified in advance of the
information provided.
(c) Force majeure-Delay in or failure of
performance of either party hereto shall not constitute a default hereunder or
give rise to any claim for damage if and to the extent such delay or failure is
caused by an act of war, natural disaster, fire, explosion, labor dispute or
any other event beyond the control of the party affected and which, by the
exercise of reasonable diligence, said party is unable to prevent. The party
affected shall notify the other party in writing of the causes and expected duration
immediately after the occurrence of any such event.
(d) Law & disputes-The agreement for
certification between AMY and Client shall be governed by prevailing law in
Egypt. Any dispute arising in connection with the agreement, which cannot be
settled by private negotiations between the parties, shall be referred to
arbitration as per the Egyptian Arbitration Act, subject to Egypt jurisdiction.
The decision of the arbitration shall be binding for both parties
(e) Appeals: Client shall appeal to AMY in
respect of the following:
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Non acceptance of client’s application for
certification.
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Granting, suspending, withdrawing or
denying certification.
AMY shall deal with the appeals according to its
procedure and shall be responsible for all decisions at all levels of the
appeal handling process. AMY shall acknowledge the receipt of the appeal and
shall provide the client with progress reports and the outcome.
(f) Complaints: AMY shall investigate the
complaint received about the client to decide what action needs to be taken and
the same shall be communicated to the client at an appropriate time. The
identity of the complainant shall not be disclosed.
(g) Fees: The fees shall be detailed in the
quotation submitted by AMY. Fees are
charged based on applicable rates at the time of submission of the quotation.
AMY may revise the fee submitted in the quotation during the Certification
period. Clients shall be notified of any
change in the fee.
If any special audit is conducted on the client
as detailed in section 2.10 of this agreement, AMY shall charge an extra fee
for such audits to cover the audit charges and other administrative costs, and
this shall be payable within 7 days from the date of the invoice.
Cancellation of Audit shall involve
re-imbursement of expenses incurred by AMY, if any.
(h) Access to the client site: The client, at
the request of AMY, shall permit access to their sites and records for AMY’s
auditors and authorized personnel on behalf of the accreditation body to which
AMY is accredited. The same shall be communicated to the client in advance.
(I) Agreement Period: This agreement comes to
force on and remains in force until the expiry of the certificate, unless
withdrawn for justified reasons or withdrawn by either party upon due notice
given to the other party.
(j) Liability: AMY’s liability shall be limited
to providing certification of the client’s management system and shall not in
any way be responsible for the liabilities arising out of the client’s products
or services.
(K) Clients can send a complaint or appeal
through any of the following channels:
Website:www.amyinternational.org,
Cellular,
Contact Us or
WhatsApp: +2012 2216 0596