BRILLIANT CERTIFICATION

         BRILLIANT CERTIFICATION is an individual firm  hasbeen established on behalf Mr. Yasser Farouk and occupied on discipline of art30 of law 17 for the year 1999 in January, 2007, the company was enrolled in the commercialregister of Giza office, enrollment number in the commercial register is 9053and dated in February, 2007, it also has a TAX card number 611-250-802, TAXfile number 6-00003-750-19-25;

It is located in El-Sheikh Zayed city, Giza Governorate – Egypt. BRILLIANTCERTIFICATION legal entity is described in detail in legal documents of thecompany available for BRILLIANT CERTIFICATION clients, the accreditation bodyand the interested parties on request. The scope of activity of BRILLIANTCERTIFICATION includes management system audit, certification services and productsystem inspection and certification services; and accredited/recognizedtraining services. 

The services whichoffered by BRILLIANT CERTIFICATION are available to all companies and countriesin a non-discriminatory manner.  Thestandards that are used for audit will be either National / International, orspecifically developed for and on behalf of BRILLIANT CERTIFICATION

          BRILLIANT CERTIFICATION uses ISO/IEC 17007 to choose the requirementsfor standards suitable for this purpose. If supplier needs any illustration tothe application of these documents for a specific certification system, itshall be formulated by the operations manager.

            BRILLIANT CERTIFICATION makes its whole services accessible to allapplicants whose activities fall within its declared field of operation orscope via the Website and brochures; and

         BRILLIANT CERTIFICATION restricts its requirements, evaluation and decisionon certification to those activities related to the scope of the certificationbeing considered.

BRILLIANT CERTIFICATION Principles

A)   General

I-            Brilliant Certificationfully committed to the general principles of the ISO/IEC 17021-1:2015 andISO/IEC 17065:2012 standards and confirm that these principles should beapplied as guidance for the decisions that may need to be made forunanticipated situations. And confirm that principles are not requirements.

II-                The overall aim of certification is to give confidenceto all parties that a management system fulfils specified requirements. Thevalue of certification is the degree of public confidence and trust that isestablished by an impartial and competent assessment by a third-party. Partiesthat have an interest in certification include, but are not limited to

                                    - Theclients of the certification bodies;

                                    - Thecustomers of the organizations whose management systems are certified;

                                    -Governmental authorities;

                                    -Non-government al organizations;

                                    - Consumersand other members of the public.

III-              Principles for inspiring confidence include:

 

-         Impartiality.

-         Competence

-         Responsibilities.

-         Openness.

-         Confidentiality.

-         Responsiveness to complaints.

-         Risk-based approach.

B)   Impartiality

I-                  Being impartial, and being perceived to beimpartial, is necessary for a certification body to deliver certification thatprovides confidence. It is important that all internal and external personnelare aware of the need for impartiality.

II-                It is recognized that the source of revenue fora certification body is its client paying for certification, and that this is apotential threat to impartiality.

III-              To obtain and maintain confidence, it isessential that a certification body’s decisions be based on objective evidenceof conformity (or nonconformity) obtained by the certification body, and thatits decisions are not influenced by other interests or by other parties.

IV-              Threats to impartiality may include but are notlimited to the following:

 

-       Self-interest: threats that arise from a personor body acting in their own interest. A concern related to certification, as athreat to impartiality, is financial self-interest.

-         Self-review: threats that arise from a personor body reviewing the work done by themselves. Auditing the management systemsof a client to whom the certification body provided management systemsconsultancy would be a self-review threat.

-         Familiarity (or trust): threats that arise froma person or body being too familiar with or trusting of another person insteadof seeking audit evidence.

-         Intimidation: threats that arise from a personor body having a perception of being coerced openly or secretively, such as athreat to be replaced or reported to a supervisor

 

C)    Competence

 

I-                  Competence of the personnel of BrilliantCertification in all functions involved in certification activities isnecessary to deliver certification that provides confidence.

II-                The competence also needs to be supported bythe management system of Brilliant Certification.

III-              It is a key issue for the management of BrilliantCertification to have an implemented process for the establishment ofcompetence criteria for the personnel involved in the audit and othercertification activities and to perform evaluation against the criteria.

 

D)   Responsibility

 

I-                  The certified client, and not BrilliantCertification, has the responsibility for consistently achieving the intendedresults of implementation of the management system standard and conformity withthe requirements for certification.

II-                Brilliant Certification the responsibility toassess sufficient objective evidence upon which to base a certificationdecision. Based on audit conclusions, it makes a decision to grantcertification if there is sufficient evidence of conformity, or not to grantcertification if there is not sufficient evidence of conformity.

NOTE Any audit isbased on sampling within an organization’s management system and therefore isnot a guarantee of 100 % conformity with requirements.

III-              For ISO 13485:2016: According to IAF MD 9:2022-  MD.4.4.1 ; ISO 13485 requires theorganization to comply with the statutory and regulatory requirementsapplicable to the safety and performance of the medical devices.

IV-               

The maintenanceand evaluation of legal compliance is the responsibility of the client organization. BrilliantCertification is responsible for verifying that the client organizationhas evaluated statutory and regulatory compliance and can show that appropriateaction has been taken in casesofnon-compliance with relevant legislation and regulations, including the notification to the Regulatory Authority of any incidencesthatrequire reporting.

 

2  Openness

I-                  Brilliant Certification provides public accessto, or disclosure of, appropriate and timely information about its auditprocess and certification process, and about the certification status (i.e. thegranting, maintaining of certification, expanding or reducing the scope ofcertification, renewing, suspending or restoring, or withdrawing ofcertification) of any organization, in order to gain confidence in theintegrity and credibility of certification. Openness is a principle of accessto, or disclosure of, appropriate information through Brilliant Certificationwebsite : (www.brilliantcert.com) or available upon requestfrom any interesting parties.

II-                To gain or maintain confidence incertification, Brilliant Certification provides appropriate access to, ordisclosure of, non-confidential information about the conclusions of specificaudits (e.g. audits in response to complaints) to specific interested parties.

E)    Confidentiality

I-                  To gain the privileged access to informationthat is needed for Brilliant Certification to assess conformity to requirementsfor certification adequately, it is essential that a Brilliant Certificationwill not disclose any confidential information.

F)    Responsiveness to complaints

I-                  Parties that rely on certification expect to havecomplaints investigated and, if these are found to be valid, should haveconfidence that these complaints will be appropriately addressed and that areasonable effort will be made by Brilliant Certification to resolve them.Effective responsiveness to complaints is an important means of protection for BrilliantCertification, its clients and other users of certification against errors,omissions or unreasonable behaviour. Confidence in certification activities issafeguarded when complaints are processed appropriately.

 

II-                An appropriate balance between the principlesof openness and confidentiality, including responsiveness to complaints, isnecessary in order to demonstrate integrity and credibility to all users ofcertification.

G)    Risk -Based Approach

 

I-                  Brilliant Certification will take into accountthe risks associated with providing competent, consistent and impartialcertification. Risks may include, but are not limited to, those associatedwith:

a)     the objectives of the audit;

b)    the sampling used in the audit process;

c)     real and perceived impartiality;

d)    legal, regulatory and liability issues;

e)     the client organization being audited and itsoperating environment;

f)      impact of the audit on the client and itsactivities;

g)     health and safety of the audit teams;

h)    perception of interested parties;

i)      misleading statements by the certified client;

j)       use of marks.