Certification Rules

ALBERK QA TECHNIC CERTIFICATION RULES

1-INTRODUCTION

These application principles has written in accordance with rules of Internatıonal Accreditation Organizations by implementing all of the operations of QA TECHNIC. QA TECHNIC works in comply with rules of acreditation organızatıons and standards of certification.

2-SCOPE

ALBERK QA TECHNIC CONTROL and CERTIFICATION LTD.CO. independently audit and certify the companies in the direction of application of firm work in the scope of related standards and regulations which act in the subject of management systems and CE product certification and inspection subjects.In addition, ALBERK provides the trainings open to general participation and certifies the successfull participants.

3-SECRECY

ALBERK QA TECHNIC is responsible from preservation of the secret documents that internal and exterior personnel testify. Therefore, secrecy agreement get signed by all of the interior and exterior personells in agreements which is applied to organizations signed mutually.

In addition, commitments related with confidentiality at contracts dealed with organisations, are reciprocally signed.

Hard copies of audit reports; stored in rooms that under responsibilty of private personel,in case of electronic copies; stored in the ALBERK QA TECHNIC private software and can not subtraced out of office.

In the case of explanation of information to third partiess by related legal authorities;information is given to the supplier in the scale of law permission.Any information doesn't given to the supplier without written demand.

4-ORGANIZATION

If is requested, QA TECHNIC organization scheme, responsibilities and report system of our organization are available.

5-GENERAL RULES

General rules to get certified and goes on certification by QA TECHNIC: Applicant company has to operate comply with rules stated in related standards, procedures and rules declared below.

5.1-This organization has to provide all of the information to complete the related audit programme.

5.2-QA TECHNIC informs the organization ıf QA TECHNIC didn't satisfied about fulfıllnes of rules and states hıtches its opinions.

5.3- When applied organization indicates that all of the rules whıch are related with corrective actions are fullfılled in the defined time period,(ıf it is not verified by documents ) our fırm get manage a new audit and costs are bılled to the organization.

5.4- If the applied organization doesn't corresponds to the correctıve action in the defined time period, a new general audit can be required and costs are billed to the organization.

5.5-Detection of properness can be carried out in the audit region and scope that is going to be written at certification scope will determined at the end of audit.

5.6-Fees are paid in the time period that is determined in bid. Certificates doesn't published up to certification fees an re-certification fee are paid. If the surveillance fees aren't paid the certificates are suspended or called back.

5.7-Applied organization should provide an audıt to QA TECHNIC in the time period which is placed in bid.

5.8-In the case of cancellation or suspensıon related accreditation of documents that is under our accreditation, depending on the request of applied organizatıon, documents can be transferred to other certification body that accredited by accreditation organization which signed the IAF mutually identification agreement.

5.9- Customer whose company gains certification right, is repsonsible to behave in accordance with "logo usage instruction" available at our website, while using logo and certificate.

6-APPLICATION OF CERTIFICATION

The form which is filled by the applied organization, is taken. According to the audit scope,the offer which include the costs send to applied organization together with apllication form.When the potential client requested the levels down the fees and details of fee,evalutaion of this request is under the authority of General Manager.Application form is signed by the management representative of applied organization .The payment fee and documents are supplied to the QA TECHNIC in annex. QA TECHNIC assigned the proper audit personel fort his Project.Auditors are responsible from the carrying out the audit complying on the procedures of QA TECHNIC.

In the stage of sıgnıfıcatıon of agreement,at least the documents that is stated below should provıded to our organization.

-System documents of organızatıon(ıf ıt is present, handbook and procedures)

-If ıt is present informative documents(brochures, catalogue, advertisement CD)

-Sıgnatory circular that belongs to the authoritized person to sign agreements.

-Copy of trade registry newspaper

-Certificate of activity

- In GAP (Good agricultural practices) ve GLOBALGAP applications beside of "Preparation Form" , other related documents requested on behalf of you.

7-AUDIT

Audıts of management systems certıfıcatıons are carried in two stages. The goal of stage 1 audıt;re-verification of process flow and organization scope in the audıt regıon,evaluatıon of the location and specific conditions of the area,properity,the scope related with the legal standards and corrective elements,processes,holding of required information according to the location,investigation of recognıtıons which is related with process standards and substructure, whether interior audit and revising of management is planned and ımplemented effectively and evaluation of the applied organization that is ready for stage 2,controlling of activity,control of audıtors according to scope of the organization,revising of the properness of the organization to the logic standards of system setup.revising the provision of the stage 2 sources and interviewing of stage 2 audıt details with the applied organization,by providing processes and management systems of applied organization, focusing to the plan for stage 2 is enabled. Audit duration is determined within the frame of conditions stated in guidelines belongs to related standards and it is notified to customer by audit approval form. GLOBALGAP, PAP ve BRC audits are come true according to the last version of related legislation and regulation.

Auditors have a right to stop the audit in case of detection any cases including any critical and very high risks.

8-CERTIFICATION & SURVEILLANCE& UNAWARE AUDIT

Certification: Reports taken from the lead audıtor is investigated by Certification manager and as a result of this certification manager controll sufficiency of report in the aspect of content. Then the report is paraphed and presented to the committee of certification. Certification committee interview the audıt report and its annex belongs to related organization. In this interview, audıt report, annex and if it is present corrected ineptitudes are investigated detailly. As a result of revising and evaluation by committee,Decision of whether the organization is certificated or contiuned the usage of certificate, is taken.

Without being sure about the correction of the ineptitudes, committee doesn't give a decision of certification.Organization deserve a certificate or go on the usage of certificate after obtaining organization porvide sufficient standard of related management system and certification committee give positive decision on the organization.

Surveillance: Surveillance audits is the invastigation of the organization taking a base of issue date of management system of certificated organization at least per year. Surveillance audits can involve whole management system or department of it. Surveillance audit does't have to involve all of the audit. At least surveillance audit should involve;

-Internal audit and Revising of management

-Revising of the actions that is performed depending the detected ineptitudes in previous audits.

-Holding up complains and activities that is performed related with topic.

-Efficiency of the system in the aspect of client's goal

-Developments in planned activities as a goal of contınuos improvement

-Continuing operational activities

-Control of the every alteration in the system

-Usage of trademark/committed references to the certificate

Surveillance audits can not be individualized as stage 1 and stage 2.In surveillance audits only stage 2 audit is performed. Number of the surveillance report can be increased according to the decision of certification committee, attained client's complains, class of the ineptitudes that is detected previous audits, or in the direction of offers that is stated in audit report. The company supposed to revise the reference standard of management and applications related with the internal audits at least one time per year. Also records which belongs to surveillance reports has to submit to certification committee.

BRC certification renewal intervals are conducted as it is detailed in BRC standarts and activities are followed stated below.

BRC Global Standard - Food

A grade would be obtained according to the number of non-conformities and categories. This grade would specify the time of the next audit (6 or 12 months later).

Unaware audit: Audit frequency of ITU and GLOBALGAP is once a year, however; additional visits can be conducted depending on the appreciation of QA TECHNIC Project managers. For %10 of recorded manufacturers at QA TECHNIC, unaware audits are performed for once a year.

QA TECHNIC reserve the unaware audit right throughout the period of validity in BRC audits. Unaware audit right would be arised from the requests, reports or security of published certificate issue. In the results of unaware audits, when the presence of problem is verified, cost of the actions to be taken and visit will be invoiced to client.

9-RE-CERTIFICATION

Management system agreements are valid for three year period. Three months prior to new audit date, a bid is prepared for new 3 years period.

Global gap and GAA(good agriculture applications) documents are valid for one year from the certificate issue date to re-audit date. All of the clients will keep a record system for the complains which are included in the scope of deserved certificate.

BRC Global Standard - Food certificate is valid in the obtained re-certification period interval.

10-EXTENSION/NARROW DOWN OF THE SCOPE OF CERTIFICATE

When the new product/process/place is requested, application form is wanted from the client to extent scope of the certificate.

Audıt which is given in object 6 is performed in the requested area by exclduding other areas Cost of the expension scope of certificate is prepared depending on the audit programme.

When the products is in direction of reduced number of products in the production line, the orıgınal scope of the certificates will narrow down. When these sort of informations are taken audit is performed by changing the scope. Cost of narrow down of scope of certificate will be formed by sum of requested audıt programme and cost of addıtıonal executive activities form.

If the audıt whıch presents the related scope activities of company completes succesfully, certificates is prepared by re-editing. Old certificate is sent to QA TECHNIC.

11-ALTERATION

If the company requested any alteration that can affect standards of management system or product/process/activities, company wıll inform the QA TECHNIC.

QA TECHNIC can cancel the certificate when any negation is detected. The company has to inform us related wtih alterations stated below.

a)legal, trade or status, possession of foundation

b)key manager, taking a decisison and technical staff

c)contact adres and significant areas

d)scope of the process that is under the certificated management systems

e) In the case of product feedback, QA TECHNIC management would be informed about the condition and the details of the case.

12-ADVERTISEMENT PERFORMED BY OWNER OF CERTIFICATE

Certificate owner has right to make an advertisement for indication of product, service and performance of environment are audited. Also, brand which is related with scope(stated certificate detailly) of certificate can be used for fixed promotional materials. Company can not use this trademark on products and packages. Company has to provide indivualization for certificated and non-certificated products/process and activities in the advertisements and publications. Company wouldn't be in effort to believe the client's and any activities to attempt decieve client although product/process and activities are not in the scope of certificate. In addition to this, publication of the certification doesn't mean it is confirmed by management team of acrreditation organization of that country.

13-MISUSAGE OF CERTIFICATE

QA TECHNIC takes all of the proper precautıons to control usage of certıfıcate. In the case of inaccurate scope or inaccurate usage of trademark of certicate in publıshments and catalogues, proper activities for cancellation or suspension of certificate, legal activity or announce of infringement can be performed.

14-SUSPENSION OF CERTIFICATE

This certificate can be suspended in the cases that is stated below;

-If the corrective actions didn't be followed and be corrected in the requested time scala

-Delay of the surveıllance audıt or refusal of surveıllance audıt

- If contradictory situation related with the certificated product and system regulations has occured.

The company will stop the activities of suspended certificates immediately. QA TECHNIC wıll inform the formal suspension of certificate and rules to relieve of certificates from suspension will stated clearly. In the end suspension period, the activities that is performed related with the causes of suspensed certificate. Potential suspension cases in the GLOBALGAP, GAA and BRC certification, activities are conducted with respect to GLOBALGAP genereal regulations, GAA regulations and last version of BRC standard

If the conditions are satisfied, certificate is converted to active; If it is not, certificate is cancelled.

15-CANCELLATION OF CERTIFICATE

This certificate can be cancelled in the cases that is stated below;

-Up to end of suspension period (max. 6 months),refusal of audıt by company

-If the activities(audit, documents, investigation etc.) to over come suspension condition don't be performed by company in requested time

-In the case of bankrupt of company or end of activities which is in the scope of certificate

-In the case of giving decent and ıllusıve directions

-Illusive and misapplication usage of certificate

-No payment fees that is realized by QA TECHNIC

-Detection of loss of properness of management system of the company in performed audits in validity period.

-If the company doesn't give a confirmation in the end of suspension period for tracking audits

-If the company doesn't present at the facility adres,

-If the corporate person belongs the company changes,

-If the company makes an alteration on the documents and annex,

-Informing QA ALBERK by inscriptive depending on the request of company.

-If the company refuse the surveillance audit

-In the case incorrection case of detected as contradictory, related with regulations, nonconformities

In the case of possible cancellation and feedback in GLOBALGAP, GAA and BRC certification, process would be performed with respect to GLOBALGAP general regulations, GAA regulations and BRC standards. QA TECHNIC wouldn't be responsible to answer for give back any paid audit fees. QA TECHNIC publish the cancellation of certificate. It is a misuage of logos and certificates by company after they are cancelled. Calling back of certificates is the sophisthıcated right of the brand owner and it is decided by law.

16-FEES

Fees will detailed in the sent bid to apllied company. All of the costs wıll take place in bid depending on time. Also, rising in the fees will takes place during the certification. These kind of increments will informed in writing to applied company. When the company applied to the certification, company has a responsibilty to pay fee of first year independent from the result of audit. For the following other 3 years period, before the 3 months of audit new pricing bid wıll formed and wıll be invoiced in comply with the application date. If the first year fee of 3 years period doesn't be paid in 30 days, the application wıll be refused. When the application is taken, the commitment about the payment other 3 years period will taken from the applied company. Also, extras that doesn't be included in the original bid such as immediate visits, additional audits to be sure from continuos implementation of the quality management system will be invoiced. All of fees are priced for the audit and surveillance activities excluding expenses of accommodation and journey (if it is not asserted contrary in bid).When it is required, these expenses(fare, food etc.) are invoiced as an extra. All of the fees wıll be taxed according to tazation rates of that country.

In product certification audits, all of the samples are taken throughout the audit are sent to laboratories which are accredited by related ministry to be analayzed. Test fee belongs to client.

Fees after determining according to related instruction, proposal which is sent to applied firm, will be detailed.

17-APPLICATIONS AND OBJECTIONS

Organisations have right to appeal to audit team, audit date, audit plan, decisions of audit team regarding nonconformities and decisions of certification committee. These appeals are evaluated in line with complaints and appeals management procedure. You can reach to this procedure from www.qatechnic.com/pr06_sikayet_itiraz_yonetim_proseduru.asp link.

Related with the applied company for certification; in the case of disagreement about the audit plan, audit date and assigned auditors etc. considering the request of the organization, these disagreement is soluted making a new process by the certification manager. In the case of requested alteration of assigned audıtors by the applied organization, this request should be sent with its reasons and in writing. By evaluating the reasons, alterations can be done.

Ojections to the decisions ofcertification committe after the result of audit activities, objection topic is referred to agenda of complain and objection evalutaion committee by director of the management committee. Name and CV's of the members of committee are sent to respective party for verification. Organizations can join the meeting ıf they demand. Organization has an objection right for members of committee stating valid reason.

Committee gives a precise decision in 15 days after reaching of objection to the QA technic. Decision of complain and objection committee is informed to complainer organizaion/person and management representative in writing by QA Technic and it is filed.

BRC is instructed separately by QA TECHNIC about the complains and taken actions related with BRC audit and certification.

18-COMPLAINS

ALBERK QA TECHNIC records all of complains taken via e-mail, verbal or in writing.

Every sort of complains that is related with ALBERK QA TECHNIC activities are evaluated in the direction of related procedures at the latest in a week and if it is required corrective actions are started, respective parties are informed at the latest in 15 days. In the requıred cases, independency, objectivity and confidentiality is a basis in evaluation of complains which are considered by complin and objection committee.

Complain that is related with the product or service of certificated organization is referred to organization immediately and evaluated in the frame of corrective action procedure requesting to get a solution at the latest in 15 days. Evaluation results are sent to the complainer organization regarding the confidentiality principles in the case of required. Received client's complains are evaluated as an opportunity for ALBERK QA to review itself.

19-MANAGEMENT OF CERTIFICATED ORGANIZATION

All of the responsibilities that is related with the certificated organizations belongs to QA TECHNIC. Certificated and uncertificated organization can be announced to public opinion if it is demanded.

20-VISITATION OF ACCREDITATION ORGANIZATIONS

In the case of witness audıt performance is requested in your organization by accreditation body, if your organization confirm this, witness audıt wıll be performed. If the wıtness audıt is performed, accreditation organization wıll suıt the confidentiality principles.

21-ISO 13485-RELATED RULES FOR CLÄ°ENT'S OF MEDICAL INSTRUMENTS

According to the requirements of standard rules; For medical devices,

If the audıt of subcontractor and suppliers is found necessary, subcontractor and suppliers will be included to audıt programme and be audıted.

22-MANAGEMENT OF AMENDMENTS

QA Technic makes a written announcement to all customers and publishes at website when amendments related with national and international organisations, national laws, regulations and standards, accreditation organisations and their documents, and document amendment regarding interior operations. Overseas representatives are informed via e-mail and it provides that representative notifies their customer. Following, taking decisions about amended rules and its publish at website; QA Technic provides that each certified customer makes a required regulations in their documents within three months. Performed amendments are controlled during the surveillance audit. In case of required amendments are not implemented, certificate is suspended as it is stated in related procedure. Amendments( address, scope, title, process, key personnel etc.) done by customer, are notified to QA Technic as quick as possible and this situation is verified by the way of additional audit when it is required.

23-PRODUCT RECALL

Customer shall inform ALBERK QA TECHNIC Management about the status of the situation and the details in case of the situation of product recall.

24- CODE OF ETHICS HARMONIZATION

ALBERK QA TECHNIC's aim while managing own job is to fullfil the highest possible ethic level and to catch the legal standards. ALBERK makes it obligatory to take CODE of ETHICS as a guide for all full-time and part-time employees and subcontractors.

25- MISAPPLICATION OR IMPROPER USAGE OF CERTIFICATE

Companies has gained the certificate right, could be detected misapplication of system certificates or misusage of informations which belongs to certificate on promotion documents.

This detection;

When the false matters related with certification, are detected, organisation is initially notified documentarily. Certification management evaluates the subject cooperating with legal experts when it is needed. As a result of notifications to organisation; if the organisation rejects to make required amendments, suspension, withdrawal of certificate and legal interventions are implemented as it is stated in certification procedures and instructions.

In case of usage of QA Technic System certificate or logo without an agreement or detection of agreement is brought to end for any reason; legal methods are applied since the damage of QA Technic financially or deceptive statement to its customers.

Legal methods are applied when the matters related with misapplication of certificate is detected.

Decisions taken by Certification Committee are delivered to Certification Managements documentarily to be transferred to related foundations.

Records of cases such as misapplication and unfair usage of certificate, are conserved by Certification Management and when it is needed corrective and preventice activities are started.

In case of not realisation of corrective activities in determined time interval, activities stated below are started to be applied by QA Technic:

- Related accreditation organisation is notified,

- Cancellation of certificate which is arranged previously, is declared to public,

- Required interventions are applied to start prosecutions. Legal and criminal actions are started together with pecuniary and non-pecuniary damages request not being less than fee stated in certification contract.

DD.01 Rev.04, 05.03.2012