• General Certification Rules

1-INTRODUCTION

These application principles has written in accordance with rules of international Accreditation Organizations and international regulatory authorities by implementing all of the operations of QA TECHNIC. QA TECHNIC works in comply with rules of acreditation organizations, international regulatory authorities’ guidelines and certification standards.

2-SCOPE

ALBERK QA TECHNIC CONTROL and CERTIFICATION CORP. 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-CONFIDENTIALITY

QA Technic has established its own committees, external organizations and all persons operating on its behalf; applies the principle of confidentiality at every stage of certification activities. For this purpose, a confidentiality agreement is signed with all internal and external personnel.

In addition, commitments regarding confidentiality are mutually signed in all contracts made with organizations.

If information is given to the third party due to legal obligations or due to contractual arrangements made with authorities (such as the contract with the accreditation institution), your company agrees to share this information. However, information is given to the relevant authorities to the extent permitted by law. A written official request is requested from the authority to share the information.

QA Technic informs the customer in advance of the information that it intends to present to the public domain. All information other than the information made available to the public by the customer is considered as intellectual property and is considered confidential information.

Information about the customer (complainants, regulators) from sources other than the customer is treated confidentially, consistent with QA Technic policy

All information obtained or created during the performance of QA Technic's activities, including staff, contractors, personnel of outsourced organizations operating on behalf of QA Technic, including committee members, is kept confidential, except for a legal obligation.

Your company undertakes to share the case reports (Vigilance System Incident Reports) of your medical devices with QA TECHNIC during and after the application, inspection and certification activities in the conformity assessment activities to be carried out within the scope of the Medical Devices Directive.

QA Technic has the necessary equipment and facilities to ensure the secure handling of confidential information (such as documents, records) and has competent personnel to use it. Written copies of audit reports; In archive rooms under the responsibility of special personnel, electronic copies are archived in Alberk QA Teknik special software and are not taken out of the office.

Our Privacy Policy are published on our website.

4-ORGANIZATION

Permission for access is granted for QA TECHNIC’s organization chart, responsibilities and reporting system when requested.

5-GENERAL CONDITIONS

Fundamental conditions for to certified and to maintain the validity of certificate from QA TECHNIC are stated as in the following:

5.1 Applicant company has to operate comply with rules stated in guidelines which are in relation with applied standards, procedures and conditions declared below.

5.2 Applicant organization has to provide all required information to QA TECHNIC to complete the relavant Audit Programme.

5.3 In case, QA TECHNIC concludes that the applicant organization does not meet the conditions to gain a right for certification, these negative opinions and considerations are delivered to applicant organisation.


5.4 When the applicant organisation proves that required conditions have been fulfilled by the realisation of corrective / preventive activities (if these activities could not be verified as documentational) within specific time period, our company arranges re-audit plan and charges this activity in the invoice as an expenditure.


5.5 If the applicant organization can not correspond the requirements in terms of corrective / preventive activities within determined time interval, QA TECHNIC may need to re-arrange an initial audit and relavant expenses could be charged to organisation as an expenditure.


5.6 Determination of organisation’s conformity, is determined at site audits and the scope is going to be written on certification scope, is determined at the end of audit.


5.7 Fees are paid within the time interval determined in certification agreement. Certificates are not published till initial certification and re-certification fees are delivered. In case of surveillance fee is not paid, current certificates are suspended or recalled.


5.8 Applicant organization should facilitate to be conducted for realisation of surveillance audits by QA TECHNIC within the time frame determined in certification agreement.


5.9 In case of any accreditation suspension or cancellation situation related with the certificates arranged under the scope of our accreditation, is faced, certificate could be transferred upon your request to another certification body which is accredited by the accreditation body had countersigned mutual recognition agreement of IAF.


5.10 Our client who gained a right to get certified, has responsibility to act in accordance with requirements of ‘’logo, mark and brand usage’’ instruction is published at our website for logo, brand, statement and certificate usage.

  1. a) Comply with the conditions of QA TECHNIC, when the certification status is released to public over communication medias such as internet, documents, brochures, advertisements or other documents,
  2. b) Not to make or disallow any deceptive statement regarding its certification
  3. c) Not to make any misleading usage of certification document and its any part of it, or disallow of its usage.
  4. d) In case of certificate recall, usage of all kind of advertising material and activities refer to certification complying with the directives of QA Technic, need to be stopped.
  5. e) When the certification scope is reduced, amendment of all kind of advertising materials according to this revision.
  6. f) Disallow the usage of Certification of management system, to give the impression of as if the QA TECHNIC had certified the product (including service) or process.
  7. g) Prevent to give the impression of certification is applied to activities and addresses other than the certification scope.

5.11 Third parties seeking further information from our company is kindly requested to send e-mail to info@qatechnic.com in order to be directed to relevant personnel in our company.

6-APPLICATION OF CERTIFICATION

By signing the application form, the applicant's personal data; ALBERK QA ULUSLARARASI TEKNİK KONTROL VE BELGELENDİRME A.Ş. Within the scope of the information provided by QA Technic, accreditation and accreditation in accordance with the Law No. 6698 on the Protection of Personal Data within the framework of the information provided within the scope of the information regarding the Personal Data Protection Law No. 6698, which was announced by (“QA Technic”). to fulfill the requirements of the ministry, to be informed about the services, to be processed in the light of the information contained in the Lighting Text through all channels and to be shared with the people specified in the Lighting Text in case of actual requirements related to the law or service and / or business relationship. It is illuminated in a way that it does not hesitate and as it is informed, it gives approval with its explicit consent.

Services provided by our company is described on our website. Application forms prepared in accordance with these services, are also opened to sharing on our website. As well as these forms could be completed over website, can also be printed out and delivered via fax-mail and cargo. Application form is evaluated in terms of suitability, by our company. In case of the evaluations is found as inappropriate, required explanation is made to applicant. In case of evaluations resulted as suitable, pricing stage is stepped.

The proposal covers the prices according to audit scope, is delivered to applicant organisation.

In case the potential client requests to make discount on the fees, and demands on its details, assessment of this request under the authority of General Manager. Application form is undersigned by management representative of applicant organisation and delivered to QA TECHNIC together with documents and payment fee attached in the annex. QA TECHNIC assigns technical personnel appropriate for this project. Auditors are responsible to conduct the audit in compliance with QA TECHNIC procedures.

In the stage of signature of agreement, at least the documents are identified below need to be delivered to our organisation.

-System documents of organisation (if available, quality manual and procedures)

- SOA and ISMS documentstion for organizations seeking ISO 27001 Certification

-If it is availabe, introductory documents (brochures, catalogue, advertisement CD etc.)

-Authorised signatories belong to the authoritized person who signs agreements.

- Copy of trade registry gazette

- Certificate of activity

7-AUDIT

Management systems certification audits are carried out in two-stage. Aim of Stage 1 audit performance; re-verification of company scope and process flow, evaluation of location and site specific conditions, gathering an information required according to scope, processes, locations related with conformity, legal conditions and regulatory authorities, investigation of definitions related with substructure and process conditions, assessment of whether the internal audit and Management review is planned and implemented effectively or not, and the management system application level is sufficient enough for Stage 2 audit of the client or not. , control of its effectiveness, control of the auditors’ competence, who will conduct the audit in terms of compliance to scope of client organisation, review of system setup logic of company regarding to conformity to standards, review for provision of Stage 2 sources and discussion the Stage 2 audit details with client organisation, enable to concentrate on planning of stage 2 audit planning to ensure from the sufficient understanding of applicant organisation’s processes and management system.

Duration between the Stage 1 and stage 2 audits determined according to customer requirements but can not exceed 6 months.

Stage 1 audits results can cause the delay or cancellation of Stage 2 audit.

In case of any amendment occur which can affect the management system, QA Technic evaluate situation and consider the repeating the whole or any part of Stage 1 audit.

Audit duration; is determined within the frame of conditions stated in guidelines belongs to related standards and it is declared to customer by audit approval form.

In case auditors detect any situation includes critical and high risk, during the audit, have a right to stop the audit.

Audit duration is determined in accordance with guidance documentation of the related standart and is communicated with client via Audit Confirmation Form.

In case, audited company would be failing in fulfilling the meeting the requirement of standart or not meeting requirement of standart completely, FR-31 Audit Discrepany Form would be generated. The classifaction of findings on FR-31 is realized as in the following:

Major nonconformity:

Nonconformity that affects the capability of the management system to achieve the intended results

Note: Nonconformities could be classified as major in the following circumstances:

— if there is a significant doubt that effective process control is in place, or that products or services will meet specified requirements;

— a number of minor nonconformities associated with the same requirement or issue could demonstrate a systemic failure and thus constitute a major nonconformity

Minor nonconformity:

Nonconformity that does not affect the capability of the management system to achieve the intended results

Observation:

Raised when it is assumed to have caused a nonconformity if not necessary precaution in management system of audited company would not be taken and is generated in written format.

Crtitical nonconformity:

Nonconformity that would be raised once is found out to be affecting and/or may have possibility of creating serious danger on human health or the violation/not taking into account of statutory provisions during audits within the scope of ISO 22000 standart.It is considered the same as major nonconformity.The company would be re-audited once critical nonconformity would be raised.

8- CERTIFICATION & SURVEILLANCE & UNANNOUNCED AUDIT

Certification Audit: Reports received from the lead auditor, is controlled by Certification Manager and as a result of this evaluation, certification manager control, paraph the competency of report in terms of content and present it to certification committee. Certification committee discuss the audit report and its annexes belong to relavant company. In this discussion, audit report, its annexes and if any closed nonconformities, are detailly investigated. As a result of discussion and review performed by certification committee, it is decided that whether the certification will be guaranteed or not to relavant company, or usage of certification will be continued or not. Certification committee do not give certification decision till ensure that detected major and minör nonconformities are closed off appropriately. Company, gains a right for certification or to continue the usage of current certification, in case the certification committee give positive decision.

Surveillance Audit : It is ensured that the first surveillance audit following the intial certification would be realized in a manner that time interval between certification decision and surveillance audit date would not be exceeding 12 months.(For example; the certification decision date of the first year is 01.02.2016 and 1.st surveillance is conducted prior 01.02.2017 and certification is granted.Since the 2.nd surveillance audit shall be realized till February of 2018, time interval in between could exceed 12 months.)

Note- It can be necessary to adjust the frequency of surveillance audits to accommodate factors such as seasons or management systems certification of a limited duration (e.g. temporary construction site)

Surveillance audits are on-site audits, but are not necessarily full system audits, and shall be planned together with the other surveillance activities so that the certification body can maintain confidence that the client’s certified management system continues to fulfil requirements between recertification audits.

Each surveillance for the relevant management system standard shall include:

  1. a) internal audits and management review;
  2. b) a review of actions taken on nonconformities identified during the previous audit;
  3. c) complaints handling;
  4. d) effectiveness of the management system with regard to achieving the certified client’s objectives

and the intended results of the respective management system (s);

  1. e) progress of planned activities aimed at continual improvement;
  2. f) continuing operational control;
  3. g) review of any changes;
  4. h) use of marks and/or any other reference to certification.

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, received client's complaints, classification of audit findings detected during previous audits, or recommendations stated within audit report. The company is obliged to ensure that reference standard is reviewed by its management at least once a year and relevant actions related with application of internal audit clauses would be taken. Moreover; records belonging to applied measures shall be demonstrated to the audit team during surveillance audit by the company.

9-RE-CERTIFICATION

Management system contracts are valid for three years period. Prior to 3 months before new audit date, proposal for new 3 years period is prepared. To maintain re-certification; client organization has to complete audit, close off nonconformities and deliver the audit report to QA TECHNIC before the expiry date of 3 years period.

Unless the re-certification audit is completed or verified corrections and corrective activities are realised regarding any major nonconformity prior to end of 3 years period, re-certification may not take place, certificate validity can not be maintained.

On condition that completion of re-certification activities, if the company still can not correspond the conditions which leads the company to gain certification right even after 6 months passed from certification expiry date, new stage 2 audit is conducted and charged to company as an expenditure.

10-EXTENSION/REDUCING THE SCOPE OF CERTIFICATION

When scope extension regarding new product/process is requested by the client, application form is to be completed by client to extent scope of the certificate.

Audit of the client is realized as to include only process/activity belonging to the requested scope for extension by excluding remaining processes/activities as it is defined at clause 5.6.4 in Audit and Certification Procedure. The cost of scope extension process for certification is calculated in accordance with requested audit programme.

When there is a reduction of company’s products/ processes within its organization then company’s scope published on certificate would be reduced. When there would be a feedback regarding such issue, necessary evaluation would be realized as to arrange re-audit for client so that scope would be revised. The cost of scope reduction on certificate would be calculated in accordance with requested audit programme and additional administrative activities in order to renew certification.

If the audit representing the company’s activities to be included within its scope would be justified then company’s certificate would be renewed on condition that previous certificate would be returned to ALBERK QA TECHNIC.

11-AMENDMENT

If the company request to make any alteration in product/ process/ activities or management system that can affect relavant standards, the company notify the QA TECHNIC. In case of requirement, QA TECHNIC verify these amendments with additional audits. When the QA TECHNIC detects any negativity, the certificate could be cancelled. The company have to make required announcement to us regarding any amendments related with those seen below;

  1. a) legal, commercial or status, property of body
  2. b) Amendments in key managerial personnel, decisison maker and technical staff of organisation or management,
  3. c) Contact address and important fields
  4. d) Scope of the processes take place under the certified management systems
  5. e) Amendments in sectoral legislative regulation
  6. f) In case of product recall, customer will notify the QA TECHNIC management regarding the status and details of the situation.
  7. g) Same conditions are applicable in case of any amendments in accreditation conditions.

12-ADVERTISING ACTIVITY OF THE CERTIFIED CLIENT

Certified client has right to use all kind of advertising material to indicate its product, service and environmental performances which have been audited. In addition, it could use the brand related with certification scope provided on certificate, on fundamental promotion materials. The Certified client may not use this brand on its products and packages. The company also need to ensure that required discrimination between the certified and uncertified product/process or service on advertisements and notices, are made. The company will not get involved in any activities to take their customers in, who make purchase, to convince them even the product/process or activities are not certified. Furthermore, publish of related certificate does not mean that product, process or service is approved by management board of national accreditation body.

13-MISUSAGE OF CERTIFICATE

QA TECHNIC takes all kind of appropriate precautions to control usage of certificiates are already published. In case of certificate scope is incorrect or misusage of certificate brand on advertisements or catalogues, QA TECHNIC can realise appropriate actions for suspension or cancellation of certificate, legal action or announcement for violation.

14-SUSPENSION OF CERTIFICATE

In case; one of the conditions that are stated below comes to the picture, certificate would be suspended for a period not exceeding 6 months via decision of the certification committee.

REASON

ACTIONS TO BE TAKEN

Temporary suspension request of certified customer voluntarily.

Certificate is suspended and 14.1-14.2 clauses are applied. New audit is conducted to remove suspension status.

In case of continuous fail of customer severely in fulfill of required certification conditions of certified management system, including the ones regarding effectivity of management system

Certificate is suspended and 14.1-14.2 clauses are applied. New audit is conducted to remove suspension status and management system conformity is assessed. Clause of 5.1.2 is evaluated.

In case of certified customer does not allow to conduct its surveillance or re-certification audits as often as required.

Certificate is suspended and 14.1-14.2 clauses are applied. Suspension status is hold stable till it is permitted to conduct the audit. Suspension status is removed by new audit.

Detection of critical nonconformity at audit (for ISO 22000 audits)

Certificate is suspended and 14.1-14.2 clauses are applied. New audit is conducted to remove suspension status. Clause of 14.3 is evaluated.

For the cases that are stated below, ALBERK could suspend the certificates in order to make further detailed assessment.

REASON

ACTIONS TO BE TAKEN

In case of any official act regarding product safety or licences

Suspension process is kept stable until the company proves and announce to QA Technic that there is not any inconveniences regarding the product or legal process. Clauses of 14.1-14.2 are applied.

In case of product recall occurs.

Report regarding the situation, is requested and site assessment is realised. Suspension is requested throughout this process. Clauses of 14.1-14.2 are applied.

In case the company suffer from a major loss of site, as a result of incidents such as natural disasters or fire

Certificate is suspended until the site audit is conducted since the situation cause troubles in terms of the current system’s functionality. Decision is determined according to audit result. Clauses of 14.1-14.2 are applied.

In case of inelimination of major nonconformities detected at audits, within defined periods,

The company could be suspended in case the nonconformities do not be eliminated within 3 months period and clauses of 14.1-14.2 are applied. However, this suspension could be removed by the investigation of evidence, if the company is not subjected to follow up audit, in previous audit.

In case company breaches the responsibilities take place contract to some extent do not require the cancellation of certificate

It is suspended till it is proved that contract conditions are corresponded and clauses of 14.1-14.2 8 are applied.

In case the detection of legal sanctions’ violation, which needs to be applied apart from the relevant standard regarding the product/ service take place certification scope

The certificate is suspended till the legal conformity is corresponded and clauses of 14.1-14.2 are applied. After, legal conformity report is delivered, suspension status is removed.

Interruption of product/service by company’s request because of the reasons such as strike, lock-out, re-organisations, natural disasters, raw material shortage, order failure, any amendment at location address of site or similar reasons.

The certificate is kept as suspended till the company withdraw the suspension request. Clauses of 14.1-14.2 are applied.

Breach of certification rules

Application could vary depending on the conditions violated.

Misusage of certification document, statement and logo

Suspension status is continued until it is proved that certification document, statement or logo is used appropriately. Clauses of 14.1-14.2 are applied. Suspension status is removed by committee member decision given for objective evidence assessment and site assessment.

Repudiate the certificate or audit fees

In case of any payment do not be received after the performance of audit, certificate is not dispatched by accounting department. If it is still not paid within 1 month, suspension process is applied. Clauses of 14.1-14.2 are applied.

In case of any delay on first surveillance audit date 2 weeks and/or more for no reason

Suspension process is continued till the surveillance audit is conducted. Clauses of 14.1-14.2 are applied.

14.1 Consequences of the Suspension of Certificate

  • Certificate is not valid for temporary period.
  • Company can not take advantage of rights belong to certificate
  • Customer should refuse to declare its certification status.
  • Certificate can not be referenced on promotion materials and advertising activities.
  • Suspension status is declared to public. / Suspension status is an information available for public.
  • QA Technic could take all other precautions considered as appropriate within the frame of contract.

14.2 Scope, duration and type of the audit conducted within the context of suspension status removal, is determined depending on certificate suspension justification.

Suspension status of the company whose conformity is verified at the end of audit, is removed. In case the suspension justifications are not removed, certificate is cancelled.

In case any failure in re-solutions of issues within defined period, it is resulted as certificate withdrawal or reduction of certificate scope. Removal of suspension status is notified to company in written.

14.3. In case any continuous or severe failure to meet the system conditions for some part of the scope, QA Technic reduce the certification scope of its customer as leaving out the part whose conditions are not met. However, same situation is not applicable for ISO 22000 certification. Any trouble observed at any process stage or product manufacturing line, requires review of all certification conditions and cause the suspension or cancellation of certification.

15-CANCELLATION OF CERTIFICATE

Decison for cancellation of certification, is determined for the cases stated below:

REASON

ACTIONS TO BE TAKEN

In case the company does not allow to conduct the audit till the end of determined suspension period.

Certificate is cancelled and clause of 15.1 is applied.

In case of failure in closing off nonconformities within foreseen period, at realised activities (audit, document assessment etc.) to remove suspension status

Certificate is cancelled and clause of 15.1 is applied.

Company's bankruptcy or termination of activity take place in certificate scope.

Certificate is cancelled and clause of 15.1 is applied.

Usage of certificate, in the fields other than the product or service stated within scope of management system certificate

Certificate is cancelled and clause of 15.1 is applied.

Supply of incomplete information and misstatement by company during the audits,

Certificate is cancelled and clause of 15.1 is applied.

Misleading and misapplication of certificate,

Certificate is cancelled and clause of 15.1 is applied.

In case fees realised by QA Technic, are not paid within 6 months following issue date of invoice,

Certificate is cancelled and clause of 15.1 is applied.

In case of detection that the management system of the company lost its conformity, at audits conducted within the period of certification validity

Certificate is cancelled and clause of 15.1 is applied.

In case the company do not accept the suspension conditions

Certificate is cancelled and clause of 15.1 is applied.

In case the company does not remove suspension justifications within 6 months

Certificate is cancelled and clause of 15.1 is applied.

In case the company does not give confirmation to conduct follow up audit at the end of suspension period

Certificate is cancelled and clause of 15.1 is applied.

Absence of company at site address stated on certificate,

Certificate is cancelled and clause of 15.1 is applied.

Amendment of legal entity belongs to company

Certificate is cancelled and clause of 15.1 is applied.

In case the company falsify the certificate and its annexes

Certificate is cancelled and clause of 15.1 is applied.

For any reason, if the company have a request to delay surveillance audit date notified by QA Technic, without giving any exact date or any request to cancel surveillance audit or the company rejects the surveillance audit

Certificate is cancelled and clause of 15.1 is applied.

In case of notification to QA Technic in written, at a request of company,

Certificate is cancelled and clause of 15.1 is applied.

For the cases stated below, ALBERK re-conducts the audit in order to give right decision and it could determine cancellation decision as a result of this audit.

- In case of any official act regarding product safety or licences

- In case of product recall occurs.

- In case the company suffer from a major loss of site, as a result of incidents such as natural disasters or fire

- In case any alteration of company owner

15.1 Consequences of Withdrawal Process of the Certificate

  • Certificate is invalid, (in case of any request to satisfy appropriate conditions and for continuation of certification; it is subjected to initial certification process)
  • Company can not take adavantage of rights belong to certificate
  • Customer should refuse to declare its certification status
  • Following the cancellation of certificate, company have to remove certification logo, brand and statement from all kind of correspondence and promotion material within 1 month.
  • Withdrawal status is declared to public. / Withdrawal status is an information available for public.
  • QA Technic could take all other precautions considered as appropriate within the frame of contract.

Otherwise, QA Technic;

  • announce the issue to accreditation bodies and other certification bodies
  • announce to various media organs to declare that company is used the certificate illegally violating the contract conditions,
  • apply to legal procedures in order to recover the pecuniary loss and intangible damages because of this reason.

QA TECHNIC will not be responsible to return any paid audit fee. QA TECHNIC publishes the withdrawal of certificate. Usage of certificates and logo by the company following the withdrawal process, is a mistake, recall of this certificate and logo is intellectual property of trademark holder and laid down by the laws.

16-FEES

Fees will be detailed in the proposal delivered to applicant organisation. All expenses will take place on the proposal depending on the time, price increases during certification will be reflected to proposal. This sort of increases will be notified to customer company in writing.

When it is applied, the company is responsible to pay the cost of first year during progress of certification process regardless of the consequence. Application will be refused if the cost belongs to first year of three years certification period, does not be paid within thirty days. Costs related to extras do not take place within the scope of original proposal, unplanned visits, additional audit in order to verify maintenance quality management system in terms of competency in practice, will be invoiced. All costs in audit and surveillance fees, are priced out excluding transportation and accommodation expenses (unless otherwise specified in proposal). When necessary, those expenses (transportation, food expenses etc.) will be invoiced as an extra. All costs are taxed according to tax rate of the country whereabouts.

During product certification assessment, a sample taken out from the each product is sent to the laboratory either accredited or authorised by relevant ministry in order to be analysed. The cost of analysis belongs to the client.

Once the related fees would be determined in accordance with related instruction, they are going to be given in detail within the proposal being sent to the client.

17-APPLICATIONS AND OBJECTIONS

Organisation have a right to object to audit team, audit date, audit plan, nonconformity decisions taken by audit team and decisions determined by certification committee. These appeals, are assessed in compliance with complaint and appeals management procedure in our website via www.qatechnic.com/pr06_sikayet_itiraz_yonetim_proseduru.asp .

Regarding the company applied for certification; in case of any disagreement on situations such as audit plan, audit date of company and assigned auditors etc. , certification manager finds a solution to disagreement between the parties re-processing the matter considering request of company. In case of any request for amendment on assigned auditors, it is expect to deliver this request in writing. Amendment is realised after the relevant assessments related to justifications, are performed.

As for appeal is realised against to certification committee decisions taken as a conclusion of audit activities; when it is delivered to QA TECHNIC, subject of objection, is delivered to agenda of Complaint and Appeal Committee by CEO. Name and CVs of committee members, are notified to interested party for confirmation. Organisation may participate to meeting upon request. Organisation have objection right to complaint and appeal committee members indicating rightful justifications.

Committee gives a precise decision within 15 days following delivery of objection to QA Technic. Complaint and Appeal committee decision; is notified to appeal holder organisation/ individual and management representative in writing and filed by QA Technic.

18-COMPLAINTS

ALBERK QA TECHNIC records all kind of complaints received via e-mail on website, verbal or in writing. All sort of complaint received in relation to ALBERK QA TECHNIC activities, are assessed at the lates within one week in accordance with relavant procedure and if any corrective action is necessary, it is started and interested parties are notified within 15 days. Independency, impartiality and confidentiality principles are based in assessment of complaints handled by Complaint and Appeal Committee.

Information related with the customer, obtained from the sources (for instance; complain owner or regulative authorities) other than the customer, are evaluated in confidential manner.

In case the complaint is related with the product or service presented by the certified organisation, complaint is immediately delivered to organisation and is requested to be concluded at the latest in 15 days within the frame of corrective action procedure. Assessment results are delivered to complain holder company considering confidentiality principles. Received customer complaints are considered for QA Technic as an opportunity to review itself.

All of our certified organisations could indicate the records upon request, belong to customer complaints and corrective preventive activities initiated in accordance with these complaints.

QA Technic assess those records considering at surveillance audits.

If the complaint holder, does not satisfy with the complaint handling process of ALBERK, complaint holder will direct its complaint to interested accreditation body.

The complaints had already agreed with complaint holder and have not closed off within documentated time interval, will be presented to upper management of ALBERK and be ensured that the complaint get an appropriate priority. Nonconformities have not been closed off within agreed time interval, will be presented to attention of Accreditation body.

19-MANAGEMENT OF CERTIFICATED ORGANIZATION

All responsibilities regarding certified organizations belong to QA TECHNIC. Organisations certified or whose certification are cancelled, could be announced to public upon request.

In addition, information on the database of certified products can be accessed by searching through the link http://www.qatechnic.com/hizmet/genel-dokumanlar/belgeli-firma-personel-arama-193/ 

20-VISIT OF AN ACCREDITATION BODY

In case the accreditation body have a request to conduct witness audit at your organization, witness audit will be realised by the confirmation of your company. In case the witness audit is conducted at your organisation, accreditation body will comply with the confidentiality principles.

Accreditation bodies have an authority to conduct the unannounced site audit. Accreditation bodies participate to these audits in order to evaluate ALBERK QA TECHNIC not to observe and assess your company.

Throughout these visits, in case any critical situation related with company is detected and declared to your attention, your company will take a proper action according to its own procedures.

Situations sample for this case, could be observed below;

- If there is an address amendment of company and it is not notified to our attention and if this amendment is noticed at site, the company is suspended till the audit for address amendment is conducted.

- If the company close down officially and the company does not provide any information regarding this situation, certificate of the company will be cancelled.

- If the company initiated to act on activities apart from the ones stated on certificate of the company (for instance; the company had activities on glass manufacturing process but they continue to use the certificate even the glass manufacturing activities had been stopped) but relavant information have not been announced, certificate of the company will be suspended until the audit for scope amendment, is conducted.

- In case it is detected during the audit of the company that conformity to provisions pose severe risk, interim audits are planned to company and actions taken in the light of findings.

- In case the misusage of certificate or logo, is detected by accreditation body or any other third party, corrective action is requested from the company.

21-MANAGEMENT OF AMENDMENTS

QA TECHNIC announces the document amendments regarding national and international organisations, national laws, regulation and standards, accreditation bodies, their documentation and interior operation, to all clients in writing and publishes on website. Global representatives are informed via mail and it is ensured that their clients are notified. QA TECHNIC ensures that required arragements in its own procedures of all certified organisations, are realised within 3 months following decision taken related to amended rules and their publish date. Realised amendments are controlled during surveillance audits. In case of required amendments are not implemented, it is suspended as it is stated at procedure related with certification.The amendments (address, scope, title, process, key personnel etc.) performed by our clients, will be announced to QA Technic at the latest within 2 weeks period and in case of necessary, those amendments will be verified by additional audits.

NOTIFICATIONS OF CHANGES TO CUSTOMERS WITH ISO 45001 CERTIFICATION

Matters that may affect the ability of a certified client management system to continue to meet mandatory requirements will be notified to ALBERK QA Technic within 2 weeks at the latest, and these changes will be confirmed by additional audit where necessary. These include, for example, changes related to:

a) legal, commercial, organizational status or ownership;

b) organization and management (eg key manager, decision-making or technical staff);

c) contact address and sites;

d) scope of operations under the certified management system;

e) major changes to the management system and processes.


22-PRODUCT RECALL

In case of product recall, customer shall inform ALBERK QA TECHNIC Management related to status of the situation and its details.

23- COMPLIANCE WITH CODE OF ETHICS

The aim of ALBERK QA TECHNIC while managing its own business; is to meet the possible highest ethic level and reach to legal standards. ALBERK obliges its all full time and part time employee and its subcontractors to act basing on principles written on CODE OF ETHICS as a guideline.

QA Technic acts in accordance with its impartiality throughout all of its activities. It is also supported by the declaration of upper management. Service applications are open to all organisation. Any party or group are not granted any privileges during the realization of service. QA TECHNIC limits its conditions, evaluation, decision and surveillance within certified scope of the client.

24- 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 their advertisement documentation. This detection;

When a misleading issue related with certificate would be found out, organisation is initially notified via written format. 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.

25-NOTIFICATION REGARDING OCCUPATIONAL HEALTH AND SAFETY

If, during the audit, the audit team member, based on his personal judgment, detects a rule violation within the scope of OHS or identifies a situation against local legal-regulatory requirements, the client will notify the organization as soon as possible and will suspend the audit. The company will be audited again. (Critical non-compliance)

However, OHS auditors appointed by Alberk QA Technic; They are not the OSH regulator's auditors. They must not provide "statements" or "statements" of conformity. However, they can "validate the assessment of legal compliance" to assess compliance with the applicable ISO 45001 standard.

Accredited certification of an OHSMS that fulfills the requirements of an OHSMS standard cannot be an absolute and continuing guarantee of legal compliance, but neither can any certification or legal scheme guarantee ongoing legal compliance. However, an OH&SMS is a proven and effective tool for achieving and maintaining regulatory compliance and provides top management with relevant and timely information on the organization's compliance status.

An OHS standard requires a commitment to comply with legal requirements. The organization must be able to demonstrate that it has achieved compliance with applicable legal requirements through its own conformity assessment prior to Alberk QA Technic certification.

Our customers, who have received audit and certification services on ISO 45001 from our company, are obliged to inform our company in the following cases;

  • Customer fatalities, serious injuries, occupational disease, or legal action by a regulatory authority (includes, but is not limited to)
  • Presence of findings related to OHS detected by 3rd parties during the audit, at the time of surveillance and re-certification to QA Technic.

26 - ISO 13485- RULES RELATING TO MEDICAL DEVICE CUSTOMERS

In accordance with the standard rules, if the audit of your company's subcontractors and suppliers is deemed necessary for medical devices, your subcontractors and suppliers will be included in the audit program and audited.

27- SUSPENSION AND WITHDRAWAL PROCESS FOR G MARK CERTIFICATE OF CONFORMITY

Manufacturer would be notified by means of formal writing and would be requested to sned corrective action when it is found out that results of surveillance experiment would not be fulfilling the requirements of conformity assessment criterias stated in standarts and initial type experiment.G Certificate of conformity would be suspended immediately within the scope of concrete class and unplanned audit would be conducted within one month.If the results of unplanned audit results would not be at satisfactory level and additional experiment results would not be fulfilling the prespecified criterias then referred certificate would be withdrawn from concrete class of G Mark Certificate of Conformity.

Unplanned audits are not considered to be a part of product surveillances that are realized 3 times a year.

28- PRODUCT CERTIFICATION ACTIVITIES

Our product certification activities are defined in detail in our certification programs at the link https://www.qatechnic.com/hizmet/urun-belgelendirme/ The rules in the certification program are taken as basis in carrying out the activities. 

29- MUTUAL RESPONSIBILITIES

29-1. Responsibilites of the Client

  • CLIENT is to assist with audit procedures; in particular, the client shall provide appropriate information to demonstrate compliance with the standard to ALBERK QA TECHNIC and grant authorised access to the fields, storage facilities, processing plants, to all relevant documents (including client agreement, reports, records etc) and allow ALBERK QA TECHNIC in order to enable its audit team to gather objective evidence.
  • CLIENT commits to convey requested documentation and records specified at audit programme confirmation form without exceeding required time interval to ALBERK QA TECHNIC.
  • CLIENT commits to assign its assigned personnel at adequate number to ALBERK QA TECHNIC as guide for purposes of providing guidance for audit team during audit duration.
  • CLIENT commits to provide access to ALBERK QA TECHNIC enabling the its audit team to gain general understanding as to related departments and other interrelating departments whose activities are indicated at application stage of the certification.
  • CLIENT is not to request pre-scheduled audit to be delayed unless there is a relevant reason for this delay.
  • CLIENT provides feedback to ALBERK QA Technic regarding the planned amendments to be realized for its legal status or address fifteen days (15) in advance by written format. Followed by feedback, CLIENT commits to evaluate its status and to renew its certification decision in order to be certified by ALBERK QA TECHNIC. The audit for amended scope of client is to be realized as earliest as possible by ALBERK QA TECHNIC.
  • CLIENT commits that its certificate would be withdrawn on condition that audit planning process would not be completed within six months documented in ALBERK QA TECHNIC’s as the maximum suspension period for clients whose scopes written on their certificates were partly or fully suspended.
  • CLIENT provides feedback to ALBERK QA Technic regarding amendments related with its association, management structure and kind of amendments (quality management system,personnel,equipment etc..) effecting the activities within accredited scope during fifteen days (15) by written format. ALBERK QA TECHNIC evaluates the status after official declaration of the client.
  • CLIENT commits to represent the closing evidences of non-conformities detected by ALBERK QA TECHNIC within time period specified at documentation of ALBERK QA TECHNIC with effect from the audit date. Client give its confirmation for a follow-up audit on condition that audit team concludes that closing evidences submitted by client shall be justified duing on-site evaluation.
  • CLIENT also commits to represent the closing evidences to ALBERK QA TECHNIC against notifications (complaints, correction request, improvement etc…) submitted to them after adequate evaluation of ALBERK QA TECHNIC except scheduled audits.
  • CLIENT is obliged to ensure that all precautions are taken for audit team assigned by ALBERK QA TECHNIC in terms of occupational health and safety measures.
  • ALBERK QA TECHNIC is able to conduct unannounced audits/visits to premises of the client. CLIENT commits to cooperate with the audit team generated for this purpose and gives its confirmation for this audit.
  • CLIENT commits not to use its certificate in a misleading way as to damage ALBERK QA TECHNIC’s reputation.
  • CLIENT commits to use ALBERK QA TECHNIC logo and its certificate within its certified scope after the certification decision would be given.
  • CLIENT commits not to use ALBERK QA TECHNIC logo and its certificate for activities, subsidiaries or affiliates that are not included within its certified scope.
  • CLIENT is not authorized to transfer the certificate and ALBERK QA TECHNIC logo usage right to third parties.
  • CLIENT is obliged to act in accordance with logo,trademark and certificate usage instruction published at website for to use ALBERK QA TECHNIC’s logo and its certificate.
  • CLIENT commits to submit information and records requested by ALBERK QA TECHNIC within specified time interval.
  • CLIENT commits not to disclose any given information or ALBERK QA TECHIC audit report that are not made accessible to public and confidentiality of other documentation or information belonging to audit team while giving its confirmation to ensure the confidentiality of referred information and documentation to any third party unless it is a legal necessity and/or with consent of ALBERK QA TECHNIC.

29.2. Responsibilites of the Alberk QA Technic

  • ALBERK QA TECHNIC reviews the conformity of CLIENT’s Quality Management System and its conformity assesment activities in accordance with related legislation,standart and documentation via audit and document evaluation and reports its assesment result; if appropriate; generates its certficate and submits certificate to the CLIENT.
  • ALBERK QA TECHNIC publishes the certified CLIENT’s name,its address,certification date and scope at its official website.
  • ALBERK QA TECHIC is obliged to preserve whole information, documentation that are provided by audited CLIENT by its personnel, assigned auditors and experts in accordance with confidentiality and security criterias.
  • ALBERK QA TECHNIC determines the auditors and experts to be assigned for the audit in order not to create conflict of interest with the CLIENT. ALBERK QA TECHNIC evaluates any appeal which may arise from client in this manner.
  • ALBERK QA TECHNIC communicates the information of asigned audit team and audit programme 10 (ten) days prior the audit to CLIENT for initial certification, surveillance and re-certification audits. Referred information could be communicated to the client within a time interval less than 10 (ten) days provided that it would be confirmed by client.
  • ALBERK QA TECHNIC commits not to revise audit date unles there is a significant reason (health problem etc..).
  • ALBERK QA TECHNIC commits not to share or reproduce any information, documentation belonging to CLIENT with any third party without consent of the CLIENT unless it would be requested by formal authorities or is requested as a fundamental necessity emerging as an outcome of agreement with Accreditation Body(ies).Referred confidental information belonging to the client is only made accesible to related department,auditor,expert or decision mechanism.
  • ALBERK QA TECHNIC commits to communicate the amendments regarding certification rules or transt,ons plans belonging to these amendments via its official web page and/or e-mail etc.. to the CLIENT.


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