Product Inspection ISO / IEC 17065:2012 & HALAL

PQS Company provide Product inspection Certificate for Food & Cosmetic Products – Accreditation Under process .

PQS Company provide HALAL inspection Certificate  – Accreditation Under process .

Scope of the Quality Management System

The Quality Management System of PQS is designed to meet the requirements of the following international standards and regulations

a) ISO/IEC 17065: Conformity assessment – Requirements for bodies certifying products, processes and services

b) GSO 2055-2:2012 Halal products –– Part 2 : General Requirements for Halal Certification Bodies

c) The relevant guidelines or mandatory documents, the regulations of the accreditation body, as well as the legal requirements related to the inspections, product certifications and notified body

 The present Quality Management System) QMS) is the basic tool for the operation as a Certification Body and as a Certification body for products and Halal

In addition, QMS provides the necessary transparency regarding the internal functions, the duties, the authorities, and the responsibilities of the personnel, as well as the means for the quality assurance of the provided services

PQS Product Certification Policy Statement 

PQS is product certification bodies which provide confidence and demonstrate the impartiality of the certification processes and believes in the principle of openness, confidentiality and delivering consistent, flexible services satisfying customers’ needs and maximizing its potential in our markets.

PQS committed to:

  • Comply with interested parties’ requirement including customers, accreditation bodies and regulators.
  • Continually improve our product certification services and demonstrating passion for the business; communicating, sharing and acting upon a meaningful vision for the future;
  • Ensure that business dealings are conducted in ethical manner, demonstrating respect for others within a diverse cultural environment, that does not tolerate prejudice or discrimination;
  • Maintain a quality management system, incorporating all accreditation requirements, which supports this quality policy and our Key Performance Values and encourages a culture of continual process improvement throughout the business.
  • Follow the principles set out in ISO/IEC 17065:2012.
  • Safeguard impartiality and avoid confect of interest to inspire confidence from the public and interested parties that an organization certified by PQS fulfils specified requirements.
  • Provides publicly accessible information about the certification status of each of its clients through the Certificate and Client Directory.
  • Take complaints and appeals against itself and its clients seriously.

     PQS Statement of Impartiality

PURPOSE:

Describe the methodology followed by PQS for:

  • The identification and assessment of potential risks to impartiality, arising through any source, during carrying out of the certification activities and the determination of measures to safeguard impartiality.
  • Independence of PQS
  • Confidentiality Management
  • PQS Liability and financing
Scope:

Safeguarding Impartiality , independence, confidentiality, liability and financing  for product certification activity management.

Applicability:
This procedure applied on PQS staff and CB activity.

Responsibility: CEO, Certification Manager.

Reference:
ISO/IEC 17065: Conformity assessment – Requirements for bodies certifying products, processes and services

Management of Impartiality and independence

 Impartiality management and risk assessment methodology done by Product certification Manager, in cooperation with the Quality Manager and other PQS staff, as appropriate.

  • The basic methodology consists of the following steps:
  • Identification of sources and potential risks to impartiality
  • Identification of existing measures for safeguarding impartiality
  • Assessment of risks to impartiality
  • Taking measures for safeguarding impartiality
  • Identification of sources and potential risks to impartiality:

 Sources of impartiality

  • Identify and analyze the sources of impartiality (e.g. activities other than certification performed by the organization, clients, pressures from competition, and employees/committees at PQS who may affect certification decisions).
  1. Identifications of risks
  • Self-interest (e.g. overdependence on a contract for service or the fees, or fear of losing the customer or fear of becoming unemployed, to an extent that adversely affects impartiality in carrying out conformity assessment activities).
  • Self-review (e.g. performing a conformity assessment activity in which the certification body evaluates the results of other services it has already provided, such as consultancy).
  • Advocacy (e.g. a certification body or its personnel acting in support of, or in opposition to, a given company, which is at the same time its customer).
  • Over-familiarity (i.e. risks that arise from a certification body or its personnel being overly familiar or too trusting, instead of seeking evidence of conformity in the product certification).
  • intimidation (e.g. the certification body or its personnel can be deterred from acting impartiality by risks from, or fear of, a customer or other interested party).
  • Consultation (e.g.: between PQS Staff and client)
  • Competition (e.g. between the customer and a contracted person).
  • Such situations will analyze during the risk analysis.
  1. Identification of affected activities

     Analyze, for example:

  • establishment of policies (e.g. pressures from competition results in degrading certification activities in order to reduce costs)
  • client application (e.g. pressure for accepting clients who do not fulfill prerequisites)
  • planning of assessments (e.g. pressure from client for reducing the duration of assessment)
  • Identification of existing measures for safeguarding impartiality
  • Before determining the risk to impartiality for each identified threat, the existing measures for safeguarding impartiality identified and taken into account in order to ensure their suitability and effectiveness at a later stage.
  • Indicative measures are:
  • Organizational structures and processes (e.g. committee for safeguarding impartiality)
  • Implementing of policies for recruiting, training, retaining of assessors which enhance the impartiality of assessors
  • Procedures for selecting assessors and other personnel in positions that affect impartiality
  • Procedures for internal audits and necessary corrective actions for impartiality
  • Measures applicable in special situations such as an assessor will not assess a company he has been employed with in the past
  • Policy of zero tolerance in situations such as accepting money or other gifts by the assessors.
  • Assessment of risks to impartiality
–          The assessment of risk to impartiality done by using a combination of the probability of occurrence and the significance of the impact on the certification activity. Both of these factors are split into 3-4 levels, i.e.
Risk level Importance
Low average high
 

 

Occurrence

Very possible Average Average High
possible Low Average High
Unlikely Low Low Average
Very unlikely No Low Low
  • Taking measures for safeguarding impartiality:
Measures taken depend on the level of risk assessed, as shown in the next table:
Risk level decision Indicative measures and time for implementation
low Risk level is acceptable and has to be maintained at current level No additional measures are required, only maintaining of existing measures.
Average

 

Risk level is acceptable only in cases where its mitigation is impractical or the cost is disproportionate to the improvement achieved The possibility of reducing the risk level to an acceptable level should explored, taking into account the cost of needed measures. If this is not done, the process (es) affected are continuously monitored. Risk mitigation measures assigned medium priority and implemented in the medium term. Maintaining of the measures must ensure.
High Risk level is not acceptable and must reduce to an acceptable or tolerable level by taking measures immediately. Immediate measures for reducing risk levels must be applied. These measures assigned high priority and must implemented in a short-term horizon.

Also, it may be necessary to limit the activity concerned or  to devote significant resources in order to safeguard impartiality

Reporting conflict of Interests:

  • Each individual involved in certification activities (internal or outsourcing) is required to report to the management of PQS any situation, which may present the individual with a conflict of interests.
  • If a subcontractor (such: PQS Test Laboratory or other test laboratory) will be involved in certification activities, the agreement shall be complemented with the Confidentiality and Impartiality requirement of ISO 17065.
  • Any situation that may present the subcontractor with a conflict of interests shall report to the management of PQS.
  • PQS decides how to handle each reported situation. The recommendation and decision shall document.

  PQS responsibilities in regard to impartiality and independence:

  • PQS is responsible for the impartiality of its conformity assessment activities and not allows commercial, financial or other pressures to compromise impartiality” document.
  • This commitment is demonstrated through “the statement on impartiality” document (attached) and is accessible to the Public through PQS website.
  • PQS has top management commitment to impartiality in management system certification activities This commitment is demonstrated through “the statement on impartiality”. This statement understands the importance of impartiality in carrying out its management system certification activities manages conflict of interest and ensures the objectivity of its management system certification activities.
  • PQS has a process to identify, analyze, evaluate, treat, monitor, and document the risks related to conflict of interests arising from provision of certification (e.g.  auditors, staff, accreditation bodies, clients, consultants, competition, sub-contracted, agents,) including any conflicts arising from its relationships on an ongoing basis sources of  threats  to impartiality of  the certification  body  can  be  based  on ownership,  governance, management, personnel, shared resources, finances, contracts,  training, marketing and payment of a sales commission or other inducement for the referral  of  new  clients, etc.
  • Where there are, any threats to impartiality resulted from certification activities, PQS documents and demonstrate how it eliminates or minimizes such threats and documents any residual risk.
  • The demonstration covers all potential threats that are identified, whether they arise from within PQS itself or from the activities of other persons, bodies or organizations.
  • When a certain relationship identified between PQS personnel and the applicant and this may lead to an unacceptable threat to impartiality then PQS immediately not provides the certification for this client.
  • PQS top management reviews regularly any residual risk to determine if it is within the level of acceptable risk.
  • PQS developed a process to make a consultation with appropriate interested parties through all available communication or social media (e.g telephone, video or audio conference,) to advise on matters affecting impartiality including openness and public perception. The consultation may be conducted through an official meeting for some or all selected members of interested parties , The selected consultation team with appropriate interested parties is balanced with no single interest predominating. Interested parties may include personnel and clients of the PQS, customers of organizations whose management systems are certified, representatives of industry trade associations, representatives of governmental regulatory bodies or other governmental services, or representatives of non-governmental organizations, including consumer organizations. In all cases, appropriate records will be kept for these consultation activities, the apprpeorite record may include ( mail , Facebook post , comment , social media advise , mintues of meeting…ect).
  • PQS does not carry out management system consultancy as it cares about the impartiality in carrying out its certification activities. And because it is an independent certification body which has no related bodies that could affect the impartiality of its certifications, or that could offer or provide those services to others to perform consulting services in order to obtain or maintain certification.
  • PQS does not offers or provides internal audits to its certified clients. A recognized mitigation of this threat is that PQS not certifies a management system on which it provided internal audits for a minimum of two years following the completion of the internal audit.
  • Where a client has received consultancy from a consultancy firm that has a certain relationship with PQS, which represents a significant threat to impartiality. A recognized mitigation of this threat is that the PQS not certifies the management system for a minimum of two years following the end of the consultancy.
  • PQS not outsources evaluations to a consultancy firm, as this poses an unacceptable threat to the impartiality of PQS.
  • PQS activities not be marketed or offered as linked  with  the activities  of  an  organization  that  provides  management  system  PQS take action to correct inappropriate links or statements by any consultancy organization stating or implying that certification would be simpler, easier, faster or less expensive if it were used.
  • PQS not state or imply that certification would be simpler, easier, faster or less expensive if a specified consultancy organization were used.
  • In order to ensure that there is no conflict of interests, personnel who have provided management system consultancy, including those acting in a managerial capacity, not be used by PQS to take part in  an  audit  or other  certification  activities  if  they  have been involved  in  management  system  consultancy towards  the    A recognized mitigation of this threat is that personnel not be used for a minimum of two years following the end of the consultancy.
  • PQS takes action to respond to any threats to its impartiality arising from the actions of other persons, bodies or organizations outside PQS.
  • All PQS personnel, either internal or external, or committees, who could influence the certification activities, act impartially and not allow commercial, financial or other pressures to compromise impartiality.
  • All Auditors must declare any potential or actual conflict of interest when asked to undertake an audit/surveillance assignment. For every auditing activity, a Job order is issued, which contains a declaration. The Auditor must accept the assignment and declare that they have no interest in the client (e.g. shareholder, owner or consultant, close relative to client or consultant or has not worked as a consultant for the client within the last two years).  Similarly, if the Auditor does have an interest (e.g. shareholder, owner or consultant, or has worked as a consultant for the client within the last two years), then the declaration must be rejected accordingly and the Job Instruction declined.
  • PQS usually require personnel, internal and external, to reveal any situation known to them that can present them or PQS with a conflict of PQS record and use this information as input to identifying threats to impartiality raised by the activities of such personnel or by the organizations that employ them, and shall not use such personnel, internal or external, unless they can demonstrate that there is no conflict of interest. For this reason, each assigned auditor must confirm in the job instruction that there is no any commercial interests with this client before proceed on this audit.
  • The results of the impartiality assessment and effectiveness of measures taken are reviewed periodically by PQS management and, at least once a year, by the Committee Safeguarding Impartiality.

Impartiality committee

 (PQS) has appointed an impartiality committee has been constituted by the (PQS) Board of Management, which will act as an Impartiality and independent body with no single interest predominating, to assist in the formulation of policy matters relating to (PQS) Certification Services provided in EGYPT & Oversees the ongoing implementation.

  • PROPRIETOR/CEO identifies the availability of such experts and their CV’s are reviewed by the Board of Management.
  • After the initial acceptance by the Board of Management, CEO issues the request letters to the probable members by giving the details of the Certification process and expectations from the committee members.
  • Acceptance of the members is then obtained and the process of the appointment of the chairman is then decided in the 1st probable meeting.
  • The Committee comprises of suitably qualified persons with technical expertise, representing various interests, in a balanced manner, who are nominated by the professional institutions, industry and management associations and users.
  • The Impartial Committee shall meet at least once in a year and additionally, as and when required by the (PQS) Board of Management.
  • The Impartial Committee will at the request of (PQS) Board of Management, consider and approve the expansion of the Committee by inclusion of additional members to represent the technology and industry sectors for which accreditation is required from the accrediting bodies. (PQS) PROPRIETOR/CEO will be a member of the Impartiality Committee and will constitute the quorum. The nomination of additional members shall ensure the balanced representation of various interests without any single interest to predominate.
  • In the event of any existing Committee member’s resignation or inability to continue to undertake the functional responsibilities, as per the terms additional members may be nominated without disturbing the balance between various interests. The impartiality committee has access to all information related (PQS) services.
  • PROPRIETOR/CEO of (PQS) attends the meeting in an official capacity but does not have the right to vote. The Impartiality Committee has constituted separate Experts Panels comprising experts in each panel specializing in their area of expertise to assist the Committee, as and when required, in their respective area of expertise.
  • The roles and responsibilities of the Impartiality Committee are set out below:
  • Formally approve the (PQS) documented Management System for certification as defined in (PQS) policy & procedure manual.
  • Review and approve any proposed changes in the Rules and Regulations covering (PQS) Accredited System Certification Schemes.
  • Review the developments in the quality management certification and related fields in EGYPT and abroad and to provide unsolicited advice to the Board of Directors with a view to ensuring impartiality and competence in the application of (PQS)’s certification services in various sectors of the industry.
  • Act as an Appellate Body and to nominate members with appropriate qualifications to constitute an Appeals Panel, as and when an appeal is lodged against any decision of the (PQS)’s PROPRIETOR/CEO, in respect of the certification scheme. It also gives Delegation of authority to committees or individuals, as required, to undertake defined activities on its behalf.
  • Exercise an overview of continual financial viability of (PQS)’s certification scheme and discuss the fee structure with the management in order to ensure that (PQS)’s certification operations remain independent of any commercial pressures. It also under takes supervision of finances of certification body.
  • Provide technical and general advice as and when required, by the (PQS) Board of Management, in all matters relating to the proper implementation of the certification scheme including the mode and frequency of assessments in compliance with the requirements.
  • Decide whether any advice rendered, unsolicited or otherwise, in respect of the content and implementation of the certification activities is considered binding on (PQS) for adoption within its certification scheme.
  • The impartiality committee shall verify the (PQS) operating accounts and discuss financial resources if necessary, with the PROPRIETOR/CEO of (PQS) who is a member of the Impartiality Committee but does not has a voting right.
  • Provide guidance for use of and meanings of the certificate, statements and logo, also advise on matters affecting confidence in certification, including openness and public perception.
  • Communicate to the Accrediting Bodies any inconsistency observed in the implementation of (PQS) Certification Scheme approved by it, after taking due note of the reasons provided by (PQS) where any recommendations made by the Impartiality Committee are not accepted by (PQS).
  • Members of the Impartiality Committee and Appeals Panel shall observe the confidentiality as per the (PQS) policy and contractual agreement conditions with clients and auditors.
  • No member of the Impartiality Committee shall be dismissed for any reason, whatsoever, without the consent of the Impartiality Committee as a whole by at least two thirds majority. The Impartiality Committee has the right to refer to the accrediting bodies in the event of the forgoing condition being contravened.
  • The Chairman Impartiality Committee will ensure that a quorum is present before proceeding with a meeting of the Committee. The minutes of the meeting shall be recorded and confirmed by the Chairman with regard to the accuracy and content before being circulated to the members for comments and approval at the next meeting.
  • The Impartiality Committee has the accessibility to all the relevant information in (PQS) as necessary to enable it to fulfill its function.
  • Conduct a review of the impartiality of the audit, certification and decision making processes of (PQS). Details of review will include contract review, auditor allocation, Review of reports and grant of certification, monitoring of surveillance audits with an objectivity of verifying the confidentiality and impartiality.
  • Safe-guarding impartiality and review of risk associated with impartiality or conflicts of interest arising from its relationship.
  • Impartiality Committee reviews the overall performance of (PQS) on yearly (at least once in 12 months) basis to check – Internal Audit/ management review/ external audit/risk analysis/sampling of client files/ Auditor performance/ regional Performance  basis, while doing this inputs are taken from all members on their past experiences with other certifying body audits if any. Also their experiences and inputs/ feedbacks of other similar committees. Members will be encouraged to collect the data from various other forums meetings data etc.

TERMS & CONDITIONS OF COMMITTEE

  • The term of appointment of each member will be for a period of 3 years from the date of the nomination which may be extended for a further period of one year.
  • The nominating organization may re-nominate the existing member or nominate a new member after the maximum term of 4 years.
  • At least one third of the total number of the committee members with a minimum of three members are required to be present to constitute a quorum of holding a meeting.
  • It shall be ensured that members constituting the minimum number required for quorum provide a balance of interests.
  • The chairman need to be present in every impartiality Committee meeting if the chairman is not present due to some valid reason the committee members shall elect a officiating chairman for the particular meeting.
  • The Impartiality Committee shall elect a Chairman out of its members by simple majority vote in the first Impartiality Committee meeting.
  • The Chairman will hold office for a period of three years but may be re-elected for a further term of one year.
  • The impartiality Committee meeting shall be conducted on yearly basis (at least once in 12 month).
  • All the members of the Impartiality Committee need to sign the Confidentiality agreement.

The composition of impartiality assessment and impartiality committee is the same  for same of Management system certification system which detailed in procedure no: PQSC -MSP-23 Impartiality, Liability and financing procedure for System Certification.

Liability and Financing

  • PQS Egypt usually evaluates the risks arising from its certification activities and evaluates liability according to the “liability assessment”.
  • PQS has insurance against accidents, Indemnity insurance to cover liabilities arising from its operations in each of its fields of activities.
  • Before the commencement of any activity, the PQS Evaluation team (at the opening meeting) assures themselves that the client has sufficient insurance to cover the risks which may exist whilst the team is conducting their activities.
  • The risks may include those that are inherent within the working environment or those created by the team. For example, if an evaluator inadvertently or deliberately touches                   something hot; if they lift and drop a work-piece and injure themselves or someone else; if they are hit by a fork lift truck etc., etc.
  • PQS has the financial stability and adequate resources required for the operation of certification activities (human at all levels, adequate number of auditors, IT equipment, offices, training and conference room,) The financial situation had been reviewed at the end of the financial year as a part of normal meeting activities. a calculation is made to determine any work paid for but not executed. Also monthly meeting held and attended by PQS shareholders/ and or the general manager to discuss the financial situation.
  • PQS staff is free from any commercial, financial and other pressures, which might influence the results of the certification process.
  • The Managing director of PQS Egypt is responsible to put the budget for different projects and provide financial resources needed to achieve the company’s goals and also monitors the financial stability in co-ordination with the finance manager via the KPI(s) reporting system.

Confidentiality

  • PQS shall, through a legally enforceable agreement and through confidential statement within the policy ensures that the confidentiality of information obtained or created during its certification activities is kept confidential by all personnel acting on its behalf, including, committee members, contractors, or individuals.
  • The personnel of external bodies e.g. accreditation body are bound to keep the information confidential as per the agreement with (PQS).
  • PQS keep in public domain the information about the certification status of a client.
  • PQS maintain the certified status of the clients in the register of certified clients at the registered office of (PQS) and anyone who wishes to seek any information about any particular client shall do so from the register.
  • PQS do not divulge any information about a particular client or individual to a third party without the written consent of the client or the individual concerned.
  • PQS as required by law, furnish the information to a third party about a particular client or individual with prior notification to the client or the individual concerned, unless regulated by law.
  • PQS shall not, as part of its policy, divulge the identity of the source that has provided information about a client or has complained about the client. However, if required, (PQS) shall pass the information or complaint to the client at an appropriate time for initiating corrective action. Otherwise these shall be kept confidential.
  • PQS keep the confidential information (documents. records) of its clients in safe custody and shall permit restricted access to the office staff only.
  • When confidential information about a client is made available to external bodies e.g. accreditation body or peer assessment body as per (PQS)’s agreement with such external bodies, the same shall be informed to the client by (PQS).

Non-discrimination Conditions

  • All applicants that meet the criteria outlined in this Quality Manual are eligible for certification. PQS does not discriminate against applicants in any way other than what is outlined in ISO/IEC 17065 to ensure high quality results in certification.
  • The success of PQS depends on the fair and equitable treatment of all applicants.
  • Access to certification and testing services is not conditional upon the size of the client or membership in any association or group, nor is certification conditional upon the number of certificates already issued.
  • There are no undue financial conditions; specifically, fees are invoiced on a monthly basis as services are performed. Evaluation prices and site lease fees are fairly distributed between each site and evaluation.
  • PQS confines its requirements, evaluations, surveillance, review, and decisions concerning certification to the scope defined in ISO/IEC 17065. These specific Standards outline the criteria used in certifying products, components and devices.

Complaint & Appeals

  • Purpose:

To document, establish, implement and maintain the system for addressing Appeal, Complaints and Disputes received by (PQS) as per requirements of ISO 17065:2012, ISO/IEC 17021-1:2015, ISO 17021-2:2016, 17021-3:2016, ISO 22003:2013, 17021-10:2018, IAF MD 22 and other applicable international standards for certification bodies offering management system certifications

2.0. Scope:

This procedure is applicable to all appeal, complaints and disputes received by (PQS) related to its Management System Certification.

  • Responsibility: 

Managing Director

3.0  Procedure:

4.1 Appeals

 4.1.1 Any client shall make an appeal to the Managing Director of (PQS) in respect of the following,

  • Non acceptance of client’s application for certification
  • Granting, suspending, withdrawing or denying of certification

4.1.2 (PQS) shall record all appeals in document ((PQS) 40 B Appeal – (PQS)-40 C – Register for Appeal & complaints) and acknowledge the receipt of the appeal. All appeals shall be addressed within 30 working days from the receipt of the appeal and (PQS) shall provide the client with progress reports and the outcome.

4.1.3 All appeals are reviewed by the appeal panel constituted by managing director for each appeal. The appeal panel shall contain at least two members from the (PQS) auditor panel who have not been part of the audit and also not involved in certification decision or involved in the subject of the appeal. For appeal against the decision of the Managing Director the matter shall be referred to the chairman of the Impartiality Board (IB) for constituting the panel and taking the decision.

4.1.4 The appeal panel shall investigate the appeal by looking into the records and / or talking to the appellant and (PQS) and shall take a decision taking into account the results of any previous such appeals.

4.1.5 Based on the decision of the appeal panel (PQS) shall initiate appropriate correction and corrective action and the same recorded in ((PQS) 40 B Appeal – (PQS)-40 C – Register for Appeal & complaints )

4.1.6 (PQS) shall be responsible for all decisions at all levels of the appeal handling process. The decision on the appeal is reviewed and approved by managing director and is communicated to the client. This completes the appeal process and (PQS) shall also inform the appellant at this time about the closure of the appeal.

4.1.7 (PQS) shall ensure that the submission, investigation and decision on appeals shall not result in any discriminatory action against the appellant.

4.1.8 The right of the client to appeal against any decision by (PQS) is communicated at the time of sending the quotation through document PD-01.

4.1.9 Information about appeal handling process of (PQS) is made publicly available through web site and / or document PD-01

4.2 Complaints

4.2.1 Information about complaint handling process of (PQS) is made publicly available through web site and / or document PD-01. The complaints handling process includes the following

An outline of the process for receiving, validating, investigating the complaint and for deciding what actions to be taken in response to it.

 The Managing Director is responsible for gathering and verifying all necessary information to validate the complaint.

4.2.2 The complaint can be made to the Managing Director by the client or any other interested party in writing giving details of the complaint. The complaint shall either relate to the certification activities of (PQS) or to the certified client and its activities.

 4.2.3 The complaints received are recorded in ((PQS) 40 A complaints – (PQS)-40 C – Register for Appeal & complaints) and is acknowledged to the complainant. The managing director shall review the complaint to ascertain the seriousness and the genuineness of the complaint.  (PQS) shall provide the complainant with progress reports and the outcome.

4.2.4. The complaint redressed process:

4.2.4.1. Complaints about (PQS) from the client or third party

  • Depending on the nature of the complaint, Chairman of the Impartiality Board shall decide to conduct the investigation himself or appoint a complaint panel for each complaint. The complaint panel shall contain at least two members from the (PQS)’s auditor panel who have not been part of the audit and also not involved in certification decision or involved in the subject of the complaint. Further, the complainant shall be given an opportunity to present the case to the panel in person if he so desires.
  • The complaint panel shall investigate the complaint by looking into the records and / or talking to the complainant and (PQS) and shall take a decision taking into account the results of any previous such complaints.
  • The details of investigation and the correction and the corrective actions identified are recorded in the complaint register. Upon verification on the effectiveness of corrective action taken, (PQS) shall inform the complainant about the correction and corrective action taken and if the complainant is satisfied with the actions taken the complaint is treated as closed. The final Decision on the resolution of complaint shall be taken by the chairman of the Impartiality Board.

4.2.4.2. Complaints about the certified client from its customers or any other third    party:

  • (PQS) shall inform the client about the complaint received and ask the client to investigate the complaint and report the findings to (PQS) within two weeks from the date of receiving the complaint by the client.
  • If (PQS) does not receive any response from the client or the action taken by the client is not found effective, (PQS) shall inform the client accordingly and ask for a special audit at the client site by (PQS). On confirmation from the client (PQS) shall conduct a special audit as per (PQS) procedure, PQS-MSP-07 and investigate the complaint.
  • If the complaint is of serious nature (PQS) shall initiate the special audit directly with the client
  • As its policy, (PQS) shall not disclose the identity of the complainant to the client.
  • If any action is needed to be taken by the client (PQS) shall verify the effectiveness of such action by suitable means appropriate to the gravity of the problem.
  • If the corrective action taken by the client is found effective (PQS) shall inform the complainant accordingly and the complaint shall then be treated as closed.

4.2.5. (PQS) shall decide to make public the complaint and its resolution if agreed with client and complainant.

4.2.6. All the complaints received and their status with respect to their resolution are presented in the MRM and the IB meeting

4.3 Client feed back

4.3.1 After every audit (certification, surveillance and re-certification) a feedback from the client in obtained in document (PQS)-36, to assess,

  • (PQS)’s office responsiveness to client queries at various stages of the certification process
  • Performance of the audit team
  • Areas for further improvement

4.3.2 All the feedback received from the clients are analyzed and appropriate action taken if required.

4.3.3 The actions taken are recorded in (PQS)-36

4.3.4 A summary of feedback and the findings with corrective action taken are reviewed in MRM and (Impartiality Board) IB meeting.

4.4 Disputes

4.4.1. Any dispute arising out of (PQS)’s certification activities shall be settled by private negotiations between the parties, and if this is not possible it shall be referred to arbitration as per the Egyptian Arbitration Act, subject to Egypt  jurisdiction. The decision of the arbitration shall be binding for the both parties

4.4.2 Records of all the disputes are maintained and reviewed in MRM and IB meeting

  Product Certification Evaluation Process

Objectives:

 The objective of this document is to provide general guidance on the evaluation process for PQS product certification in respect to the product specific scheme.

Scope:

  • Some of food products as per Saudi FDA standards.
  • Some cosmetic products as per Saudi FDA standards.

 Applicability:

 Applicable to all PQS operation in relation to product certification activities.

 Reference:

  • ISO/IEC 17065:2012 Conformity assessment – Requirements for bodies certifying products, processes and services.

Forms:

No. Form Code Responsibility Retention time
1. Product certification application form. F05/01 Certification Manager 5 years
2. Self-assessment form F05/02 Certification Manager 5 years
3. Application review form F05/03 Certification Manager 5 years
4. applications register form F05/04 Certification Manager 5 years
5. Product certification offer form “Quotation” F05/05 Certification Manager 5 years
6. Product certification agreement form F05/06 Certification Manager 5 years
7. Evaluation team nomination form F05/07 Certification Manager 5 years
8. Product certification evaluation plan F05/08 Certification Manager 5 years
9. Initial assessment report F05/09 Certification Manager 5 years
10. Testing plan F05/10 Certification Manager 5 years
11. Sampling report F05/11 Certification Manager 5 years
12. Laboratory evaluation checklist F05/12 Certification Manager 5 years
13. List of approved laboratories F05/13 Certification Manager 5 years
14. Management system evaluation report F05/14 Certification Manager 5 years
15. Product certification non conformity report F05/15 Certification Manager 5 years
16. Product certification Technical review report

 

 

F05/16 Certification Manager 5 years
17. Product certification Decision making report F05/17 Certification Manager 5 years
18. Certificate template F05/18 Certification Manager 5 years
19. Suspension, withdrawal, termination report. F05/19 Certification Manager 5 years

 General Steps of PQS Product certification process:

Pre requisite requirement before application:

There are some requirements for the client to fulfill (i.e. certification requirements), including the following: 

–          Scope of client combatable within this scheme scope.” Selection of elements in the PQS scheme within the declared scope specifies the requirements that the products are intended to fulfill the product requirements. These requirements are specified by reference to SFDA standards, technical specifications”.

·         Client covers the requirement of the scheme including compliance with the technical specifications.

·         Completing the certification agreement,

·         providing information about changes to the certified product and

·         providing access to certified products for surveillance activities.

·         payment of prescribed fees for certification services rendered.

 

Evaluation information 

This PQS scheme provides information to be used for evaluation activities, such as:

a) sampling, testing and other evaluation activities where these have not been adequately specified in the product requirements or scheme documents;

b) assessing the production process; and

c) auditing those elements of the client’s management system which are identified as critical to ongoing product conformity.

Product certification application process.

–          Company/factory find all date related to PQS product certification process within PQS website including General conditions and requirements related to the product certification process.

–          Coordinators and technical Director of PQS will answer all inquiries from applicants via phone or meeting as appropriate to client.

–          PQS provides the potential client with necessary information the form of a brochure or informative documents to understand and follow the rules for the specific certification scheme.

–          These rules are publicly available and provided on demand.

–          The client makes an application to PQS for certification of its specified products.

·         The application provides the PQS with all necessary information as prescribed in 7.2 of ISO IEC 17065:2012 to enable it to plan the evaluation and certification process.

·         Once the application is received from the client, PQS checks that the information provided by the client is clear and sufficient and, if it is not, asks the client for the necessary clarification or additional information.

Application Filling

1)      Clients has to fill the application form that present on the website according to the product he is seeking for.

2)      The required data should be available according to the established application form and has to be completed and attached all the following documents with the completed application and to be sent via mail to PQS.

a)      Completed Product certification application form “F05/01”

b)      A copy and an original copy of the proof of legal entity and tax documents to be viewed and attched to the application.

c)      Sign the general condition of certification document.

d)     Quality Manual.

e)      List of procedures.

f)       Copy of company Certificates which related to the scope of product certification.

g)      List of company equipment.

h)      Copy of calibration certificates.

i)        Organization chart.

j)        Copy of testing results that have been conducted on the product in accordance with the standard the standards related to the certificate as per the requirement of PQS scheme, it is possible that this report from the company/lab factory and/or an outside laboratory, believes “sufficiency of these reports during the first assessment process with the obligation to protect confidential company information.

k)      Sample of batch record related to the product intended to be certified.

l)        Completed Self-assessment form “F05/02” as specified in the scheme related to the product.

3)      All Applications has to be reviewed by technical manager and recorded within application review form F05/03, in case of failure to meet the minimum requirements and information needed to find, you must inform the applicant within 7 working days from the date of application or the request is cancelled and not registered, Application review decision will be registered at the end of application form with justification when applicable.

4)      Applications that meet only the minimum requirements and information required, these applications are registered and moved forward to the next step.

5)      Registered applications take the client number which is unique for every client as following:

For food products: PQS F-01-05-22

PQS: main in all codes.

(F): referring to the food product

(01): client number

(05): Month of application

(22): Year of application.

For cosmetics products: PQS C-01-05-22

PQS: main in all codes.

(C): referring to the cosmetics product

(01): client number

(05): Month of application

(22): Year of application.

All Approved application will be registered within applications register form “F05/04”.

 Determination:

·  PQS gathers information to determine the extent to which the client demonstrates its fulfillment of product certification requirements.

·  Evaluation plan from the information provided in the application, PQS ascertains that it has the competence and capability to undertake the work.

·  Based on the scheme PQS prepares an evaluation plan setting out:

a) the product type for which certification is sought,

b) the SFDA standards and other normative documents that specify the product requirements,

c) the evaluation methods and procedures to be used,

d) the product samples and/or the sampling procedures required for evaluation,

e) the methods and procedures to be used when assessing the production process,

f) the coverage and the extent of the auditing of the management system,

g) the personnel and other resources, including outsourcing, to be used for the evaluation.

· PQS advises the client of the plan, including any financial and timescale aspects required by the PQS scheme, and ensures that the client has completed, or has undertaken to complete, the certification agreement.

· After confirmation of the acceptance of the application, PQS makes the necessary arrangements with the client for the initial evaluation in accordance with the evaluation plan and inspection plan. The determination activities are:

a) initial testing and examination of the product,

b) inspection of the production processes, and

c) audit of the elements of the management system addressed by the client that are critical to product conformity.

· PQS is responsible for all actions included in the particular certification scheme, including sampling, testing, inspection of the production process, auditing of the management system, and surveillance of the certified product.

· This PQS product certification scheme don’t accepts conformity assessment results (including such items as test results and management system certification) which are generated prior to the application, or are provided by the client.

·  This PQS product certification scheme accept conformity assessment results (including such items as test results and management system certification) which are generated after to the application, or are provided by the client and verify it by the following:

a) checks that the conformity assessment results relate to the certification requirements; and

b) Identifies whether the conformity assessment results come from a body that fulfills the applicable requirements of ISO/IEC 17020 or ISO/IEC 17021-1 or ISO/IEC 17025, or are accredited to these standards with an accreditation scope relevant to the certification requirements.

Product certification agreement process:

– Certification team prepare commercial product certification offer “F05/05” and sent it to client.

– Once client accept it, the certification team send to client the product certification agreement “F05/06”

– Client has to singe the agreement which including commitment to all PQS rules of certification that comply with ISO 17065:2012.

initial evaluation process

1)      The first evaluation can be done on one, two or more products as needed by the competent evaluation team in charge.

2)      The concerned department, through the technical manager with cooperation with the Quality Manager, shall select the evaluation team, the team leader  and the names of the rest of the accompanying team of residents, trainees, observers or additional experts if necessary according competence requirement which stated in competence procedure PQS-PC-06.

3)      The team designated to carry out the evaluation work accepts and signs the Evaluation team nomination form “F05/07” which agreeing that it he does not violate the recognition of impartiality, independence and confidentiality rules.

4)       Evaluation team shall be based on the size of the company / factory and the number of products and production or technical qualities by technical manager and the number of evaluation hours within the company / factory.

5)      ISO 9001 Tables for man/days calculation may be used as guidance according to IAF MD 5.

6)      Certification team prepare the sampling plan for the concerned product

7)      Evaluation team (by the evaluation team leader) is doing the Product certification evaluation plan including the date and purpose of the visit and during the visit, the tasks and the schedule for the visit, the evaluation team names (the evaluation team leader – resident – intern – observer) in coordination with the applicant to ensure that the production processes for products on the application will be available during the initial evaluation work planned.

8)      The evaluation team leader is the responsible for present evaluation plan after notifying the company/factory on time and not having any objections before the formation of the team in terms of any conflict of interest or the date the plan is presented to technical manager with its visit form before the implementation date by at least three days form its approval.

9)      During the initial assessment, where applicable according to the specific scheme requirement, evaluation team may check the following list of requirements:

·         Product scheme requirement.

·         Management system of the applicant company.

·         Evaluate the production processes for the applicant products.

·         Verification, evaluation, methods of quality control to ensure product quality. “quality control plans”.

·         Check the competence and efficiency of the workers on the production lines for the products.

·         Status of laboratory equipment and the efficiency of its laboratory workers.

·         Verification of laboratory equipment, data and validity of calibration.

·         Attend the tests on the applicant sample of at least one of the tests that can be tested in the factory and conformity to be sure, the verification mechanism inside the factory of the conformity of products/

·         Evaluation of production records, quality control and laboratory tests and stores.

·         evaluation of warehouses and storage facilities and appropriateness.

Assessors prepare initial assessment report F05/09 including objective evidence for compliance from client system.

10)  If all of the above has been verified and meets and match requirements:

·         Samples of the final product is withdrawn according to Sampling plan “F05/10” and evaluator must withdraw the samples that covers a product applicant and are tested according to the product certification scheme.

· Sampling and testing can be conducted before the evaluation process under responsibility of PQS.

· PQS collect the samples and registered it within sampling report “F05/11”

PQS scheme specifies the sampling methods to be used for evaluation. Samples need to be:

a) Statistically representative of the population of products to be certified;

b) made using components and sub-assemblies identical to those used in production; and

c) made using production tools and assembled using methods established for the production run.

Where evaluation is performed on prototype samples, further evaluation of subsequent production samples is necessary.

PQS will consider the requirement of ISO 2859-1for the sampling process.

Initial testing and examination:

· The product evaluation is carried out in accordance with the methods specified in the applicable SFDA standard(s) and the procedures specified by the PQS scheme.

· The objective is to ascertain if the product fulfills the specified requirements.  Testing facilities used in product evaluation should demonstrate to PQS that they meet the technical requirements of ISO/IEC 17025:2017.

· This can be demonstrated by:

a) the testing facility having a current accreditation as fulfilling the requirements of ISO/IEC 17025 with a scope of testing covering the test methods established by the normative document for the product being certified, or

b) the assessment of the competence of the testing laboratory, if not accredited, by PQS in accordance with the requirements of ISO/IEC 17025 using a suitably competent laboratory assessor, including the witnessing of testing on a periodic basis, and fill Laboratory evaluation checklist F05/12

c) the testing laboratory having a peer assessment recognition by a competent organization with a scope covering the product being certified.

If test results are accepted, test reports and samples are examined together to ensure that test results are applicable to product samples under consideration.

PQS has list of approved laboratories F05/13

Samples withdrawal during the evaluation process:

· Evaluation team after sampling is responsible for sampling description within sampling report which include the following:

· reference to the sampling method used;

· date and time of sampling;

· data to identify and describe the sample (e.g. number, amount, name);

· identification of the personnel performing sampling;

· identification of the equipment used;

· environmental or transport conditions;

· diagrams or other equivalent means to identify the sampling location, when appropriate;

· deviations, additions to or exclusions from the sampling method and sampling plan.

· samples will be tested in laboratories accredited according to the requirements of ISO 17025.

· PQS team is responsible for the samples transfer to the laboratory in safe way.

· Sample coding shall be as following:

· Client code/sampling date, this code shall be linked with sampling report and written on sample pancaking.

Clinet code/day.Month.year.

· Eg: if PQS team withdraw sample in 1/9/2022 and client code is PQSF010522.

The sampling code will be PQSF010522/1922.

 · Notes: product testing can be before or after system evaluation.

Evaluation of the production process and audit of the management system 

·  Evaluation of the client’s production process and audit of the elements of the management system critical to product conformity forms part of the initial inspection in accordance with this product certification scheme. The client designates:

a) A responsible person as the main contact with PQS;

b) a person(s) with management responsibility for the technical performance of the production processes and management system.

·         Document review The first stage of undertaking an evaluation of the production process and audit of the management system is a document review.

·         PQS conducts a document review of the client’s management system in order to determine the readiness for the onsite evaluation.

·         To facilitate the document review, the client provides information on the management system pertinent to the production process. The client makes available to PQS records that demonstrate the effective implementation of the management system.

·         PQS may, at its discretion, take into account the client’s current management system certification, provided that the certification covers:

a) the scope of products being considered; and

b) the sites where the activities take place.

·         Consideration is also given to the extent that the management system certification is mutually recognized, through it originating from PQS that is accredited and/or peer assessed in accordance with relevant International Standards (e.g. ISO/IEC 17021-1).

·         PQS shall review the list of testing equipment’s available within the applicant company to assess the capacity of the company to comply with the requirements of the Standard and its Scheme of Testing and Inspection.

·         PQS evaluates the information provided, requests additional information as needed, and determines whether the application can proceed to the onsite stage of the determination function.

·         PQS arranges a date for a visit to each of the client’s site(s) where the certified product is produced and constitutes an inspection/audit team that includes persons competent in:

a)  the applicable product requirements;

b)  appropriate test and/or inspection procedures and techniques;

c)  conformity assessment procedures; and

d)  the management system requirements and audit methodologies as included in the PQS scheme.

·         The matters to be investigated by the inspection/audit team at the client’s facilities include:

a) determine that all information provided in the application is correct and complete;

b) inspection of the production process;

c) audit of the elements of the management system critical to product conformity.

·         At the Preliminary Inspection Stage, the inspection/audit team thoroughly assess the applicant’s readiness for Factory Audit.

·         During this stage, Client provides PQS with plan of Testing for his products.

·         Also, other GHP and GMP related requirements in the factory are assessed.

·         At the Factory Audit Stage, the inspection/audit team thoroughly carries out process inspection of the products against the requirements and audit of management system.

·         During the Factory Audit, the company’s adoption and acceptance of the Standard and STI are established.

·         The production process is inspected include assessing the client through direct observation and examination of the production line and communicating with production personnel in accordance with PQS requirement to demonstrate:

a) the client has the necessary facilities, equipment, personnel and procedure for carrying out the tasks associated with producing the product in accordance with the product requirements;

b) the client’s capability and competence to monitor, measure and test the product during and after production so as to assure conformity with the specific product requirements used in the PQS scheme;

c) that the client sampling and testing (whether it be in-house or outsourced) is undertaken in accordance with the certification requirements (including the specific product standards and methods of tests) and the applicable requirements of ISO/IEC 17025 and the certification requirements;

d) taking of samples by PQS and subsequent verification of test results or inspection reports by PQS;

e) quality control of the product through the production process in accordance with the certification requirements, from the receipt of inputs, through all transformation processes, through to dispatch of the completed products.

f) the ability of the client to identify and separate nonconforming product and to maintain product traceability where there is a certification requirement.

·         Elements of the management system critical for product conformity PQS audits the elements of the management system critical for product conformity.

·         PQS team will fill Management system and production process evaluation report F05/14.

ISO 9001:2015 Compliance

·         PQS Follow ISO 9001:2015 Requirement for assessing the management system of client with focus on:

a) procedures covering the production processes, including quality control, production resources and personnel competence that can affect product conformity,

b) documents and records control in relation to production processes and product conformity,

c) existing management system certifications and associated audit reports if any,

d) internal audits and management reviews,

e) procedures and records associated with product nonconformance, corrective and preventive actions,

f) the identification, marking, and marketing of conforming products in accordance with certification requirements and license agreements,

g) those management system processes that are carried out by the client as part of the product certification scheme, and that the client has the necessary planned arrangements to ensure that the management system processes will continue to be effectively implemented and maintained.

· PQS gives consideration to the amount of audit time when the client’s management system is ISO 9001:2015 certified by an accredited certification body.

· Non conformities will be raised within product certification report form F05/15

Step 3: Technical Review:

 ·The evaluation team and PQS Coordinators has to send the evaluation document to technical manager including the following:

·         Application form

·         Self-assessment form

·         Applications register form

·         Evaluation team nomination form

·         evaluation plan

·         Evaluation report

·         sampling plan

·         Non conformity report

·         Corrective actions with evidences

·         Lab results.

·         A copy and an original copy of the proof of legal entity and tax documents to be viewed and attached to the application.

·         PQS and client agreement.

·         Signed Certification general conditions

·         Quality Manual.

·         List of procedures.

·         Copy of company Certificates which related to the scope of product certification.

·         List of company equipment.

·         Copy of calibration certificates.

·         Organization chart.

·         Other supporting documents.

·         Technical manager has to review the whole client file and fill Product Certification Technical review report F05/16 including his recommendation which of the following:

·         Raising non-conformities and request corrective actions from the evaluation team in coordination with client.

·         If no non-conformities or solved non-conformities, directing the file to certification committee for issuing the decision.

Step 4: Decision Making:

Decision maker(s) will review the client file and make decision as following:

·         Grant the certificate:

·         Not grant the certificate

Company to be notified within 7 days by the decision with justification and decision maker(s) record the decision within Product certification decision report F05/16

Step 5: certificate issuance: “F05/18”

Once Certification manager receive decision to issue the certificate from decision maker, he direct the certification coordinator to issue the certificate with its code, the code including the following:

Client number+certifcate number

· Eg: client code is PQSF010522.

· Certificate number 01

· Certificate code: PQSF010522 01

The certificate shall include the following:

· PQS Name, logo and address

· The date certification is granted (the date shall not precede the date on which the certification decision

· was completed);

· The name and address of the client;

· The scope of certification.

· Reference to scheme, other standards or normative documents, these do not need to be included in the formal certification documentation.

· Certificate expiry date

· Any other information required by the certification scheme.

Product certification renewal

  • Certification manager send a letter to the company/manufacturer notify them about the near expiry of certification 2 months before expiry.
  • Renewal evaluation visit and certification decision must be done before one day of certificate expiry.
  • The client has to refill the application and the self-assessment report and send it with the updated same documents that sent before in initial evaluation.
  • Certification manager will plan renewal evaluation using all the same format of initial evaluation process.
  • Evaluation team is conducting the evaluation using the same format of initial evaluation and send the file to technical review which do the same process of initial evaluation then send to decision maker to issue the decision.
  • Certification manager send to evaluation team, technical reviewer and decision maker all periodical evaluations during the certification period according to the regulation of certification scheme related to the certified product.
  • Client is forbidden to use any certification logo after certificate expiry in case of certificate renewal not
  • If there are non-conformity raised during the renewal evaluation, corrective actions shall be taken before expiry date.
  • If the certificate expired and client want to be re certified, client has to apply as new applicant.

Periodic evaluation and market surveillance

  • Every product certification scheme manages the process of periodic evaluation and market surveillance if applicable.
  • Evaluation team is using the same format of initial evaluation for evaluation process.

Suspension of certificate

  • Certification Committee may decide to suspend the certificate in case one of the following:
  • A violation of terms and conditions, requirements of certification scheme and/or contract.
  • Non conformities in the result of testing of 2 consecutive samples of certified products according to the relevant standard, whether the samples withdrawn during the periodic evaluation or from market or as a result of complaint investigations or due to any other cause.
  • Measuring devices that affect the quality of product are being out of calibration.
  • Not following the period of corrective action reporting.
  • Suspension period is one month, after this date, certificate withdrawal decision will be taken.

Certificate withdrawal

Certification Committee may decide to withdraw the certificate in case of the following:

  1. failure to make the required corrective actions within one month from suspension decision
  2. critical non-conformities issued.
  3. Certification fees not done.

Suspension, withdrawal, termination report F05/19 is issued in case of any of above actions taken.

Processes for granting, refusing, maintaining, renewing, suspending, restoring or withdrawing

  • It has been entitled to issue a decision in order to suspend the certificate of using the mark after raising to the certification and decision-making committee in the following cases: –
  1. Violation of the company / factory of any of the rules and conditions and the general way of grant schemes.
  2. In case of suspension of a certificate according to the company request for a specified period (up to 6 months maximum- approved by certification body) because of production stop, or any other reasons. The suspension of certificate  will be cancelled after the end of the expiration of the time period for suspension after make sure to avoid the root causes of this suspension.
  3. In the following cases, PQS has the right to issue a decision in order to withdraw the Certificate of use the mark after raising to the certification and decision-making committee:
  • If the decision was taken to suspend the certificate and company/ factory still continued in the violation.
  • Lack of company / factory’s commitment to the licensing requirements and frequency of cases of non-conforming without taking the necessary measures to prevent the causes of nonconformity to prevent its recurrence.
  • Non-application of the company / factory of the amendments taken over the licensing requirements after allowing the regularization period.
  • If the company misused the certificate or the mark or in case of brand appearance in order to misleading customers and the public consumers.
  • If it has been stopped the production of certificate d product to use the mark.
  • If the company/factory does not pay the costs accrued in the planned schedule and the withdrawal of the certificate does not exempt it from payment.
  • Complains and appeals:
  • Be entitled to file a complaint from any of the participants in the service or actions of the excesses in the specified time or anything contrary during the proceedings, all justifications has to be explained and the decision will be issued within 30 days from the date of the complaint.
  • Also Be entitled to file a complaint against the decision disapproval of grant or renew or adding scope, reduce or suspend or cancel the certificate within 60 days from the date of receipt of the decision notification to be submitted to the first party, explaining the reasons and justifications and attachments function on the reasons for the complaint . The complaint will be checked and the decision will be taken within 30 days’ complaint submission.
  • In the case of the preceding paragraph (2) if the complainant is not satisfied regards to his complaint result, he has a right to appeal within another 30 days of complaint notification result and displays appeal to the Appeals Committee and the decision will be taken within 30 days of filing the petition date and the decision.
  • The appellant or his designee has the  right to present his appeal to all Committee members in order to help them to issue/ take a decision
  • The handling process of complaints and appeals has to be in accordance with established procedure in this regard. The appellant can find the necessary information that it has been included in the used forms on the first party website or by asking the certification body directly .
  • Confidentiality of the information :

All participants in the certification procedures are committed to maintaining the confidentiality of the information and not to disclose any information obtained from the applicant for service during and after the procedure except in the following cases:

  1.  The information has been with the PQS in advance before the company provides it.
  2.   If the regulatory or legal bodies asked to disclose some of the information after a writing notification to the company / factory. The second party is also committed to maintaining the confidentiality of information and documents and bond granted during and after the licensing procedures by the first party in order to preserve property rights.

Information about Granting, Maintaining, Renewing, Suspending, Restoring or Withdrawing Certification or Expanding or Reducing the Scope of Certification

  • PQS ensures that the person or the group of persons involved in the decision making for granting, refusing, maintaining, extending, reducing, renewing, suspending or restoring suspension and withdrawal of certification against management system standards have not participated in the evaluation process.
  • PQS ensures that the personnel involved in decision-making as stated above have the competence to evaluate the audit processes and the related recommendations of the audit team.

Granting Certificate

  • Granting certification means the state that the compliance to the Certification requirements has been confirmed by the PQS as per its Certification Procedures.
  • The certification is granted and recorded in List of Certified Clients and on the website after the following conditions have been met by the applicant organization:
  • Client has a documented management system that meets applicable standard or other normative documents.
  • Comply with PQS applicable scheme.
  • One internal audit and management review cycle has been completed and nonconformities, if any, have been corrected.
  • The applicant meets the criteria of certification and all on-conformities, if any found during assessment have been closed.
  • There are no adverse reports/ information/ complaints with the PQS about the applicant regarding the quality and effectiveness of implementation of system as per PQS product certification scheme criteria.
  • The applicant has paid all the fees.
  • PQS will refuse to issue certificate, if any of the above not followed.

Maintaining Certificate:

The Certification is maintained for a period specified within product certification scheme under the following conditions:

  • When applicable, The Surveillance Audits are conducted as planned and the client has demonstrated that it continues to satisfy the requirements of the management system standard as confirmed by PQS
  • All the non-conformance raised during previous evaluation are closed within the time frame agreed and correction and corrective actions for the non-conformities raised during the current evaluation are identified and accepted by PQS.
  • The internal audit and the management reviews are conducted as scheduled and there are no issues pending.
  • 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 PQS Assessors.

All outstanding dues to PQS are paid.

Expanding and Reducing scope of product Certification:

  • PQS, in response to client request for expanding the scope of a certification already granted, undertake a review of the application and determine any evaluation activities necessary to decide whether or not the extension may be granted.
  • PQS wherever applicable reduce the scope of certification if during the time of routine
  • surveillance audits / re approval or renewal evaluation it finds that the certified client has continually seriously failed to meet the certification requirements for those parts of the scope of certification.
  • Such exclusions shall be consistent with the certification scheme.
  • If the reduction in scope is requested by the client shall be dealt with. The expansion and reduction in scope will be approved by the Certification Manager.
  • PQS issue a new certificate with amended scope without any change in the certification period as identified in the previous certification document. The new certificate shall contain revision number and date.

Suspension of certification:

  • Suspension of certification may be done in the following cases:
  • The certified client’s system and or product has persistently failed to meet certification requirements.
  • The certified client does not allow surveillance or recertification evaluation to be conducted at the required frequencies.
  • The certified client has voluntarily requested a suspension.
  • In case of not following new requirement that changed due to certification scheme updates within the stated time frame.
  • Misuse of logo & reference to certification.
  • Violate contract or agreement of certification.
  • In case of providing false information or document during evaluation process.
  • Non-compliance to submission of corrective action as stated in procedure
  • Non-payment of dues to PQS.
  • The suspension shall be for a period of maximum 03 months and the suspended status of the client shall be publicly made available in the register of certified clients being maintained by PQS at its registered office.
  • During this period the client should discontinue the use of logo or any reference of certification in advertising matter, as directed by PQS, at the time of giving notice of suspension.
  • Restoring of certification
    • PQS shall restore the suspended certification if the issue that has resulted in the suspension has been resolved. Failure to resolve the issues that have resulted in the suspension within 3 months shall result in withdrawal or reduction of the scope of certification.

    Withdrawing certification

    • PQS informs the customer through email notification about the withdrawal of certification, if the reasons of suspension are not removed.
    • PQS revises List of Certified customers and update the information on PQS website to make it publicly accessible.
    • The termination of withdrawal of certification means that certification is no longer valid.
    • The customer may re-apply to PQS for Initial Certification when all the reasons for the withdrawal have been removed and communicated to PQS.
    • Any application received from a withdrawn client is processed as for new client.

     

    • PQS shall withdraw the certificate under the following circumstances.
    • Failure of the client to resolve the issues of suspension within 3 months shall result in withdrawal of certification.
    • Other reasons like major legal complaint; company involved in malpractices,
    • Client voluntarily requested for a withdrawal.
    • Upon withdrawal of certification the client ceases to enjoy the certification status and shall accordingly return the certificate as directed by PQS at the time of withdrawal notice.
    • The decision for withdrawing certification is taken by the Decision Maker.
    • Upon request from any party, PQS shall correctly state the status of certification for client as being suspended, withdrawn or reduced.

    Renew of certification or recertification

    – PQS makes decision on renewing certification based on the following,

    (a) The results of the re-certification evaluation.

    (b) The results of the review of the system over the period of certification.

    (c) Complaints received from customers of certified clients.

The obligations and rules of use of the PQS name and certification mark or logo

Objectives:

 The objective of this document is to specify how PQS certification marks shall be depicted and conditions relating to their use.

Scope:

  • PQS product certification in the field of food product certification and or Cosmetics product certification.

 Applicability:

 Applicable to all PQS product certification activities.

 Reference:

  • ISO/IEC 17065:2012 Conformity assessment – Requirements for bodies certifying products, processes and services.
  • GSO 2055-2:2021 Halal products –– Part two: General Requirements for Halal Certification Bodies
  • ISO/IEC 17030:2021Conformity assessment — General requirements for third-party marks of conformity.

Procedure:

 A client who is certified by PQS is entitled to use the applicable certification mark of PQS.

  • For multi-site organization, only sites whose activities are included in the scope of the certification may use the applicable certification mark.
  • The right to use the certification mark does not extend to the parent company or to subsidiary (ies) of the certified client unless these entities are also included in the certification.
  • PQS’s certification mark may be used on its own and shall clearly reflect the certification scheme for which the client has been certified.
  • The applicable certification mark when used on its own shall be as shown in Annex 1.
  • The use of PQS’s name, logo, trademarks or any intellectual property under any circumstances without prior written approval of the PQS is strictly forbidden.
  • The requirements of use of certification marks as follows:
  • All PQS certification marks are the sole property of PQS’s and it shall be used according to these guidelines ONLY.
  • There is no minimum size requirement for the mark, but it must be legible and readily identifiable.
  • The size of the Certification Mark may be reduced or enlarged proportionately as required.
  • The certification marks may be reproduced in black and white, or in the case of preprinted material e.g. letterhead, stationery, newspaper and magazine articles, in the predominant color of these items.
  • Client shall apply the certification mark ONLY to products that are:
  1. specifically listed on the certificate;
  2. Complied to the Specified Standard, Scheme and procedures including relevant regulatory provisions,
  3. fulfilled the markings requirement as stipulated in the certificate
  • The Certification Mark shall be directly applied to each product except where the physical characteristics of the products do not permit, in which the case, the Certification Mark may be applied to the smallest packaging unit or warranty card.
  • The certification mark shall be applied in such manner that is NOT transferable from one products, processes or services to another.
  • The usage of the certification mark on the products, processes or services, may not be used to imply a relationship such as partnership PQS.
  • The certified client shall not reference the intent to submit a product, processes or services for certification or the expectation that the product, processes or services may be certified in the future.
  • PQS certification marks shall not be preceded or followed by a qualifier that indicates a degree of certification or acceptability. For example, “exceeds”” first” or “only” shall not be used to qualify any PQS’s.
  • Only original artwork of the certification mark proposed to PQS shall be used.
  • The certification marks shall not be altered in any way other than to resize the artwork proportionately.
  • Unacceptable uses of the certification mark include, but are not limited to, adding/deleting wording or artwork, reducing the artwork to an illegible size, or distortion.
  • Certification marks may be used on advertising materials, articles, catalogs, manuals, booklets, mill certificate, signage and news releases.
  • NO PQS certification mark or aspect thereof shall be incorporated as part of business name, business stationery, Internet domain name, or brand name/trademark for products, processes or services. This includes both designs aspects and words aspects.
  • If certified client chooses to use only wordings in the advertising material to describe the product, processes or services being certified by PQS, the certified client shall use the wordings as “PQS CERTIFIED TO (standard no.)” and followed by “CERT.NO”.

Misuse of the Certification Marks

  • Any act such as addition and/or omission by certified client with or without intention that has breach the term and guidelines provided herein shall be considered as an act of misuse the certification mark.
  • PQS shall have the right to make an investigation including providing support to enforcement body to raid the premises related to the products, processes or services without giving notice to the certified client once PQS received such complaint.
  • PQS shall have the right to terminate the certified client and the agreement with the certified client if it is shown there are evidences of misuse of the certification mark.
  • PQS shall have the right to claim from the certified client for any lost and cost incurred that PQS has to suffer as a result of the misuse including legal proceedings and public notification cost.
  • PQS shall have the right to make a claim through court jurisdiction if the remedy provided by arbitration is not sufficient to cover the loss and cost suffered by PQS due to the misuse.
  • The certified client shall inform the public through media that they had misused the certification mark and to recall the product.

Appeals and Complaints Procedure

  • Purpose:
  • To document, establish, implement and maintain the system for addressing Appeal, Complaints and Disputes received by (PQS) as per requirements of ISO 17065:2012, ISO/IEC 17021-1:2015, ISO 17021-2:2016, 17021-3:2016, ISO 22003:2013, 17021-10:2018, IAF MD 22 and other applicable international standards for certification bodies offering management system certifications
  • 2.0. Scope:
  • This procedure is applicable to all appeal, complaints and disputes received by (PQS) related to its Management System Certification.
  • Responsibility: 
  • Managing Director
  • 3.0  Procedure:
  • 4.1 Appeals
  •  4.1.1 Any client shall make an appeal to the Managing Director of (PQS) in respect of the following,
  • Non acceptance of client’s application for certification
  • Granting, suspending, withdrawing or denying of certification
  • 4.1.2 (PQS) shall record all appeals in document ((PQS) 40 B Appeal – (PQS)-40 C – Register for Appeal & complaints) and acknowledge the receipt of the appeal. All appeals shall be addressed within 30 working days from the receipt of the appeal and (PQS) shall provide the client with progress reports and the outcome.
  • 4.1.3 All appeals are reviewed by the appeal panel constituted by managing director for each appeal. The appeal panel shall contain at least two members from the (PQS) auditor panel who have not been part of the audit and also not involved in certification decision or involved in the subject of the appeal. For appeal against the decision of the Managing Director the matter shall be referred to the chairman of the Impartiality Board (IB) for constituting the panel and taking the decision.
  • 4.1.4 The appeal panel shall investigate the appeal by looking into the records and / or talking to the appellant and (PQS) and shall take a decision taking into account the results of any previous such appeals.
  • 4.1.5 Based on the decision of the appeal panel (PQS) shall initiate appropriate correction and corrective action and the same recorded in ((PQS) 40 B Appeal – (PQS)-40 C – Register for Appeal & complaints )
  • 4.1.6 (PQS) shall be responsible for all decisions at all levels of the appeal handling process. The decision on the appeal is reviewed and approved by managing director and is communicated to the client. This completes the appeal process and (PQS) shall also inform the appellant at this time about the closure of the appeal.
  • 4.1.7 (PQS) shall ensure that the submission, investigation and decision on appeals shall not result in any discriminatory action against the appellant.
  • 4.1.8 The right of the client to appeal against any decision by (PQS) is communicated at the time of sending the quotation through document PD-01.
  • 4.1.9 Information about appeal handling process of (PQS) is made publicly available through web site and / or document PD-01
  • 4.2 Complaints
  • 4.2.1 Information about complaint handling process of (PQS) is made publicly available through web site and / or document PD-01. The complaints handling process includes the following
  • An outline of the process for receiving, validating, investigating the complaint and for deciding what actions to be taken in response to it.
  •  
  • The Managing Director is responsible for gathering and verifying all necessary information to validate the complaint.
  • 4.2.2 The complaint can be made to the Managing Director by the client or any other interested party in writing giving details of the complaint. The complaint shall either relate to the certification activities of (PQS) or to the certified client and its activities.
  •  4.2.3 The complaints received are recorded in ((PQS) 40 A complaints – (PQS)-40 C – Register for Appeal & complaints) and is acknowledged to the complainant. The managing director shall review the complaint to ascertain the seriousness and the genuineness of the complaint.  (PQS) shall provide the complainant with progress reports and the outcome.
  • 4.2.4. The complaint redressed process:
  • 4.2.4.1. Complaints about (PQS) from the client or third party
  • Depending on the nature of the complaint, Chairman of the Impartiality Board shall decide to conduct the investigation himself or appoint a complaint panel for each complaint. The complaint panel shall contain at least two members from the (PQS)’s auditor panel who have not been part of the audit and also not involved in certification decision or involved in the subject of the complaint. Further, the complainant shall be given an opportunity to present the case to the panel in person if he so desires.
  • The complaint panel shall investigate the complaint by looking into the records and / or talking to the complainant and (PQS) and shall take a decision taking into account the results of any previous such complaints.
  • The details of investigation and the correction and the corrective actions identified are recorded in the complaint register. Upon verification on the effectiveness of corrective action taken, (PQS) shall inform the complainant about the correction and corrective action taken and if the complainant is satisfied with the actions taken the complaint is treated as closed. The final Decision on the resolution of complaint shall be taken by the chairman of the Impartiality Board.
  • 4.2.4.2. Complaints about the certified client from its customers or any other third    party:
  • (PQS) shall inform the client about the complaint received and ask the client to investigate the complaint and report the findings to (PQS) within two weeks from the date of receiving the complaint by the client.
  • If (PQS) does not receive any response from the client or the action taken by the client is not found effective, (PQS) shall inform the client accordingly and ask for a special audit at the client site by (PQS). On confirmation from the client (PQS) shall conduct a special audit as per (PQS) procedure, PQS-MSP-07 and investigate the complaint.
  • If the complaint is of serious nature (PQS) shall initiate the special audit directly with the client
  • As its policy, (PQS) shall not disclose the identity of the complainant to the client.
  • If any action is needed to be taken by the client (PQS) shall verify the effectiveness of such action by suitable means appropriate to the gravity of the problem.
  • If the corrective action taken by the client is found effective (PQS) shall inform the complainant accordingly and the complaint shall then be treated as closed.
  • 4.2.5. (PQS) shall decide to make public the complaint and its resolution if agreed with client and complainant.
  • 4.2.6. All the complaints received and their status with respect to their resolution are presented in the MRM and the IB meeting
  • 4.3 Client feed back
  • 4.3.1 After every audit (certification, surveillance and re-certification) a feedback from the client in obtained in document (PQS)-36, to assess,
  • (PQS)’s office responsiveness to client queries at various stages of the certification process
  • Performance of the audit team
  • Areas for further improvement
  • 4.3.2 All the feedback received from the clients are analyzed and appropriate action taken if required.
  • 4.3.3 The actions taken are recorded in (PQS)-36
  • 4.3.4 A summary of feedback and the findings with corrective action taken are reviewed in MRM and (Impartiality Board) IB meeting.
  • 4.4 Disputes
  • 4.4.1. Any dispute arising out of (PQS)’s certification activities shall be settled by private negotiations between the parties, and if this is not possible it shall be referred to arbitration as per the Egyptian Arbitration Act, subject to Egypt  jurisdiction. The decision of the arbitration shall be binding for the both parties
  • 4.4.2 Records of all the disputes are maintained and reviewed in MRM and IB meeting.
  • 5- Appendices
  •  
  •  ** List of Formats Used:
Sr. no. Quality Record Reference No. Storing Location Retention Period Remarks
1 Complaints (PQS)-40 A Main Head Office 5Years Electronic Form
2 Appeal (PQS)-40 B Main Head Office 5Years Electronic Form
3 Register for Appeal & complaints (PQS)-40 C Main Head Office 5Years Electronic Form
4 Feedback form (PQS)-36 Main Head Office 5Years Electronic Form
5 Special Audit Report (PQS)-19 Main Head Office 5Years Electronic Form
  • 6.0 References
  • PD-01-Rules and regulation for certification
  • PQS-MSP-07-Procedure for Special Audit.

Enquiry/Application form

 

Date of Application  
Name of the Company  
Address  
Website, Email and Phone number  
No of Sites  
Site 1 Address  
Site 2 Address (For more site attach separate Sheet)  
Contact Person Name and position  
Legal Status  
Statutory and Regulatory Requirement  
Accreditation Required  
Certification Scheme  
Scope of Certification  
Outsourced Process, If any  
No. of Employees Location Shifts Full Time Part time Performing Same type of Job Temporary Unskilled workers Effective No. of Employees
Site 1  

 

         
 

Please list the number of employees in each area/site:

(Please use additional sheets if required)

Site 1 Site 2 Site 3 Site 4
Full time Part time Full time Part time Full time Part time Full time Part time
Senior Management                                            
Management                                            
Administration Staff                                            
Management / Service Area                                            
Quality Control / Technical                                            
Storage / Warehouse                                            
Other                                            
Seasonal Staff                                            
Site total number of staff                                            
Approx. number of Sub Contractors:       Type of work Sub Contracted:
% of total work Sub Contracted:      
% of work carried out at Clients Site:      
Do you hold any other third party registrations?

 We don’t hold any other third party registrations.

 

Type of application (please select from the following options):
New Renewal Scope Extension    
Type of management system: Single Combined Integrated
Scope: Please describe what activities your organisation carries out:
 

 

 

Certification Program Required Initial     Surveillance   Recertification   
Is Already Certified for any Standard Yes                     No

If Answer is Yes Mention Name of the Standard: 

Is Consultants Involved Yes                     No

If Answer is Yes Mention Name of the Consultants: 

Key Business Process Involved  
Additional Information Required
   
 

 

Details about the products:

 

Product: Please fill below table and repeat it for each product.

Product name  

 

 

Product description  

 

 

 

Product applicable standards  

 

 

 

PQS applicable Certification scheme  
SFDA Applicable standard  
Codex applicable standards  
Customer applicable standards  
Testing lab name / accreditation  
Last testing result findings/date  
Last internal audit covering the product scope date.  
Last management review covering the product scope.  

 

 

Please provide PQS with the following to proceed for application review as following:

 

Completed Product certification application form “F05/01”

  1. A copy and an original copy of the proof of legal entity and tax documents to be viewed and attached to the application.
  2. Sign the general condition of certification document.
  3. Quality Manual.
  4. List of procedures.
  5. Copy of company Certificates which related to the scope of product certification.
  6. List of company equipment.
  7. Copy of calibration certificates.
  8. Organization chart.
  9. Accreditation certificate of testing lab.
  10. Copy of testing results that have been conducted on the product in accordance with the standard the standards related to the certificate as per the requirement of PQS scheme, it is possible that this report from the company/lab factory and/or an outside laboratory, believes “sufficiency of these reports during the first assessment process with the obligation to protect confidential company information.
  11. Sample of batch record related to the product intended to be certified.
  12. Completed Self-assessment form “F05/02” as specified in the scheme related to the product.
  13. Other supporting data related to the scope.

 

DECLARATION: The above information is true to the best of my knowledge and belief and I am authorized to provide such information on behalf of the company.
Name   Position   Signature  

 

PQS Official Use

Can the Application Proceed for Application Review:            Yes          No

Name of Application reviewer   Signature  

 

Date  

 

 

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