Regulations to be met by CABs

R-CAB-5-1

INDEX

  1. GENERAL
  2. PRESCRIPTION OF RELEVANT ACCREDITATION CRITERIA
  3. DOCUMENT HAS TO BE SUBMITTED BY THE CONFORMITY ASSESSMENT BODIES
  4. CONDITIONS TO BE MET BY CONFORMITY ASSESSMENT BODIES:
  5. SIGNIFICANCE OF ACCREDITATION
  6. NOTIFICATION OF CHANGE
  7. SUSPENSION AND WITHDRAWAL
  8. APPEALS
  9. COMPLAINTS

1.      GENERAL

1.1.    UK International Accreditation Forum Limited (UKIAF) operates under the terms of the presidential decree number 248/2006. UKIAF is the sole Egyptian national body for the assessment and accreditation of all conformity assessment bodies (CABs) undertaking testing, calibration, certification, inspection and proficiency testing.

1.2.     DEFINITIONS

1.2.1.      The term “certification” is deemed to cover product conformity certification, certification of quality management systems, certification of environmental management systems, certification of persons, certification of food safety management system, occupational health and safety management system specification involved in quality verification and halal product conformity certification ".

1.2.2.      The term “inspection” is deemed to cover examination of a product design, product, service, process or plant, inspection bodies of forensic service providers and determination of their conformity with specific requirements or on the basis of professional judgment and general requirements.

1.2.3.      The term “laboratory” is deemed to cover calibration, testing, medical laboratories including the calibration and testing laboratories of forensic service providers (FSP).

1.2.4.      The term “proficiency testing” cover the CABs provides PT schemes for all types of laboratories.

1.2.5.      The terms “applicant CABs” and “accredited CABs” are deemed to cover laboratories, certification bodies, inspection bodies, PT providers and forensic service providers.

1.3.     These regulations apply to the accreditation of certification bodies against:

-  ISO 15189:2012 for medical laboratories;

-  ISO/IEC 17020:2012 for inspection bodies including FSP inspection bodies;

-  ISO/IEC 17021-1:2015 for certification of management systems;

-  ISO/IEC 17024:2012 for person certification;

-  ISO/IEC 17025:2017 for testing and calibration laboratories including FSP labs;

-  ISO/IEC 17065:2012 for product conformity certification;

-  UAE S 2055-2:2016 for halal products conformity certification.

These standards shall be followed along with any other relevant criteria of competence specified by UKIAF.

1.4.     Granting, maintenance, extension and renewal of accreditation will be afforded only to the CAB which:

(a)      Is legally identifiable

(b)     Demonstrates compliance with these UKIAF requirements, relevant standard and related national/international publication and guidelines;

(c)      Pays such fees as are due to UKIAF;

(d)     Gives such undertakings as UKIAF may require.

1.5.     Applicant CABs for accreditation will undergo initial assessment as required by UKIAF to enable UKIAF assessors to determine the competence of CAB and its compliance with criteria for which accreditation is sought. In the event that accreditation is awarded, an accreditation certificate and accreditation schedule defining the scope of accreditation will be issued to the accredited CAB.

1.6.     UKIAF will indicate how continuing compliance with these regulations and relevant criteria will be monitored.

The frequency with which accredited CAB is normally subject to consecutive assessment and reassessment will be prescribed by UKIAF. UKIAF will make its program to have a first assessment visit within the last 6 months at the 1st year of accreditation, and a second assessment visit within last 6 months at the 2nd year of accreditation, and a third assessment visit within last 6 months at the 3rd year of accreditation.

If the 1st, 2nd and 3rd  assessment  showed  that  the  CAB  needs  more  frequent  visits  then EGAC relative accreditation manager in consultation with EGAC accreditation director would decide on more 4th un-planned assessment visit.

The reassessment will be every 4 years, reassessment preparations will start by inform UKIAF its CAB within 11 months before the expiry date of the accreditation certificate.

1.7.   Over and above this, UKIAF reserves the right to carry out additional or unscheduled assessment visits or reassessments at intervals other than those prescribed. UKIAF reserves the right to witness assessment visits made by applicant or accredited CAB.

1.8.     UKIAF will specify the procedures by which application for accreditation should be made, the conditions for granting, maintaining, extending and renewal of accreditation, and the conditions under which accreditation may be refused, suspended, reduced, withdrawn or reinstated.

1.9.     UKIAF may suspend or withdraw accreditation, reduce the scope of an accreditation, extent or reassessment, if:

(a)     There is any change in any aspect of accredited CAB’s status or operation that affects compliance with these regulations and relevant criteria or affects accredited CAB’s capability or scope of activity; or

(b)     The CAB fails to comply with the requirements of these regulations and/or relevant criteria specified by UKIAF.

1.10. UKIAF has authority to terminate accreditation if accredited CAB:

(a)     Being owned by an individual, such individual is declared bankrupt or enters into a composition with his creditors; or

(b)     Being a company, enters into liquidation, whether compulsory or voluntary (but not including liquidation for the purposes of reconstruction), or has a receiver of its business appointed; or

(c)      Fails in any respect to comply with the law of the country;

1.11. Made unreasonable or irresponsible use of subcontracting from the reasonable view of UKIAF.

1.12. All information gained by UKIAF and its representatives in the granting, maintenance and renewal of accreditation will be treated as confidential between the CAB and UKIAF. Such information will be handled within UKIAF on a strict ‘need to know’ basis and will not, subject to the law of the country, be discloses without the express written instructions of the CAB’s management.

2.      PRESCRIPTION OF RELEVANT ACCREDITATION CRITERIA

2.1.     UKIAF have the rights to specify the relevant accreditation criteria against which an applicant CAB shall be assessed.

2.1.     The criteria set out in the relevant standard will normally be taken as the basis for assessing the competence of the CAB but additional or alternative criteria may be prescribed at the discretion of UKIAF.

3.      DOCUMENT HAS TO BE SUBMITTED BY THE Conformity Assessment Bodies (CABs)

General:

All CABs shall submit the following updated documents at its assessment or re-assessment case to UKIAF relevant department:

  1. Fully completed AF/5/1_UKIAF application form (soft and hard);
  2. Two original copies of CABA/5/1_UKIAF CAB agreement;
  3. Application fee according to R/AF/5/1 or R/AF/5/2;
  4. Commercial registration/legal entity;

1.1.  Accreditation testing and/or calibration labs according to ISO/IEC 17025:2017 shall submit the following documents electronically at initial assessment or re-assessment case to UKIAF testing/calibration labs accreditation departments:

  1. Assessment checklist report SA/TCL/5/1 (self-assessment) for testing and/or calibration labs quality system implementation;
  2. Updated quality manual (if applicable) with updated organization chart indicating where the lab is included within parent organization;
  3. Management procedures and arrangements that address ISO/IEC 17025:2017 management requirements;
  4. Technical procedures and arrangements that address ISO/IEC 17025:2017 technical requirements;
  5. Testing and/or calibration scope of which accreditation is sought;
  6. Work instructions/SOPs;
  7. Cal/test procedure Uncertainty calculation;
  8. A CAB CMC for each scope;
  9. Uncertainty calculation for each scope;
  10. An updated proficiency testing (PT) report for each scope with satisfactory result with a scope covering plan;
  11. A list of used equipments standard with a copy of last "non-expired" calibration certificate for each one;
  12. Calibration plan;
  13. A list of involved employees for each scope.

1.2.   Accreditation for inspection according to ISO/IEC 17020:2012 shall submit the following documents electronically at initial assessment or re-assessment case to UKIAF inspection body’s accreditation departments:

  1. Assessment checklist report SA/IB/5/1 (self-assessment) for inspection body quality system implementation;
  2. Updated quality manual with updated organization chart indicating where the lab is included within parent organization;
  3. Management procedures and arrangements that address ISO/IEC 17020:2012 management requirements;
  4. Technical procedures and arrangements that address ISO/IEC 17020:2012 technical requirements;
  5. Inspection scope of which accreditation is sought;
  6. Work instructions/SOPs;
  7. List of authorized inspectors;
  8. Last management review meeting minuets;
  9. Last internal audit;
  10. Supporting inspection methods/standards/regulations........... ;
  11. List of used instruments/equipment with appropriate calibration certificates.

1.3.  Accreditation for certification bodies of management system according to ISO/IEC 17021- 1:2015 or halal products according to UAE S 2055-2:2016 shall submit the following documents electronically at initial assessment or re-assessment case to UKIAF certification bodies accreditation departments:

  1. Assessment checklist report SA/MSCB/5/1 (self-assessment) for management system CBs;
  2. Legal entity documents of the CAB (company);
  3. Latest version of CAB documents (company's distinguished documents);
  4. Quality manual;
  5. Administrative procedures and technical procedures;
  6. List of accredited auditors;
  7. A list of the countries and activities in which the company operates and wishes to use accreditation symbol of UKIAF.

1.4.  Accreditation for product or person certification bodies, according to ISO/IEC 17065:2012 or ISO/IEC 17024:2012 shall submit the following documents electronically at initial assessment or re-assessment case to UKIAF PT providers accreditation departments:

  1. Assessment checklist report SA/PCB/5/1 (self-assessment) for product CBs and SA/PeCB/5/1 (self-assessment) for person CBs quality system implementation;
  2. Electronic copies of the applicant’s management system and relevant associated documentation;
  3. List of all forthcoming evaluation activities (the fields and types of activity, the assigned evaluators and client details);
  4. Evidence of the identity of the legal entity applying for accreditation.