GENERAL PRINCIPLES FOR THE ASSESSMENT OF MANAGEMENT SYSTEMS/ PRODUCT/PERSONS CERTIFICATION BODIES

Transcription

1 Document No: AP 12: Part 3 Issue No: 2 GENERAL PRINCIPLES FOR THE ASSESSMENT OF MANAGEMENT SYSTEMS/ PRODUCT/PERSONS CERTIFICATION BODIES Prepared by: SADCAS Approved by: Chief Executive Officer Approval Date: Effective Date:

2 Table of Contents Page 1. PURPOSE AND SCOPE GENERAL APPLICATION, PRE-ASSESSMENT, INITIAL ASSESSMENT AND WITNESSING OF SCOPES THE ASSESSMENT CONDUCT OF ASSESSORS SURVEILLANCE ASSESSMENTS RE-ASSESSMENT MULTI-SITE CERTIFICATION BODIES, REGIONAL AND INTERNATIONAL ACCREDITATION OF CRITICAL FOREIGN LOCATIONS EXTENSION AND REDUCTION OF SCOPES TIMESCALE FOR ACCREDITATION PROCESS COMPLAINTS AND APPEALS CERTIFICATE AND SCHEDULE OF ACCREDITATION REFERENCES APPENDIX 1 - CRITICAL SCOPES APPENDIX 2 - AMENDMENT RECORD Page 2 of 23

3 1. PURPOSE AND SCOPE The purpose of this document is to outline how SADCAS plans and conducts the assessment of the certification bodies (CBs) to the requirements of the relevant international standard, the applicable International Accreditation Forum (IAF) document and SADCAS requirements. This document is applicable to all applicant and accredited certification bodies providing services under ISO/IEC , ISO/IEC and ISO/IEC Surveillance and re-assessment visits to certification bodies working to the respective standard are on a five year cycle basis. Other visits such as scope extension are on an as required basis. This document also refers to the assessment techniques employed during such visits. Certification Bodies are accredited to certify organizations according to the NACE scopes given in Appendix 1 and, for product certification bodies, detailed specifications or standards. An accredited CB cannot certify outside these classifications unless written permission is granted by SADCAS. It is SADCAS policy to define the scope of an organization s accreditation as precisely as possible. The scope will be agreed upon before the assessment in order to determine the extent of the assessment activities. Following successful assessment, the scope including applicable ISO standards and guides will be identified on the accreditation schedule. Note: IAF Mandatory, informative and guidance documents are available on the IAF website 2. GENERAL 2.1 Assessment of the competence of a CB is performed using a range of assessment technique which include document reviews, visits to the CB and on-site witnessing the CB performing audits. 2.2 The purpose of the assessment is to determine whether the CB performs its audits in a competent manner and in compliance with the requirements of the applicable standards and guides such as the IAF documents and SADCAS requirements. 2.3 The SADCAS Policy (PM) and all other documents applicable to the CB are available on the SADCAS website. 2.4 SADCAS shall endeavor to have trained assessors available with experience in the NACE codes for the files to be reviewed. SADCAS shall also use Technical Experts where necessary. The assessment teams are required by SADCAS to maintain confidentiality by signing the confidentiality forms which also specify the need to declare any potential conflict of interest. The assessment teams activities will be confined to assessing for compliance with the requirements and reporting their findings to the CBs and to SADCAS. 2.5 The CB will be sent a notification of the proposed assessment team for approval. Rejection of assessors will only be considered if there are conflicts of interest. In this case, the CB is to provide SADCAS with clear and valid reasons for the rejection of the assessor, in writing, within Page 3 of 23

4 seven working days of receipt of the notification. The Technical Manager (TM) will decide whether a change of assessor is warranted or not. 2.6 If the CB has good reasons to reject an assessor and no other local assessor is available to carry out the assessment, SADCAS may opt to use assessors/experts from other countries. They shall be accompanied during the assessment by a SADCAS qualified assessor at all times. The CB will be liable for the full costs covering travel, subsistence and accommodation of the international assessor. 3. APPLICATION, PRE-ASSESSMENT, INITIAL ASSESSMENT AND WITNESSING OF SCOPES 3.1 Application A CB wishing to be accredited submits directly to SADCAS duly completed SADCAS F 43 (d): Application for accreditation of certification bodies for management systems/sadcas F 43 (e): Application for accreditation of certification bodies - Products/SADCAS F 43 (g): Application for accreditation of certification bodies for personnel together with the certification body s quality manual, duly completed SADCAS F 43 (f): Application for approval of personnel i.e. nominated representative in the case of certification bodies and duly completed and signed SADCAS F 44: SADCAS accreditation agreement Upon receipt of the above documents, SADCAS TM will undertake the following: a) Review the application forms for completeness; b) Ensure that the scopes applied for by the CB are contained in Appendix 1; c) Ensure that detailed information is available on the spread of its customer base relevant to the scope of application; d) Ensure that the relevant SADCAS checklist indicate where in the quality manual the requirements are addressed Should a CB require accreditation for a scope not listed in Appendix 1, this shall be reviewed by the TM and if required the Certification Advisory Committee for a recommendation The wording used by the CB for the scope description for a certified organization must be an accurate description of the activity certified and should not be open to misinterpretations by others. For product certification the specifications are to be detailed and for the sector specific schemes, the detail must be as required by the scheme SADCAS will contact the organization to: a) Seek agreement from the applicant to the appointment of a specified Lead Assessor, as appropriate; b) Confirm the scope for which the organization is seeking accreditation; c) Confirm the different locations from which the organization s service is managed and the activities which are carried out at each of these; Page 4 of 23

5 d) Confirm that the CB has performed at least one certification If a CB expects to expand its customer base into new scopes they may, at the time of the initial assessment, apply for accreditation for a scope which they have not certified to yet. SADCAS will include these on the assessment plan and will assess the CBs capability to certify these scopes. Access to competent CB auditors or experts will be part of this assessment. The scopes may be included in their scope of accreditation subject to the organization meeting the accreditation criteria but also subject to the organization informing SADCAS of their first certification. This is necessary so that SADCAS may witness the CB performing the certification and also review at least one company file prior to granting accreditation for the specific scope In those instances where a CB has not performed any certifications in a specific scope at the time of the assessment and wish to have the scope included in their accreditation, this may be done under the following conditions: a) SADCAS will assess the system in place at the CB to ensure that they have the expertise to certify the scope applied for. SADCAS will also ensure access to qualified auditors in this regard. b) Should SADCAS make a positive recommendation on the scope, this will only come into effect after: The CB has performed a minimum of one certification; After SADCAS has been given the opportunity to witness at least one certified organization in the specific scope; and after SADCAS has reviewed the file of at least one certified organization in the specific scope After SADCAS has confirmed that the application is within SADCAS scope of activity and all the above requirements have been addressed, SADCAS shall process the application in the normal manner. The fact that SADCAS agrees to process the application is indicative that a review of the application has been done and the application has met the criteria specified in clause Prior to any work being carried out, SADCAS will provide a quotation detailing the cost of the application, the document review and initial assessment. Acceptance of the quotation and payment of the pertaining invoice will be required before proceeding with each stage of the accreditation. Annual fees will also be quoted and invoiced on a pro - rata basis after the CB has been accredited. The CB is liable for all travel and subsistence costs associated with the initial assessment. Where additional visits are required additional charges will be calculated and invoiced to the CB separately The organization s quality manual and procedures will be reviewed for compliance against the requirements of the applicable ISO/IEC standard, SADCAS requirements and any applicable IAF mandatory documents using the SADCAS relevant checklists On completion of the document review, a report SADCAS F 61 (a-3): Document review report for certification of products, processes will be submitted to the CB. The report will contain comments on any nonconformity, areas which are not addressed, areas where actions are Page 5 of 23

6 needed, areas where there are concerns or weaknesses and a recommendation on the way forward. A maximum of 6 months is allowed for the applicant CB to address the document review findings The initial assessment must be done within 1 year of completeness check. Failure to do so results in the CB having to reapply to SADCAS. 3.2 Pre-assessment Although not mandatory, a pre-assessment may be carried out, normally by a Lead Assessor to: a) Discuss any findings related to the document review; b) Seek further information on the quality manual submitted; c) Briefly examine the systems which have been established and implemented; d) Discuss any arrangements which have been made to include multiple locations, subcontracted activities, etc. within the quality system; e) Agree on the proposed scope of accreditation; f) Finalize the expertise required for the assessment team The pre-assessment visit will normally be completed within one day The CB may need to make changes to its policies, procedures and practices prior to SADCAS undertaking the initial assessment visit Once all the findings raised during the pre - assessment have been effectively cleared, SADCAS will arrange the initial assessment of the certification body within 6 months If necessary, further Technical Assessors (TA)/ Experts (TE) will be identified and the agreement of the organization to their appointment will be sought. 3.3 Initial assessment preparation Prior to the initial assessment, the CB shall provide SADCAS with all the information required to plan the assessment. This information is usually available in the application form, although SADCAS may request additional information The time required for the initial assessment is normally two days but it will be left to the TM s discretion depending on the complexity of the organization, the geographical spread of its activities, the proposed scope of accreditation and the structure of the supporting quality system The nature of the initial assessment will depend on the schedule of accreditation applied for by the organization and the complexity of the supporting quality system that is being operated. Page 6 of 23

7 However the following elements will be covered: a) Assessment of head office; b) Assessment of multiple sites (branch offices) where applicable SADCAS shall assign specific assessors to assess the various aspects of the applicant CB During the initial assessment, the assessors shall evaluate the organization s files and management system for compliance against the applicable ISO/IEC standard, SADCAS requirements and any applicable IAF Mandatory documents using the appropriate SADCAS checklists In addition to the CB system and file review assessment, each critical scope is expected to be successfully witnessed by a SADCAS assessor prior to granting accreditation Specific requirements for HACCP auditors used by an accredited CB are as follows: (a) Meet the requirements of ISO 19011, especially with regards to completing a training course in auditing techniques; (b) Have completed a formal course in HACCP requirements and be familiar with all such requirements; (c) Be technically competent in the field of HACCP for which they are auditing. This would require a formal base qualification and experience specific to that discipline. For example, a meat HACCP auditor shall be qualified in this discipline or a closely related one and also be able to demonstrate relevant work experience in that discipline. (d) Comply with the ongoing auditor requirements as detailed in ISO/IEC TS , applicable IAF guidance and SADCAS documents. 3.4 Witnessing of Scopes The aim of the witnessing performed by SADCAS is to verify that the CB has implemented the procedures on site. It is also to verify that the CB covers all the necessary certification requirements and that they use appropriately qualified auditors. All observations made during the witnessing shall be recorded on SADCAS F 61 (h-1): Report on witnessing of a management system certification body (ISO/IEC ) or SADCAS F 61 (h-2): Report on witnessing of a product certification body (ISO/IEC 17065) or SADCAS F 61 (h-3): report on witnessing of a certification body for persons (ISO/IEC 17024). The witnessing report summary shall be completed on SADCAS F 81: Witness summary for certification bodies. It may be necessary for the SADCAS assessor to witness more than one auditor during the witnessing assessment. It is not necessary that the same auditor be witnessed throughout the activity. Separate witnessing report forms shall be completed for each auditor witnessed It is preferable that witnessed audits planned by the CB are for initial or re-certification audits in order that the full process can be evaluated by the SADCAS assessor. Page 7 of 23

8 3.4.3 SADCAS is responsible for developing a 5-year assessment schedule to allow for the appropriate sampling of scopes to be assessed through either witnessing and/or file review. The sampling shall be based on the number of critical scopes included in the application and volume of certifications in the scopes and shall be such SADCAS gains evidence in order to make a fair decision on the competence of the CB to perform certifications Where the application for an initial assessment contains critical scopes, SADCAS shall discuss the witnessing aspect of the accreditation process with the customer. It shall be explained to the applicant that critical scopes shall be witnessed before accreditation can be granted Where the number of critical scopes applied for is greater than 4, then SADCAS may, based on various factors, increase the number of witnessing. Preferably only one witnessing shall be performed in a critical scope at each assessment. SADCAS may reduce the number of witnessing for a CB based on various factors (history of competence, previous competence of the CB, etc.). The reason for the reduction is to be filed within the company file. It is normal practice to replace some on-site witnessing with an additional office visit to review a larger number of files Where the application for an initial assessment contains more than 4 non-critical scopes, SADCAS shall witness a minimum of 2 certifications. SADCAS will sample the rest of files for review before accreditation. If the application contains 4 or less than 4 non-critical scopes, SADCAS will witness a minimum of 1 scope Where the application for an initial and/or extension of scope contains scopes in the food sector, SADCAS shall discuss the witnessing aspect of the accreditation process with the customer. It shall be explained to the applicant that food scopes are regarded as critical and SADCAS will witness critical scopes before granting accreditation After the initial assessment and the CB having been accredited SADCAS disperses the witnessing throughout the 5-year cycle SADCAS can reduce the number of witnessing to a minimum of one per field (e.g. QMS, EMS) in 24/36 months based on the history of the CB, the number of certifications performed and the confidence as a result of consistent demonstrated competence For every 500 certifications done in a particular critical scope at least one witnessing shall be done. When the number exceeds 500 but less than 1000, a minimum of two witnessing shall be done. When the number of certifications exceeds 1000 in a specific critical scope SADCAS shall determine the number of witnessing to be done but they shall not be less than three. This applies for the initial assessment. Thereafter the number of witnessing may be reduced in accordance with this procedure Either the LA or, in the case of EMS, HACCP witnessing, the TA/TE shall perform the witness activity. Page 8 of 23

9 Once a witness audit has been agreed upon between SADCAS and a CB, the following applies: a) The CB is to ensure that SADCAS receives an audit plan including location(s) and contact details of the CB auditor two (2) weeks prior the audit date; b) The CB is to ensure that SADCAS receives information on any special requirements such as safety, dress code, security clearance, etc. at least two (2) weeks prior to the audit date; c) The CB is to ensure that SADCAS receives a copy of the selected auditor s CV and a competency assessment report two (2) weeks prior the audit; d) The CB is to ensure that its team leader communicates SADCAS role to the facility at the opening meeting and reaffirms confidentiality; e) The CB is to ensure that its auditor makes allowance for the SADCAS assessor to review any documentation that the CBs auditor sampled at the facility being audited; f) In order to make an informed decision at the end of the witnessed audit process, the SADCAS assessor needs to witness as much of the audit process as possible and therefore the requirement to witness any meetings and discussions between the team as well as the organization as possible; g) No opening nor closing meeting is held by SADCAS with witness audit activities; h) SADCAS will arrange travel and accommodation for their assessors; i) The CB is to ensure that SADCAS receives a copy of the audit report within one month of completion of the audit. Failure to do so within this timeline may result in the witness activity being declared null and void and a new witness activity will have to be arranged; j) On receipt of the final report from the CB, it is forwarded to the SADCAS Assessor who shall finalize the witnessing report SADCAS F 61 (h-1)/sadcasf 61 (h-2)/sadcas F 61 (h-3) stating whether the CB and the audit team performed a competent audit of the organization and highlight areas of concerns by completing SADCAS F 81 Witness summary within fifteen (15) days; k) The final report from the assessor may undergo an Accreditation Approval Committee (AAC) as outlined in SADCAS AP 14. Should a problem be identified which affects the competence of the CB to perform certifications, SADCAS shall communicate the feedback to the CB for appropriate action. The reports will be followed up at the next assessment An additional witness activity may be required as part of the clearance for such a nonconformity All annual witnessing for maintenance of accreditation shall preferably be conducted before the on-site assessments. It is the responsibility of the CB to forward audit dates on a quarterly basis to SADCAS. Should a witnessing not be done before the on-site visit, the assessment team will recommend continued accreditation subject to a successful witnessing. The AAC will also take this aspect into consideration. 4. THE ASSESSMENT 4.1 The SADCAS assessment team shall hold an opening meeting with the applicant CB. Refer to SADCAS F 46 (a): Onsite assessment Opening meeting agenda. The completed SADCAS F 46 Page 9 of 23

10 (c): Attendance register is considered as a record of the opening meeting. All items on the agenda are to be addressed. 4.2 The assessment shall follow the guidelines contained in ISO The assessment shall, where practical, cover all activities and services for which accreditation is sought. The initial assessment shall cover the critical scopes as per SADCAS plan. This coverage of scopes shall be done by reviewing at least one file that the CB has of companies certified for that specific scope. The files are assessed by trained and qualified assessors or by experts under the supervision of qualified assessors. Normally a qualified assessor will supervise a Technical Expert for the duration of the assessment. Where Technical Experts are experienced in assessing but not qualified, SADCAS may authorize that one qualified assessor may supervise more than one expert at the same time up to a maximum of three at any one time. In unusual circumstances and in agreement with SADCAS, the LA may supervise Technical Experts that are allocated to their team provided that additional time has been allocated for this function. The review of the files is done with the intention of verifying that the files contain sufficient evidence that the CB performs the certifications in accordance with accreditation criteria. The files are assessed using the appropriate sections of the relevant SADCAS checklists. 4.3 In the case of dormant scopes where the CB does not have active files or clients accredited scopes, the Technical Assessor will inform the Lead Assessor and assess if the CB has the required competency to maintain the scope. The SADCAS assessor will also verify that the CB s auditors have a contract and that the auditors were witnessed and/or deemed competent according to the CB s procedure. The competency of the auditors will be assessed in accordance with the relevant international standard. 4.4 The Lead Assessor shall ensure that each assessor has sufficient time to determine the competence of the applicant to perform certification assessments. SADCAS shall be prepared to substantiate the amount of time spent on the assessment. 4.5 The assessors shall assess the CB by conducting interviews, examining documents and observing activities and conditions in areas of concern and by collecting evidence of the state of implementation of the system within the organization. Information gathered from interviews shall be cross-checked by over means, i.e. physical observation or records. 4.6 The Lead Assessor shall concentrate on assessing the CB s management system and its implementation. The Lead Assessor is responsible for ensuring that the requirements for a particular assessment are assessed. Those requirements that are not assessed during one surveillance visit shall be covered during the 5-year assessment cycle. 4.7 On completion of the assessment, the team shall complete the assessment matrix (SADCAS F 101/SADCAS F 102/SADCAS F103 as relevant) which is used to capture what has been assessed during the assessment. The matrix is then included into the next assessment pack in order to track what has been previously assessed and also to identify any trends. In addition the assessment team will indicate what was assessed on the current schedule of accreditation which will also be included in the next assessment pack. Page 10 of 23

11 4.8 Significant revisions by an accredited CB to the quality system or any other significant changes that has an impact on accreditation shall be notified to SADCAS. 5. CONDUCT OF ASSESSORS The assessors shall behave in a manner consistent with ISO Assessors shall not be superior to any other personnel and maintain a professional manner at all times. Assessors shall not be cynical or sarcastic in their language or approach to the assessment or in their dealing with the certification personnel. 5.1 Recording of observations During the on-site assessment, observations are recorded on the relevant SADCAS checklists. Checklists are not exhaustive and are meant to be used as a prompt for the assessors and to record the detail of what was assessed. The relevant ISO/IEC standard/iaf Mandatory documents are to be referred to by the assessors for detailed requirements In the event that there are any deviations from the relevant ISO/IEC standard /IAF Mandatory documents, they will be recorded clearly as detailed observations on the SADCAS F 61 (b): Conformity assessment bodies nonconformity, corrective action and clearance report. Each assessor is responsible for ensuring that the CB s area/field representative signs each observation as an indication that the observation is factual statement at the time of the assessment. It must be noted that refusal by the CB to sign the SADCAS F 61 (b) does not invalidate the observation. 5.2 Assessors meeting After the assessment team has completed their individual assignments, the Lead Assessor shall hold a pre-closing assessor meeting at which each team member can summarize their conclusions and contribute to a coordinated view of the status of the applicant CB. The Lead Assessor shall schedule sufficient time for this meeting to allow a fair conclusion to be made T The assessors shall reach an agreement on whether observations are converted into nonconformities and whether they are classified as major or minor. In the assessment of CBs it is very often that several assessors make observations from different areas of the organization which are related to the same requirement. It is the responsibility of the Lead Assessor together with the team members to identify all related observations and to combine them where possible into one finding. Example of the one finding may be attached to the overall findings The Lead Assessor shall then summarize the conclusions of the assessment team with regard to the CBs management system and the scope of accreditation The Lead Assessor shall report any matters for the attention of SADCAS or the SADCAS Advisory Committee on the SADCAS F 57: Feedback from Assessment. Page 11 of 23

12 5.2.5 The Lead Assessor shall complete: The accreditation assessment report: SADCAS F 61 (c): Assessment Recommendation Report together with Each nonconformity report: SADCAS F 61 (b) Witness summary as applicable: SADCAS F 81 A copy of the above is left with the CB at the time of the closing meeting. No other report is made thereafter If in the opinion of the Technical Assessor/Technical Expert, there is any reason to doubt the CB s competence to perform any of the types of work for which accreditation is sought, for example, through lack of experienced staff, this shall be noted on the SADCAS F 61 (c) In this instance it would be necessary to review the scope of accreditation of the CB with the intention of reducing the scope to eliminate those areas where there is a lack of expertise or competence. In the case of an initial assessment the recommendation should be such that the scope applied for is reduced by the areas for which there is doubt as to the CB s competence. 5.3 The final meeting and summary of findings The final meeting and the presentation of the summary of the assessment team s findings shall follow the guidelines contained in ISO Refer to SADCAS F 46 (b): Onsite assessment Closing meeting agenda. The completed SADCAS F 46 (c) is considered a record of the closing meeting. All items on the agenda are to be addressed The Lead Assessor shall ensure that the management representative of the CB signs the bottom of the SADCAS F 61 (c) Should the applicant not agree with the contents of the forms, he/she shall be advised on how to take the matter up with SADCAS in accordance with the SADCAS AP 08: Customer feedback handling procedure. 5.4 Factors affecting recommendation for initial accreditation Where the assessment team cannot recommend immediate accreditation, it will normally be recommended that accreditation is subject to the satisfactory clearance of nonconformities. Evidence that the corrective action has been taken may be provided either by submitting the necessary documents to SADCAS or through a further visit by a SADCAS assessor. The Lead Assessor shall recommend which option is to be taken. It is vital that the LA states in detail on the SADCAS F 61 (c) whether an additional visit is required to clear out the findings. Should this be the case the Lead Assessor shall also inform the CB that all costs associated with the additional visit are to be for the account of the CB. Page 12 of 23

13 5.4.2 Where the number and seriousness of the nonconformities found is such that the whole of the CB s quality system, organization and/or competence is inadequate, the assessment team shall not recommend accreditation of the CB Where a successful witnessing has not been conducted, but the assessment team are happy with the CB s system and organization, the assessment team shall recommend accreditation subject to successful witnessing at agreed timelines All recommendations made by the assessment team after an initial/extension of scope assessment will be subject to a final decision by the SADCAS Accreditation Approvals Committee (AAC) once the nonconformities raised have been satisfactorily cleared. Refer to the SADCAS AP 14: Accreditation decision making process. 5.5 The report, recommendation and clearance of the nonconformities A recommendation report - SADCAS F 61 (c) and any nonconformity reports SADCAS F 61 (b) shall be provided to the CB at the time of the assessment. The assessment report shall be prepared in accordance with SADCAS AP 13: Preparation of assessment reports. Where corrective action by the CB is required, the CB has one month to identify and propose corrective actions to SADCAS and these are to be cleared within three (3) months. In most cases evidence can be provided by post/fax/ although there may be situations where additional visits to the CB will be required. The additional visits will be at cost to the CB. The respective assessors will review the evidence provided and decide upon its acceptability. The SADCAS Accreditation Administrator will monitor the submission of the corrective action by the CB Should the CB not adhere to the set dates for corrective actions, the SADCAS Accreditation Administrator shall inform the Technical Manager who shall take the matter up with the CB. The SADCAS Accreditation Administrator shall remind the CB in writing and requested to submit the corrective actions within one week. If the CB fails to respond, SADCAS shall remind the CB in writing that suspension of the CB may be imposed On completion of all corrective actions to the team s satisfaction including those arising from visits to multiple sites, the assessment pack will be reviewed by the AAC. The CB will be notified with the AAC final decision. Refer to the SADCAS AP It is the responsibility of the facility to ensure that their details are correct on the SADCAS website directory Following accreditation, the certificate and associated schedule of accreditation is the property of SADCAS and will form the basis of the SADCAS directory of accredited organizations which is on the SADCAS website Certificates and schedules of accreditation shall only be issued after the final decision of the SADCAS Accreditation Approvals Committee. Page 13 of 23

14 5.5.7 Only in exceptional circumstances, an accredited facility schedule of accreditation will not be listed on the directory of accredited organizations or available to the public. 6. SURVEILLANCE ASSESSMENTS 6.1 Surveillance assessments Following accreditation, SADCAS will check for continuing compliance with accreditation requirements by carrying out surveillance visits to the CB. The first surveillance assessment is undertaken not more than 12 months after accreditation thereafter annually throughout the accreditation cycle. No extensions or changes to an agreed assessment date can be made without the authorization of SADCAS. The justification shall be filed with the company file. Once an adjustment has been made to a surveillance visit, e.g. re-instatement after withdrawal, it is the responsibility of SADCAS to ensure that the next scheduled visit reverts to the normal assessment period The surveillance visit is done in exactly the same manner as the initial assessment except that the coverage of the scope will not be as extensive. At least the following will be assessed: a) Effectiveness of corrective actions taken on all nonconformities recorded at the previous SADCAS assessment; b) Effectiveness of the CB s operations with regard to achieving the objectives of the relevant standard used; c) An interview with the management responsible for the quality system; d) The internal audit process including reporting of deficiencies to management and follow up of corrective actions taken; e) Customer complaints; f) Changes to the documented system; g) Areas subject to change; h) Progress of continual improvement of operational performance SADCAS shall put a programme in place to ensure that the majority of the CB s scopes, where practical, are sampled over the 5-year cycle. This programme shall be determined at the time of the initial assessment and again prior to the re-assessment. The Lead Assessor in consultation with the Technical Manager may change the programme at any time. The reason for the changes shall be maintained in the CB s file An assessment team shall be composed of sufficient expertise to ensure that the assessment is conducted according to the plan Qualified assessors will be used to assess the company files in the CB. Where this is not possible, Technical Experts shall be used and qualified SADCAS assessors shall accompany Technical Experts for the duration of the assessment. For files reviews, the Lead Assessor shall be responsible for the supervision of the experts completed documentation so as not to negatively Page 14 of 23

15 affect the assessment. In the case of witnessing, Technical Experts may be used unsupervised on condition that they have been previously monitored with a positive recommendation of the Technical Manager The Lead Assessor shall concentrate on assessing the CB s management system and its implementation. Changes must be communicated to SADCAS at least six (6) weeks in advance. Extensive changes may require additional assessment time The assessment team members shall have a meeting at the conclusion of the assessment as for the initial assessment. At the close out meeting the team will present the final report to the CB using the same forms as used for an initial assessment. Where corrective action by the CB is required, the CB has one month to identify and propose corrective actions to SADCAS and these are to be cleared within three (3) months The recommendation report shall clearly indicate the acceptable method to be used to verify the close out of all corrective actions. This can either be by an additional visit or by submission of documentary evidence by fax/post/ The Lead Assessor must return to SADCAS copies of the nonconformities raised to follow up the CB s clearance thereof The SADCAS Accreditation Administrator will monitor the submission of the corrective action by the CB. Should the CB not adhere to the set dates for corrective actions, the SADCAS Accreditation Administrator shall inform the Technical Manager who shall take the matter up with the CB Where target dates are not met, SADCAS shall inform the CB in writing that suspension of the organization is imminent. The CB has to respond immediately to prevent this recommendation coming into effect. Refer to SADCAS TR 06: Suspension and re-instatement of accredited organizations. 7. RE-ASSESSMENT Re-assessment visits are done after a 5-year period and involve a comprehensive re-examination of the CB s compliance to all accreditation requirements. The re-assessment is performed in the same manner as the initial assessment. The reassessment shall be undertaken at least 6 months prior to the start of each new 5-year accreditation cycle Assessment matrix forms are used to capture what has been assessed during the previous cycle(s) and also to capture any trends. Page 15 of 23

16 8. MULTI-SITE CERTIFICATION BODIES, REGIONAL AND INTERNATIONAL 8.1 Where CBs have branch offices in other countries, these branch offices shall be subject to assessment visits provided they are not just a sales office. Branch offices that perform any of the following shall be subject to a maximum of one assessment per twelve (12) month period. This may be reduced to a minimum of one visit every two years. The decision on the number of assessments to be performed shall be determined by SADCAS. Any branch office conducting the following activities shall be visited: a) Arrange certifications; b) Maintain the files of CBs; c) Appoint auditors; d) Maintain a different quality system; e) Maintain a quality system similar to the main office but manage it themselves. 8.2 SADCAS shall ensure that each branch office is on the schedule for assessment at the appropriate interval. 8.3 Where a branch office is found not to comply with the accreditation criteria, the CB shall ensure that the nonconformities identified in one branch office do not occur in any of the other branch offices or shall implement corrective action in all branch offices where the nonconformity does occur. 8.4 The certificate of a multi-site CB shall detail the name and location of the head office and all locations included in the accreditation. Separate certificates will not be issued for each site. The activities and personnel involved in the branch CB shall be clearly distinguishable from the main CB on the combined schedule of accreditation. SADCAS shall supply copies of the original certificate for each site accredited. 8.5 Locations which are operated outside the country will be subject to the same assessment requirements unless these sites hold accreditation from a national accreditation authority recognized as part of the IAF MRA. In such cases SADCAS will take into account the accreditation held when determining the extent and nature of the assessment process required. Where locations can be classified as a foreign critical location and falls within the IAF Policy on Cross Frontier, then the SADCAS AP 19: Cross Frontier Accreditation come into effect. 9. ACCREDITATION OF CRITICAL FOREIGN LOCATIONS Refer to SADCAS AP 19: Cross Frontier Accreditation. Page 16 of 23

17 10. EXTENSION AND REDUCTION OF SCOPES 10.1 Extension of scopes An accredited facility may apply to SADCAS to extend their scope of accreditation. Applications for extension should be made at least six (6) weeks in advance prior to the next scheduled assessment on the SADCAS F 43 (d)/sadcas F 43 (e)/sadcas F 43 (g) as appropriate SADCAS shall plan witnessing for the extension based on section 4.4 of this document For extension to critical scopes, SADCAS shall witness the scope prior to accreditation being granted to the CB for that scope For non-critical scopes SADCAS shall witness a minimum of 1 scope per application for extension prior to the extension being given as outlined in section 3.4 and conduct a file review on the remainder In those instances where in the opinion of SADCAS the extension is such that it involves no new expertise by the CB, SADCAS may waiver the on-site assessment of the office. The reason for this should be documented in the specific file for the company For product certification, once a scope has been approved, it is possible for a CB to add additional standards to the approved scope without being assessed by SADCAS for the additions, provided that the CB can demonstrate that they have access to the competence required by the applicable specifications/standards such as: a) The written specifications/standard; b) Competent auditors; c) Competent testing facilities; d) Specific requirements as required by IAF GD The CB is however required to apply and notify SADCAS of any such additions to an already approved scope in order to SADCAS to formally review this request All costs including travel costs associated with the review of specifications and/or extension of scope shall be for the account of the CB The assessment of the extension shall be done in the same manner as for the surveillance assessment except that the scope shall be confined to the application of extension only Reduction of Scope A CB may apply to SADCAS to have their scope of accreditation reduced at any time. An application for the reduction in scope may be for a number of reasons such as lack of access to the expertise needed for the scope, insufficient applications in the scope, etc. If the CB fails to Page 17 of 23

18 meet the requirements for accreditation for the sub scopes already accredited, SADCAS shall reduce the scope of accreditation to exclude these sub scopes. SADCAS will update the certificate and schedule of accreditation accordingly and publish the amended version on the SADCAS website CBs are prohibited from making any alterations to their certificates and schedules of accreditation. Only certificates and schedules of accreditation issued by SADCAS are valid. 11. TIMESCALE FOR ACCREDITATION PROCESS 11.1 SADCAS makes every effort to ensure that all applications are processed as efficiently as possible. The time taken to process an application depends on a number of factors, some of which are outside the control of SADCAS. These factors include: a) The quality of the applicant s documentation and the extent to which it complies with SADCAS requirements. A delay can occur due to insufficient documented procedures and submission of inadequate quality manual. b) The availability of suitable assessors. c) The level of implementation of the quality system and availability of evidence of the technical competence. d) The efficiency with which the applicant organization clears the nonconformities after the initial assessment. e) The availability of the resources within SADCAS. 12. COMPLAINTS AND APPEALS Complaints, appeals or disputes can be handled in accordance with SADCAS AP 08: Customer feedback handling procedure which maintains independency and impartiality. 13. CERTIFICATE AND SCHEDULE OF ACCREDITATION 13.1 The SADCAS accreditation certificate bears the formal accreditation status of an accredited facility. The accreditation certificate consists of two parts namely the certificate and the schedule of accreditation. Refer to SADCAS TR 01: Part 1: Conditions for the use of SADCAS accreditation mark and SADCAS TR 01: Part 2: Use of combined mark The schedule of accreditation for certification bodies indicates: a) The accreditation number of the facility; b) The name, permanent address(es), postal address; c) The contact details of the CB where the certification activities were carried out; d) The name of the management signatory/nominated representative; Page 18 of 23

19 e) The issue number, date of issue and expiry date of the schedule of accreditation; f) The scope of accreditation; g) The original date of accreditation; h) The page number (page x of y); and i) The signature of the relevant TM. 14. REFERENCES IAF Mandatory, informative and guidance documents are available on the IAF website ISO/IEC : Conformity assessment Requirements for bodies providing audit and certification of management systems Part 1: Requirements ISO/IEC TS : Conformity assessments- Requirements for bodies providing audit and certification of management systems of quality management systems ISO/IEC 17024: Conformity assessment Requirements for bodies operating certification of persons ISO/IEC 17065: Conformity assessment Requirements for bodies certifying products, processes and services ISO 19011: Guidelines for auditing management systems SADCAS TR 01: Part 1: Conditions for the use of SADCAS accreditation SADCAS TR 01: Part 2: Use of combined marks SADCAS TR 03: Nominated representative and signatories - Responsibilities SADCAS TR 06: Suspension and re-instatement of accredited organizations SADCAS AP 08: Customer feedback handling procedure SADCAS AP 13: Preparation of assessment report SADCAS AP 14: Accreditation decision making process SADCAS AP 19: Cross frontier accreditation SADCAS F 43 (d): Application for accreditation of certification bodies for management systems SADCAS F 43 (e): Application for accreditation of certification bodies Products SADCAS F 43 (g): Application for accreditation of certification bodies for personnel SADCAS F 43 (f): Application for approval of personnel SADCAS F 44: SADCAS accreditation agreement SADCAS F 46 (a): Onsite assessment Opening meeting agenda SADCAS F 46 (b): Onsite assessment Closing meeting agenda SADCAS F 46 (c): Attendance register Onsite assessment Opening/closing meetings SADCAS F 57: Feedback from assessments SADCAS F 61 (b): Conformity assessment body Nonconformity, corrective action and clearance report SADCAS F 61 (c): Assessment recommendation report SADCAS F 61 (h-1): Report on witnessing of a management systems certification body (ISO/IEC 17021) SADCAS F 61 (h-2): Report on witnessing of a product certification body (ISO/IEC SADCAS F 61 (h-3): Report on witnessing of a certification body for persons SADCAS F 81: Witness summary for certification bodies Page 19 of 23

20 SADCAS F 93: Completeness check of application and Resource review SADCAS F 101: Assessment cycle matrix ISO/IEC :2015 SADCAS F 102: Assessment cycle matrix ISO/IEC 17065:2012 SADCAS F 103: Assessment cycle Matrix ISO/IEC 17024:2012 Page 20 of 23

21 APPENDIX 1: CRITICAL SCOPES Table 1: NACE Codes EAC Code NACE Code Description QMS EMS OHSMS 1 (part) A Agriculture 1 (part) B Fishing 2 C Mining and quarrying 3 DA Food products, beverages and tobacco 4 DB O 93,01 Textiles and textile products Washing and (dry-) cleaning 5 DC G Leather and leather products Repair or articles of leather 6 DD Wood and wood products 7 (part) DE 21.1 Pulp and paper 7 (part) DE 21.2 Paper products 8 9 (part) DE 22.1, 3 Publishing companies Reproduction of recorded media 9 (part) DE 22.2, 3 Printing companies 10 DF 23.1, 2 Manufacturer of coke and refined petroleum products 11 DF 23.3 Nuclear fuel 12 DG minus 24.4 Chemicals, chemical products and fibres 13 DG 24.4 Pharmaceuticals 14 DH Rubber and plastic products 15 DI minus 26.5,6 Non-metallic mineral products 16 Di 26.5,6 Concrete, cement, lime, plaster, etc. 17 (part) DJ 27 Basic metals 17 (part) DJ 28 Fabricated metal products 18 DK minus 29.7 Machinery and equipment 19 (part) DL 32.1 Electronic valves, tubes and other (micro-) electronic components 19 (part) DL minus 32.1; DK 29.7 G 52.72, 73, 74 Electrical and optical equipment Domestic appliances Repair of household goods etc. 20 DM 35.1 Shipbuilding 21 DM 35.3 Aerospace 22 DM 34, 35.2, 4, Other transport equipment 5 23 DN 36 Manufacturing not elsewhere classified 24 DN 37 Recycling 25 E 40.1 Electricity supply 26 E 40.2 Gas supply 27 E 40.3, 41 Water supply 28 F Construction 29 (part) 31 (part) G 51, 52 I minus 64 Wholesale & retail trade Transport & storage 29 (part) G 50 Sale, maintenance & repair of motor vehicles, motor cycles 30 H Hotels and restaurants 31 (part) I 64 Post and telecommunication 32 (part) J Financial mediation 32 (part) K 70 Real estate 32 (part) K 71 Renting 33 K 72 Information technology 34 K 73, 74, 2, 3, 7, 81 Engineering services Research and development 35 K 74 minus Other professional services 74, 2, 3, 7, L Public administration 37 M Education 38 N Health and social work 39 (part) O 90 Sewage & refuse disposal & sanitation 39 (part) O 92 Recreational, cultural and sporting activities 39 (part) O 91, 93 minus Other social services Page 21 of 23

22 Table 2: Hazard Analysis of Critical Control Point (HACCP) 1 Meat and edible meat offal, preparations and products 2 Fish, crustaceans, mollusks and other aquatic invertebrates, preparations and products 3 Sugars, honey and sugar confectionaries 4 Edible oils and fats 5 Vegetables, fruits, nuts or other parts of plants, preparations and products 6 Grains, cereals, cocoa, starch and pastry-cook, preparations and products 7 Beverages, beer, wine and spirits, preparations and products 8 Milk and dairy, preparations and products 9 Food preparations and catering (excluding street-vendors) 10 Street vended foods 11 Coffee, tea, salt, herbs and spices 12 Poultry, preparations and products Page 22 of 23

23 APPENDIX 2: AMENDMENT RECORD Revision status Change Page No. Clause Description of change Approved by Effective Date Issue SADCAS CEO Issue After 1 st sentence added If the CB fails to meet the requirements for accreditation for the sub scopes already accredited, SADCAS shall reduce the scope of accreditation to exclude these sub scopes. SADCAS CEO Added: SADCAS F 93 Completeness check of application and Resource review Page 23 of 23