Conformity Assessment System for Electronic Components (Iecq)

IECQ SAR IEC 61340-5-1 Site Assessment Report (SAR) CONFIDENTIAL Site Assessment Report No: Include name and identification of IECQ Certification Body, CB Body Page 1 of 11

INTERNATIONAL ELECTROTECHNICAL COMMISSION

CONFORMITY ASSESSMENT SYSTEM FOR ELECTRONIC COMPONENTS (IECQ) (IECQ System)

IECQ Site Assessment Report SAR IEC 61340-5-1 Edition 3.0

This Document provides a standardised Report format for the recording of site assessments of organisations seeking certification under the IECQ Approved Process for ESD according to IEC 61340-5-1.

This SAR IEC 61340-5-1 is applicable to, both initial and surveillance assessment.

It should be noted that the same level and depth of assessment undertaken at the initial assessment must also be undertaken at surveillance assessments

While primarily intended for use by IECQ Certification Bodies (CBs), this SAR may also be used by Organisations when conducting internal assessments for compliance with the IECQ Approved Process Scheme.

Document History

Date Summary 2009 02 Original Draft (Edition 1.0) 2011 05 Updated references 2017 11 Updated to align with Ed2 of 61340-5-1 IECQ SAR IEC 61340-5-1 Site Assessment Report (SAR) CONFIDENTIAL Site Assessment Report No: Include name and identification of IECQ Certification Body, CB Body Page 2 of 11

Name of Organisation and Type (e.g., component manufacturer):

Address (site(s) assessed) : include post code/zip code

No. of employees : include the total number of employees on site

Type of assessment : initial assessment  on-going assessment  (prior to certification) (to maintain certification)

Name of Designated Management Representative (DMR):

Scope and Description of work performed:

Assessment Team Leader :______print name

Assessment Team Leader :______signature IECQ SAR IEC 61340-5-1 Site Assessment Report (SAR) CONFIDENTIAL Site Assessment Report No: Include name and identification of IECQ Certification Body, CB Body Page 3 of 11

1 SUMMARY REPORT

Summary of observations: State the most important results of the initial/surveillance assessment

Nonconformities Indicate the number (and details) of nonconformities raised. Individual nonconformities are recorded on the nonconformity reports

Audit Team Leader recommendations Recommendations are subject to review by the IECQ CB management who has veto power regarding all decisions

SAR issued, indicating compliance with IECQ Approved Process Requirements and IEC 61340-5-1 recommending that Certification be issued/maintained*

SAR issued, indicating general compliance with IECQ Approved Process Requirements and IEC 61340-5-1, even if minor non conformances are raised, recommending that Certification be issued/maintained* following receipt of satisfactory documentary evidence supporting effective corrective action. Corrective action to be verified at next surveillance visit

SAR issued, indicating Non-compliance with IECQ Approved Process Requirements and IEC 61340-5-1, due to Major Non-conformances being raised, recommending that Certification be issued only after a satisfactory follow-up visit. Operations cannot be claimed as being covered by IECQ ESD Approved Process Certification until a follow up visit is conducted (must be within 2 calendar months of assessment)*. Follow up visits are required to verify that corrective actions have been effectively documented and implemented. In such situations the following shall be observed:

a) For surveillance assessment, the IECQ CB shall determine the need any non-complying product released to the market, to be traced and re-assessed. The IECQ CB shall further determine whether the IECQ ESD Approved Process Certification shall be suspended or cancelled

b) For initial assessments, the certification application process shall not proceed until a successful follow up site visit has been conducted by the IECQ CB.

* denotes delete where applicable Assessment Team Leader: Organisation Representative: sign sign to accept Lead Assessor recommendations “I understand the Lead Assessor recommendations” IECQ SAR IEC 61340-5-1 Site Assessment Report (SAR) CONFIDENTIAL Site Assessment Report No: Include name and identification of IECQ Certification Body, CB Body Page 4 of 11

2 INTRODUCTION

Organisation being assessed (auditee) :

Scope of assessment Initial /reassessment  On-going assessment  Follow up assessment  Special assessment visit, (eg due to relocation or major changes)

Assessment criteria : List any other reference documents against which assessment was conducted in addition to IEC 61340-5-1

Date(s) and duration : of assessment indicate the actual number of man-days on-site IECQ SAR IEC 61340-5-1 Site Assessment Report (SAR) CONFIDENTIAL Site Assessment Report No: Include name and identification of IECQ Certification Body, CB Body Page 5 of 11

3.1 ASSESSMENT DATA

Composition of assessment team:

Interviewed representatives of Organisation (auditee): Include name and position

Reference documents used: e.g. checklists, customer specifications etc IECQ SAR IEC 61340-5-1 Site Assessment Report (SAR) CONFIDENTIAL Site Assessment Report No: Include name and identification of IECQ Certification Body, CB Body Page 6 of 11

3.2 Documentation Review and Assessment of Implementation 3.2.1 ISO 9001 QMS assessment The following items are to be reviewed to ensure they have been satisfactorily been covered by ISO 9001 assessment, where ISO 9001 certification exists. If not then the IECQ CB shall assess requirements accordingly

Organisation’s Doc. Ref. ISO 9001:2008 clauses Assessed List organisations document(s) viewed, with revision status and Comments. NCR (Y, N or List any pertinent details / compliance Ref. N/A) with requirements of clause and comments of the Assessor 4. Quality Management System 4.1 General requirements 4.2 Documentation requirements 4.2.2 Quality Manual 4.2.3 Control of documents 4.2.4 Control of records 5. Management Responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality Policy 5.4 Panning & Quality objectives 5.5 Responsibility, authority, internal communications 5.6 Management review 6. Resource Management 6.2 Human Resources 6.3 Infrastructure 6.4 Work environment 7. Product Realisation 7.1 Planning of product realisation 7.2 Customer requirements 7.2.3 Customer communication 7.3 Design and development (not in scope of this document) 7.4 Purchasing 7.5 Production and service operations 7.6 Control of monitoring and measuring devices 8. Measurement, Analysis & Improvement 8.2.1 Customer satisfaction 8.2.2 Internal Audit 8.2.3 Monitoring & measurement of processes 8.3 Control of non-conforming product IECQ SAR IEC 61340-5-1 Site Assessment Report (SAR) CONFIDENTIAL Site Assessment Report No: Include name and identification of IECQ Certification Body, CB Body Page 7 of 11

Organisation’s Doc. Ref. ISO 9001:2008 clauses Assessed List organisations document(s) viewed, with revision status and Comments. NCR (Y, N or List any pertinent details / compliance Ref. N/A) with requirements of clause and comments of the Assessor 8.4 Analysis of data 8.5 Corrective & Preventive action 8.5.1 Continual improvement (not in scope of this document)

Organisation’s Doc. Ref. ISO 9001:2015 clauses Assessed List organisations document(s) viewed, with revision status and Comments. NCR (Y, N or List any pertinent details / compliance Ref. N/A) with requirements of clause and comments of the Assessor 4. Context of the organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the quality management system 4.4 Quality management system and its processes 5. Leadership 5.1 Leadership and commitment 5.1.1 General. 5.1.2 Customer focus 5.2 Policy 5.2.1 Establishing the quality policy 5.2.2 Communicating the quality policy 5.3 Organizational roles, responsibilities and authorities 6. Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes 7. Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information IECQ SAR IEC 61340-5-1 Site Assessment Report (SAR) CONFIDENTIAL Site Assessment Report No: Include name and identification of IECQ Certification Body, CB Body Page 8 of 11

Organisation’s Doc. Ref. ISO 9001:2015 clauses Assessed List organisations document(s) viewed, with revision status and Comments. NCR (Y, N or List any pertinent details / compliance Ref. N/A) with requirements of clause and comments of the Assessor 8. Operation 8.1 Operational planning and control 8.2 Requirements for products and services 8.3 Design and development of products and services 8.4 Control of externally provided processes, products and services 8.5 Production and service provision 8.6 Release of products and services 8.7 Control of nonconforming outputs 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review 10 Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement

3.2.2 IEC 61340-5-1 REQUIREMENTS

Results of the review of the organisations Documented System + Implementation for compliance with IEC 61340-5-1

Organisation’s Doc. Ref. IEC 61340-5-1 Requirement Assessed List document(s) viewed, with revision NCR (Y, N or status and Comments. List any pertinent Ref. N/A) details / compliance with requirements of clause and comments of the Assessor 4 Personnel safety

5.1 ESD control program - General 5.1.1 ESD control program requirements

5.1.2 ESD coordinator

5.1.3 Tailoring

5.2 ESD control program - ESD control IECQ SAR IEC 61340-5-1 Site Assessment Report (SAR) CONFIDENTIAL Site Assessment Report No: Include name and identification of IECQ Certification Body, CB Body Page 9 of 11

Organisation’s Doc. Ref. IEC 61340-5-1 Requirement Assessed List document(s) viewed, with revision NCR (Y, N or status and Comments. List any pertinent Ref. N/A) details / compliance with requirements of clause and comments of the Assessor program administrative requirements 5.2.1 ESD control program plan

5.2.2 Training plan

5.2.3 Product qualification 5.2.4 Compliance verification plan

5.3 ESD control program - ESD Control program plan technical requirements 5.3.1 General 5.3.2 Grounding/equipotential bonding systems

5.3.3 Personnel grounding

5.3.4 ESD protected areas (EPA)

5.3.5 Packaging

5.3.6 Marking

Annex A Test methods

3.2.3 Completed by: (IECQ CB Assessor conducting the document review)

3.2.4 Results:

3.2.5 Assessor comments regarding implementation of the Organisations Documented System regarding item 3.2.3 above. IECQ SAR IEC 61340-5-1 Site Assessment Report (SAR) CONFIDENTIAL Site Assessment Report No: Include name and identification of IECQ Certification Body, CB Body Page 10 of 11

4 NONCONFORMITY REPORT NCR No: (This format is to be used when CBs raise NCRs) NONCONFORMITY Include section & Para No. of IEC 61340-5-1 or Organisation’s Documented Management System

Description

Organisation’s Representative: Assessor: sign sign & date ______

PROPOSED CORRECTIVE/PREVENTATIVE ACTION to be completed by organisation completion date:

Organisation’s Representative: Confirmed by IECQ CB sign sign & date ______

CORRECTIVE/PREVENTATIVE ACTION REPORT Include a statement describing actual corrective/preventative action implemented. This may vary slightly from the proposed corrective/preventative action

Organisation’s Representative: Confirmed by IECQ CB: sign sign

Date: Date: IECQ SAR IEC 61340-5-1 Site Assessment Report (SAR) CONFIDENTIAL Site Assessment Report No: Include name and identification of IECQ Certification Body, CB Body Page 11 of 11

6 APPENDICES (optional) additional assessor notes summary of assessment trail (e.g. who? what? when? etc.)