ISO IEC 17020 2012 Conformity assessment

ISO / IEC 17020 : 2012 Conformity assessment – Requirements for the operation of various types of bodies performing inspection Katerina Bouranta Physicist MSc. Dynamics of Engineering Structures TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 -8 September 2015

Introduction Ø Promoting confidence in bodies performing inspection Ø Requirements document for accreditation, or peer assessment or other assessment. Ø Requirements can be interpreted when applied to particular sectors Ø Shall, should, may and can TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

Introduction Inspection bodies carry out assessments on behalf of: private clients, their parent organizations, authorities, with the objective of providing information about the conformity of inspected items with: regulations, standards, specifications, inspection schemes or contracts. TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

Introduction Inspection parameters include matters of: quantity, quality, safety, fitness for purpose, and continued safety compliance of: installations or systems in operation. TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

Introduction The general requirements with which these bodies are required to comply in order that their services are accepted by clients and by supervisory authorities are harmonized in this International Standard. TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

Introduction The International Standard covers the activities of inspection bodies whose work can include: the examination of: o o o o materials, products, installations, plants, processes, work procedures or services and the determination of their conformity with requirements and the subsequent reporting of results of these activities to: o o clients and, when required, to authorities. TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

Introduction Inspection can concern all stages during the lifetime of these items, including the design stage. Such work normally requires the exercise of professional judgment in performing inspection, in particular when assessing conformity with general requirements. Inspection activities can overlap with testing and certification activities where these activities have common characteristics. However, an important difference is that many types of inspection involve professional judgment to determine acceptability against general requirements, for which reason the inspection body needs the necessary competence to perform the task. TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

Introduction Inspection can be an activity embedded in a larger process (surveillance in a product certification scheme) Inspection can be an activity that precedes maintenance Inspection can simply provides information about the inspected item with no determination of conformity with requirements. In such cases further interpretation might be needed. TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

Introduction The categorization of inspection bodies as type A, B and C is a measure of independence. Demonstrable independence of inspection body can strengthen the confidence of the inspection body’s client with respect to the body’s ability to carry out inspection work with impartiality. TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

ISO / IEC 17020 : 2012 Contents 1. Scope 2. Normative references 3. Terms and definitions 4. General requirements 5. Structural requirements 6. Resource requirements 7. Process requirements 8. Management system requirements Annex A ( Normative) Independence requirements Annex B ( informative ) TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

ISO / IEC 17020 : 2012 1. Scope v Competence of bodies performing inspection, impartiality and consistency of inspection activities v The stages of inspection (design, type examination, initial inspection, in service inspection, surveillance) 2. Normative references v ISO/ IEC 17000 Conformity assessment – Vocabulary and general principles TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

ISO / IEC 17020 : 2012 3. Terms and Definitions v. Inspection (product, process, service, installation) v. Products are not only engineering products v. Process, service v. Inspection body v. Inspection system and inspection schemes v. Impartiality v. Appeal and complaint TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

ISO / IEC 17020 : 2012 4. GENERAL REQUIREMENTS TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

4. 1 Impartiality & independence 4. 1. 1. Inspection activities undertaken impartially 4. 1. 2. Commercial, financial or other pressures to compromise impartiality 4. 1. 3. Identify Risks to impartiality on an on – going basis –risks that arising from IB’s activities, its relationships, or from the relationships of its personnel. NOTE: A relationship that compromises the impartiality of the Inspection Body can be based on ownership, governance, management, personnel, shared resources, finances, contracts, marketing (including branding), and payment of a sales commission or other inducement for the referral of new customers, etc. 4. 1. 4. Demonstrate how it eliminates or minimizes such risk TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

4. 1 Impartiality & independence 4. 1. 5. Top management commitment to impartiality 4. 1. 6. Independent to the extent that is required with regard to conditions under which it performs inspection l Third party – Type A meets the requirements Annex A. 1 l First party or second party or both – separate, identifiable and supplies to parent Type B (in house IB Annex A. 2 l First party or second party or both – identifiable but not necessarily separate supplies to parent/ others – Type C meets the requirements Annex A. 3 TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

4. 2 Confidentiality 4. 2. 1. Legally enforceable commitment for the management of information obtained or created during the performance of inspection activities. Information placed in the public domain inform the client in advance. Except for information that the customer makes publicly available, or when agreed between the inspection body and the customer (e. g. for the purpose of responding to complaints). All other information considered proprietary information and regarded as confidential. TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

4. 2 Confidentiality 4. 2. 2. Releasing confidential information (by law or contractual commitments) the client, unless prohibited by law, is notified of the information provided 4. 2. 3. Information about the client obtained from other sources treated as confidential TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

ISO / IEC 17020 : 2012 5. STRUCTURAL REQUIREMENTS TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

5. 1 Administrative requirements 5. 1. 1. Legal entity or defined part of a legal entity NOTE: A governmental inspection body is deemed to be a legal entity on the basis of its governmental status 5. 1. 2. Part of a legal entity involved in activities other than inspection identifiable within that entity 5. 1. 3. Documentation which describes the activities for which it is competent TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

5. 1 Administrative requirements 5. 1. 4. Adequate provision to cover liabilities arising from its operations (e. g. insurance or reserves) NOTE: The liability can be assumed by the State in accordance with national laws or by the organization of which the inspection body forms a part. 5. 1. 5. Documentation describing the contractual conditions Except when it provides inspection services to the legal entity of which it is a part TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

5. 2 Organisation and management 5. 2. 1. Structured and managed to safeguard impartiality 5. 2. 2. Organised and managed to maintain capability to perform inspection NOTE: Inspection schemes can require that the inspection body participates in the exchange of technical experience with other inspection bodies to maintain this capability. 5. 2. 3. Define and document the responsibilities and reporting structure of the organization 5. 2. 4. Define relationship between legal entity activities and IB (part of legal entity) activities TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

5. 2 Organisation and management 5. 2. 5. Availability of one or more person(s) as technical manager(s), that have overall responsibility to ensure that the inspection activities are carried out in accordance with this International Standard. Technically competent and experienced in the operation of the inspection body 5. 2. 6. Deputies in the absence of any technical manager responsible for on going inspection activities 5. 2. 7. Description of the job(s) or other documentation for each position category within its organization involved in inspection activities TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

ISO / IEC 17020 : 2012 6. RESOURCE REQUIREMENTS TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

6. 1 Personnel 6. 1. 1. Defined competence requirements for all personnel involved in inspection activities. NOTE: The competence requirements can be part of the job description or other documentation mentioned in 5. 2. 7. 6. 1. 2. Sufficient number of persons (employ or have contracts) with the required competencies, including, where needed, the ability to make professional judgements, to perform the type, range and volume of its inspection activities TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

6. 1 Personnel 6. 1. 3. Personnel responsible for inspection Qualifications, training, experience and knowledge (relevant knowledge in details) manufacturing of products, operation of process, delivery of services. Relevant knowledge of: • the technology used for the manufacturing of the products inspected, operation of processes and delivery of services • the way in which products are used, processes are operated and services delivered and • any defects which may occur during the use of the product, any failures in the operation of the process and any deficiencies in the delivery of services TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

6. 1 Personnel 6. 1. 4. Each person knows clearly their: vduties vresponsibilities and vauthorities 6. 1. 5. Documented procedure for: vselecting vtraining vformally authorising and vmonitoring TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

6. 1 Personnel 6. 1. 6. Documented procedures for training a) an induction period; b) a mentored working period with experienced inspectors; and c) continuing training to keep pace with developing technology and inspection methods. 6. 1. 7. Training required depends upon the ability, qualifications and experience of each inspector and other personnel involved in inspection activities and upon the results of monitoring TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

6. 1 Personnel 6. 1. 8 Personnel familiar with the inspection methods and procedures monitor all inspectors and other personnel involved in inspection activities for satisfactory performance. Results of monitoring used as one means to identify training needs NOTE: Monitoring can include a combination of techniques such as on-site observations, report reviews, interviews, simulated inspections and other techniques to assess performance and will depend on the nature of inspection activities. TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

6. 1 Personnel 6. 1. 9. Each inspector observed on-site unless there is sufficient supporting evidence that the inspector is continuing to perform competently NOTE: It is expected that on-site observations are performed in a way that minimizes the disturbance of the inspections, especially from the customer’s viewpoint. 6. 1. 10. Records of monitoring, education, training, technical knowledge and experience 6. 1. 11. Personnel involved in inspection activities remunerated – preventing influence of inspection results TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

6. 1 Personnel 6. 1. 12. All personnel of the Inspection Body, either internal or external, that could influence the inspection activities, act impartially 6. 1. 13. All personnel of the inspection body including sub contractors, personnel of external bodies, or individuals acting on the IB’s behalf keeping confidential all information obtained or created during the performance of the inspection activities, except as required by law Reduce the potential of compromises by pressures- and maintain confidentiality. TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

6. 2 Facilities & equipment 6. 2. 1. Available suitable and adequate facilities and equipment – competent and safe manner NOTE: The inspection body need not be the owner of the facilities or equipment that it uses. Facilities and equipment can be borrowed, rented, hired, leased or provided by another party (e. g. the manufacturer or installer of the equipment). However, the responsibility for the suitability and the calibration status of the equipment used in inspection, whether owned by the inspection body or not, lies solely with the inspection body. 6. 2. 2. Rules for the access to and the use of specified facilities and equipment 6. 2. 3. Ensure continued suitability of the facilities and the equipment TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

6. 2 Facilities & equipment 6. 2. 4. Define equipment having a significant influence on the results of the inspection, and, where appropriate, uniquely identified 6. 2. 5. All equipment (6. 2. 4) properly maintained, in accordance with documented procedures and instructions 6. 2. 6. Measurement equipment having a significant influence on the results of the inspection calibrated: • before being put into service and • thereafter according to an established programme TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

6. 2 Facilities & equipment 6. 2. 7. Overall programme of calibration of equipment designed and operated to ensure that, wherever applicable, measurements traceability to national, international standards. Where traceability is not applicable evidence of correlation or accuracy of inspection results 6. 2. 8. Reference standards used for calibration only reference standards of measurement calibrated providing traceability to a national or International Standard of measurement TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

6. 2 Facilities & equipment 6. 2. 9. Equipment subjected to in service checks between recalibration 6. 2. 10. Reference materials traceable to national or International Standard reference materials 6. 2. 11. Procedure for the outcome of inspection activities for: a) selection and approval of suppliers; b) verification of incoming goods and services c) ensuring appropriate storage facilities 6. 2. 12. Condition of stored items assessed at appropriate intervals to detect deterioration TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

6. 2 Facilities & equipment 6. 2. 13. Ensure: a) computer software is adequate for use b) integrity and security of data c) computer and automated equipment is maintained 6. 2. 14. Documented procedure for defective equipment – appropriate corrective action in case the defective equipment effected previous inspections 6. 2. 15. Records for calibration maintenance TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

6. 3 Sub contracting 6. 3. 1. IB shall itself normally perform inspections that it contracts to undertake. Sub contractor must be competent NOTE 1 Reasons to sub-contract can be I. an unforeseen or abnormal overload, II. key inspection staff members are incapacitated or III. key facilities or items of equipment are temporarily unfit for use or IV. part of the contract from the client involves inspection not covered by the inspection body’s scope or V. is beyond the capability or VI. resources of the inspection body. 6. 3. 2. Inform the customer for sub contracting 6. 3. 3. Responsibility for determination of conformity rests with the inspection body 6. 3. 4. Records of competence of sub contractors (list for subcontractors) TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

ISO / IEC 17020 : 2012 7. PROCESS REQUIREMENTS TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

7. 1 Inspection methods & procedures 7. 1. 1. Methods and procedures which are defined in specific inspection requirements, (laws, standard, or developed by IB) 7. 1. 2. Documented instructions on inspection planning, sampling procedures and inspection techniques, where the absence of such instructions could jeopardize the effectiveness of the inspection process 7. 1. 3. Inspection methods or procedures which are Non standard appropriate and fully documented 7. 1. 4. Instructions, standards or written procedures, worksheets, check lists and reference data relevant to the work of the inspection body maintained up to date and be readily available to the personnel TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

7. 1 Inspection methods & procedures 7. 1. 5. Contract or work order control system ensures that: a. Work to be undertaken is within its expertise and that the organization has adequate resources to meet the requirements; b. The requirements of those seeking the inspection body's services are adequately defined and that special conditions are understood so that unambiguous instructions can be issued to personnel performing the duties to be required c. Work being undertaken is controlled by regular review and corrective action d. The requirements of the contract or work order have been met TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

7. 1 Inspection methods & procedures 7. 1. 6. Verification of integrity of information supplied by any other party as part of the inspection process 7. 1. 7. Observations or data obtained in the course of inspections recorded in a timely manner to prevent loss of relevant information TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

7. 1 Inspection methods & procedures 7. 1. 8. Calculations and data transfer shall be subjected to appropriate checks NOTE: Data can include textual material, digital data and anything else that is transferred from one location to another where errors could be introduced. 7. 1. 9. Documented instruction for carrying out inspections safely TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

7. 2 Handling inspection samples & items 7. 2. 1. Items and samples to be inspected are uniquely identified to avoid confusion regarding the identity of such items and samples 7. 2. 2. Establishment whether the item to be inspected has been prepared (equipment, personnel etc. ) 7. 2. 3. Notifying abnormalities – Where there is any doubt as to the item's suitability for the inspection to be carried out, or where the item does not conform to the description provided, the IB shall contact the customer and record the outcome before proceeding 7. 2. 4. Documented procedures to avoid deterioration and damage TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

7. 3 Inspection Records 7. 3. 1. Maintain record system to demonstrate the effective fulfillment of the inspection procedures and enable an evaluation of the inspection 7. 3. 2. Traceability of reports and certificates Ø traceable to the inspector(s) who performed the inspection? TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

7. 4 Inspection reports &certificates 7. 4. 1. The work carried out by the Inspection Body covered by retrievable reports / certificates 7. 4. 2. Content of inspection reports a) identification of the issuing body; b) unique identification and date of issue; c) date(s) of inspection; d) identification of the item(s) inspected; e) signature or other indication of approval, by authorized personnel; f) a statement of conformity where applicable; and g) the inspection results except where detailed in accordance with clause 7. 4. 3. Note: (see Annex B for optional elements) TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

7. 4 Inspection reports &certificates 7. 4. 3. Conditions for issuing inspection certificates without including results traceability has to be assured 7. 4. 4. Information (7. 4. 2) reported correctly, accurately, and clearly identified results supplied by sub contractors 7. 4. 5. Corrections or additions to an inspection report or inspection certificate the amended report or certificate identifying the report or certificate it replace TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

7. 5 Complaints & appeals 7. 5. 1. Documented processto receive, evaluate and make decisions on complaints and appeals 7. 5. 2. Availability to interested parties on request description of the handling process 7. 5. 3. Confirmation whether the complaint relates to inspection activities responsible 7. 5. 4. Responsibility for decisions at all levels of the handling process 7. 5. 5. Investigation and decision shall not result in any discriminatory actions TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

7. 6 Compliant & appeals process 7. 6. 1. The handling process a) a description of the process for receiving, validating, investigating the complaint or appeal, and deciding what actions are to be taken in response to it b) tracking and recording complaints and appeals, including actions undertaken to resolve them c) ensuring that any appropriate action is taken 7. 6. 2. Gathering & Verifying all information to validate the complaint / appeal 7. 6. 3. Acknowledging receipt, reporting progress and outcome – to complainant 7. 6. 4. Independence of personnel who make decisions 7. 6. 5. Giving formal notice of the end of the process TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

ISO / IEC 17020 : 2012 8 MANAGEMENT SYSTEM REQUIREMENTS TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

8. 1 Options 8. 1. 1. A management system that is capable of achieving the consistent fulfilment of the requirements of this international standard ( i. e. ISO / IEC 17020) TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

8. 1 Options 8. 1. 2. Option A l Specified requirements ( 8. 3 – 8. 8 and 7. 5 and 7. 6) 8. 1. 3. Option B l A management system in accordance with the requirements of ISO 9001, and that is capable of supporting and demonstrating the consistent fulfilment of the requirements of this international standard (i. e. ISO / IEC 17020) fulfils the management system section (Section 8. 2 8. 8) requirements TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

8. 1 Options 8. 1. 2. Option A l General management system documentation (e. g. , manual, policies, definition of responsibilities – 8. 2); l Control of documents (8. 3); l Control of records (8. 4); l Management review (8. 5); l Internal audit (8. 6); l Corrective actions (8. 7); l Preventive actions (8. 8); l Complaints and appeals (see 7. 5 and 7. 6). TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

8. 2 Management system documentation (Option A) 8. 2. 1. Establish, document, and maintain policies and objectives 8. 2. 2. Top management commitment to the development and implementation of the management system 8. 2. 3. Member of management appointed for a) Ensuring that processes and procedures needed for the management system are established, implemented and maintained, and b) Reporting to top management on the performance of the management system and any need for improvement. 8. 2. 4. Documentation of the management system 8. 2. 5. Personnel involved in inspection activities have access to the parts of the management system documentation their responsibilities. TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

8. 3 Control of documents 8. 3. 1. Procedures to control the documents 8. 3. 2. Definition of controls needed to: a) Approve documents for adequacy prior to issue b) Review and update as necessary and re approve documents c) Ensure that changes and the current revision status of documents are identified d) Ensure that relevant versions of applicable documents are available at points of use e) Ensure that documents remain legible and readily identifiable f) Ensure that documents of external origin are identified and their distribution controlled and g) Prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. NOTE: Documentation can be in any form or type of medium and includes proprietary and in house developed software. TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

8. 4 Control of records 8. 4. 1 Establish procedures to q define the controls needed for q the identification, q storage, q protection, q retrieval, q retention time and q disposition of its records 8. 4. 2. Establish procedures for retaining records for a period consistent with its contractual and legal obligations TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

8. 5 Management review 8. 5. 1 Procedures to review its management system ensure its continuing suitability, adequacy and effectiveness (conducted at least once a year, records) 8. 5. 2. Review inputs a) b) c) d) e) f) g) Results of internal and external audits Feedback from customers and interested parties The status of preventive and corrective actions Follow up actions from previous management reviews The fulfilment of objectives Changes that could affect the management system and Appeals and complaints. TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

8. 5 Management review 8. 5. 3. Review outputs decisions and actions related to: a) Improvement of the effectiveness of the management system and its processes b) Improvement of the inspection body related to the fulfilment of this international standard and c) Resource needs. TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

8. 6 Internal audits 8. 6. 1 Procedures for internal audits to verify that it fulfils the requirements of this International Standard and that the management system is effectively implemented and maintained NOTE: ISO 19011 provides guidelines for conducting internal audits 8. 6. 2. Audit programm taking into consideration the importance of the processes and areas to be audited, as well as the results of previous audits TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

8. 6 Internal audits 8. 6. 3. Conduct periodic internal audits covering all procedures in a planned and systematic manner, to verify that the management system is implemented and is effective. TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

8. 6 Internal audits 8. 6. 4. Least once every 12 months 8. 6. 5. Ensure that a) Internal audits are conducted by qualified personnel b) Auditors do not audit their own work c) Personnel responsible for the area audited are informed d) Actions resulting from internal audits in a timely & appropriate manner e) Identified opportunities for improvement and f) Documented results of the audit? TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

8. 7 Corrective actions 8. 7. 1 Procedures for identification and management of non conformities 8. 7. 2. Eliminate the causes of non conformities in order to prevent recurrence 8. 7. 3. Appropriate to the impact of the problems encountered TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

8. 7 Corrective actions 8. 7. 4. Procedures define requirements for: a) Identifying non conformities b) Determining the causes of non conformity c) Correcting non conformities d) Evaluating the need for actions to ensure that non conformities do not recur e) Determining and implementing in a timely manner, the actions needed f) Recording the results of actions taken and g) Reviewing the effectiveness of corrective actions TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

8. 8 Preventive actions 8. 8. 1 Procedures for taking preventive actions to eliminate the causes of potential non conformities 8. 8. 2. Appropriate preventive actions taken to the probable impact of the potential problems TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

8. 8 Preventive actions 8. 8. 3. Procedure defines requirements for: a) Identifying potential non conformities and their causes b) Evaluating the need for action to prevent the occurrence of non conformities c) Determining and implementing the action needed d) Recording the results of actions taken and e) Reviewing the effectiveness of the preventive actions taken. TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

Annex A ( Normative) Independence requirements Requirements for inspection bodies ( Type A) Requirements for inspection bodies ( Type B) Requirements for inspection bodies ( Type C) TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

Annex B ( informative ) Optional elements of inspection reports and certificates Ø Designation of document Ø Description of the work ordered Ø What has been omitted Ø Inspection methods & procedures Ø Equipment Ø Sampling methods TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015

Annex B ( informative ) Optional elements of inspection reports and certificates Ø Where the inspection was carried out Ø Environmental conditions Ø Statement on inspection results Ø Statement on conditions for reproducing the report Ø Inspectors mark or seal Ø Names / identification of those who performed the inspection TAIEX Workshop on Better Understanding the Requirements for Accreditation Cairo 7 8 September 2015