Guidance for accreditation of EN 15224:2012 Health care services Quality management systems Requirements based on EN ISO 9001:2008

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1 Guidance for accreditation of EN 15224:2012 Health care services Quality management systems Requirements based on EN ISO 9001:2008 This document is mandatory for the consistent application of ISO/IEC All clauses of ISO/IEC continue to apply and this document does not supersede any of the requirements in that standard. This mandatory document is exclusively for the certification of organization s management system to EN Introduction ISO/IEC is an International Standard that sets out the general requirements for bodies operating audit and certification of organizations management systems. If such bodies are to be accredited as complying with ISO/IEC with the objective of auditing and certifying health care services quality management system in accordance with EN 15224, some additional requirements and guidance to ISO/IEC are necessary. This document follows the structure of ISO/IEC Swedac specific criteria are identified by the letter G followed with a reference number that incorporates the related requirements clause in ISO/IEC In all cases a reference in the text of this document to "clause XX" refers to a clause in ISO/IEC unless otherwise specified. The certification body is required to implement the new scheme to the existing management system for ISO/IEC in order to address all new requirements. Some requirements on an overall level such as impartiality, internal audits, publicly available information need to be taken care of. These requirements are not addressed here. The scopes for application of accreditation are listed in annex 1. 1 Scope This document specifies normative criteria for certification bodies auditing and certifying organization s quality management system to EN 15224, in addition to the requirements contained with ISO/IEC Normative reference For the purposes of this document, the normative references given in ISO/IEC and the following apply. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO/IEC 17021:2011 Conformity Assessment - Requirements for bodies providing audit and certification of management systems ISO/IEC TS Competence requirements for auditing and certification of quality management systems 1 (5)

2 EN Health care services - Quality management systems - Requirements based on EN ISO 9001:2008 IAF MD 1 IAF Mandatory Document for the Certification of Multiple Sites Based on Sampling IAF MD 5 IAF Mandatory Document for Duration of QMS and EMS Audits IAF MD 11 IAF Mandatory Document for the application of ISO/IEC for the audit of Integrated Management Systems 3 Terms and definitions The terms and definitions in EN clause 0.1, 0.2 and 3 and ISO/IEC 17021:2011 apply. 4 Principles 5 General requirements 6 Structural requirements 7 Resource requirements G Competence of management and personnel Competence criteria for personnel involved in certification activities shall fulfil the requirements in ISO/IEC annex A and applicable requirements in ISO/IEC TS Health care services quality management systems auditors and lead auditors shall have knowledge and skills within the following areas, in order to perform the audit successfully and draw the applicable audit observations and conclusions: 1. applicable standards and certification requirements; 2. applicable statutory and regulatory requirements; 3. terminology related to the applicable health care areas; 4. quality aspects and characteristics in the health care area, see EN 15224: ; 5. health care specific preconditions according to EN 15224: ; 6. concept of process approach and understanding of the involved clinical processes; 7. methods to evaluate conditions related to health care management including methods for preventive and reactive actions as well as evaluation tools including incident and accident evaluation; 8. clinical risk management; 9. organization and administration inter-relationships in the health care business sector, including contractual and financial conditions for service; 10. human behavior and interactions between people and processes, including environment factors (for example work environment, equipment and 2 (5)

3 utilities, transportation and information technology) that may have impact on quality performance; 11. personal attributes suitable for acting in health care environment. A lead auditor for ISO 9001 experienced in the health care sector that fulfills the above requirements may be suitable to be qualified as a lead auditor for EN The audit team shall have the knowledge and skills required to provide expertise, including relevant medical knowledge, requirements and professional standards, in the specific health care area relevant to the audit objectives and scope. Additional members of the audit team (i.e. technical experts) may be included in the audit team, in order to appoint a team with the competence to achieve the objectives of the audit. 8 Information requirements G 8.2 Certification Documents The certification documents shall clearly identify what part of the business that is certified so that there will be no misunderstanding. The certification documents shall clearly state when research and education are a part of the scope of certification. In addition to issue a certificate for EN a certificate for ISO 9001:2008 can be issued, if the CB can confirm that a proper contract review has been made and that it is stated in the audit objectives and plan. Also the CB shall be accredited for both ISO 9001:2008 and EN and follow the relevant EA and IAF mandatory documents. 9 Process requirements G Determination of audit time For determination of audit time the requirements in IAF Mandatory document IAF MD 5 is applicable. As a starting point for estimation of audit time for an initial audit add 30% to table QMS 1 for Quality management systems in IAF MD 5. From the new starting point factors for adjustment of audit time are applicable. As health care services are a high risk business activity in most cases it will not be relevant to decrease audit time. When the certification body decides to reduce the audit time it shall be well motivated by risk assessment. Combined audits shall be performed according to the requirements in IAF MD 11. For a combined audit for EN and environmental management system ISO the complexity is high and therefor it is unlikely that reduction can be made according to MD 11. For a combined audit for EN and ISO 9001, a certificate for ISO 9001:2008 can be provided if the requirements in G 8.2 are fulfilled G Multi-site sampling Requirements in IAF MD 1 are applicable. G Audit report 3 (5)

4 The audit report shall include conclusions from all sites audited. 10 Management system requirements for certification bodies Annex G. Annex A 4 (5)

5 Annex 1 Scope for accreditation Group Technical area Examples of health care service 1 General medicine Occupational and environmental medicine Occupational health care Occupational therapy Physiotherapy Preventive health care Primary health care Rehabilitation 2 Internal medicine Dermatology and venereology diseases Ear, nose and throat diseases Eye diseases Geriatrics Infectious disease medicine Neurology Obstetrics and gynaecology Oncology Rheumatology 3 Surgery Orthopaedics Plastic surgery Thoracic surgery Urology Vascular surgery 4 Intensive care Ambulance care Anaesthesia 5 Mental health services Addiction treatment Psychiatry 6 Dental services 7 Nursing homes Hospices 8 Pharmacies 5 (5)

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