7.3 Awareness How are people aware of: Persons doing work under the The quality policy? shall be organization’s control Relevant quality objectives? aware of: Their contribution to the a) the quality policy; effectiveness of the QMS? b) relevant quality objectives; The benefits of improved c) their contribution to the performance? effectiveness of the quality The implications of not conforming 7.3 management system, including to the QMS requirements? q1 the benefits of improved quality performance; d) The implications of not conforming to the quality management system requirements. 7.4 Communication How do you determine internal The organization shall determine and external communications the internal and external relevant to the QMS? communications relevant to the How do you determine: quality management system What? including: 7.4 When? a) on what it will communicate; q1 With Whom? b) when to communicate; How? c) with whom to communicate; d) How to communicate. 7.5 Documented information 7.5.1 General The quality What documented information Documented information required by organization’s management system shall include: do you have as required by this this standard. a) documented information standard? Documented information necessary What documented information for the effectiveness of the QMS. required by this International Standard; do you have as being necessary 7.5.1 b) Documented information for the effectiveness of your QMS? q1 determined by the organization as being necessary for the effectiveness of the quality management system. NOTE The extent of documented information for a quality management system can differ from one organization to another due to: a) the size of organization and its type of activities, processes, products and services; b) the complexity of processes and their interactions; c) The competence of persons. 7.5.2 Creating and updating When creating and updating Documented information (in various documented information the media) needs identification, Show me that your documented organization shall ensure description. information contains: appropriate: Review / approval process? Identification; a) identification and description Description; 7.5.2 (e.g. a title, date, author, or In what media format? reference number); q1 Show me how the documented b) format (e.g. language, software information is reviewed and version, graphics) and media (e.g. approved for suitability and paper, electronic); adequacy. c) Review and approval for suitability and adequacy.
7.3 Awareness 7.3 q1 Persons doing work under the organization’s control shall be aware of: a) the quality policy; b) relevant quality objectives; c) their contribution to the effectiveness of the quality management system, including the benefits of improved quality performance; d) The implications of not conforming to the quality management system requirements. How are people aware of: The quality policy? Relevant quality objectives? Their contribution to the effectiveness of the QMS? The benefits of improved performance? The implications of not conforming to the QMS requirements? 7.4 Communication 7.4 q1 The organization shall determine the internal and external communications relevant to the quality management system including: a) on what it will communicate; b) when to communicate; c) with whom to communicate; d) How to communicate. How do you determine internal and external communications relevant to the QMS? How do you determine: What? When? With Whom? How? 7.5 Documented information 7.5.1 General 7.5.1 q1 The organization’s quality management system shall include: a) documented information required by this International Standard; b) Documented information determined by the organization as being necessary for the effectiveness of the quality management system. What documented information do you have as required by this standard? What documented information do you have as being necessary for the effectiveness of your QMS? Documented information required by this standard. Documented information necessary for the effectiveness of the QMS. NOTE The extent of documented information for a quality management system can differ from one organization to another due to: a) the size of organization and its type of activities, processes, products and services; b) the complexity of processes and their interactions; c) The competence of persons. 7.5.2 Creating and updating 7.5.2 q1 When creating and updating documented information the organization shall ensure appropriate: a) identification and description (e.g. a title, date, author, or reference number); b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic); c) Review and approval for suitability and adequacy. Show me that your documented information contains: Identification; Description; In what media format? Show me how the documented information is reviewed and approved for suitability and adequacy. Documented information (in various media) needs identification, description. Review / approval process?
Portrait-Audit-Checklist.docx