SB EMS Questionnaire 9001 - LRQA

1 small BUSINESSQMS Self Appraisal ISO 9001:2015 This Questionnaire is designed to help you judge whether your Quality Management System (QMS) is ready for assessment by you are unsure about any of the questions, please do not hesitate to contact us. small business Advisors:0800 783 2179 Guidance NoteThe following Questionnaire should be completed in all sections by answering Yes, No or Not Applicable in the appropriate column. Not Applicable should only be recorded if you do not undertake the process described as part of your operational processes. This only applies to section explain any NO answers in the space given at the end of this Questionnaire .

2 Where there is a specific reference in your system that addresses this requirement in your quality management system, please record this. A reference MUST be recorded where the ISO 9001:2015 standard indicates a need for a documented document is numbered in accordance with the ISO 9001:2015 complete and return with the signed proposal documentsImproving performance, reducing risk4 Context of the Understanding the organisation and its contextQuestion:Yes/No:Reference/Link:Do you know how your organisation determines external and internal issues that are relevant to its purpose and strategic direction? Does your organisation determine the external and internal issues that could affect its ability to achieve the results that your QMS is trying to achieve?

3 Does your organisation monitor and review information about these external and internal issues? Understanding the needs and expectations of interested partiesQuestion:Yes/No:Reference/Link:Ca n you list the interested parties that are relevant to your organisation s quality management system? Have the requirements of these interested parties been determined and defined? Is information relating to your organisation s interested parties and their relevant requirements monitored and reviewed? Determining the scope of the quality management systemQuestion:Yes/No:Reference/Link:Whe n determining the scope of your QMS, were the following issues considered:a) The boundaries and applicability of the quality management system?

4 B) The relevant external and internal issues? c) The relevant requirements of interested parties? d) The products and services provided? Is the scope of your management system documented and available throughout the organisation? Does your scope clearly state the following:a) The types of products and services provided? b) Any requirement of ISO 9001:2015 that your organisation determines is not applicable to the scope of your QMS? Quality management system and its processesQuestion:Yes/No:Reference/Link: Does your organisation s QMS fully establish, implement, maintain and improved on a continual basis?

5 Has your organisation identified the processes required in your QMS? Have the following requirements for the processes within your QMS been determined:a) The required inputs and outputs? b) Their sequence and interaction? c) The criteria and methods needed to ensure the effective operation and control of these processes? d) The resources needed for these processes? e) Responsibilities and authorities for these processes? f) The relevant risks and opportunities? Are the processes measured or monitored and evaluated?

6 When required are process changes implemented to ensure that they achieve their intended results? Does your organisation seek opportunities to improve its processes? Where required, does your organisation provide documentation to support the operation of its processes? Does your organisation retain documentation to give and prove that the processes are being carried out as planned? 5. Leadership and commitmentQuestion:Yes/No:Reference/ GeneralIn relation to your QMS, can top management clearly demonstrate their leadership and commitment with respect to the following:a) Accountability for the effectiveness of your QMS?

7 B) Ensuring that your quality policy and objectives are established for your QMS and are compatible with the context and strategic direction of the organisation? c) Ensuring the quality policy is communicated, understood and applied? d) Ensuring the QMS requirements are integrated into the organisation s business processes? e) Promoting the use of the process approach and risk-based thinking? f) Ensuring that the sufficient resources are provided for the application of your QMS? g) Communicating the importance of effective quality management and of conforming to the requirements of your QMS?

8 H) Ensuring that your QMS achieves its intended results and targets? i) Engaging, directing and supporting persons to contribute to the effectiveness of your QMS? j) Promoting continual improvement? k) Supporting other relevant management to enable them to demonstrate their leadership in their areas of responsibility? Customer focusCan top management demonstrate their leadership and commitment with respect to customer focus by ensuring that the following aspects are completed:a) Customer and applicable statutory and regulatory requirements are determined, understood and consistently met?

9 B) Risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed? c) That products and services provided consistently meet the requirements of customers and applicable statutory and regulatory requirements? d) The focus on enhancing customer satisfaction is maintained? PolicyQuestion:Yes/No:Reference/ Developing the quality policyHave your top management established, implemented and maintained a quality policy that:a) Reflects the purpose and context of your organisation and supports its strategic direction?

10 B) Provides the basis for setting quality objectives to support the achievement of the quality policy? c) Gives a clear commitment to satisfy applicable requirements? d) Gives a clear commitment to continual improvement of your QMS? Communicating the quality policyIs the quality policy:a) Documented and maintained? b) Communicated, understood and applied within the organisation? c) Available to relevant interested parties? Organisational roles, responsibilities and authoritiesQuestion:Yes/No:Reference/Lin k:Have top management ensured that the responsibilities and authorities for relevant roles have been assigned, communicated and understood with the organisation?