Isms Internal Audit Checklist Free Public Full

How does top management assign the responsibility and authority for: Ensuring that the QMS conforms to the International standard Ensuring processes are delivering their intended outputs How is the performance of the QMS, opportunities for improvement and the need for change or innovation reported to top management How is customer focus promoted within the organization How is the integrity of the QMS maintained when changes to the QMS are planned and implemented 6 Planning for the quality management system 6.1 Actions to address risks and opportunities 6.1.1 6.1.1q1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to: a) give assurance that the quality management system can achieve its intended result(s); b) prevent, or reduce, undesired effects; c) achieve continual improvement.

The purpose of an internal audit is to systematic and independent assess the effectiveness of any organizations quality management system and its overall performance.

Internal audit demonstrate the compliance with a planned arrangements, e.g.

QMS and how its processes are implemented and maintained.

Isms Internal Audit Checklist Free Public Full

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How has the organization determined external and internal issues relevant to its purpose and strategic direction How do these affect the ability to achieve the intended result of the QMS 4.1q2 The organization shall monitor and review the information about these external and internal issues.

How do you monitor and review information about these internal and external issues NOTE 1 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional or local.

NOTE 2 Understanding the internal context can be facilitated by considering issues related to values, culture knowledge and performance of the organization.

Understanding the needs and expectations of interested parties 4.2q1 Due to their impact or potential impact on the organizations ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine: a) the interested parties that are relevant to the quality management system; b) the requirements of these interested parties that are relevant to the quality management system.

How have you determined what interested parties are relevant to the QMS How have you determined what requirements those parties have that are relevant to the QMS How has impact or potential impact been determined 4.2q2 The organization shall monitor and review the information about these interested parties and their relevant requirements.

How do you monitor and review the information about interested parties and their relevant requirements 4.3 Determining the scope of the quality management system 4.3q1 The organization shall determine the boundaries and applicability of the quality management system to establish its scope.

How have the boundaries and applicability of the QMS been used to establish the scope of the organization 4.3q2 When determining this scope, the organization shall consider: a) the external and internal issues referred to in 4.1; b) the requirements of relevant interested parties referred to in 4.2; c) the products and services of the organization.

How has the application of the International Standard within the scope been determined, and how has it been applied by the organization Page 1.

How have any requirements of the International Standard been determined as not applicable Show me how conformity of products and services are not affected by this.

The scope shall be available and be maintained as documented information stating the: - products and services covered by the quality management system; - justification for any instance where a requirement of this International Standard cannot be applied.

Where is the scope available Where is it maintained as documented information Does it state what products and services are covered by the QMS Does it justify how instances of requirements of the QMS cannot be applied Scope required as documented information.

Quality management system and its processes 4.4q1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.

How has the QMS been established Show me how this is implemented.

How is it maintained and continually improved How have the processes been determined and how do they interact 4.4q2 The organization shall determine the processes needed for the quality management system and their application throughout the organization and shall determine: a) the inputs required and the outputs expected from these processes; b) the sequence and interaction of these processes; c) the criteria, methods, including measurements and related performance indicators needed to ensure the effective operation, and control of these processes; d) the resources needed and ensure their availability; e) the assignment of the responsibilities and authorities for these processes; f) the risks and opportunities in accordance with the requirements of 6.1, and plan and implement the appropriate actions to address them; g) the methods for monitoring, measuring, as appropriate, and evaluation of processes and, if needed, the changes to processes to ensure that they achieve intended results; h) opportunities for improvement of the processes and the quality management system.

How have the processes been determined for the QMS What are the inputs and outputs for those processes What is the sequence and interaction of the processes What are the criteria, methods, measurement and related performance indicators needed to operate and control those processes What resources are needed and how are these made available How are responsibilities and authorities assigned for those processes How are risks and opportunities considered and what plans are made to implement actions to address them What methods are used to monitor, measure and evaluate processes and, if needed, what changes are made to achieve intended results How are opportunities to improve the processes and the QMS determined Page 2.

Show me how top management demonstrates leadership and commitment w.r.t.

QMS by taking accountability of the effectiveness of the QMS.

How is the quality policy and objectives established for the QMS and how are they compatible with the strategic direction and the organizational context How is the quality policy communicated within the organization Show me how this is understood and applied.

How are the requirements of the QMS integrated into the business processes How do you promote awareness of the process approach How do you ensure that resources needed for the QMS area available How do you communicate the importance of effective quality management How do you communicate the importance of conforming to the QMS requirements How do you ensure that the QMS achieves its intended results How do you engage, direct and support people to contribute to the effectiveness of the QMS How do you promote continual improvement How do you support other relevant management roles to demonstrate leadership in their areas of responsibility Page 3.

How are risks and opportunities that can affect conformity of products and services determined How is the ability to enhance customer satisfaction determined and addressed How is the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements maintained How is customer satisfaction maintained 5.2 Quality policy 5.2.1 5.2.1q1 T op man age ment shal l e stab lish, rev iew and mai ntai n a qu alit y po licy tha t: a) i s ap prop riat e to the pur pose and con text of the orga niza tion; b) p rovi des a fr amew ork for sett ing and revi ewin g qual ity o bje ctiv es; c) i nclu des a co mmit ment to sati sfy appl ica ble requ irem ents; d) i nclu des a co mmit ment to cont inua l im prov emen t of t he qu ali ty m anag emen t sy stem.

How does top management establish, review and maintain a quality policy How is it determined to be appropriate to the purpose and context of the organization Does it provide a framework for setting and reviewing quality objectives Does it contain a commitment to satisfy applicable requirements Does it include a commitment to continual improvement of the QMS 5.2.2 Page 4.

Where is the quality policy available as documented information How is it communicated Show me how it is understood and applied within the organization.

How have you made it available to relevant interested parties Quality Policy as document information 5.3 Organizational roles, responsibility and authorities 5.3q1 T op management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.

How does top management ensure that responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization 5.3q2 T op management shall assign the responsibility and authority for: a) ensuring that the quality management system conforms to the requirements of this International Standard; b) ensuring that the processes are delivering their intended outputs; c) reporting on the performance of the quality management system, on opportunities for improvement and on the need for change or innovation, and especially for reporting to top management; d) ensuring the promotion of customer focus throughout the organization; e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.