ISO checklist. Help Contact Us. It stands as a reference point before, during and after the audit process and if developed for a specific audit and used correctly will provide the following benefits:. This audit checklist may be used for element compliance audits and for process audits. Any changes in external and internal issues that are relevant to the quality management system, the input shall be reviewed by top management of Company as it required by clause 9. These includes the fulfillment of requirement to meet the product specification and compliance with the applicable laws.
The information of the interested parties demonstrated by the List of Stakeholders. The organization shall monitor and review this document to maintain the compliance of needs of interested parties and their relevant requirements. Note: This section is addressed to meet the requirement of clause 4.
Consideration is important for Company before determining the scope of certification 1. Company shall apply all the requirements of ISO if applicable within the determined scope of quality management system.
Therefore the scope of certification to be justified for Company is; [scope of activity] To run their activities at below site address; [Company Address] By stating the abovementioned scope, justification is also being provided to determine any requirement of ISO Standard that Company is not applicable to the scope of quality management system. Company confirmed that the following elements are not applicable and does not affect the organizations ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction; Clause: XXXXXX Clause: XXXXXX Note: This section is addressed to meet the requirement of clause 4.
The top management of Company shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of ISO Company has determined the processes needed for the quality management system and its application throughout the company as follows:. Clause 8. Requirement for products and services, and 3. Internal Audit Procedure 2. Risk Management Procedure and, 3. Management Review as defined in clause 9.
Refer to; 1. KPI Monitoring, 2. Corrective Action. Procedure, and, 3. Top management of Company shall demonstrate leadership and commitment with respect to customer focus by: customer requirements are determined, understood and consistently met Refer to clause 8. Requirement for products and services of this Quality Manual applicable statutory and regulatory requirements are determined, understood and consistently met Reference: Legal Register List and Evaluation the risks and opportunities that can affect conformity of products and servicesReference: Risk Analysis document ability to enhance customer satisfaction are determined and addressed and maintaining to focus for enhancing customer satisfaction Reference: Clause 9.
Note: This section is addressed to meet the requirement of clause 5. Top management of Company shall assign the responsibility and authority for executing the below tasks: Responsibility: ensuring that the quality management system conforms to the requirements of ISO Standard How to achieve?
Internal Audit refer to clause 9. Management review as per clause 9. Business Process Mapping, 2. Refer to Quality Manual 1. Clause Refer to Quality Manual; 1. Clause 5. Clause 7. This also in line with the aspect described in clause 4. Therefore, determination to the risks and opportunities is needed to: 1. The planning of risk management has concerned on the following aspects; a actions to address these risks and opportunities; b how to: 1 integrate and implement the actions into its QMS according to 4.
In the context of Company, risk management shall taking into account on the following aspects 1. Applicable legal compliance 2. Working environment see 7. The requirement of Documented Information Control Procedure is followed The effectiveness of actions taken to address risks and opportunities shall be reviewed by top management of Company as it required by clause 9.
The quality objectives shall: a be consistent with the quality policy; b be measurable; c take into account applicable requirements; d be relevant to conformity of products and services and to enhancement of customer satisfaction; e be monitored; f be communicated; g be updated as appropriate. The planning how to achieve quality objectives, Company shall determine:. Reference: KPI monitoring In conformance with clause 4. The requirement of Documented Information Control Procedure is.
Note: This section is addressed to meet the requirement of 6. It shall consider: a the purpose of the changes and their potential consequences; see clause 6. Explain how resources are defined.
Check how process control is implemented. Show documented information that shows methods have been carried out as intended and can prove the conformity of products and services.
Determine how the output from the planning method is fitting for operations. Determine how planned changes are monitored. Verify how unintended changes are reviewed and what actions are taken to mitigate any adverse effects, as required. Verify how outsourced methods are controlled. Verify method to determine the demands for products and services to be given to potential customers and how the method is verified, implemented and sustained.
Verify how output and service demands including statutory and regulatory obligations are defined. Verify that the company has the ability to meet the specified demands and substantiate any claims for its outputs. Verify how the company reviews Show that the review is carried previous to the organization's engagement to supply products and services to the buyer.
Verify documented information of improved reviews and how those changes are communicated to important personnel. Verify how the company confirms customer demands where the customer doesn't implement a documented statement. Verify documented information of reviews outlining new or changed demands to outcomes. Confirm how the organization resolves disagreements in the contract or order demands from those earlier defined. Establish documented information that proves design and development demands have been met.
Confirm that the inputs are whole and unambiguous. Establish documented information on design and improvement inputs are retained. Establish documented information of these activities is retained.
Establish documented information on design and improvement outputs are maintained. Verify documented information on design and improvement changes, the result of reviews, the permission of changes and the actions taken to limit adverse consequences are retained. Verify controls applied to externally provided methods, products and services when products and services are designed for incorporation into the company's own outcomes, products and services are provided straight to the customer or a process, or part of a method is provided by an external provider as a consequence of a decision by the company.
Verify the effectiveness of the controls used by the external provider. Verify how the company determines and applies guidelines for the evaluation, selection, controlling of administration and re-evaluation of external providers. Check how the company determines charges applied to the external requirement of methods, products and services.
Verify how the company considers the possible impact of the external provided methods, products and services on its ability to meet buyer and applicable legal and regulatory demands. Verify how the company determines the verification, or other actions, needed to ensure the externally provided methods, products and services meet demands. Establish documented information on activities and actions resulting from the assessments. Verify the company communicates to external providers its demands for Verify the effectiveness of suitable infrastructure and environment for the operation of processes.
Verify the implementation of controlling and measuring activities at proper stages to verify that criteria for control of methods or outputs, and acceptance standards for products and services, have been met. Our easily editable management system templates can help any business achieve their certification goals by providing the knowledge, tools, techniques and documentation required for successful implementation.
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