Audits and inspection
Customer experience
Quality and operations
Retail

ISO 9001 Internal audit (manufacturing)

ISO 9001 is the international standard specifying requirements for a quality management system (QMS). It supports organisations' ability to provide products and services that meet customer and regulatory requirements at all times.
Backround information
Location name
Date
Reporter
Quality Management System (QMS)
14 Questions
Does the QMS documentation include documented statements of quality policy and objectives?
Does the QMS documentation include a quality manual?
Does the QMS documentation include required documented procedures?
Does the QMS documentation include documents, including records, to ensure planning operation and control of processes?
Does the Quality Manual include the scope of the QMS and exclusions?
Does the Quality Manual include the documented procedures or references to them?
Does the Quality Manual include a description of the interaction between the processes?
Is there a procedure for the Control of Documents that defines the approval, review and update of documents?
Is there a procedure for the Control of Documents that defines the identification of the revision status and format of changes to documents?
Is there a procedure for the Control of Documents that defines the identification and use of obsolete documents?
Is there a procedure for the Control of Documents that defines the identification and control of necessary external documents?
Is there a procedure for the Control of Documents that defines how the latest version of the documents are available on site (if applicable)?
Is there a procedure for the Control of Records that covers the identification, storage, protection, retrieval, retention time and disposition?
Are records readily identifiable and retrievable?
Management Responsibility
5 Questions
Has management ensured that Responsibility and Authority are defined and communicated within the organisation?
Has a member of the organisation’s management been appointed with the responsibility and authority to manage the QMS?
Are appropriate communication processes established within the organisation?
Has management planned the review of the QMS including assessing opportunities for improvement using all available inputs?
Are records of the QMS reviews maintained/actioned?
Resource management
6 Questions
Are resources provided to implement, maintain and improve the QMS and to meet customers requirements?
Are personnel with the necessary competence performing work affecting the conformity of the product?
Is training provided to meet required competencies?
Are personnel aware of the relevance and importance of their activities and their contribution to the quality objectives?
Does the organisation manage the conditions under which work is performed that are needed to achieve conformity to product requirements?
Product realization
31 Questions
Is a quality plan prepared for a specific project/contract detailing the processes and documents?
Are appropriate records maintained?
Does the organisation determine and review requirements related to the product (including maintenance) prior to tendering?
Are records and actions from the review maintained?
Are documents amended and relevant personnel notified when changes are made to the product?
Are there affective arrangements for dealing with customer complaints?
Does the organisation plan and control the development of a product?
Are design and development inputs determined and records maintained for the functional and performance requirements?
Are design and development inputs determined and records maintained for applicable statutory and regulatory requirements?
Are design and development outputs approved and do they meet the input requirements?
Are design and development outputs approved and do they contain or reference acceptance criteria?
Are systematic review of design and development performed to evaluate the ability of the results to meet requirements?
Are systematic review of design and development performed to identify any problems and propose necessary actions?
Are planned verification and/or validation requirements performed and are outcomes and necessary actions recorded?
Are design and development changes identified, reviewed verified, validated as appropriate and approved?
Are records maintained of the changes, review of the changes and necessary actions?
Does the organisation ensure that a purchased product confirms to specified requirements?
Is the type and extent of control of the supplier dependant on the effect of the purchased product on the final product?
Does the organisation evaluate and select suppliers on their ability to meet the organisation's selection criteria?
Are results and actions of evaluations recorded?
Does the purchase information define the specified requirements?
Does the organisation establish and implement the inspection of other activities to ensure product verification?
Has the organisation controlled processes for planning and production of the specifications of the product?
Has the organisation controlled processes for planning and production of the availability of work instructions, as necessary?
Has the organisation controlled processes for planning and production of the use of suitable equipment?
Has the organisation controlled processes for planning and production of the availability and use of monitoring and measuring devices?
Has the organisation controlled processes for planning and production of the implementation of monitoring and measuring and the release of hold points?
Are processes validated where the resulting output cannot be verified by subsequent monitoring or measurement?
Is the product identified where appropriate?
Is the product status identifiable with respect to monitoring and measuring requirements?
Where necessary, is measurement equipment identifiable and calibrated to appropriate standards and at nominated intervals and are calibration records maintained?
Measurement, analysis and improvement
14 Questions
Does the organisation implement the monitoring, measurement, analysis and improvement processes needed to demonstrate conformity of product?
Does the organisation implement the monitoring, measurement, analysis and improvement processes needed to ensure conformity of the QMS?
Does the organisation implement the monitoring, measurement, analysis and improvement processes needed to continually improve the effectiveness of the QMS?
Are methods determined for the monitoring of Contractor Performance Reports?
Is there a planned audit program covering and including processes relative to their status and importance?
Is there a documented procedure defining the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records?
Are the actions to eliminate detected nonconformities followed up and verified?
Is there evidence of specification criteria in ITPs and the authorisation for release of the product (including Hold Points if appropriate)?
Is there a documented procedure defining the controls and related responsibilities and authorities for dealing with a nonconforming product?
Are there records of nonconformities, actions taken, including concessions obtained?
Are records available from processes to verify conformity to product requirements?
Does the organisation continually improve the effectiveness of the QMS through the use of quality policy, quality objectives, audit results, corrective and preventative actions and management reviews?
Is there a procedure to manage nonconformities and potential nonconformities?
Any ambiguity in this checklist shall be referred to the International standard for resolution?
Signature
Inspector's signature
Falcony signature
January 20, 2023 - 15:42
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