Internal Audit Checklist QMS ISO 9001:2008
Clause Requirements Description
of Findings
Category of Findings 4.0 Quality Management System
4.1 • General requirements
• Has the organization:
• Established the processes required by QMS and its applications throughout the organization (see 1.2);
• Determined the order and interaction of these processes;
• Determined the criteria and methods necessary to ensure that the implementation and control of these processes runs effectively;
• Ensure the availability of the resources and information needed to support the operation and monitoring of these processes;
• Monitor, measure, and analyze these processes, and;
• Implement the necessary actions to achieve the planned results and continuous improvement of these processes;
4.2. Documentation Requirements
4.2.1 General
Whether the organization has established the required ISO 9001:2008 QMS documentation.
QMS documentation must include:
• Documented requirements on quality policy and quality goals;
• Quality guidelines;
• Documented procedures required by these international standards;
• The documents, including notes, are determined by the organizations necessary to ensure effective planning, operation and control of processes.
4.2.2 Quality guidelines
Has the organization established and maintained quality guidelines that include:
• The scope of the quality management system, including the reason for each requirement exception (see 1.2);
• Documented procedures established for quality management systems or their references, and;
• An explanation of the interaction of the processes of the quality management system;
4.2.3. Document control
Is there a written procedure set out to control the documents and records required by QMS. Whether the written procedure includes controls for:
• verify the appropriate document before publication;
• review and update as necessary and reauthorize documents;
• ensure that changes and revision status of documents are identified;
• ensure that the appropriate version of the applicable document is available at the time of use;
• ensure that documents remain readable and identifiable;
• ensure that documents from outside the organization and necessary for the planning and operation of quality management systems are identified and their distribution is controlled, and
• prevent the use of undue expired documents, and to apply appropriate identification if the document remains stored for a particular purpose;
4.2.4. • Control records
• Whether written procedures have been established for identification, storage,
protection, recall, storage time and disposition of records.
• Whether the organization has identified the quality records needed to provide evidence of conformity to the effectiveness of the
implementation of QMS, which includes:
• management review results (5.6.1).
• results of education and training, skills and experience, personal competence (6.2.2).
• evidence that the realization of the resulting process and product has met the requirements (7.1)
• the results of a review of the requirements related to the product and follow-up actions from the review (7.2.2)
• results from design and development inputs related to product requirements (7.3.2)
• design and development review results and necessary measures (7.3.4)
• design and development verification results and necessary measures (7.3.5)
• design and development validation result along with necessary actions (7.3.6)
• review of design and development changes and necessary measures (7.3.7)
• supplier evaluation results and necessary follow-up based on the evaluation results (7.4.1)
• if required by the organization to indicate that validation of the process that produced the output could not be verified by the monitoring or measurement subsequest (7.5.2)
• unique identification of the product, if able to trace (traceability) the product is required (7.5.3)
• customer's lost, damaged or other belongings found to be unsuitable for use (7.5.4)
• basic criteria used for calibration or verification of measurement equipment if there are no national or international measurement standards (7.6)
• validation of previous measurement results if the measurement equipment found to be incompatible with the measurement (7.6)
• results of calibration and verification of measurement equipment (7.6)
• internal audit results and follow-ups conducted based on the results of the internal audit (8.2.2)
• statement of the person authorized to issue or pass the product (8.2.4)
• circumstances of product discrepancies and actions taken, including concessions or allowances obtained (8.3)
• the results of corrective action (8.5.2)
• results of precautions (8.5.3) 5.0. Management responsibility
5.1. Management commitment
Is there any evidence of commitment from top
management to develop and improve the effectiveness of QMS by:
• communicate to the entire organization the importance of meeting customer requirements and laws and regulations;
• establish quality policies;
• ensure that quality goals have been set;
• conduct management reviews, and;
• ensure that resources are available;
5.2. Focus on customers
• Does the top management implement methods to ensure that customer needs and
expectations have been set through QMS and elaborated into requirements that are in accordance with the objectives to achieve customer satisfaction?
• Have the responsibility related to the product, including the applicable legal and regulatory requirements identified and established to meet customer requirements?
5.3. Quality policy
Has the top management ensured that the quality policy:
• In accordance with the objectives of the organization;
• It is a commitment to meet the requirements and improve the effectiveness of QMS on an ongoing basis;
• Provide a framework for setting and reviewing quality goals;
• Communicated and understood at all levels in the organization, and;
• Reviewed to always be appropriate.
• Controlled (4.2.3) 5.4. Planning
5.4.1. Quality goals
• Have quality goals been set at relevant functions at all levels of the organization?
• Are the quality goals in accordance with quality policy, including the commitment to make continuous improvements?
• Are the quality goals set in accordance with the product requirements?
5.4.2. Quality management system planning
• Has QMS planning been carried out in accordance with the requirements of clause 4.1, including quality goals?
• Whether QMS planning has included:
a. The processes of QMS and the requirements in the realization of the product.
b. Assessment of the required resources c. QMS improvements that are joined
• Is the integrity of QMS maintained?
5.5. Responsibility, authority and communication 5.5.1. Responsibility and authority
• Has the organization identified the functions and their interrelationships to facilitate the effectiveness of quality management?
• Does the organization define the composition of top management?
• Has an organizational structure been created to identify functional relationships and
relationships?
• Have responsibilities and authorities been defined and communicated to those involved in QMS operations?
5.5.2. Management representative
Whether the top management has appointed a member of management, which regardless of other responsibilities, must have responsibility and authority, to:
• Ensure that the processes required in the quality management system are defined, implemented and maintained;
• Report to top management on the performance of the quality management system as well as any need for improvement; and
• Ensuring to advance awareness of customer requirements to the entire organization;
5.5.3. Internal communication
• Does top management guarantee that proper communication processes have been
established within the organization?
• Whether the communication is related to the QMS process and its effectiveness.
5.6. Management review 5.6.1. General
Does peak management review QMS to ensure continuity of suitability, adequacy and effectiveness?
• Has the review period been planned and set?
5.6.2. Input for management review
Does the input for the management review include information on:
a. Audit results;
b. Customer feedback;
c. Process performance and product conformity;
d. Status of preventive and corrective actions;
e. Follow-up from previous management reviews;
f. Changes that can affect the quality management system, and;
g. Recommendations for improvement 5.6.3. Outputs from management review
Does the output of the management review include any decisions and related actions:
a. Increasing the effectiveness of the quality management system and its processes;
b. Product improvement related to customer requirements;
c. Resource requirements.
6. Resource management
6.1 Provision of resources
Has the organization determined and provided the required resources:
a. to implement and maintain a quality management system and continually improve its effectiveness and;
b. to enhance customer satisfaction by meeting customer requirements;
6.2. Human Resources 6.2.1. General
Does the PIC for performing work that affects product quality have competency based on:
a. appropriateness of education and training b. experiential expertise and skills.
6.2.2. Competence, training and awareness Has the organization:
a. Determine the competency of the personnel required to perform work that affects product requirements conformity;
b. Provide training or take other actions to meet the required competencies;
c. Ensure that the required competencies have been achieved;
d. Ensure that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives;
and
e. Maintain appropriate records of education, training, skills and experience (see 4.2.4).
6.3. Infrastructure
Has the organization determined, provided and maintains the infrastructure necessary to achieve product requirements conformity, which includes:
a. Building, work space and related facilities;
b. Process equipment (both hardware and software), and;
c. Support services (such as transportation, communication or information systems);
6.4. Work environment
a. Has an appropriate work environment for the organization's operational processes been established?
b. Has the organization established and managed the work environment necessary to achieve
conformance to product requirements?
7.0. Product realization
7.1. Product realization planning
In planning product realization, does the organization have determined the following:
a. Quality objectives and product requirements;
b. The need to define processes, documents, and provide specific resources for products;
c. Verification, validation, monitoring, measurement, inspection and testing activities specific to the product and product acceptance criteria required.
d. Records needed to provide evidence that the process and product realization met the requirements (see 4.2.4).
• Is the product realization planning consistent with other requirements of the QMS and documented?
• Is there a clause in the product realization section (clause 7.0) that the organization cannot apply and has considered for exclusion and has been stated in the Quality Manual (4.2.2.)?
7.2. Process related to customers
7.2.1. Determination of requirements related to product Does the organization have set:
a. Requirements specified by the customer, including requirements for shipping and post-delivery
activities,
b. Requirements not specifically stated by the customer but required for a specified purpose or specific intended use, if known;
c. Legal and regulatory requirements and those that apply to the product, and
d. Any additional requirements deemed necessary for the organization.
7.2.2. Overview of requirements related to the product
• Has the organization reviewed product-related requirements that were implemented before the organization promised to supply the product to the customer?
• Have the review stages, (e.g., submitting a tender, accepting a contract or order, accepting a change to a contract or order) have been defined?
• Has the review process guaranteed the following:
a. Product requirements are defined appropriately;
b. In the event that a customer provides an unwritten requirement, the requirement has been reconfirmed before it is agreed;
c. If the product requirements change, the organization shall ensure that the relevant documents have been amended and that the relevant personnel are aware of any changes to the requirements made;
d. The organization has the ability to fulfill predetermined requirements.
Records of the results of the review and the actions required from the review shall be maintained (see 4.2.4).
7.2.3 Customer communication
Has the organization established and implemented an effective plan for communicating with customers, which relates to:
a. product information,
b. request, contract or order handling, including changes, and
c. consumer feedback, including consumer complaints.
7.3. Design and development
7.3.1. Design and development planning
• Has the organization planned and controlled product design and development During design and
development planning, does the organization have established:
a. the stages of the design and development process,
b. review, verification and validation activities appropriate for each design and development stage, and
c. responsibility and authority for design and development.
• Does the organization manage linkages between the parts involved in design and development activities to ensure effective communication and clarity of
responsibilities?
Are the progress of design and development planning activities output monitored?
7.3.2. Design and development input
• Are the inputs related to product requirements defined and documented appropriately?
• Does the design and development inputs include:
a. performance and functional requirements b. the requirements of applicable laws and
regulations,
c. where applicable, information resulting from similar prior designs, and
d. other requirements essential for design and development.
e. this input should be reviewed for adequacy.
Have all incompleteness, ambiguity or conflicting requirements been identified during the review?
7.3.3. Design and development output
• Are the outputs of the design and development process available in a suitable form for verification of design and development inputs?
• Whether all design and development output documents have been approved prior to publication.
• Does the design and development output address the following:
a. Meet the design and development input requirements;
b. Provide appropriate information for the purpose of purchasing, production and service provision;
c. Contains or becomes a reference for product acceptance criteria; and
Describe product characteristics that are important for correct and safe use.
7.3.4. Design and development review
• Does the organization have established a systematic design and development review stage and has been implemented according to the planned arrangements (see 7.3.1)?
• Has during the design and development review been carried out:
a. evaluation of design and development results capabilities in meeting requirements;
b. identify any problems and action required.
• Do the personnel involved in this review include representatives from the functions associated with the design and development phases being reviewed?
• Do recording results of the review and any necessary actions shall be maintained (see 4.2.4)?
7.3.5. Design and development verification
• Does design and development verification have been carried out according to planned arrangements (see 7.3.1) to ensure that design and development outputs meet design and development input requirements.
• Do records of verification results and any necessary actions have been maintained (see 4.2.4).
7.3.6. Design and development validation
• Is the validation of design and development carried out according to planned arrangements (see 7.3.1) to ensure that the product is capable of meeting the requirements for a particular application or for its intended purpose?
• If it is not possible to carry out full validation prior to product delivery, does the organization carry out partial validation according to established rules?
• Have records of validation results and any necessary actions been maintained (see 4.2.4)?
7.3.7. Control of design and development changes
• Does the organization have a process for controlling design and development change?
• Are records of design and development change control results maintained?
• Have design and development changes been reviewed, verified and validated, as required, and approved before implementation?
• Has the design and development change review included an evaluation of the impact of the changes on product parts and products that have been shipped?
Has a results of review record of changes and the necessary actions been maintained? (See 4.2.4).
7.4. Purchasing
7.4.1. Purchasing process
• Does the organization control the purchasing process to ensure that products purchased comply with specified purchasing requirements?
• Has the organization evaluated and selected suppliers based on its ability to supply products that match the organization's requirements?
• Has the organization defined criteria for selection, evaluation and re-evaluation?
• Are records of evaluation results and any necessary actions arising from the evaluation have been preserved?
(see 4.2.4).
7.4.2. Purchase information
• Has the organization defined the key information in the purchase document?
• Does the purchase document contain information describing the product purchased, including:
a. Requirements for product, procedure, process and equipment approval;
b. Requirements for personnel qualifications, and;
c. Quality management system requirements.
• Has the organization established the adequacy of the requirements set before presenting to suppliers?
7.4.3. Verify the product purchased
• Has the organization established and implemented the necessary inspections or other activities to ensure that the products purchased comply with the specified purchase requirements?
• When the organization or its customers intend to carry out verification at the supplier's premises, has the
organization stated the desired verification structure and method of product release in the purchase information?
7.5. Production and service provision
7.5.1. Control of production and service provision
Has the organization planned and carried out production and service under controlled conditions, such as:
a. Availability of information describing product characteristics;
b. Availability of work instructions, if required;
c. Use of appropriate equipment;
d. Availability and use of monitoring and measurement equipment;
e. Monitoring and measurement application, and;
Application of delivery and post-delivery processes.
7.5.2. Validation of production processes and service provision
• Has the organization validated any processes for production and service provision where the resulting output cannot be verified through monitoring and measurement at a later stage?
• Has the validation demonstrated the ability of the process to achieve the planned results?
Has the organization established arrangements for this process, including:
a. Specific criteria established for review and approval processes;
b. Equipment approval and personnel qualifications;
c. Use of certain methods and procedures;
d. Requirements for records (see 4.2.4); and Re-validate.
7.5.3. Identification and traceability
• Has the organization identified the product in a manner that is appropriate for all stages of product realization?
• Has the organization identified product status related to monitoring and measurement requirements at all stages of product realization?
• Does the organization control and record the unique identification of the product, if traceability is a defined requirement (see 4.2.4)
7.5.4. Customer property
• Has the organization been concerned about customer property as long as it is under the control of the organization or is being used by the organization?
• Has the organization identified, verified, protected and maintained customer property when not in use or in combination with the product?
• Has the organization reported the matter to the customer, if any of the customer's property is lost, damaged or found unusable?
• Has the organization-maintained records (See 4.2.4).
7.5.5. Product preservation
• Has the organization established methods and controls for maintaining product during internal processing and delivery to the desired destination?
• Does this preservation method include identification, handling, packaging, storage and protection?
• Does this preservation also apply to key parts of a product?
7.6. Control of monitoring and measurement equipment
• Has the organization established monitoring and measurement performed and the monitoring and measurement equipment needed to provide evidence of product conformity to specified requirements?
• Has the organization established processes to ensure that monitoring and measurement can be carried out and carried out consistently and in accordance with monitoring and measurement requirements?
• If applied, what are measurement and monitoring equipment:
a. Calibrated and / or verified or both, at a specified time, or before use, against measurement standards traceable to international or national measurement standards; if no suitable standard exists, the basis for the use of calibration or verification should be noted (see 4.2.4).
b. Set or reset as needed;
c. Must be identified to indicate the calibration status d. Be protected from adjustments that may result in
incorrect measurement results
e. Protected from damage and deterioration during handling, maintenance and storage;
• Has the software used for measurement and monitoring been validated prior to use?
8. Measurement, analysis and improvement
8.1. General
• Has the organization planned and implemented the necessary monitoring, measurement, analysis and improvement processes?
• Does the organization have established processes for measurement and monitoring activities to:
a. indicate conformance to product requirements, b. ensures the conformity of the quality management
system, and
c. continuously improves the effectiveness of the quality management system;
determine the appropriate method, including statistical techniques and their level of use.
8.2. Monitoring and measurement 8.2.1. Customer satisfaction
• Has the organization established a method for
monitoring information related to customer perception or satisfaction?
• Is the information being monitored a measure of the organization's QMS performance?
8.2.2. Internal audit
• Has the organization conducted internal audits at planned time intervals to determine what the quality management system is:
a. In accordance with the planned structure (see 7.1), the requirements of this international standard and the requirements of the quality management system established by the organization, and