Audit_9001 Quality Management Systems

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AUDIT SPECIFICATIONS
Audit Number:
Organisation/Operation
Location
PersonnelResponsiblefor Quality:
ResponsibleSeniorManagerfor Quality:
Date of Audit:
Auditor:
This audit is prepared with consideration of those systems present in writing and sampled in the workplace. The audit provides no warranty of
compliance but is only a review of those items available and present in the work environment sampled, at the time of the audit and that were made
obvious to the auditor. The provision of opinion based on this audit tool is not given as legal advice or for the purposes of validating legal
compliance and all suggestions made regarding the audit; its content; its outcome and the expression of any opinion should be independently
verified by the party requesting the audit or any party that may review or act on anything contained herein.

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Table of Contents
AUDIT SPECIFICATIONS.........................................................................................................................................................................1
0.20 Process-based Quality Management System...............................................................................................................................4
4.00 Quality Management System (QMS)..............................................................................................................................................4
4.10 General requirements....................................................................................................................................................................4
4.20 Documentation requirements ........................................................................................................................................................4
5.00 Management responsibility............................................................................................................................................................5
5.10 Management commitment.............................................................................................................................................................5
5.20 Customer focus .............................................................................................................................................................................5
5.30 Quality policy .................................................................................................................................................................................5
5.40 Planning.........................................................................................................................................................................................5
5.50 Responsibility, authority and communication................................................................................................................................5
5.60 Management review ......................................................................................................................................................................5
6.00 Resource management ...................................................................................................................................................................6
6.10 Provision of Resources .................................................................................................................................................................6
6.20 Human resources..........................................................................................................................................................................6
6.30 Infrastructure .................................................................................................................................................................................6
6.40 Work environment .........................................................................................................................................................................6
7.00 Product realisation..........................................................................................................................................................................6
7.10 Planning of product realisation......................................................................................................................................................6
7.20 Customer-related processes.........................................................................................................................................................7
7.30 Design and development...............................................................................................................................................................7
7.40 Purchasing.....................................................................................................................................................................................7
7.50 Production and service provision ..................................................................................................................................................7
7.60 Control of monitoring and measuring equipment..........................................................................................................................8
8.00 Measurement, analysis and improvement ....................................................................................................................................8
8.10 General..........................................................................................................................................................................................8
8.20 Monitoring and measurement .......................................................................................................................................................8
8.30 Control of nonconforming product.................................................................................................................................................9
8.40 Analysis of data .............................................................................................................................................................................9
8.50 Improvement..................................................................................................................................................................................9
8.60 Continual improvement .................................................................................................................................................................9

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NOTES AND ADDITIONAL ITEMS

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No. SECTION QUESTIONS AuditResponse
0.20 Process-based Quality Management System
0.20.01 Is there a model of a process-based quality management system? O Yes O No
0.20.02 Does that model include: O Yes O No
0.20.03 - Customer Requirements O Yes O No
0.20.04 - Customer Satisfaction O Yes O No
0.20.05 - Management Responsibility O Yes O No
0.20.06 - Resource Management O Yes O No
0.20.07 - Product Realisation O Yes O No
0.20.08 - Measurement, Analysis and Improvement O Yes O No
0.20.09 - Continual Improvement O Yes O No
0.20.10 Is there a need to demonstrate the ability to meet statutory and regulatory requirements? O Yes O No
0.20.11 Is there a list/table that describe those requirements: O Yes O No
0.20.12 - Legislation O Yes O No
0.20.13 - Regulations O Yes O No
0.20.14 - Codes O Yes O No
0.20.15 - Standards O Yes O No
0.20.16 - Other O Yes O No
0.20.17 Are there aims defined to meet: O Yes O No
0.20.18 - Conformity of Product O Yes O No
0.20.19 - Customer Satisfaction O Yes O No
0.20.20 - Statutory and regulatory requirements O Yes O No
0.20.21 - Continual Improvement O Yes O No
Comments:
4.00 Quality Management System (QMS)
4.10 General requirements
4.10.01 For the QMS, has the organisation determined: O Yes O No
4.10.02 - The sequence/interaction of the quality management processes O Yes O No
4.10.03 - The criteria to measure the effectiveness of these processes O Yes O No
4.10.04 - How to ensure the availability of resources and information necessary for these processes O Yes O No
4.10.05 - The means to monitor, measure and analyse these processes O Yes O No
4.10.06 - How to implement actions necessary to achieve planned results O Yes O No
4.10.07 - How to identify the means for continual improvement of these processes O Yes O No
4.10.08 Does the organisation outsource any process that affects product conformity? O Yes O No
4.10.09 Does the organisation ensure control over such outsourced processes? O Yes O No
4.10.10 Is the type and extent of control defined within the QMS? O Yes O No
4.10.11 Are there any products outsourced and are there quality controls for those products? O Yes O No
Comments:
4.20 Documentation requirements
4.20.01 Does the QMS documentation include: O Yes O No
4.20.02 - Documented quality policy and objectives O Yes O No
4.20.03 - Documented quality manual O Yes O No
4.20.04 - Recognition of this standard in documentation O Yes O No
4.20.05 - Documents and records determined necessary to ensure the effective planning, operation and control of its
processes
O Yes O No
4.20.06 Is there evidence that procedures are: O Yes O No
4.20.07 - Established O Yes O No
4.20.08 - Documented O Yes O No
4.20.09 - Implemented O Yes O No
4.20.10 - Maintained O Yes O No
4.20.11 Does the quality manual include the: O Yes O No
4.20.12 - Scope of the QMS and any exclusions O Yes O No
4.20.13 - Documented procedures for the QMS or reference to them O Yes O No
4.20.14 - Description of the relationship of the processes of the QMS whererelevant O Yes O No
4.20.15 Are there any exclusions of the product from the QMS? O Yes O No
4.20.16 Is the reason for exclusion defined? O Yes O No
4.20.17 Are documents required by the QMS controlled? O Yes O No
4.20.18 Are there controls to ensure: O Yes O No
4.20.19 - The review for adequacy and approve documents O Yes O No
4.20.20 - The review and update documents O Yes O No
4.20.21 - That changes and current revisions of documents are identified O Yes O No

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4.20.22 - That current versions are available at points of use O Yes O No
4.20.23 - That documents remain legible and readily identifiable O Yes O No
4.20.24 - That external documents required by the QMS are identified and their distribution controlled O Yes O No
4.20.25 - That obsolete documents are superseded by current documents O Yes O No
4.20.26 - That obsolete documents are appropriately recorded they are required to be retained O Yes O No
4.20.27 Is the document control process defined and does it include means by which records are: O Yes O No
4.20.28 Identified: O Yes O No
4.20.29 - Stored O Yes O No
4.20.30 - Protected O Yes O No
4.20.31 - Retrieved O Yes O No
4.20.32 - Retained O Yes O No
4.20.33 - Disposed of O Yes O No
Comments:
5.00 Management responsibility
5.10 Management commitment
5.10.01 Is there an organisational chart and management hierarchy identified in the QMS? O Yes O No
5.10.02 Are top management positions relevant to the QMS named/titled? O Yes O No
5.10.03 Does top management evidence its commitment to the quality management and continual improvement? O Yes O No
5.10.04 Does this evidence: O Yes O No
5.10.05 - Communication of the importance of meeting customer, statutory and regulatory requirements O Yes O No
5.10.06 - Support for establishing the quality policy O Yes O No
5.10.07 - Support for quality objectives O Yes O No
5.10.08 - Involvement in management reviews O Yes O No
5.10.09 - Provision of necessary resources O Yes O No
Comments:
5.20 Customer focus
5.20.01 Top management shall ensure that customer requirements are determined and are met with the aim of enhancing
customer satisfaction (see 7.2.1 and 8.2.1)
O Yes O No
5.30 Quality policy
5.30.01 Is there evidence that top management is willing to ensure the quality policy is: O Yes O No
5.30.02 - Appropriate to the organisation O Yes O No
5.30.03 - Committed to comply with requirements and continually improve the effectiveness of the QMS O Yes O No
5.30.04 - A framework for establishing and reviewing quality objectives O Yes O No
5.30.05 - Communicated and understood within the organisation O Yes O No
5.30.06 - Is reviewed for continuing suitability O Yes O No
Comments:
5.40 Planning
5.40.01 Is there a methodology for management in planning quality objectives? O Yes O No
5.40.02 Does this methodology include quality objective defined and supported by management? O Yes O No
5.40.03 Are these objectives measureable and consistent with the quality policy? O Yes O No
5.40.04 Are changes that result from the methodology reviewed by management they support the integrity of the QMS? O Yes O No
Comments:
5.50 Responsibility, authority and communication
5.50.01 Are there responsibilities and authorities defined, communicated and supported by top management? O Yes O No
5.50.02 Are there members of the organisations management who have responsibility and authority for quality
management?
O Yes O No
5.50.03 Do their responsibilities include: O Yes O No
5.50.04 - Ensuring that processes needed for the QMS are established, implemented and maintained O Yes O No
5.50.05 - Reporting to top management on the performance of the QMS and any need for improvement O Yes O No
5.50.06 - Ensuring the promotion of awareness of customer requirements throughout the organisation O Yes O No
5.50.07 Does top management ensure there are communications on the effectiveness of the QMS? O Yes O No
Comments:
5.60 Management review

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5.60.01 Are there planned intervals for top management to review the effectiveness of the QMS? O Yes O No
5.60.02 Does the review include assessing opportunities for improvement and the need for changes to the QMS? O Yes O No
5.60.03 Are records from management reviews maintained? O Yes O No
5.60.04 Does the management review include information on: O Yes O No
5.60.05 - Results of audits O Yes O No
5.60.06 - Customer feedback O Yes O No
5.60.07 - Process performance and product conformity O Yes O No
5.60.08 - Status of preventive and corrective actions O Yes O No
5.60.09 - Follow-up actions from previous management reviews O Yes O No
5.60.10 - Changes that could affect the QMS O Yes O No
5.60.11 - Recommendations for improvement O Yes O No
5.60.12 Does the output from the management review include any decisions and actions on: O Yes O No
5.60.13 - Improvement of the QMS O Yes O No
5.60.14 - Improvement of product in meeting customer requirements O Yes O No
5.60.15 - Resource needs O Yes O No
Comments:
6.00 Resource management
6.10 Provision of Resources
6.10.01 Does the organisation determine and provide the resources needed for the QMS to be: O Yes O No
6.10.02 - Implemented O Yes O No
6.10.03 - Maintained O Yes O No
6.10.04 - Continually improved in its effectiveness O Yes O No
6.10.05 - Enhance customer satisfaction by meeting customer requirements O Yes O No
Comments:
6.20 Human resources
6.20.01 Are personnel who affect product conformity appropriately educated, trained, skilled and experienced? O Yes O No
6.20.02 Does the organisation: O Yes O No
6.20.03 - Determine levels for competency for personnel O Yes O No
6.20.04 - Provide training or take actions to achieve competency O Yes O No
6.20.05 - Evaluate the efficacy such training/actions O Yes O No
6.20.06 - Create awareness of the effect personnel have on quality management O Yes O No
6.20.07 - Maintain records of education, training, skills and experience O Yes O No
Comments:
6.30 Infrastructure
6.30.01 What infrastructure is necessary for product conformity? O Yes O No
6.30.02 - Buildings O Yes O No
6.30.03 - Workspace O Yes O No
6.30.04 - Associated utilities O Yes O No
6.30.05 - Computer hardware and software O Yes O No
6.30.06 - Support services (transport, communication or information systems) O Yes O No
6.30.07 Is necessary infrastructure determined, provided and maintained to achieve product conformity requirements? O Yes O No
Comments:
6.40 Work environment
6.40.01 Does the organisation manage the work environment needed to achieve conformity? O Yes O No
6.40.02 NOTE: “Work Environment” is those conditions where work is performed that affect product conformity
(such as noise, temperature, humidity, lighting or weather).
Comments:
7.00 Product realisation
7.10 Planning of product realisation
7.10.01 Does the organisation define/describe what the quality product is? O Yes O No
7.10.02 Does the organisation define the processes needed for product realisation? O Yes O No
7.10.03 Does the product realisation define the: O Yes O No
7.10.04 - Quality requirements for the product O Yes O No

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7.10.05 - Processes, documents and resources specific to the product O Yes O No
7.10.06 - Techniques for verification, validation, monitoring, measurement, inspection and testing of the product O Yes O No
7.10.07 - Tolerance for product acceptance and failure O Yes O No
7.10.08 - Records of evidence to show the product meet requirements O Yes O No
Comments:
7.20 Customer-related processes
7.20.01 Does the organisation define the: O Yes O No
7.20.02 - Requirements for the product specified by the customer O Yes O No
7.20.03 - Requirements not stated by the customer but necessary for the intended use O Yes O No
7.20.04 - Statutory and regulatory requirements applicable to the product to meet customer demands O Yes O No
7.20.05 - Any additional requirements considered necessary by the organisation. O Yes O No
7.20.06 Are the contractual requirements of the customer reviewed in the supply of the product? O Yes O No
7.20.07 Do the contractual requirements meet: O Yes O No
7.20.08 - Product requirements O Yes O No
7.20.09 - Contract or order requirements O Yes O No
7.20.10 - The ability to meet the defined requirements O Yes O No
7.20.11 Does the organisation have arrangements for communicating with customers in relation to: O Yes O No
7.20.12 - Product information O Yes O No
7.20.13 - Enquiries, contracts or order handling, including amendments O Yes O No
7.20.14 - Customer feedback, including customer complaints O Yes O No
Comments:
7.30 Design and development
7.30.01 Was there a process for the design and development of the product? O Yes O No
7.30.02 Did that process involve: O Yes O No
7.30.03 - Design and development stages, O Yes O No
7.30.04 - Review, verification and validation at each design and development stage O Yes O No
7.30.05 - Responsibilities and authorities for design and development O Yes O No
7.30.06 Does design and development involvemultiple parties? O Yes O No
7.30.07 Is there means for each to interact with the other if necessary? O Yes O No
7.30.08 In the design and development are records maintained that document the: O Yes O No
7.30.09 - Functional and performance requirements O Yes O No
7.30.10 - Applicable statutory and regulatory requirements O Yes O No
7.30.11 - Where applicable, information derived from previous similar designs O Yes O No
7.30.12 - Other requirements essential for design and development. O Yes O No
7.30.13 Does the product meet the intended design? O Yes O No
7.30.14 Is there appropriate information for purchasing, production and service provision? O Yes O No
7.30.15 Does it refer to the requirements for product acceptance criteria? O Yes O No
7.30.16 Is there specification for the products safe and proper use? O Yes O No
7.30.17 Has reviews in design and development been performed in accordance with planned arrangements (see 7.3.1) O Yes O No
7.30.18 Did the reviews: O Yes O No
7.30.19 - Evaluate the results of design and development against the requirements O Yes O No
7.30.20 - Identify any problems and propose necessary actions O Yes O No
Comments:
7.40 Purchasing
7.40.01 Are purchasing functions for inputs critical to product realisation controlled to ensure quality? O Yes O No
7.40.02 Are suppliers of critical inputs evaluated against requirements for product realisation? O Yes O No
7.40.03 Are records kept of these evaluations? O Yes O No
7.40.04 When purchasing critical inputs, does the purchasing function define: O Yes O No
7.40.05 - Requirements for approval of product, procedures, processes and equipment, O Yes O No
7.40.06 - Requirements for qualification of personnel O Yes O No
7.40.07 - QMS requirements O Yes O No
7.40.08 Is the critical input product checked to ensure it meets the specified needs? O Yes O No
Comments:
7.50 Production and service provision
7.50.01 Is production carried out under controlled conditions? O Yes O No

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7.50.02 Do those controls identify and include the: O Yes O No
7.50.03 - Information that describes the characteristics of the product O Yes O No
7.50.04 - Work instructions O Yes O No
7.50.05 - Useof equipment, O Yes O No
7.50.06 - Implementation of monitoring and measurement O Yes O No
7.50.07 - Useof monitoring and measuring equipment O Yes O No
7.50.08 - Requirements for product release, delivery and post-delivery activities O Yes O No
7.50.09 Are there methods to validate that the product will achieve planned results, prior to delivery? O Yes O No
7.50.10 Do these methods: O Yes O No
7.50.11 - Defined criteria for review and approval O Yes O No
7.50.12 - Define necessary equipment and qualification of personnel O Yes O No
7.50.13 - Detail the methods and procedures for validation O Yes O No
7.50.14 - Require records to be kept O Yes O No
7.50.15 - Contain contingencies for failed product O Yes O No
7.50.16 Is there a requirement for traceability of the product to identify its origin O Yes O No
7.50.17 Is the product preserved so it arrives to the customer in its intended condition? O Yes O No
7.50.18 Does preservation include: O Yes O No
7.50.19 - Identification O Yes O No
7.50.20 - Handling O Yes O No
7.50.21 - Packaging O Yes O No
7.50.22 - Storage O Yes O No
7.50.23 - Protection O Yes O No
Comments:
7.60 Control of monitoring and measuring equipment
7.60.01 Does the organisation use monitoring and measuring equipment for the product? O Yes O No
7.60.02 Is monitoring and measurement carried out in accordance with equipment requirements? O Yes O No
7.60.03 Is the measuring equipment: O Yes O No
7.60.04 - Calibrated or verified, at specified intervals or prior to use, against measurement standards O Yes O No
7.60.05 - Able to be adjusted or re-adjusted as necessary O Yes O No
7.60.06 - Able to identify its calibration status O Yes O No
7.60.07 - Unable to be tampered with to invalidate the measurement result O Yes O No
7.60.08 - Not subject to damage and deterioration O Yes O No
7.60.09 Does the organisation recheck previous product if the equipment is found to be faulty? O Yes O No
7.60.10 Are records of calibration and verification kept? O Yes O No
Comments:
8.00 Measurement, analysis and improvement
8.10 General
8.10.01 Can the organisation demonstrate: O Yes O No
8.10.02 - Conformity to product requirements O Yes O No
8.10.03 - Conformity of the QMS O Yes O No
8.10.04 - Continual improvement in the effectiveness of the QMS O Yes O No
Comments:
8.20 Monitoring and measurement
8.20.01 Is there a process to: O Yes O No
8.20.02 - Gather customer feedback O Yes O No
8.20.03 - Allows customers to volunteer feedback O Yes O No
8.20.04 - Review customer feedback O Yes O No
8.20.05 - Identify any actions from customer feedback O Yes O No
8.20.06 NOTE: Examples of customer feedback are customer satisfaction surveys, customer data on delivered
product quality, user opinion surveys, lost business analysis, compliments, warranty claims and dealer
reports.
8.20.07 Is there a documented procedure for auditing and does it define: O Yes O No
8.20.08 - Responsibilities of auditors and participants O Yes O No
8.20.09 - Requirements for planning and conducting audits O Yes O No
8.20.10 - Required audit records O Yes O No
8.20.11 - Methods for reporting results O Yes O No
8.20.12 Is there an audit program for internal audits? O Yes O No

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8.20.13 Is the audit criteria, scope, frequency and methods defined? O Yes O No
8.20.14 Are auditors objective and impartial (not auditing their own work)? O Yes O No
8.20.15 Are external audits included in the program? O Yes O No
8.20.16 Are customer audits included in the program? O Yes O No
8.20.17 Does the audit include monitoring and measuring product characteristics? O Yes O No
8.20.18 Were there any non-conformances raised? O Yes O No
8.20.19 Were there any actions arising from non-conformances? O Yes O No
8.20.20 Were these actions resolved within an appropriate time frame? O Yes O No
Comments:
8.30 Control of nonconforming product
8.30.01 Is product that does not conform to product requirements is identified and controlled to prevent use or delivery? O Yes O No
8.30.02 Is there a documented procedure to for dealing with nonconforming product? O Yes O No
8.30.03 Does the procedure define how to eliminate the detected nonconformity? O Yes O No
8.30.04 Are other products sampled and checked for non-conformities? O Yes O No
8.30.05 In dealing with non-conforming product, are action recorded? O Yes O No
Comments:
8.40 Analysis of data
8.40.01 Is there data collected for analysis of the effectiveness of the QMS? O Yes O No
8.40.02 Does the data provide information relating to: O Yes O No
8.40.03 - Customer satisfaction O Yes O No
8.40.04 - Conformity to product requirements O Yes O No
8.40.05 - Characteristics and trends, including opportunities for preventive action O Yes O No
8.40.06 - Suppliers and customers O Yes O No
Comments:
8.50 Improvement
8.50.01 Is the effectiveness of the QMS checked against the to: O Yes O No
8.50.02 - Quality policy O Yes O No
8.50.03 - Quality objectives O Yes O No
8.50.04 - Audit results O Yes O No
8.50.05 - Analysis of data O Yes O No
8.50.06 - Corrective and preventive actions O Yes O No
8.50.07 - Management review O Yes O No
8.50.08 Is there a documented procedure for non-conformities to define requirements for: O Yes O No
8.50.09 - Reviewing non-conformities (including customer complaints) O Yes O No
8.50.10 - Determining the causes of non-conformities O Yes O No
8.50.11 - Evaluating the need for actions to ensure that non-conformities do not recur O Yes O No
8.50.12 - Determining and implementing actions required O Yes O No
8.50.13 - Recording the results of actions taken O Yes O No
8.50.14 - Reviewing the effectiveness of the corrective actions taken O Yes O No
Comments:
8.60 Continual improvement
8.60.01 Haveany of the following continual improvement actions been undertaken: O Yes O No
8.60.02 - Analysing and evaluating the existing situation to identify areas for improvement O Yes O No
8.60.03 - Establishing the objectives for improvement O Yes O No
8.60.04 - Searching for possible solutions to achieve the objectives O Yes O No
8.60.05 - Evaluating these solutions and making a selection O Yes O No
8.60.06 - Implementing the selected solution O Yes O No
8.60.07 - Measuring, verifying, analysing and evaluating results of the implementation O Yes O No
8.60.08 - Evidence of objectives being met O Yes O No
8.60.09 - Formalising changes O Yes O No
8.60.10 - Customer feedback sought, reviewed and acted on O Yes O No
8.60.11 - Formalising changes O Yes O No
8.60.12 - Customer feedback sought, reviewed and acted on O Yes O No
8.60.13 Is the SMS reviewedfor continuing, suitability, adequacy and effectiveness, by top management? O Yes O No
8.60.14 Does this occur at identified intervals (least every two years)? O Yes O No

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8.60.15 Is the review documented? O Yes O No
8.60.16 Where appropriate, does management suggest changes to SMS policy, objectives, responsibilities or other
areas?
O Yes O No
8.60.17 Is the review of the SMS carried out by the level of management that defined them? O Yes O No
8.60.18 Does the review include: O Yes O No
8.60.19 - Result from audits O Yes O No
8.60.20 - The extent to which objectives and targets have been met O Yes O No
8.60.21 - The continuing suitability of the SMS inrelation changing conditions and information O Yes O No
8.60.22 - Concerns of relevant interested parties O Yes O No
8.60.23 Does the review also take into consideration: O Yes O No
8.60.24 - Health and safety performance reports O Yes O No
8.60.25 - Incident reports O Yes O No
8.60.26 - Hazard identification O Yes O No
8.60.27 - Statutory OHS performance O Yes O No
8.60.28 - Corrective action reports O Yes O No
8.60.29 - Changes to regulatory requirements O Yes O No
8.60.30 - Changes to OHS standards O Yes O No
8.60.31 - Community expectations O Yes O No
8.60.32 Is the work authorised by a manager who controls the workplace? O Yes O No
Comments:

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NOTES AND ADDITIONAL ITEMS

Audit_9001 Quality Management Systems

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