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Auditing of QMS As per ISO 9000 : 2000

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Quality Policy

Has the organization defined its mission? Have the factors critical to the accomplishment of mission been analyzed to determine subjects to be controlled by the organization? How and by whom has the quality policy been formulated? Have the people responsible for implementation been involved in development of the policy? How have regulatory requirements been considered in formulation of the quality policy? How is the quality policy communicated throughout the organization?

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Quality Objectives

Have quality objectives been defined in measurable terms? What is the basis for establishing quality objectives? It could be: - customer expectations - past performance - standard of competitors Have the persons responsible for achieving objectives been involved in the establishment of quality objectives, in order to secure their commitment?

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Quality Objectives (contd.)

How have the risks to achieving objectives been evaluated? Have appropriate objectives been established in different functional areas which contribute to achieving overall objectives? How is the achievement of quality targets verified? What analysis is carried out in case of discrepancies between planned and actual results?

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Organization

Have you defined an organizational structure with clearly defined responsibility and authority at all levels? What is the role of management representative and what is the coordination process for ensuring that QMS is implemented and maintained in all functional areas?

Does the MR have appropriate status and authority to effectively coordinate the activities of QMS throughout the organization?
How does the MR promote awareness of customer requirements throughout the organization?

Does the MR have adequate secretariat support for the satisfactory discharge of his duties?

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Human Resource Management

How are the responsibilities within each role defined and assigned to the various functionaries in the organizational structures? How do you determine the need of additional personnel and their qualification and expertise.? How does the recruitment and selection process ensure that the defined requirements of the staff are met?

What is the process for identifying training needs and development for all staff?

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Human Resource Management (contd.)

What is the process for carrying out skills assessment, taking into account current capabilities as well as needs based upon future business objectives?
What is the process for providing training and development? Is a training plan and record of training (both within the company and outside) available? What improvements in HR have been planned?

What improvement in results was obtained from the last review of the human resource process?

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Physical Resource Management

Provision of Resources
What is the process for provision of physical resources like buildings, utilities, process equipment and supporting services? Have the responsibilities for planning and provision of different types of physical resources been defined? Do the users of resources participate in the planning process? What is the basis for determining additional resources?

Have you identified any specific work environment that affects conformity to product requirement?
What is the process to review whether adequate resources have been provided?

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Maintenance of Physical Resources

Have processes for maintenance of various types of resources such as buildings and equipment been defined?
Have the standards of various types of resources been established? How are maintenance processes controlled? How do you determine has any legal requirement impact on maintenance? Have you out-sourced maintenance of buildings and any equipment? If so, how are these services monitored and controlled? Have you established improvement objectives for maintenance? If so to what extent have those objectives been achieved over a specified period?

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Management of Services

Have you determined what kind of services are required by the organization? These services could be transportation, communication, cleaning, security, etc. Have the processes for planning, procurement and control of these services been defined and responsibilities allocated? Have the standards for these services been established? How is service performance assessed for conformity and improvement?

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Product Realization Processes

General questions
The following questions are applicable to all processes involved in product realization: What is the purpose or output of the process? What are the pre-requisites for commencement of the process? What information and other resources are required for the process? What inputs are needed and where will they come from?

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General questions (contd.)

What are the main stages of the process and how is interconnection between stages managed? What controls are exercised for satisfactory operation of the processes?

How are the results of the process measured?

What action is taken when a desired output is not achieved?

These questions will oblige the process owner to examine all aspects of any process. This will help bring clarity about the process and help in effective management of processes.

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Marketing Processes

What market research has been carried out to understand the sector in which you operate? Have you identified factors necessary for your organization to succeed in the market? How do you determine the current and future needs and expectations of customers? How do you evolve the marketing strategy? Are other key functional groups involved in this process? Once customer requirements are determined, how are these communicated within the organization? How do you assess the effectiveness of marketing process?

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Sales Process

Have you defined your sales strategy and established sales objectives? What are the key stages in the process to achieve sales objectives?

How is information on the organizations products and services conveyed to potential customers and how is its integrity maintained?
What are the principal activities of the process by which customer inquiries are converted into orders?

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Sales Process (contd.)

How do you determine whether the organization has the capability to satisfy customer requirements before accepting orders? How are customer requirements of accepted orders conveyed to those responsible for their implementation? How are changes in orders/contracts captured, accepted and conveyed to those responsible for their implementation?

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Sales Process (contd.)

What checks are carried out to verify that the customers receive the products and services they have ordered? What analysis has been performed to determine the cause in the case of differences between actual and planned results? What improvement in results was obtained from the last review of the sales process?

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Design and Development Processes

Do you have a system of preparing a design plan before starting any design and development activity? Does the plan identify various design inputs and how these are to be obtained? Have you defined various stages in the development processes sequential and parallel work schedules and persons responsible for the completion of design elements?

Have you defined design and development output in verifiable terms?

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Design and Development Processes (contd.)

Is systematic review of design and development carried out at suitable stages? Is a checklist for such a review available? What is the process of design verification? Are the results of verification recorded? Do you have a design and development validation process where you have to demonstrate that the resulting product is capable of meeting the requirements of the intended user? What is the process of making changes to the design?. Are these changes verified and reviewed by authorized persons before implementation?

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Purchase Processes

Has the organization formulated a purchase policy and guidelines? How and by whom are the items to be purchased determined?

relevant

Are specifications or detailed particulars of all items to be purchased available? What is the process for determining quantities to be purchased? How do you determine the relevant legal requirements that impact the purchase of these products?

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Purchase Processes (contd.)

How are those who require any products involved in the purchase process?
How are suppliers assessed for their ability to supply conforming product? Do you maintain an updated list of approved suppliers? How do you ensure that complete information about specification of the products is provided to the suppliers?

How do you ensure that any supplier is informed about the procedures for approval of material and critical processes in cases where these are applicable?

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Purchase Processes (contd.)

What is the process for qualification of personnel when their skill is critical for ensuring product quality? What is the verification process for critical materials or processes used by any supplier (If required by purchase procedures)? What action is taken when there are minor deviations from the specification which may not affect the serviceability of the product? What actions are taken when whole or part of a supplied product batch is found to be non-conforming?

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Purchase Processes (contd.)

What extra safeguards are adopted for verification when non conforming product is submitted after rectification? How is the performance of suppliers evaluated? Are results of evaluation shared with suppliers to enable them to improve? Are suppliers involved in quality improvement projects? What steps are taken to encourage long-term relationship with suppliers?

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Production Planning

What is your production policy to ensure that the right quantity of products is produced at the right time to optimize utilization of production resources? What are the inputs to production planning? These could be confirmed orders, sales forecast and planned inventory levels. Have you carried out any process capability study of your equipment to determine production capacity? What is the process of machine loading and work scheduling to ensure smooth flow of production? How is production control exercised to ensure that planned production is achieved? Are causes of production shortfall analyzed to improve the production planning process and productivity?

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Process Planning for Product Realization

Have you defined the sequence of operations or activities for each product and the output required at each stage? Have you determined which process stages require written instructions for proper compliance? Do your process plans specify parameters to be checked or measured at different stages and how these measurements are to be carried out? Have you defined criteria for acceptance at each stage and actions to be taken in case these criteria are not met?

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Process Planning for Product Realization (contd.)

Does the process plan give details of tooling, software and measuring devices to be used in the process? Where a customer-supplied product is to be integrated with the final product, does the process plan provide specifications for such a product and instructions for assessing conformity and related issues? Have you defined methods of identification and traceability where these are applicable? Does the process plan contain instructions for preservation, packaging and storage of the product where appropriate?

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Production Control

How it is ensured that the concerned personnel fully understand process plans and activities to be carried out by them? Where written instructions are required, have you ensured that these are available at the workstations where they are applicable? What is the method of approval of any process before commencing regular production? How do you ensure that specified process controls are being used and are effective?

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Production Control (contd.)

Do the operators know what corrective action is to be taken when a process goes out of control or non conforming product is produced? How it is ensured that an out-of-control process is not operated until its causes are determined and it is again brought under control? Have you defined action to be taken for dealing with non-conforming product? What is the process for accepting product deviations that do not significantly affect product serviceability?

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Control of Monitoring and Measuring Devices

Are all monitoring and measuring devices uniquely identified?

How it is determined that these devices meet the measurement requirements of products and processes?
Do you have calibration procedures and are records of calibration maintained? Is calibration status clearly identifiable on the devices?

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Control of Monitoring and Measuring Devices (contd.)

Are concerned personnel aware of proper handling, maintenance and storage method to prevent damage/deterioration? Are suitable environmental conditions maintained for measurement and calibration activities? What is the system of revalidation of previous measurements if the measuring equipment is found to be out of calibration?

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Measurement, Monitoring and Process Improvement

What are the methods for measuring and monitoring productrealization processes? Are there records to show that the processes are being monitored and necessary follow up action is taken to keep them under control? Is there a documented plan for inspection and testing of the product (including acceptance criteria) before the release of any product?

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Measurement, Monitoring and Process Improvement (contd.)

Is there a documented procedure for control of non-conforming products? Have you defined what action is to be taken if defects are found after delivery and is there an adequate product recall procedure? Is there a procedure for corrective and preventive action to prevent occurrence of defects?. Does it address the root causes on the basis of investigation and analysis of non-conformities?

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Measurement, Monitoring and Process Improvement (contd.)

Is there a documented procedure for measuring customer satisfaction and handling of customer complaints?

Are internal audits carried out according to a plan, and the necessary follow up action taken?
Are there documented audit procedures along with a check list? Is there a formal system for analysis of data for continuous improvement of processes and the quality management system?