Audit Check list for ISO 9001.doc

Audit Check list for ISO 9001:2000

ISO 9001 Clauses Audit Check list questions

4.1 Quality Management systems General Requirements

1. Has the key work processes of the organization been identified?

2. Does the company measure efficiency and effectiveness of the work process?

3. How does the company achieve control of the processes?4. Are there any outsourcing or subcontracted work to external

party(s), if yes how the organization control those processes and identify relevant Controls within them?

5. Is continuous improvement on performance being implemented?

6. Are the process management activities supported by appropriate operational records (to show planning, operation and control)

4.2.1 General Documentation requirements

1. Are the six mandatory documented procedures documented, namely, control of documents, control of records, internal audits, and control of nonconforming product, corrective action, and preventive action?

2. Are there documents such as flow charts, memos, policies that guide the work for the employees?

3. Are there appropriate records kept to show evidence of the implementation of the processes?

4.2.2 Quality Manual 1. Does the company compile has a quality manual (QM) established and maintained? Are the following included?

a) the work processes within the scope of the quality management systems,

b) scope of the QMS,including details and justification for any exclusions,

c) the reference to the documented systems, and d) descriptions of the interactions between the processes of the

quality management system?2. Are there documented statements of a quality policy and

quality objectives?3. Are there documented procedures required by the standard,

(Viz,control of documents, control of records, control of nonconforming product, corrective action, preventive action, internal audit)

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4.2.3 Control of documents

1. Has the company appointed designated personnel for the approval and issue of the documents?

2. Is there a documented procedure for the control, issue, review and approval for changes to existing documents and issues of the new documents?

3. How was the quality management system and its documented procedures implemented?

4. Are external documents used within the organization? Are these documents being identified properly to preclude uses of obsolete documents?

5. Does the company distribute its quality management systems documents with identification to ensure proper references?

6. Have all controlled documents, including forms, been defined? (e.g. QA manual, procedures, forms, quality plans, work instructions, user manuals, training manuals, LIA manuals, etc.)

7. Who is responsible for the control of documents? Where this responsibility defined (documented)?

8. How is electronic (computer) data controlled? Where is this defined?

9. How are documents of external origin, such as standards and circulars, identified and controlled?

10. Who is responsible for the identification and control of document and control of documents from external sources, such as standards, regulatory standards and circulars?

11. Is the pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality management system are performed

12. Invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use

13. Any obsolete documents retained for legal and /or knowledge preservation purposes are suitably identified.

14. Who is responsible ensuring that invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise protected from unintended use? How is this accomplished?.

15. Who is responsible for ensuring that any obsolete documents retained for legal and/or knowledge preservation purposes are suitability identified? How is this accomplished?

4.2.4 Control of Records 1. Is there a documented procedure for the identification, storage, protection, retrieval, retention times and disposition of the records related to quality management system?

2. Who is responsible for the collection of each record? (Remaining questions are usually directed toward the

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appropriate person in each area.)3. How records are identified, indexed and filed? Can you show

me example in process?4. How do you ensure that records are legible?5. How do these records are demonstrate conformance to the

specified requirements and effective operation of the quality management system

6. Who has access to these records? Are all the records stored in here? (To determine whether off-site storage if used)

7. What is the retention time for each record? Were applicable regulatory and legal requirements taken in to consideration in establishing these retention times? If so, can you show me the applicable regulatory and legal requirements that were consulted?

8. Who is responsible for maintaining these records? Does that person also dispose of records where in this process defined in your quality plan ad /or documented procedures?

9. How do you store and retain records in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and prevent loss?

10. Do you keep electronic (computer) records? Do you create backups of this data? How often? Who is responsible for initiating these backups? Can you load a recent back up (bring up the header) so that I can verify the date? Where is this process defined in your quality plan and /or documented procedures?

11. Do you maintain pertinent suppliers’ records? Can you show me examples of this?

12. Are quality records available for evaluation by the customer or the customer’s representative, where agreed by contract, for the agreed period? How is this accomplished?

5.1 Management commitment

1. How does the management demonstrate leadership, commitment and involvement?

2. Does top management actively involved in establishing, maintaining and reviewing the quality management system?

3. Does the top management develop specific programs for communicating customer and regulatory requirements and creating awareness of the importance and establish a list of quality objectives or is there any communication to the organization the importance of meeting customer and well as statutory and regulatory requirements?

4. Is there evidence of top management commitment example in the management review minutes.

5. Does top management review resource requirements to

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ensure the availability of relevant resources?6. Is there top commitment on the continual improvement of the

effectiveness of the quality management system?

5.2 Customer focus 1. Does top management ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction?

2. How does the company identify customer needs on continual basis?

3. How does the company management identify peoples’ needs for recognition, work satisfaction, competence and personal development?

4. How does the company consider potential benefits of establishing partnerships with suppliers?

5. How does the company ensure that statutory and regulatory requirements are met?

5.3 Quality policy 1. What is the organization quality policy?2. Does the quality policy consider the vision of meeting

requirements, customer requirements and continual improvement?

3. How does the quality lead to visible and expected improvements?

4. Where is your quality policy, including objectives for quality and commitment to quality documented?

5. How does the quality policy ensure that the needs and expectation of the customers are understood?

6. How is the quality policy appropriate to the purpose of the company?

7. Who is responsible for ensuring that your company quality policy and quality objectives are communicated to all levels of the organization?

8. How are your quality policy communicated and understood within the organization?

9. How do you ensure that the quality policy is understood at all level of the organization? Can you provide evidence that demonstrates this?

10. Is the quality policy being reviewed for continuing suitability and address in management review minutes?

11. Is the quality policy includes a commitment to continually improve the effectiveness of the quality management system by top management?

5.4 Planning5.4.1 5.4.1 Quality Objectives 5.4.2 Quality management system planning

1. Are suitable quality objectives being set to translate quality policy in to measurable goals?

2. Are the objectives deployed by functions, and by individuals so as to assure individuals contribution to the achievement of

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the objectives?3. Are resources allocated to implement the stated quality

objectives?4. Are quality objectives established at relevant function and

levels within the organization (cascading formula)?5. Are these quality objectives measurable and consistent with

the quality policy? Responsibility, authority and

communication5.5.1 Responsibility and authority

1. Does the management ensure that responsibility are documented and communicated to people in the organization?

2. Who in your company has the organizational freedom and authority to initiate action to prevent the occurrence of any nonconformity relating to product, process and quality system? Where is the defined and documented?

3. Who is in your company is authorized or responsible for verifying the implementation of solutions?Where is this defined and documented?

5.5.2 Management Representative

1. Is a management representative appointed to promote the quality management system implementation and to raise awareness of customer requirements within the organization?

2. Who is your management representative and where is this documented?

3. Is the management representative member of management?4. What evidence are in place to show the management

representative promote awareness of customer requirements within the organization?

5.5.3 Internal communication

1. Does the management communicate to all parties on the quality requirements, quality procedures to all employees of the company to ensure improvement and implementation of procedures?

2. Is there internal communication established and carried out for each individual level?

5.6 Management Review 1. Does top management review the effectiveness of the quality

management systems at least once year? Are records kept for the management review?

2. Does the review input and output conform to the standard requirements? How to ensure valid information is collected for management review?

3. Who is/are involve in its continued suitability and effectiveness in satisfying the requirements of ISO 9001 standard?

4. How is determination as to the effectiveness of the quality management system made?

5. How are the management reviews recorded?(documented)6. When was last management review? May I see it?

6 Resource management 1. How does the company allocate the resources in a timely manner

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6.1 Provision of resources to ensure customer satisfaction?

6.2 Human Resources 1. Does the company implement processes/procedures to ensure that the training needs for the employees are met?

2. What action is in place for improving the competency of personnel, and employee awareness programs?

3. Are there activities to ensure that the employees in the organization are capable and competent for the current and future needs of the organization?

4. Are there objective evidence on the effectiveness of training that are evaluated on specific training provided?

5. Does the HR process look at the competence of personnel from recruitment to deployment right up till the staff leave the organization (e.g., qualification or education of staff upon recruitment, training of staff for the right job,etc)?

6. Are the effectiveness of the training evaluated?

6.3 Infrastructure 1. Does the company provide adequate support for the product requirement?

2. Are building, wok place, and utilities provided?3. Is process equipment set up to meet the product requirement?4. Are supporting services such as transportation, training in

place to ensure conformance to products requirements?5. Are the infrastructure for example, building, workspace and

associated utilities, equipment and supporting services such as transport etc appropriate to achieve conformity to product requirements?

6. Are these infrastructure maintained?

6.4 Work environment 1. Does the management ensure that work environment promote motivation, satisfaction, development and performance of the people in the organization?

2. Is the work environment suitable so as to achieve conformity to product or service requirements?

7. Product realization7.1 Planning for product realization

1. Does the company determine the quality objectives related to the product requirements?

2. Does the company in planning product realization, determine the required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance?

3. Are the processes planned to achieve the product requirement?

4. Are monitoring and inspection activities in place?5. Are these activities recorded to provide evidence of

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implementation?6. The identification and preparation of records.

7.2 Customer related processes7.2.1 Determination of required related to the products7.2.2 Review of the requirements related to the product

1. How are customer related processes activities coordinated? Where is this defined (documented)?

2. Does the organization determine a) Requirement specified by the customerb) Requirement not stated by the customerc) Statutory and regulatory requirements related to the

product/service?d) Any other additional requirements?

3. What is your system for receiving incoming orders/contracts? Are personnel (pone operators, mail room personnel, fax room personnel, etc) instructed as to how to recognize orders and where to direct them?

4. Is there an established process to ensue that the product requirements are communicated and understood by the company?

5. Does the information collected include: requirements specified by customers for delivery and post delivery activities, requirements necessary for intended use of the product but not stated by the customer, statutory requirements of the product, and additional requirements of the organization on the product?

6. The review requirements shall be carried out prior to the supply of the product is there such a review to ensure that product requirements are defined?

7. Are contract/order requirements differing from previously expressed requirements are resolved?

8. Does the company have the capability to meet the order requirements?

9. Are the records on the review kept?10. How do you communicate contract requirements to necessary

functions (design, production, etc)? How are special contract requirements communicated to the necessary functions?

7.2.2 Review of requirements related to the product

1. When a product requirements are changes, is there a procedure to change the related document to inform people on the change of the product requirements?

2. When the customer provide no documentary evidence of the product requirements, the product requirements shall be confirmed by the organization before supplying the products. Are there any measures in this aspect?

7.2.3 Customer communication

1. Are there arrangements within the organization for communicating to the customers with respect to product information, enquires including amendments?

2. Is there a channel for customer feed back, including customer

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complaints?3. What controls are in place to ensure that amendments to

contracts re correctly transferred to functions concerned? Can you demonstrate that system to me using an example where this was necessary?

4. Is there arrangements to communicating with customers ona) Product information?b) Enquiries, contracts or order handling, including

amendments?c) Customer feedback, including customer complaints?

7.3 Design and Development7.3.1 Design and development planning

1. Are there any efforts or resources allocated for the design and development of the products?

2. Are the design activities controlled through planning on:a) The design and development stagesb) The review, verification and validation of the each of

the stagesc) The responsibilities for design and development of the

each of the stages?

7.3.2 Design and developments inputs

1. Are records provided to indicate that functional and performance requirement s are determined prior to the design?

2. Are the statutory/regulatory requirement consider/included in the product requirements?

3. Are the experiences from previous design work utilized?4. Are the design input reviewed to ensure that there is no

conflict, ambiguity among them?

7.3.3 Design and development outputs

1. Are the requirements for the design out put define to ensure that Out put meets the input requirements Provide adequate information for purchasing, production

and servicing Contain or reference product acceptance criteria Specify characteristic s that are essential for safe and

proper use of the product Specify characteristics that are essential for safe and

proper use of the products 7.3.4 Design and Development review7.3.5 Design and development verification7.3.6 Design and development verification

1. Are records and participants defined for the review of the design and development activities? These review shall:

Evaluate the ability of the results in meeting the product, and organization requirements

Identify problems and provide solutions to the problems

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7.3.7 Control of design and development changes

2. Records of verification that the design output meet in put requirement shall be kept. Are the design verification carried out?

3. Validation of the design shall be planned prior to the use of the products and records shall be kept. Are design validation activities carried out?

4. Design changes shall be verified and approved before implementation. Are there activities to ensure these?

5. Are the actions to evaluate the impact of the design changes recorded and is the review evidence on the design changes kept?

7.4 Purchasing7.4.1 Purchasing process

1. Is the company purchasing materials and the services basing on the requirements of the products?

2. Does the company review and approve its document/message sent to the suppliers?

3. Does the organization select and evaluate the suppliers in terms of their ability to supply material/ services to meet the product requirements?

4. Are suppliers evaluated and selected on the basis of their ability to meet organization requirements (including quality management system and any specific quality assurance requirements?)

5. Where is the type and extent of control exercised by the organization over the suppliers defined (documented)? Is this dependent upon the type of product and the impact of subcontracted product on the quality of the final product?

6. Are the evaluation/selection criteria applied to suppliers of critical and/ or custom product s different those applied to suppliers of standard catalog items (distributors)?

7. Are the evaluation /selection criteria applied to suppliers of product /raw materials different those applied to suppliers of services (e.g. calibration or testing services)?

8. Are calibration services subcontracted? What evaluation methods are applied to assure capability of the subcontractor to meet the requirements of clause 7.6?

9. Do you use a “Vendor Rating System” ? If so where is this system defined?

10. How does a suppliers become a disqualified? Where is this defined?

11. May I see qualification records for the auditor who visited the suppliers? (If applicable)

12. Are records maintained for each acceptable suppliers?13. Do you use an “Approved suppliers list”? Who supplies your

“Approved suppliers list” to you?How do you know this one is the most current revision? Who is responsible for its upkeep?

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14. If calibration services are subcontracted, how are the requirements of section 7.6 as a minimum, invoked? (Is the quality management system standard to be applied specifically stated?)

7.4.2 Purchasing information

1. Does the company provide purchasing document s that describe the product to be purchased and include information on : Requirements of approval Requirements of qualification for personnel Quality management systems requirements?

2. Who reviews and approved the purchase order? How can one identify the individual who approved this one?

3. Are review parameters defined? (Are verification requirements specified)

4. When complex requirement exist, are other departments included in the review and approval process?

5. Do you issue documents (e.g. product specifications, drawings, and workmanship standards) to subcontractors? If so how are these documents controlled?

6. Are substitutions allowed from your suppliers? Who approves and authorizes substitutions?

7. If substitutions are allowed, what instructions are given to your suppliers regarding whom to contact for approval or authorization? How are they given?

7.4.3 Verification of purchased products

1. Does the company have processes and activities to verify or inspect materials to ensure that the purchased products meet specified requirements?

2. Does the customer intend to verify the materials at suppliers premises, has this information been include in the purchasing documents sent to the supplier

3. Where applicable, how do you ensure that where you verify purchased product at a suppliers premises, the verification arrangements, and the method of product release are specified in the purchasing documents?

4. When specified in a contract, how do you communicate to your supplier that your customer or the customers representative is afford the right to verify at the suppliers premises that subcontracted product conforms too specified requirements? Where is this procedure defined?

5. How do you ensure that, when specified in a contract, your customer or customers representative is afford the right to verify at your premises that subcontracted product conforms to specified requirements? Where is this procedure defined?

Production and service 1. Does the company plan its provision of products and services

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provision7.5.1 Control of production and service provision

to include? Availability of information on product requirements Availability of work instructions Implementation of monitoring and measurements Implementation of release, delivery and post delivery activities

7.5.2 validation of processes for production an

1. Does the company validate the products prior to delivery to ensure that the processes that cannot be validated after the processes have been carried out?

2. The validation of the special process shall include: Defined criteria for the validation and approval of the

processes Approval of equipment and qualification of processes Use of specific method Requirements of records Revalidation

7.5.3 Identification and Traceability

1. How is this product or service identified? Where is this defined (documented)?

2. Does the company identify the product status throughout its production processes?

3. How is product identification and traceability maintained from receipt and during all stages of process?

4. Where and, to the extent that traceability is a specified requirement; how is the need for traceability communicated to respective process function? Can you show me examples of how this works? How and where is traceability recorded? May I see an example of this?

5. Are the monitoring/ measurement status, such as rejects, accepts waived identified?

6. Are there any specific requirements for traceability of the products?

7.5.4 Customer property 1. Is there any usage of customer property such as documents manual equipments

2. Are these customer property handled in appropriate manner?3. Is customer property examined upon receipt to check for,

correct quantity? Correct identity? Any transit damage?4. How are discrepancy reported to the customer?5. How is customer property identified to differentiate it from

other product? Where is this defined (documented)?6. How is customer property stored? How are special storage

and maintenance requirements communicated form the customer to those responsible for its storage and maintenance

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7. Who is responsible for the storage and maintenance of customer property? Where is this authority defined?

8. Is customer property periodically inspected to detect signs to deterioration? verify that proper storage conditions are being maintained? Identify the product that has exceeded its storage time limitations (expiration date)?

9. If customer property is lost, damaged or otherwise unsuitable for use, how is each instance recorded and reported to the customer? Where is this documented?

10. Who is responsible for reporting customer property that is lost, damaged, otherwise unsuitable for use to the customer?

7.5.5 Preservation of the product

1. Are there handling, packaging, storage and protection and protection of the final product /services prior to customer usage?

2. What methods have young adopted/developed for handling products/services that prevent damage or deterioration? Where is this defined(documented)

3. What criteria used in assessing the condition of product in sock in order to detect deterioration?Do any records substantiate that this has occurred?

4. How are packing, packaging, and marking processes (including material used) controlled to the extent necessary to ensure conformance to specified requirements? What evidence support that this control is in place and effective?

5. How are packing, packaging, and marking processes (including material used) controlled to the extent necessary to ensure conformance to specified requirements? What evidence supports that this control is in place and effective.

6. How do you arranger for the protection of the quality of product/service after final inspection and test where continually specified, does this protection extend to include delivery to destination (e.g use of approved suppliers)? How can this be verified?

7.6 Control of monitoring and measuring devices

1. Does the company determine and provide necessary monitoring and measuring devices to provide evidence of conformity of the products to requirements?

2. Who is responsible for determining the measurements to be made and the accuracy required? How is this determined? Where is this documented?

3. Who is responsible for selecting the appropriate inspection, measuring, and test equipment and ensuring

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that it is capable of the necessary accuracy and precision? Where is this documented?

4. Who is responsible for identifying all inspection, measuring, and test equipment that can affect product quality? Does this include employee –owned equipment? Who ensure that this equipment is calibrated and adjusted at prescribed intervals, or prior to use?

5. How is inspection, measuring and test equipment that has exceeded its calibration due date identified and handled?

6. Does your calibration system define the process employed for the calibration of inspection, measuring, and test equipment, including details of

Equipment type Unique identification Location Frequency of checks (Calibration interval) Check method (calibration procedure) Acceptance criteria Action to be taken when results are unsatisfactory Where is this defined?(Documented)

7. Are these devices: Calibrated or verified at defined intervals against national

and international standards. Where no such standards exist, is the basis used for calibration documented? How can this he verified?

Adjusted and re-adjusted as necessary Safeguarded from unwanted adjustments Protected from damage and deterioration during handling,

maintenance and storage? Show the calibration status

8. How do you safeguard inspection, measuring and test facilities, including both test hardware and both test software, from adjustments that would invalidate the calibration setting? (Do you require the use of tamper resistant seals? Do you “Write protect” or “Password-encrypt” test software?)

9. How do you ensure that the environmental conditions are suitable for the calibration, inspections, measurements, and test being carried out? Is there any documented evidence to support this?

10. Does the company validate past test results if there is a failure of the measuring /monitoring devices?

11. What calibration records does your calibration system require you to maintain?

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8.Measurement, analysis and improvement8.1 General

1. Does the company use appropriate methods to demonstrate conformity of the products, conformity of the quality management systems to requirements and continually improve of the effectiveness of the quality management system?

2. What are these methods?8.2 Monitoring and measurements8.2.1 Customer satisfaction

1. Does the company monitor information relating to customer perceptions as to whether the company has met customer requirements?

2. The methods for obtaining such information shall be defined?

8.2.2 Internal Audit 1. Who is responsible for maintaining and managing your

internal audit program?2. Does the company conduct internal audit at planned

interval on the conformance of the quality systems?3. How are internal Audit scheduled? (On the basis of status

and importance of the activity?)4. What criteria do you use for determining the effectiveness

of the quality management system?5. Have training and qualification requirements for auditors

been defined and documented? Are records available that detail the training and qualification of each internal auditor?

6. Is a formal schedule for internal quality audits prepared and authorized? May I see it? How can I verify that this scheduled is being followed?

7. How are the results of internal audits recorded? How can I verify that all of the applicable requirements of the ISO 9001:2000 have been audited?

8. Are auditors selected and trained so that they do not audit their own work?

9. Is the procedure for internal audit documented? Does the procedure include the necessity of corrective actions after the audit?

10. How do you ensure that management personnel responsible for the are audited take timely corrective action on deficiencies found during the audit? How do you define the word “timely”?

11. When do you conduct follow up audit activities that verify and record the implementation and effectiveness of the corrective action taken? How is this documented?

12. Does the company keep records of audit and follow up verification of the corrective actions?

13. How are the results of the audits input to management

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review activities?

8.2.3 Monitoring and measurement of the processes

1. Are the planned results for each of the processes defined?2. Are there methods to track and monitor these planned

results areas?3. Does the activities include the follow up and corrective

actions needed when the planned results are not achieved?

8.2.4 Monitoring and measurement of the product

1. Does the company define the measurements of product characteristics at various stages of the production process or service provision process?

2. Are evidence /records of conformance kept?3. Do such records indicate the authority for release of

products?4. Are there measures to ensure that only products

conforming too all the requirements are dispatched to the customers?

8.3 Control of nonconforming product

1. Are the procedures to ensure that the nonconforming products are controlled to prevent inadvertent uses?

2. Is there a procedure documented to define authority and responsibility for the disposition of nonconforming products?

3. How do you ensure that product which does not conform to specified requirements is prevented-from unintended use or installation?

4. How do you provide for identification, documentation, evaluation, segregation (when practical), disposition of nonconforming product, and for notification to the functions concerned?

5. Who is authorized and responsible for review and the disposition of nonconforming products? where is this defined (documented)

6. Are the records for the disposition for the nonconforming products kept including the concession (waiver) of the products?

7. Does the procedure specify clearly that corrected nonconforming products shall be re verified for conformance?

8. Are the repair or rework instructions accessible and utilized by the appropriate personnel?

9. When required by contract, how do you report the proposed use or repair of product that does not conform to specified requirements for concession to the customer or customer’s representative?

10. How do you ensure that customer authorization is received

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prior to shipping nonconforming material?11. How is the description of nonconformity that has been

accepted, and any repairs, record to denote the actual condition?

8.4 Analysis of Data 1. Does the company collect and analyse data to monitor and improve quality management system?The data analyzed shall include: Customer satisfaction Conformance of product requirements Trend of product characteristics including opportunities

for preventive actions Suppliers?

8.5 Improvement8.5.1 Continual improvement

1. Are processes established to continually improve on quality management systems such as the analysis of data implementation of corrective and preventive actions?

1. Does the organization have a documented procedure on corrective actions on customer complaint and product nonconformity?

2. Does the procedure address: Reviewing nonconformity Determining the causes Evaluating the needs for actions Determining the actions needed and implement the

actions Records of the results Reviewing of the corrective actions taken?

3. How do you ensure the effective handling of customer complaints and reports of product nonconformities?

4. Who is responsible for investigation of the cause of nonconformities relating to product, process, and quality system, and recording the results of the investigation? Where is this documented?

5. Who is responsible for determination of the corrective action needed to eliminate the cause of nonconformities? Where is this defined?

6. Who is responsible for the application of controls to ensure that corrective action is taken and that it is effective? How is this demonstrated?

8.5.3 Preventive action 1. What have you defined as “appropriate” sources of information (such as processes and work operations that affect product quality, concessions, audit results, quality

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records, service reports, and customer complaints) to detect, analyze and eliminate potentional causes of nonconformities?

2. Who is responsible for determination of the steps needed to deal with any problems requiring preventive action? How is this determination made?

3. Who is responsible for initiation of preventive action and application of controls to ensure that it is effective?

4. How is the “effectiveness” of preventive action determined or measured?

5. How is relevant information on actions taken submitted for management review? What form does this take? How can I verify this?

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Documents

Audit Check list for ISO 9001.doc