5.1

Management commitment

5.1.1

Is there evidence of commitment by top management towards development and improvement of the Quality Management System through the following:

a)    does sufficient awareness to regulatory and legal requirements exist as applicable to organization scope of product offered?

b)    does top management initiate action / measures to communicate to the organization the importance of meeting customer requirement?

c)    does top management review resource requirements or have in place measures to collect data on the same and provide timely resources to achieve quality objectives?

d)    does the top management actions provide evidence of commitment to the 8 principles of quality management?

e)    Does the top management conduct Management Review of their Quality Management System?

5.2

Customer focus

5.2.1

Does the top management have methodologies to ensure that:

Customer needs and expectations are determined through their Quality Management System, and these are converted into requirements and fulfilled with the aim of achieving customer satisfaction.

5.2.2

Are obligations related to product, including legal and regulatory requirements identified and measures established to fulfill the same?

5.3

Quality policy

5.3.1

Has the top management:

a)    established a Quality Policy?

b)    is the Quality Policy signed by top management?

c)    is the Quality Policy appropriate to the purpose of the organization?

d)    does the Quality Policy include a statement of commitment to meeting requirements, customer satisfaction and to continual improvement?

e)    is the Quality Policy communicated and understood at appropriate levels in the organization through adequate measures?

f)     are mechanism for review of Quality Policy for its suitability established by the top management?

g)    is the Quality Policy controlled? (5.5.6)

5.4

Planning

5.4.1

Quality objectives

5.4.1.1

Are quality objectives established by top management at relevant functions and levels within the organization?

5.4.1.2

Are the objectives measurable to ensure efficiency and effectiveness of the organization?

5.4.1.3

Are the objectives consistent with the Quality Policy including commitment to continual improvement?

5.4.1.4

Does the objectives include relevant objective to meet requirements of product?

5.4.2

Quality planning

5.4.2.1

Are the output of quality planning documented?

5.4.2.2

Does quality planning include:

i)     the processes of Quality Management System,  considering permissible exclusions (Sec 1.2 of ISO 9001 – 2000);

ii)     assessment of resource needed;

iii)    continual improvement of the Quality Management System.

5.4.2.3

Are changes to quality planning effected in a controlled manner?

5.4.2.4

Is the integrity of Quality Management System maintained during the change process, when changes are initiated?

5.5

Administration

5.5.1

General

5.5.2

Responsibility and authority

5.5.2.1

Has the organization identified function and interrelations to facilitate effective quality management?

5.5.2.2

Has the organization define composition of top management?

5.5.2.3

Has an organization chart been prepared to identify various interrelationships?

5.5.2.4

Have responsibilities and authorities been defined and communicated to those involved in the effective operation of the Quality Management System?

5.5.3

Management representative

5.5.3.1

Are member(s) of the management appointed as a “Management Representative” by the top management?

5.5.3.2

Does the Management Representative have responsibility and authority that includes:

a)    ensuring that the processes of the Quality Management System are established and maintained.

b)    reporting to management on the performance of the Quality Management System, including needs for improvement.

c)    promoting awareness of customer requirements throughout the organization.

5.5.4

Internal communication

5.5.4.1

Does organization ensure communication at various levels and functions regarding the processes of Quality Management System and their effectiveness?

5.5.5

Quality manual

5.5.5.1

Has a Quality Manual been established and maintained?

5.5.5.2

Does the Quality Manual include:

a)    scope of Quality Management System;

b)    details of exclusion to Section 7.0 with justification;

c)    documented procedures or reference to them;

d)    description of the sequence and interaction of the processes included in the Quality Management System relevant to the organization activities, its size, complexity of operations and competency of personnel.

5.5.5.3

Is the Quality Manual controlled? (5.5.6)

5.5.6

Control of documents

5.5.6.1

Has a documented procedure been established to control all documents (including documents defined as Quality Records) required for the Quality Management System?

5.5.6.2

Does the procedure include controls for:

a)    approval of documents for adequacy prior to issue;

b)    review, update, as necessary and re-approve documents;

c)    to identify the current revision status of documents;

d)    to ensure that relevant versions of applicable documents are available at points of use;

e)    to ensure that documents remain legible, readily identifiable and retrievable;

f)     to ensure that documents of external origin are identified and their distribution controlled;

g)    to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

5.5.7

Control of quality records

5.5.7.1

Has a documented procedure been established for the identification, storage, retrieval, protection, retention time and disposition of quality records?

5.5.7.2

Are quality records subjected to control?

5.5.7.3

Has the organization identified quality records to the extent required to provide evidence of conformance to requirements and of effective operation of the Quality Management System?

5.5.7.4

Check control of records for the following:

Ÿ     Results of management review (5.6);

Ÿ     Records of education, experience, training and qualification (6.2.2);

Ÿ     Results of review of product requirements and subsequent follow-up actions (7.2.2);

Ÿ     Results of design and / or development review and subsequent follow-up actions (7.3.4);

Ÿ     Results of design and / or development verification and subsequent follow-up actions (7.3.5);

Ÿ     Results of design and / or development validation and subsequent follow-up actions (7.3.6);

Ÿ     Results of design and / or development changes and subsequent follow-up actions (7.3.7);

Ÿ     Results of supplier evaluations and follow-up actions (7.4.1);

Ÿ     Unique identification of the product, when traceability is requirement (7.5.2).

Ÿ     Results of calibration for measurement and monitoring devices (7.6).

Ÿ     Authority responsible for release of the product (8.2.4).

5.5.7.5

Are there recorded evidences of compliance for the following, as applicable:

Ÿ     Customer property that is lost, damaged or otherwise unsuitable for use reported to the customer;

Ÿ     Process validation records;

Ÿ     Basis of calibration in the absence of traceable national or international standards;

Ÿ     Results of corrective action taken;

Ÿ     Results of preventive action taken.

5.6

Management review

5.6.1

Does the top management review the Quality Management System to ensure its continuing suitability, adequacy and effectiveness?

Are the review intervals planned?

5.6.2

Review input

5.6.2.1

Does review input include current performance and improvement opportunities related to:

a)    results of audits;

b)    customer feedback;

c)    process performance and product conformance;

d)    status of corrective and preventive actions;

e)    follow-up action from earlier management reviews;

f)     changes that could affect Quality Management System

5.6.3

Review output

Does output from management review include actions related to:

a)    improvement of the Quality Management System and its processes;

b)    improvement of product related to customer requirements;

c)    resource needs.

5.6.4

Are results of management review recorded (5.5.7)

Summary:               Ÿ    Acceptable

                              Ÿ    Nonconformity Observed

Auditor Signature:__________________

*Evaluation Status:  Indicate “Yes” for compliance         “No” for non-compliance

6.1

Provision of resources

6.1.1

Does the organization implement methods to determine and provide resources needed to?

a)    implement and improve the processes of the Quality Management System and

b)    address customer satisfaction.

6.1.2

Are the resources allocated on time?

6.2

Human resources

6.2.1

Assignment of personnel

6.2.1.1

Are personnel with assigned responsibilities defined in the Quality Management System competent on the basis of:

Ÿ     applicable education;

Ÿ     training;

Ÿ     skills;

Ÿ     experience.

6.2.2

Training, awareness and competency

6.2.2.1

Are competency needs for personnel performing activities affecting quality identified?

6.2.2.2

Are training provided to satisfy the competency needs?

6.2.2.3

Are the effectiveness of the training evaluated and follow-up action initiated?

6.2.2.4

Does the organization ensure that its employees are aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives?

6.2.2.5

Are records of education, experience, training and qualifications maintained? (5.5.7)

6.3

Facilities

6.3.1

Have the facilities needed to achieve the conformity of product been identified and provided including:

a)    work space and associated facilities;

b)    equipment, hardware and software;

c)    supporting services.

6.3.2

Are such facilities maintained to achieve conformity of product?

6.4

Work environment

6.4.1

Have the type of work environment suitable for process operations defined?

6.4.2

Are human and physical factors of the work environment needed to achieve conformity of product identified and managed by the organization?

Summary:               Ÿ    Acceptable

                              Ÿ    Nonconformity Observed

Auditor Signature:__________________

*Evaluation Status:  Indicate “Yes” for compliance         “No” for non-compliance

7.1

Planning of realization processes

7.1.1

Has the organization determined the following, as appropriate, in planning the processes for realization of product:

Ÿ     quality objectives for the product, project or contract;

Ÿ     the need to establish processes and documentation and provide resources and facilities specific to the product;

Ÿ     verification and validation activities and the criteria for acceptability;

Ÿ     the records that are necessary to provide confidence of conformity of the processes and resulting product.

7.1.2

Is the planning of the realization processes consistent with other requirements of the organization’s Quality Management System and documented in a form suitable for the organization’s method of operation?

7.1.3

Are there any exclusion adopted by the organization on the requirements in section 7.0 of ISO 9001 – 2000 and are such exclusions defined in the Quality Manual (5.5.5) with justification?

7.2

Customer related processes

7.2.1

Identification of customer requirements

7.2.1.1

Are processes established by the organization to determine customer requirements including:

Ÿ     product requirements specified by the customer, including requirements for availability, delivery and support;

Ÿ     product requirements not specified by the customer but necessary for intended or specified use.

Ÿ     obligations related to product, including regulatory and legal requirements.

7.2.2

Review of product requirements

7.2.2.1

Does the organization review customer requirements and other requirements determined by the organization prior to commitment to supply a product?

7.2.2.2

Are stages of review (submission of a tender, acceptance of contract or order) established?

7.2.2.3

Does the review process ensure that:

Ÿ     product requirements are defined;

Ÿ     where the customer provides no documented statement of requirement, the customer requirements are confirmed before acceptance;

Ÿ     contract or order requirements differing from those previously expressed are resolved;

Ÿ     the organization has the ability to meet defined requirements.

7.2.2.4

Does the review processes ensure that product change requirements are made aware to relevant personnel in the organization?

7.2.2.5

Are amendments made to relevant documentation?

7.2.2.6

Are the results of review and subsequent follow-up actions recorded? (5.5.7)

7.2.3

Customer communication

7.2.3.1

Are arrangements for communication identified and implemented by the organization relating to:

Ÿ     product information;

Ÿ     enquiries, contract or order handling, including amendments;

Ÿ     customer feedback, including customer complaints.

7.3

Design and / or development

7.3.1

Design and / or development planning

7.3.1.1

Does the organization plan and control design and / or development of the product?

7.3.1.2

Does the design and / or development planning determine:

Ÿ     stages of design and / or development processes;

Ÿ     review, verification and validation activities appropriate to each design and / or development stage;

Ÿ     responsibilities and authorities for design and / or development activities.

7.3.1.3

Does the organization manage interfaces between different groups involved in design and / or development to ensure effective communication and clarity of responsibilities?

7.3.1.4

Are the design and / or development planning output updated, as appropriate, as the design and / or development progresses?

7.3.2

Design and / or development inputs

7.3.2.1

Are inputs relating to product requirements defined, documented and reviewed for adequacy?

7.3.2.2

Does the design and / or development input include:

Ÿ     functional and performance requirements;

Ÿ     applicable regulatory and legal requirements;

Ÿ     applicable information derived from previous similar design and / or development;

Ÿ     any other requirements essential for design.

7.3.2.3

Are all incomplete, ambiguous or conflicting requirements identified during review and resolved?

7.3.3

Design and / or development outputs

7.3.3.1

Does the organization document design output in a manner that enables verification against the design and / or development inputs?

7.3.3.2

Does the design and / or development output:

Ÿ     meet the design input requirements;

Ÿ     provide appropriate information for production and service operations;

Ÿ     contain or reference product acceptance criteria;

Ÿ     define the characteristics of the product that are essential to its safe and proper use.

7.3.3.3

Are all design and / or development output approved prior to release?

7.3.4

Design and / or development review

7.3.4.1

Does the organization identify suitable stages for systematic reviews of design and / or development to:

a)    evaluate the ability to fulfill requirements;

b)    identify problems and propose follow-up actions.

7.3.4.2

Does the participants in such reviews include representatives of function concerned with the design and / or development stage(s) being reviewed?

7.3.4.3

Are the results of review and subsequent follow-up actions recorded? (5.5.7)

7.3.5

Design and / or development verification

7.3.5.1

Are design and / or development verification performed to ensure the output meets the design and / or development inputs?

7.3.5.2

Are the results of verification and subsequent follow-up actions recorded? (5.5.7)

7.3.6

Design and / or development validation

7.3.6.1

Is the design and / or development validation performed to confirm that resulting product is capable of meeting the requirements of intended use?

7.3.6.2

Where it is impractical to perform full validation prior to delivery or implementation, does the organization perform partial validation to the extent applicable?

7.3.6.3

Are results of validation and subsequent follow-up actions recorded? (5.5.7)

7.3.7

Control of design and / or development changes

7.3.7.1

Are processes established to identify, document and control design changes?

7.3.7.2

Are the effect of changes evaluated on constituent parts and delivered products?

7.3.7.3

Are all design and / or development changes verified and validated, as appropriate and approved before implementation?

7.3.7.4

Are the results of review of changes and subsequent follow-up actions documented? (5.5.7)

7.4

Purchasing

7.4.1

Purchasing control

7.4.1.1

Does the organization control its purchasing processes to ensure purchased product conforms to requirements?

7.4.1.2

Does the type and extent of control exercised by the organization depend upon the effect on subsequent realization processes and their output?

7.4.1.3

Does the organization evaluate and select suppliers based on their ability to supply product in accordance with the organization requirements?

7.4.1.4

Are criteria for selection and periodic evaluation of suppliers defined?

7.4.1.5

Are the results of evaluation and subsequent follow-up actions recorded? (5.5.7)

7.4.2

Purchasing control

7.4.2.1

Has the organization defined as to what constitutes a purchasing document?

7.4.2.2

Does purchasing documents contain information describing the product to be purchased, including where appropriate:

a)    requirements for approval or qualification of :

       Ÿ Product                  Ÿ Processes        Ÿ Procedures

       Ÿ Equipment and       Ÿ Personnel

b)    quality Management System requirements

7.4.2.3

Do the purchase processes of the organization ensure the adequacy of specified requirements in the purchasing documents prior to their release?

7.4.3

Verification of purchased product

7.4.3.1

Has the organization identified and implemented the activities necessary for verification of purchased product

7.4.3.2

Does the organization specify the intended verification arrangements (by organization / customer) and method of product release, as part of the purchasing information?

7.5

Production and service operation

7.5.1

Operations control

7.5.1.1

Does the organization control production and service operation through:

a)    the availability of information that specifies the characteristics of the product;

b)    where necessary, the availability of work instructions;

c)    the use and maintenance of suitable equipment for production and service operations;

d)    the availability and use of measuring and monitoring devices;

e)    the implementation of monitoring activities;

f)     the implementation of defined processes for release, delivery and applicable post-delivery activities.

7.5.2

Identification and treaceability

7.5.2.1

Does the organization identify, where appropriate, the product by suitable means throughout production and service operations?

7.5.2.2

Are the status of the product with respect to measurement and monitoring identified?

7.5.2.3

Does the organization control and record the unique identification of the product, where traceability is a requirement? (5.5.7)

7.5.3

Customer property

7.5.3.1

Are processes established to exercise care with customer property while it is under the organization’s control or being used by the organization?

7.5.3.2

Does the processes address following issues related to customer property:

Ÿ Verification              Ÿ Protection           Ÿ Maintenance

7.5.3.3

Does the process ensure that occurrence of any customer property that is lost, damaged or otherwise found to be unsuitable for use are recorded and reported to the customer?

7.5.4

Preservation of product

7.5.4.1

Are methods and controls established by the organization to preserve conformity of product with customer requirements during internal processing and delivery to intended destination?

7.5.4.2

Does the methods and controls include:

Ÿ Identification            Ÿ Handling             Ÿ Packaging

Ÿ Storage                   Ÿ Protection

7.5.4.3

Are the controls extended to constituent parts of a product?

7.5.5

Validation of processes

7.5.5.1

Has the organization identified production and service processes which requires to be validated?

Note:    Processes require validation when resulting output cannot be verified by subsequent measurement or monitoring.  This includes any process where deficiencies may become apparent only after the product is in use or the service has been delivered.

7.5.5.2

Are the processes validated to demonstrate their ability to achieve planned results?

7.5.5.3

Are the validation arrangements defined and include the following, as applicable:

a)    qualification of processes;

b)    qualification of equipment and personnel;

c)    use of defined methodologies and procedures;

d)    requirements for records;

e)    re-validation.

7.6

Control of measuring and monitoring devices

7.6.1

Has the organization identified the measurements to be made and the measuring and monitoring devices required to assure conformity of product to specified requirement?

7.6.2

Are the measuring and monitoring devices used and controlled to ensure that measurement capability is consistent with the measurement requirements?

7.6.3

Where applicable, are the measuring and monitoring devices:

a)    calibrated and adjusted periodically or prior to use, against devices traceable to international or national standards; where no such standards exit, the basis used for calibration shall be recorded;

b)    safeguarded from adjustments that would invalidate the calibration;

c)    protected from damage and deterioration during handling, maintenance and storage;

d)    have the results of their calibration recorded (5.5.7);

e)    have the validity of previous results re-assessed , if they are subsequently found to be out of calibration, and corrective action taken.

7.6.4

Are softwares used for measuring and monitoring of specified requirement validated prior to use?

Summary:               Ÿ    Acceptable

                              Ÿ    Nonconformity Observed

Auditor Signature:__________________

*Evaluation Status:  Indicate “Yes” for compliance         “No” for non-compliance

8.1

Planning

8.1.1

Has the organization established plans to implement the measurement and monitoring activities needed to assure conformity and achieve improvement?

8.1.2

Has the organization defined the processes for measurement and monitoring activities including determination of the need for, and use of, applicable methodologies including statistical techniques?

8.2

Measurement and monitoring

8.2.1

Customer satisfaction

8.2.1.1

Has the organization determined the methodologies for obtaining the information on customer satisfaction and / or dissatisfaction?

8.2.1.2

Are the informations monitored as one of the measurements of performance of the Quality Management System?

8.2.2

Internal audit

8.2.2.1

Have a documented procedure been established that include:

Ÿ     responsibilities;

Ÿ     requirements for conducting the audit;

Ÿ     ensuring audit independence;

Ÿ     recording results of the audit;

Ÿ     reporting to the management.

8.2.2.2

Are audits planned in the form of a audit programme taking into consideration:

Ÿ     status and importance of the activities and areas to be audited;

Ÿ     results of previous audits.

8.2.2.3

Is the frequency of audit defined?

8.2.2.4

Are the plans reviewed at periodic intervals?

8.2.2.5

Does the internal audit process have the following objectives to determine whether Quality Management System:

Ÿ     Conform to the requirements of this international standard;

Ÿ     Has been effectively implemented and maintained.

8.2.2.6

Does the management take timely corrective action on deficiencies found during the audit?

8.2.2.7

Are follow-up actions part of the audit process and include:

Ÿ     verification of the implementation of corrective action;

Ÿ     reporting of verification results.

8.2.3

Measurement and monitoring of processes

8.2.3.1

Are suitable methods established for measurement and monitoring of those realization processes necessary to meet customer requirements?

8.2.3.2

Do the methods confirm the continuing ability of each process to satisfy intended purpose?

8.2.4

Measurement and monitoring of product

8.2.4.1

Has the organization established appropriate stages to measure and monitor product characteristics?

8.2.4.2

Are there evidences to confirm that product characteristics meet the requirements for the product?

8.2.4.3

Are the evidence of conformity with the acceptance criteria documented?

8.2.4.4

Do the measurement and monitoring records indicate the authority responsible for release of the product? (5.5.7)

8.2.4.5

Are product / service delivery effected after all the specified activities have been satisfactorily completed, unless otherwise approved by the customer.

8.3

Control of non-conformity

8.3.1

Have a documented procedure been established to define the processes involved in control of nonconformity?

8.3.2

Does the processes ensure that product that does not conform to requirements is identified and controlled to prevent unintended use or delivery?

8.3.3

Are nonconforming product corrected and subject to re-verification after correction to demonstrate conformity?

8.3.4

Does the processes ensure that appropriate action regarding the consequences of non-conformity is initiated, when non-conforming product is detected after delivery or use has started by interested parties?

8.3.5

When required, does the organization report for concession to the customer, the end user, regulatory body or other body regarding the proposed rectification of non-conforming product?

8.4

Analysis of data

8.4.1

Does the organization employ measures to collect and analyze appropriate data to determine the suitability and effectiveness of the Quality Management System and to identify improvements that can be made?

8.4.2

Does the data include those generated by measuring and monitoring activities and other relevant sources?

8.4.3

Does the data used for analysis provide information on:

Ÿ     customer satisfaction and / or dissatisfaction;

Ÿ     conformance to customer requirements;

Ÿ     characteristics of process, product and their trends;

Ÿ     suppliers.

8.5

Improvement

8.5.1

Planning for continual improvement

8.5.1.1

Does the organization plan and manage processes necessary for the continual improvement of the Quality Management System.

8.5.1.2

Does the organization use the following information to facilitate continual improvement of the Quality Management System:

Ÿ Quality Policy                                     Ÿ Quality Objectives

Ÿ Audit Results                                      Ÿ Analysis of Data

Ÿ Corrective and Preventive Action        Ÿ Management Review

8.5.1.3

Are there objective evidences of continual improvement with involvement of top management?

8.5.2

Corrective action

8.5.2.1

Has the organization established a documented procedure for corrective action with defined requirements for:

a)    identifying non-conformities (including customer complaints);

b)    determining the causes of non-conformity;

c)    evaluating the need for actions to ensure that non-conformities do not recur;

d)    determining and implementing the corrective action needed;

e)    recording results of action taken;

f)     reviewing of corrective action taken.

8.5.2.2

Are corrective actions taken to eliminate causes of non-conformities appropriate to the impact of the problems encountered?

8.5.3

Preventive action

8.5.3.1

Has the organization established a documented procedure for preventive action with defined requirements for:

a)    identifying potential non-conformities and their causes;

b)    determining and ensuring the implementation of preventive action needed;

c)    recording results of action taken;

d)    reviewing of preventive action taken.

8.5.3.2

Are preventive action taken to eliminate causes of potential non-conformities appropriate to the impact of the potential problem?

Summary:               Ÿ    Acceptable

                              Ÿ    Nonconformity Observed

Auditor Signature:__________________

*Evaluation Status:  Indicate “Yes” for compliance         “No” for non-compliance