Clause
/

Requirements – IS/ISO 9001:2000

Process/Function

A B C

D E

/ CHECKLIST FOR QMS

Findings

C - Conformity N - Non-conformity

X - Not applicable XX – Not assessed

A / B / C / D / E / Comments/Remarks
4
4.1 /
Quality Management System
General Requirements
- Establish, document, implement & maintain QMS
-Identification, sequence and interaction of processes
-Criteria and methods for effective operation and control
-Availability of resources and information
-Monitoring, measurement and analysis of processes
-Implementation and continual improvement of processes
-Identification and control over outsourced process(es)
4.2
4.2.1 /
Documentation Requirements
General
-Documented statements of quality policy and objectives
-A quality manual
-Documented procedures required by the standard
-Documents needed by organization
-Records required by the standard
4.2.2 / Quality Manual
-Establish and maintain quality manual
-Includes scope of QMS and justification for exclusion
-Documented procedures or reference to them
-Description of interaction between processes of QMS
4.2.3 / Control of Documents
Documented procedure established to define the controls
-To approve documents prior to issue
-For review, update and re-approve documents
-For identification of changes and current revision status
-Relevant versions of applicable documents at points of use
-Legible and readily identifiable
-Identification and controlled distribution of documents of external origin
-Identification & prevention of use of obsolete documents
4.2.4 / Control of Records
-Documented procedure for identification, storage, protection, retrieval, retention time and disposition of records
-Legibility, identification and retrievability
5
5.1 /
Management Responsibility
Management Commitment to the development, implementation and continual improvement of effectiveness of QMS by
-Communication of importance of meeting customer, statutory and regulatory requirements
-Establishing the quality policy and objectives
-Conducting management reviews
Ensuring availability of resources
5.2 /
Customer Focus
Top Management shall ensure
-Customer requirements are determined and are met with to enhance customer satisfaction
Auditee (Organization)
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Doc: MSC-F6.4-22(QMS) Issue: 01 Date : JUL 2007
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Clause
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Requirements – IS/ISO 9001:2000

Process/Function

A B C

D E

/ CHECKLIST FOR QMS

Findings

C - Conformity N - Non-conformity

X - Not applicable XX – Not assessed

A / B / C / D / E / Comments/Remarks
5.3 /
Quality Policy
-Appropriate to the purpose of the organization
-Includes commitment to comply with requirements and continually improve the effectiveness of QMS
-Provides framework for establishing and reviewing quality objectives
-Communicated and understood within the organization
-Reviewed for continuing suitability
5.4
5.4.1 /
Planning
Quality Objectives
-Established at relevant functions and levels
-Measurable and consistent with the quality policy
5.4.2 / Quality Management System Planning
Top Management shall ensure that
-Planning of QMS is carried out to meet requirements of 4.1 and quality objectives
-Integrity of QMS is maintained when changes in QMS
5.5
5.5.1 /
Responsibility, authority and communication
Responsibility and authority
-Defined and communicated within the organization
5.5.2 / Management Representative – a member of management appointed by top management
-Responsibility and authority for ensuring establishment, implementation and maintenance of QMS
-Reports to top management on performance of QMS and its improvement
-Ensures promotion of awareness of customer requirements
5.5.3 / Internal Communication
-Communication channels are established within the organization
-Communication takes place regarding the effectiveness of QMS
5.6
5.6.1 /
Management Review
General
-Review of QMS at planned intervals
-Review includes opportunities for improvement & need for changes to QMS, including quality policy & objectives
-Records from management reviews maintained
5.6.2 / Review Input - Results of audits, customer feedback, process performance and product conformity, status of corrective and preventive actions, follow-up actions from previous management reviews, changes affecting QMS and recommendations for improvement
5.6.3 / Review Output - improvement of effectiveness of QMS, its processes; improvement of product related to customer requirements and resource needs
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Clause
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Requirements – IS/ISO 9001:2000

Process/Function

A B C

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/ CHECKLIST FOR QMS

Findings

C - Conformity N - Non-conformity

X - Not applicable XX – Not assessed

A / B / C / D / E / Comments/Remarks
6
6.1 /
Resource Management
Provision of Resources - Determine and provide resources
-to implement, maintain & continually improve QMS
-to enhance customer satisfaction
6.2
6.2.1
6.2.2 /
Human Resources
General
Competence, awareness and training
-Determine necessary competence for personnel
-Provide training or take other relevant actions
-Evaluate the effectiveness of the action taken
-Awareness about relevance and importance of activities
-Contribution to achievement of quality objectives
-Records of education, training, skills and experience
6.3 /
Infrastructure - Determine, provide & maintain the infrastructure
-Buildings, workspace and associated utilities
-Process equipment (hardware and software)
-Supporting services (transport, communication,etc)
6.4 / Work Environment–Determine & manage the work environment needed to achieve conformity to product requirements
7
7.1 /
Product Realization

Planning of Product Realization – Plan and develop product realization processes consistent with other processes of QMS

-Determine quality objectives and requirements for the product
-Need to establish processes, documents and provide resources
-Determine required verification, validation, monitoring, inspection and test activities & acceptance criteria
-Determine records needed to provide evidence
Output of planning in a form suitable for the organization
7.2
7.2.1 /
Customer – related processes
Determination of requirements related to the product
-Requirements specified by the customer including delivery and post delivery requirements
-Requirements not stated by the customer but necessary
-Statutory and regulatory requirements related to the product
-Additional requirements determined by the organization
7.2.2 / Review of requirements related to the product
-Prior to the organization’s commitment to supply a product
-Ensure product requirements are defined
-Requirements differing from previously expressed are resolved
-Ensure organization has ability to meet defined requirements
-Records of results of review and actions arising from review
-Confirmation of customer requirements in case of no documented statement of customer requirements
-Relevant documents are amended in case of change and relevant personnel are made aware
7.2.3 / Customer communication – Determine and implement arrangements for communicating with customers relating to
-Product information
-Enquiries, contracts or order handling including amendments
-Customer feedback, including customer complaints

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Requirements – IS/ISO 9001:2000

Process/Function

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CHECKLIST FOR QMS

Findings

C - Conformity N - Non-conformity

X - Not applicable XX – Not assessed

A / B / C / D / E / Comments/Remarks
7.3
7.3.1 /
Design and Development
Design and development planning - Plan and control design and development of product
-Determine design and development stages
-Determine review, verification and validation
-Determine responsibilities and authorities
Interfaces between different groups
Planning output shall be updated
7.3.2 / Design and development inputs – determine and maintain records
-Functional and performance requirements
-Applicable statutory and regulatory requirements
-Where applicable, information derived from previous similar designs
-Other requirements essential for design and development
Review for adequacy; shall be complete and unambiguous
7.3.3 / Design and development outputs – in the form that enables verification against inputs and approved prior to release
-Meet the input requirements for design and development
-Provide appropriate information
-Contain or reference product acceptance criteria
-Specify the characteristics of the product safety and use
7.3.4 / Design and development review – performed as planned
-To evaluate the ability to meet requirements
-To identify any problems and propose necessary actions
Participants from concerned functions and records maintained
7.3.5 / Design and development verification - in accordance with planned arrangements to ensure output meets input requirements
Records of the results
7.3.6 / Design and development validation – performed as planned
-Resulting product is capable of meeting requirements
-If practicable, shall be completed prior to delivery
-Records of results of validation and necessary actions
7.3.7 / Control of design and development changes – identified and records maintained
-Reviewed, verified and validated
-Include evaluation of the effect of changes
-Record of results of review of changes & necessary actions

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Requirements – IS/ISO 9001:2000

Process/Function

A B C

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Findings

C - Conformity N - Non-conformity

X - Not applicable XX – Not assessed

A / B / C / D / E / Comments/Remarks
7.4
7.4.1 /
Purchasing
Purchasing process- Products conform to purchase requirements
-Extent of control dependent upon effect of purchased products
Selection, evaluation, re-evaluation criteria & records
7.4.2 / Purchasing information – Describe the product to be purchased including where appropriate
-requirements for approval of product, processes & equipment
-requirements for qualification of personnel and QMS
Adequacy of purchase requirements prior to communication
7.4.3 / Verification of purchased product – Establish and implement inspection or other activities
-Verification by organization or its customer at supplier’s premises (stated in purchasing information)
7.5
7.5.1 /
Production and service provision
Control of production and service provision – plan and carry out production and service provision under controlled conditions
-Information that describes the characteristics of the product
-Availability of work instructions
-Use of suitable equipments
-Availability and use of monitoring and measuring devices
-Implementation of monitoring and measurement
-Implementation of release, delivery & post-delivery activities
7.5.2 / Validation of processes for production and service provision
-Define criteria for review and approval of the processes
-Approval of equipment and qualification of personnel
-Use of specific methods and procedures
-Requirements for records
-Revalidation
7.5.3 / Identification and Traceability
-Identify the product by suitable means
-Identify the product monitoring & measurement status
-Control and record identification where required
7.5.4 / Customer Property
-Exercise care while under control or use
-Identify, verify, protect and safeguard
-If lost, damaged or unsuitable, report to customer and record
7.5.5 / Preservation of Product
-During internal processing and delivery
-Identification, handling, packaging, storage & protection
7.6 /
Control of Monitoring and Measuring Devices - monitoring & measurement to be undertaken and devices needed
-Measuring equipment shall be calibrated or verified
-Calibrated against traceable international/national standards
-Adjusted or re-adjusted as necessary
-Calibration status identified
-Safeguarded from adjustments
-Protected from damage and deterioration
Assess and record validity of previous measuring results
Calibration records
Confirm ability of computer software for monitoring & measurement

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Requirements – IS/ISO 9001:2000

Process/Function

A B C

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CHECKLIST FOR QMS

Findings

C - Conformity N - Non-conformity

X - Not applicable XX – Not assessed

A / B / C / D / E / Comments/Remarks
8
8.1 /
Measurement, analysis and improvement
General - Plan and implement monitoring, measurement, analysis and improvement processes needed
-To demonstrate conformity of the product
-To ensure conformity of QMS
-To continually improve the effectiveness of QMS
Determination of applicable methods, statistical techniques
8.2
8.2.1 /
Monitoring and measurement
Customer satisfaction – Monitor information relating to customer perception (determine methods of obtaining & using information)
8.2.2 / Internal audit
-Documented procedure responsibilities & requirements for planning & conducting audits, reporting results & maintaining records
-At planned intervals to determine conformance to QMS requirements and requirements of this standard
-Whether effectively implemented and maintained
-Planned considering status and importance of processes & areas to be audited and results of previous audits
-Audit criteria, scope, frequency and methods defined
-Auditors selection & conduct of audits (objectivity & impartiality)
-Actions taken without delay to eliminate NCs and their causes
-Follow-up verification of actions taken and reporting
8.2.3 / Monitoring and measurement of processes
-Methods for monitoring and measurement of QMS processes
-Correction and corrective actions taken to ensure conformity
8.2.4 / Monitoring and measurement of product
-Monitor and measure the characteristics of the product at appropriate stages
-Evidence of conformity with the acceptance criteria
-Person authorizing release of product indicated in records
-Satisfactory completion of planned arrangements before product release and service delivery by relevant authority
8.3 /
Control of non-conforming product – Identified and controlled to prevent its unintended use or delivery
-Documented procedure – controls, responsibilities and authorities for dealing with non-conforming product
-Action taken to eliminate detected nonconformity
-Use, release or acceptance under concession by relevant authority, where applicable by the customer
-Actions taken to preclude original intended use or application
-Records of NCs, actions taken, concessions obtained
-Re-verification of corrected product
-Action taken on NC product detected after delivery or use
8.4 /
Analysis of data
-Determine, collect and analyse data for suitability, effectiveness and continual improvement of QMS
-Analysis provides information- customer satisfaction, product conformity, characteristics & trends of processes & products, opportunities for preventive action & information on suppliers

Auditee (Organization)

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Clause
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Requirements – IS/ISO 9001:2000

Process/Function

A B C

D E

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CHECKLIST FOR QMS

Findings

C - Conformity N - Non-conformity

X - Not applicable XX – Not assessed

A / B / C / D / E / Comments/Remarks
8.5
8.5.1 /

Improvement

Continual Improvement - of effectiveness of QMS through use of
-Quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions & management review
8.5.2 / Corrective action
-Documented procedure
-Review of non-conformities (including customer complaints)
-Determine the causes of non-conformities
-Evaluate the need for action to ensure that non-conformities do not recur
-Determine and implement action needed
-Records of the results of action taken
-Review corrective action taken
-Appropriate to the effects of non-conformities encountered
8.5.3 / Preventive action
-Documented procedure
-Determine potential non-conformities and their causes
-Evaluate the need for action to prevent occurrence of non-conformities
-Determine and implement action needed
-Records of results of action taken
-Review preventive action taken
-Preventive actions appropriate to the effects of potentialproblems

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