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Disclosure to Promote the Right To Information
Whereas the Parliament of India has set out to provide a practical regime of right to information for citizens to secure access to information under the control of public authorities, in order to promote transparency and accountability in the working of every public authority, and whereas the attached publication of the Bureau of Indian Standards is of particular interest to the public, particularly disadvantaged communities and those engaged in the pursuit of education and knowledge, the attached public safety standard is made available to promote the timely dissemination of this information in an accurate manner to the public.
इंटरनेट मानक
“!ान $ एक न' भारत का +नम-ण”Satyanarayan Gangaram Pitroda
“Invent a New India Using Knowledge”
“प0रा1 को छोड न' 5 तरफ”Jawaharlal Nehru
“Step Out From the Old to the New”
“जान1 का अ+धकार, जी1 का अ+धकार”Mazdoor Kisan Shakti Sangathan
“The Right to Information, The Right to Live”
“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता है”Bhartṛhari—Nītiśatakam
“Knowledge is such a treasure which cannot be stolen”
“Invent a New India Using Knowledge”
है”ह”ह
IS 16000 (2004): Aerospace Quality Management Systems -Requirements [TED 14: Aircraft and Space Vehicles]
nIw?lw ‘g-inn m
IS 16000:2004
Indian Standard
AEROSPACE QUALITY MANAGEMENTSYSTEMS — REQUIREMENTS
ICS 03.120. 10; 49.020
September 2004
.
0 BIS 2004
BUREAU OF INDIAN STANDARDSMANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI 110002
Price Group 6
Aircraft, Space Vehicles, Air Cargo Handling and Aircraft Electrical Equipment Sectional Committee,TED 14
FOREWORD
This Indian Standard was adopted by the Bureau of Indian Standards, after the draft finalized by the Aircraft,Space Vehicles, Air Cargo Handling and Aircraft Electrical Equipment Sectional Committee had been approvedby the Transport Engineering Division Council.
Subsequent to the third revisionof1S09001 in 2000 superseding the second editionofISO9001 :1994 togetherwith ISO 9002: 1994 and ISO 9003 : 1994, a need was felt to draw a quality management system (QMS)requirements standard to cover the aerospace industry besides those covered in ISO 9001 :2000. This aims toenhance aerospace customer satisfaction through the effective application of the system, including processes ofcontinual improvement of the system and the assurance of conformity to aerospace customer and applicableregulatory requirements
In the formulation of this standard, assistance has also been derived from SAE AS 9100:2001 ‘Quality systems —Aerospace — Model for quality assurance in design, development, production, installation and servicing’.
The organizations initially developing IS 19000 based QMS must develop a QMS based on IS/ISO 9001.
The composition of the Committee responsible for the formulation of this standard is given in Annex A.
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IS 16000:2004
CONTENTS
1
2
3
4
5
6
7
8
Scope1.1 General1.2 Application
References
Terms and Definitions
Aerospace Quality Management System
Management Responsibility5.1 General Requirements5.2 Documentation Requirements5.3 Management Commitment5.4 Customer Focus5.5 Quality Policy5.6 Planning5.7 Responsibility, Authority and Communication5.8 Management Review5.9 Resource Management
Product Realization6.1 Planning of Product Realization6.2 Customer-Related Processes6.3 Design and Development6.4 Purchasing6.5 Production and Service Provision6.6 Control of Monitoring and Measuring Devices
Measurement and Analysis7.1 General7.2 Monitoring and Measurement7.3 Control of Nonconforming Product7.4 Analysis of Data
Improvement8.1 Continual Improvement8.2 Corrective Action8.3 Preventive Action
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88899
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IS 16000:2004
Indian Standard
AEROSPACE QUALITY MANAGEMENTSYSTEMS — REQUIREMENTS
1 SCOPE
1.1 General
This standard specifies requirements for an AerospaceQuality Management System where an organizationneeds to demonstrate its ability to consistently provideproduct that meets aerospace customer and applicableregulatory requirements.
NOTE — In this standard, the term ‘product’ applies only tothe product intended for, or required by, an aerospace customer.
1.2 Application
All requirements of this standard are aerospace sector-specific and are intended to be applicable to allorganizations, regardless of tjpe, size and productprovided.
Where any requirement(s) of this standard cannot beapplied due to the nature of an organization and itsproduct, this can be considered for exclusion.
Where exclusions are made, claims of conformity tothis standard are not acceptable unless these exclusionsare limited to requirements within 7, and suchexclusions do not affect the organization’s ability, orresponsibility, to provide product that meets AerospaceCustomer and applicable regulatory requirements.
2 REFERENCES
The following standards contain provisions, which,through reference in this text, constitute provisions ofthis standard. At the time of publication the editionsindicated were valid. All standards are subject torevision, and parties to agreements based on thisstandard are encouraged to investigate the possibilityof applying the most recent editions of the standardsindicated below:
Is No.
1s/1s09000:2000
1s/1s0 10011
(Part 1): 1990(Part 2): 1991
Title
Quality management systems —Fundamentals and vocabulary(second revision)
Guidelines for auditing qualitysystemsAuditingQuantification criteria for qualitysystems auditors
IS No. Title
(Part 3): 1993 Management of audit programmed1s/1s0 10012 Quality assurance requirements
for measuring equipment(Part 1): 1992 Metrological conflation system
for measuring equipment(Part 2): 1997 Guidelines for control of
measuring processes
3 TERMS AND DEFINITIONS
For the purpose of this standard, the terms anddefinitions given in IS/ISO 9000 apply.
In addition, the following supply chain descriptionapplies to this standard:
Supplier + Organization + Customer
The term ‘organization’ refers to the unit to which thisIndian Standard applies.
Throughout the text of this standard, wherever the term‘product’ occurs, it can also mean ‘service’.
4 AEROSPACE QUALITY MANAGEMENTSYSTEM
The Aerospace Quality Management System consistsof the following:
a)
b)
c)
d)
Management responsibility (see 5),
Product realization (see 6),
Measurement and analysis (see 7), and
Improvement (see 8).
5 MANAGEMENT REffPONSIBILITY
5.1 General Requirements
Top management shall establish, document, implementand maintain an aerospace quality management systemand continually improve its effectiveness in accordancewith the requirements of this standard.
Top management shall:
a) identify the processes needed for theaerospace quality management system andtheir application throughout the organization(see 1.2). The processes identified shallinclude the processes arising out of meeting
1
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1S 16000:2004
b)
c)
d)
e)
o
customer as well as statutory and regulatoryrequirements.
determine the sequence and interaction ofthese processes,
determine criteria and methods needed toensure that both the operation and control ofthese processes are effective,
ensure the availability of resources andinformation necessary to support theoperation and monitoring of these processes,
monitor, measure and analyse these processes,and
implement actions necessary to achieveplanned results and continual improvementof these processes.
These processes shall be managed by the organizationin accordance with the requirements of this standard.
Where an organization chooses to outsource anyprocess that affects product conformity withrequirements, the organization shall ensure control oversuch processes. Control of such outsourced processesshall be identified within the aerospace qualitymanagement system.
NOTE — Processes needed for the Aerospace QualityManagement System referred to above should include processesfor management activities, provision of resources, productreal ization and measurement.
5.2 Documentation Requirements
5.2.1 General
The aerospace quality management systemdocumentation shall include:
a)
b)
c)
d)
e)
Documented statements of a quality policyand quality objectives,
A quality manual,
Documented procedures required by thisstandard,
Documents needed by the organization toensure the effective planning operation andcontrol of its processes, and
Records required by this Indian Standard(see 5.2.4). -
NOTES
1 Where the term documented procedure apperus within thisstandard, this means that the procedure is established,documented, implemented and maintained.
2 The extent of the aerospace quality management systemdocumentation can differ from one organization to another dueto:
a) size of the organization and type of activities,
b) complexity of processes and their interactions, and
c) competence of personnel.
3 The documentation can be in any form or type of medium.
5.2.2 Quality Manual
Top management shall establish and maintain a qualitymanual that includes:
a)
b)
c)
scope of the aerospace quality managementsystem, including details of and justificationfor any exclusions (see 1.2),
documented procedures established for theaerospace quality management system, orreference to them, and
a description of the interaction between theprocesses of the aerospace qualitymanagement system.
5.2.3 Control of Documents
Documents required by the aerospace qualitymanagement system shall be controlled. Records areaspecial type of document and shall be controlledaccording to the requirements given in 5.2.4.
A documented procedure shall be established to definethe controls needed:
a)
b)
c)
d)
e)
o
g)
to approve documents for adequacy prior toissue;
to review and update as necessary and re-approve documents;
to ensure that changes and the current revisionstatus of documents are identified;
to ensure that relevant versions of applicabledocuments are available at points of use,including authorized signatories, sentencingauthorities, customer, statutory and regulatoryauthorities’ representatives;
to ensure that documents remain legible andreadily identifiable;
to ensure that documents of external origin areidentified and fheir distribution controlled; and
to prevent the unintended use of obsoletedocuments, and to apply suitableidentification tQthem if they are retained forany purpose.
5.2.4 Control of Records
a)
b)
c)
Records shall be established and maintainedto provide evidence of conformity torequirements and of the effective operationof the aerospace quality management system.Records shall be available for review bysentencing authorities, customer, statutoryand regulatory authorities’ representatives;
Records shall remain legible, readilyidentifiable and retrievable; and
A documented procedure shall be established
2
to define the controls needed for theidentification, storage, protection, retrieval,retention time and disposition of records.
5.3 Management Commitment
Top management shall provide evidence of itscommitment to the development and implementationof the aerospace quality management system andcontinually improving its effectiveness by:
a) communicating to the organization theimportance of meeting customer as well asstatutory and regulatory requirements,
b) establishing the quality policy,
c) ensuring that quality objectives areestablished,
d) conducting management reviews, and
e) ensuring the availability of resources.
5.4 Customer Focus
Top management shall ensure that customerrequirements are determined and are met with the aimof enhancing customer satisfaction (see 6.2.1and 7.2.1).
5.5 Quality Policy
Top management shall ensure that the quality policy:
a)
b)
c)
d)
e)
is appropriate to the purpose of theorganization,
includes a commitment to comply withrequirements and continually improve theeffectiveness of the aerospace qualitymanagement system,
provides a framework for establishing andreviewing quality objectives,
is communicated and understood within theorganization, and
is reviewed for continuing suitability.
5.6 Planning
5.6.1 Quality Objectives
Top management shall ensure that quality objectives,including those needed to meet requirements forproduct [see 6.l(a)] are established at relevantfunctions and levels within the organization. Thequality objectives shall be measurable and consistentwith the quality policy.
5.6.2 Aerospace Quality Management System Planning
Top management shall ensure that:
a) planning of the aerospace qualitymanagement system is carried out in order tomeet the requirements given in 5.1, as well
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as the quality objectives; and
b) integrity of the aerospace quality managementsystem is maintained when changes to theaerospace quality management system areplanned and implemented.
5.7 Responsibility, Authority and Communication
5.7.1 Responsibility and Authori@
Top management shall ensure that responsibilities andauthorities are defined and communicated within theorganization.
5.7.2 Management Representative
Top management shall appoint a member ofmanagement, who irrespective of other responsibilities,shall have responsibility and authority that includes:
a)
b)
c)
Ensuring that processes needed for the qualitymanagement system are established,implemented and maintained,
Reporting to top management on theperformance of the aerospace qualitymanagement system and any need forimprovement, and
Ensuring the promotion of awareness ofcustomer requirements throughout theorganization.
Management representative shall have the necessaryresponsibility and authority and organizationalfreedom to resolve matters pertaining to quality.
NOTE — The responsibility of a management representativecan include liaison with external parties on matters relating tothe Aerospace Quality Management System.
5.7.3 Internal Communication
Top management shall ensure that appropriatecommunication processes are established within theorganization and that communication takes placeregarding the effectiveness of the quality managementsystem.
5.8 Management Review
5.8.1 General
The top management shall review the organization’saerospace quality management system, at plannedintervals, to ensure its continuing suitability, adequacyand effectiveness. This review shall include assessingopportunities for improvement and the need forchanges to the quality management system, includingthe quality policy and quality objectives.
Records from management reviews shall be maintained(see 5.2.4).
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IS 16000:2004
5.&2 Review Input
The input to management review shall includeinformation on:
a) Results of audits,
b) Customer feedback,
c) Process performance and product conformity,
d) Status of preventive and corrective actions,
e) Follow-up actions from previous managementreviews,
f) Changes that could affect the qualitymanagement system, and
g) Recommendations for improvement.
5.8.3 Review Output
The output from the management review shall includeany decisions and actions related to:
a) Improvement of the effectiveness of theaerospace quality management system and itsprocesses,
b) Improvement of product related to customerrequirements, and
c) Resource needs.
5.9 Resource Management
5.9.1 Provision of Resources
The top management shall determine and provide theresources needed:
a) to implement and maintain the aerospacequality management system and continuallyimprove its effectiveness, and
b) to enhance customer satisfaction by meetingcustomer requirements.
5.9.2 Human Resources
a)
b)
General
Personnel performing work affecting productquality shall be competent on the basis ofappropriate education, training, skills andexperience.
Competence, awareness and training.
The top management shall:
1)
2)
3)
determine the necessary competence forpersonnel performing work affectingproduct quality,
provide training or take other actions tosatisfy these needs,
evaluate the effectiveness of the actiontaken,
4)
5)
ensure that its personnel are aware of therelevance and importance of theiractivities and how they contribute to theachievement of the quality objectives, and
maintain appropriate records ofeducation, training, skills and experience(see 5.2.4).
5.9.3 Infrastructure
The organization shall determine, provide and maintainthe infrastructure needed to achieve conformity toproduct requirements. Infrastructure includes, asapplicable:
a) buildings, workspace and associated utilities,
b) process equipment (both hardware andsoftware), and
c) supporting services (such as transport orcommunication).
5.9.4 Work Environment
The top management shall determine and manage thework environment needed to achieve conformity toproduct requirements.
6 PRODUCT REALIZATION
6.1 Planning of Product Realization
The organization shall plan and develop the processesneeded for product realization. Planning of productrealization shall be consistent with the requirementsof the other processes of the aerospace qualitymanagement system (see 5.1).
In planning product realization, the organization shalldetermine the following, as appropriate:
a)
b)
c)
d)
Quality objectives and requirements for theproduct,
Need to establish processes, documents, andprovide resources specific to the product,
Required verification, validation, moni-toring, inspection and test activities specificto the product and the criteria for productacceptance, including in-process verificationpoints are identified when adequate veri-fication of conformance cannot be performedat a later stage of realization and theestablishment of appropriate processcontrols and development control planswhere key characteristics have beenidentified.
Records needed to provide evidence that therealization processes and resulting productmeet requirements (see 5.2.4).
4
The output of this planning shall be in a form suitablefor the organization’s method of operations.
NOTES
1 A document specifying the processes of the AerospaceQuality Management System (including the product realizationprocesses) and the resources to be applied to a specific product,project or contract, can be referred to as a quality plan.
2 The organization may also apply the requirements givenin 6.3 to the development of product realization processes.
6.2 Customer-Related Processes
6.2.1 Determination of Requirements Related to (he
Product
The organization shall determine:
a) requirements specified by the customer,including the requirements for delivery andpost-delivery activities,
b) requirements not stated by the customer butnecessary for specified or intended use, whereknown,
c) statutory and regulatory requirements relatedto the product, and
d) any additional requirements determined bythe organization.
6.2.2 Review of Requirements Related to the Product
The organization shall review the requirementsrelated to the product. This review shall be conductedprior to the organization’s commitment to supply aproduct to the customer (for example, submission oftenders, acceptance of contracts or orders, acceptanceof changes to contracts or orders) and shall ensurethat:
a)
b)
c)
d)
product requirements are defined,
contract or order requirements differing fromthose previously expressed are resolved,
organization has the ability to meet thedefined requirements, and
risk associated with new technology andlorshort delivery time scale have been evaluated.
Records of the results of the review and actions arisingfrom the review shall be maintained (see 5.2.4).
Where the customer provides no documented statementof requirements, the customer requirements shall beconfirmed by the organization before acceptance.
Where product requirements are changed, theorganization shall ensure that relevant documents areamended and that relevant personnel are made awareof the changed requirements.
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IS 16000:2004
NOTE — In some situations, such as internet sales, a formalreview is impractical for each order. Instead the review cancover relevant product information, such as catalogues oradvertising material.
6.2.3 Customer Communication
The organization shall determine and implementeffective arrangements for communicating withcustomers in relation to:
a)
b)
c)
product information;
enquiries, contracts or order handling,including amendments; and
customer feedback, including customercomplaints.
6.3 Design and Development
6.3.1 Design and Development Planning
The organization shall plan and control the design anddevelopment of product.
During the design and development planning, theorganization shall determine:
a) design and development stages,
b) review, verification and validation that areappropriate to each design and developmentstage, and
c) responsibilities and authorities for design anddevelopment.
The organization shall manage the interfaces betweendifferent groups involved in design and developmentto ensure effective communication and clearassignment of responsibility.
Planning output shall be updated, as appropriate, asthe design and development progresses.
6.3.2 Design and Development Inputs
Inputs relating to product requirements shall bedetermined and records maintained (see 5.2.4). Theseinputs shall include: ~
a) functional and performance requirements,including specified reliability, maintainabilityand safety requirements,
b) applicable statutory and regulatoryrequirements,
c) where applicable, information derived fromprevious similar designs, and
d) other requirements essential for design anddevelopment.
These inputs shall be reviewed for adequacy.Requirements shall be complete, unambiguous and notin conflict with each other.
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6.3.3 Design and Development Outputs
The outputs of design and development shall beprovided in a form that enables verification againstthe design and development input and shall beapproved prior to release.
Design and development outputs shall:
a)
b)
c)
d)
meet the input requirements for design anddevelopment;
provide appropriate information forpurchasing, production and for serviceprovision, including all pertinent datarequired to allow the product to be identified,manufactured, inspected, used and maintainedshall be defined;
contain or reference product acceptancecriteria; and
specify the characteristics of the product thatare essential for its safe and proper use.
6.3.4 Design and Development Review
At suitable stages, systematic reviews of design anddevelopment shall be performed in accordance withplanned arrangements (see 6.3.1):
a)
b)
To evaluate the ability of the results of designand development to meet requirements, and
To identify any problems and proposenecessary actions.
participants in such reviews shall includerepresentatives of functions concerned with the designand development stage(s) being reviewed. Records ofthe results of the reviews and any necessary actionsshall be maintained, including the decision necessaryfor progression to the next stage (see 5.2.4).
6.3.5 Design and Development Verification
a) Verification shall be performed in accordancewith planned arrangements (see 6.3.1) toensure that the design and developmentoutputs have met the design and developmentinput requirements.
b) Records of the results of the verification andany necessary actions shall be maintained(see 5.2.4).
6.3.6 Design and Development Validation
a) Design and development validation shall beperformed in accordance with plannedarrangements (see 6.3.1 ) to ensure that theresulting product is capable of meeting therequirements for the specified application orintended use, where known.
b)
c)
Wherever practicable, validation shallbe completed prior to the delivery orimplementation of the product.
Records of the results of validation and anynecessary actions shall be maintained(see 5.2.4). Records shall ensure that reports,calculations, test results, etc, demonstratethat the product definition meets therequirements for all identified operationalconditions and the product will functioncorrectly.
6.3.7 Control of Design and Development Changes
a)
b)
c)
d)
Design and development changes shall beidentified and records maintained.
The changes shall be reviewed, verified andvalidated, as appropriate, and approved beforeimplementation. The review of design anddevelopment changes shall include evaluationof the effect of the changes on constituentparts and product already delivered.
Design control system of the organizationshould provide for customer and/or regulatoryagency approval of changes, when required.
Records of the results of the review of changesand any necessary actions shall be maintained(see 5.2.4).
6.4 Purchasing
6.4.1 Purchasing Process
a)
b)
c)
d)
e)
6
The organization shall ensure that purchasedproduct conforms to specified purchaserequirements.
The type and extent of control applied to thesupplier and the purchased product shall bedependent upon the effect of the purchasedproduct on subsequent product realization orthe final product. The control shall includethe right of access by the organization, theircustomer and%egulatory authorities to allfacilities in the order and all the applicablequality records.
The organization shall evaluate and selectsuppliers based on their ability to supplyproduct in accordance with the organization’srequirements.
Criteria for selection, evaluation and re-evaluation of the suppliers shall beestablished.
Records of the results of evaluations and anynecessary actions arising from the evaluationshall be maintained (see 5.2.4).
6.4.2 Purchasing Information
Purchasing information shall describe the product tobe purchased, including where appropriate:
a) Requirements for approval of product,procedures, processes and equipment,
b) Requirements for qualification of personnel,and
c) Quality management system requirements.
The organization shall ensure the adequacy of specifiedpurchase requirements prior to their communicationto the supplier.
6.4.3 Verljlcation of Purchased Product
a)
b)
c)
The organization shall establish andimplement the inspection or other activitiesnecessary for ensuring that purchased productmeets specified purchase requirements.
Where the organization or its customerintends to perform verification the supplier’sorganization shall state the intendedverification arrangements and method ofproduct release in the purchasing information.
When certification test reports are utilized toaccept material, the supplier shall assure thatdata in said reports are acceptable as perapplicable specifications. The organizationshall periodically validate test reports.
6.5 Production and Service Provision
6.5.1 The organization shall plan and carry outproduction and service provision under controlledconditions. Controlled conditions shall include, asapplicable:
a)
b)
c)
d)
e)
0
.!3)
Availability of information that describes thecharacteristics of the product;
Availability of work instructions, asnecessary;
Use of suitable equipment;
Availability and use of monitoring andmeasuring devices;
The implementation of monitoring andmeasurement, including for the prevention,detect ion, and removal of foreign objects andcompletion of all manufacturing andinspection operations as planned, or asotherwise documented and authorized; and
The controls required for off-site works, and
The implementation of release, delivery andpost-delivery activities.
IS 16000:2004
6.5.2 Validation of Processes for Production and
Service Provision
The organization shall validate any processes forproduction and service provision where the resultingoutput cannot be verified by subsequent monitoringor measurement. This includes any processes wheredeficiencies become apparent only after the product isin use or the service has been delivered.
Validation shall demonstrate the ability of theseprocesses to achieve planned results.
The organization shall establish arrangements for theseprocesses including, as applicable:
a)
b)
c)
d)
e)
Defined criteria for review and approval ofthe processes,
Approval of equipment and qualification ofpersonnel,
Use of specific methods and procedures,
Requirements for records (see 5.2.4),including the significant operations andparameters in the process to be controlled, and
Revalidation.
6.5.3 Identlflcation and Traceability
a) The organization shall identify the product bysuitable means throughout product realizationin order to identify the actual configurationand the agreed configuration.
b) The organization shall identify the productstatus with respect to monitoring andmeasurement requirements.
c) Where traceability is a requirement, theorganization shall control and record theunique identification of the product(see 5.2.4).
NOTE — In some industry sectors, configuration managementis a means by which identification and traceability aremaintained.
6.5.4 Customer Properiy
a)
b)
c)
The organization shall exercise care withcustomer property while it is under theorganization’s control or being used by theorganization.
The organization shall identi&, veri&, protectand safeguard customer property provided foruse or incorporation into the product.
If any customer properly is lost, damaged orotherwise found to be unsuitable for use, thisshall be reported to the customer and recordsmaintained (see 5.2.4).
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IS 16000:2004
NOTE — Customer property can include intellectual property.
6.5.5 Preservation of Product
a)
b)
c)
Organization shall preserve the conformity ofproduct during internal processing anddelivery to the intended destination.
This preservation shall include identification,packaging, storage and protect ion.
Preservation shall also apply to the constituentparts of a product.
6.6 Control of Monitoring and Measuring Devices
The organization shall determine the monitoring andmeasurement to be undertaken and the monitoring andmeasuring devices needed to provide evidence ofconformity of product to determined requirements(see 6.2.1).
The organization shall establish processes to ensurethat monitoring and measurement can be carried outand are carried out in a manner that is consistent withthe monitoring and measurement requirements.
Where necessary to ensure valid results, measuringequipment shall:
a) be calibrated or verified at specified intervals,or prior to use, against measurement standardstraceable to international or nationalmeasurement standards; where no suchstandards exist, the basis used for calibrationor verification shall be recorded;
b) be adjusted or re-adjusted as necessary;
c) be identified to enable the calibration statusto be determined;
d) be safeguarded from adjustments that wouldinvalidate the measurement result; and
e) be protected from damage and deteriorationduring handling, maintenance and storage.
In addition, the organization shall assess and recordthe validity of the previous measuring results whenthe equipment is found not to conform to requirements.The organization shall take appropriate action on theequipment and any product affected. Records of theresults of calibration and verification shall bemaintained (see 5.2.4).
When used in the monitoring and measurement ofspecified requirements, the ability of computersoftware to satisfy the intended application shall beconfirmed. This shall be undertaken prior to initial useand reconfirmed as necessary.
NOTE — See 1S/1S0 10012 (Part 1) and 1S/1S0 10012(Part 2) for guidance.
8
7 MEASUREMENT AND ANALYSIS
7.1 General
The organization shall plan and implement themonitoring, measurement, analysis and improvementprocesses needed:
a) to demonstrate conformity of the product,
b) to ensure conformity of the aerospace qualitymanagement system, and
c) to continually improve the effectiveness ofthe quality management system.
This shall include determination of applicable methods,including statistical techniques, and the extent of theiruse.
7.2 Monitoring and Measurement
7.2.1 Customer Satisfaction
As one of the measurements of the performance of thequality management system, the organization shallmonitor information relating to customer perceptionas to whether the organization has met customerrequirements. The methods for obtaining and using thisinformation shall be determined.
7.2.2 Internal Audit
The organization shall conduct internal audits atplanned intervals to determine whether the qualitymanagement system:
a)
b)
conforms to the planned arrangements(see 7.1) to the requirements of this standardand to the quality management systemrequirements established by the organization,and
is effectively implemented and maintained.
An audit programme shall be planned, taking intoconsideration the status and importance of theprocesses and areas to be audited, as well as the resultsof previous audits. The audit criteria, scope, frequencyand methods shall be defined. Selection of auditorsand conduct of audits 3hall ensure objectivity andimpartiality of the audit process. Auditors shall notaudit their own work.
The responsibilities and requirements for planning andconducting audits, and for reporting results andmaintaining records (see 5.2.4) shall be defined in adocumented procedure.
The management responsible for the area being auditedshall ensure that actions are taken without undue delayto eliminate detected nonconformities and their causes.Follow-up activities shall include the verification ofthe actions taken and the reporting of verificationresults (see 7.5.2).
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The organization shall conduct internal quality auditsthat assess compliance to their quality system and therequirements of this standard. A flow down of therequirements from this standard through the qualitymanual to the working-level procedures must beshown. Detailed tools and techniques shall bedeveloped, such as check sheets, process flowcharts,or any similar method to support audit of the proceduralrequirements. The acceptability of the selected toolswill be measured against the effectiveness of theinternal audit process and overall organizationperformance.
NOrE — See 1S/1S0 10011 (Part 1), 1S/1S0 10011 (Part 2)and 1S/1S0 10011 (Part 3) for guidance.
7.2.3 Monitoring and Measurement of Processes
The organization shall apply suitable methods formonitoring and, where applicable, measurement of thequality management system processes. These methodsshall demonstrate the ability of the processes to achieveplanned results. When planned results are not achieved,correction and corrective action shall be taken, asappropriate, to ensure conformity of the product.
7.2.4 Monitoring and Measurement of Product
a)
b)
c)
d)
The organization shall monitor and measurethe characteristics of the product to verify thatproduct requirements have been met. Thisshall be carried out at appropriate stages ofthe product realization process in accordancewith the planned arrangements (see 6.1). Theorganization’s system shall provide a process,as appropriate, for the first productqualification.
Evidence of conformity with the acceptancecriteria shall be maintained.
Records shall indicate the person(s)authorizing release of product (see 5.2.4).
Product release and service delivery shall notproceed until the planned arrangements(see 6.1) have been satisfactorily completed,unless otherwise approved by a relevantauthority and, where applicable, by thecustomer.
7.3 Control of Nonconforming Product
a)
b)
The organization shall ensure that productwhich does not conform to productrequirements is identified and controlled toprevent its unintended use or delivery.
The controls and related responsibilities andauthorities for dealing with nonconformingproduct shall be defined in a documentedprocedure. The procedure shall also take into
c)
d)
e)
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IS 16000:2004
account process non-conformity that mayresult i~roduct non-conformity.
The organization shall deal withnonconforming product by one or more of thefollowing ways:
1)
2)
3)
By taking action to eliminate the detectednonconformity;
By authorizing its use, release oracceptance under concession by arelevant authority and, where applicable,by the customer;
By taking action to preclude its originalintended use or application.
Records of the nature of nonconformities andany subsequent actions taken, includingconcessions obtained, shall be maintained(see 5.2.4). Product disposed for re-gradeshall require a change in product identificationto preclude the product’s original use.Adequate test reports and certifications shallreflect the regrading. Product disposed forscrap shall be conspicuously and permanentlymarked until rendered physically unsuitablefor use in completed products.
When nonconforming product is correctedit shall be subject to re-verification todemonstrate conformity to the requirements.
When nonconforming product is detected afterdelivery or use has started, the organizationshall take action appropriate to the effects, orpotential effects, of the nonconformity. Theorganization shall provide for timely reportingof non-conformance that may affect productalready delivered.
7.4 Analysis of Data
The organization shall determine, collect and analyseappropriate data to demonstrate the suitability andeffectiveness of the quality management system andto evaluate where continual improvement of theeffectiveness of the quality management system canbe made. This shall include data generated as a resultof monitoring and measurement and from otherrelevant sources.
The analysis of data shall provide information relatingto:
a)
b)
c)
d)
9
Customer satisfaction (see 7.2. 1),
Conformity to product requirements(see 6.2.1),
Characteristics and trends of processes andproducts including opportunities forpreventive action, and
Suppliers.
1S 16000:2004
8 IMPROVEMENT
8.1 Continual Improvement “
The organization shall continually improve theeffectiveness of the quality management systemthrough the use of the quality polity, quality objectives,audit results, analysis of data, corrective and preventiveactions and management review.
8.2 Corrective Action
The organization shall take action to eliminate the causeof nonconformities in order to prevent recurrence.Corrective actions shall be appropriate to the effectsof the nonconformities encountered.
A documented procedure shall be established to definerequirements for:
a)
b)
c)
d)
e)
reviewing non-conformities (includingcustomer complaints),
determining the causes of nonconformities,
evaluating the need for action to ensure thatnonconformities do not recur,
determining and implementing action needed,
records of the results of action taken(see 5.2.4), and
t) reviewing corrective action taken, includingspecific actions where timely and/or effectiveactions are not achieved.
8.3 Preventive Action
The organization shall determine action to eliminatethe causes of potential nonconformities in order toprevent their occurrence. Preventive actions shall beappropriate to the effects of the potential problems.
A documented procedure shall be established to definerequirements for:
a)
b)
c)
d)
e)
determining potential nonconformities andtheir causes;
evaluating the need for action to preventoccurrence of nonconformities;
determining and implementing action needed;
records of results of action taken (see 5.2.4);and
reviewing preventive action taken, includingspecific actions where timely and /or effectiveactions are not achieved.
10
IS 16000:2004
ANNEX A
(Foreword)
COMMITTEE COMPOSITION
Aircraft, Space Vehicles, Air Cargo Handling and Aircraft Electrical EquipmentSectional Committee, TED 14
Organization
Aerial Delivery R&D Establishment, Agra Cantt
Amphetronix Pvt Ltd, Bangaiore
Research Centre Imarat, Hyderabad
Aeronautical Development Agency (ADA), Bangalore
Aeronautical Development Establishment (ADE), Bangalore
Airport Authority of India, New Delhi
Allied Electronics Corporation, Mumbai
Bharat Dynamics Ltd., Hyderabad
Cee Cee Power Hydraulics Pvt Ltd, Indore
Centre for Military Air Worthiness and Certification(CEMILAC), Bangalore
Directorate General of Civil Aviation. New Delhi
Directorate General of Aeronautical Quality Assurance(DGAQA), New Delhi
Himlustan Aeronautics Ltd, Nashik
Hindustan Aeronautics Ltd, Bangalore
Honeycomb India Pvt Ltd, Bangalore
Incab Industries Ltd. Pune
Indian Airlines, New Delhi
Indian Space Research Organization, Thiruvananthapuram
Mahindra Enginners & Chemical Products Ltd, Pune
OEN Connectors Ltd, Cochin
Sanghavi Aerospace Pvt Ltd, Ahmedabad
Space Application Centre (ISRO), Department of Space,Ahmedabad
‘Ihermodors Pvt Ltd, Pune
Representative(s)
SHRI M. L. SIDANA(Chairman)SHRI RAIW JAIN (Mterrrde)
SHRI MOHAN PHILIP
Srnu RAJENDRAPRASAD
SHRJS. C. SHRJMALI
SHRJPERDUMANSINGH
SHsr N. C. SUD (Alternate)
SHRI H.P. DASH
Srwu S. P. S. CHowosnmY (Alternate)
SHRJ BAKUL HARJSHANKER
Smu PARDIPBAKOL (A/terrrate)
W-m P. R. K. CHAKRAPANI
SrrruR. N. Dssm (Alferrra(e)
Smu h4ANU CHHUGANI
Smu JAYESHCHHUGANt(Alternate)
SHJUK. V. MORALI
Smu V. K. KALYANAM(Alternate)
Sm B. K. Josrn
SrrruN. S. MONDAY (Ahervrafe)
SHRJS. G. KAVIMANDAN
Ss+mM. C. SHARMA(Alternate)
!%u G. M. SATBHAI
Swu P. B. PruBr+orw(Alternate)
SHRJS. K. VELLUSWAMY
SHJUN. MGTHUSWAMY(Alternate)
SHRI M. B. R.AKSFUT
SHIU K. V. R. RAOSmu A. J. BASU (Mernate)
SHRJRAhSANCHOPRA
SHRJS.B. R. SENOY
SHIUM. K. KJUSHANSWAMY(Alternate)
SHRJJ. P. RATH
Smu H. S. MEHTA(Alternate)
SHRJP. DILIP KUMAR
Smu KETAN SANGHVI
Smu BHARATSANGHVI(Alternate)
Wru VIJAY KIMAR
SHRJP. N. VENKATARAMAN
Smu MONAN IYER (Alternate)
11
IS 16000:2004
Organization
Vikram Sarabhai Space Centre, Thiruvananthapuram
BIS Directorate General
Representative(s)
StrrrrS. V. SHARMA
SmuSOJANTHOMAS(Akerwate)
SHNK. K. VASHISTHA,Dkector & Head (TED)[RepresentingDirectorGeneral (Ekofficio)]
Member-Secretary
SHRI J. M. KHANNAJoint Director (TED),BIS
Ad-hoc Panel on Aerospace Quality System Standards, TED 14/AP-l
Research Centre Imarat, Hyderabad
DirectorateGeneralof AeronauticalQuality Assurance (DGAQA),NewDelhi}
Centre for Military Airworthiness and Certification(CEMILAC), Bangalore
Aeronautical Development Establishment (ADE), Bangalore
Hindustan Aeronautics Ltd, Bangalore
Bharat Dynamics Ltd, Hyderabad
Directorate General of Civil Aviation, New Delhi
Smu WNDM PRASAD (Convener)
Srmr D. GANCOPADHYAY
Smu K. N. SINNA
SHRt V. K. KALYANAM
SW PERDUMANSINGH
Srmr N. C. AGARWALSmu M. V. MOHAN(Alternate)
Srrnr R.N. DESAI
SHRIN. S. MUNDAY
12
Bureau of Indian Standards
BIS is a statutory institution established under the Bureau of Indian Standards Act, 1986 to promoteharmonious development of the activities of standardization, marking and quality certification of goodsand attending to connected matters in the country.
Copyright
BIS has the copyright of all its publications. No part of these publications may be reproduced in any formwithout the prior permission in writing of BIS. This does not preclude the free use, in the course ofimplementing the standard, of necessary details, such as symbols and sizes, type or grade designations.Enquiries relating to copyright be addressed to the Director (Publications), BIS.
Review of Indian Standards
Amendments are issued to standards as the need arises on the basis of comments. Standards are also reviewedperiodically; a standard along with amendments is reaffirmed when such review indicates that no changes areneeded; if the review indicates that changes are needed, it is taken up for revision. Users of Indian Standardsshould ascertain that they are in possession of the latest amendments or edition by referring to the latest issue of‘BIS Catalogue’ and ‘Standards: Monthly Additions’.
This Indian Standard has been developed from Doc : No. TED 14 (352).
Amendments Issued Since Publication
Amend No. Date of Issue Text Affected
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