IQA iso9001-iso14001

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No.: CL_27_01_002e Edition: 01/2009 Page 1 of 44

Created by: Hackenauer Checked by: Kreiter Released by: Scheiber

A-4020 Linz, Am Winterhafen 1, phone: (+43 732) 34 23 22,Fax: (+43 732) 34 23 23, Homepage: www.qualityaustria.com,

E-mail: [email protected]

CHECKLIST

ISO 9001:2008 / 14001:2004This checklist must neither be copied nor reproduced, it remains QAs intellectual property.

Copyright 2008, by Quality Austria Trainings-, Zertifizierungs- und Begutachtungs GmbH /

Training, Certification and Evaluation Ltd.

Issuing date of the standards: ISO 9001:2008, ISO 14001:2004

Purpose 9001:2000 9001:2008

Self-assessment Date:

Short audit Date:

Certification audit Date:

Surveillance audit Date:

Recertification audit Date:

Follow-up audit Date:

Date:

Organization

Name

Address

Postal Code, town/city

Certified area

Area of activity

Contact person

Phone/fax

E-mail

Auditor team

1. Auditor (audit manager): Signature:

2. Auditor: Signature:

Observer: Signature:

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Email: [email protected]

Table of Contents:

Notes.......................................................................................................................... 4Management process................................................................................................. 8

Management obligations (provision of resources)...................................................... 9Management system................................................................................................ 10Document control ..................................................................................................... 12Control of quality records.......................................................................................... 14Processes and components in ISO 9001:2000......................................................... 15Competence, training and awareness ...................................................................... 16Internal audit............................................................................................................. 18Corrective action....................................................................................................... 20Preventive action...................................................................................................... 22Improvement process............................................................................................... 24Customer-related processes..................................................................................... 26Design and development.......................................................................................... 28Production / service provision................................................................................... 30Planning of the product realization (process control E.) ........................................... 31Management of resources (infrastructure, work environment).................................. 32

Purchasing................................................................................................................ 34Control of measuring and testing devices................................................................. 36Environmental aspects / environmental objectives................................................... 38Legal obligations and other requirements................................................................. 40Emergency preparedness and response and........................................................... 42Measurement, analysis, improvement...................................................................... 43Summary.................................................................................................................. 44Hints relating to the checklistt

U All those questions that are exclusively concerned with the environmental management system are marked with anE.

In the combined checklist, the requirements placed by the EMAS Regulation 761/2001 have been considered.

Notes on changes:

Parts marked in grey come from EN ISO 9001:2008. New words that have been inserted or changed words have partlybeen underlined.

Hint relating to handling risk management:

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EN ISO 9001:2008 (see 0.4 Compatibility with other management systems) does not include any requirements that

are specific for other management systems, such as environmental management, OH&S (Occupational Health andSafety) management, financial management or risk management. Nevertheless, this International Standard enables

an organization to align its own quality management system with the relevant management system requirements or

to combine its own quality management system with these systems (see further hints on p. 21 Preventive Action).

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Notes

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Processes and components in ISO 9001:2008Audi t objectives: Strengths/weaknesses + -

P*WW*

Standardpoints

Short name

4.1

4.2.1 General

4.2.2 Quality Management Manual

4.2.3 Document control

4.2.4 Control of records

5.1 Management commitment

5.2 Customer orientation

5.3 Quality policy

5.4.1 Quality objectives

5.4.2 Planning of the quality management system

5.6.1 General

5.6.2 Review input

5.6.3 Review output

5.5.1 Responsibility and authority

5.5.2 Management responsibility

5.5.3 Internal communication

6.1 Provision of resources

6.2.1 General

6.2.2 Competence, training and awareness

6.3 Infrastructure

6.4 Work environment

8.1 General

8.2.1 Customer satisfaction

8.2.2 Internal audit

8.2.3 Monitoring and measurement of processes

8.2.4 Monitoring and measurement of the product

8.3 Control of nonconforming product

8.4 Analysis of data8.5.1 Continual improvement

8.5.2 Corrective action

8.5.3 Preventive action

7.1 Planning of product realization

7.2.1 Determination of requirements related to the product

7.2.2 Review of the requirements in regard to the product

7.2.3 Customer communication

7.3.1 Design and development planning

7.3.2 Design and development inputs

7.3.3 Design and development results

7.3.4 Design and development evaluation

7.3.5 Design and development verification

7.3.6 Design and development validation

7.3.7 Control of the design and development process

7.4.1 Purchasing process

7.4.2 Purchasing information

7.4.3 Verification of purchased products

7.5.1 Control of the product/service provision

7.5.2 Validation of processes for product/service provision

7.5.3 Identification and traceability

7.5.4 Customer property

7.5.5 Preservation of product

7.6 Control of monitoring and measuring equipment

Key*P = Priority, *WW = Interaction, = Processes, = Components, = Components relating to a process

4. Quality Management System

Documentation requirements

6. Managementof resources

Ability,awarenessandtraining

Infrastructure

Work-

environment

7. Product realization

Customer-related processes

Development

Production /services provision

ID. /

traceab.

Customer

property

Protection ValidationSpecification/input

Product/service

Planning

Purchasing

Testequipment

Generalrequirements

(processmanagement)

Provisionofresources

Personnelresources

5. Responsibility of the management

Management

com

ittment

Policy

targets

planning

review

Responsibilityof

personappointed

byManagement

Customer

orientation

Internal

Co

mmunication

Quality

management

manual

Document

Control

Controlofrecords

8. Measurement, analysis andimprovement

Analysis ofdata

Customersatisfaction

Process-

measuringand

monitoring

Product

measurement

and

Internalaudits

Control of

non-comlyingproducts

Preventiveaction

Impro

vementmeasures

Co

rrectiveaction

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Protocol / notes: Discussion partner:

Vision:

Mission:

Policy:

Strategies:

Projects:

Programs:

Methods:

Tools:

Processes:

Key processes:

Key parameters:

Functions /responsibilities:

Roles:

The most importantkey data:

Audi t object ives:

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Processes and components in ISO 9001:2008Strengths/weaknesses + -

Shortname

4.1 General requirements

G 4.2.1 General

Q 4.2.2 Quality Management Manual

D 4.2.3 Document control

C 4.2.4 Control of records

M 5.1 Management commitment

C 5.2 Customer orientation

Q 5.3 Quality policy

Q 5.4.1 Quality objectives

P 5.4.2 Planning of the quality management system

G 5.6.1 General

R 5.6.2 Review input

R 5.6.3 Review output

R 5.5.1 Responsibility and authority

M5.5.2 Management responsibilityI 5.5.3 Internal communication

P 6.1 Provision of resources

G 6.2.1 General

C 6.2.2 Competence, training and awareness

I 6.3 Infrastructure

W 6.4 Work environment

G 8.1 General

C 8.2.1 Customer satisfaction

I 8.2.2 Internal audit

M 8.2.3 Monitoring and measurement of processes

M 8.2.4 Monitoring and measurement of the product

C 8.3 Control of nonconforming product

A 8.4 Analysis of dataC 8.5.1 Continual improvement

C 8.5.2 Corrective action

P 8.5.3 Preventive action

P 7.1 Planning of product realizationD 7.2.1 Determination of requirements related to the product

R 7.2.2 Review of requirements related to the product

C 7.2.3 Customer communication

D 7.3.1 Design and development planning

D 7.3.2 Design and development inputs

D 7.3.3 Design and development results

D 7.3.4 Design and development evaluation

D 7.3.5 Design and development verification

D 7.3.6 Design and development validationC 7.3.7 Control of the design and development process

P 7.4.1 Purchasing process

P 7.4.2 Purchasing information

V 7.4.3 Verification of purchased products

C 7.5.1 Control of the product/service provision

V 7.5.2 Validation of processes for product/service provision

I 7.5.3 Identification and traceability

C 7.5.4 Customer property

P 7.5.5 Preservation of product

C 7.6 Control of monitoring and measuring equipment


Objectives

Planningsub-objectives

Meansprocessesproducts/services

Customersatisfaction

auditsprocessesproducts /

services system

Update statisticaldata

Evaluation of theservice

Systemmodification

Improvement

Vision / missionpolicy

Strategy

Implementationtaking requirements

into account

Measurementmonitoringcorrectionprevention

Analysissequential, parallel,

periodic checks

Review

Management process E 4.2/4.3.3/4.6

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Management processAudit objectives:

Observations/references:

Nonconformities with the Standard (number of theimprovement measure protocol):

Hints, recommendations:

Y N

5.3 Policy (Q+E)

Does top management ensure that the quality policy:

5.3-01 is suitable for the purpose of the organization?

5.3-02 contains an obligation for the fulfilment of the requirementsand for the continuous improvement of the effectiveness of thequality management system?5.3-03 offers a framework for the establishing and evaluation ofthe quality objectives?5.3-04 is distributed and understood within the organization?5.3-05 is evaluated in terms of its continuing suitability for purposerequired?E 4.201 Does an environmental policy in writing, established bytop management exist?E 4.202 Is it appropriate in terms of the type, extent andenvironmental effects of the activities, products or services of theorganization?E 4.203 Does it contain an obligation for continuousimprovement and the avoidance of environmental pollution?E 4.204 Does it contain an obligation for the maintaining of therelevant environmental legislation and regulations plus otherrequirements?E 4.205 Does it form a framework for the establishing andevaluation of the environment related objectives and individualtargets?E 4.206 Are all persons who work for or on behalf of thecompany informed about it?

E 4.207 Is it accessible to the public?5.4 Planning

5.4.1 Quality objectives and environmental objectives

5.4.1-01 Does the top management ensure that the qualityobjectives have been established for the relevant functional areasand levels including those that are required for the fulfilment of therequirements for products?

5.4.1-02 Are the quality objecitves measurable and are theyconsistent with the quality policy?

E 4.3.301 Have environmental related objectives and separateobjectives been established and are these being maintained?

E 4.3.302 Does the objective process take account:- applicable statutory requirements,- the significant environmental aspects,- the technological options,- economic circumstances,- the operative environment,- the standpoint of parties involved?

5.6 Management review

5.6.1 General

5.6.1-01 Does the top management review the quality management

system of the organization at planned intervals in order to ensure itscontinuing suitability, applicability and effectiveness?

5.6.1-02 Does this review of the evaluation of possibilities forimprovements and the change requirement for the qualitymanagement system also include the quality policy and the qualityobjectives?

5.6.1-03 Are the notes made concerning the management reviewmaintained?

5.6.2 Input for review

Does the input for the management review contain information about thefollowing issues:

5.6.2-01 Results of audits?5.6.2-02 Feedback from customers?5.6.2-03 Process performance and product conformity?5.6.2-04 The status of preventive and corrective actions?5.6.2-05 Measures to be taken as a consequence of precedingmanagement reviews?5.6.2-06 Planned changes that could have an effect on the qualitymanagement system?5.6.2-07 Recommendations for improvements?

E 4.6-01 The results of the review in regard to the fulfilment ofthe relevant regulations

E 4.6-02 Information provided by external interested partiesincluding complaintsE 4.6-03 Environmental achievements of the organizationE 4.6-04 The extent of the achievement of objectives

5.6.3 Results of the management review

Do the results contain all the decisions and measures from the review on thefollowing issues:

5.6.3-01 Improvement of the effectiveness of the qualitymanagement systems and its processes?

5.6.3-02 Product improvement in regard to customer requirements

5.6.3-03 Resources requirements?

Please note: Requirement in accordance with the QA general terms andconditions and/or EN 45012

Arecomplaints also dealt with and documented in the scope of thisevaluation in regard to the QM system?

AA

AA

AA

N

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Management obligations (provision of resources)Audit objectives:




YN

5.1 Management Obligations

5.1-01 Can top management prove fulfilment of itsobligation in regard to the development and implementationof the quality management system?

Can it prove that the effectiveness of the QMS is beingcontinuously improved by:

5.1-02 conveying to the organization the significance offulfilment of customer requirements as well as of thestatutory and official requirements?

5.1-03 establishing the quality policy?

5.1-04 assuring that quality objectives have beenestablished?

5.1-05 conducting management reviews and assuring theavailability of resources?


5.2-01 Has top management assured that the issue ofcustomer requirements has been communicated and fulfilledwith the objective of increasing customer satisfaction?

5.4.2 Planning of th e quality management s ystemDoes top management ensure that:

5.4.2-01 the planning of the quality management system isdone in a manner so as to fulfil the specifications given insection 4.1 and to achieve the quality objectives?

5.4.2-02 the functionality of the quality management systemis maintained, when changes to the quality managementsystem are planned and implemented?

5.5.1 Responsibility and authori ty (Q+E)

5.5.1-01 Does top management assure that theresponsibilities and authorities and their interactions withinthe organization have been defined and have been madeknown?

5.5.2 Management Representative

Has top management appointed a member, who independent of allother responsibilities, has responsibility and authority including thefollowing points:

5.5.2-01 Ensuring that the required processes areintroduced, implemented and maintained for the quality

management system?5.5.2-02 That top management receives reports on theperformance of the quality management system and anyrequirements for improvements?

5.5.2-03 That the requirements for the awareness ofcustomer requirements are established throughout theentire organization?

5.5.3 Internal commun ication

5.5.3-01 Does top management assure that suitableprocesses of communication within the organization areintroduced and that a communication about theeffectiveness of the quality management system actuallytakes place?

E 4.4.301 Does a procedure in writing exist for thereciprocal internal communications in regard toenvironmental aspects and for the EMS?

4.4.3 Communication (external)

E 4.4.302 Does a procedure in writing exist for thereception of reported information in regard to the EMS fromexternal interested parties?

E 4.4.303 Is this reported information from externalinterested parties suitably documented and answered?

E 4.4.304 Is a documented decision in regard to thisexternal communication concerning significantenvironmental aspects available and, where relevant, is thisprocedure defined?

Note: e.g. essential information in accordance with environmentallaw6.1 Provision o f resources

Does the organization determine the resources and provide themfor:

6.1-01 the quality management system forimplementation and maintenance and for continualimprovement of effectivity?

6.1-02 to increase customer satisfaction by increasing thefulfilment of the customer requirements?

AA

AA

AA

AA

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Management systemAudit objectives:


Nonconformities with theStandard(no. of the improvementmeasure protocol):


Y N

4 Quality management system

4.1 General specifications (Q+E)4.1-01 Has the organization built up, documented, realizedand maintained a quality management system and has itconstantly improved its effectiveness?

4.1-02 Are the processes and their application required forthe quality management system recognizable in the entireorganization?

4.1-03 Is the sequence and interaction of these processesdefined?

4.1-04 Have the required criteria and methods beenestablished for assuring the effective implementation andsteering of these processes?

4.1-05 Has the availability of resources and informationbeen assured that are required for the implementation andmonitoring of these processes?

4.1-06 Are these processes monitored, measured andanalyzed?

4.1-07 Have the required measures been established inorder to achieve the planned results together with a constant

improvement of these processes?4.1-08 Has the organization decided to outsource aprocess influence product conformity with the requirements?

4.1-09 Does the organization ensure control of theseprocesses?

4.1-10 Is the control of such outsourced processesestablished in the quality management system?

E 4.1-01 Has the environmental management system beenfully developed and introduced (all elements of ISO 14001)?

E 4.1-02 Has the area of application of the EMS beenclearly defined?

4.2 Documentation requirements

4.2.1 General (Q+E)

Does the documentation on the management system contain:

4.2.1-01 a documented quality policy and quality objectives?

4.2.1-02 a quality management manual?

4.2.1-03 documented procedures that are required by thisinternational standard?

4.2.1-04 documents that are required by the organization forthe assuring of the effective planning, implementation andsteering of all its processes?

4.2.1-05 the quality notes specified by this internationalstandard?

Does the EMS documentation contain:

- a description of the main elements of the EMS and itsinteraction plus notes referring to the documents belongingto it?

- documents and notes taken (reports) as demanded bythis international standard?

- documents and notes taken that are classed as essentialby the organization in order to assure effective planning,implementation and controlling of processes that relate tosignificant environmental aspects.

Has it been ensured that documents of external origin thatare classed as essential for the planning and the operationof the EMS are recognized and that their distribution ismonitored?

EXPLANATORY NOTE 1:When the designation "documented procedure" is used, this meansthat the relevant procedure is defined, documented, realized andmaintained.EXPLANATORY NOTE 2:The scope of the documentation of the quality management systemcan vary from organization to organization as a result of:a) The size of the organization and the type of its activities,b) The complexity and the interaction of the processes, andc) The capabilities of the personnel.EXPLANATORY NOTE 3:The documentation can be implemented in any form or type ofmedium.


Does the Quality Management Manual contain:

4.2.2-01 the area of application of the quality managementsystem including the details and the reasons for anyexclusions?

4.2.2-02 the documented procedure created for the qualitymanagement system or references to it?

4.2.2-03 a description of the interaction of the processes inthe quality management system?

AA

AA

NOTE 2 An outsourced process is a processthe organization needs for its qualitymanagement system and that theorganization has chosen to be carried out byan external party.

NOTE 3 Ensuring control of the outsourcedrocesses does not relieve the organization

of the responsibility for fulfilment of thecustomer requirements and the legal andregulatory requirements. The type and scope

of control to be used for the outsourcedrocesses can be influenced by such factors

as:a) the potential influence of the outsourcedrocesses on the organizations capability of

delivering products meeting therequirements;b) the extent to which control of the therocess is broken down;

c) the capability of reaching required controlby applying Clause 7.4.

NOTE 1 Processes required for the qualitymanagement system include processes forservice provision, provision of resources,roduct realization and measurement,

analysis and improvement.

NOTE 2: The scope of documentation of the qualitymanagement system can be different from oneorganization to the other because ofa) the organizations size and the type of itsactivities;b) complexity and interaction between theprocesses; andc) the capabilities of the personnel

NOTE 3: Documentation can be implemented inany form or type of a medium.

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Processes and components in ISO 9001:2008Strengths/weaknesses +-

P*WW*

Norm-points

Short name


4.2.1 General






5.3 Quality policy



5.6.1 General

5.6.2 Review input

5.6.3 Review output


5.5.2 Management responsibility5.5.3 Internal communication


6.2.1 General


6.3 Infrastructure


8.1 General






8.4 Analysis of data

8.5.1 Continual improvement





7.2.2 Review of requirements related to the product



















Publishingupdating

withdrawalremoval

destroyingarchiving of the original

Creating, maintaining

Identifyingmarking

cataloging

Reviewreleasing

Publishingupdating

Withdrawalremoval

destroying

Changingreview

releasing

Document Control

E 4.4.5

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Document contro lAudit objectives:




Y N

4.2.3 Document control (Q+E)

4.2.3-01 Are the documents required for the qualitymanagement system being controlled?

4.2.3-02 Quality records represent a special documenttype. Are they being controlled in accordance with thespecifications in section 4.2.4?

Does a documented procedure exist for establishing the controlmeasures required in order:

4.2.3-03 to approve the documents prior to publicationin respect to their adequacy?

4.2.3-04 to evaluate documents, update them if requiredand approve them anew?

4.2.3-05 to ensure that the changes and the currentediting status of the documents are marked?

4.2.3-06 to ensure that the valid versions of relevantdocuments are available at the appropriate points of use?

4.2.3-07 to ensure that the documents are legible and

easily recognized?4.2.3-08 to ensure that those documents of externalorigin are marked and that their distribution is controlled?

4.2.3-09 to prevent the unintentional use of outdateddocuments and to make sure that these are marked in anappropriate manner, in the event that they must bepreserved for any reason?

E 4.4.5-01 Has it been ensured that documents ofexternal origin that are classed as essential for the planningand the operation of the EMS are recognized and that theirdistribution is monitored?N

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P*WW*

Norm-points

Short name


4.2.1 General






5.3 Quality policy



5.6.1 General

5.6.2 Review input

5.6.3 Review output




6.2.1 General


6.3 Infrastructure


8.1 General































Destroying

Creatingcollectingordering

identifyingcataloging

Releasingdistributing

Filingsecuring

Defiing the timeof keeping

Protectingpreseving

Control of quality records

E 4.5.3

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Control of quality recordsAudit objectives:




Y N4.2.4 Control of quality records (Q+E)

4.2.4-01 Are quality records produced and maintained,as a proof of conformity with the specifications and of theeffective functioning of the quality management system?

4.2.4-02 Are the quality records kept legible, easy torecognize and easy to find at all times?

4.2.4-03 Does a documented procedure exist forestablishing the control measures that are essential for themarking, keeping, protection, ready accessibility, themaintenance deadline for preserving quality records andthe power of disposal over quality records?

E 4.5.301 Are the required environment-related recordsdefined and do they comprise among other points:- Training notes?

- Audit evidence?

- Review evidence?

- The results of the evaluation in regard to the fulfillment ofthe relevant regulations?

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P*WW*

Norm-points

Short name


4.2.1 General






5.3 Quality policy



5.6.1 General

5.6.2 Review input

5.6.3 Review output




6.2.1 General


6.3 Infrastructure


8.1 General































E 4.4.2

Analysis of theneedsabilitiesgaps

Planningbudgetingselection

of providers

Agreementimplementation

Evaluation of benefits

Checkingcoverage of needs

Competence, training and awareness

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Competence, training and awarenessAudit objectives:




Y N

6.2 Personnel Resources (Q+E)

6.2.1 General6.2.1-01 Ist the personnel performing tasks which affectfulfilment of the product requirements competent on thebasis of adequate education, training, skills andexperiences?

6.2.2 Competenc e,trainin g and awareness

6.2.2-01 Does the organization determine the requiredcompetence for personnel performing work affectingproduct quality?

6.2.2-02 Does the organization determine providetraining or take other actions to satisfy these needs?

6.2.2-03 Does the organization evaluate theeffectiveness of the actions taken?

6.2.2-04 Does the organization ensure that its personnelare aware of the relevance and importance of theiractivities and how they contribute to the achievements ofthe quality objectives?

6.2.2-05 Does the organization maintain appropriaterecords of education, training, skills, and experience?

NOTE: Fulfilment of the product requirements can beinfluenced by the personnel carrying out any activitywithin the quality management system directly orindirectly.

E 4.4.2-01 Is it ensured that every person performingtasks for the organization or on behalf of the organization,from which - following determination oft he organization(an) important effect(s) on the environment may result, isqualified based on his/her education, training, andexperience.

E 4.4.202 Is the need for training of employees inenvironmentally relevant fields established?

E 4.4.203 Are there proceedings for the building ofawarenessfor the following complex of questions foremployees in environmentally relevant functions andcontractors?

a) The importance of adherence to enivromental politicsand all demands of EMSb) personel contribution to environmental protection?

c) tasks and responsibitlities in EMS?d) possible consequences in the event of deviation frompredefined work processes?

E 4.4.204 Does the qualification (competence) of thepersonnel with specifically attributed and environmentallyrelevant tasks with regard to eduction, training andexperience exist?

Hint: Verification and review, e.g., based on a list of theenvironmental representatives

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P*WW*

Norm-points

Short name


4.2.1 General






5.3 Quality policy



5.6.1 General

5.6.2 Review input

5.6.3 Review output




6.2.1 General


6.3 Infrastructure


8.1 General































Analysis of theneeds andfrequency

Definition of thearea

processes

persons

Planningselection of the

auditorsmethods and

means

Implementing

coordinatingcomparison of conformitydeveloping an improvement

potential

Establishing and implementing

follow-up acitivities

Internal audit

Reporting

E 4.5.4

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Internal auditAudit objectives:




Y N8.2.2 Internal audit(Q+E)

Does the organization coduct internal audits at planned intervals todetermine whether the quality management system:

8.2.2-01 conforms to the requirements specified by thisInternational Standard and to the quality managementsystem requirements established by the organization?

8.2.2-02 is effectively implemented and maintained?

8.2.2-03 Is an audit program created in which thesignificance of the processes to be audited and the areasas also the results of previous audits are taken intoaccount?

8.2.2-04 Are the audit criteria, the scope of the audit,the audit frequency and the audit method defined?

8.2.2-05 Does the selection of auditors and the carryingout of the audits ensure the objectivity and impartiality ofthe audit process?

8.2.2-06 Is it assured that the auditors are not auditingtheir own activities?

8.2.2-07 Are the responsibilities and requirements forplanning and conducting audits as also on the reporting ofthe results and the maintaining of records defined in adocumented procedure?

8.2.2-08 Has the management responsible for the areabeing audited assured that actions are being taken withoutundue delay to eliminate detected nonconformities andtheir causes

8.2.2-09 Do the follow-up measures include provisionsfor the verification of the actions taken and the reporting ofverification results?

E 4.5.401 Are these procedures suitable for establishingwhether the environmental management system:-complies with the internal arrangements and theISO 14001 requirements?

- has been implemented and maintained in an orderlymanner?

E 4.5.402 Does the audit and the environmentaloperational auditing program take account of:- The significance of the activity for the environment?

- The results of previous audits?

AA

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P*WW*

Norm-points

Short name


4.2.1 General






5.3 Quality policy



5.6.1 General

5.6.2 Review input

5.6.3 Review output




6.2.1 General


6.3 Infrastructure


8.1 General










7.1 Planning ofproduct realization





















Selectingweightingevaluatingexisting

problems

Analyzingcauses

Definingand implementing

measures

Checkingthe effectivenessof the measures

Correction measures

Definingintroducing

implementingevaluating

follow-up measures

E 4.5.2

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Corrective actionAudit objectives:




Y N8.5.2 Corrective action (Q+E)

8.5.2-01 Have corrective actions been taken for dealingwith the causes of nonconformities to prevent them fromreoccurence?

8.5.2-02 Corrective actions shall be appropriate to theeffects on the nonconformieties encountered. Is this thecase?

Has a documented procedure een established to definerequirements for :

8.5.2-03 Reviewing nonconformities (including customercomplaints)?

8.5.2-04 Determining the causes of nonconformities?

8.5.2-05 Evaluating the need for action to ensure thatnonconformities do not recur?

8.5.2-06 Determining and implementing action needed?

8.5.2-07 Records of the results of actions taken?

8.5.2-08 Reviewing of corrective action taken?

E 4.5.201 Has it been assured that environmentallyrelevant occurrences are systematically and appropriatelyrecorded?

AA

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E 4.5.2

Identifyingweightingevaluating

potential butstill non-existentproblems / risks

Consideringpotential causes

Defining andimplementing

preventive actions

Verification whether

risks arereduced

Preventive action

Definingintroducing


subsequent activities

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Preventive actionAudit objectives:




Y N

8.5.3 Preventive action8.5.3-01 Has preventive action been determined toeliminate the causes of potential nonconformities in order toprevent their occurence?

8.5.3-02 Preventive actions shall be appropriate to theeffects of potential problems. Is this the case?

Does an introduced documented procedure exist to definerequirements for:

8.5.3-03 Determining potential nonconformities and theircauses?

8.5.3-04 Evaluating the need for action to preventoccurrence of nonconformities?

8.5.3-05 Determining and implementing action needed?

8.5.3-06 Records of results of action taken?

8.5.3-07 Reviewing preventive action taken?

Reference to risk management ISO/DIS 31000

(see the hint relating to handling risk management on page2 of this checklist)

Making people aware of potential risks, particularly relating

to the QM System, is a concern of Quality Austria. Thisprocedure can be demonstrated best by making a risk

analysis in the context of management review. Still anotheroption is to integrate the risk management aspects in the

process of preventive action.

Risk management (excerpt from the definition in the coursefor risk management offered by Quality Austria):

Risk management means to know the risks and be capable ofwinning relevant opportunities. The general objective of risk

management is to contribute to sustainably securing the

existence and subsistence of the organization by adequatelyhandling risks. By no means does this mean the complete

elimination of all the conceivable potentials of disturbance. Itrather is a matter of striving for a risk or safety level that is

optimal under aspects of economic efficiency.

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6.2.1 General


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7.3.4 Design and development evaluation7.3.5 Design and development verification













E

Defining and settingpriorities for the

improvement potentialthe system,

the processes,the products,the services,

the communication,the Information

Consider objectivesand make them

binding

Planning,Implementing, and

monitoring of activities,

Verifying achievement ofobjectives

Improvement process

Definingintroducing


subsequent activities

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Improvement processAudit objectives:




Y N

8.5.1 Continuous improvement8.5.1-01 Is the effectiveness of the quality managementsystem continuously improved through the use of qualitypolicy, quality objectives, audit results, data analysis,corrective and preventive actions as also throughmanagement assessment?

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Requirements

Analysisidentificationcomparison

Evaluation of thesuitability for implementation and

feasibility

Chancesrisks

standardsfactors of influence

Analysis of thefeedback

Customer-related processes

External / internalcommunication

interactivesequential

parallelproactivereaktive

Follow-up activities

E 4.3.1/4.3.2/4.4.3/4.4.6

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Customer-related processesAudit objectives:




Y N7.2 Customer-related processes7.2.1 Determination of r equirements relating to the product

Does the organization determine:7.2.1-01 requirements specified by the customer,including the requirements for delivery and post-deliveryactivities?

7.2.1-02 requirements not stated by the customer butnecessary for specified or intended use, where known?

7.2.1-03 statutory and regulatory requirements relatedto the product?

7.2.1-04 All other specifications defined by theorganization ?

NOTE Activities after delivery include measures takenbecause of warranty conditions, contractual obligations,such as maintenance, and supplementary services, such asrecycling and reuse or waste disposal.

7.2.1 Review of the requi rements related to the prod uct

7.2.2-01 Does the organization review the requirements

related to the product?

7.2.2-02 Is this review conducted prior to theorganization s commitment to supply a product to thecustomer ( e.g. submission of tenders, acceptance ofcontracts or orders, acceptance of changes to contracts ororders)?

Does it ensure:

7.2.2-03 That product requiements are defined?

7.2.2-04 contract or order requirements differing fromthose previously expressed are resolved?

7.2.2-05 That the organization has the ability to meedthe definded requirements?

7.2.2-06 That records of the results of the review andactions arising from the review are maintained?

7.2.2-07 That the customer requirements prior toacceptance are confirmed by the organization when thecustomer has not previously presented a documentedstatement of requirement?

7.2.2-08 Does the organization ensure when product

requirements change that the relevant documents are alsochanged and that the personnel responsible are madeaware of the changed requirements?

EXPLANATORY NOTE: In a number of cases e.g. Internet sales,a formal evaluation of each separate order is not practicable.Instead of this the evaluation can refer to relevant productinformation such as catalogs or advertising material for example.

7.2.3 Customer commun ication

Does the organization have effective regulations for communicationwith the customer that have been established to cover the followingpoints and have these been implemented with regard to:

7.2.3-01 Product information?

7.2.3-02 Enquiries, contracts or order handlingincludingamendments?

7.2.3-03 Feedback from the customer includingcustomer complaints?

E 4.4.601 Is the checking of the customersenvironmental requirements done before the producing ofan offer or the acceptance of an order (feasibility study)?

E 4.4.602 Is a relevant consultation and instruction withthe customer made about handling products that arehazardous to the environment?

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E 4.4.6

Ideasanalyses

customer wishesinternal / external

specifications

Specification

Decisionplanning

project planning

Design / development process

Design/deve

lopment

Design/rReviews

Verification

Valididation

Designresults/

development

resuts

Design

developmentchanges

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Design and developmentAudit objectives:



Notes, recommendations:

Y N

7.3 Design and Development

7.3.1 Design and development planning7.3.1-01 Does the organization plan and control the designdevelopment of the products?7.3.1-02 Are appropriate evaluation, verification andvalidation for each development phase during the design anddevelopment planning and the design and development phasesand the responsibilities and authorities for the design anddevelopment defined?7.3.1-03 Does the organization manage and control theinterfaces between the different groups involved in the designand development groups, in order to assure an effectivecommunication and a clear assignement of responsibility?7.3.1-04 Is the planning output updated with the continuingdesign and development insofar as this is appropriate?

NOTE Design and development review, verification and validationserve for certain purposes. They may be conducted and recordedindividually or in any combination suitable for the product andorganization.

E 4.4.601 Are environmentally relevant aspects taken intoaccount in the design and development planning and in theentire design and development process?


7.3.2-01 Are inputs in regard to the product requirements

established and recorded?Do these include:

7.3.2-02 Functional and performance requirements?

7.3.2-03 Applicable statutory and regulatory requirements?

7.3.2-04 Where appropriate is information derived fromprevious similar designs and developments?7.3.2-05 Other specifications important for the design anddevelopment?7.3.2-06 Are these inputs evaluated on the basis of theirappropriateness?7.3.2-07 Are the specifications complete, clear and free fromcontradictions?e 4.4.602 Are the environmentally relevant specificationsmade for the product that is to be developed (DL) (including allstatutory and authority specifications) clearly andcomprehensively defined?


7.3.3-01 Are the development results provided in a form,making their verification possible over and against thedevelopment inputs, and are they subject to approval beforerelease?

Is it ensured that the development results:

7.3.3-02 Fulfill the development specifications?7.3.3-03 That suitable information is provided for the buying,production and services provision?7.3.3-04 Acceptance criteria for the product are contained orreference made to them?7.3.3-05 Those characteristics of the product areestablished that are essential for a use for the purpose intended?

NOTE Information for production and service provision can includedetails for maintenance of the product.


Are systematic reviews carried out in suitable phases in order to:

7.3.4-01 Assess the suitability of the development results forthe fulfillment of the specifications?7.3.4-02 To recognize all problems and to suggestnecessary measures?7.3.4-03 Do the participants of reviews of this kind includerepresentatives of the functional areas that are affected by theevaluated development phase or the evaluated developmentphases?7.3.4-04 Are notes taken about the results of the reviewsand about essential measures?


7.3.5-01 Is a verification is carried out in order to assure thatthe design and development results fulfill the design anddevelopment specifications?7.3.5-02 Are notes taken about the results of the verificationand about essential measures?

7.3.6 Design and development validation 7.3.6-01 Has a development validification been carried outin accordance with the planned arrangements (see 7.3.1), toensure that the resultant product is capable of meeting therequirements for the defined or intended use, where known?7.3.6-02 Has the validation been completed where possiblebefore the delivery or the introduction of the products?7.3.6-03 Are notes taken about the results of the validationand about essential measures?

7.3.7 Control of design and odevelopment changes

7.3.7-01 Are design and development changes identifiedand recorded?7.3.7-02 Are changes reviewed, verified and validated andalso approved before their implementation insofar as it isreasonable to do so?7.3.7-03 Does the evaluation of the development changesinclude the assessment of the effects of the changes on the

components and the delivered products?7.3.7-04 Are records of the results of the review of changes

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Specifications

Planningavailability of:informationinstructionscheck lists

equipmentmeasuring & testing

aidsresources

Implementationsteeringcontrol

Resultproduct /service

Production / service provision

Validation

Protectionoftheproducts/services

Iden

tificationandtracability

Customerprpoerty

E 4.4.6

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Production / service provisionAudit objectives:




Y N

7.5 Production and service pro vision

7.5.1 Control o f the product/ service provi sion7.5.1-01 Are production and service provision in the

planned form and are they implemented under controllableconditions?

Do the controllable conditions contain where appropriate:

7.5.1-02 The availability of data describing thecharacteristics of the product?7.5.1-03 The availability of the working instructions?

7.5.1-04 The use of suitable equipment?

7.5.1-05 The availability and use of monitoring andmeasuring equipment?7.5.1-06 The implementation of monitoring andmeasurements?7.5.1-07 The implementing of release and deliveryactivities and activities subsequent to the delivery?E 4.4.601 Are raw materials, auxiliary and operatingmaterials that are hazardous to the environment identifiedaccording to statutory or internal specifications?E 4.4.602 Are notes taken about raw materials, auxiliaryand operating materials that are hazardous to theenvironment as also about wastes according to statutory orinternal specifications?E 4.4.603 Are procedures available for handling, storage,packaging and dispatch of raw materials, auxiliary andoperating materials that are hazardous to the environmentas also about wastes?e 4.4.604 Are suitable storage conditions in existence forthe storage of raw materials, auxiliary and operatingmaterials that are hazardous to the environment as alsoabout wastes?

7.5.2 Validation of processes for product/service provision7.5.2-01 Have all the processes for production andservice provision where the resulting output cannot beverified y subsequent monitoring or measurement beenvalidated?7.5.2-02 Does this also included all processes wheredeficiencies become apparent only after the product is inuse or the service has been delivered?7.5.2-03 Does this validation demonstrate the ability ofthese processes for the achievement of the plannedresults?

Have arrangements been established for these processes insofaras this is relevant, containing:

7.5.2-04 defined criteria for review and approval of theprocesses?7.5.2-05 Approval of equipment and qualification ofpersonnel?7.5.2-06 Use of specific methods and procedures?

7.5.2-07 Specifications to be recorded?

7.5.2-08 Renewed validation?

7.5.3 Identification and traceability7.5.3-01 Is identification of the products with suitablemeans during the entire product realization performedinsofar as this is reasonable?7.5.3-02 Is identification made of the product status inrespect to the monitoring and measurement requirements?7.5.3-03 If traceability is a requirement, does theorganization control and record the unique identification ofthe product?

7.5.4 Customer p roperty7.5.4-01 Does the organization exercise care withcustomer property while it is under the organizations controlor being used by the organization?7.5.4-02 Does the organization identify, verify protectand safeguard the customer property that is entrusted to itfor use or for inclusion in the product?7.5.4-03 In the event that any customer property is lost,damaged or otherwise found to be unsuitable for use, isthis reported to the customer and are records maintainedthereof ?EXPLANATORY NOTE: Customer property canalso include intellectual property.

7.5.5 Preservation of pr oduct 7.5.5-01 Is the conformity of the product maintainedduring the internal processing and delivery to the intendeddestination?7.5.5-02 Does this preservation include identification,handling, packaging, storage and protection?7.5.5-03 Does this preservation also apply to theconstituent parts of a product?

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Planning of the product realization(process control E.)

Audit objectives:Observations/references:



Y N

7.1 Planning of product realization (Q+E)7.1-01 Does the organization plan and develop theprocesses that are required for the product realization?

7.1-02 Is the planning of the product realization inharmony with the specifications for the other processes ofthe quality management system?

Does the organization establish the following in the productrealization, insofar as this is reasonable:

7.1-03 Quality objectives and requirements for theproduct?

7.1-04 The necessity of introducing processes, creatingand compiling documents and the product specific makingavailable of resources?

7.1-05 The required verification, validation, monitoring,inspection and test activities specific to the product and thecriteria for product acceptance?

7.1-06 The records needed to provide evidence that the

realization processes and resulting product meetrequirements?

7.1-07 Are the outputs of this planning available in a formsutiable for the organization s method of operation?

EXPLANATORY NOTE 1: A document specifying the processes ofthe quality 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.

EXPLANATORY NOTE 2: The organization can also use therequirements given in section 7.3 for the development of theproduct realization processes.

E 4.4.601 Have those processes and activities beenestablished that are in the context of the significantenvironmental aspects that have been identified?

Note: Examples from ISO 14004: Research/development, design/engineering, purchasing, implementation of the contracts; rawmaterials handling and -storage; production and maintenanceprocedures.; laboratories; storage of products; transport; marketing,advertising; customer service; acquisition, erecting or changingproperties and plant.

E 4.4.6-02 Has it been established by means of thefollowing measures that these processes and establishedconditions have been carried out:

E 4.4.603 Documented procedures for situations in whichinfringements against the environmental policy and theenvironmental targets may occur without the existence ofappropriate regulations

E 4.4.604 Establishing the operational specifications inthe procedure?

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Management of resources (infrastructure, workenvironment)

Audit objectives:Observations/references:



Y N

6.3 Infrastructure

6.3-01 Does the organization determine, provide andmaintain the infrastructure needed to achieve conformityproduct requirements?

The infrastructure includes, e.g.:Buildings, workspace and the supply facilities connected to them,process equipment, both hardware and software, and supportingservices such as transport or communication.

E 4.4.601 Are environmentally relevant criteria taken intoaccount in establishing, preparing and maintaining theinfrastructure (real estate plot, building and plant)?


6.4-01 Does the organization determine and manage thework environment needed to achieve conformity to productrequirements?

NOTE The designation work environment refers to conditionsunder which work is being carried out, including physical, ecologicaland other factors, e.g. noise, temperature, humidity, lighting or

weather.

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Documents

IQA iso9001-iso14001