IQA Iso9001-Iso14001

CHECKLIST
ISO 9001:2008 / 14001:2004

This 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
Self-assessment Short audit Certification audit Surveillance audit Recertification audit Follow-up audit
9001:2000
Date: Date: Date: Date: Date: Date: Date:
9001:2008
Organization
Name Address Postal Code, town/city Certified area Area of activity Contact person Phone/fax E-mail
Auditor team
1. Auditor (audit manager): 2. Auditor: Observer: Signature: Signature: Signature:
No.: CL_27_01_002e Created by: Hackenauer
Edition: 01/2009 Checked by: Kreiter
Page 1 of 44 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: office@qualityaustria.com
CHECKLIST ISO 9001:2008 / 14001:2004

Table of Contents: Notes .......................................................................................................................... 4 Management process ................................................................................................. 8 Management obligations (provision of resources) ...................................................... 9 Management system ................................................................................................ 10 Document control ..................................................................................................... 12 Control of quality records.......................................................................................... 14 Processes and components in ISO 9001:2000......................................................... 15 Competence, training and awareness ...................................................................... 16 Internal audit............................................................................................................. 18 Corrective action....................................................................................................... 20 Preventive action ...................................................................................................... 22 Improvement process ............................................................................................... 24 Customer-related processes..................................................................................... 26 Design and development .......................................................................................... 28 Production / service provision................................................................................... 30 Planning of the product realization (process control E.) ........................................... 31 Management of resources (infrastructure, work environment).................................. 32 Purchasing................................................................................................................ 34 Control of measuring and testing devices................................................................. 36 Environmental aspects / environmental objectives ................................................... 38 Legal obligations and other requirements................................................................. 40 Emergency preparedness and response and ........................................................... 42 Measurement, analysis, improvement ...................................................................... 43 Summary .................................................................................................................. 44
Hints relating to the checklistt U All those questions that are exclusively concerned with the environmental management system are marked with an E. 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 partly been underlined. Hint relating to handling risk management:
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CHECKLIST ISO 9001:2008 / 14001:2004

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 and Safety) 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).
CHECKLIST ISO 9001:2008 / 14001:2004

Notes
CHECKLIST ISO 9001:2008 / 14001:2004

Processes and components in ISO 9001:2008 Audit objectives:
4. Quality Management System
Documentation requirements
Strengths/weaknesses
Standard points 4.1 4.2.1 4.2.2 General Quality Management Manual Document control Control of records Management commitment Customer orientation Quality policy Quality objectives Planning of the quality management system General Review input Review output Responsibility and authority Management responsibility Internal communication Provision of resources General Competence, training and awareness Infrastructure Work environment General Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of the product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action Planning of product realization Determination of requirements related to the product Review of the requirements in regard to the product Customer communication Design and development planning Design and development inputs Design and development results Design and development evaluation Design and development verification Design and development validation Control of the design and development process Purchasing process Purchasing information Verification of purchased products Control of the product/service provision Validation of processes for product/service provision Identification and traceability Customer property Preservation of product Control of monitoring and measuring equipment Short name
P* WW*
Control of records
Quality management manual
Document Control
General requirements (process management)
4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 5.4.2
5. Responsibility of the management

Responsibility of person appointed by Management
5.6.1 5.6.2
Internal Communication
Customer orientation
5.6.3 5.5.1 5.5.2 5.5.3 6.1
6. Management of resources
Management comittment
8. Measurement, analysis and improvement
Policy targets planning review
6.2.1 6.2.2 6.3 6.4 8.1 8.2.1

Improvement measures
Ability, awareness and training
Customer satisfaction
Provision of resources
Personnel resources
Internal audits
8.2.2 8.2.3 8.2.4 8.3 8.4 8.5.1 8.5.2 8.5.3 7.1
Processmeasuring and monitoring
Product measurement and monitoring
Infrastructure
Workenvironment
Control of noncomlying products
Preventive action
Corrective action
Analysis of data
7. Product realization
7.2.1 7.2.2 7.2.3 7.3.1

Product / service
Customer-related processes Specification / input
Development
7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1
Production / services provision ID. / traceab. Customer property Protection Validation
Test equipment
Purchasing
7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6
Key
*P = Priority, *WW = Interaction, = Processes, = Components, = Components relating to a process
Planning
CHECKLIST ISO 9001:2008 / 14001:2004

Protocol / notes: Discussion partner:
Vision: Mission: Policy: Strategies: Projects: Programs: Methods: Tools: Processes: Key processes: Key parameters: Functions / responsibilities:
Roles: The most important key data: Audit objectives:
CHECKLIST ISO 9001:2008 / 14001:2004

Processes and components in ISO 9001:2008
Management process + Short name 4.1 G Q D C M C Q Q P l G R R R M I P G C I W G 4.2.1 4.2.2 4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 5.4.2 5.6.1 5.6.2 5.6.3 5.5.1 5.5.2 5.5.3 6.1 6.2.1 6.2.2 6.3 6.4 8.1 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.5.1 8.5.2 8.5.3 7.1 7.2.1 7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6 General requirements General Quality Management Manual Document control Control of records Management commitment Customer orientation Quality policy Quality objectives Planning of the quality management system General Review input Review output Responsibility and authority Management responsibility Internal communication Provision of resources General Competence, training and awareness Infrastructure Work environment General Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of the product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action Planning of product realization Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development planning Design and development inputs Design and development results Design and development evaluation Design and development verification Design and development validation
Control of the design and development process
4.2/4.3.3/4.6
Vision / mission policy
Objectives
Strategy
Planning sub-objectives
Implementation taking requirements into account
Means processes products/ services
Measurement monitoring correction prevention
Customer satisfaction audits processes products / services system
C I M M C A C C P
Analysis sequential, parallel, periodic checks
Update statistical data
P l D
e R e
11
Review Evaluation of the service
D D D D D D
C o
P P V C
V a
Purchasing process Purchasing information Verification of purchased products Control of the product/service provision
Validation of processes for product/service provision
Improvement
System modification
I d C P C
Key
*P = Priority, *WW = Interaction, = Processes, = Components, =
Identification and traceability Customer property Preservation of product Control of monitoring and measuring equipment
Components relating to a process
CHECKLIST ISO 9001:2008 / 14001:2004

Y N
5.3 Policy (Q+E) Does top management ensure that the quality policy:
Management process
Audit objectives: Observations/references:
5.3-01 is suitable for the purpose of the organization? 5.3-02 contains an obligation for the fulfilment of the requirements and for the continuous improvement of the effectiveness of the quality management system? 5.3-03 offers a framework for the establishing and evaluation of the quality objectives? 5.3-04 is distributed and understood within the organization? 5.3-05 is evaluated in terms of its continuing suitability for purpose required? E 4.201 Does an environmental policy in writing, established by top management exist? E 4.202 Is it appropriate in terms of the type, extent and environmental effects of the activities, products or services of the organization? E 4.203 Does it contain an obligation for continuous improvement and the avoidance of environmental pollution? E 4.204 Does it contain an obligation for the maintaining of the relevant environmental legislation and regulations plus other requirements? 4.205 Does it form a framework for the establishing and N E evaluation of the environment related objectives and individual targets? E 4.206 Are all persons who work for or on behalf of the company 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 quality objectives have been established for the relevant functional areas and levels including those that are required for the fulfilment of the requirements for products?
Nonconformities with the Standard (number of the improvement measure protocol):
5.4.1-02 Are the quality objecitves measurable and are they consistent with the quality policy?
Hints, recommendations:
E 4.3.301 Have environmental related objectives and separate objectives 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 its continuing suitability, applicability and effectiveness?
5.6.1-02 Does this review of the evaluation of possibilities for improvements and the change requirement for the quality management system also include the quality policy and the quality objectives?
5.6.1-03 Are the notes made concerning the management review maintained? 5.6.2 Input for review Does the input for the management review contain information about the following 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 preceding management reviews? 5.6.2-06 Planned changes that could have an effect on the quality management system? 5.6.2-07 Recommendations for improvements? E 4.6-01 The results of the review in regard to the fulfilment of the relevant regulations E 4.6-02 Information provided by external interested parties including complaints E 4.6-03 Environmental achievements of the organization E 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 the following issues: 5.6.3-01 Improvement of the effectiveness of the quality management 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 and conditions and/or EN 45012 Are complaints also dealt with and documented in the scope of this evaluation in regard to the QM system?
CHECKLIST ISO 9001:2008 / 14001:2004

Protocol / notes: Audit objectives: Observations/references: Discussion partner:
Management obligations (provision of resources)

Y N
5.1 Management Obligations 5.1-01 Can top management prove fulfilment of its obligation in regard to the development and implementation of the quality management system? Can it prove that the effectiveness of the QMS is being continuously improved by: 5.1-02 conveying to the organization the significance of fulfilment of customer requirements as well as of the statutory and official requirements? 5.1-03 establishing the quality policy? 5.1-04 assuring that quality objectives have been established? 5.1-05 conducting management reviews and assuring the availability of resources? 5.2 Customer orientation 5.2-01 Has top management assured that the issue of customer requirements has been communicated and fulfilled with the objective of increasing customer satisfaction? 5.4.2 Planning of the quality management system Does top management ensure that: 5.4.2-01 the planning of the quality management system is done in a manner so as to fulfil the specifications given in section 4.1 and to achieve the quality objectives? 5.4.2-02 the functionality of the quality management system is maintained, when changes to the quality management system are planned and implemented? 5.5.1 Responsibility and authority (Q+E) 5.5.1-01 Does top management assure that the responsibilities and authorities and their interactions within the organization have been defined and have been made known? 5.5.2 Management Representative Has top management appointed a member, who independent of all other responsibilities, has responsibility and authority including the following points: 5.5.2-01 Ensuring that the required processes are introduced, implemented and maintained for the quality management system? 5.5.2-02 That top management receives reports on the performance of the quality management system and any requirements for improvements? 5.5.2-03 That the requirements for the awareness of customer requirements are established throughout the entire organization? 5.5.3 Internal communication 5.5.3-01 Does top management assure that suitable processes of communication within the organization are introduced and that a communication about the effectiveness of the quality management system actually takes place? E 4.4.301 Does a procedure in writing exist for the reciprocal internal communications in regard to environmental aspects and for the EMS? 4.4.3 Communication (external) E 4.4.302 Does a procedure in writing exist for the reception of reported information in regard to the EMS from external interested parties? E 4.4.303 Is this reported information from external interested parties suitably documented and answered? E 4.4.304 Is a documented decision in regard to this external communication concerning significant environmental aspects available and, where relevant, is this procedure defined? Note: e.g. essential information in accordance with environmental law 6.1 Provision of resources Does the organization determine the resources and provide them for: 6.1-01 the quality management system for implementation and maintenance and for continual improvement of effectivity? 6.1-02 to increase customer satisfaction by increasing the fulfilment of the customer requirements?
A
CHECKLIST ISO 9001:2008 / 14001:2004

Y 4 Quality management system 4.1 General specifications (Q+E) 4.1-01 Has the organization built up, documented, realized and maintained a quality management system and has it constantly improved its effectiveness? 4.1-02 Are the processes and their application required for the quality management system recognizable in the entire organization? 4.1-03 Is the sequence and interaction of these processes defined? 4.1-04 Have the required criteria and methods been established for assuring the effective implementation and steering of these processes? 4.1-05 Has the availability of resources and information been assured that are required for the implementation and monitoring of these processes? 4.1-06 Are these processes monitored, measured and analyzed? 4.1-07 Have the required measures been established in order to achieve the planned results together with a constant improvement of these processes? NOTE 1 Processes required for the quality management system include processes for 4.1-08 Has the organization decided to outsource a service provision, provision of resources, process influence product conformity with the requirements? product realization and measurement, 4.1-09 Does the organization ensure control of these analysis and improvement. processes? 4.1-10 Is the control of such outsourced processes established in the quality management system? E 4.1-01 Has the environmental management system been fully developed and introduced (all elements of ISO 14001)? NOTE 2 An outsourced process is a process the organization needs for its quality E 4.1-02 Has the area of application of the EMS been management system and that the clearly defined? organization has chosen to be carried out by 4.2 Documentation requirements an external party. 4.2.1 General (Q+E) Does the documentation on the management system contain: NOTE 3 Ensuring control of the outsourced 4.2.1-01 a documented quality policy and quality objectives? processes does not relieve the organization 4.2.1-02 a quality management manual? of the responsibility for fulfilment of the customer requirements and the legal and 4.2.1-03 documented procedures that are required by this regulatory requirements. The type and scope international standard? of control to be used for the outsourced 4.2.1-04 documents that are required by the organization for processes can be influenced by such factors the assuring of the effective planning, implementation and as: steering of all its processes? a) the potential influence of the outsourced 4.2.1-05 the quality notes specified by this international processes on the organizations capability of standard? delivering products meeting the Does the EMS documentation contain: requirements; - a description of the main elements of the EMS and its b) the extent to which control of the the interaction plus notes referring to the documents belonging process is broken down; to it? c) the capability of reaching required control by applying Clause 7.4. - documents and notes taken (reports) as demanded by this international standard? - documents and notes taken that are classed as essential by the organization in order to assure effective planning, implementation and controlling of processes that relate to significant environmental aspects. Has it been ensured that documents of external origin that are classed as essential for the planning and the operation of the EMS are recognized and that their distribution is monitored? EXPLANATORY NOTE 1: When the designation "documented procedure" is used, this means NOTE 2: The scope of documentation of the quality that the relevant procedure is defined, documented, realized and maintained. management system can be different from one EXPLANATORY NOTE 2: organization to the other because of The scope of the documentation of the quality management system a) the organizations size and the type of its can vary from organization to organization as a result of: activities; a) The size of the organization and the type of its activities, b) complexity and interaction between the b) The complexity and the interaction of the processes, and processes; and c) The capabilities of the personnel. c) the capabilities of the personnel EXPLANATORY NOTE 3: The documentation can be implemented in any form or type of NOTE 3: Documentation can be implemented in medium. any form or type of a medium. 4.2.2 Quality Management Manual N
Management system
Nonconformities with the Standard (no. of the improvement measure protocol):
Does the Quality Management Manual contain: 4.2.2-01 the area of application of the quality management system including the details and the reasons for any exclusions? 4.2.2-02 the documented procedure created for the quality management system or references to it? 4.2.2-03 a description of the interaction of the processes in the quality management system?
CHECKLIST ISO 9001:2008 / 14001:2004

P* WW*
+ -
Document Control
NormShort name points 4.1 General requirements 4.2.1 General Quality Management Manual Document control Control of records Management commitment Customer orientation Quality policy Quality objectives Planning of the quality management system General Review input Review output Responsibility and authority Management responsibility Internal communication Provision of resources General Competence, training and awareness Infrastructure Work environment General Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of the product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action Planning of product realization
Determination of requirements related to the product
E
Creating, maintaining
4.4.5
4.2.2 4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 5.4.2 5.6.1 5.6.2 5.6.3 5.5.1 5.5.2 5.5.3
Identifying marking cataloging
Review releasing
6.1 6.2.1 6.2.2 6.3 6.4 8.1 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4
Publishing updating
Withdrawal removal destroying
8.5.1 8.5.2 8.5.3 7.1 7.2.1 7.2.2
Review of requirements related to the product Customer communication Design and development planning Design and development inputs Design and development results Design and development evaluation Design and development verification Design and development validation
Changing review releasing
7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5
Publishing updating withdrawal removal destroying archiving of the original
7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6
Key
CHECKLIST ISO 9001:2008 / 14001:2004

Document control
Y N
4.2.3 Document control (Q+E) 4.2.3-01 Are the documents required for the quality management system being controlled? 4.2.3-02 Quality records represent a special document type. Are they being controlled in accordance with the specifications in section 4.2.4? Does a documented procedure exist for establishing the control measures required in order: 4.2.3-03 to approve the documents prior to publication in respect to their adequacy? 4.2.3-04 to evaluate documents, update them if required and approve them anew? 4.2.3-05 to ensure that the changes and the current editing status of the documents are marked? 4.2.3-06 to ensure that the valid versions of relevant documents 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 external origin are marked and that their distribution is controlled? 4.2.3-09 to prevent the unintentional use of outdated documents and to make sure that these are marked in an appropriate manner, in the event that they must be preserved for any reason? E 4.4.5-01 Has it been ensured that documents of external origin that are classed as essential for the planning and the operation of the EMS are recognized and that their distribution is monitored? N
CHECKLIST ISO 9001:2008 / 14001:2004

Strengths/weaknesses Control of quality records
P* WW* NormShort name points 4.1 General requirements 4.2.1 4.2.2 4.2.3 4.2.4 General Quality Management Manual Document control Control of records Management commitment Customer orientation Quality policy Quality objectives Planning of the quality management system General Review input Review output Responsibility and authority Management responsibility Internal communication Provision of resources General Competence, training and awareness Infrastructure Work environment General Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of the product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action Planning of product realization
+ -
4.5.3
Creating collecting ordering identifying cataloging
5.1 5.2 5.3 5.4.1 5.4.2 5.6.1 5.6.2 5.6.3 5.5.1 5.5.2 5.5.3 6.1 6.2.1 6.2.2 6.3 6.4
Releasing distributing
Filing securing
8.1 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4
Defiing the time of keeping
8.5.1 8.5.2 8.5.3 7.1 7.2.1 7.2.2
Protecting preseving
7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5
Destroying
7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6
Key
CHECKLIST ISO 9001:2008 / 14001:2004

Control of quality records

Y N
4.2.4 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 the effective functioning of the quality management system? 4.2.4-02 Are the quality records kept legible, easy to recognize and easy to find at all times? 4.2.4-03 Does a documented procedure exist for establishing the control measures that are essential for the marking, keeping, protection, ready accessibility, the maintenance deadline for preserving quality records and the power of disposal over quality records? E 4.5.301 Are the required environment-related records defined and do they comprise among other points: - Training notes? - Audit evidence? - Review evidence? - The results of the evaluation in regard to the fulfillment of the relevant regulations?
CHECKLIST ISO 9001:2008 / 14001:2004

Strengths/weaknesses Competence, training and awareness
P* WW* NormShort name points 4.1 General requirements 4.2.1 General Quality Management Manual Document control Control of records Management commitment Customer orientation Quality policy Quality objectives Planning of the quality management system General Review input Review output Responsibility and authority Management responsibility Internal communication Provision of resources General Competence, training and awareness Infrastructure Work environment General Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of the product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action Planning of product realization
E
Analysis of the needs abilities gaps
4.4.2
4.2.2 4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 5.4.2 5.6.1 5.6.2 5.6.3 5.5.1 5.5.2 5.5.3 6.1 6.2.1 6.2.2
Planning budgeting selection of providers
Agreement implementation
6.3 6.4 8.1 8.2.1 8.2.2
Evaluation of benefits
8.2.3 8.2.4 8.3 8.4 8.5.1 8.5.2
Checking coverage of needs
8.5.3 7.1 7.2.1 7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6
Key
CHECKLIST ISO 9001:2008 / 14001:2004

Competence, training and awareness

Y N
6.2 Personnel Resources (Q+E) 6.2.1 General 6.2.1-01 Ist the personnel performing tasks which affect fulfilment of the product requirements competent on the basis of adequate education, training, skills and experiences? 6.2.2 Competence,training and awareness 6.2.2-01 Does the organization determine the required competence for personnel performing work affecting product quality? 6.2.2-02 Does the organization determine provide training or take other actions to satisfy these needs? 6.2.2-03 Does the organization evaluate the effectiveness of the actions taken? 6.2.2-04 Does the organization ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievements of the quality objectives? 6.2.2-05 Does the organization maintain appropriate records of education, training, skills, and experience? NOTE: Fulfilment of the product requirements can be influenced by the personnel carrying out any activity within the quality management system directly or indirectly. E 4.4.2-01 Is it ensured that every person performing tasks 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, is qualified based on his/her education, training, and experience. E 4.4.202 Is the need for training of employees in environmentally relevant fields established? E 4.4.203 Are there proceedings for the building of awarenessfor the following complex of questions for employees in environmentally relevant functions and contractors? a) The importance of adherence to enivromental politics and all demands of EMS b) personel contribution to environmental protection? c) tasks and responsibitlities in EMS? d) possible consequences in the event of deviation from predefined work processes? E 4.4.204 Does the qualification (competence) of the personnel with specifically attributed and environmentally relevant tasks with regard to eduction, training and experience exist? Hint: Verification and review, e.g., based on a list of the environmental representatives
CHECKLIST ISO 9001:2008 / 14001:2004

P* WW*
Internal audit
NormShort name points 4.1 General requirements 4.2.1 General Quality Management Manual Document control Control of records Management commitment Customer orientation Quality policy Quality objectives Planning of the quality management system General Review input Review output Responsibility and authority Management responsibility Internal communication Provision of resources General Competence, training and awareness Infrastructure Work environment General Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of the product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action Planning of product realization Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development planning Design and development inputs Design and development results Design and development evaluation Design and development verification Design and development validation
E
Analysis of the needs and frequency
4.5.4
4.2.2 4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 5.4.2 5.6.1 5.6.2 5.6.3 5.5.1 5.5.2 5.5.3 6.1 6.2.1
Definition of the area processes persons
Planning selection of the auditors methods and means
6.2.2 6.3 6.4 8.1 8.2.1 8.2.2 8.2.3 8.2.4
Implementing coordinating comparison of conformity developing an improvement potential
8.3 8.4 8.5.1 8.5.2 8.5.3 7.1 7.2.1 7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4
Reporting
Establishing and implementing follow-up acitivities
7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6
Purchasing process Purchasing information Verification of purchased products Control of the product/service provision Validation of processes for product/service provision Identification and traceability Customer property Preservation of product Control of monitoring and measuring equipment
Key
CHECKLIST ISO 9001:2008 / 14001:2004

Internal audit
Y N
8.2.2 Internal audit (Q+E) Does the organization coduct internal audits at planned intervals to determine whether the quality management system: 8.2.2-01 conforms to the requirements specified by this International Standard and to the quality management system 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 the significance of the processes to be audited and the areas as also the results of previous audits are taken into account? 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 carrying out of the audits ensure the objectivity and impartiality of the audit process? 8.2.2-06 Is it assured that the auditors are not auditing their own activities? 8.2.2-07 Are the responsibilities and requirements for planning and conducting audits as also on the reporting of the results and the maintaining of records defined in a documented procedure? 8.2.2-08 Has the management responsible for the area being audited assured that actions are being taken without undue delay to eliminate detected nonconformities and their causes 8.2.2-09 Do the follow-up measures include provisions for the verification of the actions taken and the reporting of verification results? E 4.5.401 Are these procedures suitable for establishing whether the environmental management system: -complies with the internal arrangements and the ISO 14001 requirements? - has been implemented and maintained in an orderly manner? E 4.5.402 Does the audit and the environmental operational auditing program take account of: - The significance of the activity for the environment? - The results of previous audits?
CHECKLIST ISO 9001:2008 / 14001:2004

Strengths/weaknesses Correction measures
P* WW* NormShort name points 4.1 General requirements 4.2.1 General Quality Management Manual Document control Control of records Management commitment Customer orientation Quality policy Quality objectives Planning of the quality management system General Review input Review output Responsibility and authority Management responsibility Internal communication Provision of resources General Competence, training and awareness Infrastructure Work environment General Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of the product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action Planning ofproduct realization Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development planning Design and development inputs Design and development results Design and development evaluation Design and development verification Design and development validation
+ -
E
Selecting weighting evaluating existing problems
4.5.2
4.2.2 4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 5.4.2 5.6.1 5.6.2 5.6.3 5.5.1 5.5.2 5.5.3 6.1 6.2.1
Analyzing causes
Defining and implementing measures
6.2.2 6.3 6.4 8.1 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.5.1 8.5.2 8.5.3 7.1 7.2.1 7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6
Checking the effectiveness of the measures
Defining introducing implementing evaluating follow-up measures
Key
CHECKLIST ISO 9001:2008 / 14001:2004

Corrective action
Y N
8.5.2 Corrective action (Q+E) 8.5.2-01 Have corrective actions been taken for dealing with the causes of nonconformities to prevent them from reoccurence? 8.5.2-02 Corrective actions shall be appropriate to the effects on the nonconformieties encountered. Is this the case? Has a documented procedure een established to define requirements for : 8.5.2-03 Reviewing nonconformities (including customer complaints)? 8.5.2-04 Determining the causes of nonconformities? 8.5.2-05 Evaluating the need for action to ensure that nonconformities 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 environmentally relevant occurrences are systematically and appropriately recorded?
CHECKLIST ISO 9001:2008 / 14001:2004

P* WW*
Preventive action
E
Identifying weighting evaluating potential but still non-existent problems / risks
4.5.2
4.2.2 4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 5.4.2 5.6.1 5.6.2 5.6.3 5.5.1
Considering potential causes
5.5.2 5.5.3 6.1 6.2.1 6.2.2
Defining and implementing preventive actions
6.3 6.4 8.1 8.2.1 8.2.2 8.2.3 8.2.4
Verification whether risks are reduced
8.3 8.4 8.5.1 8.5.2 8.5.3 7.1 7.2.1
Defining introducing implementing evaluating subsequent activities
7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6
Key
CHECKLIST ISO 9001:2008 / 14001:2004

Preventive action
Y N
8.5.3 Preventive action 8.5.3-01 Has preventive action been determined to eliminate the causes of potential nonconformities in order to prevent their occurence? 8.5.3-02 Preventive actions shall be appropriate to the effects of potential problems. Is this the case? Does an introduced documented procedure exist to define requirements for: 8.5.3-03 Determining potential nonconformities and their causes? 8.5.3-04 Evaluating the need for action to prevent occurrence 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 page 2 of this checklist)
Making people aware of potential risks, particularly relating to the QM System, is a concern of Quality Austria. This procedure can be demonstrated best by making a risk analysis in the context of management review. Still another option is to integrate the risk management aspects in the process of preventive action. Risk management (excerpt from the definition in the course for risk management offered by Quality Austria):
Risk management means to know the risks and be capable of winning relevant opportunities. The general objective of risk management is to contribute to sustainably securing the existence and subsistence of the organization by adequately handling risks. By no means does this mean the complete elimination of all the conceivable potentials of disturbance. It rather is a matter of striving for a risk or safety level that is optimal under aspects of economic efficiency.
CHECKLIST ISO 9001:2008 / 14001:2004

Strengths/weaknesses Improvement process
P* WW* Norm point s 4.1 4.2.1 4.2.2 4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 5.4.2 5.6.1 5.6.2 5.6.3 5.5.1 5.5.2 5.5.3 6.1 6.2.1 6.2.2 6.3 6.4 Short name General requirements General Quality Management Manual Document control Control of records Management commitment Customer orientation Quality policy Quality objectives Planning of the quality management system General Review input Review output Responsibility and authority Management responsibility Internal communication Provision of resources General Competence, training and awareness Infrastructure Work environment General Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of the product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action Planning of product realization Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development planning Design and development inputs Design and development results Design and development evaluation Design and development verification Design and development validation
E
Defining and setting priorities for the improvement potential the system, the processes, the products, the services, the communication, the Information
Consider objectives and make them binding
Planning, Implementing, and monitoring of activities,
8.1 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.5.1 8.5.2 8.5.3 7.1 7.2.1 7.2.2
Verifying achievement of objectives
Defining introducing implementing evaluating subsequent activities
7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6
Key
CHECKLIST ISO 9001:2008 / 14001:2004

Improvement process
Y N
8.5.1 Continuous improvement 8.5.1-01 Is the effectiveness of the quality management system continuously improved through the use of quality policy, quality objectives, audit results, data analysis, corrective and preventive actions as also through management assessment?
CHECKLIST ISO 9001:2008 / 14001:2004

P* WW*
Customer-related processes
NormShort name points 4.1 General requirements 4.2.1 4.2.2 4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 General Quality Management Manual Document control Control of records Management commitment Customer orientation Quality policy Quality objectives Planning of the quality management system General Review input Review output Responsibility and authority Management responsibility Internal communication Provision of resources General Competence, training and awareness Infrastructure Work environment General Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of the product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action Planning of product realization Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development planning Design and development inputs Design and development results Design and development evaluation Design and development verification Design and development validation Control of the design and development process Purchasing process Purchasing information Verification of purchased products Control of the product/service provision Validation of processes for product/service provision Identification and traceability Customer property Preservation of product Control of monitoring and measuring equipment
E 4.3.1/4.3.2/
4.4.3/4.4.6 Requirements
Analysis identification comparison
5.4.2 5.6.1 5.6.2 5.6.3 5.5.1 5.5.2 5.5.3 6.1 6.2.1 6.2.2 6.3 6.4 8.1
Evaluation of the suitability for implementation and feasibility
Chances risks standards factors of influence
8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.5.1 8.5.2 8.5.3 7.1 7.2.1 7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5
External / internal communication interactive sequential parallel proactive reaktive
Analysis of the feedback
7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6
Follow-up activities
Key
CHECKLIST ISO 9001:2008 / 14001:2004

Customer-related processes
Y N
7.2 Customer-related processes 7.2.1 Determination of requirements relating to the product Does the organization determine: 7.2.1-01 requirements specified by the customer, including the requirements for delivery and post-delivery activities? 7.2.1-02 requirements not stated by the customer but necessary for specified or intended use, where known? 7.2.1-03 statutory and regulatory requirements related to the product? 7.2.1-04 All other specifications defined by the organization ? NOTE Activities after delivery include measures taken because of warranty conditions, contractual obligations, such as maintenance, and supplementary services, such as recycling and reuse or waste disposal. 7.2.1 Review of the requirements related to the product 7.2.2-01 Does the organization review the requirements related to the product? 7.2.2-02 Is this review conducted prior to the organizations commitment to supply a product to the customer ( e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders)? Does it ensure: 7.2.2-03 That product requiements are defined? 7.2.2-04 contract or order requirements differing from those previously expressed are resolved? 7.2.2-05 That the organization has the ability to meed the definded requirements? 7.2.2-06 That records of the results of the review and actions arising from the review are maintained? 7.2.2-07 That the customer requirements prior to acceptance are confirmed by the organization when the customer has not previously presented a documented statement of requirement? 7.2.2-08 Does the organization ensure when product requirements change that the relevant documents are also changed and that the personnel responsible are made aware 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 product information such as catalogs or advertising material for example. 7.2.3 Customer communication Does the organization have effective regulations for communication with the customer that have been established to cover the following points and have these been implemented with regard to: 7.2.3-01 Product information? 7.2.3-02 Enquiries, contracts or order handlingincluding amendments? 7.2.3-03 Feedback from the customer including customer complaints? E 4.4.601 Is the checking of the customers environmental requirements done before the producing of an offer or the acceptance of an order (feasibility study)? E 4.4.602 Is a relevant consultation and instruction with the customer made about handling products that are hazardous to the environment?
CHECKLIST ISO 9001:2008 / 14001:2004

Strengths/weaknesses Design / development process
P* WW* NormShort name points 4.1 General requirements 4.2.1 General Quality Management Manual Document control Control of records Management commitment Customer orientation Quality policy Quality objectives Planning of the quality management system General Review input Review output Responsibility and authority Management responsibility Internal communication Provision of resources General Competence, training and awareness Infrastructure Work environment General Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of the product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action Planning of product realization
Determination of requirements related to the product Review of requirements related to the product
E
Ideas analyses customer wishes internal / external specifications
4.4.6
4.2.2 4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 5.4.2 5.6.1
Specification
5.6.2 5.6.3 5.5.1 5.5.2 5.5.3 6.1 6.2.1 6.2.2
Decision planning project planning Design development changes
6.3 6.4 8.1 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.5.1 8.5.2 8.5.3 7.1 7.2.1 7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5
Design / development
Design /rReviews
Customer communication Design and development planning Design and development inputs Design and development results Design and development evaluation Design and development verification Design and development validation
Verification
Valididation
Design results / development resuts
7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6
Key
CHECKLIST ISO 9001:2008 / 14001:2004

Y N
7.3 Design and Development 7.3.1 Design and development planning 7.3.1-01 Does the organization plan and control the design development of the products? 7.3.1-02 Are appropriate evaluation, verification and validation for each development phase during the design and development planning and the design and development phases and the responsibilities and authorities for the design and development defined? 7.3.1-03 Does the organization manage and control the interfaces between the different groups involved in the design and development groups, in order to assure an effective communication and a clear assignement of responsibility? 7.3.1-04 Is the planning output updated with the continuing design and development insofar as this is appropriate?
NOTE Design and development review, verification and validation serve for certain purposes. They may be conducted and recorded individually or in any combination suitable for the product and organization.
Design and development

E 4.4.601 Are environmentally relevant aspects taken into account in the design and development planning and in the entire design and development process? 7.3.2 Design and development inputs 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 from previous similar designs and developments? 7.3.2-05 Other specifications important for the design and development? 7.3.2-06 Are these inputs evaluated on the basis of their appropriateness? 7.3.2-07 Are the specifications complete, clear and free from contradictions? e 4.4.602 Are the environmentally relevant specifications made for the product that is to be developed (DL) (including all statutory and authority specifications) clearly and comprehensively defined? 7.3.3 Design and development results 7.3.3-01 Are the development results provided in a form, making their verification possible over and against the development inputs, and are they subject to approval before release? 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 or reference made to them? 7.3.3-05 Those characteristics of the product are established that are essential for a use for the purpose intended?
NOTE Information for production and service provision can include details for maintenance of the product.
Notes, recommendations:
7.3.4 Design and development evaluation Are systematic reviews carried out in suitable phases in order to: 7.3.4-01 Assess the suitability of the development results for the fulfillment of the specifications? 7.3.4-02 To recognize all problems and to suggest necessary measures? 7.3.4-03 Do the participants of reviews of this kind include representatives of the functional areas that are affected by the evaluated development phase or the evaluated development phases? 7.3.4-04 Are notes taken about the results of the reviews and about essential measures? 7.3.5 Design and development verification 7.3.5-01 Is a verification is carried out in order to assure that the design and development results fulfill the design and development specifications? 7.3.5-02 Are notes taken about the results of the verification and about essential measures? 7.3.6 Design and development validation 7.3.6-01 Has a development validification been carried out in accordance with the planned arrangements (see 7.3.1), to ensure that the resultant product is capable of meeting the requirements for the defined or intended use, where known? 7.3.6-02 Has the validation been completed where possible before the delivery or the introduction of the products? 7.3.6-03 Are notes taken about the results of the validation and about essential measures? 7.3.7 Control of design and odevelopment changes 7.3.7-01 Are design and development changes identified and recorded? 7.3.7-02 Are changes reviewed, verified and validated and also approved before their implementation insofar as it is reasonable to do so? 7.3.7-03 Does the evaluation of the development changes include 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 k d i i i d?
CHECKLIST ISO 9001:2008 / 14001:2004

P* WW*
Production / service provision
NormShort name points 4.1 General requirements 4.2.1 General Quality Management Manual Document control Control of records Management commitment Customer orientation Quality policy Quality objectives Planning of the quality management system General Review input Review output Responsibility and authority Management responsibility Internal communication Provision of resources General Competence, training and awareness Infrastructure Work environment General Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of the product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action Planning of product realization Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development planning Design and development inputs Design and development results Design and development evaluation Design and development verification Design and development validation Control of the design and development process Purchasing process Purchasing information Verification of purchased products Control of the product/service provision Validation of processes for product/service provision Identification and traceability Customer property Preservation of product Control of monitoring and measuring equipment 4.2.2 4.2.3 4.2.4
E
Specifications
4.4.6
5.1 5.2 5.3 5.4.1 5.4.2
Protection of the products / services
Planning availability of: information instructions check lists equipment measuring & testing aids resources Identification and tracability
5.6.1 5.6.2 5.6.3 5.5.1 5.5.2 5.5.3 6.1 6.2.1 6.2.2 6.3 6.4 8.1 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.5.1 8.5.2 8.5.3 7.1 7.2.1
Customer prpoerty
Implementation steering control Validation
Result product / service
7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6
Key
CHECKLIST ISO 9001:2008 / 14001:2004

Y N
7.5 Production and service provision 7.5.1 Control of the product/ service provision 7.5.1-01 Are production and service provision in the planned form and are they implemented under controllable conditions? Do the controllable conditions contain where appropriate: 7.5.1-02 The availability of data describing the characteristics 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 and measuring equipment? 7.5.1-06 The implementation of monitoring and measurements? 7.5.1-07 The implementing of release and delivery activities and activities subsequent to the delivery? E 4.4.601 Are raw materials, auxiliary and operating materials that are hazardous to the environment identified according to statutory or internal specifications? E 4.4.602 Are notes taken about raw materials, auxiliary and operating materials that are hazardous to the environment as also about wastes according to statutory or internal specifications? E 4.4.603 Are procedures available for handling, storage, packaging and dispatch of raw materials, auxiliary and operating materials that are hazardous to the environment as also about wastes? e 4.4.604 Are suitable storage conditions in existence for the storage of raw materials, auxiliary and operating materials that are hazardous to the environment as also about wastes? 7.5.2 Validation of processes for product/service provision 7.5.2-01 Have all the processes for production and service provision where the resulting output cannot be verified y subsequent monitoring or measurement been validated? 7.5.2-02 Does this also included all processes where deficiencies become apparent only after the product is in use or the service has been delivered? 7.5.2-03 Does this validation demonstrate the ability of these processes for the achievement of the planned results? Have arrangements been established for these processes insofar as this is relevant, containing: 7.5.2-04 defined criteria for review and approval of the processes? 7.5.2-05 Approval of equipment and qualification of personnel? 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 traceability 7.5.3-01 Is identification of the products with suitable means during the entire product realization performed insofar as this is reasonable? 7.5.3-02 Is identification made of the product status in respect to the monitoring and measurement requirements? 7.5.3-03 If traceability is a requirement, does the organization control and record the unique identification of the product? 7.5.4 Customer property 7.5.4-01 Does the organization exercise care with customer property while it is under the organizations control or being used by the organization? 7.5.4-02 Does the organization identify, verify protect and safeguard the customer property that is entrusted to it for 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, is this reported to the customer and are records maintained thereof ? EXPLANATORY NOTE: Customer property can also include intellectual property. 7.5.5 Preservation of product 7.5.5-01 Is the conformity of the product maintained during the internal processing and delivery to the intended destination? 7.5.5-02 Does this preservation include identification, handling, packaging, storage and protection? 7.5.5-03 Does this preservation also apply to the constituent parts of a product?
Production / service provision

CHECKLIST ISO 9001:2008 / 14001:2004

Planning of the product realization (process control E.)

Y 7.1 Planning of product realization (Q+E) 7.1-01 Does the organization plan and develop the processes that are required for the product realization? 7.1-02 Is the planning of the product realization in harmony with the specifications for the other processes of the quality management system? Does the organization establish the following in the product realization, insofar as this is reasonable: 7.1-03 Quality objectives and requirements for the product? 7.1-04 The necessity of introducing processes, creating and compiling documents and the product specific making available of resources? 7.1-05 The required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance? 7.1-06 The records needed to provide evidence that the realization processes and resulting product meet requirements? 7.1-07 Are the outputs of this planning available in a form sutiable for the organizations method of operation? EXPLANATORY NOTE 1: A document specifying the processes of the quality management system (including the product realization processes) 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 the requirements given in section 7.3 for the development of the product realization processes. E 4.4.601 Have those processes and activities been established that are in the context of the significant environmental aspects that have been identified? Note: Examples from ISO 14004: Research/development, design/ engineering, purchasing, implementation of the contracts; raw materials handling and -storage; production and maintenance procedures.; laboratories; storage of products; transport; marketing, advertising; customer service; acquisition, erecting or changing properties and plant. E 4.4.6-02 Has it been established by means of the following measures that these processes and established conditions have been carried out: E 4.4.603 Documented procedures for situations in which infringements against the environmental policy and the environmental targets may occur without the existence of appropriate regulations E 4.4.604 Establishing the operational specifications in the procedure? N
CHECKLIST ISO 9001:2008 / 14001:2004

Management of resources (infrastructure, work environment)

Y 6.3 Infrastructure 6.3-01 Does the organization determine, provide and maintain the infrastructure needed to achieve conformity product requirements? The infrastructure includes, e.g.: Buildings, workspace and the supply facilities connected to them, process equipment, both hardware and software, and supporting services such as transport or communication. E 4.4.601 Are environmentally relevant criteria taken into account in establishing, preparing and maintaining the infrastructure (real estate plot, building and plant)? 6.4 Work environment 6.4-01 Does the organization determine and manage the work environment needed to achieve conformity to product requirements? NOTE The designation work environment refers to conditions under which work is being carried out, including physical, ecological and other factors, e.g. noise, temperature, humidity, lighting or weather. N
CHECKLIST ISO 9001:2008 / 14001:2004

P* WW*
Purchasing process
NormShort name points 4.1 General requirements 4.2.1 General Quality Management Manual Document control Control of records Management commitment Customer orientation Quality policy Quality objectives Planning of the quality management system General Review input Review output Responsibility and authority Management responsibility Internal communication Provision of resources General Competence, training and awareness Infrastructure Work environment General Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of the product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action Planning of product realization Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development planning Design and development inputs Design and development results Design and development evaluation Design and development verification Design and development validation Control of the design and development process Purchasing process Purchasing information Verification of purchased products Control of the product/service provision Validation of processes for product/service provision Identification and traceability Customer property Preservation of product Control of monitoring and measuring equipment 4.2.2 4.2.3 4.2.4
E
Specifications
4.4.6
5.1 5.2 5.3 5.4.1 5.4.2
Selection market analysis
5.6.1 5.6.2 5.6.3 5.5.1 5.5.2 5.5.3
Procurement information
Selection of existing, new suppliers
6.1 6.2.1 6.2.2 6.3 6.4 8.1 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.5.1 8.5.2 8.5.3 7.1 7.2.1
Implementation commissioning drafting of contracts peripheral requirements
Evaluation, re-evaluation using suitable methods and instruments
7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6
Key
CHECKLIST ISO 9001:2008 / 14001:2004

Purchasing
Y N
7.4 Purchasing 7.4.1 The purchasing process 7.4.1-01 Does the organization ensure that the purchased products conform to the specified purchase requirements? 7.4.1-02 Does the type and extent of the monitoring applied to the supplier and the purchased product, depend on the influence of the purchased product on the subsequent product realization or on the end product? 7.4.1-03 Does the organization assess suppliers on the basis of their capabilities for supplying products that are compliant with the specifications of the organization? 7.4.1-04 Does it select suppliers on this basis? 7.4.1-05 Do criteria exist for selection, assessment and re-assessment? 7.4.1-06 Are records of the results of evaluations and all necessary actions arising from the evaluation maintained? 7.4.2 Purchasing information 7.4.2-01 Does purchasing information describe the product that is to be purchased? Does this information contain, insofar as this is reasonable: 7.4.2-02 Requirements for the approval of products, procedures, processes and equipment? 7.4.2-03 Requirements for the qualification of the personnel? 7.4.2-04 Requirements for the quality management system? 7.4.2-05 Does the organization ensure the adequacy of specified purchase requirements prior to their communication to the supplier? 7.4.3 Verification of purchased product 7.4.3.-01 Are the specified tests or other activities by means of which it is ensured that the procured product fulfils the defined procurement specifications both established and realized? 7.4.3.-02 Does the organization establish the intended verification measures and the methods for the release of the product in the purchasing information when either the organization itself or the customer intends to carry out verification activities at the suppliers premises? Has it been established by means of the following measures that the environmentally relevant purchasing process has been carried out under the established conditions: E 4.4.601 The procedure in respect to significant environmental aspects in connection with the purchasing of goods and services. Note: e.g. requirements in purchasing documents such as safety data sheets, waste product collection permits, requirement specifications for transport companies,... E 4.4.602 Making the relevant procedures and requirements known to suppliers and contractors.
CHECKLIST ISO 9001:2008 / 14001:2004

Strengths/weaknesses Measurement and testing equipment monitorinng
P* WW* NormShort name points 4.1 General requirements 4.2.1 4.2.2 4.2.3 4.2.4 General Quality Management Manual Document control Control of records Management commitment Customer orientation Quality policy Quality objectives Planning of the quality management system General Review input Review output Responsibility and authority Management responsibility Internal communication Provision of resources General Competence, training and awareness Infrastructure Work environment General Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of the product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action Planning of product realization Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development planning Design and development inputs Design and development results Design and development evaluation Design and development verification Design and development validation
E
Need
4.5.1
Specifications
5.1 5.2 5.3 5.4.1 5.4.2 5.6.1
Purchasing Consistency of measurements to the mesaurement specifications
Verification
5.6.2 5.6.3 5.5.1 5.5.2 5.5.3 6.1 6.2.1 6.2.2 6.3 6.4 8.1 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.5.1 8.5.2 8.5.3 7.1 7.2.1 7.2.2 7.2.3 7.3.1 7.3.2
Stock
Calibration
Issue
Control
Withdrawal
Calibration
Follow-up measures stock, scrapping, devaluation evaluation of the required services, activvities with regard to products / services
7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6
Key
CHECKLIST ISO 9001:2008 / 14001:2004

Control of measuring and testing devices

Y N
7.6 Control of monitoring and measuring equipment (Q+E) 7.6-01 Has the organization determined the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements? 7.6-02 Have processes been established to ensure that monitoring and measurement can be carried our and are carried out in a manner that is consistent with the monitoring and measurement requirements? To the extent that valid results are required, is the measuring equipment: 7.6-03 Calibrated or verified at specified intervals before use? 7.6-04 And can this be done on the basis of measuring standards that are based on international or national measuring standards? 7.6-05 When there are no measuring standards of this kind, is the basis for the calibration or verification recorded? 7.6-06 Is measuring equipment adjusted or re-adjusted as necessary? 7.6-07 Are they identified so that the calibration status can be recognized? 7.6-08 Are they safeguarded from adjustments that would invalidate the measurement result? 7.6-09 Are they protected from damage or deterioration during handling, maintenance and storage? 7.6-10 Does the organization assess the validity of previous measuring results and are these recorded when it has been established that the measuring equipment does not fulfill the requirements? 7.6-11 Are suitable measures being taken in respect to the measuring equipment and all the products affected? 7.6-12 Are records of the results of calibration and verification maintained? 7.6-13 When computer software is used in the monitoring and measurement of specified requirements, is its ability to satisfy the intended application confirmed? 7.6-14 Is this done prior to initial use and reconfirmed as necessary later? NOTE Confirming computer software is capable of fulfilling the intended functions would typically include its verification and configuration management in order to maintain usability. E 4.5.1-01 Are environmentally relevant testing equipment and monitoring devices appropriately monitored (calibration, maintenance) and are records maintained in this respect?
CHECKLIST ISO 9001:2008 / 14001:2004

Strengths/weaknesses Environmental aspects
+ -
P* WW*
4.3.1
NormShort name points 4.1 General requirements 4.2.1 4.2.2 4.2.3 General Quality Management Manual Document control Control of records Management commitment Customer orientation Quality policy Quality objectives Planning of the quality management system General Review input Review output Responsibility and authority Management responsibility Internal communication Provision of resources General Competence, training and awareness Infrastructure Work environment General Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of the product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action Planning of product realization Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development planning Design and development inputs Design and development results Design and development evaluation Design and development verification Design and development validation
Statutory and other requirements
4.2.4 5.1 5.2 5.3
Identification of environmental aspects
Environmental relevant activities
5.4.1 5.4.2 5.6.1 5.6.2 5.6.3
Monitoring and evaluation
5.5.1
Keeping the information at the latest state
5.5.2 5.5.3 6.1 6.2.1 6.2.2
Environmentally relevant targets
Environmental programs
6.3 6.4 8.1 8.2.1 8.2.2
Management evaluation
8.2.3 8.2.4 8.3 8.4 8.5.1 8.5.2 8.5.3 7.1
Continuous improvement
7.2.1 7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6
Key
CHECKLIST ISO 9001:2008 / 14001:2004

Y N
Environmental aspects / environmental objectives A

4.3.1 Environmental aspects E 4.3.101 Does a procedure defined in writing exist to record and assess the environmental aspects and whether: - they can or do have a significant effect on the environment N - taking account of planned or new developments and also new or modified activities? Does this procedure ensure where necessary that the following aspects are established? Direct environmental aspects (according to EMAS) a) Emissions in the atmosphere b) Channeling to or from water sources, c) The avoidance, use, re-use, disposal and recovery of solid and other wastes, in particular of hazardous wastes, d) The use and pollution of the soil, e) The use of natural resources and raw materials (including energy), f) Local phenomena (noise, vibrations, smells, dust, aesthetic considerations,...), g) Traffic (goods and services, employees), h) Hazards from environmental accidents and from environmental effects resulting from or that could result from incidents, accidents and potential emergency situations, i) The effects on bio-diversity. Definition: direct environmental aspects relate to the activities of the organization, the sequence of which it controls. Indirect environmental aspects (according to EMAS) a) Product related effects (design, development, packaging, transport, use and re-use/disposal of wastes), b) Capital investments, the issuing of credit loans and insurance services, c) New markets, d) Selection and composition of services (e.g. transport or catering trade), e) Administration and planning decisions, f) Composition of the product offer, g) The environmental services and environmental behavior of contractors, sub-contractors and suppliers. Definition: Indirect environmental aspects refer to the activities, products and services, which under certain circumstances cannot be fully controlled by the organization. E 4.3.102 Are the environmental aspects with significant effects for the environment taken into account in establishing the environmental objectives and the individual targets? E 4.3.103 Is the information about environmental aspects kept fully up-to-date? Note: Changes on the basis of the previous years environmental program, changed activities, products, services and framework conditions (e.g. legislation, new knowledge) 4.3.3 Objectives, individual targets, environment management program(s) E 4.3.301 Is an (are any) environmental management program(s) available, introduced and up-to-date? E 4.3.302 Is an (are any) environmental management program(s) consistent with the environmentally related objectives and separate targets? E 4.3.303 Does this program contain responsibilities, means and deadlines for the achieving of the objectives? E 4.3.304 Does this comprise all hierarchy levels and the relevant functions? E 4.3.305 Is environmental management also applied in the case of changes to business activities? Note: e.g. projects, new developments, modifications, ... E 4.3.306 Do basic changes in the business activities also flow into the environmental management program(s) where appropriate?
CHECKLIST ISO 9001:2008 / 14001:2004

P* WW*
Statutory and other requirements
E
Establish relevant reqirements for environmental aspects
4.3.2
4.2.2 4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 5.4.2 5.6.1
Making accessible
5.6.2 5.6.3 5.5.1 5.5.2 5.5.3 6.1
Management process
6.2.1 6.2.2 6.3 6.4 8.1 8.2.1 8.2.2 8.2.3 8.2.4
E4.3.3
Objectives, individual targets, program
Monitoring and measuring
8.3 8.4 8.5.1 8.5.2 8.5.3 7.1 7.2.1 7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6
4.5.2
Evaluation of the fulfilment of relevant environmental statutory rules
Key
CHECKLIST ISO 9001:2008 / 14001:2004

Y N
Legal obligations and other requirements A

4.3.2 Statutory obligations and other specifications E 4.3.201 Does a procedure in writing exist for the establishing of (external) environmental requirements? E 4.3.202 Does the procedure take into account: a) Statutory specifications, b) Other specifications by the authorities (notification on decisions,..), c) Additional own corporate obligations (e.g. Responsible Care, ICC-Charter, etc.)? Note: Building permission; traffic permits; forestry permits environmental compatibility test law; permits under the railways legislation; immissions legislation permits; permission for company plant; water rights permits; permits under control of radiation law; preservation of nature legislation permits; wastes legislation permits; E 4.3.203 Is access to the identified documents assured? E 4.3.2-04 Has it been defined how the regulations are applicable to the environmental aspects? E 4.5.2-01 Does a documented procedure exist for the regular evaluation of the fulfillment of the relevant statutory environmental regulations? Note: Interaction with 4.5.1 Monitoring and measuring
CHECKLIST ISO 9001:2008 / 14001:2004

Strengths/weaknesses Emergency plan and hazard avoidance
P* WW* NormShort name points 4.1 General requirements 4.2.1 General Quality Management Manual Document control Control of records Management commitment Customer orientation Quality policy Quality objectives Planning of the quality management system General Review input Review output Responsibility and authority Management responsibility Internal communication Provision of resources General Competence, training and awareness Infrastructure Work environment General Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of the product Control of nonconforming product Analysis of data Continual improvement Corrective action Preventive action Planning of product realization Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development planning Design and development inputs Design and development results Design and development evaluation Design and development verification Design and development validation
E
Identify potential accidents and emergency situations
4.4.7
4.2.2 4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 5.4.2 5.6.1
Produce emergency plan
5.6.2 5.6.3 5.5.1 5.5.2 5.5.3
Check emergency plan
6.1 6.2.1 6.2.2 6.3 6.4 8.1 8.2.1 8.2.2 8.2.3 8.2.4
Precautionary measures
8.3 8.4 8.5.1 8.5.2 8.5.3 7.1 7.2.1 7.2.2 7.2.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6
4.5.2
Establish the measures
Key
CHECKLIST ISO 9001:2008 / 14001:2004

Y 4.4.7 Emergency plan and risk prevention E 4.4.701 Is there a procedure for the establishing of potential accidents and emergency situations? N
Emergency preparedness and response and risk prevention

Note: Risk analysis interaction with 4.5.2 Deviations, corrections and precautionary measures and 4.3.1 Environmental aspects
E 4.4.702 Are there procedures that regulate the course of action in emergency situations (accidents and emergencies)?
Note: Emergency plans

E 4.4.703 Are these procedures suitable for preventing and limiting possible environmental effects? E 4.4.704 Are the measures in the emergency plan regularly evaluated and checked? E 4.4.705 Is the emergency concept worked through and edited where relevant following the occurrence of an emergency situation?
Note: Interaction with 4.5.2 Deviations, corrections and precautionary measures

E 4.4.706 Is the functionality of the procedure for emergency situations regularly field-tested?
CHECKLIST ISO 9001:2008 / 14001:2004

Y 8.1 General Has the organization planned and realized monitoring, measuring, analysis and improvement processes that are required in order to: 8.1-01 Demonstrate the conformity of the product? 8.1-02 To assure the conformity of the quality management system? 8.1-03 To constantly improve the effectiveness of the quality management system? 8.1-04 Does this contain the establishment of applicable methods including statistical methods and the extent of their application? 8.2 Monitoring and measuring (Q+E) E 4.5.101 Do documented procedures exist for the regular monitoring and measuring of significant characteristics of the environmentally relevant working processes and activities? E 4.5.102 Do appropriate record notes exist for the defined information and characteristics? E 4.5.103 Do these record notes permit - The tracing of the service achieved? - The monitoring of the processes? - The assessment of conformity with environmental objectives? E 4.5.104 Does a documented procedure for the regular evaluation of the fulfillment of the relevant statutory environmental regulations? 8.2.1 Customer satisfaction 8.2.1-01 Is information for awareness about the customer in the issue of whether the organization has fulfilled customer requirements monitored as one of the benchmarks for the performance of the quality management system? 8.2.1-02 Have the methods for obtaining and using this information been defined? 8.2.3 Monitoring and measurement of processes 8.2.3-01 Are suitable methods for the monitoring and where applicable for the measurment of the quality management system processes applied? 8.2.3-02 Do these methods demonstrate the ability of the processs to achieve planned results? 8.2.3-03 When the planned results are not achieved are corrections made and corrective actions taken in order to assure product conformity insofar as this is reasonable? 8.2.4 Monitoring and measurement of the product 8.2.4-01 Are the characteristics of the product monitored and measured, in order to verify that product requirements have been met? 8.2.4-02 Is this carried out in appropriate stages of the product realization process in accordance with the planned arrangements? 8.2.4-03 Is evidence of conformity with the acceptance criteria maintained? 8.2.4-04 Do these records state who is or who are the person/s responsible for the release of the product ? 8.2.4-05 Is a product release and service provision only made after the satisfactory completion of all the defined activities, insofar as this is not done otherwise by a responsible position and, to the extent that this is required, with the permission of the customer? 8.3 Control of nonconforming product 8.3-01 If it is ensured that a product which does not conform to the product requirements is identified and controlled to prevent its unintended use or delivery? 8.3-02 Are the controls and related responsibilities and authorities for dealing with nonconforming product identified in a documented procedure? Are nonconforming products dealt with in one or more of the following ways: 8.3-03 By taking action to eliminate the detected nonconformity? 8.3-04 By authorizing its use, release or acceptance under concession by a relevant authority, and , where applicable by the customer? 8.3-05 By taking action to preclude its original intended use or application? 8.3-06 Are recordes of the nature of nonconformities and any subsequent actions taken including concessions obtained, maintained? 8.3-07 When a noncoconforming product is corrected is it subject to re-verification to demonstrate conformity to the requirements? 8.3-08 If a noncoconforming product is discovered after the delivery or in use, are measures introduced that are appropriate for the consequences or the potential consequences? 8.4 Analysis of data 8.4-01 Are appropriate data determined,, collected and analyzed to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made? 8.4-02 Does this also include data that is obtained from monitoring and measurement and from other relevant sources? Does the data analysis provide information relating to: 8.4-03 Customer satisfaction? 8.4-04 Conformity to product requirements? 8.4-05 Characteristics and trends of processes and products? 8.4-06 Including possibilities for prevention measures? 8.4-07 Suppliers? N
Measurement, analysis, improvement
NOTE Monitoring and control of customer perception may include the following: obtaining inputs from such sources as customer satisfaction surveys, customer data relating to the quality of the delivered product, surveys made among the users, analyses of lost business transactions, recognitions and awards, claims for warranties, reports given by merchants.

NOTE When establishing suitable processes and methods, it is recommendable for the organization to consider the kind and extent of monitoring and control and/or measurements that are adequate for each of its processes relating to their influence on fulfilment of product requirements and effectiveness of the quality management system.
CHECKLISTE ISO 9001:2000 / 14001

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CHECKLIST

ISO 9001:2008 / 14001:2004

No.: CL_27_01_002e Created by: Hackenauer

Edition: 01/2009 Checked by: Kreiter

Page 1 of 44 Released by: Scheiber

CHECKLIST ISO 9001:2008 / 14001:2004

No.: CL_27_01_002e Created by: Hackenauer

Edition: 01/2009 Checked by: Kreiter

Page 2 of 44 Released by: Scheiber

CHECKLIST ISO 9001:2008 / 14001:2004

No.: CL_27_01_002e Created by: Hackenauer

Edition: 01/2009 Checked by: Kreiter

Page 3 of 44 Released by: Scheiber

CHECKLIST ISO 9001:2008 / 14001:2004

No.: CL_27_01_002e Created by: Hackenauer

Edition: 01/2009 Checked by: Kreiter

Page 4 of 44 Released by: Scheiber

CHECKLIST ISO 9001:2008 / 14001:2004

Quality management manual

General requirements (process management)

4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 5.4.2

5. Responsibility of the management

5.6.3 5.5.1 5.5.2 5.5.3 6.1

8. Measurement, analysis and improvement

Policy targets planning review

6.2.1 6.2.2 6.3 6.4 8.1 8.2.1

Ability, awareness and training

8.2.2 8.2.3 8.2.4 8.3 8.4 8.5.1 8.5.2 8.5.3 7.1

Processmeasuring and monitoring

Product measurement and monitoring

Control of noncomlying products

7.2.1 7.2.2 7.2.3 7.3.1

Customer-related processes Specification / input

7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1

Production / services provision ID. / traceab. Customer property Protection Validation

7.4.2 7.4.3 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6

No.: CL_27_01_002e Created by: Hackenauer

Edition: 01/2009 Checked by: Kreiter

Page 5 of 44 Released by: Scheiber

CHECKLIST ISO 9001:2008 / 14001:2004

Roles: The most important key data: Audit objectives:

No.: CL_27_01_002e Created by: Hackenauer

Edition: 01/2009 Checked by: Kreiter

Page 6 of 44 Released by: Scheiber

CHECKLIST ISO 9001:2008 / 14001:2004

Vision / mission policy

Implementation taking requirements into account

Means processes products/ services

Measurement monitoring correction prevention

Customer satisfaction audits processes products / services system

Analysis sequential, parallel, periodic checks

Update statistical data

Components relating to a process

No.: CL_27_01_002e Created by: Hackenauer

Edition: 01/2009 Checked by: Kreiter

Page 7 of 44 Released by: Scheiber

CHECKLIST ISO 9001:2008 / 14001:2004

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

No.: CL_27_01_002e Created by: Hackenauer