Audit Question List For ISO 9001

Audit question list (topic list)
ISO 9001:1994 and ISO 9001:2000
Audit type: • C-Audit • S-Audit • R-Audit

• Upgrade to ISO 9001:2000
Standard based • ISO 9001:94 • ISO 9002:94 • ISO 9003:94
• ISO 9001:2000
Audit period (on site):
Company / customer:
Street / P.O. box:
Zip code / city:
Lead auditor / auditor:
Site / branch office etc. actual number of

• Matrix-Certification employees
Order / customer no.:
________________ ____________________
Date (Lead ) auditor
Remarks on how to use the audit question list / topic list:

1. There are no basic changes as far as the handling of the audit question list is concerned.
− In the column with the heading "Requirement / topic" the relevant requirements of the standard are reproduced
in the form of key words rather than in fully formulated questions.
− Relevant documentation (no. of QM chapter, DP no., etc.) is entered in the "Documentation" column;
evaluation is effected in the adjacent column, "E".
− In the column with the heading "Documents reviewed" you find potential documents or records, that might be
presented by the company. Only documents that have really been submitted by the company or evidence of
which has been provided in another way (e.g. database) are to be ticked. If evidence is provided by means of
other documents, these other documents or records shall be recorded either in the "Documents reviewed" or
"Audit notes" columns.
In general, additional information such as date, order no. customer, design and development project, product,
identification no. of inspection, measuring and test equipment etc. is to be provided in as far as applicable and
expedient in connection with evidence of reviewed documentation.
− The "Audit notes„ column is to be used as hitherto. (short description of the performance) Evaluations are
entered in the adjacent column "E". If all sub-points of a question block have been complied with, an overall
evaluation of "1" will suffice. If sub-points have not been complied with or are only complied with to some extent,
they must be identified separately by an evaluation score of "2" or "3" in the column "E".
2. The audit question list must be completed separately for each audit, i.e. a new list must be used for surveillance
and repeat audits. Each relevant element and question must be scored and filled out completly.
3. As a rule, a separate question list for pertinent process elements must be kept for each site of multi-site
companies.
4. Evaluation is as hitherto, with 1 = conformance, 2 = observation (minor nonconformity for which the relevant
corrective action will be verified in the next audit), 3 = major nonconformity (re-audit or submission of new
documentation by a defined date necessary)
5. The "Documentation" column must only be completed in cases involving initial evaluation; in subsequent audits,
this column must only be completed in cases involving amendments/additions.
6. Column headings are only quoted on the first page.
7. The numbers in brakets shows the elements of ISO 9001:1994
E: evaluation: 1 = conformance 2 = observation (minor nonconformance) 3 = major nonconformance n.a.: not applicable
File: crt_f_07.31e.doc, Revision: 2, Effective: 2001-04-01 Page 1 of 21
ISO 9001:1994 and ISO 9001:2000
8. Text marked with „ ∆ “ shows the additional requirements of the ISO 9001:2000 against the requirements of the ISO
9001:1994. Therefore the audit question list (topic list) also can be used for audits acc. to ISO 9001:1994. The
relevant standard must be marked on the cover sheet.
E: Evaluation: 1 = conformance 2 = observation (minor nonconformance) 3 = major nonconformance n.a.: not applicable
ISO 9001:1994 and ISO 9001:2000
Chapter of standard: 4. Quality Management System

4.1 General requirements ( 4.2.1 )
Requirement / subject Docu- E Documents reviewed Audit notes E
mentation
Obligation to establish and ο Quality Manual
maintain a QMS (s.5.4.2) : ο Documented processes/procedures
∆ identification and and other applicable documents
application of quality ο Process flow charts
system processes ο Management review
∆ determination of ο Investment plans
sequence and interaction ο Action catalogs
of these processes
− determination of process
operations and control
methods
− availability of resources
and of informations
required for process
support and monitoring
∆ process monitoring,
measurement and
analysis
− implementation of
necessary actions for
continuous improvement
of these processes (s. 8.1
+8.2.3)
∆ control of outsourced
processes
4.2 Documentation requirements

4.2.1 General (4.2.2 )
Documentation must ο Quality Manual
include: ο Documented procedures
− quality policy and quality ο Commitment to continuous
objectives (s. 5.3, 5.4.1) improvement
− quality manual ο On-going evaluation
− documents required for ο Communication within the
process control organization
∆ documented procedures ο
required by this standard ο Description of interactions
(s. 4.2.4) ο Test plans
− quality records ο Process flow charts
ο Drawings
ο Organizational charts
∆ DP Document control
∆ DP Control of quality records
∆ DP Control of internal audits
∆ DP Control of nonconforming product
∆ DP Control of corrective action
∆ DP Control of preventive action
ο Order records
ο Manufacturing records
ο Minutes/records
ο Checklists
ο Test certificates
ο Qualification certificates
ISO 9001:1994 and ISO 9001:2000
4.2.2 Quality Manual (must include): ( 4.2.1 )
∆ Scope of QMS including ο Quality Manual
justifikation of exclusions ο Documented procedures
(s. 1.2) ο Organizational charts
− Descriptions of ο Geographic or technical scope of
procedures and application
∆ Interaction between ∆ Justification for exclusions from
quality system processes requirements as per Chapter 7
(cf. footnote to 4.1 in ο Process descriptions / flow charts
standard)
4.2.3 Control of document ( 4.5.1 + 4.5.2 + 4.5.3 )

− Review of adequacy prior ο DP Document control
to issue and approval ο Quality Manual
− Review, up-date and re- ο Approval documents
approval ο Revision procedures
− Identification of revision ο Approval procedures
status and changes ο Documented procedures
− Steps taken to ensure that ο Test plans
relevant documents are ο Lists of revision stati
available at point of use ο Distribution list
− Steps taken to ensure that ο Evidence of issue and receipt
documents are legible ο Review of external documents
and readily identifiable ο On-site review
− Identification and
controlled distribution of
external documents
− Steps taken to ensure that
the unintentional use of
obsolete documents is
prevented and that the
latter are suitably
identified
4.2.4 Control of records ( 4.16 )

controls must enshure ο Quality Manual
− Legibility ο DP Control of records
− Identification ο sales and order records
− storage ο Manufacturing records
− Protection from damage ο Minutes/records
− Retrievability ο Check lists
− Retention period ο Test certificates
− disposition ο Documentation of internal audits
ο Qualification certificates
ο purchase records
ο logistic records
ISO 9001:1994 and ISO 9001:2000
Chapter of standard: 5. Management responsibility

5.1 Management commitment ( 4.1 )
∆ Evidence of quality ο Management review
system effectiveness and ο Written quality policy
continual improvement ο Training schedules / evidence
(s. 8.4+8.5.1) ο Employee information (notices,
∆ Determination and agenda of informative events)
communication of ο Manpower-development plans
customer and statutory ο Quality plans
and regulatory ο Records of defined objectives
requirements (s. 5.2) ο Project plans
− Establishing of quality ο Investment plans
policy and quality ο Plant agreements
objectives (s. 5.3 + 5.4)
− Conduct of management
reviews (s. 5.6)
− Steps taken to ensure
availability of resources
(s. 6)
5.2 Customer focus

∆ Top Management shall ∆ Evaluation of customer surveys
ensure the determination ∆ Market analyses
of customer requirements ∆ Complaint documentation /
and expectation analyses
(s.a. 7.2.1 + 8.2.1) ∆ Product validation records
∆ Standards
∆ Customer-satisfaction analyses
∆ external quality costs
∆ ppm-statistics
5.3 Quality policy ( 4.1.1 )

− Suitability for organization ο Quality Manual
∆ Commitment to ο Corporate guidelines and principles
continuous improvement ο Written quality policy
(s. 8.5.1) ο Training schedules and evidence
∆ Definition and review of ο Employee information (notices,
quality objectives meetings etc.)
− Communication within the ο Management review
organization ο Internal audits
∆ On-going review of
suitability
5.4 Planning
5.4.1 Quality objectives ( 4.1.1 )
∆ Determination on the ο Quality Manual
basis of data and ο Internal/external target agreements
parameters (s. 8.4+8.5.1) (business plans, project plans,
− Alignment with quality quality assurance agreements)
policy ο company-related
∆ Alignment with product ο product-related
requirements (s. 7.1a) ο customer-related
ο general Employee information
ο Records of employee interviews
ο trend analysis
ISO 9001:1994 and ISO 9001:2000
5.4.2 Quality management system planning ( 4.2.3 )
∆ Steps taken to ensure ο Quality Manual
that quality objectives and ο Documented procedures
− requirements outlined in ο Investment plans
4.1 are satisfied ο Strategic plans
∆ Steps taken to ensure that ο Quality plans
changes to the QMS do ο Production plans
not impair integrity ο Resource plans / records
− Documentation ο Documented procedures / process
descriptions
ο Work and test plans
5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority ( 4.1.2.1 )
− Definition and ο Quality Manual
communication of ο Documented procedures (QM)
responsibilities and ο Job / function profiles
authorities ο Requirement profiles
∆ ensuring by top
management
5.5.2 Management representative (4.1.2.3 )

− Appointment and ο Quality Manual
announcement of an ο Organizational chart and
independent member of organizational structure
the management ο QMR appointment letter
responsible for this task ο QMR function profile
− Tasks: ο QMR job profile
− Quality system ο Status report /Q analyses
establishment ο Internal audit reports
− Reporting to top ο Reports re quality situation
management ο Statistical evaluation
∆ Sensitization to
customer
requirements
5.5.3 Internal communication

∆ Establishment of suitable ο Minutes and reports of meetings
communication ο Team training and other meetings
processes within the ο Notice boards, internal magazines
organization ο Audio-visual and electronic media
(s. a. 7.2.3 ) ο Agenda of company events
∆ Communication ο Circular letters
regarding quality system ο Statistics
effectiveness ο Reports on quality system
effectiveness
ISO 9001:1994 and ISO 9001:2000
5.6 Management review

5.6.1 General ( 4.1.3 )
− Regular review of quality ο Management-review report
system ο monthly management reports
− Assessment of ο controlling reports
opportunities for ο finance reports
improvements to quality ο Q-reports
policy and quality ο supplier evaluations
objectives ο logistic reports
− Recording of the need for
changes to the quality
system
5.6.2 Review input

∆ Management review must ο Management-review report
include: ο Customer-satisfaction analyses
∆ audit results ο Process analyses
∆ customer feedback ο Evidence of corrective and preventive
∆ process performance action
and ο Resource deployment and
productconformity application planning
∆ status of preventive ο Benchmarking results
and corrective action ο Quality analyses
∆ follow-up action from ο Risk analyses (technical/economic)
previous ο Internal audit reports
management reviews ο Process audits
∆ changes that could ο Product audits / reports
affect the quality ο Action reports
system ο Investment planning
∆ recommendations for
improvement
(s. 8.1+8.2+8.4+8.5 )
5.6.3 Review output

∆ Decisions and actions ο Management-review report
shall include: ο Business plan
∆ improvement of the ο Strategic plans
effectiveness of the ο Investment plans
QMS and its ο Human-resources plans
processes ο new objectives
∆ product ο Projects
improvements ο action plans
∆ resource needs
ISO 9001:1994 and ISO 9001:2000
Chapter of standard: 6. Resource management

6.1 Provision of resources ( 4.1.2.2 )
− Determination and ο Quality Manual
provision of resources ο Investment plans
required for: ο relating to personnel
− implementing, ο relating to equipment
maintaining and ο relating to real estate
continually improving ο Staffing schedules
the quality system ο Other target plans
− ensuring customer
satisfaction
6.2 Human resources

6.2.1 General ( 4.1.2.2 )
− Personnel performing ο Quality Manual
work affecting product ο Job / function profiles
quality must be ο Employment contracts
competent based on: ο Manpower-development plans
− education ο Qualification documentation
− training ο Records of employee interviews
− skills ο Employee certificates
− experience. ο qualifikation matrix
6.2.2 Competence, awareness and training ( 4.18 )

− Determination of training ο Records of quality requirements
needs ο Job / function profiles
− Provision of appropriate ο Induction plans
training ο Records of employee interviews
∆ Evaluation of training ο Training schedules
effectiveness ο Training certificates
∆ actions of awareness- ο Records on the evaluation of training
building measures for the effectiveness
relevant activities and for ο Training objectives
the achievements of the ο Training benefits
objectives ο Training efficiency
− Maintaining of relevant ο Company benefits
records ο practice in the trained part
ISO 9001:1994 and ISO 9001:2000
6.3 Infrastructure ( 4.9 )

∆ Determination, provision ο Workplace investigations
and maintenance of ο Investment plans
infrastructure, e.g.: ο Maintenance and servicing plans and
∆ buildings, workplace records
and associated ο Records of process capability studies
utilities ο Records of
∆ process equipment, ο supplier evaluation
hardware and ο (including service providers)
software
∆ support services
(such as transport or
communication)
6.4 Work environment ( 4.9 )

∆ Definition and control of ο Evidence of instruction in
work-environment factors occupational safety
needed to achieve ο Evidence of the satisfaction of
product conformity. statutory and regulatory requirements
or conditions
ο Maintenance / servicing plans
(records)
ο Workplace investigations
ο Benchmarking re work environment
ο Employee -satisfaction analyses
ο Analyses re labor turnover /
absenteeism
ISO 9001:1994 and ISO 9001:2000
Chapter of standard: 7. Product realization

7.1 Planning of product realization ( 4.2.3 + 4.10.1 )
− Planning and ο Project-strategy approaches
development of product- ο Specifications
realization processes. ο Quality plans
Such planning must take ο Project-development plans
the following points into ο Milestone plans
account: ο Feasibility records
∆ quality objectives and ο Measurement and test strategies
product requirements ο Logistic strategies
− the need to establish ο Records relating to risk assessment
or provide product- and process evaluation (technical,
specific processes, economic)
documents and ο FMEA
resources ο criteria for process release
− product-specific
verification, validation,
monitoring,
inspection and test
activities and criteria
for product
acceptance
∆ appropriate records
to provide
documented
evidence for the
realization of product
and process (s.
4.2.4)
7.2 Customer-related processes

7.2.1 Determination of requirements related to the product ( 4.3.2 + 4.4.4 )
Determination of: ο Order letter
∆ product requirements ο Customer inquiries
including delivery and ο Records of consultations with
post-delivery support customers
∆ requirements not stated ο specifications
by the customer but ο drawings
necessary for the use ο Trend analyses
∆ statutory and regulatory ο Competitor analyses
requirements ο Research re standards and statutory
− all additional requirements
requirements laid down
by the organization
ISO 9001:1994 and ISO 9001:2000
7.2.2 Review of requirements related to the product ( 4.3.2 + 4.3.3 + 4.3.4 )
Review of product ο Evidence of quotations, contracts,
requirements prior to contract review
commitment to supply ο Documentation of amendments
product to customer. The ο Feasibility analysis records
following must be ensured: ο Feasibility studies
− definition of product ο Confirmations of orders
requirements ο calculations
− elimination of ο price lists
contradictions ο delivery schedules
− contract review
∆ feasibility
• technical
• commercial
• qualitative
∆ documentation and
understanding of
amendments
7.2.3 Customer communication ( 4.3.2 )

∆ Determination and ο process description
implementation of ο work instructions
communication with ο projects
customers concerning: ο Customers' product specifications
∆ product information ο Inquiry documents
∆ inquiries, contracts or ο Contracts
order handling, ο Confirmation of order
including ο Advertising material
amendments ο Customer surveys and reports of
∆ customer feedback, customer visits
including customer ο Customer-satisfaction analyses
complaints ο Queries, complaints
ο Complaint analyses
ο Customer requests for changes
ISO 9001:1994 and ISO 9001:2000
7.3 Design and development

7.3.1 Design and development planning ( 4.4.2 +4.4.3 )
− Planning and controlling ο Project plans
of design and ο Design and development plans and
development; in this flow charts
context, the following ο Milestone plans
aspects must be defined: ο Measurement and test plans
− design and ο Verification and validation
development stages specifications
− review, verification ο Approval provisions
and validation ο Responsibility matrix
process ο Risk assessment
− responsibilities and
authorities
− actualisation of plans
∆ interfaces and
communication
between the various
groups involved
7.3.2 Design and development inputs ( 4.4.4 )

− Determination and ο Specifications / terms of reference
recording of input relating ο Statutory and/or regulatory
to product requirements. implementing guidelines
This includes ο Result reports from previous similar
− functional and design and development activities
performance ο Evaluation of customer-requirement
requirements analyses
− applicable statutory ο Patent research
and regulatory ο Approval documents
requirements ο trend in customer complaints
∆ previous design and ο trends in ppm-statistics
development results ο garanties evaluations
obtained in ο FMEA’s
connection with
similar products
− other requirements
(price, service life,
recyclability)
− adequate, clearcut
requirements
ISO 9001:1994 and ISO 9001:2000
7.3.3 Design and development outputs ( 4.4.5 )
Design and development ο drawings
output must: ο FE-calculations
− meet input requirements ο QM-plans
for design and ο Acceptance certificates
development ο Order documents containing
∆ provide information for specifications
purchasing, production ο Risk analyses (e.g. FMEA)
and service provision ο Test records (for production,
− reference product verification and validation)
acceptance criteria ο Approval documents
− specify product ο sample test
characteristics essential
for its safe and proper
use
7.3.4 Design and development review ( 4.4.6 )

− Systematic review of ο Intermediate / final design and
design and development development reports
at suitable stages ο Appropriate test records, e.g. of
(s. 7.3.1) laboratory or field testing
− to assess their ability ο Minutes of meetings
to fulfill requirements ο Milestone and phase reviews
∆ to identify problems ο FMEA
and propose ο Models and simulations
necessary action ο Approval documents
− The results of the review
and the necessary action
must be documented.
(s. 4.2.4)
7.3.5 Design and development verification ( 4.4.7 )

− Design and development ο Test plans (verification requirements)
verification must ensure ο Prototypes / test samples
that: ο Test records / reports
− design and ο Records of alternative calculations
development outputs /analyses
satisfy design and ο Test / simulation reports
development input ο Records of experiments / trials
requirements ο Description of follow-up measures
(s. 7.3.1) ο Approval documents
− follow-up action is
defined
− verification results
have been
documented.
(s. 4.2.4)
ISO 9001:1994 and ISO 9001:2000
7.3.6 Design and development validation ( 4.4.8 )
− Design and development ο Test plans (validation requirements)
validation must ensure: ο laboratory tests
(s. 7.3.1) ο environmental tests
− fitness for use ο Results of pilot series / field testing
− partial validation, if ο Test records / reports
applicable ο (possibly from customers, too)
∆ validation prior to ο Results of -life testing
product delivery, if ο field testing
possible ο Evaluation results from other bodies
− documentation ο Validation approvals
(s. 4.2.4)
7.3.7 Control of design and development changes ( 4.4.9 )

This involves review of the ο Documented requests for changes
following aspects: (e.g. by the customer, production, ...)
− identification and ο New revision stati of e.g.
documentation of specifications, drawings, process
changes descriptios, test procedures,
∆ review, verification, measurement systems,
validation and approval ο Comments, test reports in connection
prior to implementation with changes
∆ review of effects of ο Approval documents in connection
changes in design and with implemented changes
development and of ο Communication of changes to
follow-up action on customers, units
product ο Withdrawn documents
∆ documentation of review ο history of changes
results (s. 4.2.4)
7.4 Purchasing
7.4.1 Purchasing process ( 4.6.2 )
− The purchased product ο Product specifications
must conform to product ο Supplier's quality system
requirements. The documentation
supplier must be ο Checklist
evaluated and criteria for ο Evidence of supplier evaluation
such evaluation ο List / database of approved suppliers
established. The ο Evaluation criteria
following aspects must ο compaints
be considered in the ο ppm-statistics
purchasing process, e.g.: ο specifications
− external product
quality
− factors of influence
− supplier capability
∆ criteria for supplier
selection, regular
evaluation and re
evaluation
− documentation of
evaluation (s. 4.2.4)
ISO 9001:1994 and ISO 9001:2000
7.4.2 Purchasing information ( 4.6.3 )
− Purchasing information ο Product specifications
must describe the product ο Order forms
to be purchased. Such ο purchasing specifications in EDP
information must include, ο Order lists, piece lists
where appropriate, a ο Performance / delivery contracts
description of the ο Quality assurance agreements
requirements pertaining ο Order approval documents
to:
− product approval,
procedures,
processes, facilities
and equipment
− personnel
qualification
− the quality system.
− The adequacy of
requirements must be
ensured prior to their
communication to the
supplier
7.4.3 Verification of purchased products ( 4.6.4 )

In this context ο Acceptance criteria
inspection/other activities ο Verification plans
must be established and ο Test regulations
implemented which verify ο Regulations re approval under
product conformity with concession
requirements. ο Test records of suppliers or of
For verification measures organization's own incoming
conducted at the supplier's inspection
premises, the intended ο Certifications
verification measures and ο incoming inspection
methods must be defined.
7.5 Production and service provision

7.5.1 Control of production and service provision ( 4.9 + 4.15.6 + 4.19 )
In this context: (s.a. 7.1) ο Acceptance criteria
− product characteristics ο Work instructions
must be defined, ο Test plans
− work instructions, as ο drawings
necessary, must be made ο Maintenance plans
available, ο Installation plans
− suitable equipment must ο Service contracts
be used, ο Operating instructions
− monitoring and ο Process flow charts
measuring devices must
be made available,
− activities must be
monitored and measured
− release and delivery of
products/services must
be ensured
∆ post-delivery activities
must be implemented
ISO 9001:1994 and ISO 9001:2000
7.5.2 Validation of processes for production and service provision
Validation must ο Evidence of machinery and process
demonstrate process capability
capability. In this context, the ο Process descriptions
following must be taken into ο data of process control
account: ο Skills documentation and training
validation of all production certificates
processes where the ο Qualification certificates
resulting output cannot be ο Validation specifications
verified by subsequent
monitoring or
measurement. This
includes all processes
where deficiencies become
apparent only after the
product has been delivered.
Validation must include
(where appropriate):
− criteria for review and
approval
− approval of equipment
and personnel
qualification
− use of specific methods
and procedures
− requirements pertaining
to quality records (s.
4.2.4)
− possible necessity of
renewed validation
7.5.3 Identification and traceability ( 4.8 + 4.10.5 + 4.12 )

− Where appropriate, the ο Work instructions
product must be identified ο Accompanying documents, e.g.
throughout product routing slips
realization ο production plans
− The product status must ο IT records
be identyfied with respect ο Product identification
to monitoring and ο Test certificates
measurement ο Segregation slips
requirements. ο Approvals
− . Identification must be
controlled and recorded, if
traceability is required
7.5.4 Customer property ( 4.7 )

In this context, the following ο Inventory of customer property
must be observed: ο Identification (e.g. labels, stickers)
∆ careful handling (also ο Correspondence with customers
where intellectual property ο Records on verification and
is concerned) maintenance conducted
− identification, verification, ο Incoming inspection
protection and
maintenance
− procedure and
documentation in cases
involving damage or loss
(notification of customer)
ISO 9001:1994 and ISO 9001:2000
7.5.5 Preservation of product ( 4.15.2 + 4.15.3 + 4.15.4 + 4.15.5 )
− This refers to both internal ο Regulations on packing, storage,
processing and delivery preservation and delivery
and must include: ο Piece lists
− preservation of ο Inventory lists
product conformity ο Stock-replenishment and -withdrawal
− identification plans
− handling ο Regulations on storage periods and
− packaging segregation (where appropriate)
− storage ο delivery labels
− protection ο Assembly / operating instructions
∆ This also applies to the
constituent parts of
products.
7.6 Control of monitoring and measuring devices ( 4.11.1 + 4.11.2 )

− Determination of required ο Test certificates including acceptance
monitoring and criteria
measuring devices ο Evidence of capability of monitoring
− Determination of and measuring devices
monitoring and ο List or use of EDP for monitoring and
measuring device abillity measuring devices
− Calibration and ο Calibration instructions
adjustment at regular ο Calibration records
intervals ο Gauging records
− Identification of ο Calibration standards
measuring equipment ο Calibration certificates
− Identification of calibration ο Records on comparative
status measurements and inter-laboratory
− Steps to ensure tests
protection and handling ο Records on software qualification
− Documentation of testing
calibration results
− Definition of corrective
action
− Documentation
− If the equipment is found
not to conform to
calibration requirements,
previous measuring
results must be re-
assessed and
documented.
− The capability of computer
software must be
confirmed. Capability
must be confirmed prior
to initial use and
reconfirmed as
necessary.
ISO 9001:1994 and ISO 9001:2000
Chapter of standard: 8. Measurement, analysis and improvement

8.1 General ( 4.10 + 4.20.1 + 4.20.2 )
∆ Monitoring, ο Design and development flow charts
measurement, analysis ο Design and development test plans
and continuous ο company data system
improvement processes ο objectives and the actualisation
must be ο Improvement schemes
− defined ο Statistics
− planned ο Progress reports
− implemented(s.a. ο Information boards
4.1) ο inputs for continual improvements
to demonstrate conformity
of the product and the
quality system and
improvement of quality
system effectiveness.
∆ Determination of
applicable requirements
must include the use of
suitable statistical
techniques.
8.2 Monitoring and measurement

8.2.1 Customer satisfaction
∆ Customer perception ∆ Action catalogs
must be monitored. ∆ Customer-satisfaction analyses
Methods of obtaining and ∆ Benchmarking
using this information ∆ Checklists
must be determined. ∆ Evaluation of mailing and telephone
(s.a. 5.2) initiatives
∆ Evaluation records (general)
∆ Records of target requirement review
8.2.2 Internal audit ( 4.17 )

− Conducting of internal ο DP internal audits
audits to the planed ο Audit plans
arrangements (s.7.1) at ο Audit reports
planned intervals ο Nonconformance reports
− planning ο Action catalogs for the establishment
− execution of corrective action
− documentation ο Test records etc.
− evaluation ο Management reviews
− definition and ο Reports on effectiveness of corrective
implementation of action
corrective action ο Evidence of auditor qualification
− surveillance
− The results of previous
audits must be taken into
account.
− The objectivity and
impartiality of auditors
must be ensured.
ISO 9001:1994 and ISO 9001:2000
8.2.3 Monitoring and measurement of processes ( 4.17 + 4.20.1 + 4.20.2 )
∆ Suitable methods for ο company data
monitoring and ο Process data
measurement of quality ο controlling data
system processes must ο statistic analysis
be determined, applied, ο Quality data
reviewed and corrective ο SPC-data and evaluations
and preventive action ο Work instructions
implemented, where ο Risk analysis records (FMEA)
appropriate. (s. 7.1+5.1) ο Maintenance and servicing plans and
implementation measures
ο Q records
ο Test plans
ο Test records
8.2.4 Monitoring and measurement of product ( 4.10.2 + 4.10.3 + 4.10.4 + 4.10.5 + 4.20.1 + 4.20.2 )
− Product characteristics: ο Test plans
− monitoring ο Test instructions
− measuring ο Test records
− verification ο Sampling plans (attributive und
− documentation variable)
− at appropriate stages of ο Checklists
product realization.(s. 7.1) ο Comparative samples
− Products or service may ο Q records
only be approved after ο Approval under concession by the
conformity has been customer or an authority (where
established. appropriate)
∆ The responsible person
for release must be
identified in each case.
8.3 Control of nonconforming product ( 4.13.1 + 4.13.2 )

− Nonconforming products ο DP control of nonconforming product
must be: ο Nonconformance records
− identified ο Test regulations
− separated ο Test certificates
− controlled ο Customer information
− corrected ο Additional test plans, where
− re-verified appropriate
− documented ο Approval records
− corrected nonconforming ο Expert opinions
products must be: ο Approval under concession
− re-verified, ο Identification requirements
− approval by customer
under concession, where
appropriate
∆ Consequences of
nonconformances , also
for products in use must
be:
− determined and
− action taken
− records of concessions
shall be maintained
ISO 9001:1994 and ISO 9001:2000
8.4 Analysis of data ( 4.20.1 + 4.20.2 )

∆ Appropriate data to ο Measurement and test records
demonstrate quality ο Nonconformance records
system suitability and ο Records of customer complaints
effectiveness must be: ο Customer-satisfaction analyses
ο determined ο Audit reports
ο collected ο Q reports
ο analyzed ο Records relating to field experience
∆ to provide information ο Target/performance comparison
relating to reports
ο customer
satisfaction/dis-
satisfaction (s. 8.2.1)
ο conformity of product
requirements (s. 7.2.1
ο process and product
characteristics
(s. 8.2.3 + 8.2.4)
ο suppliers (s. 7.4.1)
for the purpose of
continuous improvement of
the effectiveness of the
quality management
system
8.5 Improvement
8.5.1 Continuous improvement ( 4.1.3 )
∆ Continuous improvement ο Quality management plans
must be made possible ο Project plans
through the use of ο Documentation of target
− the quality policy requirements
− quality objectives ο Progress reports
− audit results ο Management reviews
− data analysis ο Corrective-action catalogs
− corrective and ο Preventive-action catalogs
preventive action ο inputs for continual improvements
− management review.
(s. 4.1)
8.5.2 Corrective action ( 4.14.1 + 4.14.2 )

To prevent the recurrence of ο DP Control of corrective action
nonconformances, the ο Nonconformance records
documented procedure ο 8-D-reports
must cover the following ο Statistical evaluations
aspects: ο Test / result records
− reviewing noncon- ο Instructions re corrective action
formities (incl. Customer ο Training plans
complaints) ο Training certificates
− determination of the ο Complaints analyses
causes of ο Amended delivery contracts (where
nonconformities appropriate),
− required measures to ο Q agreements
prevent recurrence ο Investment plans
− action / corrective action ο Documentation of reviews
− monitoring and evaluation
of corrective action
− documentation
ISO 9001:1994 and ISO 9001:2000
8.5.3 Preventive action ( 4.14.1 + 4.14.3 )
To eliminate the causes of ο DP Control of preventive action
potential nonconformances, ο Risk analyses (economic / technical)
the documented procedure ο Nonconformance records
must cover the following ο 8-D-reports
aspects: ο Analyses records
− determination of potential ο Test records
nonconformances ο Action catalogs
− planning of preventive ο Training plans
action ο Training certificates
− implementation of ο Amended delivery contracts
preventive action ο Q agreements
− evaluation of preventive ο Investment plans
action taken ο Trend analysis
− documentation ο cost evaluations
ο inputs for continous improvement

Audit Question List For ISO 9001

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Audit Question List For ISO 9001

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Audit question list (topic list)

ISO 9001:1994 and ISO 9001:2000

Audit type: • C-Audit • S-Audit • R-Audit

Street / P.O. box:

Zip code / city:

Lead auditor / auditor:

Site / branch office etc. actual number of

Remarks on how to use the audit question list / topic list:

Chapter of standard: 4. Quality Management System

4.2 Documentation requirements

4.2.3 Control of document ( 4.5.1 + 4.5.2 + 4.5.3 )

4.2.4 Control of records ( 4.16 )

Chapter of standard: 5. Management responsibility

5.2 Customer focus

5.3 Quality policy ( 4.1.1 )

5.5 Responsibility, authority and communication

5.5.2 Management representative (4.1.2.3 )

5.5.3 Internal communication

5.6 Management review

5.6.2 Review input

5.6.3 Review output

Chapter of standard: 6. Resource management

6.2 Human resources

6.2.2 Competence, awareness and training ( 4.18 )

6.3 Infrastructure ( 4.9 )

6.4 Work environment ( 4.9 )

Chapter of standard: 7. Product realization

7.2 Customer-related processes

7.2.3 Customer communication ( 4.3.2 )

7.3 Design and development

7.3.2 Design and development inputs ( 4.4.4 )

7.3.4 Design and development review ( 4.4.6 )

7.3.5 Design and development verification ( 4.4.7 )

7.3.7 Control of design and development changes ( 4.4.9 )

7.4.3 Verification of purchased products ( 4.6.4 )

7.5 Production and service provision

7.5.3 Identification and traceability ( 4.8 + 4.10.5 + 4.12 )

7.5.4 Customer property ( 4.7 )

7.6 Control of monitoring and measuring devices ( 4.11.1 + 4.11.2 )

Chapter of standard: 8. Measurement, analysis and improvement

8.2 Monitoring and measurement

8.2.2 Internal audit ( 4.17 )

8.3 Control of nonconforming product ( 4.13.1 + 4.13.2 )

8.4 Analysis of data ( 4.20.1 + 4.20.2 )

8.5.2 Corrective action ( 4.14.1 + 4.14.2 )

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