ISO9001-2000 Score by Process Group
Score
95% 90% 85% 80% 75% 70% 65% 60% 55% 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% Row 4 Row 5 Row 6 Row 7
Column S
Row 8 Row 9
Row 10
Row 11
Process Group
Row 12
Column S
ISO9001-2000 Score by Paragraph
TOTAL 8.4 8.2 7.6 7.4 Paragraph
7.2 Column P
6.4 6.2 5.6 5.4 5.2 4 0% 10% 20% 30% 40%
50%
60%
70%
Score
80%
90%
100%
Column P
Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
CHECKLIST ABOUT ISO9001:2000 IMPLEMENTATION Instructions for use: This scorecard is intended to provide you with a means to measure the level of your compliance with the requirements of ISO9001-2000. It is not, by any means, intended to be an exact representation of your status but it will help you focus on those areas where the most work may be needed. Because it also graphically depicts your running score, it is a simple and excellent visual tool to keep Management and the entire workforce attuned to your progress. Each question in Column B derives from specific requirements of the standard. Review each one carefully to determine if your quality management system presently complies and score yourself as follows : Yes, we presently comply = 1 It does not apply to us = 1 No, we do not presently comply = 0 Percentage scores for each section are automatically computed in Column C You may use Column G to identify in which of your documents (procedure, manual, work instruction, etc.) the requirement is covered. Wherever possible, cite the appropriate paragraph or section. You may use Column H to identify whether or not you have confirmed compliance by audit. The Scorecard is protected so that you may only make entries in Columns B, G and H. This was done to prevent inadvertent entries or changes to the scorecard formulas, leading to erroneus results. Columns K thru S summarize the scores by sub-paragraph, paragraph and by each Process Group of the standard. Chart 1 depicts the level of compiance against the standard's major paragraphs (Columns O & P) Chart 2 depicts the level of compliance against the standard's Process Groups , i.e. major sections (Columns R & S)
Company/Organization Prepared by Current Issue Date
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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 Question (Those relating to new/revised requirements are in italics)
SCORING Question
Audit Guidelines
Section
Organization's9001:1994 Fully Documentation Cross Ref Documented
Fully Implemented
4 Quality Management System 4.1 QMS General requirements
0%
4.1 Has the organization established and implemented a
(Note: clause 4.2 defines documentation requirements; the
quality management system (QMS) in accordance with the
general requirements of clause 4.1 are met if the specific
requirements of ISO 9001:2000? Specifically:
4.2.1
requirements of clauses 5-8 are met )
a) Are QMS processes identified?
0
Review quality manual to determine if a systematic
Quality manual and/or
b) Have the sequence and interaction of QMS processes
0
approach is defined for:
process flow charts /
1) identifying and managing QMS processes (or elements)
diagrams
been determined? c) Have the criteria and methods required to ensure
0
the effective operation and control of QMS processes been defined? d) Are resources & information available to support QMS
clause 0.2 and Figure 1 of ISO 9001:2000 identifying and 0
process operation and monitoring? e) Are QMS processes measured, monitored and analyzed to
showing the relationship between the following QMS processes (or elements) & their related sub-processes: Clause:
0
ensure actions are implemented to achieve planned results and
5. Management Responsibility 6. Resource Management
continual improvement? f) Are actions implemented to achieve planned results and
in accordance with the "process approach" defined in
7. Product Realization 0
continuous improvement of QMS processes?
8. Measurement, Analysis and Improvement 2) ensuring the criteria, methods, information and responsibilities for managing QMS processes are in place.
When processes affecting product conformity are outsourced,
0
3) ensuring that data is collected, analyzed and used to assess
i) are they controlled and ii) are the controls identified in the
QMS process effectiveness and to identify needed actions or
QMS?
improvements.
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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 4.2 General documentation requirements 4.2.1 a) Are statements of quality policy and quality objectives
0% (Note: The requirements of clause 4.2.1 a) are met 0
documented? 4.2.1 b) Is there a quality manual?
if the requirements of 4.2.2 are met.) Review quality manual to ensure it complies with clause 4.2.2 and that it
0
contains documented statements of a quality policy and qual objectives.
4.2.1 c) Are procedures required by ISO 9001:2000 established,
Review quality manual to ensure it contains or references documented
documented, implemented and maintained including, at a minimum:?
procedures as required by the standard and other documented
Document Control (clause 4.2.3)?
0
procedures as appropriate for the size and type of the organization, the
Control of Quality Records (clause 4.2.4)?
0
complexity and interaction of processes, and competence of personnel.
Internal Audit (clause 8.2.2)?
0
Review QMS documentation to determine if documented
Control of Nonconformity (clause 8.3)?
0
procedures are appropriate for the size and type of the
Corrective Action (clause 8.5.2)?
0
organization, the complexity and interaction of processes, and
Preventive Action (clause 8.5.3)?
0
competence of personnel.
Planning (5.4.2, 7.1, 8.1, 8.5.1)
0
Review QMS processes to ensure they are adequately defined in
Communications (5.5.3)
0
procedures, process or job descriptions, work instructions, or
Management Review (5.6)
0
other appropriate system documentation.
Resource Management (6)
0
Training (6.2.2)
0
Customer Related Processes (7.2)
0
Design and Development (7.3)
0
Purchasing(7.4)
0
Control of Products & Services (7.5.1)
0
Product ID/Traceability ( 7.5.3)
0
Customer Property (7.5.4)
0
Preservation of Product (7.5.5)
0
Validation of Processes (7.5.2)
0
Process Meas/Monitoring (8.2.3)
0
Product Meas/Monitoring (8.2.4)
0
Analysis/ Improvement (8.4, 8.5)
0
Control of Measuring & Monitoring Devices (7.6)
0
Customer Satisfaction Monitoring (8.2.1)
0
4.2.1 d) & e) Does the QMS identify all other appropriate documentation &
0
Others, as appropriate, which may include:
Quality manual
4.2.1
Documented procedures
4.2.2
Other QMS documentation
(Note: all required QMS documents and records are controlled
Other QMS docs and
per clauses 4.2.3 and 4.2.4)
records
4.2.1 4.5.1
0
Verify that quality manual is controlled per clause 4.2.3
Quality manual,
4.2.1
0
Review the quality manual to verify that it addresses all ISO 9001
records needed to ensure effective planning, operation and control. 4.2.2 Quality Manual - Is a quality manual established, maintained, and controlled. And does it include: a) the scope of the QMS, including details and justification for any exclusions?
requirements or includes appropriate statements of exclusions and related justifications (permitted by clause 1.2).
b) documented procedures or reference to them?
0
Review the quality manual to verify that it contains or references
Documented procedures,
required documented procedures (per clause 4.2.1c) and a c) a description of the interaction between QMS processes:
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0
description of the sequence and interaction of QMS processes /
QMS process descriptions,.
elements (per clause 4.1).
flow charts, etc.
Adaptado para el Curso Gestión Integral de Calidad UNI-FIM
Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 4.2.3 Control of documents
0%
Is a documented procedure established to control all
0
documents required for the QMS
Verify that the doc. procedure details rules (per 4.2.3 a-g)
Document Control
for controlling:
procedure
4.5.1
Quality manual Documented Procedures External Documents Work Instructions Product documentation (including drawings, specifications, bills of material, parts lists, production plans, control plans, etc.). 4.2.3.a) and b): Are new/revised docs reviewed for adequacy
0
Review documents for evidence of review/approval.
and approved by authorized personnel prior to issue?
All new and
4.5.2,
revised documents
4.5.3
4.2.3 Are documents: c) identified by their current revision status,
0
Review documents for proper identification, revision status,
All controlled documents, 4.5.2
and legibility d) available at locations where they are needed
0
Test the distribution system to verify documents are available
e) legible, readily identifiable and retrievable?
0
and retrievable.
4.2.3.f) Are external documents identified and their
0
Review external documents for proper .
distribution controlled?
identification and control
Master lists, Distribution lists, etc. All applicable external
4.5.2
documents: standards, customer documents, and statutory/regulatory documents
4.2.3.g) Are obsolete docs prevented from unintended use
0
Review retained obsolete documents for proper identification;
& suitably identified if retained for any purpose.
4.5.2
Ask for a record and note how long it takes to retrieve; identify
Quality records
###
causes for breakdowns in the record management system.
procedure
identify any obsolete documents not removed from points of use
4.2.4 Administration - Control of quality records 4.2.4 Is a documented procedure established to control the
All obsolete documents
0% 0
identification, storage, retrieval, protection, retention and disposition of quality records? Specifically, Are quality records legible and readily retrievable?
0
Are quality records (hard copy or electronic media) stored in a
0
suitable environment to prevent deterioration, damage or loss? Are quality records retained per established procedures and for
Verify that records are suitably protected and note any signs of record deterioration, damage or loss due to inadequate storage.
0
the specified periods?
Verify that record holders, locations and retention periods are stipulated for each record or record category.
Are appropriate records maintained to demonstrate conformance
0
Verify that records are retained as required by established
to requirements and effective operation of the QMS incl. as minimum?
procedures (and/or customer requirements).
Management Review (5.6.1) Competency & Training (6.2.2)
Verify that records are disposed of in a timely manner.
Prod Reqmnts Review (7.2.2) Design Inputs (7.3.2)
Note: The adequacy of quality records is determined throughout
Design Reviews (7.3.4)
the audit or assessment.
Design Verification (7.3.5)
Design Validation (7.3.6) Design Change Review (7.3.7) Supplier Evaluation (7.4.1) Cust Product Reports (7.5.4) Calibration / Verif Results (7.6)
Inspection Results (8.2.4) Corrective Actions (8.5.2)
Internal Audit Results (8.2.2)
Nonconforming Product (8.3)
Preventive Actions (8.5.3)
Traceability (7.5.3)
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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 5.1 Management responsibility 5.1 Management commitment 5.1 Is there evidence of top management's commitment to QMS
0% 0
Interview top management to assess their awareness of and
development and improvement? Has top management: a) communicated the importance of meeting customer and
commitment to fulfilling their responsibilities for QMS 0
development/improvement.
regulatory/statutory requirements?
Quality manual, management review
b)established the quality policy and objectives?
0
Review evidence of top management involvement in establishing
c) conducted management reviews?
0
quality policy and objectives, communicating requirements,
allocation data, internal
d) provide necessary resources
0
conducting management reviews, and providing resources
memos, letters, briefing
needed for QMS development and improvement.
notes, etc.
5.2 Customer focus Are customer requirments determined and fulfilled
4.1., 4.2.1 4.1.3
minutes, resource 4.1.2.2
0% Review available information to determine if customer 0
with the aim of achieving customer satisfaction?
needs/expectations are known and defined in terms of key
Product information
product characteristics, delivery, price or other customer concern.
brochures, customer
Interview managers responsibe for customer related process to assess
information.
organization's strategy for enhancing customer satisfaction Review contracts and quality plans to determine if customer
Contracts/ agreements
needs & expectations, including those for specified but known or intended use are converted into requirements
Quality Plans
per clause 7.1 & 7.2.1)
5.3 Quality policy 5.3 Has top management established a quality policy that:
Review any evidence of customer perceptions (per clause
Customer complaints
8.2.1) that may indicate customer needs/expectations are
and/or satisfaction
unknown or not being met.
survey results.
Review the quality manual to ensure top management has
Quality manual
0% 0
4.1.1
established/approved the quality policy. a) is appropriate to the organization's purpose?
0
b) includes a commitment to complying with requirements & to
0
Review other organizational policy documents to determine their consistency with the quality policy.
continualy improving QMS effectiveness? c) provides a framework for establishing and reviewing quality
Review the quality policy to determine if it promotes customer satisfaction and continual improvement.
0
objectives?
Ask a random sampling of managers and/or employees if they understand the process for establishing and reviewing quality objectives (per clause 5.4.1).
d) is communicated and understood within the
0
organization?
Ask a random sampling of employees what the quality policy is and how they contribute to attaining its objectives (also see clauses 5.5.3, 5.5.4 and 6.2.2.d).
e) is reviewed for continuing suitability?
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0
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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 5.4.1 Quality Objectives
0%
5.4.1 Are quality objectives: established at relevant functions & levels within the organization?
(Note: Quality objectives are used to facilitate improvement of 0
include objectives related to meeting product requirements? measurable and consistent with the quality policy (incl. the
Quality manual
4.1.1
commitment to carrying out and updating plans to met QMS
Corporate resource
4.2.3
requirements defined in clause 4.1 and achieve objectives defined
allocation plan and
in clause 5.4.1 especially during periods of significant change (I.e major
related provisions or .
organizational, process and product changes.)
procedures regarding its
products and product realization processes per clause 8.2.4 and to facilitate continual improvement of the QMS per clause 8.5.1)
0
Review the quality manual or other documentation to determine if
commitment to continual improvement)?
top management has established quality objectives and defined responsibilities for their achievement, including those needed to meet product requirements
5.4.2 QMS Planning 5.4.2 a) Has Top Management caried out plans to meet QMS
0% Interview management and review records to assess management's 0
requirments and obkectives for improving the QMS, and 5.4.2 b) Maintained QMS integrity during periods of significant change?
0
development and update 5.5.1 Responsibility,authority & communication 5.5.2 Are responsibilities and authorities & their interrelationship
0% 0
defined and communicated?
Review the quality manual or other appropriate documents to
Quality manual,
verify that quality management authorities and responsibilities
Organization charts,
& interrelationships (including responsibilities for achieving
job descriptions
4.1.2.1
quality objectives) are clearly defined. 5.5.2 Management Representative
0%
5.5.2 Has top management appointed a management representative
Review the quality manual or other appropriate documentation to
Quality manual,
with responsibility and authority for:
verify that a management representative is appointed and actively
job descriptions, internal
involved in establishing, implementing and maintaining the QMS.
memos
a) ensuring QMS processes are established, implemented & maintained?
0
b) reporting QMS performance and improvement needs to
0
top management? c) ensuring promotion of awareness of customer requirements
importance of meeting customer and other requirements. (also see clauses 5.3.d , 5.5.3, and 6.2.2.d)
5.5.3 Internal communication effectiveness communicated to the organization?
4.1.3
Ask a random sampling of employees if they are aware of the 0
throughout the organization
5.5.3 Is information regarding QMS processes and their
4.1.2.3
0% 0
Review the quality manual or other documentation to determine if
Quality manual
internal communication systems have been established and responsibilities for their maintenance defined. Ask a random sampling of employees about some recent quality system issue to verify that appropriate information was effectively communicated. (also see clauses 5.3.d , 5.5.3 and 6.2.2.d)
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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 5.6 Management review 5.6.1 Does top management review the QMS at planned intervals to
0% 0
Verify that a management review procedure or process is
Quality manual (or
established to ensure the QMS (including the quality policy and
management review
0
objectives) is periodically reviewed for change or improvement.
procedure)
0
Review management review records for evidence that the required
Management review
inputs were considered.
minutes/records
Review management review records for evidence that the required
Management review
outputs are recorded and used for improvement of the QMS and
minutes/records
ensure its continuing suitability, adequacy and effectiveness? Are the quality policy & objectives reviewed for needed
4.1.3
changes? 5.6.2 Do inputs to the management review consider current performance and improvement opportunities, including: a) results of audits
0
b) customer feedback
0
c) process performance and product conformance indicators
0
d) status of corrective and preventive actions
0
e) follow-up actions from previous management reviews
0
f) planned changes that could affect the quality system
0
g) recommendations for improvement
0
5.6.3 Are results of management reviews recorded and do they
0
include actions related to: a) improvement of the effectiveness of QMS & processes
0
its processes (per clause 8.5.1) , products and resource needs
b) improvement of product related to customer requirements
0
and/or used to make appropriate changes to the QMS, quality
c) resource needs
0
policy, and process/product quality objectives.
4.1.3
4.1.3
6 Resource Management 6.1 Provision of resources Are resources needed to implement and continually improve
0% 0
Note: required resources are identified during quality planning per
Resource allocation plans 4.1.2.2
QMS processes and enhance customer satisfaction provided in a
clause 5.4.2.
and related provisions
timely manner?
Through observation or interviews, identify any evidence that
or procedures regarding
required resources are not provided as needed.
their development and update.
6.2.1Human resources - Assignment of personnel Are personnel assigned responsibilities defined in the QMS
0% 0
competent on the basis of appropriate education, training, skills
Review organization charts, job descriptions, to verify that
Organization charts,
personnel are qualified to perform work assignments.
job descriptions, etc.
Review qualification review results to verify that personnel
Qualification review
competency is evaluated to determine training needs.
results
Review training plans and records to verify that:
Training plans & records
4.1.2.2
and work experience? 6.2.2 H.R. Training, awareness & competency 6.2.2.a) Do qualifications for personnel performing activities affecting
0% 0
quality include identification of appropriate education, training, skills
###
and experience? 6.2.2.b) Is required training provided or other actions taken to
0
satisfy those needs? 6.2.2.c) Is the training provided/actions taken evaluated for
required training is provided/actions taken and they are 0
evaluated for effectiveness
effectiveness? 6.2.2.d) Are employees aware of the relevance/importance of
0
their activities and how they contribute to quality objectives? 6.2.2.e) Are appropriate records of training, education, skills
QMS awareness training is provided &/or interview employees to assess awareness (see also clauses 5.3.d & 5.5.3 )
0
Verify adequacy of employee qualification/training records.
& experience maintained?
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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 6.3 Infrastructure 6.3 Are the organization's facilities suitable and maintained to
0% 0
ensure process capability and product conformance?
Through observation or interviews, identify any evidence that
Equipment preventive .
facilities do not meet needs of all interested parties.
and/or predictive
Facilities include:
###
maintenance plans
a) buildings, workspace and associated facilities
0
Review equipment and facilities maintenance plans for adequacy
b) process equipment, hardware and software
0
(i.e. completeness and consistency relevant criteria, such as
c) supporting services such as transportation or communication
0
manufacturer’s recommendations) Verify that plans are consistently implemented especially as they relate to production or service operations (see clause 7.5.1).
6.4 Work environment 6.4 Is the organization's work environment identified & managed
0% 0
Through observation or interviews, verify that the work .
to ensure process capability and product conformance?
environment is suitable, clean and well organized Review for adequacy the processes, procedures or practices
Process capability
###
studies Production plans
governing the identification and control of environmental factors.
7 Product Realization 7.1 Planning of product realization processes 7.1 Is the planning of product realization processes consistent with
0% 0
other requirements of the QMS and suitably documented?
4.2.3
Review quality plans for consistency with the QMS and verify that
Quality plans, production
###
appropriate quality objectives are established.
plans, work orders,
###
Review quality plans, production plans, work orders and other.
process sheets, etc.
a quality plan. 0
requirements for products? b) Does the quality plan define appropriate realization processes
Quality plans
to a specific product, project or contract may be referred to as
Specifically: a) Does the quality plan contain quality objectives and
Note: documentation defining how QMS processes are applied
0
and identify documentation and resource requirements
appropriate documentation to verify that realization processes,
specific to products?
and documentation and resource requirements are defined Note: operations control is discussed in clause 7.5.1.
c) Does the quality plan identify required verification and
0
validation, monitoring, inspection & test activities specific to the product and the criteria for acceptance? d) Does the quality plan identify the records that are necessary to provide evidence that the realization processes and resulting product meet requirements?
0
Review quality plans, production plans, work orders, process
Quality plans, production
###
sheets, inspection procedures or instructions and other
plans, work orders,
4.10
appropriate documentation to verify that:
process sheets, etc.
###
Verification and validation activities and criteria for acceptance, and related record requirements are defined. Note: process and product monitoring activities are discussed in clauses7.4.3, 8.2.3 and 8.2.4, and validation requirements (for special processes) are discussed in clause 7.5.2
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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 7.2.1 Customer-related processes - Determination of requirements relating to product Does the organization have processes in place to ensure
0% 0
customer requirements are identified? Including: a) requirements specified by the customer, including
0
Requirements ident-
inclusion of all applicable specified requirements and
ification procedure or
requirements necessary to fulfill specified, known or
process
intended use as well as all applicable regulatory and
delivery and post delivery activities b) requirements not specified by the customer but
Review contracts or other customer agreements to verify the
statutory requirements. 0
necessary for specific or known and intended use c) requirements (including regulatory and statutory requirements)
0
related to the product d) any additional requirments determined by the organization
0
7.2.2 Customer-related processes - Review requirements re product
Review performance claims made by company relating to
Product descriptions,
products/services and verify that appropriate requirements
catalogues, brochures
are provided for in quality plans (see clause 7.1) 0% Product requirements
4.3.1
review and change Is there a requirements review process in place to ensure that
control procedure or
prior to acceptance
Review customer complaints, and/or shipping records for any
a) product requirements are defined?
0
b) order requirements different than previously expressed are resolved
0
c)the organization confirms its ability to meet defined requirements
0
process
evidence that requirements were not known or not met.
4.3.2
Review quotes or offers and contract or orders to verify they are properly reviewed, that any differences or ambiguities are
Where customer provides no documented statement of
0
resolved, and that feasibility reviews have been performed.
4.3.3
0
Review change orders to verify they are properly reviewed, and.
4.3.4
requirements, are they confirmed? Where product requirements are changed, is relevant documentation amended and personnel made aware of the changes? Are results of the review, actions & follow-ups recorded?
that all concerned functions are informed 0
7.2.3 Customer-related processes - Customer communications
Review records for adequacy. 0%
Has the organization determined & implemented effective
Review the quality manual and/or other appropriate .
arrangements for communication with the customer regarding:
documentation to verify that responsibilities for internal
Quality manual,
a) product information?
0
communications with the customer are clearly defined
Organization charts,
b) inquiries, contracts or order handling, including
0
Interview customer service or other contact personnel to verify
job descriptions, etc.
amendments? c) customer feedback, including customer complaints?
communications system are effectively implemented. 0
Review customer complaints for any evidence that communications were ineffective.
NOTE: Throughout the FDIS version "design and/or development" has been changed to "Design and development" and "legal" has been changed to "statutory"
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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 7.3.1 Design and development planning Is there a procedure or established process in place for
0% 0
planning and controlling product design & development activities?
Verify that a procedure or process exists and adequately covers
Design and /or
4.4.1
all applicable design and development activities.
development procedure
4.4.2
or process
4.4.3
Have design plans for each design project been established to include: a) stages of design & development processes
0
Review design/development plans to verity they adequately define
Design and/or
b) review, verification and validation activities appropriate to
0
design schedules, assignment of personnel, and technical
development plans
each design and development stage c) responsibilities and authorities for design & development activities? Are interfaces between groups involved in design & development
interface responsibilities and communication processes. 0 0
effectively managed to ensure effective communications and clear assignment of responsibilities? Is planning output updated as the design and development
0
Review design/development plans to verify they are updated as
progresses?
appropriate.
7.3.2 Design and development inputs Are design & development inputs relating to product requirements
0% 0
determined and recorded (see 4.2.4) including: a) functional and performance requirements?
0
b) applicable regulatory/statutory requirements?
0
c) applicable information from derived from previous similar designs?
0
d) any other requirements essential for design and/or development?
0
Are design & development requirements complete, unambiguous
0
Design and /or
all applicable requirements
development input
4.4.4
documents
Verify that design input documents are properly reviewed and
and not in conflict?
approved.
7.3.3 Design and development outputs Are outputs of the design & development provided in a
Review design input documents to verify they address .
0% 0
form that enables verification against inputs? Specifically, do outputs: a) meet the input requirements?
0
b) provide appropriate information for purchasing, production and
0
Review design & development output documents for completeness,
Design and /or
including acceptance criteria, and to verify they are properly
Development Output
reviewed and approved.
Documents
4.4.4
service operations? c) contain or reference product acceptance criteria?
0
d) define characteristics of the product essential to its safe and
0
proper use? Are design/development output documents approved prior
0
to release?
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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 7.3.4 Design and development review
0%
Are design & development reviews conducted at suitable stages to: a) evaluate the ability of des. & development results to fulfill rqrments?
0
Review design & development plans to verify that reviews are .
b) identify problems and propose required actions?
0
planned at suitable stages
0
Review design& development review minutes, results or reports to
Do design/development review participants include representatives of all functions concerned with the design & development stage(s) being reviewed? Are results of design/development reviews and subsequent
0
Development Review
appropriate personnel, and that related results are properly
minutes, results or reports
recorded and controlled.
Quality records control procedure
7.3.5 Design & development verification
0% Review design/development plan and design project files for
0
i.e. feasibility studies,
planned.
prelim. drawings,
documents have been verified and approved, that other 0
appropriate records are established and controlled, and that
actions recorded and controlled (per Clause 4.2.4)?
Design stage docs: .
evidence that verification/validation activities are performed as Review design project files for evidence that design stage
requirements? Are verification results and any necessary
4.4.6
Design and/or
verify that reviews are performed as planned, attended by
follow-up actions recorded and controlled (per Clause 4.2.4)?
7.3.5 Is verification performed to ensure output staisfies input
Design and /or Development Plans
appropriate follow-up actions are taken to address failures.
4.4.7
calculations, etc Validation and testing procedures
4.4.8
Quality Records Control Procedure
7.3.6 Design and development validation
0% Review design & development plan and design project files for evidence that verification/validation activities are performed as
7.3.6 Is validation performed in accordance with planned arrangements
0
planned.
(see 7.3.1) to ensure that resulting product is
Review design project files for evidence that design stage
Design stage docs: .
capable of fulfilling requirements for the specified or known intended
documents have been verified and approved, that other
i.e. feasibility studies,
use prior to delivery/implementation?
appropriate records are established and controlled, and that
prelim. drawings,
appropriate follow-up actions are taken to address failures.
calculations, etc
Are validation results and subsequent follow-up
0
actions recorded and controlled (per Clause 4.2.4)?
4.4.7
Validation and testing procedures
4.4.8
Quality Records Control Procedure 7.3.7 Control of design and development changes Are design & development changes documented, reviewed, verified
0% 0
& validated before implementation? is the effect of changes on parts and delivered product evaluated?
0
Are results of the review of changes and subsequent follow-up
0
actions documented (per Clause 4.2.4)?
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Verify that design changes are evaluated and approved prior to implementation. Verify that the effect of changes on parts & delivered product are evaluated. Verify that required records are established and controlled.
Design and /or
4.4.9
development Change Control Procedure or Process Quality Records Control Procedure
Adaptado para el Curso Gestión Integral de Calidad UNI-FIM
Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 7.4.1 Purchasing control Is there a suitable purchasing process to ensure purchased
0% 0
Review the purchase control procedure or process to ensure it
product conforms to requirements? Are the type and extent of controls on supplier & product
0
dependent upon the effect the purchased product has on
Purchasing and/or
adequately addresses purchased products to be incorporated
supplier evaluation
into the final product and procured services that directly affect
processes or procedures
4.6.1
product quality.
subsequent product realization or the final product? Are suppliers evaluated and selected based on their ability to
0
Review supplier qualification records to ensure suppliers are
supply product in accordance with the organization's requirements?
List of Approved Suppliers4.6.2a
qualified on the basis of their ability to meet both quality system and product quality assurance requirements.
Is criteria for the selection, evaluation and re-evaluation
0
Review supplier files to verify that suppliers are evaluated and
of suppliers defined?
4.6.2b
selected on the basis of established criteria and that their performance is monitored and periodically reevaluated.
Are results of evaluations/reevaluations of suppliers and related
0
Review supplier quality records to verify that results of
follow-up actions recorded? 7.4.2 Purchasing information 7.4.2 Does purchasing information contain data that describes
0% 0
the product or service being ordered? Including, where appropriate: a) requirements for approval product, procedures,
4.6.2c
evaluations and follow-up actions are recorded.
0
Review purchasing processes or procedures for adequacy and/or
Purchasing processes
interview personnel who prepare purchase documents to verify
or procedures
4.6.3
that they know and use relevant processes or procedures.
processes and equipment b) requirements for personnel qualification c) quality management system requirements Does the organization ensure the adequacy of requirements
0
Review purchase documents to verify that they contain all
0
appropriate requirements and are properly reviewed and approved
Quality manual or other
prior to issuance.
relevant document,
0
including applicable
specified in purch. docs prior to communicating them to the supplier?
contracts
7.4.3 Verification of purchased product 7.4.3 Is there a suitable process of inspection or other activities for
0% 0
ensuring purchased products meet specified requirements? Where applicable, are there provisions for the organization (or customer) to verify and release purchased product at source?
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4.6.4.1
Review records to verify that all purchased product is inspected as planned (see clause 7.1.c) and that received items are properly
0
identified (see clause 7.5.3). Review applicable contracts or other appropriate documents to
Purchasing processes
4.6.4.2
or procedures Quality manual or other relevant document,
verify they specify verification arrangements and methods of
including applicable
product release.
contracts
Adaptado para el Curso Gestión Integral de Calidad UNI-FIM
Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 7.5.1 Production and service provision
0% Note: product realization processes, including verification and
###
validation activities and criteria for acceptance, and related record requirements are defined/planned per clause 7.1. 7.5.1 Does the organization carry out production and service
Production plans, quality
operations under controlled conditions including as applicable: a) the availability of information that specifies the characteristics of
control plans, work 0
Review documents and verify they are authorized or approved &
the product? b) the availability of work instructions, where necessary?
cover all production steps. 0
c) the use of suitable equipment?
0
d) the availability and use of measuring and monitoring devices
0
e) the implementation of monitoring and measuring activities
0
f) the implementation of defined processes for release, delivery
Review documentation for selected processes and verify that
drawings, or any other
where needed.
documentation that Equipment preventive
devices) used in production or service operations is appropriate and
and/or predictive
available (see 6.3 and 7.6) to ensure continuing process capability.
maintenance plans.
Witness process control activities; ask about the criteria for
Process control .
identifying and reporting unacceptable product, and verify
docs, control plans
activities are performed per instructions & as planned (see 7.1)
inspect. Insructions, etc
Observe operations and review related records to verify that
and applicable post-delivery activities?
work instructions, specs,
work instructions and workmanship standards are available/used Verify that equipment (including measuring and monitoring
0
orders, process sheets, workmanship standards,
uninspected or nonconforming products are prevented from
Inspection and/or instructions or
product identification and inspection status is maintained
procedures, process
throughout all operations.
sheets, work travelers
adequacy in assuring the protection of product quality during
###
inspection status
being used in the next processing stage; and, to verify that
Review delivery procedure, specification or instructions for
4.10.2
Delivery procedure,
4.15.6
specifications or instruction
delivery to destination per clause 7.5.5. Review servicing agreements and related documentation governing post delivery activities and verify organization’s
After delivery
###
servicing agreements
ability to meet applicable requirements. 7.5.2 Validation of processes for production & service
0%
(Re: Special processes) Are production and service processes validated where the resulting
0
Review validation requirements and plans (see clause 7.1) and
Validation requirements/
output cannot be verified by subsequent measurement or monitoring,
records to verify validation activities are performed and results
plans, and relevant work
including processes where deficiencies become apparent only after
recorded as planned .
instructions
###
product is in use or service is delivered? Does validation demonstrate the ability of the process to meet
0
planned arrangements?
Review criteria used to identify special processes (where the results cannot be fully verified by subsequent inspection and
Do arrangements for validation include, as applicable:
testing), and verify suitability and effectiveness of controls:
a) defined criteria for review & approval of the process;
0
Documented work
b) approval of equipment and qualification of personnel;
0
instructions, process
c) use of specified methodologies/procedures;
0
equipment & personnel
d) requirements for records (4.2.4);
0
qualification records
e) re-validation
0
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Adaptado para el Curso Gestión Integral de Calidad UNI-FIM
Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 7.5.3 Identification & Traceability
0%
Is product identified by suitable means throughout production?
0
Review for adequacy the system of assigning, documenting &
Is product identified with respect to measuring & monitoring
0
recording product identification numbers, including part numbers,
requirements? Where traceability is a requirement is the unique identification of the
0
product controlled and recorded?
Product Identification
###
procedures and related
serial numbers, or other unique identification as appropriate for
bills of material, parts
raw materials and other purchased products, in-process
lists, etc.
materials and finished goods. Verify that all materials, components, and products in all areas and at all stages of production are
Product identification tags, labels
identified with appropriate markings, labels, tags etc. Verify that product inspection & acceptance status is identified throughout production Review traceability plans or other documents for inclusion of all
Inspection status docs
###
travelers, stamps Traceability plans
###
applicable requirements; verify plans are authorized, available & used in receiving, storage and production areas, and that all required records are maintained. 7.5.4 Customer property 7.5.3 Is care exercised in the use of customer property while under
0% 0
the organization's control? Is customer's intellectual property included when req'd by contract?
Confidentiality agreements 0
Does the organization identify, verify, protect and safeguard customer property provided for use or incorporation into the product? Are records maintained and reports provided to the customer for
Verify that intellectual property is controlled per any agreements
Customer specifications
Verify that customer property is examined upon receipt to check
and/or procedures or
quantity, identity, and damage. 0
Verify compliance with any contractual requirements regarding
processes related to the verification, identification,
customer property that is lost, damaged or otherwise unsuitable
verification, identification, storage, or handling of customer
storage, and handling
for use?
property.
of purchased product
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###
Adaptado para el Curso Gestión Integral de Calidad UNI-FIM
Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 7.5.5 Preservation of product
0%
7.5.4 Is product conformity with customer requirements preserved during internal processing and final delivery to the intended destination? Including: Identification,
0
Verify that product identification established per clause 7.5.2 is
4.15.1
maintained during internal processing and final delivery. Handling,
0 Verify that handling equipment is appropriate and maintained;
Handling process,
that equipment operators are certified or trained and follow
procedure, and/or
applicable work instructions; and, note any signs of products
relevant work instructions
4.15.2
being damaged or at risk. Packaging (and preservation),
0
Verify that packaging is formally defined and followed; when
Packaging process,
packaging requires special methods, use the same criteria that
procedure and/or
apply to process control.
relevant work instructions
Verify that personnel follow relevant instructions; &, note signs of products deteriorating or being at risk.
Preservation process,
4.15.4
4.15.5
procedure and/or work instructions
Storage, and
0
Verify that storage areas are clearly identified; contain only the
Storage and inventory
kind of products for which they are designated; and, are properly
control processes,
maintained.
procedures, and/or
Verify that receipt/issue authorizations and/or inspection
4.15.3
relevant work instructions
sign-offs or indicators are clear. Verify that stock assessments are conducted as scheduled. Protection (of product quality during delivery to the destination)
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0
Review loading operations for compliance with instructions
Delivery procedure,
and/or verify that subcontracted shippers are approved and that
specifications or
their performance is monitored.
instruction
4.15.6
Adaptado para el Curso Gestión Integral de Calidad UNI-FIM
Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 7.6 Control of measuring and monitoring (M+M) devices Does the organization identify the monitoring & measurements to be
0% 0
Verify that required measurements and applicable inspection,
Quality control plans,
made and the M+M devices required to assure product
measuring and test equipment (IM&TE) are identified; see
IM&TE Control
conformity (including software used for product verification)?
clause 7.1 for related planning activities & 7.2.1 for product review
processes and/or
activities.
4.11.1
procedures and relevant work instructions
Are measuring and monitoring devices used and controlled to
0
Review for adequacy methods for determining how the
ensure that measurement capability is consistent with requirements?
Gage R&R studies
4.11.2.a
Calibration control
4.11.2 b - i
required accuracy of measurements is known and documented, how M+M equipment capability is recorded, and how the influence of differing environmental conditions and other factors is accounted for.
When applicable, are measuring and monitoring devices: a) calibrated or verified periodically or prior to use against
Review a sample of calibration procedures; verify M+M equipment was 0
appropriately and accurately calibrated and that personnel
devices traceable to international or nationalmeasurment standards or
performing calibrations know how to use calibration procedures /
other recorded basis?
instructions.
b) adjusted/re-adjusted as necessary
0
c) identified & calibration status recorded?
0
d) safeguarded from adjustments that would invalidate
0
Verify that M+M equipment found in production and inspection areas is properly identified, maintained, stored, and safeguarded against
the calibration? e) protected from damage and deterioration during handling,
0
maintenance and storage?
0
processes, procedures
unauthorized adjustments, and that current calibration results
and relevant work
are recorded and calibration status is known.
instructions
Review applicable records to verify that appropriate actions, including customer notification, are taken on product and process
f) validity of previous results re-assessed if they are subsequently
0
when IM&TE is found to be out of calibration.
found to be out of calibration, and corrective action taken?
8 Measurement, analysis and improvement 8.1 Measurement, analysis and improvement - Planning Has the organization identified and planned the measurement
0% 0
and monitoring activities needed
Review for adequacy the procedures or processes for
Measurement,
identifying methods, techniques and data used to measure,
monitoring, inspection,
a) to demonstrate conformity of the product b) ensure conformity of the QMS
0
monitor or improve products, processes, customer satisfaction .
& improvement
0
or organizational performance
processes, plans,
c) continually improve QMS effectiveness
0
procedures and relevant
0
work instructions.
Have the methods of measuring, analysis and improvement, including staistical techniques & the extent of their use been determined?
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0
4.10.1
4.20
Adaptado para el Curso Gestión Integral de Calidad UNI-FIM
Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 8.2.1 Customer satisfaction 8.2.1 Does the organization monitor information relating
0% Review for adequacy the process for obtaining and using customer
Processes or procedures
to customer perception as to whether it has fulfilled
0
satisfaction information to monitor, measure and improve the quality
for requesting,
customer requirements? And
management system
measuring, & monitoring customer feedback,
Are the methods for obtaining and using information on
0
including complaints,
customer satisfaction defined?
surveys, etc.
8.2.2 Internal Audit 8.2.2 Are internal audits conducted at planned intervals to determine
0% 0
Review the documented internal audit procedures for adequacy
whether the QMS a) conforms to planned arrangements, to
in explaining all aspects of the auditing system.
Documented Internal
###
Quality Audit Procedure
ISO9001-2000 requirements & the QMS requirments established by the organization and b) has been effectively implemented?
Review internal audit plan to verify that it includes all applicable
Internal Audit Plan
0
Is there an internal audit plan and does it consider the status and
requirements and addresses all appropriate considerations.
importance of audit activities and areas and the results of previous audits? Is the critieria scope, frequency and methodologies of internal audits
Review internal audit reports to: 0
verify that the scope, frequency, and methodologies are defined
defined? Are audits conducted by personnel who are objective, independent
and clearly communicated . 0
verify that internal auditors are trained and independent of the
of the activity being audited and not assigned to audit their own work? Is there a documented procedure identifying
activities/areas audited. 0
verify that results are recorded, processed and evaluated by
responsibilities/requirements for planning and conducting audits,
Internal audit notifications, relevant work instructions and/or checklists Internal audit reports
management per procedure.
recording results and reporting to management? Does management of audited area take timely action to eliminate
0
verify that corrective actions are implemented and followed-up in
nonconformities and their causes. Are follow-ups performed to verify implementation of
a timely manner and that all results are recorded. 0
actions taken and are related results recorded?(see 8.5.2) 8.2.3 Measurement and monitoring - of processes 8.2.3 Are suitable methods applied for measurement and monitoring
0% 0
of QMS processes? Do these methods confirm the continuing ability of each process
0
to achieve planned results? When planned results are not achieved, is appropriate correction and corrective action taken to ensure product conformity?
Review the implementation of process controls (including
inspection, and
used to assess process capability of product conformity.
improvement processes,
Verify that employees were trained to perform measurement and monitoring assignments (including inspection activities and
0
Measurement, monitoring,
statistical techniques) identified per clause 8.1 to verify they are
plans, procedures and
### 4.10.1
relevant work instructions. 4.20.2
tasks requiring the use of statistical techniques) and that they are properly using them as an aid in assessing the need for corrective/preventive ancions or improvement activities.
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Adaptado para el Curso Gestión Integral de Calidad UNI-FIM
Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 8.2.4 Measurement and monitoring - of product
0% Note: measurement and monitoring activities required to determine product conformance are identified during planning
Inspection and Test
4.10.1
procedures & instructions 4.20.2
activities; see clause 7.1 Are product characteristics measured and monitored at
0
appropriate stages of product realization and in accordance with
Review quality plans and inspection processes, procedures,
Quality control plans
planned arrangements to very that requirementsare fulfilled?
instructions, etc. for completeness and adequacy (including
and related records
Are records evidencing product conformity and identifying
0
the authorities responsible for release of product maintained?
clearly defined acceptance criteria, requirements for records, and product release authorities). Review records to verify receiving inspections are performed
Is there assurance that no product is released or service completed
0
as planned, and:
until all planned arrangements have been completed, unless otherwise approved by a relevant authority and. Where applicable, the customer.
4.10.5
Receiving inspection
4.10.2
process, procedures and/or relevant work
Products with different status are adequately segregated and appropriately labeled. Inspectors are qualified, and required supplier submittals
instructions Quality plans Supplier submittals
are on file.
Verify that inspection personnel are trained and that procedures are available and followed. Review records to verify that uninspected or nonconforming products are prevented from being used in the next processing stage; and, to verify that inspection status is maintained throughout all stages of production. Review records to verify that all activities specified in the
In-process inspection
4.10.3
process, procedures and/or relevant work instructions Process sheets and/or Quality plans Final inspection process, 4.10.4
quality plan / procedures are satisfactorily completed,
procedures and/or
associated data and documents are available / authorized; and
relevant work instructions
product released as authorized Verify that inspectors are qualified, and that procedures are available and followed.
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Quality plans; final audit checklists, etc.
Adaptado para el Curso Gestión Integral de Calidad UNI-FIM
Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 8.3 Control of nonconformity 3 Is there a documented procedure defining the controls and related
0% 0
Review the documented procedure for adequacy.
responsibilities and authorities for dealing with nonconforming product? Specifically, Are products that do not conform to product requirements identified
Through observation, verify that all nonconforming products, 0
Nonconforming Product
4.13.1
Control procedure and
4.13.2
relevant work instructions
wherever they are found, are clearly identified and segregated;
and/or inspection
and controlled per the established procedure to prevent their
and, verify that nonconformity reports are being established and
procedures
unintended use or delivery?
further processed to document disposition decisions and inform
Does the organization deal with the nonconforming product by one
other functions concerned.
of the following ways?"
Review nonconformity reports to verify that dispositions are
a) By taking action to eliminate the detected nonconformity
0
appropriate, authorized at the appropriate level and that reworked
b) By authorizing its use, release or acceptance under concession by
0
product is re-verified.
c) By taking action to preclude its original intended use or application
0
recorded and performed as required.
Are records of the nature of the nonconformity and any subsequent
0
a relevant authority and, where applicable, by the customer
Verify that proposed actions are reported and that concessions are
actions taken, including concessions obtained maintained? (see clause 4.2.4) Is corrected nonconforming product subject to re-verification to
0
demonstrate conformity to requirements? Is action taken appropriate to the effects, or potential effects, of
0
the nonconformity, when nonconforming product is detected after delivery or use? 8.4 Analysis of data Is data collected and analyzed to determine the suitability and
0% 0
Review for adequacy the process for deetrmining, collecting, and
Data analysis
effectiveness of the QMS and to identify QMS improvement
analyzing data to assess QMS effectiveness and evaluate where
procedure and/or
opprtunities?
continual improvement of the QMS can be made.
process or procedure
4.20.1
Does analysis provide information on: a) customer satisfaction (see 8.2.1) ?
0
b) conformance to product requirements? (see 7.2.1)
0
c) characteristics and trends of processes, products including
0
opportunties for preventive action d) suppliers?
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0
Adaptado para el Curso Gestión Integral de Calidad UNI-FIM
Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 8.5.1 Improvement - Continual improvement Does the organization continually improve the effectiveness of the
0% 0
Verify that a procedure or established process is in place to identify
QMS through the use of the: (1) quality policy, (2) quality objectives, (3) audit results,
and manage improvement projects based on information re: 0
The continuing suitability of the quality policy (clause 5.3) and
(4) analysis of data, (5) corrective and preventive actions
Improvement process or procedure Quality manual
4.1.1
quality objectives (clause 5.4.1)
and (6) management reviews?
Internal audit results (clause 8.2.2) Output from data analysis, including customer satisfaction, supplier performance, product conformance, and process
Internal Audit Procedure ### Data Analysis process
###
or procedure
performance trends (clause 8.4) Corrective and Preventive action results (clauses 8.5.2 and 8.5.3)
Corrective and Preventive ### Action procedures
Management review actions (clause 5.6.3)
###
Management review process or procedure
8.5.2 Improvement - Corrective action Is there a documented procedure to ensure appropriate
0% 0
Verify that the documented procedure adequately explains and
corrective actions are taken to eliminate the causes of
defines responsibilities for the corrective action process.
nonconformity and prevent their recurrence? Specifically,
Documented Corrective
4.14.1
Action procedure
Review customer complaints, nonconforming material reports,
a) are nonconformities (including customer complaints) reviewed?
0
outputs from management review, internal audit reports, and
b) are causes of the nonconformity determined?
0
outputs from data analysis to verify that corrective action
c) are evaluations conducted to identify actions that will
0
requests are initiated when nonconformities are identified.
4.14.2
prevent recurrence? d) are needed corrective actions defined and implemented?
0
e) are records of actions taken & results recorded? (see 4.2.4)
0
identified, that actions aimed at preventing recurrence are
Review corrective action records to verify that root causes are
f) are follow-up reviews of actions taken performed to verify their
0
recorded and implemented in a timely manner, and that follow–up
effectiveness?
reviews are performed.
8.5.3 Improvement - Preventive action Is there a documented procedure to determine & initiate appropriate
0% 0
preventive actions to eliminate the causes of potential
Verify that the documented procedure adequately explains and defines responsibility for the preventive action process.
Documented Preventive
4.14.1
Action procedure
nonconformity to prevent their occurrence? Specifically, a) are potential nonconformities and their causes determined?
0
b) are evaluations conducted to determine the need for preventive
0
Review for adequacy the methods used to identify potential nonconformities and their causes.
4.14.3
action? c) are actions identified, implemented and appropriate to the effects
0
of potential problems
Review preventive action records to verify that potential nonconformance and their causes are identified, that actions
d) are results of action taken recorded?
0
aimed at preventing occurrence are recorded and implemented
e) are follow-up reviews of actions taken performed to verify their
0
in a timely manner, and that follow–up reviews are performed.
effectiveness?
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Adaptado para el Curso Gestión Integral de Calidad UNI-FIM
Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 Score by Sub-Paragraph SubPara
Score by Paragraph Score
Para
4.1
4.1 QMS General requirements
0.0%
4
4.2
Score 0% QMS General
4.2 General documentation requirements
0.0%
5.1
0% Management responsibility - Management commitment
4.2.3
4.2.3 Control of documents
5.2
0% Management responsibility - Customer focus
4.2.4
4.2.4 Administration - Control of quality records
0.0% 0.0%
5.3
0% Management responsibility - Quality policy
5.1
5.1 Management commitment
0.0%
5.4
0% Management Responsibility - Planning
5.2
5.2 Customer focus
0.0%
5.5
0% Management Responsibility - Administration
5.3
5.3 Quality policy
0.0%
5.6
0% Management responsibility - Management review
5.4.1
5.4.1 Quality Objectives
0.0%
6.1
0% Resource management - Provision of resources
5.4.2
5.4.2 QMS Planning
0.0%
6.2
0% Resource management - Human resources
5.5.1
5.5.1 Responsibility,authority & communication
0.0%
6.3
0% Resource management - Infrastructure
5.5.2
5.5.2 Management Representative
0.0%
6.4
0% Resource management - Work environment
5.5.3
5.5.3 Internal communication
0.0%
7.1
0% Product realization - Planning of realization processes
5.6
5.6 Management review
0.0%
7.2
0% Product realization - Customer-related processes
6.1
6.1 Provision of resources
0.0%
7.3
0% Product realization - Design and development
6.2.1
6.2.1Human resources - Assignment of personnel
0.0%
7.4
6.2.2
6.2.2 H.R. Training, awareness & competency
0.0%
7.5
6.3
6.3 Infrastructure
0.0%
7.6
0% Product realization - Control of measuring and monitoring devices
6.4
6.4 Work environment
0.0%
8.1
0% Measurement, analysis and improvement - Planning
7.1
7.1 Planning of product realization processes
0.0%
8.2
0% Measurement, analysis and improvement - Measurement and monitoring
7.2.1 7.2.2
7.2.1 Customer-related processes - Determination of requirements relating to product 7.2.2 Customer-related processes - Review requirements re product
0.0% 0.0%
8.3 8.4
0% Measurement, analysis and improvement - Control of nonconformity 0% Measurement, analysis and improvement - Analysis of data
7.2.3
7.2.3 Customer-related processes - Customer communications
0.0%
8.5
0% Measurement, analysis and improvement - Improvement
7.3.1
7.3.1 Design and development planning
0.0%
TOTAL
7.3.2 7.3.3
7.3.2 Design 7.3.3 Designand anddevelopment developmentinputs outputs
0.0% 0.0%
7.3.4
7.3.4 Design and development review
0.0%
7.3.5
7.3.5 Design & development verification
0.0%
7.3.6
7.3.6 Design and development validation
0.0%
7.3.7
7.3.7 Control of design and development changes
0.0%
7.4.1
7.4.1 Purchasing control
0.0%
Score by Process Group Group 4
5 6 7 8 Total
0% Product realization - Purchasing
0% Product realization - Production and service operations
0%
CHART 1 Score by Paragraph
100% 75% 50% Adaptado para el Curso Gestión Integral de Calidad UNI-FIM
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25%
Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
7.6
7.6 Control of measuring and monitoring (M+M) devices
8.1
0.0%
0.0%
8.1 Measurement, analysis and improvement - Planning
0.0%
8.2.1
8.2.1 Customer satisfaction
0.0%
8.2.2
8.2.2 Internal Audit
0.0%
8.2.3
8.2.3 Measurement and monitoring - of processes
0.0%
8.2.4
8.2.4 Measurement and monitoring - of product
0.0%
8.3
8.3 Control of nonconformity
0.0%
8.4
8.4 Analysis of data
0.0%
8.5.1
8.5.1 Improvement - Continual improvement
0.0%
8.5.2
8.5.2 Improvement - Corrective action
0.0%
8.5.3
8.5.3 Improvement - Preventive action
0.0%
TOTAL
0.0%
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75% 50% 25% 0%
Adaptado para el Curso Gestión Integral de Calidad UNI-FIM
4
0.0%
7.5.5 Preservation of product
7.
7.5.4 Customer property
7.5.5
2
7.5.4
100%
7.
0.0%
6. 4
7.5.3 Identification & Traceability
2
0.0%
7.5.3
6.
0.0%
7.5.2 Validation of processes for production & service
6
7.5.1 Production and service provision
7.5.2
5.
7.5.1
CHART 1 Score by Paragraph
5. 4
0.0%
2
0.0%
7.4.3 Verification of purchased product
5.
7.4.2 Purchasing information
7.4.3
4
7.4.2
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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000 Score by Process Group Score
CHART 2 Score by Process group
0%
100% 0% 0% 0% 0% 0%
95% 90% 85% 80% 75% 70% 65% 60% 55%
Column S
50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% 4
5
6
7
8
Total
CHART 1 Score by Paragraph
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L TO TA
4 8.
2 8.
7. 6
4 7.
2 7.
6. 4
2 6.
6 5.
5. 4
5.
2
CHART 1 Score by Paragraph
Adaptado para el Curso Gestión Integral de Calidad UNI-FIM
Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
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