ISO9001-2000 Score by Process Group

100%

90%

80%

70%

60%

Score 50%
Column S
40%

30%

20%

10%

0%
4 5 6 7 8 Total

Process Group
 ISO9001-2000 Score by Paragraph

TOTAL
8.5
8.4
8.3
8.2
8.1
7.6
7.5
7.4
7.3
7.2
Paragraph

7.1
6.4
6.3 Column P
6.2
6.1
5.6
5.5
5.4
5.3
5.2
5.1
4
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Score
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

3 de 22 Adaptado para el Curso Gestión Integral de Calidad UNI-FIM

Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented 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 4.2.1
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: 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 /
been determined? 1) identifying and managing QMS processes (or elements) diagrams
c) Have the criteria and methods required to ensure 0 in accordance with the "process approach" defined in
the effective operation and control of QMS processes been defined? clause 0.2 and Figure 1 of ISO 9001:2000 identifying and
d) Are resources & information available to support QMS 0 showing the relationship between the following QMS
process operation and monitoring? processes (or elements) & their related sub-processes: Clause:
e) Are QMS processes measured, monitored and analyzed to 0 5. Management Responsibility
ensure actions are implemented to achieve planned results and 6. Resource Management
continual improvement? 7. Product Realization
f) Are actions implemented to achieve planned results and 0 8. Measurement, Analysis and Improvement
continuous improvement of QMS processes? 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.

4 de 22 Adaptado para el Curso Gestión Integral de Calidad UNI-FIM

Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
4.2 General documentation requirements 0% (Note: The requirements of clause 4.2.1 a) are met
4.2.1 a) Are statements of quality policy and quality objectives 0 if the requirements of 4.2.2 are met.)
documented? Review quality manual to ensure it complies with clause 4.2.2 and that it
4.2.1 b) Is there a quality manual? 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 Quality manual 4.2.1
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 Documented procedures 4.2.2
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.
Others, as appropriate, which may include: Other QMS
Planning (5.4.2, 7.1, 8.1, 8.5.1) 0 Review QMS processes to ensure they are adequately defined in documentation
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 (Note: all required QMS documents and records are controlled Other QMS docs and
records needed to ensure effective planning, operation and per clauses 4.2.3 and 4.2.4) records 4.2.1
control. 4.5.1
4.2.2 Quality Manual - Is a quality manual established, 0 Verify that quality manual is controlled per clause 4.2.3 Quality manual, 4.2.1
maintained, and controlled. And does it include:
a) the scope of the QMS, including details and 0 Review the quality manual to verify that it addresses all ISO 9001
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: 0 description of the sequence and interaction of QMS processes / QMS process descriptions,.
elements (per clause 4.1). flow charts, etc.

5 de 22 Adaptado para el Curso Gestión Integral de Calidad UNI-FIM

Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
4.2.3 Control of documents 0%
Is a documented procedure established to control all 0 Verify that the doc. procedure details rules (per 4.2.3 a-g) Document Control 4.5.1
documents required for the QMS for controlling: procedure
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. All new and 4.5.2,
and approved by authorized personnel prior to issue? 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  Master lists,
e) legible, readily identifiable and retrievable? 0 and retrievable. Distribution lists, etc.
4.2.3.f) Are external documents identified and their 0 Review external documents for proper .  All applicable external 4.5.2
distribution controlled? identification and control 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; All obsolete documents 4.5.2
& suitably identified if retained for any purpose. identify any obsolete documents not removed from points of use

4.2.4 Administration - Control of quality records 0%

4.2.4 Is a documented procedure established to control the 0 Ask for a record and note how long it takes to retrieve; identify Quality records ###
identification, storage, retrieval, protection, retention and disposition causes for breakdowns in the record management system. procedure
of quality records? Specifically,
 Are quality records legible and readily retrievable? 0
 Are quality records (hard copy or electronic media) stored in a 0 Verify that records are suitably protected and note any signs of
suitable environment to prevent deterioration, damage or loss? record deterioration, damage or loss due to inadequate storage.
 Are quality records retained per established procedures and for 0 Verify that record holders, locations and retention periods are
the specified periods? 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) Design Verification (7.3.5) the audit or assessment.
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) Internal Audit Results (8.2.2)
Inspection Results (8.2.4) Nonconforming Product (8.3)
Corrective Actions (8.5.2) Preventive Actions (8.5.3)
Traceability (7.5.3)

6 de 22 Adaptado para el Curso Gestión Integral de Calidad UNI-FIM

Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
5.1 Management responsibility
5.1 Management commitment 0%
5.1 Is there evidence of top management's commitment to QMS 0 Interview top management to assess their awareness of and
development and improvement? Has top management: commitment to fulfilling their responsibilities for QMS
a) communicated the importance of meeting customer and 0 development/improvement. Quality manual, 4.1., 4.2.1
regulatory/statutory requirements? management review 4.1.3
b)established the quality policy and objectives? 0 Review evidence of top management involvement in establishing minutes, resource
c) conducted management reviews? 0 quality policy and objectives, communicating requirements, allocation data, internal 4.1.2.2
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 0% Review available information to determine if customer

Are customer requirments determined and fulfilled 0 needs/expectations are known and defined in terms of key Product information
with the aim of achieving customer satisfaction? 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)
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.

5.3 Quality policy 0%

5.3 Has top management established a quality policy that: 0 Review the quality manual to ensure top management has Quality manual 4.1.1
established/approved the quality policy.
a) is appropriate to the organization's purpose? 0 Review other organizational policy documents to determine their
consistency with the quality policy.
b) includes a commitment to complying with requirements & to 0 Review the quality policy to determine if it promotes customer
continualy improving QMS effectiveness? satisfaction and continual improvement.
c) provides a framework for establishing and reviewing quality 0 Ask a random sampling of managers and/or employees if they
objectives? understand the process for establishing and reviewing quality
objectives (per clause 5.4.1).
d) is communicated and understood within the 0 Ask a random sampling of employees what the quality policy is
organization? 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? 0

7 de 22 Adaptado para el Curso Gestión Integral de Calidad UNI-FIM

Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
5.4.1 Quality Objectives 0%
5.4.1 Are quality objectives: (Note: Quality objectives are used to facilitate improvement of Quality manual 4.1.1
 established at relevant functions & levels within the organization? 0 products and product realization processes per clause 8.2.4 and to
include objectives related to meeting product requirements? facilitate continual improvement of the QMS per clause 8.5.1)
 measurable and consistent with the quality policy (incl. the 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 0% Interview management and review records to assess management's
5.4.2 a) Has Top Management caried out plans to meet QMS 0 commitment to carrying out and updating plans to met QMS Corporate resource 4.2.3
requirments and obkectives for improving the QMS, and requirements defined in clause 4.1 and achieve objectives defined allocation plan and
5.4.2 b) Maintained QMS integrity during periods of significant change? 0 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
development and update

5.5.1 Responsibility,authority & communication 0%

5.5.2 Are responsibilities and authorities & their interrelationship 0 Review the quality manual or other appropriate documents to Quality manual, 4.1.2.1
defined and communicated? verify that quality management authorities and responsibilities Organization charts,
& interrelationships (including responsibilities for achieving job descriptions
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, 4.1.2.3
with responsibility and authority for: verify that a management representative is appointed and actively job descriptions, internal 4.1.3
a) ensuring QMS processes are established, implemented & maintained? 0 involved in establishing, implementing and maintaining the QMS. memos
b) reporting QMS performance and improvement needs to 0
top management? Ask a random sampling of employees if they are aware of the
c) ensuring promotion of awareness of customer requirements 0 importance of meeting customer and other requirements.
throughout the organization (also see clauses 5.3.d , 5.5.3, and 6.2.2.d)

5.5.3 Internal communication 0%

5.5.3 Is information regarding QMS processes and their 0 Review the quality manual or other documentation to determine if Quality manual
effectiveness communicated to the organization? 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)

8 de 22 Adaptado para el Curso Gestión Integral de Calidad UNI-FIM

Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
5.6 Management review 0%
5.6.1 Does top management review the QMS at planned intervals to 0 Verify that a management review procedure or process is Quality manual (or 4.1.3
ensure its continuing suitability, adequacy and effectiveness? established to ensure the QMS (including the quality policy and management review
 Are the quality policy & objectives reviewed for needed 0 objectives) is periodically reviewed for change or improvement. procedure)
changes?
5.6.2 Do inputs to the management review consider current 0 Review management review records for evidence that the required Management review 4.1.3
performance and improvement opportunities, including: inputs were considered. minutes/records
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 Review management review records for evidence that the required Management review 4.1.3
include actions related to: outputs are recorded and used for improvement of the QMS and minutes/records
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.
6 Resource Management
6.1 Provision of resources 0%
Are resources needed to implement and continually improve 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 0%

Are personnel assigned responsibilities defined in the QMS 0 Review organization charts, job descriptions, to verify that Organization charts, 4.1.2.2
competent on the basis of appropriate education, training, skills personnel are qualified to perform work assignments. job descriptions, etc.
and work experience?

6.2.2 H.R. Training, awareness & competency 0%

6.2.2.a) Do qualifications for personnel performing activities affecting 0 Review qualification review results to verify that personnel Qualification review ###
quality include identification of appropriate education, training, skills competency is evaluated to determine training needs. results
and experience?
6.2.2.b) Is required training provided or other actions taken to 0 Review training plans and records to verify that: Training plans & records
satisfy those needs? required training is provided/actions taken and they are
6.2.2.c) Is the training provided/actions taken evaluated for 0 evaluated for effectiveness
effectiveness?
6.2.2.d) Are employees aware of the relevance/importance of 0 QMS awareness training is provided &/or interview employees
their activities and how they contribute to quality objectives? to assess awareness (see also clauses 5.3.d & 5.5.3 )
6.2.2.e) Are appropriate records of training, education, skills 0 Verify adequacy of employee qualification/training records.
& experience maintained?

9 de 22 Adaptado para el Curso Gestión Integral de Calidad UNI-FIM

Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
6.3 Infrastructure 0%
6.3 Are the organization's facilities suitable and maintained to 0 Through observation or interviews, identify any evidence that Equipment preventive . ###
ensure process capability and product conformance? 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 0%

6.4 Is the organization's work environment identified & managed 0 Through observation or interviews, verify that the work .  Process capability ###
to ensure process capability and product conformance? environment is suitable, clean and well organized studies

Review for adequacy the processes, procedures or practices  Production plans

governing the identification and control of environmental
factors.

7 Product Realization
7.1 Planning of product realization processes 0%
7.1 Is the planning of product realization processes consistent with 0 Note: documentation defining how QMS processes are applied Quality plans 4.2.3
other requirements of the QMS and suitably documented? to a specific product, project or contract may be referred to as
Specifically: a quality plan.
a) Does the quality plan contain quality objectives and 0 Review quality plans for consistency with the QMS and verify that Quality plans, production ###
requirements for products? appropriate quality objectives are established. plans, work orders, ###
b) Does the quality plan define appropriate realization processes 0 Review quality plans, production plans, work orders and other. process sheets, etc.
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 Review quality plans, production plans, work orders, process Quality plans, production ###
validation, monitoring, inspection & test activities specific to the sheets, inspection procedures or instructions and other plans, work orders, 4.10
product and the criteria for acceptance? appropriate documentation to verify that: process sheets, etc. ###
d) Does the quality plan identify the records that are necessary to 0 Verification and validation activities and criteria for
provide evidence that the realization processes and resulting acceptance, and related record requirements are defined.
product meet requirements? 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

10 de 22 Adaptado para el Curso Gestión Integral de Calidad UNI-FIM

Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
7.2.1 Customer-related processes - Determination of requirements relating
to product 0%
Review contracts or other customer agreements to verify the Requirements ident-
Does the organization have processes in place to ensure 0 inclusion of all applicable specified requirements and ification procedure or
customer requirements are identified? Including: requirements necessary to fulfill specified, known or process
a) requirements specified by the customer, including 0 intended use as well as all applicable regulatory and
delivery and post delivery activities statutory requirements.
b) requirements not specified by the customer but 0
necessary for specific or known and intended use
c) requirements (including regulatory and statutory requirements) 0 Review performance claims made by company relating to Product descriptions,
related to the product products/services and verify that appropriate requirements catalogues, brochures
d) any additional requirments determined by the organization 0 are provided for in quality plans (see clause 7.1)

7.2.2 Customer-related processes - Review requirements re product 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 process
a) product requirements are defined? 0 evidence that requirements were not known or not met. 4.3.2
b) order requirements different than previously expressed are resolved 0
c)the organization confirms its ability to meet defined requirements 0 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
requirements, are they confirmed?
 Where product requirements are changed, is relevant 0 Review change orders to verify they are properly reviewed, and. 4.3.4
documentation amended and personnel made aware of the changes? that all concerned functions are informed
 Are results of the review, actions & follow-ups recorded? 0 Review records for adequacy.

7.2.3 Customer-related processes - Customer communications 0%

Has the organization determined & implemented effective Review the quality manual and/or other appropriate . Quality manual,
arrangements for communication with the customer regarding: documentation to verify that responsibilities for internal
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? communications system are effectively implemented.
c) customer feedback, including customer complaints? 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"

11 de 22 Adaptado para el Curso Gestión Integral de Calidad UNI-FIM

Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
7.3.1 Design and development planning 0%
Is there a procedure or established process in place for 0 Verify that a procedure or process exists and adequately covers Design and /or 4.4.1
planning and controlling product design & development activities? all applicable design and development activities. development procedure 4.4.2
 Have design plans for each design project been established to include: or process 4.4.3
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 interface responsibilities and communication processes.
c) responsibilities and authorities for design & development activities? 0
 Are interfaces between groups involved in design & development 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 0%

Are design & development inputs relating to product requirements 0 Review design input documents to verify they address . Design and /or 4.4.4
determined and recorded (see 4.2.4) including: all applicable requirements development input
a) functional and performance requirements? 0 documents
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 Verify that design input documents are properly reviewed and
and not in conflict? approved.

7.3.3 Design and development outputs 0%

Are outputs of the design & development provided in a 0 Review design & development output documents for completeness, Design and /or 4.4.4
form that enables verification against inputs? including acceptance criteria, and to verify they are properly Development Output
Specifically, do outputs: reviewed and approved. Documents
a) meet the input requirements? 0
b) provide appropriate information for purchasing, production and 0
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?

12 de 22 Adaptado para el Curso Gestión Integral de Calidad UNI-FIM

Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
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 .  Design and /or 4.4.6
b) identify problems and propose required actions? 0 planned at suitable stages Development Plans
 Do design/development review participants include representatives 0 Review design& development review minutes, results or reports to Design and/or
of all functions concerned with the design & development stage(s) verify that reviews are performed as planned, attended by Development Review
being reviewed? appropriate personnel, and that related results are properly minutes, results or reports
 Are results of design/development reviews and subsequent 0 recorded and controlled.  Quality records
follow-up actions recorded and controlled (per Clause 4.2.4)? control procedure

7.3.5 Design & development verification 0%

Review design/development plan and design project files for Design stage docs: .
evidence that verification/validation activities are performed as i.e. feasibility studies, 4.4.7
planned. prelim. drawings,
7.3.5 Is verification performed to ensure output staisfies input 0 Review design project files for evidence that design stage calculations, etc
requirements? documents have been verified and approved, that other Validation and testing
 Are verification results and any necessary 0 appropriate records are established and controlled, and that procedures 4.4.8
actions recorded and controlled (per Clause 4.2.4)? appropriate follow-up actions are taken to address failures. 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, 4.4.7
use prior to delivery/implementation? appropriate records are established and controlled, and that prelim. drawings,
 Are validation results and subsequent follow-up 0 appropriate follow-up actions are taken to address failures. calculations, etc
actions recorded and controlled (per Clause 4.2.4)? Validation and testing
procedures 4.4.8
Quality Records
Control Procedure

7.3.7 Control of design and development changes 0%

Are design & development changes documented, reviewed, verified 0 Verify that design changes are evaluated and approved prior to Design and /or 4.4.9
& validated before implementation? implementation. development Change
is the effect of changes on parts and delivered product evaluated? 0  Verify that the effect of changes on parts & delivered Control Procedure or Process
 Are results of the review of changes and subsequent follow-up 0 product are evaluated. Quality Records Control
actions documented (per Clause 4.2.4)? Verify that required records are established and controlled. Procedure

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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
7.4.1 Purchasing control 0%
Is there a suitable purchasing process to ensure purchased 0 Review the purchase control procedure or process to ensure it Purchasing and/or 4.6.1
product conforms to requirements? adequately addresses purchased products to be incorporated supplier evaluation
Are the type and extent of controls on supplier & product 0 into the final product and procured services that directly affect processes or procedures
dependent upon the effect the purchased product has on 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 List of Approved Suppliers 4.6.2a
supply product in accordance with the organization's requirements? 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 4.6.2b
of suppliers defined? 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 4.6.2c
follow-up actions recorded? evaluations and follow-up actions are recorded.

7.4.2 Purchasing information 0%

7.4.2 Does purchasing information contain data that describes 0 Review purchasing processes or procedures for adequacy and/or Purchasing processes 4.6.3
the product or service being ordered? Including, where appropriate: interview personnel who prepare purchase documents to verify or procedures
a) requirements for approval product, procedures, 0 that they know and use relevant processes or procedures.
processes and equipment
b) requirements for personnel qualification 0 Review purchase documents to verify that they contain all
appropriate requirements and are properly reviewed and approved Quality manual or other 4.6.4.1
c) quality management system requirements 0 prior to issuance. relevant document,
 Does the organization ensure the adequacy of requirements 0 including applicable
specified in purch. docs prior to communicating them to the supplier? contracts

7.4.3 Verification of purchased product 0%

7.4.3 Is there a suitable process of inspection or other activities for 0 Review records to verify that all purchased product is inspected as  Purchasing processes 4.6.4.2
ensuring purchased products meet specified requirements? planned (see clause 7.1.c) and that received items are properly or procedures
 Where applicable, are there provisions for the organization 0 identified (see clause 7.5.3).  Quality manual or other
(or customer) to verify and release purchased product at source? Review applicable contracts or other appropriate documents to relevant document,
verify they specify verification arrangements and methods of including applicable
product release. contracts

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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
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: control plans, work
a) the availability of information that specifies the characteristics of 0 Review documents and verify they are authorized or approved & orders, process sheets,
the product? cover all production steps. workmanship standards,
b) the availability of work instructions, where necessary? 0 Review documentation for selected processes and verify that work instructions, specs,
work instructions and workmanship standards are available/used drawings, or any other
where needed. documentation that
c) the use of suitable equipment? 0 Verify that equipment (including measuring and monitoring Equipment preventive
d) the availability and use of measuring and monitoring devices 0 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.
e) the implementation of monitoring and measuring activities 0 Witness process control activities; ask about the criteria for Process control . 4.10.2
identifying and reporting unacceptable product, and verify docs, control plans
activities are performed per instructions & as planned (see 7.1) inspect. Insructions, etc
f) the implementation of defined processes for release, delivery 0 Observe operations and review related records to verify that Inspection and/or ###
and applicable post-delivery activities? uninspected or nonconforming products are prevented from inspection status
being used in the next processing stage; and, to verify that instructions or
product identification and inspection status is maintained procedures, process
throughout all operations. sheets, work travelers
Review delivery procedure, specification or instructions for Delivery procedure, 4.15.6
adequacy in assuring the protection of product quality during specifications or instruction
delivery to destination per clause 7.5.5.
Review servicing agreements and related documentation  After delivery ###
governing post delivery activities and verify organization’s 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 Review criteria used to identify special processes (where the
planned arrangements? 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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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
7.5.3 Identification & Traceability 0%

 Is product identified by suitable means throughout production? 0  Review for adequacy the system of assigning, documenting & Product Identification ###
 Is product identified with respect to measuring & monitoring 0 recording product identification numbers, including part numbers, procedures and related
requirements? serial numbers, or other unique identification as appropriate for bills of material, parts
 Where traceability is a requirement is the unique identification of the 0 raw materials and other purchased products, in-process lists, etc.
product controlled and recorded? materials and finished goods.
 Verify that all materials, components, Product identification
and products in all areas and at all stages of production are tags, labels
identified with appropriate markings, labels, tags etc.
 Verify that product inspection & acceptance status is Inspection status docs ###
identified throughout production travelers, stamps
Review traceability plans or other documents for inclusion of all 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 0%

7.5.3 Is care exercised in the use of customer property while under 0
the organization's control? Confidentiality agreements
 Is customer's intellectual property included when req'd by contract? 0 Verify that intellectual property is controlled per any agreements Customer specifications ###
 Does the organization identify, verify, protect and safeguard Verify that customer property is examined upon receipt to check and/or procedures or
customer property provided for use or incorporation into the product? quantity, identity, and damage. processes related to the
 Are records maintained and reports provided to the customer for 0 Verify compliance with any contractual requirements regarding 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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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
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, 4.15.2
that equipment operators are certified or trained and follow procedure, and/or
applicable work instructions; and, note any signs of products relevant work instructions
being damaged or at risk.
 Packaging (and preservation), 0 Verify that packaging is formally defined and followed; when Packaging process, 4.15.4
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 Preservation process, 4.15.5
of products deteriorating or being at risk. procedure and/or
work instructions
 Storage, and 0 Verify that storage areas are clearly identified; contain only the Storage and inventory 4.15.3
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 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) 0 Review loading operations for compliance with instructions Delivery procedure, 4.15.6
and/or verify that subcontracted shippers are approved and that specifications or
their performance is monitored. instruction

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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
7.6 Control of measuring and monitoring (M+M) devices 0%

Does the organization identify the monitoring & measurements to be 0 Verify that required measurements and applicable inspection, Quality control plans, 4.11.1
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. procedures and relevant
work instructions
 Are measuring and monitoring devices used and controlled to 0 Review for adequacy methods for determining how the Gage R&R studies 4.11.2.a
ensure that measurement capability is consistent with requirements? 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: Review a sample of calibration procedures; verify M+M equipment was
a) calibrated or verified periodically or prior to use against 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 Verify that M+M equipment found in production and inspection areas is Calibration control 4.11.2 b - i
c) identified & calibration status recorded? 0 properly identified, maintained, stored, and safeguarded against processes, procedures
d) safeguarded from adjustments that would invalidate 0 unauthorized adjustments, and that current calibration results and relevant work
the calibration? are recorded and calibration status is known. instructions
e) protected from damage and deterioration during handling, 0
maintenance and storage? 0 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 0%
Has the organization identified and planned the measurement 0 Review for adequacy the procedures or processes for Measurement, 4.10.1
and monitoring activities needed identifying methods, techniques and data used to measure, monitoring, inspection,
a) to demonstrate conformity of the product 0 monitor or improve products, processes, customer satisfaction . & improvement
b) ensure conformity of the QMS 0 or organizational performance processes, plans,
c) continually improve QMS effectiveness 0 procedures and relevant
 Have the methods of measuring, analysis and improvement, including 0 work instructions.
staistical techniques & the extent of their use been determined? 0 4.20

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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
8.2.1 Customer satisfaction 0%

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 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 0%

8.2.2 Are internal audits conducted at planned intervals to determine 0 Review the documented internal audit procedures for adequacy Documented Internal ###
whether the QMS a) conforms to planned arrangements, to in explaining all aspects of the auditing system. Quality Audit Procedure
ISO9001-2000 requirements & the QMS requirments established by
the organization and Review internal audit plan to verify that it includes all applicable Internal Audit Plan
b) has been effectively implemented? 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? Review internal audit reports to:
 Is the critieria scope, frequency and methodologies of internal audits 0 verify that the scope, frequency, and methodologies are defined Internal audit
defined? and clearly communicated . notifications, relevant
 Are audits conducted by personnel who are objective, independent 0 verify that internal auditors are trained and independent of the work instructions and/or
of the activity being audited and not assigned to audit their own work? activities/areas audited. checklists
 Is there a documented procedure identifying 0 verify that results are recorded, processed and evaluated by Internal audit reports
responsibilities/requirements for planning and conducting audits, 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. a timely manner and that all results are recorded.
 Are follow-ups performed to verify implementation of 0
actions taken and are related results recorded?(see 8.5.2)

8.2.3 Measurement and monitoring - of processes 0%

8.2.3 Are suitable methods applied for measurement and monitoring 0  Review the implementation of process controls (including Measurement, monitoring,
of QMS processes? statistical techniques) identified per clause 8.1 to verify they are inspection, and
used to assess process capability of product conformity. improvement processes, ###
 Do these methods confirm the continuing ability of each process 0  Verify that employees were trained to perform measurement plans, procedures and 4.10.1
to achieve planned results? and monitoring assignments (including inspection activities and relevant work instructions. 4.20.2
 When planned results are not achieved, is appropriate correction 0 tasks requiring the use of statistical techniques) and that they
and corrective action taken to ensure product conformity? are properly using them as an aid in assessing the need for
corrective/preventive ancions or improvement activities.

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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
8.2.4 Measurement and monitoring - of product 0% Note: measurement and monitoring activities required to Inspection and Test 4.10.1
determine product conformance are identified during planning 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 4.10.5
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 clearly defined acceptance criteria, requirements for records,
the authorities responsible for release of product maintained? and product release authorities).

Review records to verify receiving inspections are performed Receiving inspection 4.10.2
Is there assurance that no product is released or service completed 0 as planned, and: process, procedures
until all planned arrangements have been completed, unless otherwise and/or relevant work
approved by a relevant authority and. Where applicable, the customer. Products with different status are adequately segregated and instructions
appropriately labeled. Quality plans
Inspectors are qualified, and required supplier submittals Supplier submittals
are on file.

 Verify that inspection personnel are trained and that procedures  In-process inspection 4.10.3
are available and followed. process, procedures
 Review records to verify that uninspected or and/or relevant work
nonconforming products are prevented from being used in the instructions
next processing stage; and, to verify that inspection status is  Process sheets
maintained throughout all stages of production. and/or Quality plans

Review records to verify that all activities specified in the 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 Quality plans; final
available and followed. audit checklists, etc.

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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
8.3 Control of nonconformity 0%

3 Is there a documented procedure defining the controls and related 0 Review the documented procedure for adequacy. Nonconforming Product 4.13.1
responsibilities and authorities for dealing with nonconforming product? Control procedure and 4.13.2
Specifically, Through observation, verify that all nonconforming products, relevant work instructions
 Are products that do not conform to product requirements identified 0 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.
a relevant authority and, where applicable, by the customer Verify that proposed actions are reported and that concessions are
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

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 0%

Is data collected and analyzed to determine the suitability and 0 Review for adequacy the process for deetrmining, collecting, and Data analysis 4.20.1
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
 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? 0

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Checklist para analizar nivel de Implementacion de la norma ISO9001:2000
Question SCORING Audit Guidelines Organization's9001:1994 Fully Fully
(Those relating to new/revised requirements are in italics) Question Section Documentation Cross Ref
Documented Implemented
8.5.1 Improvement - Continual improvement 0%

Does the organization continually improve the effectiveness of the 0 Verify that a procedure or established process is in place to identify Improvement process
QMS through the use of the: and manage improvement projects based on information re: or procedure
 (1) quality policy, (2) quality objectives, (3) audit results, 0 The continuing suitability of the quality policy (clause 5.3) and Quality manual 4.1.1
(4) analysis of data, (5) corrective and preventive actions quality objectives (clause 5.4.1)
and (6) management reviews? Internal audit results (clause 8.2.2) Internal Audit Procedure ###
Output from data analysis, including customer satisfaction, Data Analysis process ###
supplier performance, product conformance, and 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 0%

Is there a documented procedure to ensure appropriate 0  Verify that the documented procedure adequately explains and Documented Corrective 4.14.1
corrective actions are taken to eliminate the causes of defines responsibilities for the corrective action process. Action procedure
nonconformity and prevent their recurrence? Specifically,  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  Review corrective action records to verify that root causes are
e) are records of actions taken & results recorded? (see 4.2.4) 0 identified, that actions aimed at preventing recurrence 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 0%

Is there a documented procedure to determine & initiate appropriate 0  Verify that the documented procedure adequately explains and Documented Preventive 4.14.1
preventive actions to eliminate the causes of potential defines responsibility for the preventive action process. Action procedure
nonconformity to prevent their occurrence? Specifically,
a) are potential nonconformities and their causes determined? 0  Review for adequacy the methods used to identify potential
b) are evaluations conducted to determine the need for preventive 0 nonconformities and their causes. 4.14.3
action?
c) are actions identified, implemented and appropriate to the effects 0  Review preventive action records to verify that potential
of potential problems 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?

22 de 22 Adaptado para el Curso Gestión Integral de Calidad UNI-FIM