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 Process Group Total

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

Paragraph

Column P

100%

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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Question
(Those relating to new/revised requirements are in italics)

SCORING
Question
Section

Audit Guidelines

Organization's 9001:1994 Fully Documentation Cross Ref Documented

Fully Implemented

4 Quality Management System
4.1 QMS General requirements 4.1 Has the organization established and implemented a quality management system (QMS) in accordance with the requirements of ISO 9001:2000? Specifically: a) Are QMS processes identified? b) Have the sequence and interaction of QMS processes been determined? c) Have the criteria and methods required to ensure the effective operation and control of QMS processes been defined? d) Are resources & information available to support QMS process operation and monitoring? e) Are QMS processes measured, monitored and analyzed to ensure actions are implemented to achieve planned results and continual improvement? f) Are actions implemented to achieve planned results and continuous improvement of QMS processes? When processes affecting product conformity are outsourced, i) are they controlled and ii) are the controls identified in the QMS? 0 0 0 0 0 0 0 0% (Note: clause 4.2 defines documentation requirements; the general requirements of clause 4.1 are met if the specific requirements of clauses 5-8 are met ) Review quality manual to determine if a systematic approach is defined for: 1) identifying and managing QMS processes (or elements) in accordance with the "process approach" defined in clause 0.2 and Figure 1 of ISO 9001:2000 identifying and showing the relationship between the following QMS processes (or elements) & their related sub-processes: Clause: 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement, Analysis and Improvement 2) ensuring the criteria, methods, information and responsibilities for managing QMS processes are in place. 3) ensuring that data is collected, analyzed and used to assess QMS process effectiveness and to identify needed actions or improvements. Quality manual and/or process flow charts / diagrams 4.2.1

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Question
(Those relating to new/revised requirements are in italics) 4.2 General documentation requirements 4.2.1 a) Are statements of quality policy and quality objectives documented? 4.2.1 b) Is there a quality manual? 4.2.1 c) Are procedures required by ISO 9001:2000 established, documented, implemented and maintained including, at a minimum:? Document Control (clause 4.2.3)? Control of Quality Records (clause 4.2.4)? Internal Audit (clause 8.2.2)? Control of Nonconformity (clause 8.3)? Corrective Action (clause 8.5.2)? Preventive Action (clause 8.5.3)? Others, as appropriate, which may include: Planning (5.4.2, 7.1, 8.1, 8.5.1) Communications (5.5.3) Management Review (5.6) Resource Management (6) Training (6.2.2) Customer Related Processes (7.2) Design and Development (7.3) Purchasing(7.4) Control of Products & Services (7.5.1) Product ID/Traceability ( 7.5.3) Customer Property (7.5.4) Preservation of Product (7.5.5) Validation of Processes (7.5.2) Process Meas/Monitoring (8.2.3) Product Meas/Monitoring (8.2.4) Analysis/ Improvement (8.4, 8.5) Control of Measuring & Monitoring Devices (7.6) Customer Satisfaction Monitoring (8.2.1) 4.2.1 d) & e) Does the QMS identify all other appropriate documentation & 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? b) documented procedures or reference to them? c) a description of the interaction between QMS processes: 0 0 0 Review the quality manual to verify that it addresses all ISO 9001 requirements or includes appropriate statements of exclusions and related justifications (permitted by clause 1.2). Review the quality manual to verify that it contains or references required documented procedures (per clause 4.2.1c) and a description of the sequence and interaction of QMS processes / elements (per clause 4.1). QMS process descriptions,. flow charts, etc. Documented procedures, 0 Verify that quality manual is controlled per clause 4.2.3 Quality manual, 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 (Note: all required QMS documents and records are controlled per clauses 4.2.3 and 4.2.4) Other QMS docs and records Review QMS processes to ensure they are adequately defined in procedures, process or job descriptions, work instructions, or other appropriate system documentation. 0 0 0 0 0 0 0 0

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Audit Guidelines
0% (Note: The requirements of clause 4.2.1 a) are met if the requirements of 4.2.2 are met.) Review quality manual to ensure it complies with clause 4.2.2 and that it contains documented statements of a quality policy and qual objectives. Review quality manual to ensure it contains or references documented procedures as required by the standard and other documented procedures as appropriate for the size and type of the organization, the complexity and interaction of processes, and competence of personnel. Review QMS documentation to determine if documented procedures are appropriate for the size and type of the organization, the complexity and interaction of processes, and competence of personnel.

Organization's 9001:1994 Fully Documentation Cross Ref Documented

Fully Implemented

Quality manual Documented procedures

4.2.1 4.2.2

Other QMS documentation

4.2.1 4.5.1
4.2.1

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Question
(Those relating to new/revised requirements are in italics) 4.2.3 Control of documents Is a documented procedure established to control all documents required for the QMS 0

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Audit Guidelines
0% Verify that the doc. procedure details rules (per 4.2.3 a-g) for controlling: Quality manual Documented Procedures External Documents Work Instructions Product documentation (including drawings, specifications, bills of material, parts lists, production plans, control plans, etc.).

Organization's 9001:1994 Fully Documentation Cross Ref Documented
Document Control procedure 4.5.1

Fully Implemented

4.2.3.a) and b): Are new/revised docs reviewed for adequacy and approved by authorized personnel prior to issue? 4.2.3 Are documents: c) identified by their current revision status, d) available at locations where they are needed e) legible, readily identifiable and retrievable? 4.2.3.f) Are external documents identified and their distribution controlled?

0

Review documents for evidence of review/approval.

All new and revised documents

4.5.2, 4.5.3 4.5.2

0 0 0 0

Review documents for proper identification, revision status, and legibility Test the distribution system to verify documents are available and retrievable. Review external documents for proper . identification and control

All controlled documents,  Master lists, Distribution lists, etc.  All applicable external documents: standards, customer documents, and statutory/regulatory documents

4.5.2

4.2.3.g) Are obsolete docs prevented from unintended use & suitably identified if retained for any purpose. 4.2.4 Administration - Control of quality records 4.2.4 Is a documented procedure established to control the identification, storage, retrieval, protection, retention and disposition of quality records? Specifically,  Are quality records legible and readily retrievable?  Are quality records (hard copy or electronic media) stored in a suitable environment to prevent deterioration, damage or loss?  Are quality records retained per established procedures and for the specified periods?  Are appropriate records maintained to demonstrate conformance to requirements and effective operation of the QMS incl. as minimum? Management Review (5.6.1) Competency & Training (6.2.2) Prod Reqmnts Review (7.2.2) Design Inputs (7.3.2) Design Reviews (7.3.4) 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) Internal Audit Results (8.2.2)

0

Review retained obsolete documents for proper identification; identify any obsolete documents not removed from points of use 0%

All obsolete documents

4.5.2

0

Ask for a record and note how long it takes to retrieve; identify causes for breakdowns in the record management system.

Quality records procedure

###

0 0 0 0 Verify that records are suitably protected and note any signs of record deterioration, damage or loss due to inadequate storage. Verify that record holders, locations and retention periods are stipulated for each record or record category. Verify that records are retained as required by established procedures (and/or customer requirements). Verify that records are disposed of in a timely manner. Note: The adequacy of quality records is determined throughout the audit or assessment.

Inspection Results (8.2.4)
Corrective Actions (8.5.2) Traceability (7.5.3)

Nonconforming Product (8.3)

Preventive Actions (8.5.3)

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Question
(Those relating to new/revised requirements are in italics)

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Section

Audit Guidelines

Organization's 9001:1994 Fully Documentation Cross Ref Documented

Fully Implemented

5.1 Management responsibility
5.1 Management commitment 5.1 Is there evidence of top management's commitment to QMS development and improvement? Has top management: a) communicated the importance of meeting customer and regulatory/statutory requirements? b)established the quality policy and objectives? c) conducted management reviews? d) provide necessary resources 0 0 0 Review evidence of top management involvement in establishing quality policy and objectives, communicating requirements, conducting management reviews, and providing resources needed for QMS development and improvement. 5.2 Customer focus Are customer requirments determined and fulfilled with the aim of achieving customer satisfaction? 0 0% Review available information to determine if customer needs/expectations are known and defined in terms of key product characteristics, delivery, price or other customer concern. Interview managers responsibe for customer related process to assess organization's strategy for enhancing customer satisfaction Review contracts and quality plans to determine if customer needs & expectations, including those for specified but known or intended use are converted into requirements per clause 7.1 & 7.2.1) Review any evidence of customer perceptions (per clause 8.2.1) that may indicate customer needs/expectations are unknown or not being met. 5.3 Quality policy 5.3 Has top management established a quality policy that: a) is appropriate to the organization's purpose? b) includes a commitment to complying with requirements & to continualy improving QMS effectiveness? c) provides a framework for establishing and reviewing quality objectives? d) is communicated and understood within the organization? e) is reviewed for continuing suitability? 0 0 0 0 0 0 0% Review the quality manual to ensure top management has established/approved the quality policy. Review other organizational policy documents to determine their consistency with the quality policy. Review the quality policy to determine if it promotes customer satisfaction and continual improvement. 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). 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). Quality manual 4.1.1 Customer complaints and/or satisfaction survey results. Quality Plans Contracts/ agreements Product information brochures, customer information. 0 0 0% Interview top management to assess their awareness of and commitment to fulfilling their responsibilities for QMS development/improvement. Quality manual, management review minutes, resource allocation data, internal memos, letters, briefing notes, etc. 4.1.2.2 4.1., 4.2.1 4.1.3

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Question
(Those relating to new/revised requirements are in italics) 5.4.1 Quality Objectives 5.4.1 Are quality objectives:  established at relevant functions & levels within the organization? include objectives related to meeting product requirements?  measurable and consistent with the quality policy (incl. the commitment to continual improvement)? 0 0

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Audit Guidelines
0% (Note: Quality objectives are used to facilitate improvement of products and product realization processes per clause 8.2.4 and to facilitate continual improvement of the QMS per clause 8.5.1) Review the quality manual or other documentation to determine if top management has established quality objectives and defined responsibilities for their achievement, including those needed to meet product requirements

Organization's 9001:1994 Fully Documentation Cross Ref Documented
Quality manual 4.1.1

Fully Implemented

5.4.2 QMS Planning 5.4.2 a) Has Top Management caried out plans to meet QMS requirments and obkectives for improving the QMS, and 5.4.2 b) Maintained QMS integrity during periods of significant change? 0 0

0% Interview management and review records to assess management's commitment to carrying out and updating plans to met QMS requirements defined in clause 4.1 and achieve objectives defined in clause 5.4.1 especially during periods of significant change (I.e major organizational, process and product changes.) Corporate resource allocation plan and related provisions or . procedures regarding its development and update 4.2.3

5.5.1 Responsibility,authority & communication 5.5.2 Are responsibilities and authorities & their interrelationship defined and communicated? 0

0% Review the quality manual or other appropriate documents to verify that quality management authorities and responsibilities & interrelationships (including responsibilities for achieving quality objectives) are clearly defined. Quality manual, Organization charts, job descriptions 4.1.2.1

5.5.2 Management Representative 5.5.2 Has top management appointed a management representative with responsibility and authority for: a) ensuring QMS processes are established, implemented & maintained? b) reporting QMS performance and improvement needs to top management? c) ensuring promotion of awareness of customer requirements throughout the organization 5.5.3 Internal communication 5.5.3 Is information regarding QMS processes and their effectiveness communicated to the organization? 0 0 0 0

0% Review the quality manual or other appropriate documentation to verify that a management representative is appointed and actively involved in establishing, implementing and maintaining the QMS. Ask a random sampling of employees if they are aware of the importance of meeting customer and other requirements. (also see clauses 5.3.d , 5.5.3, and 6.2.2.d) 0% Review the quality manual or other documentation to determine if 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) Quality manual Quality manual, job descriptions, internal memos 4.1.2.3 4.1.3

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Question
(Those relating to new/revised requirements are in italics) 5.6 Management review 5.6.1 Does top management review the QMS at planned intervals to ensure its continuing suitability, adequacy and effectiveness?  Are the quality policy & objectives reviewed for needed changes? 5.6.2 Do inputs to the management review consider current performance and improvement opportunities, including: a) results of audits b) customer feedback c) process performance and product conformance indicators d) status of corrective and preventive actions e) follow-up actions from previous management reviews f) planned changes that could affect the quality system g) recommendations for improvement 5.6.3 Are results of management reviews recorded and do they include actions related to: a) improvement of the effectiveness of QMS & processes b) improvement of product related to customer requirements c) resource needs 0 0 0 0% 0 Note: required resources are identified during quality planning per clause 5.4.2. Through observation or interviews, identify any evidence that required resources are not provided as needed. Resource allocation plans 4.1.2.2 and related provisions or procedures regarding their development and update. 6.2.1Human resources - Assignment of personnel Are personnel assigned responsibilities defined in the QMS competent on the basis of appropriate education, training, skills and work experience? 6.2.2 H.R. Training, awareness & competency 6.2.2.a) Do qualifications for personnel performing activities affecting quality include identification of appropriate education, training, skills and experience? 6.2.2.b) Is required training provided or other actions taken to satisfy those needs? 6.2.2.c) Is the training provided/actions taken evaluated for effectiveness? 6.2.2.d) Are employees aware of the relevance/importance of their activities and how they contribute to quality objectives? 6.2.2.e) Are appropriate records of training, education, skills & experience maintained? 0 0 QMS awareness training is provided &/or interview employees to assess awareness (see also clauses 5.3.d & 5.5.3 ) Verify adequacy of employee qualification/training records. 0 0 Review training plans and records to verify that: required training is provided/actions taken and they are evaluated for effectiveness Training plans & records 0 0% Review qualification review results to verify that personnel competency is evaluated to determine training needs. Qualification review results ### 0 0% Review organization charts, job descriptions, to verify that personnel are qualified to perform work assignments. Organization charts, job descriptions, etc. 4.1.2.2 0 0 0 0 0 0 0 0 Review management review records for evidence that the required outputs are recorded and used for improvement of the QMS and its processes (per clause 8.5.1) , products and resource needs and/or used to make appropriate changes to the QMS, quality policy, and process/product quality objectives. Management review minutes/records 4.1.3 0 Review management review records for evidence that the required inputs were considered. Management review minutes/records 4.1.3 0 0

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Audit Guidelines
0% Verify that a management review procedure or process is established to ensure the QMS (including the quality policy and objectives) is periodically reviewed for change or improvement.

Organization's 9001:1994 Fully Documentation Cross Ref Documented
Quality manual (or management review procedure) 4.1.3

Fully Implemented

6 Resource Management
6.1 Provision of resources Are resources needed to implement and continually improve QMS processes and enhance customer satisfaction provided in a timely manner?

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(Those relating to new/revised requirements are in italics) 6.3 Infrastructure 6.3 Are the organization's facilities suitable and maintained to ensure process capability and product conformance? Facilities include: a) buildings, workspace and associated facilities b) process equipment, hardware and software c) supporting services such as transportation or communication 0 0 0 Review equipment and facilities maintenance plans for adequacy (i.e. completeness and consistency relevant criteria, such as 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 to ensure process capability and product conformance? 0 0% Through observation or interviews, verify that the work . environment is suitable, clean and well organized Review for adequacy the processes, procedures or practices governing the identification and control of environmental factors.  Process capability studies  Production plans ### 0

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0% Through observation or interviews, identify any evidence that facilities do not meet needs of all interested parties.

Organization's 9001:1994 Fully Documentation Cross Ref Documented
Equipment preventive . and/or predictive maintenance plans ###

Fully Implemented

7 Product Realization
7.1 Planning of product realization processes 7.1 Is the planning of product realization processes consistent with other requirements of the QMS and suitably documented? Specifically: a) Does the quality plan contain quality objectives and requirements for products? b) Does the quality plan define appropriate realization processes and identify documentation and resource requirements specific to products? 0 0 0 0% Note: documentation defining how QMS processes are applied to a specific product, project or contract may be referred to as a quality plan. Review quality plans for consistency with the QMS and verify that appropriate quality objectives are established. Review quality plans, production plans, work orders and other. appropriate documentation to verify that realization processes, 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 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 0 Review quality plans, production plans, work orders, process sheets, inspection procedures or instructions and other appropriate documentation to verify that: 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 Quality plans, production plans, work orders, process sheets, etc. ### 4.10 ### Quality plans, production plans, work orders, process sheets, etc. ### ### Quality plans 4.2.3

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Question
(Those relating to new/revised requirements are in italics) 7.2.1 Customer-related processes - Determination of requirements relating to product Does the organization have processes in place to ensure customer requirements are identified? Including: a) requirements specified by the customer, including delivery and post delivery activities b) requirements not specified by the customer but necessary for specific or known and intended use c) requirements (including regulatory and statutory requirements) related to the product d) any additional requirments determined by the organization 0 0 Review performance claims made by company relating to products/services and verify that appropriate requirements are provided for in quality plans (see clause 7.1) Product descriptions, catalogues, brochures 0 0 0

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Audit Guidelines

Organization's 9001:1994 Fully Documentation Cross Ref Documented

Fully Implemented

0% Review contracts or other customer agreements to verify the inclusion of all applicable specified requirements and requirements necessary to fulfill specified, known or intended use as well as all applicable regulatory and statutory requirements. Requirements identification procedure or process

7.2.2 Customer-related processes - Review requirements re product

0% Product requirements review and change 4.3.1

Is there a requirements review process in place to ensure that prior to acceptance a) product requirements are defined? b) order requirements different than previously expressed are resolved c)the organization confirms its ability to meet defined requirements  Where customer provides no documented statement of 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? 0 0 Review change orders to verify they are properly reviewed, and. that all concerned functions are informed Review records for adequacy. 0 0 0 0 Review quotes or offers and contract or orders to verify they are properly reviewed, that any differences or ambiguities are resolved, and that feasibility reviews have been performed. Review customer complaints, and/or shipping records for any evidence that requirements were not known or not met.

control procedure or process 4.3.2

4.3.3 4.3.4

7.2.3 Customer-related processes - Customer communications Has the organization determined & implemented effective arrangements for communication with the customer regarding: a) product information? b) inquiries, contracts or order handling, including amendments? c) customer feedback, including customer complaints? 0 0 0

0% Review the quality manual and/or other appropriate . documentation to verify that responsibilities for internal communications with the customer are clearly defined Interview customer service or other contact personnel to verify communications system are effectively implemented. Review customer complaints for any evidence that communications were ineffective. Organization charts, job descriptions, etc. Quality manual,

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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Question
(Those relating to new/revised requirements are in italics) 7.3.1 Design and development planning Is there a procedure or established process in place for planning and controlling product design & development activities?  Have design plans for each design project been established to include: a) stages of design & development processes b) review, verification and validation activities appropriate to each design and development stage c) responsibilities and authorities for design & development activities?  Are interfaces between groups involved in design & development effectively managed to ensure effective communications and clear assignment of responsibilities?  Is planning output updated as the design and development progresses? 7.3.2 Design and development inputs Are design & development inputs relating to product requirements determined and recorded (see 4.2.4) including: a) functional and performance requirements? b) applicable regulatory/statutory requirements? c) applicable information from derived from previous similar designs? d) any other requirements essential for design and/or development?  Are design & development requirements complete, unambiguous and not in conflict? 7.3.3 Design and development outputs Are outputs of the design & development provided in a form that enables verification against inputs? Specifically, do outputs: a) meet the input requirements? b) provide appropriate information for purchasing, production and service operations? c) contain or reference product acceptance criteria? d) define characteristics of the product essential to its safe and proper use?  Are design/development output documents approved prior to release? 0 0 0 0 0 0% Review design & development output documents for completeness, including acceptance criteria, and to verify they are properly reviewed and approved. Design and /or Development Output Documents 4.4.4 0 0 0 0 0 Verify that design input documents are properly reviewed and approved. 0 0% Review design input documents to verify they address . all applicable requirements Design and /or development input documents 4.4.4 0 Review design/development plans to verify they are updated as appropriate. 0 0 0 0 Review design/development plans to verity they adequately define design schedules, assignment of personnel, and technical interface responsibilities and communication processes. 0

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0% Verify that a procedure or process exists and adequately covers all applicable design and development activities.

Organization's 9001:1994 Fully Documentation Cross Ref Documented
Design and /or development procedure or process Design and/or development plans 4.4.1 4.4.2 4.4.3

Fully Implemented

0

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(Those relating to new/revised requirements are in italics) 7.3.4 Design and development review Are design & development reviews conducted at suitable stages to: a) evaluate the ability of des. & development results to fulfill rqrments? b) identify problems and propose required actions?  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 follow-up actions recorded and controlled (per Clause 4.2.4)? 7.3.5 Design & development verification 0% Review design/development plan and design project files for evidence that verification/validation activities are performed as planned. 7.3.5 Is verification performed to ensure output staisfies input requirements?  Are verification results and any necessary actions recorded and controlled (per Clause 4.2.4)? 0 0 Review design project files for evidence that design stage documents have been verified and approved, that other appropriate records are established and controlled, and that appropriate follow-up actions are taken to address failures. Design stage docs: . i.e. feasibility studies, prelim. drawings, calculations, etc Validation and testing procedures 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 (see 7.3.1) to ensure that resulting product is capable of fulfilling requirements for the specified or known intended use prior to delivery/implementation?  Are validation results and subsequent follow-up actions recorded and controlled (per Clause 4.2.4)? 0 0 planned. Review design project files for evidence that design stage documents have been verified and approved, that other appropriate records are established and controlled, and that appropriate follow-up actions are taken to address failures. Design stage docs: . i.e. feasibility studies, prelim. drawings, calculations, etc Validation and testing procedures Quality Records Control Procedure 7.3.7 Control of design and development changes Are design & development changes documented, reviewed, verified & validated before implementation? is the effect of changes on parts and delivered product evaluated?  Are results of the review of changes and subsequent follow-up actions documented (per Clause 4.2.4)? 0 0 0 0% 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 development Change Control Procedure or Process Quality Records Control Procedure 4.4.9 4.4.8 4.4.7 4.4.8 4.4.7 0 0 0 0 Review design & development plans to verify that reviews are . planned at suitable stages Review design& development review minutes, results or reports to verify that reviews are performed as planned, attended by appropriate personnel, and that related results are properly recorded and controlled.  Design and /or Development Plans Design and/or Development Review minutes, results or reports  Quality records control procedure 4.4.6

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Organization's 9001:1994 Fully Documentation Cross Ref Documented

Fully Implemented

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(Those relating to new/revised requirements are in italics) 7.4.1 Purchasing control Is there a suitable purchasing process to ensure purchased product conforms to requirements? 0 0

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Audit Guidelines
0% Review the purchase control procedure or process to ensure it adequately addresses purchased products to be incorporated into the final product and procured services that directly affect product quality.

Organization's 9001:1994 Fully Documentation Cross Ref Documented
Purchasing and/or supplier evaluation processes or procedures 4.6.1

Fully Implemented

Are the type and extent of controls on supplier & product
dependent upon the effect the purchased product has on subsequent product realization or the final product?  Are suppliers evaluated and selected based on their ability to supply product in accordance with the organization's requirements?  Is criteria for the selection, evaluation and re-evaluation of suppliers defined?  Are results of evaluations/reevaluations of suppliers and related follow-up actions recorded? 7.4.2 Purchasing information 7.4.2 Does purchasing information contain data that describes the product or service being ordered? Including, where appropriate: a) requirements for approval product, procedures, processes and equipment b) requirements for personnel qualification c) quality management system requirements  Does the organization ensure the adequacy of requirements specified in purch. docs prior to communicating them to the supplier? 7.4.3 Verification of purchased product 7.4.3 Is there a suitable process of inspection or other activities for ensuring purchased products meet specified requirements?  Where applicable, are there provisions for the organization (or customer) to verify and release purchased product at source?

0

Review supplier qualification records to ensure suppliers are qualified on the basis of their ability to meet both quality system and product quality assurance requirements.

List of Approved Suppliers 4.6.2a

0

Review supplier files to verify that suppliers are evaluated and selected on the basis of established criteria and that their performance is monitored and periodically reevaluated.

4.6.2b

0

Review supplier quality records to verify that results of evaluations and follow-up actions are recorded. 0%

4.6.2c

0 0 0 0 0

Review purchasing processes or procedures for adequacy and/or interview personnel who prepare purchase documents to verify that they know and use relevant processes or procedures. Review purchase documents to verify that they contain all appropriate requirements and are properly reviewed and approved prior to issuance.

Purchasing processes or procedures

4.6.3

Quality manual or other relevant document, including applicable contracts

4.6.4.1

0% 0 0 Review records to verify that all purchased product is inspected as planned (see clause 7.1.c) and that received items are properly identified (see clause 7.5.3). Review applicable contracts or other appropriate documents to verify they specify verification arrangements and methods of product release.  Purchasing processes or procedures  Quality manual or other relevant document, including applicable contracts 4.6.4.2

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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) 7.5.1 Production and service provision

SCORING
Question
Section

Audit Guidelines
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.

Organization's 9001:1994 Fully Documentation Cross Ref Documented
###

Fully Implemented

7.5.1 Does the organization carry out production and service operations under controlled conditions including as applicable: a) the availability of information that specifies the characteristics of the product? b) the availability of work instructions, where necessary? 0 0 Review documents and verify they are authorized or approved & cover all production steps. Review documentation for selected processes and verify that work instructions and workmanship standards are available/used where needed. c) the use of suitable equipment? d) the availability and use of measuring and monitoring devices e) the implementation of monitoring and measuring activities 0 0 0 Verify that equipment (including measuring and monitoring devices) used in production or service operations is appropriate and available (see 6.3 and 7.6) to ensure continuing process capability. Witness process control activities; ask about the criteria for identifying and reporting unacceptable product, and verify activities are performed per instructions & as planned (see 7.1) f) the implementation of defined processes for release, delivery and applicable post-delivery activities? 0 Observe operations and review related records to verify that uninspected or nonconforming products are prevented from being used in the next processing stage; and, to verify that product identification and inspection status is maintained throughout all operations. Review delivery procedure, specification or instructions for adequacy in assuring the protection of product quality during delivery to destination per clause 7.5.5. Review servicing agreements and related documentation governing post delivery activities and verify organization’s ability to meet applicable requirements. 7.5.2 Validation of processes for production & service (Re: Special processes) Are production and service processes validated where the resulting output cannot be verified by subsequent measurement or monitoring, including processes where deficiencies become apparent only after product is in use or service is delivered? Does validation demonstrate the ability of the process to meet planned arrangements?  Do arrangements for validation include, as applicable: a) defined criteria for review & approval of the process; b) approval of equipment and qualification of personnel; c) use of specified methodologies/procedures; d) requirements for records (4.2.4); e) re-validation 0 0 0 0 0 0 Review criteria used to identify special processes (where the results cannot be fully verified by subsequent inspection and testing), and verify suitability and effectiveness of controls: 0 Review validation requirements and plans (see clause 7.1) and records to verify validation activities are performed and results recorded as planned . 0%

Production plans, quality control plans, work orders, process sheets, workmanship standards, work instructions, specs, drawings, or any other documentation that Equipment preventive and/or predictive maintenance plans. Process control . docs, control plans inspect. Insructions, etc Inspection and/or inspection status instructions or procedures, process sheets, work travelers Delivery procedure, 4.15.6 specifications or instruction  After delivery servicing agreements ### ### 4.10.2

Validation requirements/ plans, and relevant work instructions

###

Documented work instructions, process equipment & personnel qualification records

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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) 7.5.3 Identification & Traceability  Is product identified by suitable means throughout production?  Is product identified with respect to measuring & monitoring requirements?  Where traceability is a requirement is the unique identification of the product controlled and recorded? 0 0 0

SCORING
Question
Section

Audit Guidelines
0%  Review for adequacy the system of assigning, documenting & recording product identification numbers, including part numbers, serial numbers, or other unique identification as appropriate for raw materials and other purchased products, in-process materials and finished goods.  Verify that all materials, components, and products in all areas and at all stages of production are 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 applicable requirements; verify plans are authorized, available & used in receiving, storage and production areas, and that all required records are maintained.

Organization's 9001:1994 Fully Documentation Cross Ref Documented

Fully Implemented

Product Identification procedures and related bills of material, parts lists, etc. Product identification tags, labels Inspection status docs travelers, stamps Traceability plans

###

###
###

7.5.4 Customer property 7.5.3 Is care exercised in the use of customer property while under the organization's control?  Is customer's intellectual property included when req'd by contract?  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 customer property that is lost, damaged or otherwise unsuitable for use? 0 0 0

0% Confidentiality agreements Verify that intellectual property is controlled per any agreements Verify that customer property is examined upon receipt to check quantity, identity, and damage. Verify compliance with any contractual requirements regarding verification, identification, storage, or handling of customer property. Customer specifications and/or procedures or processes related to the verification, identification, storage, and handling 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
Question
(Those relating to new/revised requirements are in italics) 7.5.5 Preservation of product 7.5.4 Is product conformity with customer requirements preserved during internal processing and final delivery to the intended destination? Including:  Identification,  Handling, 0 0 Verify that handling equipment is appropriate and maintained; that equipment operators are certified or trained and follow applicable work instructions; and, note any signs of products being damaged or at risk.  Packaging (and preservation), 0 Verify that packaging is formally defined and followed; when packaging requires special methods, use the same criteria that apply to process control. Verify that personnel follow relevant instructions; &, note signs of products deteriorating or being at risk.  Storage, and 0 Verify that storage areas are clearly identified; contain only the kind of products for which they are designated; and, are properly maintained. Verify that receipt/issue authorizations and/or inspection 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 and/or verify that subcontracted shippers are approved and that their performance is monitored. Delivery procedure, specifications or instruction 4.15.6 Packaging process, procedure and/or relevant work instructions Preservation process, procedure and/or work instructions Storage and inventory control processes, procedures, and/or relevant work instructions 4.15.3 4.15.5 4.15.4 Handling process, procedure, and/or relevant work instructions 4.15.2 Verify that product identification established per clause 7.5.2 is maintained during internal processing and final delivery. 4.15.1

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Section

Audit Guidelines
0%

Organization's 9001:1994 Fully Documentation Cross Ref Documented

Fully Implemented

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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) 7.6 Control of measuring and monitoring (M+M) devices Does the organization identify the monitoring & measurements to be made and the M+M devices required to assure product conformity (including software used for product verification)? 0

SCORING
Question
Section

Audit Guidelines
0% Verify that required measurements and applicable inspection, measuring and test equipment (IM&TE) are identified; see clause 7.1 for related planning activities & 7.2.1 for product review activities.

Organization's 9001:1994 Fully Documentation Cross Ref Documented

Fully Implemented

Quality control plans, IM&TE Control processes and/or procedures and relevant work instructions Gage R&R studies

4.11.1

 Are measuring and monitoring devices used and controlled to ensure that measurement capability is consistent with requirements?

0

Review for adequacy methods for determining how the 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.

4.11.2.a

When applicable, are measuring and monitoring devices: a) calibrated or verified periodically or prior to use against devices traceable to international or nationalmeasurment standards or other recorded basis? b) adjusted/re-adjusted as necessary c) identified & calibration status recorded? d) safeguarded from adjustments that would invalidate the calibration? e) protected from damage and deterioration during handling, maintenance and storage? f) validity of previous results re-assessed if they are subsequently found to be out of calibration, and corrective action taken? 0 0 0 0 0 0 0

Review a sample of calibration procedures; verify M+M equipment was appropriately and accurately calibrated and that personnel performing calibrations know how to use calibration procedures / instructions. Verify that M+M equipment found in production and inspection areas is properly identified, maintained, stored, and safeguarded against unauthorized adjustments, and that current calibration results are recorded and calibration status is known. Review applicable records to verify that appropriate actions, including customer notification, are taken on product and process when IM&TE is found to be out of calibration. Calibration control processes, procedures and relevant work instructions 4.11.2 b - i

8 Measurement, analysis and improvement
8.1 Measurement, analysis and improvement - Planning Has the organization identified and planned the measurement and monitoring activities needed 0 0 0 0 0 0 0% Review for adequacy the procedures or processes for identifying methods, techniques and data used to measure, monitor or improve products, processes, customer satisfaction . or organizational performance Measurement, monitoring, inspection, & improvement processes, plans, procedures and relevant work instructions. 4.20 4.10.1

a) to demonstrate conformity of the product b) ensure conformity of the QMS
c) continually improve QMS effectiveness  Have the methods of measuring, analysis and improvement, including staistical techniques & the extent of their use been determined?

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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
Question
(Those relating to new/revised requirements are in italics) 8.2.1 Customer satisfaction 8.2.1 Does the organization monitor information relating to customer perception as to whether it has fulfilled customer requirements? And  Are the methods for obtaining and using information on customer satisfaction defined? 8.2.2 Internal Audit 8.2.2 Are internal audits conducted at planned intervals to determine whether the QMS a) conforms to planned arrangements, to ISO9001-2000 requirements & the QMS requirments established by the organization and b) has been effectively implemented?  Is there an internal audit plan and does it consider the status and importance of audit activities and areas and the results of previous audits?  Is the critieria scope, frequency and methodologies of internal audits defined?  Are audits conducted by personnel who are objective, independent of the activity being audited and not assigned to audit their own work?  Is there a documented procedure identifying responsibilities/requirements for planning and conducting audits, recording results and reporting to management?  Does management of audited area take timely action to eliminate nonconformities and their causes.  Are follow-ups performed to verify implementation of 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 of QMS processes?  Do these methods confirm the continuing ability of each process to achieve planned results?  When planned results are not achieved, is appropriate correction and corrective action taken to ensure product conformity? 0 0 0 0%  Review the implementation of process controls (including statistical techniques) identified per clause 8.1 to verify they are used to assess process capability of product conformity.  Verify that employees were trained to perform measurement and monitoring assignments (including inspection activities and 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. Measurement, monitoring, inspection, and improvement processes, plans, procedures and ### 4.10.1 0 0 verify that corrective actions are implemented and followed-up in a timely manner and that all results are recorded. 0 0 0 Review internal audit reports to: verify that the scope, frequency, and methodologies are defined and clearly communicated . verify that internal auditors are trained and independent of the activities/areas audited. verify that results are recorded, processed and evaluated by management per procedure. Internal audit notifications, relevant work instructions and/or checklists Internal audit reports 0 requirements and addresses all appropriate considerations. Review internal audit plan to verify that it includes all applicable Internal Audit Plan 0 0% Review the documented internal audit procedures for adequacy in explaining all aspects of the auditing system. Documented Internal Quality Audit Procedure ### 0 0

SCORING
Question
Section

Audit Guidelines
0% Review for adequacy the process for obtaining and using customer satisfaction information to monitor, measure and improve the quality management system

Organization's 9001:1994 Fully Documentation Cross Ref Documented

Fully Implemented

Processes or procedures for requesting, measuring, & monitoring customer feedback, including complaints, surveys, etc.

relevant work instructions. 4.20.2

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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) 8.2.4 Measurement and monitoring - of product

SCORING
Question
Section

Audit Guidelines
0% Note: measurement and monitoring activities required to determine product conformance are identified during planning activities; see clause 7.1

Organization's 9001:1994 Fully Documentation Cross Ref Documented
Inspection and Test 4.10.1 procedures & instructions 4.20.2

Fully Implemented

Are product characteristics measured and monitored at appropriate stages of product realization and in accordance with planned arrangements to very that requirementsare fulfilled?  Are records evidencing product conformity and identifying the authorities responsible for release of product maintained?

0 Review quality plans and inspection processes, procedures, instructions, etc. for completeness and adequacy (including 0 clearly defined acceptance criteria, requirements for records, and product release authorities). Review records to verify receiving inspections are performed Receiving inspection process, procedures and/or relevant work Products with different status are adequately segregated and appropriately labeled. Inspectors are qualified, and required supplier submittals are on file. instructions Quality plans Supplier submittals 4.10.2 Quality control plans and related records 4.10.5

Is there assurance that no product is released or service completed until all planned arrangements have been completed, unless otherwise approved by a relevant authority and. Where applicable, the customer.

0

as planned, and:

 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 quality plan / procedures are satisfactorily completed, associated data and documents are available / authorized; and product released as authorized Verify that inspectors are qualified, and that procedures are available and followed.

 In-process inspection process, procedures and/or relevant work instructions  Process sheets and/or Quality plans

4.10.3

Final inspection process,4.10.4 procedures and/or relevant work instructions Quality plans; final audit checklists, etc.

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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) 8.3 Control of nonconformity 3 Is there a documented procedure defining the controls and related responsibilities and authorities for dealing with nonconforming product? Specifically,  Are products that do not conform to product requirements identified and controlled per the established procedure to prevent their unintended use or delivery?  Does the organization deal with the nonconforming product by one of the following ways?" a) By taking action to eliminate the detected nonconformity b) By authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer c) By taking action to preclude its original intended use or application  Are records of the nature of the nonconformity and any subsequent actions taken, including concessions obtained maintained? (see clause 4.2.4)  Is corrected nonconforming product subject to re-verification to demonstrate conformity to requirements?  Is action taken appropriate to the effects, or potential effects, of 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 effectiveness of the QMS and to identify QMS improvement opprtunities?  Does analysis provide information on: a) customer satisfaction (see 8.2.1) ? b) conformance to product requirements? (see 7.2.1) c) characteristics and trends of processes, products including opportunties for preventive action d) suppliers? 0 0 0 0 0 0% Review for adequacy the process for deetrmining, collecting, and analyzing data to assess QMS effectiveness and evaluate where continual improvement of the QMS can be made. Data analysis procedure and/or process or procedure 4.20.1 0 0 0 0 0 0 0 Through observation, verify that all nonconforming products, wherever they are found, are clearly identified and segregated; and, verify that nonconformity reports are being established and further processed to document disposition decisions and inform other functions concerned. Review nonconformity reports to verify that dispositions are appropriate, authorized at the appropriate level and that reworked product is re-verified. Verify that proposed actions are reported and that concessions are recorded and performed as required. 0

SCORING
Question
Section

Audit Guidelines
0% Review the documented procedure for adequacy.

Organization's 9001:1994 Fully Documentation Cross Ref Documented

Fully Implemented

Nonconforming Product Control procedure and relevant work instructions and/or inspection procedures

4.13.1 4.13.2

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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
Question
(Those relating to new/revised requirements are in italics) 8.5.1 Improvement - Continual improvement Does the organization continually improve the effectiveness of the QMS through the use of the:  (1) quality policy, (2) quality objectives, (3) audit results, (4) analysis of data, (5) corrective and preventive actions and (6) management reviews? 0 0

SCORING
Question
Section

Audit Guidelines
0% Verify that a procedure or established process is in place to identify and manage improvement projects based on information re: The continuing suitability of the quality policy (clause 5.3) and quality objectives (clause 5.4.1) Internal audit results (clause 8.2.2) Output from data analysis, including customer satisfaction, supplier performance, product conformance, and process performance trends (clause 8.4) Corrective and Preventive action results (clauses 8.5.2 and 8.5.3) Management review actions (clause 5.6.3)

Organization's 9001:1994 Fully Documentation Cross Ref Documented

Fully Implemented

Improvement process or procedure Quality manual 4.1.1

Internal Audit Procedure ### Data Analysis process or procedure Corrective and Preventive### Action procedures Management review process or procedure ### ###

8.5.2 Improvement - Corrective action Is there a documented procedure to ensure appropriate corrective actions are taken to eliminate the causes of nonconformity and prevent their recurrence? Specifically, a) are nonconformities (including customer complaints) reviewed? b) are causes of the nonconformity determined? c) are evaluations conducted to identify actions that will prevent recurrence? d) are needed corrective actions defined and implemented? e) are records of actions taken & results recorded? (see 4.2.4) f) are follow-up reviews of actions taken performed to verify their effectiveness? 8.5.3 Improvement - Preventive action Is there a documented procedure to determine & initiate appropriate preventive actions to eliminate the causes of potential nonconformity to prevent their occurrence? Specifically, a) are potential nonconformities and their causes determined? b) are evaluations conducted to determine the need for preventive action? c) are actions identified, implemented and appropriate to the effects of potential problems d) are results of action taken recorded? e) are follow-up reviews of actions taken performed to verify their effectiveness? 0 0 0 0 0 0 0 0 0 0 0 0 0

0%  Verify that the documented procedure adequately explains and defines responsibilities for the corrective action process.  Review customer complaints, nonconforming material reports, outputs from management review, internal audit reports, and outputs from data analysis to verify that corrective action requests are initiated when nonconformities are identified.  Review corrective action records to verify that root causes are identified, that actions aimed at preventing recurrence are recorded and implemented in a timely manner, and that follow–up reviews are performed. 0%  Verify that the documented procedure adequately explains and defines responsibility for the preventive action process.  Review for adequacy the methods used to identify potential nonconformities and their causes.  Review preventive action records to verify that potential nonconformance and their causes are identified, that actions aimed at preventing occurrence are recorded and implemented in a timely manner, and that follow–up reviews are performed. 4.14.3 Documented Preventive Action procedure 4.14.1 4.14.2 Documented Corrective Action procedure 4.14.1

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