ISO9001-2000 Score by Process Group

25%

20%

15%
Score

10%

5%

0% 4 5 6 7 8 Process Group Total

ISO9001-2000 Score by Paragraph

TOTAL 8.4 8.2 7.6 7.4 Paragraph 7.2 6.4 6.2 5.6 5.4 5.2 4 0% 5% 10% Score 15% 20% 25%

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 Documented Ref

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 1 1 29% (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. 0 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:

SCORING
Question 0 1
Section

Audit Guidelines
9% (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

Organization's 9001:1994 Fully Documentation Cross Documented Ref

Fully Implemented

Quality manual Documented procedures

4.2.1 4.2.2

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

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.

Other QMS Review QMS processes to ensure they are adequately defined in procedures, process or job descriptions, work instructions, or other appropriate system documentation. documentation

(Note: all required QMS documents and records are controlled per clauses 4.2.3 and 4.2.4)

Other QMS docs and records Quality manual,

4.2.1 4.5.1
4.2.1

0 0

Verify that quality manual is controlled per clause 4.2.3 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).

0 0

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).

Documented procedures, QMS process descriptions,. flow charts, etc.

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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

SCORING
Question 1
Section

Audit Guidelines

Organization's 9001:1994 Fully Documentation Cross Documented Ref

Document Control procedure 4.5.1

Fully Implemented

14% 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.).

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?

Review documents for evidence of review/approval.

All new and revised documents

4.5.2, 4.5.3

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, 4.5.2

Distribution lists, etc. 4.5.2 documents: standards, customer documents, and statutory/regulatory documents

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,

Review retained obsolete documents for proper identification; identify any obsolete documents not removed from points of use 40%

All obsolete documents

4.5.2

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

Quality records procedure

1 0 suitable environment to prevent deterioration, damage or loss? 0 the specified periods? 0 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) 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)

SCORING
Question
Section

Audit Guidelines

Organization's 9001:1994 Fully Documentation Cross Documented Ref

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. 0% Review available information to determine if customer 0 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 Quality Plans Customer complaints and/or satisfaction survey results. 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 4.1.2.2 memos, letters, briefing notes, etc. 4.1., 4.2.1 4.1.3

5.2 Customer focus Are customer requirments determined and fulfilled with the aim of achieving customer satisfaction?

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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:

SCORING
Question
Section

Audit Guidelines
0% (Note: Quality objectives are used to facilitate improvement of

Organization's 9001:1994 Fully Documentation Cross Documented Ref

Quality manual 4.1.1

Fully Implemented

0 0 commitment to continual improvement)?

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

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?

SCORING
Question 0 0
Section

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. Review management review records for evidence that the required inputs were considered.

Organization's 9001:1994 Fully Documentation Cross Documented Ref

Quality manual (or management review procedure) Management review minutes/records 4.1.3 4.1.3

Fully Implemented

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 0 0 0 0 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 plans4.1.2.2 and related provisions or procedures regarding their development and update. 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

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?

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 0 0 0 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% Review qualification review results to verify that personnel competency is evaluated to determine training needs. Review training plans and records to verify that: required training is provided/actions taken and they are evaluated for effectiveness 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. Qualification review results Training plans & records

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Question
(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

SCORING
Question 0
Section

Audit Guidelines
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 Documented Ref

Equipment preventive . and/or predictive maintenance plans

Fully Implemented

0 0 0

Review equipment and facilities maintenance plans for adequacy (i.e. completeness and consistency relevant criteria, such as manufacturers 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. studies

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

SCORING
Question
Section

Audit Guidelines

Organization's 9001:1994 Fully Documentation Cross Documented Ref

Fully Implemented

0% Review contracts or other customer agreements to verify the 0 0 0 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 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 0 0 0 0 requirements, are they confirmed? 0 documentation amended and personnel made aware of the changes? 0

control procedure or Review customer complaints, and/or shipping records for any evidence that requirements were not known or not met. 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 change orders to verify they are properly reviewed, and. that all concerned functions are informed Review records for adequacy. 4.3.3 4.3.4 process 4.3.2

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? 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? effectively managed to ensure effective communications and clear assignment of responsibilities?

SCORING
Question 0
Section

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

Organization's 9001:1994 Fully Documentation Cross Documented Ref

Design and /or development procedure or process Design and/or development plans 4.4.1 4.4.2 4.4.3

Fully Implemented

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 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? 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? 0 0 0 0 0 0% 0 0 0 0 0 0 0%

Review design/development plans to verify they are updated as appropriate.

Review design input documents to verify they address . all applicable requirements

Design and /or development input documents

4.4.4

Verify that design input documents are properly reviewed and approved.

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
to release?

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Question
(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? of all functions concerned with the design & development stage(s) being reviewed?

SCORING
Question
Section

Audit Guidelines
0%

Organization's 9001:1994 Fully Documentation Cross Documented Ref

Fully Implemented

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 Development Review minutes, results or reports control procedure 0% evidence that verification/validation activities are performed as planned. i.e. feasibility studies, prelim. drawings, calculations, etc 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. Control Procedure procedures Development Plans

4.4.6

0 follow-up actions recorded and controlled (per Clause 4.2.4)? 7.3.5 Design & development verification

recorded and controlled.

4.4.7

7.3.5 Is verification performed to ensure output staisfies input requirements?

0 0

4.4.8

actions recorded and controlled (per Clause 4.2.4)?

7.3.6 Design and development validation

0%

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? 0 actions recorded and controlled (per Clause 4.2.4)? procedures Control Procedure 7.3.7 Control of design and development changes 0 & validated before implementation? 0 0 actions documented (per Clause 4.2.4)? product are evaluated. implementation. 0% Design and /or development Change Control Procedure or Process Quality Records Control Procedure 4.4.9 4.4.8 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. i.e. feasibility studies, prelim. drawings, calculations, etc 4.4.7 0 planned.

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Question
(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? 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?

SCORING
Question 0
Section

Audit Guidelines
0%

Organization's 9001:1994 Fully Documentation Cross Documented Ref

Purchasing and/or 4.6.1

Fully Implemented

adequately addresses purchased products to be incorporated 0 into the final product and procured services that directly affect product quality. 0

supplier evaluation processes or procedures

List of Approved Suppliers4.6.2a qualified on the basis of their ability to meet both quality system and product quality assurance requirements.

supply product in accordance with the organization's requirements? 0 of suppliers defined? valuations/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 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? 0 (or customer) to verify and release purchased product at source? 0 0% 0 0 0 0% 0

4.6.2b selected on the basis of established criteria and that their performance is monitored and periodically reevaluated. 4.6.2c evaluations and follow-up actions are recorded.

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.

Purchasing processes or procedures

4.6.3

appropriate requirements and are properly reviewed and approved 0 0 prior to issuance.

Quality manual or other relevant document, including applicable contracts

4.6.4.1

Review records to verify that all purchased product is inspected as planned (see clause 7.1.c) and that received items are properly identified (see clause 7.5.3). relevant document, verify they specify verification arrangements and methods of product release. including applicable contracts or procedures

4.6.4.2

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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 Documented Ref

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 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 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 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. adequacy in assuring the protection of product quality during delivery to destination per clause 7.5.5. governing post delivery activities and verify organizations 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? 0 planned arrangements? 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 results cannot be fully verified by subsequent inspection and testing), and verify suitability and effectiveness of controls: Documented work instructions, process equipment & personnel qualification records 0 records to verify validation activities are performed and results recorded as planned . Validation requirements/ plans, and relevant work instructions 0% servicing agreements inspection status instructions or procedures, process sheets, work travelers 4.15.6 specifications or instruction docs, control plans inspect. Insructions, etc devices) used in production or service operations is appropriate and available (see 6.3 and 7.6) to ensure continuing process capability. and/or predictive maintenance plans. 4.10.2 0 cover all production steps. control plans, work orders, process sheets, workmanship standards, work instructions, specs, drawings, or any other documentation that

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(Those relating to new/revised requirements are in italics) 7.5.3 Identification & Traceability

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0 0 requirements? 0 product controlled and recorded? 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.

Product Identification procedures and related bills of material, parts lists, etc. Product identification and products in all areas and at all stages of production are identified with appropriate markings, labels, tags etc. Inspection status docs identified throughout production applicable requirements; verify plans are authorized, available & used in receiving, storage and production areas, and that all required records are maintained. travelers, stamps Traceability plans tags, labels

7.5.4 Customer property 7.5.3 Is care exercised in the use of customer property while under the organization's control? 0 customer property provided for use or incorporation into the product? 0 customer property that is lost, damaged or otherwise unsuitable for use? 0

0% Confidentiality agreements Customer specifications and/or procedures or quantity, identity, and damage. verification, identification, storage, or handling of customer property. processes related to the verification, identification, storage, and handling of purchased product

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(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:

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0 maintained during internal processing and final delivery. 0

4.15.1

4.15.2 that equipment operators are certified or trained and follow applicable work instructions; and, note any signs of products being damaged or at risk. 0 packaging requires special methods, use the same criteria that apply to process control. of products deteriorating or being at risk. 0 kind of products for which they are designated; and, are properly maintained. sign-offs or indicators are clear. 0 and/or verify that subcontracted shippers are approved and that their performance is monitored. specifications or instruction 4.15.6 control processes, procedures, and/or relevant work instructions procedure and/or relevant work instructions 4.15.5 procedure and/or work instructions 4.15.3 4.15.4 procedure, and/or relevant work instructions

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(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)?

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0 measuring and test equipment (IM&TE) are identified; see clause 7.1 for related planning activities & 7.2.1 for product review activities. 0

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

4.11.1

4.11.2.a

ensure that measurement capability is consistent with requirements?

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 including customer notification, are taken on product and process 0 when IM&TE is found to be out of calibration. 0 0 0 properly identified, maintained, stored, and safeguarded against unauthorized adjustments, and that current calibration results are recorded and calibration status is known. 0 appropriately and accurately calibrated and that personnel performing calibrations know how to use calibration procedures / instructions. 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 staistical techniques & the extent of their use been determined?

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(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

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

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

0 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? importance of audit activities and areas and the results of previous audits? 0 defined? 0 of the activity being audited and not assigned to audit their own work? 0 responsibilities/requirements for planning and conducting audits, recording results and reporting to management? 0 nonconformities and their causes. 0 actions taken and are related results recorded?(see 8.5.2) 8.2.3 Measurement and monitoring - of processes 8.2.3 Are suitable methods applied for measurement and monitoring of QMS processes? 0 to achieve planned results? 0 and corrective action taken to ensure product conformity? 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. 0 statistical techniques) identified per clause 8.1 to verify they are used to assess process capability of product conformity. 0% a timely manner and that all results are recorded. management per procedure. activities/areas audited. and clearly communicated . Review internal audit reports to: 0 requirements and addresses all appropriate considerations. 0 in explaining all aspects of the auditing system. 0%

Quality Audit Procedure

notifications, relevant work instructions and/or checklists

Measurement, monitoring, inspection, and improvement processes, plans, procedures and 4.10.1 relevant work instructions.4.20.2

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(Those relating to new/revised requirements are in italics) 8.2.4 Measurement and monitoring - of product

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Organization's 9001:1994 Fully Documentation Cross Documented Ref

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?

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). 4.10.2 0 as planned, and: process, procedures and/or relevant work instructions appropriately labeled. are on file. Quality control plans and related records 4.10.5

the authorities responsible for release of product maintained?

until all planned arrangements have been completed, unless otherwise approved by a relevant authority and. Where applicable, the customer.

4.10.3 are available and followed. 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. and/or Quality plans 4.10.4 quality plan / procedures are satisfactorily completed, associated data and documents are available / authorized; and product released as authorized available and followed. audit checklists, etc. procedures and/or relevant work instructions process, procedures and/or relevant work instructions

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(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,

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Nonconforming Product Control procedure and relevant work instructions

4.13.1 4.13.2

0 and controlled per the established procedure to prevent their unintended use or delivery? 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 0 0 actions taken, including concessions obtained maintained? (see clause 4.2.4) 0 demonstrate conformity to requirements? 0 the nonconformity, when nonconforming product is detected after delivery or use? 8.4 Analysis of data Is data collected and analyzed to determine the suitability and effectiveness of the QMS and to identify QMS improvement opprtunities? 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% 0 0

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. appropriate, authorized at the appropriate level and that reworked product is re-verified. recorded and performed as required.

and/or inspection procedures

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

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(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:

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0 and manage improvement projects based on information re: 0 quality objectives (clause 5.4.1) or procedure 4.1.1

(4) analysis of data, (5) corrective and preventive actions and (6) management reviews?

supplier performance, product conformance, and process performance trends (clause 8.4)

or procedure

Action procedures 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 nonconformance and their causes are identified, that actions aimed at preventing occurrence are recorded and implemented in a timely manner, and that followup reviews are performed. 0 0 nonconformities and their causes. 4.14.3 0 defines responsibility for the preventive action process. 0 0 0 identified, that actions aimed at preventing recurrence are recorded and implemented in a timely manner, and that followup reviews are performed. 0% Documented Preventive 4.14.1 Action procedure 0 0 0 0 defines responsibilities for the corrective action process. outputs from management review, internal audit reports, and outputs from data analysis to verify that corrective action requests are initiated when nonconformities are identified. 4.14.2 0% Documented Corrective 4.14.1 Action procedure

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