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Documents of Quality Management

according to ISO 9001

 

 

Documents in TQM

  • represent governing documents

  • document quality management measures

  • document results of quality management measures.

The following documents are used in the processes of the QM Process Library.

 

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Read our free excerpt - ISO 9001 processes of Quality Management


Brief summary of the TQM-relevant documents

 

Governing documents

 

Controlled Document

Controlled Documents are fundamental documents of the company (mainly organizational standards and requirements) whose complete lifecycle is controlled. This comprises:

  • creation

  • distribution

  • cancellation of validity

  • archiving.

Customer Order

Formal and binding assignment of the company by the customer to deliver products and/or services.

 

Documentation of QM System

The documentation of the quality management system consists of

  • Quality Manual (comprehensive documentation of the QM system, quality committment of management and staff, responsibilities, perspective of the organizational structure - no more mandatory since release 2015)

  • process organization (quality system procedures)

  • work instructions (realization on task level).

Inspection Plan

Within the Inspection Plan test procedures for ensuring the quality of supplies and the rendering of goods and services are planned.

Main input for the inspection plan is the quality planning.

 

Job Description

The Job Description describes a defined job. This comprises

  • qualification requirements

  • rights and duties

  • responsibilities

  • tasks

  • performance indicators for control of success

  • aso..

Planning for Quality

The Planning for Quality contains the quality attributes required for a product and/or service.

The instruments of quality planning consist of relevant company specific quality methodologies. It holds the targets for the inspection planning.

 

Process Architecture

Die Prozessarchitektur (Process Architecture) dokumentiert die Prozesslandschaft des Unternehmens mit allen Schnittstellen und Prozesskennzahlen zur Sicherstellung des reibungsfreien Zusammenspiels aller Prozesse.

 

Process Design

Das Prozessdesign beschreibt den Prozess gesamthaft. Dies umfasst

  • Verantwortlichkeit

  • Input

  • Output

  • Prozessschritten (Aktivitäten)

  • Schnittstellen

  • Prozesskennzahlen.

Prozessdesigns folgen den Vorgaben der Prozessarchitektur und des Prozessmanagements.

 

Process Documentation

The documentation of a business process contains at least

  • process owner

  • verbal short description of the process

  • goals of the process

  • process flow

  • process steps including responsibilities for execution and detailed descriptions

  • interfaces to other processes

  • performance indicators to control and monitor the process performance.

Process Landscape

The Process Landscape defines the connections of the main business processes on top level and of the underlying detail processes.

 

Quality System Procedure

Quality System Procedures are basic requirements for defined processes, their control and documentation.

 

Quality System Procedure Control of Defective Products and Services

The Quality System Procedure Control of Defective Products and Services defines all rules for the handling of goods and services which do not meet the quality requirements

  • products

  • identification marking

  • documentation

  • handling of these products

  • secured storage

  • definition of activities

  • services

  • documentation

  • handling of these services

  • definition of activities.

Quality System Procedure Control of Test Equipment

The Quality System Procedure Control of Test Equipment contains all processes, rules and methods to ensure defined maximum permissible values for the maximum absolute error of measurement of test equipment over its life-cycle.

 

Quality System Procedure Document Control

The Quality System Procedure Document Control describes all rules for handling of controlled documents

  • creation

  • checking

  • approval

  • distribution

  • entrainment

  • archiving.

Quality System Procedure Knowledge Management

The Quality System Procedure Knowledge Management defines the processes of knowledge management. This comprises criteria for

  • knowledge relevance

  • definition of responsibilities

  • categorization

  • indexing

  • validity

of documents.

 

Quality System Procedure Process Management

The Quality System Procedure Process Management defines the requirements to business processes, their design process and also the requirements to the process documentation.

 

Quality System Procedure Record Control

The Quality System Procedure Record Control describes all rules for handling of controlled records

  • creation

  • checking

  • approval

  • distribution

  • entrainment

  • archiving.

Quality System Procedure Risk Management

The Quality System Procedure Risk Management defines

  • the process of risk analysis

  • the methods for risk evaluation

  • the classification of risks

  • the processes for risk minimization respective mitigation.

Quality System Procedure Self Assessment

The Quality System Procedure Self Assessment describes the company specific processes, methods and measurement criteria for performing a self assessment.

 

Qualification Plan

The Qualification Plan documents the required qualifications of the organization on rolling basis.

Operative implementation is done by means of the training plan and the budgeting for qualification.

 

Quality Management Budget

The Quality Management Budget describes the the approved financial resources for the quality management as part of the company budget on a fiscal year basis.

 

Quality Management Manual

With the revision 2015 of the ISO 9000 the quality management manual is no more mandatory but may be used further.
 
Within the Quality Management Manual the intentions and targets of the management to ensure and optimize quality based upon the ISO 9001 standard troughout the company are documented. All relevant aspects of organizational structure, process organization and standards, regulations and procedures aso. as well are described. The quality managament manual itself is a mandatory instruction.

 

Quality Plan

The Quality Plan contains all requirements for the operationalization of the quality policy.

 

Quality Policy

The Quality Policy describes the superior ideas and orientation to quality of products and services of an organization, as formulated by the top management formally.

The Quality Policy is inseparable part of the company policy and strategy.

 

Training Plan

The Training Plan describes all planned qualification activities for the employees of the company.

 

Work Instruction

Work Instructions are detailed specifications for defined accomplishments, methods to use and documentation.

 

Work Instruction Calibration of Test Equipment

The Work Instruction Calibration of Test Equipment defines all necessary information for a for a specific test equipment. This comprises

  • infrastructure for calibration

  • reference standards

  • environmental conditions for the calibration

  • calibrating procedure

  • information about documentation and evaluation of results.

Work Instruction Customer Satisfaction Survey

The Work Instruction Customer Satisfaction Survey contains the requirements for the execution of the survey, especially the questionnaire.

 

Work Instruction Evaluation of Maturity

The Work Instruction Evaluation of Maturity defines all rules for the evaluation of the maturity of the quality management system, especially the catalogue of criteria.

 

 

Measures for the quality management system

 

Audit Plan

The Audit Plan carries the relevant planning data for a particular audit. This comprises:

  • time frame

  • audit type

  • involved persons

  • auditors

  • aso. .

Audit Planning

The Audit Planning contains the yearly planning and scheduling of audits for the separate organizational units of the company.

Based upon particular occurring discrepancies a replanning during the planning period is possible.

 

Budget Requirement for Quality Management

The Budget Requirement for Quality Management describes the prognosis of expected expenses for quality management on a fiscal year basis.

 

Change Request for Process Architecture

A change request for process architecture is placed to the process management in case the implementation or modification of a business service is not possible or causes a reduction of quality standards based upon the actual process architecture.

 

Corrective Action

Corrective Actions are defined activities to eliminate a deficiency

  • in quality management system

  • in processes

  • in products and/or services

  • controlled by quality management.

They carry a status of urgency

  • immediate action

  • to be performed as part of the portfolio of activities for the quality management system.

External Corrective Action

External Corrective Actions are defined activities to eliminate a deficiency

  • in quality management system

  • in processes

  • in products and/or services

  • of a supplier controlled by quality management.

They carry an urgency status

  • immediate activity

  • activity to be performed as part of the portfolio of activities.

External Preventive Action

External Preventive Actions are defined activities to avoid the reoccurrence of deficiencies

  • in quality management system

  • in processes

  • in products and/or services
    of a supplier controlled by quality management.

The carry an urgency status

  • immediate activity

  • activity to be performed as part of the portfolio of activities.

Preventive Action

Preventive Actions are defined activities to avoid the (re)occurrence of a deficiency

  • within the quality management system

  • in processes

  • in products and/or services

controlled by the quality management. They carry a status of urgency

  • immediate action

  • to be performed as part of the portfolio of activities for the quality management system.

Recommendation for Process Quality Improvement

Trigger for the optimization of the quality of company wide processes as input for the process review.

 

Request for IT system modification

The Request for IT system modification (Request for Change) is a formal request to perform a change required for all types of changes not defined as release free standard change.

 

Supplier Audit Planning

The Supplier Audit Planning contains the yearly planning and scheduling of audits for the separate suppliers of the company.

Based upon particular occurring discrepancies a replanning during the planning period is possible.

 

 

Documentation of quality management happenings and results

 

Appraisal Interview Protocol

The Appraisal Interview Report contains all information from the periodic appraisal interview. This comprises

  • targets

  • target agreements

  • performance appraisals

  • miscellaneous agreements

It is created on consensus basis between employee and line manager signed by both of them.

 

Audit Protocol

The Audit Protocol documents the immediate results of the audit.

 

Business Case

A Business Case investigates a certain scenario in consideration of the rentability of an investment opportunity.

It is used for the presentation and weighting of predicted economic and strategic effects of the investment, comparing different possible realizations. One option always is keeping the actual situation (no investment).

 

Complaint Register

Holistic documentation of all customer complaints including status information.

 

Controlled Record

Controlled Records are fundamental documentations of the company (mainly of (intimistic) results of service provision and control), whose complete life-cycle is controlled. This comprises

  • creation

  • distribution

  • archiving.

Fault Protocol

Within the Fault Protocol

  • the deficiency of a product respective a service

  • all steps of treatment of the deficient product repective service

are documented.

 

Fulfillment for IT system modification

The fulfillment for the modification of IT systems confirms that the change has been implemented in accordance with the requirements.

 

Improvement Register

Holistic catalogue of all improvement initiatives planned and actually under realization including actual status information. This includes:

  • corrective actions (elimination of deficiencies)

  • preventive actions (avoiding recurrences of failures)

  • optimization actions (detected improvement potentials especially regarding the maturity)

  • development actions (extension of the quality management system)

  • maintenance actions (adaptions without deficiency in behind).

An entry in the Improvement Register always comprises a deposit copy according to the quality system procedure for document and record control.

 

Quality Management Forecast

The Quality Management Forecast describes the estimation of economic results for the quality management based upon actual costs (and as appropriate earnings) of previous fiscal periods within a budgeting period looking foreward to the end of the budgeting period.

 

Quality Record

Quality Records provide information about the accomplishment of the company performance and the effectivity of the quality management system.

It is especially emphasized that the documents prove the execution of defined controls and that the control results have been that satisfying, that the checked goods and services are released for further processing.

 

Quality Relevant Occurrence

A Quality Relevant Occurrence is an event related to

  • the quality management system

  • processes

  • products and services

  • requiring immediate check for necessary corrective respective improvement activities.

Report Certification Audit

The Certification Audit Report describes the results of the certification audit by the external certification organization

  • rating

  • findings

  • improvement advice.

Report Correction and Prevention

The Correction and Prevention Report contains all relevant information about planned and ongoing corrective respective prevention activities.

 

Report Customer Satisfaction

The Customer Satisfaction Report carries a detailed evaluation and analysis of the results of the regular customer satisfaction survey.

 

Report External Audit

The External Audit Report documents the execution and the results of quality audits performed by external auditors

  • system audits

  • process audits

  • product audits

It contains requirements respective proposals for improvement and correction in case of detected deficiencies respective improvement potentials.

 

Report Internal Audit

The Internal Audit Report documents the execution and the results of internal quality audits

  • system audits

  • process audits

  • product audits

It contains requirements respective proposals for improvement and correction in case of detected deficiencies respective improvement potentials.

 

Report Management Review

The Management Review Report documents the results of the management review. This includes

  • the effectivity of the quality management system

  • development potentials.

Report Maturity

The Maturity Report documents the results of the periodic review of maturity for the quality management system.

 

Report Process Performance

The Process Performance Report documents the values for the performance indicators defined for the process on a periodical basis compared with the defined goals and detected deficiencies as well.

 

Report Process Review

The Process Review Report documents the results of the Process Reviews. This with (as appropriate)

  • process maturity

  • benchmarks

  • weaknesses

  • potentials for optimization.

Report Quality Management

The periodic Quality Management Report contains complete information about the quality situation and the effectivity of the quality management system. This comprises

  • changes of the quality management system

  • status of quality goal achievement

  • status of employee qualification

  • customer satisfaction and reclamations

  • internal audits

  • status of certification

  • audits by customers

  • other miscellaneous quality information

  • status of activity planning for quality

  • control of test equipment.

Besides the company strategy is is a major input for the definition of the quality policy and the further development of the quality management system.

 

Report Self Assessment

The Self Assessment Report documents the execution and the results of self assessments. This for

  • the quality management system

  • processes

  • products and services.

In case of detected deficiencies respective improvement potentials it documents requirements and proposals for improvement.

 

Report Supplier Audit

The Supplier Audit Report contains the results of the supplier audit and evaluates the quality capability of the supplier.

Additionally it contains requirements for improvement and correction in case of detected deficiencies.

 

Risk Log

The Risk Log is a rated catalogue of identified (conformity) risks and accordingly defined activities for minimization and mitigation.

 

Supplier Rating

The Supplier Rating is a method of business economics for systematic evaluation of supplier's performance according to defined criteria.

The focus lies on optimization of supplier relation to optimize the products and/or services to be procured according to company specifically defined criteria also.

 

Test Equipment Database

The Test Equipment Database contains the data of all test equipment. This comprises

  • type

  • purpose

  • manufacturer

  • status (released, repair, calibration, disabled, removed)

  • adjustment data

  • calibration data

  • reference standards

  • work instruction for the calibration of the test equipment.

An entry in the test equipment database means as well the archiving of the deposit copy according to the quality system procedure for document and record control.

 

Test Report

The Test Report carries the information of a performed operational quality test.

 

Training Record

The Training Record documents all performed qualification activities for a certain employee.

It is maintained by human resource department.


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Last update 2024-02-24 

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