This document contains a description of the norm elements of ISO 9001:2000, as well as the manner in which Litecad B.V. fulfills the requirements of the norm. The number and title of the respective paragraph of the norm are every time mentioned first after the norm element. After that follows the specific implementation by Litecad B.V.
4 Quality Management System
4.1 general requirements
Requirement: The organization has devised and documented a Quality Management System. It has been introduced into the organization and shall be maintained and continuously improved according to the requirement of the International Norm ISO 9001:2000.
The organization has executed the following activities for the introduction of the Quality Management System:
a) The processes of the Quality Management System have been identified;
b) The order and interaction of the processes have been determined;
c) The criteria and methods have been determined for the effective execution and control of these processes;
d) Secure the availability of the means and information that are necessary for the support and monitoring of the execution processes;
e) The processes are measured, supervised and analysed and the appropriate measures are taken to achieve the planned results and to make continuous improvements;
f) Has introduced the measures that are necessary to achieve the planned results and continuous improvement of the processes.
The processes that are refered to, are being fully controlled by the organisation in a manner according to the requirements of the International Norm ISO 9001:2000.
Specific implementation by Litecad B.V.: Litecad B.V. has identified the processes of its Quality Management System, and documented the order and interaction : see the process model in Chapter 4 of this Quality Manual.
In Chapter 4 (process models) the criteria and methods of the relevant processes have been determined and these are measured with the aid of (Key) Process Performance Indicators (KPI’s).
It has been indicated in the process models, the informations that form the basis for the management of the processes.
The defined processes are measured, monitored and analysed as indicated in the process models.
Continuous improvements are assessed on the operational level in the various meetings (see paragraph 2.4 of the Quality Manual) and for the complete system in procedure: 4.1 Execution of Management Assessment.
4.2 requirements of the Quality Management System documentation
4.2.1 general
Requirement: The documentation of the Quality Management System contains:
a) A Policy Statement in writing and Quality Goals in writing;
b) A Quality Manual;
c) The written procedures prescribed by ISO 9001:2000;
d) All documents that the organization needs for the effective planning, execution and management of its processes.
e) Quality registrations as required by ISO 9001:2000.
Specific implementation by Litecad B.V.: Litecad B.V. has written a Quality Manual that specifies the Quality Policy and defines the organization and the models of the work processes. The corresponding procedures, as well as an overview of the pertaining work instructions and the forms that can be found in the Attachments of this Manual.
4.2.2 quality manual
Requirement: The organization shall develop and maintain a Quality Manual that contains:
a) The scope of the Quality Management System inclusive the details and motivation for any exclusion;
b) The documented procedures that have been developed for the Quality Management System, or a reference to such procedures;
c) A description of the interaction between the various processes of the Quality Management System.
Specific implementation by Litecad B.V.: These requirements are met by the creation of this Quality Manual.
4.2.3 control of documents
Requirement: The documents required for the Quality Management System, shall be controlled. A Quality Registration is a specific form of document, and shall be controlled according to paragraph 4.2.4 (of the ISO norm 9001:2000).
A written procedure shall be created to define the necessary control, in order to:
a) Be able to approve the suitability of documents prior to their use;
b) Assess documents and, if necessary, modify them and approve them again;
c) Ensure that modifications and the actual revision status of documents are specified;
d) Ensure that the relevant versions of applicable documents are available at the work place;
e) Ensure that documents remain readable and recognizable;
f) Ensure that documents of external origin are identified, as well as to ensure that their distribution is controlled;
g) prevent the unintended use of superseded documents, as well as to apply a suitable identification to superseded documents that are stored for certain reasons.
Specific implementation by Litecad B.V.: A special procedure was created for the control of documents, namely procedure 2.1: Control of documents and data
4.2.4 control of quality registrations
Requirement: Quality Registrations shall be made and maintained in order to fulfil the requirements of the Quality Management System, as well as to be able to demonstrate the effectiveness of the Quality Management System.
Quality Registrations shall be readable, recognizable and retrievable. Within the Quality Management System a procedure was created for the identification, storage, retrieval, protection, archiving and destruction of Quality Registrations.
Specific implementation by Litecad B.V.:
A special procedure was created for the control of Quality Registrations: 2.2: Control of Quality Registrations.
Litecad B.V. has made a listing of the Quality Registrations that are generated and maintained in the various processes of the Quality Management System.
5 Responsibility of management
5.1 commitMENT OF management
Requirement: The management of the organization can demonstrate its commitment in the development, introduction and continuous improvement of the Quality Management System by:
a) To make the organization conscious of the importance of meeting the requirements of the clients, as well as the statutary and legal requirements;
b) Formulating a Quality Policy;
c) Ensuring that Quality Goals are defined;
d) Executing Management Evaluations;
e) Ensuring the availability of means and resources;
Specific implementation by Litecad B.V.: Litecad B.V. has the necessary procedures at its disposal, in which these subjects are treated, namely: 4.1 Execution of management evaluation, 4.2 Creation and Revision of the Annual Plan
5.2 client satisfaction
Requirement: The management ensures that it is clearly determined in the operational processes what the client requirements are and that these are fulfilled to achieve client satisfaction. The client’s requirements shall be translated into clear requirements for the organisation. The fulfilment of these requirements shall ensure the desired and needed level of client satisfaction.
Specific requirement by Litecad B.V.: Translating the needs and expectations of the client (including the compliance with the relevant applicable laws and regulations for the products to be delivered) into an actual realization of the services for the client is being handled in the procedures
1.1 Handling a request for outplacement
1.2 Signing an outplacement contract.
Litecad B.V. determines which specific laws and regulations are applicable to its services. The current state of affairs with respect to the specifically applicable laws and regulations is found in paragraph 2.9 of this Quality Manual.
5.3 Quality policy
Requirement: The management has created a general Quality Policy and has, during its formulation, taken the following aspects very seriously into account:
a) That the policy is in accordance with the organisation’s goals;
b) The obligation to fulfil client related requirements and to pursue continuous improvement;
c) That it contains a framework for the creation and assessment of Quality Goals;
d) That the policy is published and understood by the relevant groups of the organization;
e) That the policy is evaluated for its continuous suitability.
Specific implementation by Litecad B.V.: The Quality Policy of Litecad B.V. is based on Litecad B.V.’s Policy Statement, as stated in Chapter 1 of this Quality Manual. The organization is informed on the Quality Policy as follows: See the meeting structure that is described in Chapter 6 of this manual: - Personnel meeting
- Assessment meetings
- Inspections of the work place
The performance and the effectiveness of the Quality Management System are assessed during the Management Assessment. (See procedure : execution of Management Assessment.) During this assessment also the progress and effectiveness of the existing Quality Goals are evaluated and new Quality Goals for Litecad B.V. are defined, in order to achieve continuous improvement.
5.4 Planning
5.4.1 quality goals
Requirement: The top management ensures that the Quality Goals, including those that involve the realization of the product, are determined on the relevant positions and levels within the organization. The Quality Goals are measurable and in accordance with the Quality Policy.
Specific implementation by Litecad B.V.: The measurable Quality Goals are determined as a part of the Management Assessment and are made known to the organization. The necessary resources are determined and the persons responsible are appointed. A specific implementation plan is made whenever required.
See also the procedures: 4.1 Execution of Management Assessment, 4.2 Creation and Revision of the Annual Plan
5.4.2 Planning of the Quality Management System
Requirement: The top management ensures that:
a) The planning of the Quality Management System is executed in order to meet the Quality Goals as well as to meet the general requirements of the Quality Management System. See § 4.1;
b) The integrity of the Quality Management System is maintained when modifications of it are planned and executed.
Specific implementation by Litecad B.V.: See the procedures: 4.1 Execution of Management Assessment, 4.2 Creation and Revision of the Annual Plan, 4.3 Execution of preventive measures
5.5 responsibility, competences and communication
5.5.1 responsibility and hierarchy
Requirement: The top management ensures that the responsibilities, competences and their mutual relations are determined and made known within the organization.
Specific implementation by Litecad B.V.: The core tasks for each function have been listed in paragraph 4.3 of the Quality Manual of Litecad B.V. The organogram is found in paragraph 2.2.
Communication with respect to organization, responsibilities and competences is done according to the structure given in Chapter 6 of this manual.
5.5.2 representative of management
Requirement: The top management appoints a member of the management who, regardless of other responsibilities, has the responsibility and the competence to:
a) Ensure that the processes that are necessary for the Quality Management System are initiated, introduced into the organization and maintained.
b) Report to Top Management on the performance of the Quality Management System and the need to improve it.
c) Ensure that the (Quality-) awareness of the whole organization in order to meet client requirements is stimulated.
Specific implementation by Litecad B.V.: The representant of the management within Litecad B.V. is the Quality Manager. His responsibilities and competences have been defined in the summary of his core tasks in paragraph 4.3. In this summary the determination and maintenance of processes, the reporting on the performance of the Quality Management System, the need to improve as well as the stimulation of Quality Awareness in all levels of the organization are described.
Reference is made to the summary of core tasks in paragraph 4.4 of this Quality Manual, where the tasks and responsibilities of the Quality Manager are described in detail.
5.5.3 internal communication
Requirement: The top management ensures that suitable communication processes are initiated within the organization, and that communication proceeds with respect to the effectiveness of the Quality Management System.
Specific implementation by Litecad B.V.: The internal communication structure among the various levels and functions of the organization and related to the processes of Litecad B.V. has been recorded in Chapter 6 “Communication Structure” of this Quality Manual.
There it is explicitly mentioned when (in which meeting) and how the importance and/or the functioning in terms of the effectiveness of the Quality Management System are evaluated.
5.6 assessment by the management
5.6.1 general
Requirement: A specific procedure addresses the assessment and assurance of the continuous suitability, adequateness and effectiveness of the Quality Management System.
Specific implementation by Litecad B.V.: This procedure is found in procedure: 4.1 Execution of Management Assessment
5.6.2 Input for the assessment
Requirement: The input for the Management Assessment contains information about:
a) Results of audits;
b) Responses of clients;
c) The performances of processes and product compliance;
d) The status of preventive and corrective measures;
e) Actions following from previous Management Assessments;
f) Planned modifications that may influence the Quality Management System;
g) Proposals for improvement.
Specific implementation by Litecad B.V.: Reference is made to procedure: 4.1 Execution of Management Assessment
5.6.3 Output of the assessment
Requirement: The output of the Management Assessment contains all decisions and (planned) actions with respect to:
a) Improvement of the effectiveness of the Quality Management System and its related processes;
b) Improvement of products with regard to client requirements;
c) The need for means.
Specific implementation by Litecad B.V.: Reference is made to procedure: 4.1 Execution of Management Assessment
6 Management of resources
6.1 availability of resources
Requirement: The organization determines which are the necessary resources and makes them available:
a) To implement the Quality Management System, to maintain it and to improve its effectiveness continuously;
b) To obtain client satisfaction by fulfilling the requirements of the client.
Specific implementation by Litecad B.V.: The Quality Manager is responsible for the supervision, maintenance and improvement of the Quality Management System. He determines the necessary resources and assigns them.
The outplaced employee is primarily responsible for obtaining client satisfaction. The General Manager supervises the continuous fulfillment of requirements, wishes and expectations of clients, by means of the activities described in this procedure: 3.1 Management of outplacement
6.2 Human resources
6.2.1 general
Requirement: All employees, whose work may influence product quality, possess the necessary competence on the basis of relevant education, training, abilities and experience.
Specific implementation by Litecad B.V.: The manner in which Litecad B.V. handles the determination and evaluation of competences and the need for training within the organization, as well as the assessment of the effectiveness of the given training, has been described in the procedures concerning Personnel and Organization: 2.3 Execution of education and training, 2.4 Conducting Evaluation Meetings, 2.5 Management of Personnel Files
Competences are recorded in de CV’s of the employees, which are updated annually.
6.2.2 competence, awareness and training
Requirement: The organization takes care that:
a) The necessary competences are determined for those employees who influence product quality;
b) Training is offered or other activities are organized to fulfill the educational requirements;
c) The effectiveness of these activities is evaluated;
d) It is ensured that all relevant employees are aware of the relevance and the importance of their activities, and how these contribute to the realization of the Quality Goals;
e) Appropriate records are kept of education, trainings, competences and experience (see also 4.2.4)
Specific implementation by Litecad B.V.: Reference is made to the procedures with regard to Personnel and Organization: 1.4 Introduction of new employee
To advocate the quality awareness there exists an introduction programme for new employees, consisting of the Introductory Steps at Litecad and the Introduction to the client.
6.3 facilities/infrastructure
Requirement: The organization shall determine the necessary facilities, make them available and maintain them for the realization and maintenance of the product conformity. Such facilities are e.g.:
a) Buildings, work space and related facilities;
b) Equipment - including hardware and software - for the realization of the processes;
c) Supporting services, such as transport and communication facilities.
Specific implementation by Litecad B.V.: Litecad B.V. produces an annual plan in which the requirement for infrastructure is determined. See the procedure: 4.2 Creation and Revision of the Annual Plan
6.4 work environment
Requirement: The organization determines the human and physical aspects of the work environment that are necessary for the realization of the product conformity and manages them.
Specific implementation by Litecad B.V.: See Chapter 9 of this Quality Manual. At the conception of the service, sufficient attention is paid to the RI&E of the company in question. It is ensured that the requisite measures are taken by means of the discussion of the Evaluation Report RI&E Management. See procedure: 1.4 Introduction of new employee
7 Realisation of Product
7.1 Planning of the realization processes
Requirement: The realization of the product consists of the sequence of processes and sub-processes that are required to obtain the product.
Specific implementation by Litecad B.V.: The interrelations of the various realization processes within Litecad B.V. have been recorded in Chapter 13, Process model.
The organization determines specifically for the contract or client the following aspects for the benefit of the outplacement process:
a) The individual Quality Goals;
b) The need to provide special facilities;
c) The necessary verification- and validation activities, if required;
d) The criteria for acceptability of the provided service.
See the procedures: 1.1 Handling of a request for outplacement, 1.2 Signing an outplacement contract, 1.3 Signing a job contract, 1.4 Introduction of new employee
The required registrations - whenever applicable - are indicated in the mentioned procedures and have been summarized in the summary list of Quality Registrations.
7.2 client related processes
7.2.1 determination of the client requirements
Requirement: The organization shall determine:
a) The requirements of the client, including those related to the delivery and the activities after the delivery of the product;
b) Requirements and expectations related to the required or intended use, which have not been explicitly mentioned by the client;
c) Specific requirements due to e.g. legal obligations and regulations;
d) Any other additional requirements that have been identified by the organization.
Specific implementation by Litecad B.V.: Litecad B.V. registers the client requirements specifically for each client. This may happen in the form of an offer, but more generally it is in the form of an outplacement contract.
Reference is made to the following procedures for more details: 1.1 Handling of a request for outplacement, 1.2 Signing an outplacement contract
7.2.2 assessment of product requirements
Requirement: The organization shall assess all indentified requirements with regard to the product. This shall be done before notifiying the client of the delivery of the product, in order to ensure that: The product requirements are well defined;
Deviations between the requirements of the contract or order and those formulated earlier by the client are resolved;
The organization is capable of fulfilling the requested requirements.
Records of the results of this assessment or, if necessary, any consequential measures shall be kept (see 4.2.4). See also the Request for Outplacement form.
The organization shall confirm the requirements of the client prior to accepting the order in case the client does not hand over written requirements.
The organization ensures that the relevant documents are updated in case the requirements are modified. The organization ensures that the involved personnel is informed of the modified requirements. For an organization like Litecad B.V. this will hardly occur. Every contract is a specific contract.
Specific implementation by Litecad B.V.: All the client product requirements, as well as additional requirements that have been formulated by Litecad B.V., are assessed before a commitment for delivery is made.
See the procedures: 1.1 Handling a request for outplacement, 1.2 Signing an outplacement contract.
Contracts are assessed and signed by the General Manager. The signing of the contract is communicated to the organization via the Outplacement Contract.
A new bid will be made, if necessary, in case of changing of an order. The Office Manager or the General Manager ensures that the modified requirements are communicated in the organization to the involved employee in the applicable meetings.
7.2.3 communication with the client
Requirement: The organization shall determine effective means of communication with the client and implement them, in order to communicate on the subjects of :
a) Product information;
b) Bids/contracts or order handling, including changes and additions
c) Feedback to the client (including complaints)
Specific implementation by Litecad B.V.: The General Manager is wholely responsible for the communication with the client during the complete duration of the outplacement contract. See the procedures: 3.1 Management of Outplacement, 3.2 Writing Outplacements reports
NB. Design aspects are not applicable to Litecad B.V.
7.4 procurement
7.4.1 managing procurement
Requirement: The organization manages its procurement processes to ensure that the procured product meets the requirements. The kind and the amount of management and control depend on the subsequent realization processes and their output.
The organization shall assess its suppliers and select them on the basis of their ability to provide a product that conforms to the requirements of the organization. Criteria shall be determined for selection and periodical assessment. Records of the results of the assessments and subsequent measures shall be kept. (See 4.2.4)
Specific implementation by Litecad B.V.: The procurement activities are limited to the signing of job contracts with employees.
This process has been described in procedure: 1.3 Signing a job contract
Assessment is made on two levels: Process level 1.6 Evaluation of outplacement, Individual level 2.4 Conducting Evaluation Meetings
7.4.2 procurement information
Requirement: The product to be procured, shall be described in the procurement documents; this description includes (as far as relevant for the product or service to be procured):
a) The requirements for approval or qualification of: product, procedures, processes, equipment and personnel;
b) The requirements related to the qualifications of the personnel;
c) The requirements related to the Quality Management System.
The organization establishes the sufficiency of the requirements, as formulated in the procurement documents, prior to forwarding the documents to the supplier.
Specific implementation by Litecad B.V.: See for this specific implementation by Litecad B.V. the procedures: 1.3 Signing a job contract
7.4.3 verification of procured products
Requirement: The organization determines which activities are required for verification of the procured products, and supervises the execution of these activities.
In case the organization or its client wishes to perform verification activities in the premises of a supplier, the organization shall specify the intended verification procedures and the method of product delivery in its procurement information.
Specific implementation by Litecad B.V.: See for the specific implementation the procedures: 1.6 Evaluation Of Outplacement, 2.4 Conducting Evaluation Meetings
7.5 production and service activities
7.5.1 Management of production and service activities
Requirement: The organization shall manage its production and service activities by:
a) Making information available in which the properties of the product are specified;
b) Making available work instructions, where necessary
c) Taking care that the suitable equipment for production and service activities is used and maintained;
d) Ensuring the availability and use of apparatus for measurement and monitoring;
e) Introducing monitoring activities;
f) The implementation of defined processes for approval, delivery and applicable activities after delivery.
Specific implementation by Litecad B.V.: The management of the operational activities has been generally indicated in the process model with accompanying descriptions in Chapter 13 of the Quality Manual.
Furthermore, Litecad B.V. makes use of Performance Indicators (PI’s) to measure and monitor the progress of the operational process.
Litecad B.V. uses following PI’s: Nmber of clients
Number of employees
Percentage of illness
Percentage of overhead hours
Reporting of these PI’s takes place as follows: 3.2 Writing outplacement reports, 4.4 Writing company reports
7.5.2 Validation of processes related to production and services
Requirement: The organization shall determine if there are production and service processes for which the resulting output cannot be verified by measurement or monitoring. This applies to processes in which deviations only come to light after the product has been put to use or after the service has been delivered.
Validation shall demonstrate that the processes will achieve the planned results.
The organization shall determine the necessary precautions for this validation, which includes the following aspects (if applicable):
a) The qualification of the processes;
b) The qualification of equipment and personnel;
c) The use of well-defined methods and procedures;
d) Requirements for records (see 4.2.4);
e) Renewed validation.
Specific implementation by Litecad B.V.: Specific validation of processes is only partly applicable to Litecad B.V..
Services are periodically evaluated and managed. See the procedures: 1.6 Evaluation of outplacement, 3.1 Management of outplacement, 3.2 Writing outplacement reports, 3.4 Performing inspections of the work place
7.5.3 identification and traceability
Requirement: The organization shall apply identification of the product - as far as applicable - with suitable methods, in all stages of the production and service process.
The organization indicates the status of the product with respect to the requirements for measurement and monitoring.
The organization takes care of management and registration of a unique identification of the product, whenever traceability is required (see 4.2.4).
Specific implementation by Litecad B.V.: Every contract is individually registered and supervised by means of the Summary of Outplacement Contracts. See procedure: 1.2 Signing an outplacement contract
7.5.4 property of the client
Requirement: The organization handles the property of the client very carefully, whenever these are used or controlled by the organization. The organization shall identify, verify, protect and maintain the property of the client that is supplied for use or incorporation into the product. In case property of the client has been lost, damaged or in any other way become unsuitable for use, this will be recorded and reported to the client (see also 4.2.4).
Specific implementation by Litecad B.V.:
Each job contract with an employee specifies the manner in which the employee shall treat the property (including know how of the company) of the client.
See procedure: 1.3 Signing a job contract
7.6 management of measurement and monitoring means
Requirement: The organization determines which measurements shall be performed and which measurement and monitoring means are necessary to check if the product meets the agreed requirements (see 7.2.1)
The organization shall create processes to ensure that monitoring and measurement can be performed in a manner that is in agreement with the measurement requirements.
The measurement means are managed as follows (whenever applicable) :
a) The measurement means are calibrated and adjusted periodically, or prior to use, with the help of provisions that are traceable to national or international standards. The basis for calibration shall be recorded in case no specific standard is available;
b) The measurement means shall be modified if necessary;
c) The measurement means are protected against any adjustment that would make the measurement invalid;
d) The measurement means are protected against damage or deterioration during usage, maintenance and storage;
The organization shall moreover (in case this appears necessary) assess and record the validity of previous results, if it appears that measurement and monitoring means do not meet the requirements.
The organization shall take suitable measures with respect to these means and to the product that was influenced by it.
Records shall be kept of the results of calibration and verification (see 4.2.4).
The software that is used for measurement and monitoring of the specified requirements shall be validated before use. This shall take place prior to first use and be repeated if necessary.
Specific implementation by Litecad B.V.: The measurement and monitoring of the outplacement process is organized in the following procedures: 3.1 Management of Outplacement, 3.2 Writing Outplacement Reports
8 Measurement, analysis and improvement
8.1 general
Requirement: The organization shall plan the implementation of the monitoring, measurement, analysis and improvement processes that are necessary in order to:
a) Demonstrate product conformity;
b) Ensure conformity of the Quality Management System
c) Continuously improve the effectiveness of the Quality Management System.
This shall also include the determination of the suitable methods, as well as the statistical techniques and the scope of their use.
Specific implementation by Litecad B.V.: See procedures: 3.1 Management of Outplacement, 3.2 Writing Outplacement Reports, 3.3 Handling Deviations
8.2 Measurement and monitoring
8.2.1 client satisfaction
Requirement: The organization shall make and maintain an inventory of the information related to the perceptions of clients, as well as the degree in which the client’s requirements are fulfilled. Methods have been established for acquiring and handling this information.
This shall be one of the methods that the organization uses to measure the functioning of the Quality Management System.
Specific implementation by Litecad B.V.: See procedure: 1.6 Evaluation of Outplacement
8.2.2 Internal Audit
Requirement: The organization periodically performs planned internal audits to determine if the Quality Management System satisfies the requirements of the norm and has been effectively introduced and is being maintained.
An audit programme is made, taking into account the status and the importance of the activities and the results of previous audits. For every audit the scope, frequency and method are determined. Personnel who do not have a direct responsibility for the activity being audited conduct the audits.
The responsibility and the requirements for the planning and execution of audits, including the reporting and the supervision of the corresponding records, shall be recorded in a written procedure.
The responsible management shall take timely corrective action to remove deviations, which have come to light during the audits, as well as their causes. Any consequential measures shall include the implementation of the corrective measures and the reporting of the verification results.
Specific implementation by Litecad B.V.: A documented procedure with respect to internal audits has been incorporated as procedure 4.5 as an attachment to this Manual.
In this procedure it has been indicated in which manner Management takes measures with respect to the deviations that were found in an internal audit.
8.2.3 measurement and monitoring of processes
Requirement: The organization disposes of suitable methods for monitoring and if applicable, measuring the processes of the Quality Management System for the benefit of the client. The methods confirm that the processes are capable of attaining the desired goal of these processes. Suitable corrective measures shall be taken to ensure the conformity of the product, in case the planned results are not obtained.
Specific implementation by Litecad B.V.: 3.1 Management of outplacement, 3.2 Writting Outplacement Reports, 3.3 Handling Deviations, 3.4 Performing inspections of the work place
8.2.3 Measurement and monitoring of the product
Requirement: The product properties are measured and monitored during the entire operational process in order to determine if the product fulfils the predefined requirements. This is done at suitable moments during the realization process and in conformity with the planned provisions.
Records are kept to demonstrate that the product fulfils the predefined criteria of acceptance. A registration shall indicate which employee is authorized to release the product (see 4.2.4).
The release of products and the delivery of services shall not proceed until all planned provisions have been passed, unless an authorized person and, whenever applicable, the client has approved the release in another way.
Specific implementation by Litecad B.V.: 3.1 Management of outplacement, 3.2 Writing Outplacement Reports, 3.3 Handling Deviations
8.3 management of non-conforming products
Requirement: The organization ensures that a product that does not fulfil the predefined requirements is identified in such a way that unintended use or unintended delivery is prevented.
It shall be recorded in a written procedure how to handle the management, responsibilities and authorizations with respect to non-conforming products.
The organization shall handle deviations in one of the following manners:
a) By taking measures in order to remove the deviation observed;
b) By allowing use, release or conditional acceptance by an authorized person, or whenever applicable, by the client;
c) By taking measures in order to prevent or exclude unintended use.
Records shall be kept of the nature of the deviations and of all the consequential measures, including directly taken measures (see 4.2.4).
Specific implemenation by Litecad B.V.: Reference is made to procedure: 3.3 Handling Deviations
8.4 analysis of data
Requirement: The organization collects and analyses relevant data in order to assess the suitability and effectiveness of the Quality Management System and to indicate possible improvements.
The data are analysed in order to obtain information on:
a) Client satisfaction and/or client dissatisfaction
b) Conformity to product requirements
c) Properties of products, processes and trends involved
d) Suppliers
Specific implementation by Litecad B.V.: Reference is made to procedure; 4.1 Execution of Management Assessment.
All data that are relevant for the assessment of the suitability and effectiveness of the Quality Management System are collected and analysed as described in this procedure.
Reference is made to the following procedures for the collection and analysis of data with respect to suppliers: 3.2 Writing Outplacement Reports, 4.4 Writing company reports
8.5 improvement
8.5.1 continuous improvement
Requirement: The organization has planned the necessary processes and shall manage them for the continuous improvement of the Quality Management System.
For the assessment of the continuous improvement, use shall be made of documents and records that are present in the organization, such as: Quality Policy, Quality Goals, results of audits, analysis of data, corrective and preventive measures, as well as the Assessment by the Management.
Specific implementation by Litecad B.V.:
The subject of Continuous Improvement is placed on the agenda of meetings and Management Assessment, in which the results of previously formulated Quality Goals and/or previously taken improvement measures are evaluated. New Goals and measures are initiated.
See procedure: 4.1 Execution of Management Assessment, 4.4 Writing company reports
8.5.2 corrective measures
Requirement: The organization takes corrective measures to remove the cause of non-conformity and to prevent repetition. The measures shall be in agreement with the consequences of the reported problems. In the procedure the requirements have been recorded with respect to:
a) Assessment of the non-conformity (including complaints of clients);
b) The determination of the cause thereof;
c) Assessment of the measures to prevent repetition;
d) Determination and execution of corrective measures;
e) Registration of the results of the applied measures;
f) Assessment of these results.
Specific implementation by Litecad B.V.: Reference is made to procedure: 3.1 Management of Outplacement
8.5.3 preventive measures
Requirement: The organization determines which preventive measures are necessary to remove the cause of possible non-conformities, before it occurs. The preventive measures are directly related to any consequences of potential problems.
The following requirements for preventive measures have been incorporated in the procedure:
a) Identification of the possible non-conformity and its causes ;
b) Assessment of the necessity to take measures;
c) Determination and introduction of the necessary preventive measures;
d) Registration of the results of the applied measures (see 4.2.4);
e) Assessment of the applied preventive measures.
Specific implementation by Litecad B.V.: Reference is made to procedure: 4.3 Execution of preventive measures