CONSCERT publications : EN ISO 9002 Guidelines for use by the Steel Manufacturing Industry
Guidelines for use of EN ISO 9002 Quality systems in the industry for production of prestressing steel
Traceability (EN ISO 9002)


This is revision 3 of the guide-lines published by CONSCERT, the European association of certification bodies active in the field of constructional steel. The revision became necessary after the publication of edition 1 the ISO 9000 series standard in July 1994. The revision was issued one year later in order to ensure that the national translations could be available and understood by the members of the Working Group.

The main objective of these guide-lines is to help provide a common interpretation of EN ISO 9002 for certification bodies and auditors within those bodies. It also provides a guide-lines for companies which approach ISO 9000 standards for the first time or may desire to obtain certification against these standards.

It should be noted that these guide-lines do not replace the above standard but should be used in conjunction with it.



4.1.1 Quality Policy

The manufacturer should formulate a Quality Policy which should be present as an introduction to their Quality Manual and be endorsed by the Senior Executive of the company thereby illustrating to all those concerned with the document and its contents that commitment to quality comes from the top.

The policy, as written, should be simple. Its relevance to the operation of the company should be illustrated wherever possible by reference to the goals relating directly to the quality of the product.

The quality policy should make reference to the manufacturer's commitment to satisfying, as a minimum, the requirements of EN ISO 9002.

The manufacturer must ensure that the policy is understood throughout the organisation. It must therefore make it available to all. There may be many ways of doing this in practice one of which may be to introduce it into a structured training programme for employees and certainly include it in any induction training course presented to new employees.

4.1.2 Organisation4.1.2.1 Responsibility and Authority

The manufacturer's documented quality system should give a clear definition of the responsibilities of all personnel whose roles affect product quality. The roles described may not seem immediately linked to product quality but will be important in maintaining long term consistency of product quality. Examples include Order Processors, Internal Auditors, Purchasing Staff and Sales Staff.

Such definitions should also clearly illustrate the important interfaces between such staff. This may be achieved by the use of an organisational chart and/or more fully in individual role descriptions.

The manufacturer should clearly define the management representative for quality matters and illustrate that this person is responsible to Senior Management. This acts to illustrate that full credence is given to quality from the top. Resources

The manufacturer should ensure that there are sufficient resources available to provide for management and performance of all work affecting quality, including verification of the quality system or product as purchased, in-process or for despatch. Such resources should ensure some degree of independent verification of the system, process or product being audited. Where there is no such independence then procedures should ensure that traceability is present so that the source of error may be identified and corrected if necessary.

Verification personnel should be defined as in and should be trained for the activities concerned.

Independence is particularly important in the internal quality auditing function. Internal auditing procedures should ensure that internal auditors are formally trained. The complexity and range of procedures present in steel-mills demands a formal approach to auditing which is best achieved by formal training.

Whilst the manufacturer's senior management should be responsible for initiating internal audits and acting on their findings the auditors need not be from a senior management level. Management Representative

The manufacturer should allocate, to one defined person, member of the management, the responsibility and authority for ensuring that the quality system continually meets the requirements of EN ISO 9002.

In a large organisation, such as a steel-mill, it is highly probable that such a person would have no further duties but that of the management of the quality system.

The manufacturer's quality management system should ensure that organisational conflict is avoided and that the Quality Assurance function is resourced and managed such that any conflict of interest does not affect the consistency of the quality of the product.

Multi-site organisations should be organised so that each site has its own management representative who, whilst having daily responsibility for managing the system, would interface with and perhaps report to, in quality assurance terms, the overall management representative of the company.

4.1.3 Management Review

There should be a documented Management Review procedure which should outline the frequency of such reviews, who is responsible for their initiation, their structure, their agenda and in particular the action taken to correct any deficiencies found. This review should be carried out by the Senior Management and should be based on reports periodically issued by the management representative. These quality reports should contain quality indicators which allow the Senior management to evaluate the performance of the quality system in attaining the objectives of the quality policy.

The quality system should be structured so that Management Reviews are used as a flexible tool to monitor the effectiveness of the quality system. They should ensure both a pro-active and reactive approach to the quality system. In a steel-mill the review may be made up of several activities or meeting panels but there should at certain intervals be an overall review of the system. The Management Review procedure should ensure that a review of the working documents of the quality system is periodically performed.

It should be noted that the successful operation of this element will act to illustrate the commitment to quality of the senior management of the organisation.


The Quality System as defined by EN 29002 should be described by a Quality Manual.

The Quality Manual should adequately describe the manufacturer's organisational structure and policy for each element of the standard.

The extent of the detail in each section of the manual will depend on the content of the associated working documents such as Standing Instructions and Works Procedures. However brief, the manual should, wherever possible, cross refer to associated procedures which should in themselves be detailed in terms of method and responsibilities.

Whilst they are not made mandatory by the standard, it is felt that the use of Quality Plans is an excellent method for illustrating clearly, both internally and externally, how the system elements should interface and interlink. Quality Plans may be used in general form in the manual and/or in more detailed form in the associated procedures. They may alternatively be stand alone documents.

All elements of EN ISO 9002 should be addressed in the Quality Manual. A disclaimer should be made if the organisation does not involve itself in any action relating to a particular clause.

Standard documents, for example purchasing forms, reject notes, routing cards, change control forms and concession forms should be under the control of and form part of the documented quality system. A compilation of such documents would be an aid in clarifying their status and use to internal and external parties.

The procedures required by the standard are:

  1. contract review;
  2. document and data control;
  3. purchasing;
  4. control of customer-supplied products;
  5. product identification and traceability;
  6. process control;
  7. inspection and testing;
  8. control of inspection, measuring and test equipment;
  9. control of non-conforming products;
  10. corrective and preventive actions;
  11. handling, storage, packaging, preservation an delivery;
  12. internal quality audits;
  13. training
  14. servicing (where applicable)
  15. statistical techniques

A master list of all organisational procedures and working documents should be formulated by the manufacturer to fully describe the quality system.

Whilst points a) to h) in Section 4.2 of EN ISO 9002 are not in themselves mandatory it is clear that, in steel-mills, all of the points are applicable and should be given full consideration.

Quality Records act to describe to both internal and external parties how the system is being implemented and therefore should be clear concise and accessible.


The manufacturer should have procedures to ensure that any customer order that is accepted formally or informally is regarded as a contract between the purchaser and manufacturer and is reviewed accordingly.

In the case of a steel manufacturer it is highly unlikely that verbal orders would be accepted in any other than perhaps a "call-off" situation.

Procedures should ensure that all orders are vetted for their legibility and accuracy and the manufacturer's ability to adhere to them. In steel manufacturing, especially when the range of product qualities are limited, many orders placed will be standard and may be processed with limited review, especially when computerisation is present. Procedures should ensure that any non-standard orders are fully vetted by specified personnel.

The procedure for contract review, whether performed positively or by exception, should be fully documented with the personnel responsible for the procedure being fully defined.

The contract review procedure should apply to all elements of the contract. Apart, for example, from the grade or quality of the steel (when they are clearly defined by the product standard), the procedure should be designed to accommodate other delivery conditions, for example, delivery time, handling and packaging requirements.

It is important for verification purposes that all orders, after processing, show evidence of such a review. This should also apply to the amendments to orders received since the initial order. Record retention periods should be defined for contractual documents and storage and retrieval should be satisfactory.

It is important that training needs be identified and that procedures ensure that training be given to those personnel responsible for the contract review function. These training needs should be reviewed as required.

Consideration needs to be given to the point in the contract where the goods become the responsibility of the customer and at which point the responsibility for quality ceases to be the responsibility of the manufacturer. Situations such as export trade or consignment stock which may exist should be carefully considered and be controlled by the contract.


The scope of EN ISO 9002 does not include quality-system requirements for design control.


Both internal and external documents that relate to the requirements of EN ISO 9002 should be subject to control.

External documents include, principally, product standards, test method standards and specifications issued by the customer.

4.5.1 Document and data Approval and Issue

There should be documented procedures for the initial approval and issue of quality system documentation. Only the most up to date documents should be available at the point of issue and obsolete documents should have been removed from these points.

Documented procedures should define the responsibility and method used for this process and should cover all levels of working quality assurance documents.

It is very likely in a large and diverse steel-mill that the responsibility for the formulation and review of such documents would be different from that for their approval and issue.

Quality Assurance documents should be designed so as to facilitate their identity in terms of issue status and also to indicate that they have been reviewed for adequacy in terms of:

Technical detail

Quality Assurance adequacy

They may therefore be required to be endorsed by at least two authorities.

Unless there is another effective method available and practicable for control each page of such documents should illustrate their issue and review status and the authority responsible for approval.

Procedures should ensure that the management representatives of the manufacturer hold current issues (not necessarily "master copies") of all quality assurance documents in circulation and that they, in their role as administrators of the system, should maintain an updated list of all such documents in circulation.

4.5.2 Document and data Changes

Procedures should ensure that the management representative has control over the distribution of changed documents once they have been reviewed for adequacy both in terms of technical detail and quality system adequacy. Such reviews should be performed by those personnel that performed the initial review and approval. The change should be made visible on the document.

The system, which should be documented, should ensure this and should also ensure that changes be promptly transmitted to all those in the organisation responsible for the documents so that the consequence of such changes be appreciated and dealt with accordingly.

The change may affect products or processes in progress or in stock. There may be, for example, a requirement for identification, segregation, investigation and re-grading of material and the procedure should ensure that these actions are promptly taken if required.


4.6.1 General

It should be noted that the term product may cover both goods and services and that the term purchasing covers both buying and subcontracting.

The standard places upon the manufacturer the responsibility for ensuring that all "purchases" conform to the requirements specified on the order.

There may be several ways of doing this:

assessment of sub-contractor;

receipt inspection;

receipt inspection and test.

All of these may apply to a steel-mill and the method(s) chosen by the mill should form part of the documented purchasing procedure.

Note: In the case of the purchase of "semi-finished" products such as billets or wire rods for further processing supplies should preferably be purchased from a source holding an approval from an accepted* certification authority. If this is not the case the purchasers will be qualified through a documented receipt procedure which will include inspection and testing and where appropriate an assessment of the quality system.

4.6.2 Evaluation of Subcontractors

The term subcontractor should also apply to supplier.

There should be a documented procedure to ensure that sub-contractors who supply goods or services which affect the quality of the product are subject to some degree of assessment and approval. This may involve such companies that supply, for example, temperature measuring equipment or calibration services.

The documented method of assessment should recognise the criticality of the product and should be able to demonstrate that a sensible degree of assessment has been applied.

The procedure should act to monitor trends in supplier performance. It should be operated by a defined representative(s) of the company who may, as a team, include the management representative of the company.

There may be instances where such a procedure is not applicable. For example spot purchases of scrap could be purchased outside such a procedure. In such cases receipt inspection should be rigorously applied.

An approved suppliers list should be maintained by the manufacturer and be used by those personnel responsible for purchasing. The list should be continuously reviewed as a result of the monitoring of product quality, both as-received and as-produced.

4.6.3 Purchasing Data

The manufacturer should have a documented purchasing procedure which should ensure that purchases are made in writing against specified requirements. Purchase orders should contain a clear description of the goods required. If purchases are made against "in-house" standards then lines of communication between the purchaser and the supplier should be such as to ensure that any changes in the order requirements are dealt with rapidly and are conveyed promptly.

All orders should be reviewed for adequacy by some designated person prior to placing with the supplier.

4.6.4 Verification of Purchased Products

This requirement relates to the right of the manufacturer's customer, when specified in the contract, to check the manufacturer's system responsible for producing the product, at the manufacturer's premises.

Such inspections should not eliminate the manufacturer's responsibility to perform programmed inspections against documented procedures operated by the manufacturer.


The standard requires that materials that are supplied by the customer for processing and return by the manufacturer and that are verified, stored, processed and despatched are controlled by documented procedures.

Procedures should ensure that any such materials are identified and traceable so that they are not incorporated into the stocks or products resulting from the manufacturer's own material. This should apply also when such supplies are incorporated within a continuous manufacturing process such as the rolling of semi-finished products (such as slabs, bloom and billets) or the cold reduction of coil feed-stock material.

Full records of the inspection status and where applicable non-conformance of such material should be maintained. The customer, whose goods are being processed, should be made fully aware of such nonconformities.


This element applies to the product at all stages of the production process from hot metal through to despatched product. Product identification of despatched goods should relate to a specific order.

Traceability should be maintained throughout by a documented procedure, documented records and, where possible, by positive product identification.

The system used for cast separation at the casting and also billet reheating stages should be such as to readily demonstrate that cast separation is achieved. Coils of wire rod should be treated in the same way.

The manufacturer should ensure that, billets and wire rods in stock which cannot be identified specifically to cast are adequately segregated and identified. The procedure should indicate the method by which such semifinished products, should they be further processed, are identified to ensure traceability. Full records should be maintained of the movement of such semis both into, inside and out of the stocking area.

Traceability records should act to enable verification that the processing and testing conditions for the product concerned, at all stages of its processing, satisfied the documented procedure for that particular product.

Identification of the finished product should provide the information as required by the product standard and clearly show the identity of the authority responsible for certification.

Traceability should extend, where appropriate, to the producing plant and operatives concerned such that the problems arising at any stage in the production, supply or even use of the finished product, can be traced and analysed to establish the basic cause of the problem.


Processing procedures should be sufficiently detailed, clear and be available to applicable personnel to ensure that the processing is performed in the desired manner.

The manufacturer's procedures should reflect the training to be given to the personnel concerned. The application of training in the process involved may be the most suitable method for ensuring that the processing is performed as required. Such training should be reviewed at frequent intervals to ensure it reflects any changes to the processing methods.

The detailed extent of documented procedures should depend on the degree of risk that, if they were absent or diluted, the quality of the product would be affected.

The manufacturer should give consideration to the capability of the process and the equipment available for processing. Procedures should ensure that process controls are applied accordingly.

In a steel manufacturing plant with complicated and continuous processes the control documentation should be comprehensive. It may however consist of four levels of documentation:

Quality Manual;

Works Procedures (General Procedures);

Codes of Practice (Specific Instructions);

Quality Plans.

Operating instructions may contain information pertaining to the specific task in hand. These should be readily available for reference and should also be the subject of training which may act also to illustrate how these individual instructions link in with the general process involved.

The detail of such instructions should be commensurate with the level of automation in existence within the plant. The instructions should be formulated, reviewed and issued by personnel knowledgeable and responsible for the area concerned but should also be vetted for overall quality correctness by the person nominated for the document control element of the system.

Where applicable the requirements of the relevant product standard should be recognised in the procedures or instructions available for use.

It should also be noted however that other elements of the product which may not necessarily be referred to in the product standard but which affect the general fitness for purpose of the product being produced should also be recognised.

Examples in reinforcing steel include:

straightness along the length of a bar

twist along the length of a bar;

freedom from oil, grease etc.;

'hooked' ends due to poor shearing.

Internal standards or criteria for workmanship should act to control these also and should be described in documented procedures.

To this extent equipment which may be regarded as outside the area of inspection and test equipment but which acts to control the process and hence the product quality should also be controlled. This will necessitate a documented and programmed calibration and maintenance procedure which covers such equipment.

Examples in steel manufacture include:

temperature measurement equipment;

flow meters;

water pressure valves;

mechanical handling devices;

continuous cast ways and stand;

rolling cylinders and stands;

furnaces and heat treatment devices;

packaging equipment

The extent of control by the manufacturer should be set at a sensible level which may be amended as a result of on-going experience.

In steel manufacture special processes may be need to be considered because they result in characteristics that cannot readily be measured in the finished product without destructive testing, e.g..

the degree of applied cold work;

quench and self temper treatments;

decoiling and straightening of material.

Where such processes exist emphasis should be placed on the control of processing parameters and consequently on the calibration of the equipment used to control the manufacture and testing of the product.

There will almost certainly be a requirement to assess and qualify such processing parameters and to control them.

If control of the product after being subject to such a special process, (e.g.. Self Quench and Temper treatments) is by testing of the product only then Process Capability studies should be incorporated in the process control procedures. Results of such studies should be maintained and readily accessible for review.

Should special skills be required in the operation of such processes these should be achieved by designated training programmes which should be periodically reviewed for effectiveness. Again records of such training should be maintained.

4.10 INSPECTION AND TESTING4.10.1 General4.10.2 Receiving Inspection and Testing

Receipt inspection procedures and practices which should be applied to all raw materials, products or equipment which affect the quality of the product should be documented and form part of the quality system.

The extent of such receipt inspection will be at the discretion of the manufacturer and may depend on:

the rating of the supplier of goods within the approved supplier procedure.

the nature of the goods with respect to their cost or criticality within the process.

the extent of supplier quality assurance control placed on the supplier by the customer.

For such considerations to be effective there should be adequate methods and levels of communication between those applying the supplier approval procedure and those actually receiving and accepting the goods into stock. This should also apply to the acceptance of non-conforming goods under concession.

In a steel manufacturing organisation controls should therefore be exercised with raw materials such as hot metal, scrap, ferro-alloys but also with other important goods or services such as temperature measuring devices, gases and calibration services.

Documented procedures should preclude the acceptance of bulk raw materials without prior receiving inspection since, once the product has been incorporated into bulk stocks its positive identification is lost. Examples here include ferro-alloys, scrap and lime.

For other items including, for example semi-finished products, then strict traceability systems should be applied. Documented procedures should ensure that positive identification is applied whenever this is practicable in situations where receipt inspection has been by-passed.

There should be a system in place to ensure that such materials are not incorporated into products to be despatched to the customer if satisfactory evidence of compliance with purchased specifications has not been achieved by this stage.

4.10.3 In-process Inspection and Testing

In-process inspection and testing should be performed at previously planned intervals under the control of suitably documented procedures.

In a continuous or semi-continuous process such as steel manufacture the type and extent of in-process inspection will, to an extent, depend on the process control methods in use.

In-process control would normally be confined to temperature measurement, chemical analysis and to the analysis of dimensional characteristics.

They may however apply to chemical analysis or mechanical testing depending on the degree of sophistication of the control exercised over the processing parameters.

Should incorrect values result from any such inspection of process parameters or product characteristics then documented procedures should describe the subsequent and/or retrospective action to be taken.

Full records of such monitoring should be maintained and should be attributable to the batch/cast of material being produced.

4.10.4. Final Inspection and Testing

There should be documented procedures to ensure that no product is released to the customer before all of the necessary control checks have been carried out. This includes receipt inspection of applicable raw materials and sub-contractor records of compliance.

4.10.5 Inspection and Test Records

The recording system should be structured so that maintenance and retrieval of records enable verification that all the required records are present and in place. This should facilitate any review of the batch/cast records, including sub- contractors records and receipt inspection records, prior to the despatch of finished products.


This requirement relates to the control, calibration and maintenance of all Inspection, Measuring and Test equipment used within the quality system to ensure conformity of the process or product.

In practical terms within a steel-mill the following should be present in relation to such equipment:

master list or lists of all such equipment;

programme for Calibration and Maintenance;

individual identification of equipment which should include calibration status labels or other means so that the calibration of instruments is kept under control;

calibration procedures for all equipment;

records of all calibrations;

records of actions taken as a result of finding instruments out of calibration.

Measuring equipment within a steel-mill tends to confine itself to temperature and dimensional measuring equipment.

There should however be consideration given to other types of instrumentation used to control the process and therefore product quality. For example:

timing devices;

flow regulating devices;

pressure regulating devices;

The manufacturer should identify such devices in the light of their degree of interdependence with other instruments in the system.

The accuracy of software in creating the required processing or testing conditions should not be taken for granted by the manufacturer and should be validated. An obvious example is software used to control the conditions within a mechanical test.

Software may also however be used to control gas injection or power inputs with a furnace.

In general terms wherever an instrument provides data which is required by the quality system then it should be calibrated and controlled in accordance with this clause.

It is recognised that there are not always nationally accredited calibration services for every instrument in use in production, testing or inspection. In such cases the use of internal calibration procedures incorporating traceable calibration standards may be acceptable.

Paragraphs a) through to j) of the standard are all applicable in a steel manufacturing situation and are self explanatory.


Steel manufacturer's products and traceability requirements necessitate the application of this clause.

Identification of adequacy by exception may be considered as satisfactory here such that material, marked only with cast detail, may be considered as satisfactory if without a hold, quarantine or bond label which, if present, would act to signify its apparent failure to meet requirements.

This requirement should apply to raw materials, semis and finished products.

Traceability here should also apply to the inspection authority responsible for passing, rejecting or quarantining goods. Inspection records where applicable should enable such traceability.


Documented procedures should be produced to control the use of non-conforming product. Such controls should prevent inadvertent use of non-conforming product.

The type of control, for example, identification and segregation, will depend on the form of the product. The manufacturer should ensure that wherever possible positive identification of the product is maintained. Wherever possible, if space allows, non-conforming or "quarantined" products should be segregated. If however this is not possible then the stock control system employed, with associated records, should ensure definite identification of the product concerned.

4.13.2 Review and disposition of non-conforming product

It is important that the documented procedures controlling non-conforming products identify the resources allocated and the responsibility and authority for the review and disposition of such product.

Paragraph a) to d) in the standard may all be applicable in a steel manufacturing operation.

The manufacturer should maintain full records of any non-conforming material processed by sub-contractors or returned by customers as the result of a complaint. Such records are important for various reasons including the review of such non-conformances. It may be necessary or appropriate to repair or rework the material or product to enable it to meet the customers or mandatory requirements. Documented procedures should ensure that all such cases are fully recorded and, in cases where the contract demands, are reported to the customer for full acceptance of this action. Such records should be fully documented and should take the form of a concession. Any such product should be subject to re-inspection for compliance with customers requirements. Records of these inspections should be maintained.

Note: Material produced to a product standard, which may or may not carry the mark of mill identity, shall not be sold into the market as "Second Grade".


Documented procedures should be established and maintained for the purposes of establishing the basic cause of any non-conformity and the corrective action required to prevent it's recurrence. Whilst it is recognised that commercial considerations are important the procedure employed by the manufacturer should ensure that investigations lead to positive action to prevent further instances of incorrect product quality and not just in satisfying the customers financial requirements.

The relevant information on all preventive actions should be submitted to the Senior management for management review (see 4.13)

Documented procedures should ensure continued monitoring of any potential problem area and the full recording of problems, investigation results and alterations to documented procedures should they be required. This will enable long term trends to be monitored and acted upon.

Corrective actions may therefore involve physical re-work or repair to the product, alteration of procedures and re-training of staff or operatives.


4.15.1 General

Procedures should be developed and maintained for handling, storage, packaging and delivery which should ensure that, in the case of the finished product, customers particular requirements are satisfied. Such requirements should be fully noted at the review stage in any contract.

This requirement should also apply, where appropriate, to raw material, in-process material and finished products.

4.15.2 Handling

The manufacturer must ensure that the handling, particularly of intermediate and finished products, is performed in such a way and if necessary with the use of suitable equipment, to prevent its damage or deterioration.

4.15.3 Storage

The manufacturer shall provide areas for storage of materials commensurate with their form and stage within the production process.

Documented procedures should ensure that at any stage of the process, from raw material storage through to storage of finished bars or coil ready for delivery product, identification is maintained. Storage conditions should ensure security and should prevent deterioration of the product from the condition in which it is required for subsequent use. This will include areas where customers own materials are stored.

Product release procedures should be employed when products are moved from segregated or quarantined areas. Full records of such stock movements should be maintained.

Procedures pertaining to storage of products shall extend to warehousing or external storage facilities which act to store products prior to delivery to the customer. These may include contract warehouses, stockyards, docks, hauliers etc. In such cases on-going inspections may be required to be performed by the steel manufacturer.

4.15.4 Packaging

The manufacturer should ensure that the packaging requirements of the customer are understood and complied with. Bundling, bundle size, security, weight and labelling requirements should be controlled. In particular the details on product labels should satisfy the requirements of the relevant standard and/or customer. Labels should be easily located for subsequent receipt inspection purposes and should be durable and legible. This is particularly important for material transported over long distances and which, as a result, may be handled several times on its journey.

4.15.5 Preservation

It has been recognised that steel products do not require special provisions for preservation.

4.15.6 Delivery

There should be documented procedures to ensure that the material carrier has the ability to maintain the handling procedures of the manufacturer and therefore meet the requirements of the customer.

The performance of material carriers should be monitored. Such carriers may even be included in the manufacturer's supplier approval procedure.

The above requirements are valid only if the responsibility for delivery of steel rests with the producer.


The manufacturer should have a documented procedure which describes the system for maintenance of quality records. Records may be in the form of any type of media, such as hard copy or electronic media.

Quality records should include all those records which act to demonstrate the effective operation of the quality system and as such will be wide ranging.

The system for the maintenance of quality records and in particular for those records which directly indicate the quality of the product and the processing conditions relating to the product should ensure ease of retrieval and correlation. Such a system should facilitate easy retrieval of records for review so that reasons for non-conformance can be readily established and acted upon. Records must therefore be well stored and safe from deterioration and damage.

Should computer records form part of the quality system the recording system shall ensure adequate security and safety.

Quality records should be readily available for inspection at all times.

Retention times for quality records may vary according to the element of the quality system that they represent. Procedures should ensure however that they are retained for at least as long as legislation requires taking into account product liability. Retention times should be documented.

The standard requires that the following documents are regarded as quality records:

  1. management review;
  2. contract review;
  3. suppliers’ assessment documents. These should include the records provided by suppliers;
  4. records concerning customer supplied products, including reference to the products which are lost, damaged or otherwise unsuitable;
  5. record relating to product identification and traceability;
  6. documents related to the qualification of (special) processes, including equipment and personnel;
  7. records relevant to the identification of incoming products which are released for urgent production purposes prior to verification
  8. results of inspections and tests. They should normally include the name of the person responsible for the release of the product;
  9. records relevant to the calibration of measuring and test equipment;
  10. records of product nonconformities accepted under concession with or without repair;
  11. results of the investigations of the causes of nonconformities
  12. results of internal audits and follow-up activities;
  13. records of training.


The manufacturer should employ an Internal Audit procedure which ensures that the complete quality system is audited in a systematic manner.

It is essential that such audits are performed by personnel independent of the daily running of the individual element being audited. Such auditors should be trained in the principles and practices of auditing.

The internal audit procedure should ensure that audits are scheduled and performed at regular intervals, the frequency of which should be no greater than at yearly intervals but which may be reduced should the performance of the system indicate that this is required.

Audits should follow prepared check-lists and should be formally reported on. Such records should form a major element of the manufacturer's Management Review. The auditing system should ensure that non-compliances are issued in the event of discovery of system deficiencies. This should facilitate the investigation of any discrepancies found by ensuring documented evidence of corrective action taken.

This system will enable the auditor to verify the corrective actions and will also enable the manufacturer's companies management to verify the on-going effectiveness of such actions at the time of the Management Reviews.


Effective training of personnel involved in the maintenance of the overall quality system should be regarded as a major part of the quality system.

The manufacturer should have training procedures and programmes which focus on the training needs of the individual to fulfil the role within the quality system. The training needs for the role should therefore be identified and defined.

Procedures should ensure that training involves personnel at all levels within the manufacturer's organisation with regard to awareness of the quality aims and policies of the organisation.

Reinforcement of training is also important particularly in areas of the process or system which have been long established and in which it might appear that staff are settled and proficient. There is a tendency to believe that such staff are aware of all of the changes that have occurred around them and which impact on product quality.

Records for training should be maintained so that they may be reviewed in line with the development of the quality system and/or production processes so that reinforcement of training may be planned and that gaps in training be readily identified.


In most cases servicing, as defined by En ISO 9002, is not performed by steel manufacturers.

There may be however cases in which the steel manufacturers monitor the acceptance of the product on the market through checks on the customer’s satisfaction. In this case the quality system documentation should include reference to servicing an keep into account the provisions of chapter 4.19 of the standard.


This element highlights the importance of maintaining an adequate and comprehensive system of recording data resulting from the operation of the quality system.

It should be expected that, as a minimum, the manufacturer should employ an on going statistical determination of the product characteristics and that this determination should result in action to improve the quality of the product based on the results achieved. This form of analysis and action should act to supplement the long term quality determinations performed to satisfy the requirements of the applicable standard.

The manufacturer should ensure that there is provision of quality data for management control. Statistical techniques may then be applied to such data. Examples include the analysis of receipt inspection results, analysis of scrap / reject / rework rates and customer complaints.

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