Iranian Classification Society Rules

Section 4 Requirements of Quality Assurance System (KS Q ISO 9001:2009 / ISO 9001:2008)

401. General requirements

1. The manufacturers wishing to obtain the approval of quality assurance system are to comply with the requirements of this Section which based on the requirements of KS Q ISO 9001:2009 / ISO 9001 : 2008.

2. Where deemed appropriate by the Society, equivalent other than the requirements in this Section may be considered satisfactory to this Section.

3. The manufacturers intending to apply for the requirement in Par 2 above, in advance, are to in- form the Society.

4. Quality management system

(1) General requirements

(A) The manufacturer shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this Section

(B) The manufacturer shall

(a) determine the processes needed for the quality management system and their application throughout the organization,

(b) determine the sequence and interaction of these processes,

(c)

determine criteria and methods needed to ensure that both the operation and control of these processes are effective,

(d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,

(e)

(f)

monitor, measure where applicable, and analyse these processes, and

implement actions necessary to achieve planned results and continual improvement of these processes.

Processes needed for the quality management system referred to above include processes for

management activities, provision of resources, product realization, measurement, analysis and improvement.

(D) Where a manufacturer chooses to outsource any process that affects product conformity to

requirements, the manufacturer shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.

(2) Documentation requirements

(A) General

The quality management system documentation shall include

(a)

documented statements of a quality policy and quality objectives,

(b) a quality manual,

(c)

documented procedures and records required by this Section,

(d) documents, including records, determined by the manufacturer to be necessary to ensure the effective planning, operation and control of its processes.

Where the term "documented procedure" appears within this Section, this means that the

procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. and a requirement for a documented procedure may be covered by more than one document. and the extent of the quality man- agement system documentation can differ from one organization to another due to

- the size of organization and type of activities,

- the complexity of processes and their interactions, and

- the competence of personnel.

A requirement for a documented procedure may be covered by more than one document.

(B) Quality manual

The manufacturer shall establish and maintain a quality manual that includes

(a) the scope of the quality management system, including details of and justification for any exclusions

246 Guidance for Approval of Manufacturing Process and Type Approval, Etc. 2015

(b) the documented procedures established for the quality management system, or reference to them, and

Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in (D).

A documented procedure shall be established to define the controls needed

(a)

to approve documents for adequacy prior to issue,

(b) to review and update as necessary and re-approve documents,

(c)

to ensure that changes and the current revision status of documents are identified,

(d) to ensure that relevant versions of applicable documents are available at points of use,

(e)

(f)

to ensure that documents remain legible and readily identifiable,

to ensure that documents of external origin determined by the organization to be neces- sary for the planning and operation of the quality management system are identified and their distribution controlled, and

(g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

(D) Control of records

(a) Records established to provide evidence of conformity to requirements and of the effec-

tive operation of the quality management system shall be controlled. Records shall re- main legible, readily identifiable and retrievable.

(b) A documented procedure shall be established to define the controls needed for the iden- tification, storage, protection, retrieval, retention time and disposition of records.

5. Management responsibility

(1) Management commitment

Top management shall provide evidence of its commitment to the development and im- plementation of the quality management system and continually improving its effectiveness by

(A) communicating to the organization the importance of meeting customer as well as statutory

and regulatory requirements,

(B) establishing the quality policy,

(D) conducting management reviews, and

(E) ensuring the availability of resources.

(2) Customer focus

Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction

(3) Quality policy

Top management shall ensure that the quality policy

(A) is appropriate to the purpose of the organization,

(B) includes a commitment to comply with requirements and continually improve the effective- ness of the quality management system,

(D) is communicated and understood within the organization, and

(E) is reviewed for continuing suitability.

(4) Planning

(A) Quality objectives

Top management shall ensure that quality objectives, including those needed to meet require- ments for product are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.

(B) Quality management system planning Top management shall ensure that

(a) the planning of the quality management system is carried out in order to meet the re-

quirements given in 4. (1), as well as the quality objectives, and

(b) the integrity of the quality management system is maintained when changes to the qual- ity management system are planned and implemented.

(5) Responsibility, authority and communication

(A) Responsibility and authority

Top management shall ensure that responsibilities and authorities are defined and communi-

Guidance for Approval of Manufacturing Process and Type Approval, Etc. 2015 247

cated within the organization.

(B) Management representative

Top management shall appoint a member of management who, irrespective of other re-

sponsibilities, shall have responsibility and authority that includes

(a) ensuring that processes needed for the quality management system are established, plemented and maintained,

(b) reporting to top management on the performance of the quality management system any need for improvement, and

im-

and

(c)

ensuring the promotion of awareness of customer requirements throughout

organization.

the

(d) The responsibility of a management representative can include liaison with external ties on matters relating to the quality management system.

par-

Top management shall ensure that appropriate communication processes are established with- in the organization and that communication takes place regarding the effectiveness of the quality management system.

(6) Management review

(A) General

Top management shall review the organization's quality management system, at planned in- tervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall in- clude assessing opportunities for improvement and the need for changes to the quality man- agement system, including the quality policy and quality objectives. Records from manage- ment reviews shall be maintained.

(B) Review input

The input to management review shall include information on

(a)

results of audits,

(b) customer feedback,

(c)

process performance and product conformity,

(d) status of preventive and corrective actions,

(e)

(f)

follow-up actions from previous management reviews, changes that could affect the quality management system, and

(g) recommendations for improvement.

The output from the management review shall include any decisions and actions related to

(a)

improvement of the effectiveness of the quality management system and its processes,

(b) improvement of product related to customer requirements, and

(c)

resource needs.

6. Resource management

(1) Provision of resources

The manufacturer shall determine and provide the resources needed

(A) to implement and maintain the quality management system and continually improve its effec- tiveness, and

(B) to enhance customer satisfaction by meeting customer requirements.

(2) Human resources

(A) General

Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience.

(B) Competence, training and awareness

The manufacturer shall

(a) determine the necessary competence for personnel performing work affecting conformity to product requirements,

(b) where applicable, provide training or take other actions to achieve the necessary

competence.

(c)

evaluate the effectiveness of the actions taken,

(d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives,

(e)

maintain appropriate records of education, training, skills and experience.

248 Guidance for Approval of Manufacturing Process and Type Approval, Etc. 2015

The manufacturer shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable

(a)

buildings, workspace and associated utilities,

(b) process equipment (both hardware and software), and

(c)

supporting services (such as transport or communication or information systems).

(D) Work environment

The manufacturer shall determine and manage the work environment needed to achieve con- formity to product requirements.

7. Product realization

(1) Planning of product realization

The manufacturer shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system. In planning product realization, the manufacturer shall determine the

following, as appropriate:

(A) quality objectives and requirements for the product;

(B) the need to establish processes and documents, and to provide resources specific to product;

the

cific to the product and the criteria for product acceptance;

(D) records needed to provide evidence that the realization processes and resulting product meet requirements.

(2) Customer-related processes

(A) Determination of requirements related to the product

The manufacturer shall determine

(a) requirements

specified by the customer, including the requirements for delivery and

post-delivery activities,

(b) requirements

not stated by the customer but necessary for specified or intended use,

(c)

where known,

statutory and regulatory requirements applicable to the product, and

(d) any additional requirements considered necessary by the manufacturer.

(B) Review of requirements related to the product

(a) The manufacturer shall review the requirements related to the product. This review shall be conducted prior to the manufacturer's commitment to supply a product to the custom- er (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that

(i) product requirements are defined,

(ii) contract or order requirements differing from those previously expressed are resolved, and

(iii)e manufacturer has the ability to meet the defined requirements.

And records of the results of the review and actions arising form the view shall be maintained. In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material. Records of the results of the review and actions arising from the review shall be maintained.

(b) Where the customer provides no documented statement of requirement, the customer re- quirements shall be confirmed by the manufacturer before acceptance.

(c) Where product requirements are changed, the manufacturer shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

The manufacturer shall determine and implement effective arrangements for communicating with customers in relation to

(a)

product information,

(b) enquiries, contracts or order handling, including amendments, and

(c)

customer feedback, including customer complaints.

(3) Design and development

(A) Design and development planning

Guidance for Approval of Manufacturing Process and Type Approval, Etc. 2015 249

(a)

The manufacturer shall plan and control the design and development of product.

(b) During the design and development planning, the manufacturer shall determine

(i) the design and development stages,

(ii) the review, verification and validation that are appropriate to each design and devel- opment stage, and

(iii) the responsibilities and authorities for design and development.

(d) Planning output shall progresses.

manage the interfaces between different groups involved in de- to ensure effective communication and clear assignment of

be updated, as appropriate, as the design and development

(B) Design and development inputs

(a) Inputs relating to product requirements shall be determined and records maintained (see

4. (2) (D)) These inputs shall include

(i) functional and performance requirements,

(ii) applicable statutory and regulatory requirements,

(iii) where applicable, information derived from previous similar designs, and (iv)other requirements essential for design and development.

(b) These inputs shall be reviewed for adequacy. Requirements shall be complete, un- ambiguous and not in conflict with each other.

(a) The outputs of design and development shall be provided in a form that enables ver- ification against the design and development input and shall be approved prior to release.

(b) Design and development outputs shall

(i) meet the input requirements for design and development,

(ii) provide appropriate information for purchasing, production and for service provision, (iii)tain or reference product acceptance criteria, and

(iv)specify the characteristics of the product that are essential for its safe and proper use.

(D) Design and development review

(a) At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements.

(i) to evaluate the ability of the results of design and development to meet require- ments, and

(ii) to identify any problems and propose necessary actions.

(b) Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained.

(E) Design and development verification

Verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained.

(F) Design and development validation

Design and development validation shall be performed in accordance with planned arrange- ments to ensure that the resulting product is capable of meeting the requirements for the

specified application or intended use, where known. Wherever practicable, validation shall be

completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained.

(G) Control of design and development changes

Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be maintained.

(4) Purchasing

(A) Purchasing process

(a) The manufacturer shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased

250 Guidance for Approval of Manufacturing Process and Type Approval, Etc. 2015

product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.

(b) The manufacturer shall evaluate and select suppliers based on their ability to supply

product in accordance with the manufacturer's requirements. Criteria for selection, evalua- tion and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.

(B) Purchasing information

(a) Purchasing information shall describe the product to be purchased, including where ap- propriate

(i) requirements for approval of product, procedures, processes and equipment,

(ii) requirements for qualification of personnel, and (iii)quality management system requirements.

(b) The manufacturer shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

(a) The manufacturer shall establish and implement the inspection or other activities neces- sary for ensuring that purchased product meets specified purchase requirements.

(b) Where the manufacturer or its customer intends to perform verification at the supplier's

premises, the manufacturer shall state the intended verification arrangements and method of product release in the purchasing information.

(5) Production and service provision

(A) Control of production and service provision

The manufacturer shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable

(a) the availability of information that describes the characteristics of the product,

(b) the availability of work instructions, as necessary,

(d) the availability and use of monitoring and measuring equipment,

(e) the implementation of monitoring and measurement, and

(f) the implementation of product release, delivery and post-delivery activities.

(B) Validation of processes for production and service provision

(a) The manufacturer shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This

includes any processes where deficiencies become apparent only after the product is in

use or the service has been delivered.

(b) Validation shall demonstrate the ability of these processes to achieve planned results.

(i) defined criteria for review and approval of the processes,

(ii) approval of equipment and qualification of personnel, (iii)use of specific methods and procedures,

(iv)requirements for records (see 4 (2) (D)), and

(v) revalidation.

(a) Where appropriate, the manufacturer shall identify the product by suitable means throughout product realization.

(b) The manufacturer shall identify the product status with respect to monitoring and meas-

urement requirements throughout product realization.

(c) Where traceability is a requirement, the manufacturer shall control the unique fication of the product and maintain records.

(D) Customer property

The manufacturer shall exercise care with customer property while it is under the facturer's control or being used by the manufacturer. The manufacturer shall identify,

identi-

manu- verify,

protect and safeguard customer property provided for use or incorporation into the product.

If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained.

(E) Preservation of product

The manufacturer shall preserve the product during internal processing and delivery to the

intended destination in order to maintain conformity to requirements. tion shall include identification, handling, packaging, storage and

As applicable, preserva- protection. Preservation

Guidance for Approval of Manufacturing Process and Type Approval, Etc. 2015 251

shall also apply to the constituent parts of a product.

(6) Control of monitoring and measuring devices

(A) The manufacturer shall determine the monitoring and measurement to be undertaken and the

monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.

(B) The manufacturer shall establish processes to ensure that monitoring and measurement can

be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.

(a) be calibrated or verified, or both, at specified intervals, or prior to use, against measure- ment standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;

(b) be adjusted or re-adjusted as necessary;

(c)

have identification in order to determine its calibration status;

(d) be safeguarded from adjustments that would invalidate the measurement result;

(e)

be protected from damage and deterioration during handling, maintenance and storage.

(D) In addition, the manufacturer shall assess and record the validity of the previous measuring

results when the equipment is found not to conform to requirements. The manufacturer shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained.

(E) When used in the monitoring and measurement of specified requirements, the ability of

computer software to satisfy the intended application shall be confirmed. This shall be dertaken prior to initial use and reconfirmed as necessary.

8. Measurement, analysis and improvement

(1) General

(A) The manufacturer shall plan and implement the monitoring, measurement, analysis and provement processes needed

un-

im-

(a)

to demonstrate conformity to product requirements,

(b) to ensure conformity of the quality management system, and

(c)

to continually improve the effectiveness of the quality management system.

(B) This shall include determination of applicable methods, including statistical techniques, the extent of their use.

(2) Monitoring and measurement

(A) Customer satisfaction

As one of the measurements of the performance of the quality management system,

and

the

manufacturer shall monitor information relating to customer perception as to whether the

manufacturer has met customer requirements. The methods for obtaining and using formation shall be determined.

(B) Internal audit

(a) The manufacturer shall conduct internal audits at planned intervals to determine the quality management system

(i) conforms to the planned arrangements (see 7. (1)), to the requirements

this in-

whether of this

International Standard and to the quality management system requirements established

by the manufacturer, and

(ii) is effectively implemented and maintained.

(b) An audit programme shall be planned, taking into consideration the status and im- portance of the processes and areas to be audited, as well as the results of previous

audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit

process.

(c)

Auditors shall not audit their own work.

(d) A documented procedure shall be established to define the responsibilities and require- ments for planning and conducting audits, establishing records and reporting results.

(e)

(f)

Records of the audits and their results shall be maintained.

The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the

actions taken and the reporting of verification results.

252 Guidance for Approval of Manufacturing Process and Type Approval, Etc. 2015

(a) The manufacturer shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes.

(b) These methods shall demonstrate the ability of the processes to achieve planned results.

(c)

When planned results are not achieved, correction and corrective action shall be taken, as appropriate.

(D) Monitoring and measurement of product

(a) The manufacturer shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7

(1)).

(b) Evidence of conformity with the acceptance criteria shall be maintained.

(c)

Records shall indicate the person(s) authorizing release of product (see 4 (2) (D)).

(d) The release of product and delivery of services to the customer shall not proceed until the planned arrangements (see 7 (1)) have been satisfactorily completed, unless otherwise

approved by a relevant authority and, where applicable, by the customer.

(3) Control of nonconforming product

(A) The manufacturer shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and re-

lated responsibilities and authorities for dealing with nonconforming product shall be defined

in a documented procedure.

(B) Where applicable, the manufacturer shall deal with nonconforming product by one or more of the following ways:

(a)

by taking action to eliminate the detected nonconformity;

(b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;

(c)

by taking action to preclude its original intended use or application.

(d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.

conformity to the requirements.

(D) Records of the nature of nonconformities and any subsequent actions taken, including con- cessions obtained, shall be maintained.

(4) Analysis of data

(A) The manufacturer shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where con- tinual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.

(B) The analysis of data shall provide information relating to

(a)

customer satisfaction,

(b) conformity to product requirements,

(c)

characteristics and trends of processes and products including opportunities for preventive action, and

(d) suppliers.

(5) Improvement

(A) Continual improvement

The manufacturer shall continually improve the effectiveness of the quality management sys- tem through the use of the quality policy, quality objectives, audit results, analysis of data,

corrective and preventive actions and management review.

(B) Corrective action

(a) The manufacturer shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the non- conformities encountered.

(b) A documented procedure shall be established to define requirements for

(i) reviewing nonconformities (including customer complaints),

(ii) determining the causes of nonconformities ,

(iii) evaluating the need for action to ensure that nonconformities do not recur, (iv)determining and implementing action needed,

Guidance for Approval of Manufacturing Process and Type Approval, Etc. 2015 253

(v) records of the results of action taken (see 4 (2) (D)), and (vi)reviewing the effectiveness of the corrective action taken.

(a) The manufacturer0 shall determine action to eliminate the causes of potential non- conformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.

(b) A documented procedure shall be established to define requirements for

(i) determining potential nonconformities and their causes,

(ii) evaluating the need for action to prevent occurrence of nonconformities,

(iii)determining and implementing action needed, (iv)records of results of action taken (see 4 (2) (D)), and

(v) reviewing the effectiveness of the preventive action taken.

402. Special requirements

1. Control of approved drawings by the Society

The manufacturer is to establish and maintain documented procedures to control the approved draw- ings by the Society, and appoint the responsible personnel.

2. Conformity on the Rules of the Society

In purchasing incoming materials, the manufacturer is to establish and maintain the documented procedures to confirm that they meet the requirements in the Rules.

3. Identification and traceability of products possessed Society's certificate

The manufacturer is to establish and maintain the documented procedures to confirm the relation between the products with the Society's certificate and their materials for the identification and traceability of products, if necessary.

4. Qualified personnel

Welding or NDT operators among special processes operators which requiring pre-qualification of their process capability are be qualified by the Society or by another body recognized by the Society.

5. Approval of the nonconforming products by the Society

(1) Where nonconforming products are intended to use after repair or rework, the manufacturer is to ensure that the tests or inspection for use are to be carried out in the presence of the Surveyor.

(2) Any deficiencies found on products which are approved in accordance with this Chapter are

promptly to be eliminated. The manufacturer is to establish and maintain the documented proce- dures to communicate those affecting the ultimate quality of the products to the Society.

6. Notification of the corrective action

The procedures for corrective action are to include communication method to the Society confirm- ing that the corrective action is carried out and that it is effective.

254 Guidance for Approval of Manufacturing Process and Type Approval, Etc. 2015

< Previous | Contents | Next >