ISO 9001-Clause 7.2

ISO 9001-Clause 7.2 Customer-related processes

ISO 9001 Requirement

ISO 9001-Clause 7.2.1 Determination of requirements related to the product

The organization 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, where known,

c) statutory and regulatory requirements applicable to the product, and

d) any additional requirements considered necessary by the organization.

NOTE Post-delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

ISO 9001-Clause 7.2.2 Review of requirements related to the product

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

a) product requirements are defined,

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

c) the organization has the ability to meet the defined requirements.Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).

Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

NOTE 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.

ISO 9001-Clause 7.2.3 Customer communication

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

a) product information,
b) inquiries, contracts or order handling, including amendments, and
c) customer feedback, including customer complaints.

Explanation:

Customer related processes must include controls for determining customer and regulatory requirements, a review of such requirements, and communication with the customer. Customer requirements extend beyond product specifications and may include   on-time delivery, packaging, labeling, mode of delivery, documentation, communications, QMS requirements, after sales servicing, etc. Many of these requirements may also come from regulatory, industry or from within your own organization. Depending on the product or service, you must determine if any industry or regulatory requirement is applicable on product characteristics or process parameters that affect the product’s safety or compliance with regulatory requirements.  You must consider all laws and regulatory requirements that may affect your product, materials, labor, production processes, your facility and work environment, etc. Where some or all of the processes – for determining customer requirements; for contract review and customer communication; etc., are done offsite, then you must show the linkages and interaction of these offsite activities with your on-site QMS processes.  The nature of requirements review may be different for different types of product or services. Your review records must show the basis of review. Make sure you do your due diligence and risk analysis before you commit to contractual arrangements. I have seen many companies get into serious financial trouble, for taking on products transferred from another supplier, because they did not assess all the risks. Manufacturing risk analysis is an assessment of your organization’s capacity and capability to effectively and efficiently provide the customer specified deliverables. Risk analysis should include timing, resources, development costs and investments, potential for, and effects of, possible failures in processes, including  suppliers. You should also consider financial and profitability risk. Sometimes it may take a few months to receive an order or contract from the customer, after you have sent them your quotation. Your review process must ensure that you compare the customer’s order or contract with your latest quotation, and resolve any differences (accept or re-negotiate), before you accept the order or contract. Your customer relations management process must include a sub-process for change control and must include – a review of the change either from customer or internal from organization and its impact on fit, form, functionality, other processes, financial, delivery, etc. Have a process for change control. For significant issues or changes, obtain customer approval in writing for any waivers or changes of contractual or QMS requirements. Customer communications may take many forms such as  software and interfaces for design and development, logistics, customer satisfaction feedback, etc. You must ensure that personnel at all levels have the competency and training to use these communications media and tools. You must identify and document all processes addressing this clause as part of your QMS . For these processes, you must also identify what specific documents are needed for effective planning, operation and control of production activities. These documents may include – contracts, specifications, orders, product quality plans, work instruction, a documented procedure etc., combined with unwritten practices, procedures and methods. Look at the risks related to your product, processes and resources in determining the nature and extent of documented controls you need to have. Performance indicators to measure the effectiveness of customer-related processes in meeting requirements and achieving quality objectives should focus on reducing variation in and improving these processes and related use of resources. Indicators may include reduction in quote cycle time,  pre and post-award review cycle time, order-entry errors and omissions etc., and improvement in conversion ratio (i.e. ratio of contracts/orders awarded to quotes).

Audit Checklist:

For Clause 7.2.1:

  1. How are Customer requirements determined? Any specefication being provided?
  2. What are the requirements specified by the customer, including delivery and post-delivery activities?
  3. What are the requirements not specified by the customer but necessary for intended or specified use?
  4. What are the statutory, regulatory requirements and any other requirements determined by the organisation?

For Clause 7.2.2:

  1. How are product and service requirements adequately defined/documented?
  2. Are quotes/proposals reviewed prior to issue? Are they checked against subsequent orders that are received? Can orders be received verbally?
  3. Does the organisation has the ability to meet the defined requirements?
  4. How are requirements reviewed to ensure they can be met? Who does the review?
  5. Are the results of the product/contract review and subsequent follow-up actions recorded?
  6. Are customer requirements confirmed, if the customer provides no documented requirements?
  7. How are Contract or order requirements that differ from those previously expressed resolved?
  8. Where product/contract requirements are changed, does the organisation ensure that relevant documentation is amended? Relevant personnel are made aware of the changed requirements?

For Clause 7.2.3:

  1. How is product/service information provided to Customers?
  2. How are inquiries handled? Placing of orders? Changes to orders?
  3. How can Customers provide feedback? Is there a process to handle it?
  4. Does the organisation identify and implement arrangement for communication with the customers relating to product information, Inquiries, contract or order handling, including amendments and Customer feedback, including customer complaints.

Mandatory Procedure : Not applicable

Mandatory record: Records of the results of the review and actions arising from the review shall be maintained-Contract Review

pdf Example of format for contract review

Evidence/ Implementation document ( Not mandatory but helps in fulfillment of requirement):
For Clause 7.2.1:

Customer requirements extend beyond product specifications and include – on-time delivery, packaging, labeling, mode of delivery, documentation, communications, QMS requirements, after sales servicing, etc. Documents are needed for effective planning, operation and control of production activities: contracts, specifications, orders, product quality plans, work instructions, a documented procedure, etc., combined with unwritten practices, procedures and methods.

pdf Example of format of verbal order register

For Clause 7.2.2:

Evidence of review of customer requirement may include Minutes of meeting of contract review, procedure for contract review, Verbal Communication form, Order Acknowledgment,Proforma Invoice,Invoice Excise, Quotation form, Product Catalogs etc.

pdf Example of Procedure for contract review

For Clause 7.2.3:

Customer communications – management representative, computerized interfaces and software for product (EDI, CAD), Customer provided software and interfaces for design and development, logistics, customer satisfaction feedback.

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