ISO 9001 Training
 Understanding ISO 9001:2008

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ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

7.2 Customer Related Processes - Continued  

7 Product Realization  

7.2 Customer-Related Processes   

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. 

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. 

7.2.3 Customer Communication 

The organization 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. 

 




 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ISO 9001 Training - Key Explanation Points and Tips:

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 (from customer or internal) 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.

For customer communication refer to clause 5.2 customer focus. Depending on your business and industry, customer communication can take place in many ways - your  product catalogue, producty brochures, product drawings and specifications, website, CRM software, online order entry, automatic inventory replenishment, emails, attachement, PO's, RFQ's, order confirmation, change orders, sales calls, meetings with customer engineering, customer satisfaction feedback, dealing with complaints and return material requests, logistics, warrantly claims, installing arrangements, witness testing, etc., are some examples of customer communications. You must ensure that personnel at all levels have the competency and training to use these communications media and tools.

Clause 7.2 does not require a ‘documented’ procedure. However, you must identify and document all processes addressing this clause as part of your QMS (see clause 4.1). For these processes, you must also identify what specific documents are needed for effective planning, operation and control of production activities (see clause 4.2.1d).

These documents may include - contracts; specifications; orders; product quality plans; work instructions; a documented procedure; etc., combined with unwritten practices, procedures and methods.

Do you have an effective process for controlling these various means of communications and ensuring that no requirments get overlooked. Consider controls such as CRM,  order processing and ERP or similar software, key review checkpoints, interdepartment review and meetings, checklists, forms.

Look at the risks related to your product, processes and resources in determining the nature and extent of documented controls you need to have (also see clause 4.2.1 notes).

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. What would be useful quality objectives for customer-related processes? You should consider any combination of the following - Incomplete inquiry checklist; Late cost estimates;  Revisions to proposals; Incorrect order information; Incomplete/inaccurate cusotmer database;  Sales order entry errors, reduce quote cycle times, pre and post-award review cycle time and improvement in conversion ratio (i.e. ratio of contracts/orders awarded to quotes). Track performance to these measurables and take corrective actions to drive continual process improvement of customer-related processes.

For performance indicators for customer communications processes, see clause 5.5.3 first paragraph of key explanation points and tips.

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