ISO 9001 Training
Understanding ISO 9001:2008
Delicious
Digg
Reddit
Stumbleupon
Ma.gnolia
Facebook
Newsvine
BlinkList
Spurl
ISO 9001 TrainingUnderstanding ISO 9001:2008
|
|
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:
Customer
related processes must include controls for determining customer and regulatory requirements; a review of such
requirements; and communication with the customer. The starting point would be the inputs from customers and
potential customers stating their requirements - documented or undocumented. Any response to information requests
or customer request for quotation or a Purchase Order, that creates a commitment must be reviewed in terms of
capabiity and capacity to meet the customers requirements, needs to be reviewed before that commitment is
made or alternately ensure that you can later organize those resources to meet that commitment. That is why clause
7.1 realization planning is so important.
Customer
requirements extend beyond product specifications and may include - on-time delivery; packaging; labeling, mode of
delivery, documentation, communications, QMS requirements, after sales servicing, onsite installation, warranty
service, 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 (see clause
4.1).
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. Be careful of taking on other suppliers
problems!
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. Be careful of
taking on other suppliers problems!
Manufacturing risk analysis is an
assessment of your organization’s capacity and capability to effectively and efficiently provide the customer
specified deliverables. Your risk analysis should include timing; resources; development costs and investments;
potential for, and effects of, possible failures in processes, including your suppliers. You should also consider
financial and profitability risk.