ISO 9001 Training
Understanding ISO 9001:2008
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ISO 9001 TrainingUnderstanding ISO 9001:2008
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7 Product Realization 7.4 Purchasing 7.4.2 Purchasing Information Purchasing information shall describe the product to be purchased, including, where appropriate: a) requirements for approval of product, procedures, processes and equipment, b) requirements for qualification of personnel, and c) quality management system requirements. The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. 7.4.3 Verification of Purchased Product The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where the organization or its customer intends to perform verification at the supplier's premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information. |
7.4.2 Purchasing Information
ISO 9001 Training - Key Explanation Points and
Tips:
Your purchase
documents (purchase order, contract, blanket order, your organization’s supplier quality manual, etc.) must specify
your requirements for the purchased product; controls for the suppliers/subcontractors QMS and any other initial or
on-going controls you deem necessary for ensuring consistent supplier
performance.
You must define how you ensure the adequacy
of these documents before you communicate them to your supplier or subcontractor. A review of adequacy of
purchasing documents may include their completeness, accuracy, correctness, quantity, timing, cost, approval, etc.,
by one or more functions; computerized controls, etc.
In
larger organizations, this may be a separate process on-site or off-site. In either case, it must be identified and
controlled as per clause 4.1 along with 7.4.2.
While clause 7.4.2 does not specify keeping of records, you
must show evidence of carrying out (issue purchase documents) and review of these documents (see clause 7.1d
and 4.2.4 first sentence).
7.4.3 Verification of Purchased Product
Key Explanation Points and Tips:
Verification of
purchased product can range from doing no verification to 100% verification. You have flexibility in determining
the scope of purchased product verification.
As indicated earlier in 7.4.1, you can apply different controls for different
suppliers and products depending on your initial supplier evaluation and their ongoing product quality and delivery
performance. In any case these controls must be included or referenced in your quality or inspection
plans.
To the extent that you decide to do
verification of purchased product, you also have flexibility in when you do the verification. You can do it on
receipt, prior to use in production, during production and in some situations after
production. Obviously, the earlier the control is exercised, the more preventive it is and will reduce the
extent of post production verification and rework. Make sure you appropriately control un-inspected material or
product. This may include identification and storage to prevent unintended
use.
Consider using supplier quality plans,
inspection plans, etc., to verify that purchased product meets specified purchase (product and QMS)
requirements.
Your inspection process must define and document the acceptance
criteria and sampling plan for product conformity and what measurement tools needed. and records needed
to show effective control of purchased product quality and supplier
performance.