ISO/IEC 17025

This section covers remedial action while section 4.11 covers corrective action.
Use the example of a balance past the calibration due date. The following would be the results of section 4.9 control of nonconforming testing and/or calibration work:
- stop using the balance
- check other balances to determine calibration status
- calibrated any balances past due
- review results of calibration: balances within calibration requires no recall on work while calibrations outside limits require notification of clients regarding recalls
- evaluate the significance to determine if this is potentially repetitive or related to a potential problem with procedures
- when the evaluation has confirmed that this is potentially repetitive or related to a system problem then initiate corrective action (i.e., a management system change beyond the remedial action of calibrating them). If there is no reason to suspect the recurrence of the problem then the nonconformity is closed and no further need for a corrective action.

The following requires corrective action:
- investigate all direct and indirect processes related to the maintenance of the balance calibration status: causes and potential causes of the problem
- determine the most likely cause or causes
- decide if any actions are needed to eliminate the causes
- undertake any action necessary to elminate these causes and to prevent such a mistake from recurring
- do necessary follow-up
- monitor for effectiveness
- close out the corrective action

Correction = remedial action = correcting the nonconformity

Corrective action = investigate related processes or systems to determine the root cause and eliminate

The lab must have a policy and procedure for the resolution of complaints received from customers. The lab must also keep records of all complaints which include investigations and corrective actions taken by the lab.

Interpretation: ISO 17025 does not provide many definitive requirements for complaints other than producing records of their investigation and resolution. It is not necessary for complaints to produce corrective actions. A complaint can begin by being founded or not. When it is founded, it usually implies that there is a t least a nonconformity: something needs to be done to correct a problem identified by a customer. Whether this problem is potentially repetitive or related to a systemic defect will lead to the need to initiate a corrective action. Also, complaints that are not founded can lead to identifying needs for improvement or initiating preventive action. The need to provide feedback to the customer on the outcome of the investigation should form an intrinsic element of a complaint handling procedure.

iso 17025

4.7.2 The lab seeks feedback from its customers. This feedback is used and analysed to improve the management system, testing and calibration activities and customer service.

Feedback = positive and negative

Interpretation: feedback could involve customer satisfaction surveys and review of test or calibration reports with customer. The requirement for analysis provides a critical element of management review. The surveys must be meaningful in covering the activities of the lab. This requirement properly implemented will provide a source for continual improvement of the management system.

iso 17025

4.7.1 A customer's request that involves monitoring the lab's performance with respect to the work performed will be accomodated by the lab. The lab will cooperate with the respective customer or their representatives. The lab must ensure that they maintain the confidentiality of their other customers.

Note - access to lab would involve witnessing the test or calibration being performed.
Good communication, advice and guidance in technical matters, and opinions and interpretations based on results are valued services for customers.
Communications on large projects should be done periodically throughout the work.
Delays or deviations should also be communicated to the customer.

Interpretations:
Careful consideration of potential implications must be addressed prio to providing customer access to the lab to address such items as protection of the confidentiality of all the lab's customers, including the confidentiality of test/calibation items that could belong to competing cusotmers or protected by legal implications.

This clause is also cross-referenced to ISO 9001:2000 clause 6.1 (b).

iso 17025

4.6.4 Suppliers of critical consumables, supplies and services that affect test/calibration quality must be evaluated by the lab. Records of the evaluation and an approved suppliers list are maintained.

Interpretation and ISO 9001 clause 7.4.2
The organization establishes effective and efficient processes to identify potential sources for purchased materials, to develop existing suppliers or partners, and to evaluate their ability to supply the required products in order to ensure the effectiveness and efficiency of overall purchasing processes.

Examples of inputs to the supplier control processes include:
- evaluation of relevant experience
- performance of suppliers against competitors
- review of purchased product quality, price, delivery performance and response to problems
- audits of supplier management systems and evaluation of their potential capability to provide the required products effectively and efficienty and within schedule
- checking supplier references and available data on customer satisfaction
- financial assessment to assure the viability of the supplier throughout the intended period of supply and cooperation
- supplier response to inquiries, quotations and tendering
- supplier service, installation and support capability and history of performance to requirements
- supplier awareness of and compliance with relevant statutory and regulatory requirements
- supplier's logistic capability including locations and resources
- suppliers's standing and role in the community as well as perception in society

Management should consider actions needed to maintain the organization's performance and to satisfy interested parties in the event of supplier failure.

iso 17025

4.6.3 Documents for purchasing items affecting lab quality must contain data describing the services and supplies ordered. Purchasing documents are reviewed and approved for technical content before release.

Interpretation:
Selection of physical measurement calibration sources for testing labs requires specific requirements to be met by applicant and accredited testing labs in the purchase of calibration services. Labs must develop and implement procedures that meet these requirements and make available for review the requirements to outside providers of traceability.

Accredited calibration labs must in addition comply with the respective national standards of their country.

Accredited test labs must have policies for specifying the details of their calibration needs to their suppliers of calibration services.

iso 17025

4.6.2 The lab must ensure that purchased supplies and reagents and consumable materials that affect the quality of tests and/or calibrations are not used until they have been inspected or otherwise verified as complying with standard specifications or requirements defined in the methods for the tests and/or calibrations concerned. These services and supplies used must comply with specified requirements. Records of actions taken to check compliance must be maintained.

ISO 9001:2000 Reference - clause 7.4.3
The organization must 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 must state the intended verification arrangements and method of product release in the purchasing information.

iso 17025

4.6.1
POLICY and PROCEDURE must be in place for selecting and purchasing services and supplies.

The purchasing procedures for reagents and lab consumable materials must include details on:
- purchase
- reception
- storage


ISO 9001:2000 Interpretation Reference clause 7.4.1
Top management of the organization must ensure that effective and efficient purchasing processes are defined and implemented for the evaluation and control of purchased products, in order that purchased products satisfy the organization's needs and requirements, as well as those of interested parties.

Use of electronic linkage with suppliers should be considered in order to optimize communication of requirements.

To ensure the effective and efficient performance of the organization, management should ensure that purchasing processes consider the following activities:
- timely, effective and accurate identification of needs and purchased product specifications
- evaluation of the cost of purchased product, taking account of product performance, price and delivery
- the organization's need and criteria for verifying purchased products
- unique supplier processes
- consideration of contract administration, for both supplier and partner arrangements
- warranty replacement for nonconforming purchased products
- logistic requirements
- product identification and traceability
- preservation of product
- documentation, including records
- control of purchased product which deviates from requirements
- access to supplier's premises

iso 17025

- product delivery, installation or application history
- supplier development
- identification and mitigation of risks associated with the purchased product

Requirements for suppliers' processes and product specifications must be developed with suppliers in order to benefit from available supplier knowledge. The organization could also involve suppliers in the purchasing process in relation to their products in order to improve the effectiveness and efficiency of the organization's purchasing process. This could also assist the organization in its control and availability of inventory.

The organization must define the need for records of purchased product verification, communication and response to nonconformities in order to demonstrate its own conformity to specification.

4.5.4
The lab must maintain a Register of Subcontractors list. Records of compliance with ISO 17025 must be available.

Interpretation:
If a subcontractor is not accredited for the specific service, the lab must ensure that qualified and trained personnel conduct an onsite assessment of the subcontractor's facilities and must conduct regular reassessments, or otherwise ensure to the accreditation body's satisfaction the adequate competence of the subcontractor. The lab must retain records of training and qualifications of the personnel that conduct such assessments. Such an on-site assessment must cover at least all the elements of ISO 17025. Evidence of this assessment as well as findings and their resolution, must be available for review. Evidence of compliance to ISO 17025 is not applicable in the case of customer or regulator specified subcontractors.

iso 17025

4.5.3
The lab is responsible for the subcontractor's work.

Subcontractor competence could be demonstrated through:
- accreditation
- registration
- certification
- check sample / proficiency sample results
- audit results

iso 17025

4.5.2 Customer Approval
Customers must be advised in writing when any portion of their work is subcontracted to another laboratory.

Note:
It is not a requirement that the lab identify to whom they had subcontracted a test or the name of the subcontractor. Under the requirement of this section, the lab must however inform their clients of their intent to subcontract prior to having the work subcontracted. Records of client consent must be retained.

An ISO 17025 accreditation for a specific scope of capabilities and for a specific site. The requirements for subcontracting actually apply in principle only to the subcontracting of an accredited test/calibration. The subcontracting of accredited tests/calibrations should not be confused with subcontracting of other tests and work. Organizations routinely subcontract work for a variety of reasons and when this work is not an accredited test/calibration, the conditions of ISO 17025 section 4.5.1 do not actually apply as far as accreditation requirements are concerned.

Examples of activities and work that are not considered subcontracting:
- calibration of measurement or test equipment when the lab is not accredited for calibrations
- outsourcing part of a test/calibration for which the lab is not accredited

These examples would essentially be considered purchasing and in the case of the second point the accrediting body would not be reviewing the activity. The first item would be reviewed under the requirements of 4.6 Purchasing and 5.6 Traceability.

ISO 17025 views subcontracting much more formally than what most organizations normally practice. When an organization has different subcontracting practices than those required by ISO 17025, then different procedures are required with a clear distinction within the procedures as to when the ISO 17025 procedures apply.

When a lab is subcontracting an accredited test/calibration (for whatever reason) to another lab that is part of the same legal entity and is accredited for the specific test being subcontracted, the accrediting body does not consider the movement of this test/calibration item between such facilities as subcontracting. The test/calibration report produced will however need to be identified to the facility that conducted the test/calibration. The requirements of ISO 17025 section 5.8 Handling of Test and Calibration Items applies.

iso 17025

4.5.1
Competent subcontractors must be utilized when a laboratory must subcontract work out.

Interpretation:
When a lab never performs a test/calibration, it cannot be granted accreditation for that test/measurement.

When a lab subcontracts a test or calibration for which they are accredited, such as to meet peak demands, preference is given to ISO 17025 accredited labs. The requirements for subcontracting in section 4.5 of ISO17025 must be applied. Refer to interpretative note section 4.5.4. Records of review of the scope of accreditation of the service provider must be available.

When a testing lab subcontracts calibrations for which they are not accredited, this is not considered subcontracting and requirements of sections 4.6 and 5.6 of ISO 17025 are applied to these purchases for purposes of accreditation.

When a testing lab subcontracts calibrations for which they are not accredited or when a calibration lab subcontracts calibrations for which they are not accredited then the requirements of section 4.5 of ISO 17025 may be applied at the lab's discretion. However, these subcontracted tests or calibrations are outside the scope of accreditation.


iso 17025