How about ISO 9001 2015

Activities after delivery - how to stay compliant with ISO 9001: 2015 - Tips for the revision of ISO 9001 series part 5

The activities after delivery were only dealt with rudimentary by DIN EN ISO 9001: 2008 in that in subsection 7.5.1 c) the implementation of product release, delivery activities and “activities after delivery” were required. However, the details of these post-delivery activities remained in the dark. DIN EN ISO 9001: 2015 is much more specific here and, in subsection 8.5.5, lists typical factors that need to be addressed in order to adequately clarify the requirements. How complex this can be is revealed, for example, by the question of the extent to which a company that supplies machines is obliged to supply customers with spare parts. Clearly clarifying this question is associated with a lot of effort and research. But this effort is worth it, not least because of the legal certainty and satisfied customers. In this article you can read which activities are necessary after delivery, what ISO 9001 requires and which legal regulations you have to observe.

Our ISO 9001: 2015 series with tips and tricks for operational implementation:

Part 1:The quality management standard ISO 9001: 2015 emphasizes the service sector more - difference between
Product and service
Part 2:The new process requirements of ISO 9001: 2015 - this is how you keep track and adapt the ISO 9001 processes
optimally
Part 3: ISO 9001: 2015 requires in section 9 of the standard the "performance evaluation" - like you an objective and appropriate one
Ensure performance evaluation
Part 4: Measurement and monitoring of processes - with these QM key figures you meet the requirements of ISO 9001: 2015
to
Part 5: Activities after delivery - how to stay compliant with ISO 9001: 2015

Also read:
‏            ISO 9001: 2015 series on the structural and normative changes


Delivery or completion of services is not enough - ISO 9001 requires activities

DIN EN ISO 9001: 2008 already referred to the fact that the delivery of a product or the completion of the service is not enough. DIN EN ISO 9001: 2015 now goes into more detail in subsection 8.5.5 on these activities and demands that requirements be met if these are relevant after delivery of the product or provision of the service. For the determination of possible activities after delivery, in this subsection 8.5.5 of the standard, we find the following checklist with points to be checked:

a. Legal and regulatory requirements.
b. Possible undesirable consequences related to products and services.
c. The nature, use, and intended lifespan of the products and services.
d. Customer requirements.
e. Feedback from customers.

In the note following this list, it is pointed out that typical activities after delivery include aspects such as warranty provisions, contractual obligations, maintenance and additional services such as recycling or disposal.

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These are typical post-delivery activities

Delivery can relate to both products and services. Post-delivery activities typically extend to providing services. The activities in the context of these services can vary in intensity. In the following, the activities shown in the graphic above, which are sorted in ascending order according to intensity, are outlined and described in terms of their focus. This is intended to give the reader the opportunity to check the specifications made so far and, if necessary, to adapt or add to them.


Acceptance for the definition of the transfer of risk

The legal term of acceptance generally describes the process of determining whether a thing or a service item meets certain criteria and can be confirmed as suitable for performance. The successful acceptance is very important, because with this, the remuneration is typically due, the limitation period begins to run and the risk is transferred. For the client this means, among other things, that the burden of proof for the existence of a defect is now on him. This is also known as reversing the burden of proof. After the delivery of machines, a formal commissioning should take place in addition to the acceptance. All project documents (plans, operating instructions and instruction protocols) are handed over. Associations such as VDMA, VDA or large corporations have drawn up guidelines for acceptance, which bundle experience and provide companies with instructions for professional acceptance processes. Due to the importance of acceptances or commissioning, the results of these should be stored, i.e. archived, as documented information - with the names of the persons performing them - in accordance with statutory deadlines.

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Training of customers and hotline as possible activities after delivery

Customer training is of particular importance as an important service. Especially in the area of ​​complex products and services, customer training is the basis so that customers can take full advantage of the service. Customer training courses have other positive side effects:

  • Strengthening customer loyalty;
  • Reducing the risk of improper use;
  • Avoidance of unplanned service costs;
  • Generating further sales through post-purchase satisfaction.

Hotlines are of similar importance as permanently open telecommunication connections with direct access to customer service. The customer receives problem-oriented information and support services for questions about the products or services provided.


Warranty and non-contractual liability

The warranty or liability for defects (as the law calls it) establishes the statutory rights within the framework of the law of obligations that the buyer has after delivery or service provision if a defect is present. In this context, the possibilities of exclusion of liability set out in the German Civil Code must be taken into account, which are permissible in the event of the conclusion of a contract between commercial contracting parties. Further activities that may be required after delivery can be derived from other legal perspectives, summarized from non-contractual liability (fault liability / unlawful liability). Particularly important in connection with the activities after delivery are the product monitoring obligations, which are divided as follows:

Passive product monitoring
Collection of detailed information from complaints, customer complaints, feedback from sales representatives. If this information shows a significant accumulation, this indicates a product defect.

Active product monitoring
With high-risk products, it is not enough to wait for incoming reports. In this case, the manufacturer must search proactively, e.g. by carrying out customer surveys or use tests and trials, evaluating service reports, analyzing almost damage cases.

The results of the product monitoring must be evaluated in order to identify whether the errors are outliers (random error) or whether there is a development error (systematic error). If it is clearly established that a systematic error has occurred, the delivered products must be recalled from the shelves of the dealers and from the hands of the consumers.

Video: What is an ISO 9001 Quality Management System?

Video: High Level Structure ISO 9001


The seven areas of duty of a goods manufacturer

The duties listed below apply regardless of the product type:

1. Construction and planning obligations
2. Manufacturing obligations
3. Obligations to organize operations
4. Participant and supplier obligations
5. Duty to give instructions
6. Product monitoring obligations
7. Personnel obligations

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Further activities after delivery, secure operation through repairs and the supply of spare parts

Machine dealers and their manufacturers are faced with the question of providing spare parts. Regardless of specific agreements in separate maintenance or delivery contracts with the individual customers, legal obligations could require that spare parts for delivered products be kept available. A clear answer to this question is difficult because there are no comprehensive legal regulations. Companies can use the following guideline as a guide. The obligation to deliver spare parts is stronger the more valuable and durable the commodity is. Really concrete requirements can be derived from the following circumstances:

  • In the case of defective products, i.e. customer claims under the warranty, there may be obligations to
    Rectification / subsequent delivery;
  • In the event of wear and tear of the products in the context of contractual use, there is an obligation to keep and
    Delivery of certain spare parts based on the principle of good faith (§ 242 BGB).

In addition to the supply of spare parts, repair services can also be considered in many cases, which include troubleshooting, repair or replacement of defective components as well as a final test to ensure functionality in accordance with the specifications. Although not mentioned conceptually in the German Civil Code (BGB), the repair contract is legally a contract for work and services within the meaning of Section 631 BGB, which increases the risks for a company that offers repair services. A further increase in the responsibilities of the supplier would be given with the provision of personnel and materials for the independent operation of plants on behalf of the customer. For these recurring services, agreements in the form of so-called service level agreements (SLA) are made as an interface between the client and the service provider. The background of this SLA is often the outsourcing or the outsourcing of parts of the value chain to external service providers.


There are obligations from the cradle to disposal

The extended producer responsibility of the European Union (Extended Producer Responsibility = EPR) defines the legal obligation of the manufacturer to bear responsibility for his own product over its entire life cycle and also after its end of life. Ordinances regulate the post-use phase of many product or process-related elements, such as packaging, waste paper, tires, cars, electronic products. A distinction is made between the phases of production / transport, use (see scope of duties / liability for dangerous products) and disposal. Since the legal perspectives in this area are now very extensive, regulations can only be dealt with by way of example:

KrWG:
Recycling law with a five-level waste hierarchy - avoidance, preparation for reuse, recycling, other recovery, disposal;

Packaging Ordinance:
Ordinance on the avoidance and recycling of packaging waste, such as sales packaging, outer packaging, transport packaging;

AltfahrzeugV:
End-of-Life Vehicle Ordinance on the transfer, return and environmentally friendly disposal of end-of-life vehicles;

ElektroG:
Electrical law on the return and disposal of electrical and electronic equipment;

BattG:
Battery Act to exercise responsibility for the disposal of old batteries.

I wish you every success with the implementation,
Your Reinhold Kaim


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