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The purchasing information shall provide information about the purchased products (off course). The organization shall ensure that an order contains the required information prior to transferring it to the supplier. While defining the information of the purchase process, the organization would refer the next issues:
ISO 9001
| ISO 13485
| The information of purchased product would define the product and its characteristics.
When validation of products required at the suppliers premises, it is required to be documented.
| The information of purchased product would define the product and its characteristics.
When validation of products required at the suppliers premises, it is required to be documented.
| Requirements for approving products including processes, procedures, equipment etc.
| Requirements for approving products including processes, procedures, equipment etc. | The information shall regard employees' trainings and qualifications required to perform the purchase.
| The information shall regard employees' trainings and qualifications required to perform the purchase.
| The information would regard any quality requirements.
| The information would regard any quality requirements.
| | | Traceability requirements required on chapter 7.5 are applicable to purchased products as well. Therefore the organization must document the traceability over purchased product and records would be introduced to the records control procedure as required in chapter 4.2.4 – control of records.
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When performing purchase processes the organization shall: - Identify the required product – any information that related to product (name, serial number, quantities
- Identify the requirements of the product - technical specifications, edition,
- Identify any supplemental requirements such as regulatory requirements - quality documentation, safety documentation
- Identify operational requirements that the supplier must follow - packaging requirements, delivering requirements, quality tests requirements, training requirements
- Identify additional requirements – any additional requirement needed to accept an effective product.
The purchasing process is required to be reviewed and verified. In other words, every order must be checked that all details are included and approved by a relevant authorized person. There is one crucial additional requirement for the purchase information. Traceability and records of traceability must be maintained. This requirement makes a whole difference between the ISO 9001 Standard and the ISO 13485 Standard. The organization, must introduce the purchased products to traceability requirements as required in chapter 7.5 paragraph 7.5.3.2. The main idea is to provide the ability to trace back any purchased product. Traceability of the purchased products would start from the purchasing order and would finish at the customer's site (after delivering). From the beginning until the end. Review the next example to understand why. Where the medical device components, materials or work environment may cause the medical device not to satisfy its specified requirements, records would be maintained and kept. That means that any purchased component of the product that may cause any problem or non conformity to meet the medical device requirements after delivering the it, must be under a method of traceability. This requirement is very logic. Why? Suppose that a medicaments company releases a batch of medicines. After three month it is discovered that one of chemical purchased components has gone bad. An employee performed a quality test and discovered that the material reacts not according to the requirements. As a result the entire batch is required to be removed of the shelves and quick. People's lives depend on that. By introducing the purchase process to the traceability requirements, the company may trace all the batches that were manufactured containing this certain gone bad chemical. Traceability requirements would be discussed during chapter 7.5. In order to ensure that the organization is controlling the traceability according to the ISO 13485 Standard requirements, it is required to submit the purchase process and its documentation (procedure, flow chart, work instruction, or whatever) to the documents control process. The records of the traceability must be submitted to the records control process. Do not belittle this subject. I can assure you that the auditor would insist on this matter. Turn to the next article about the ISO 13485 verification of purchased product requirements. |
