Section 7.1 Planning of Product Realization
In planning product realization, the organization shall determine the following, as appropriate:
b) the need to establish processes, and documents, and to provide resources specific to the product;
c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;
Hanya penambahan 'and' dan 'measurement', Bukan perubahan yang berarti.
Section 7.2.1 Determination of Requirements Related to the Product
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.
Perubahan pada subklausul c, kata 'related' menjadi 'applicable'
Perubahan pada subklausul d, 'determined by' menjadi 'considered necessary by'
Note 1, 2 dan 3 digabung menjadi satu Note.
Tidak ada persyaratan yang berubah, hanya dinyatakan dengan cara lain.
7.3.1 Design and Development Planning
Note: Design and development review, verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as suitable for the product and the organization.
Tambahan Note baru. Ini menegaskan bahwa tahapan review, verification and validation adalah aktifitas yang berbeda dan mempunyai tujuan yang berbeda pula. Perubahan ini mungkin terkait dengan banyaknya organisasi yang sulit membedakan mana, dalam aktifitas perancangan produk mereka, tahapan yang disebut 'review', 'verification' dan 'validasi'.
7.3.2 Design and Development Inputs
The inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.
Perubahan 'this' menjadi 'the'.
7.3.3 Design and Development Outputs
The outputs of design and development shall be in a form suitable for verification against the design and development input and shall be approved prior to release.
Note: Information for production and service provision can include details for the preservation of product.
Perubahan yang perlu diperhatikan adalah pada Note baru diatas. Inipun tidak mengandul 'shall', hanya menjelaskan bahwa cara-cara preservasi produk akhir (penjagaan dari kerusakan, misalnya bentuk kemasan, dapat menjadi keluaran dari proses perancangan produk.
7.5.1 Control of Production and Service Provision
d) the availability of monitoring and measuring equipment,
f) the implementation of product release, delivery, and post-delivery activities.
Subklausul d, Kata 'devices' menjadi 'equipment
Subklausul f, katan 'product' ditambahkan (tadinya tak ada)
Bukan perubahan yang berarti.
7.5.2 Validation of Processes for Production and Service Provision
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring and measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.
Hanya perubahan struktur kalimat. Tadinya paragraph diatas terdiri dari 2 kalimat.
7.5.3 Identification and Traceability
The organization shall identify product status with respect to monitoring and measurement requirements throughout product realization.
Penambahan kata 'throughout product realization'. Kelihatannya tidak penting karena dalam definisi 'produk' sudah dinyatakan bahwa produk bukan hanya produk akhir, tapi juga produk yang dihasilkan dari tahapan-tahapan realisasi produk.
Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records (see 4.2.4).
Frase bercetak tebal diatas tadinya:...and record the unique identification of the product (see 4.2.4). Hanya perubahan dalam struktur kalimat.
7.5.4 Customer Property
Note: Customer property can include intellectual property and personal data.
Penambahan kata 'personal data' pada Note. Tidak ada penjelasan lebih lanjut tentang apa yang dimaksud dengan personal. Bila mengacu pada kamus (cambridge), personal berarti 'relating to any single person'. Jadi perlu diklarifikasi apakah yang dimaksud data-data pegawai pelanggan? atau mungkin data perusahaan?
7.5.5 Preservation of Product
The organization shall preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to constituent parts of a product.
Perubahan struktur paragraph dan penambahan kata 'as applicable'. Perubahan ini membuat persyaratan tentang preservasi produk lebih longgar dan lebih masuk akal. Sebagai contoh, selama produk tidak mungkin rusak, mungkin saja produk diangkut tanpa pengemasan.
7.6 Control of Monitoring and Measuring Equipment
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.
Kalimat diatas sama dengan yang tercantum dalam ISO-9000:2000 tetapi referesi ke klausul 7.2.1 pada akhir kalimat dihilangkan.
Where necessary to ensure valid results, measuring equipment shall:
a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurable standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded (see 4.2.4);
Penambahan kata 'or both'. Dengan begitu, bila memang diperlukan, organisasi harus mengkalibrasi sekaligus memverifikasi alat ukur yang digunakan.
c) have identification in order to determine its calibration status;
Hanya perubahan struktur kalimat. Tadinya: Be identified to enable the calibration status to be determined.
Note: Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.
Note baru. Hanya perubahan tempat, tadinya dinyatakan di paragraph khusus, sekarang di Note dan perubahan struktur kalimat.
Perubahan lain dalam klausul 7.6 adalah penggantian semua kata 'device' menjadi 'equipment'
Bersambung ...
Ir. Iim Ibrohim
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