Record ISO 9001:2008

Record atau rekaman ada disetiap perusahaan. Contoh rekaman misalnya notulen rapat. Notulen rapat sebuah contoh rekaman yang menunjukkan bukti bahwa suatu agenda telah dibahas dalam suatu rapat. Hasil notulen digunakan sebagai acuan mengambil keputusan.

Jadi, rekaman berisi informasi sebagai dasar pengambilan keputusan. Oleh sebab itu, rekaman wajib dikelola dengan baik.

Mengelola rekaman termasuk tata cara penyimpanan rekaman, perlindungan rekaman agar tidak rusak atau hilang, penetapan masa simpan supaya tidak menumpuk sebab setiap hari rekaman banyak dibuat, pengidentifikasian rekaman agar mudah dikenali atau dicari, tata cara pengambilan rekaman saat diperlukan, dan pemusnahan rekaman bila melewati masa simpan.

Pengelolaan rekaman diatur standar ISO 9001:2008 dalam klausul 4.2.4 Pengendalian rekaman.

4.2.4 Pengendalian rekaman Rekaman sebagai bukti kesesuaian persyaratan dan pengoperasian sistem manajemen mutu yang efektif harus dikendalikan. Organisasi harus menetapkan prosedur terdokumentasi untuk menetapkan kendali yang diperlukan untuk identifikasi, penyimpanan, perlindungan, pengambilan, masa simpan, dan pembuangan rekaman. Rekaman harus mudah dibaca, siap ditunjukkan dan diakses jika diperlukan.

 

Rekaman yang diminta harus tersedia antara lain:

• 5.6.1 Management reviews
• 6.2.2 e Education, training, skills and experience
• 7.1 d Evidence that the realization processes and resulting product fulfils requirements
• 7.2.2 Results of the review of requirements related to the product and actions arising from the review
• 7.3.2 Design and development inputs relating to product requirements
• 7.3.4 Results of design and development reviews and any necessary actions
• 7.3.5 Results of design and development verification and any necessary actions
• 7.3.6 Results of design and development validation and any necessary actions
• 7.3.7 Results of the review of design and development changes and any necessary actions
• 7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations
• 7.5.2 d As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by
• 7.5.3 The unique identification of the product, where traceability is a requirement
• 7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use
• 7.6 a Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist
• 7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
• 7.6 Results of calibration and verification of measuring equipment
• 8.2.2 Internal audit results and follow-up actions
• 8.2.4 Indication of the person(s) authorizing release of product
• 8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
• 8.5.2 Results of corrective action
• 8.5.3 Results of preventive action

Baca juga

• Prosedur Pengendalian Rekaman
• Definisi Rekaman