Maintained and Retained Documented Information Required by ISO 9001:2015

ISO 9001: 2015 menetapkan persyaratan untuk sistem manajemen kualitas ketika sebuah organisasi:

• perlu menunjukkan kemampuannya untuk secara konsisten menyediakan produk dan layanan yang memenuhi pelanggan dan hukum yang berlaku dan persyaratan peraturan, dan
• bertujuan untuk meningkatkan kepuasan pelanggan melalui penerapan yang efektif dari sistem, termasuk proses untuk perbaikan sistem dan jaminan kesesuaian dengan pelanggan dan persyaratan hukum dan peraturan yang berlaku.

Semua persyaratan ISO 9001: 2015 yang generik dan dimaksudkan untuk dapat diterapkan pada setiap organisasi, terlepas dari jenis atau ukuran, atau produk dan layanan yang menyediakan.

Istilah dokumen wajib di ISO 9001 :2008 ,  pada versi baru di ubah menjadi Maintained and Retained Documented Information. Beberapa dokumen yang harus ada, diantaranya :

1. The Scope of QMS (4.3)
2. Process Documentation (4.4)
3. QMS Policy (5.2.2)
4. Information on the objectives (6.2.1)
5. The “fitness for purpose” of monitoring and measurement resources (7.1.5)
6. The basis used for calibration or verification (7.1.5)
7. Evidence of Competence (7.2)
8. Evidence that processes have been carried out as planned (8.1)
9. Results of the review of customer requirements (8.2.3)
10. Confirmation that design and development requirements, and any changes have been met (8.3.2, 8.3.6)
11. Results of Evaluation, performance and re-evaluation of providers of external providers (8.4.1)
12. Characteristic of products and services provided (8.5.1a)
13. Activities to be performed and results achieved (8.5.1b)
14. Information to maintain traceability, where appropriate (8.5.2)
15. Review of changes in production or service provision (8.5.6)
16. Authorization concerning the release of products and services to the customers (8.6)
17. Actions taken on nonconforming process outputs, products and services (8.7)
18. Evidence of the results on monitoring and measurement activities (9.1)
19. Internal audit programs and audit results (9.2)
20. Results of management reviews (9.3)
21. Nonconformities and outcome of corrective action (10.1)

Sumber : 

• Modul Training ISO 9001:2015 Quality Management Systems Auditor/Lead Auditor Course (IRCA Cert. No A 17977) SGS Indonesia 15-19 February 2016.
• QualityClub@yahoogroups.com