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Mandatory Documents and Records Required

The document outlines the mandatory documented information required by ISO 9001:2015, which includes maintaining records of monitoring and measuring equipment calibration, training and qualifications, product requirements reviews, design and development outputs and changes, production and service provision, and customer property. It also lists non-mandatory documents such as procedures for determining organizational context, addressing risks and opportunities, competence and training, equipment maintenance, and more. All ISO 9001:2015 requirements are intended to be generically applied to any organization regardless of type, size, or products and services provided.

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255 views

Mandatory Documents and Records Required

The document outlines the mandatory documented information required by ISO 9001:2015, which includes maintaining records of monitoring and measuring equipment calibration, training and qualifications, product requirements reviews, design and development outputs and changes, production and service provision, and customer property. It also lists non-mandatory documents such as procedures for determining organizational context, addressing risks and opportunities, competence and training, equipment maintenance, and more. All ISO 9001:2015 requirements are intended to be generically applied to any organization regardless of type, size, or products and services provided.

Uploaded by

aldi_dudul
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Mandatory documents and records required by ISO 9001:2015

A. Mandatory Document
1. Scope of the QMS (clause 4.3)
2. Quality policy (clause 5.2)
3. Quality objectives (clause 6.2)
4. Criteria for evaluation and selection of suppliers (clause 8.4.1)

B. Non-mandatory documents
1. Procedure for determining context of the organization and interested parties (clauses 4.1
and 4.2)
2. Procedure for addressing risks and opportunities (clause 6.1)
3. Procedure for competence, training and awareness (clauses 7.1.2, 7.2 and 7.3)
4. Procedure for equipment maintenance and measuring equipment (clause 7.1.5)
5. Procedure for document and record control (clause 7.5)
6. Sales procedure (clause 8.2)
7. Procedure for design and development (clause 8.3)
8. Procedure for production and service provision (clause 8.5)
9. Warehousing procedure (clause 8.5.4)
10. Procedure for management of nonconformities and corrective actions (clauses 8.7 and 10.2)
11. Procedure for monitoring customer satisfaction (clause 9.1.2)
12. Procedure for internal audit (clause 9.2)
13. Procedure for management review (clause 9.3)

C. Mandatory records
1. Monitoring and measuring equipment calibration records* (clause 7.1.5.1)
2. Records of training, skills, experience and qualifications (clause 7.2)
3. Product/service requirements review records (clause 8.2.3.2)
4. Record about design and development outputs review* (clause 8.3.2)
5. Records about design and development inputs* (clause 8.3.3)
6. Records of design and development controls* (clause 8.3.4)
7. Records of design and development outputs *(clause 8.3.5)
8. Design and development changes records* (clause 8.3.6)
9. Characteristics of product to be produced and service to be provided (clause 8.5.1)
10. Records about customer property (clause 8.5.3)
11. Production/service provision change control records (clause 8.5.6)
Maintained and Retained Documented Information
Required by ISO 9001:2015

ISO 9001: 2015 menetapkanpersyaratanuntuksistemmanajemenkualitasketikasebuahorganisasi:

a) perlumenunjukkankemampuannyauntuksecarakonsistenmenyediakanprodukdanlayanan
yang memenuhipelanggandanhukum yang berlakudanpersyaratanperaturan, dan
b) bertujuanuntukmeningkatkankepuasanpelangganmelaluipenerapan yang efektifdarisistem,
termasuk proses
untukperbaikansistemdanjaminankesesuaiandenganpelanggandanpersyaratanhukumdanper
aturan yang berlaku.

Semuapersyaratan ISO 9001: 2015 yang


generikdandimaksudkanuntukdapatditerapkanpadasetiaporganisasi, terlepasdarijenisatauukuran,
atauprodukdanlayanan yang menyediakan.

Istilahdokumenwajib di ISO 9001 :2008 , padaversibaru di ubahmenjadiMaintained and Retained


Documented Information. Beberapadokumen yang harusada, 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.

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