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ISO 9001 implementation: Mandatory documents and records Mandatory documents and records when it comes to the ISO 13485 implementation are previously discussed. It is turned to discuss the same regarding ISO 9001:2015 implementation. These are the documents to produce in order to be compliant with ISO 9001:2015: 4. Context of the organization Clause 4.3: Scope of the QMS 5. Leadership Clause 5.2: Quality policy 6. Planning Clause 6.2: Quality objectives 8. Operation Clause 8.4.1: Criteria for evaluation and selection of suppliers And, these are the mandatory records: 7. Support Clause 7.1.5.1: Monitoring and measuring equipment calibration records Clause 7.2: Records of training, skills, experience and qualifications 8. Operation Clause 8.2.3.2: Product/service requirements review records Clause 8.3.2: Record about design and development outputs review Clause 8.3.3: Records about design and development inputs Clause 8.3.4: Records of design and development controls Clause 8.3.5: Records of design and development outputs Clause 8.3.6: Design and development changes records Clause 8.5.1: Characteristics of product to be produced and service to be provided Clause 8.5.3: Records about customer property Clause 8.5.6: Production/service provision change control records Clause 8.6: Record of conformity of product/service with acceptance criteria Clause 8.7.2: Record of nonconforming outputs 9. Performance evaluation Clause 9.1.1: Monitoring and measurement results Clause 9.2: Internal audit program Clause 9.2: Results of internal audits Clause 9.3: Results of the management review 10. Improvement Clause 10.1: Results of corrective actions Please note that some of the documents and records won’t be mandatory if the company doesn’t perform relevant processes. Non-mandatory documents: There are numerous non-mandatory documents that can be used for ISO 9001 implementation. So, these are not mandatory, but commonly used in organizations: 4. Context of the organization Clauses 4.1 and 4.2: Procedure for determining the context of the organization and interested parties 6. Planning Clause 6.1: Procedure for addressing risks and opportunities 7. Support Clauses 7.1.2, 7.2, and 7.3: Procedure for competence, training, and awareness Clause 7.1.5: Procedure for equipment maintenance and measuring equipment Clause 7.5: Procedure for document and record control 8. Operation Clause 8.2: Sales procedure Clause 8.3: Procedure for design and development Clause 8.5: Procedure for production and service provision Clause 8.5.4: Warehousing procedure Clauses 8.7 and 10.2: Procedure for management of nonconformities and corrective actions 9. Performance evaluation Clause 9.1.2: Procedure for monitoring customer satisfaction Clause 9.2: Procedure for internal audit Clause 9.3: Procedure for management review A well-structured document system guarantees quality standard is met, reduces the possible errors, reduces downtime when deviations occur due to being able to rapidly access relevant data and allows easy monitoring of the processes. It will improve the organization’s efficiency ensuring that its QMS has a strong foundation.

ISO 9001 implementation: Mandatory documents and records

Mandatory documents and records when it comes to the ISO 13485 implementation are previously discussed. It is turned to discuss the same regarding ISO 9001:2015 implementation. These are the documents to produce in order to be compliant with ISO 9001:2015: 4. Context of the organization 5. Leadership… 

Green header banner for ISO 9001 Lecture 23 titled "Beginners guide through ISO 9001," featuring a global ISO watermark and the qmsWrapper logo.

Management review – Lecture 23

Lecture summary: A management review is a management tool in the hands of the top management for evaluating the QMS. It is one of the methods dictated by the ISO 9001 standard for monitoring the QMS and evaluating its performances and effectiveness. The QMS has to be reviewed at… 

Green header banner for ISO 9001 Lecture 22 titled "Beginners guide through ISO 9001," featuring a global ISO watermark and the qmsWrapper logo.

Internal audit – Lecture 22

Lecture summary: An internal audit is an effective tool that is used for self-assessment of your organization and to determine the extent to which it fulfills the QMS requirements. The audit findings will show you the effectiveness of your QMS and identify nonconformities and opportunities for improvement. ISO 9001… 

Green header banner for ISO 9001 Lecture 20 titled "Beginners guide through ISO 9001," featuring a global ISO watermark and the qmsWrapper logo.

Control of Nonconforming Outputs – Lecture 20

Lecture summary: Treating and managing nonconformities is one of the basic objectives of the ISO 9001 Standard. Nonconforming outputs are the outputs of processes that don’t meet a needed requirement or an expectation of one of the interested parties of the organization that are specified, implied,… 

Green header banner for ISO 9001 Lecture 19 titled "Beginners guide through ISO 9001," featuring a global ISO watermark and the qmsWrapper logo.

Release of products and services – Lecture 19

Lecture summary: Release of the product or services is about verification that the product and service requirements have been met according to customer requirements. Release activities aim to ensure that the realization of the product or the service has been expectedly completed and that the product or… 

Green header banner for ISO 9001 Lecture 18 titled "Beginners guide through ISO 9001," featuring a global ISO watermark and the qmsWrapper logo.

Production and service provision – Lecture 18

Lecture summary: Control of Production and service provision Standard ISO 9001 wants to say that you need to set up control by applying and enforcing a set of principles and conditions that will lead the realization process.  Control will allow you to monitor various parameters during the product realization… 

Green header banner for ISO 9001 Lecture 16 titled "Beginners guide through ISO 9001," featuring a global ISO watermark and the qmsWrapper logo.

Design and Development of products and services – Lecture 16

Lecture summary: On every activity that is part of the Design and Development (D&D), you should look at it as a process. Why? Because, the point is that through the process you make sure that the product will be according to expectations, in other words, set specifications.…