What are the 6 documents required by ISO 9001?

What are the 6 documents required by ISO 9001?


The standard identifies only six points where a documented procedure is required. Your organization will determine what other procedures are necessary to control your processes. This is a change from the 1994 system, which required procedures for all 20 clauses.

The quality manual must outline the policies, procedures and requirements of the Quality Management System. The system has to be structured to meet the conditions set out in ISO 9001:2000.

In your quality manual it is also necessary to identify all allowable exclusions. The scope and acceptable exclusions of the quality management system are detailed in section one of the manual. Action:

Most companies will start with a new quality manual structured to meet the new 2000 standard and organizational requirements. It is also possible to include further information in a quality manual if the Quality Management System does not require a suitable procedure to describe a part of the Quality System.

What are the documents required by ISO 9001?

The mandatory documents of the QMS, according to ISO 9001:2015, are the following: The scope of the quality management system (clause 4.3). … The quality objectives (clause 6.2). Documented information required and determined as necessary (clause 7.5.).

What does ISO 9001 2015 require in relation to documented information?

Documented information required by the Quality Management System and by ISO 9001 must be controlled to ensure that: a) It is available and suitable for use when and where it is needed. b) It is adequately protected.

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As part of ISO 9001:2015 must documented information about?

Documented information to be retained (Records) according to ISO 9001:2015: … Documented information; a) on review results; and b) on any new requirements for products and services. (Requirement Documented information on design and development inputs.


In this article we are going to review the new requirements of the organization context in ISO 9001:2015, so that you have a guide and indications for the preparation of the audit in ISO 9001: 2015, and have a checklist of transition to the updated standard useful.

The new clauses and requirements to follow are described in the list of new requirements in ISO 9001:2015, a new update that goes from point 4 to point 10 of the standard. Schematically:

In this article we focus on the new requirements of the organization context in ISO 9001:2015, the following sections that we list below, we will analyze them in following articles to know all the clauses and requirements.

Each organization has to identify and establish the aspects both internally and externally that may affect or be related to the achievement of its objectives and strategic direction, and that may condition or affect the achievement of the expected results to be achieved by the Quality Management System.

When the NTC ISO 9001:2015 talks about keeping documented information, does it refer to what type of documents?

Maintain documented information

These are documents that establish requirements and necessary requirements, as support for the fulfillment of the processes and activities of the Quality Management System.

What elements should be taken into account when planning quality objectives?

a) Be in line with the quality policy. b) Be measurable. c) Consider the applicable requirements. d) Be appropriate for the conformity of products and services and for the increase of customer satisfaction.

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What is the documentation of a Quality Management System?

2.6 QUALITY SYSTEM DOCUMENTATION. The documentation provides objective evidence about the system. … The documentation explains what is the policy of the institution, defines the authorities, establishes the operating procedures which help the users to fulfill their activities and objectives.


ISO 9001 2015 offers the organization flexibility in the way it prefers to document the Quality Management System. This allows each company to establish the amount of documented information it needs to demonstrate effective planning, operation and controls for the processes and the implementation and improvement of the Quality Management System.

What ISO 9000 details is that information is needed, documents that carry the information and are the medium in which it is held, record being a document that presents results achieved or provides evidence of activities performed and documented information in which the information that a company has to control and maintain, and the medium that contains it, is established.

And when we talk about documented information, it is information that the organization has to control and maintain, specifying the medium that contains it, and it can be in any format and medium and it can come from any source.

What is the document structure of the Quality Management System?

These are the documents that establish the general quality operations: what has to be done, who has to do it, how and what has to be generated (usually records). The procedures develop and complement the points of the Quality Manual.

How is ISO 9001 applied in a company?

ISO 9001 is a generic standard that applies to any production sector or industry and affects all companies regardless of their size. They must have an effective system to manage and improve the quality of their outputs and ensure the maintenance of the ISO 9001 standard.

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What are the mandatory documents?

Mandatory Documents are documents that provide the requirements for the MLA and mandatory applications of the MLA requirements and are published under the authority of the IAAC General Assembly.

Master list of documents and records iso 9001 2015

When facing the development and implementation of a Quality Management System in an organization, based on the ISO 9001 standard, it is often believed that the documentary requirements that this would imply would be enormous. The new version of the ISO 9001:2015 standard has made this task much easier, as it is considerably more lax in terms of what the documentation requirements entail, relative to its predecessors.

Although the new ISO 9001:2015 standard has reduced the level of system documentation obligations, there are still a number of documents and records that are mandatory as a prerequisite for system certification.

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