ISO 9001 Documentation Toolkit

Description

This ISO 9001 documentation toolkit includes a policy template, quality manual, procedures, instructions, forms, audit checklists, communication matrix, and process information table.

This ISO 9001 documentation has been designed and developed by the ISODOC group as mandatory documentation requirements in clauses 5-7, which includes all the necessary documents in the quality management system as follows:
Organization chart template;
Description of responsibilities;
Description of processes;
Procedures;
Instructions;
Quality manual;
quality policy templates;
Audit checklist;
the quality plans;
Etc;

This ISO 9001 documentation toolkit includes all processes required in the ISO 9001 quality management system, such as the main processes including purchasing, sales, production, and support such as preventive maintenance, supplier evaluation, internal audit, and management processes such as management review.

What is ISO 9001?

ISO 9001 is an international standard known as the quality management system.

By establishing the ISO 9001 standard, the organization achieves discipline in its processes, operations, and activities.

The ISO 9001 standard, with a process approach and the use of a continuous improvement cycle (PDCA), always seeks to improve the activities and processes of the organization to achieve quantitative and qualitative goals.

ISO 9001 Documentation Requirements

ISO 9001:2015 clause 4.4 Quality management systems have required organizations to create and maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned.

ISO 9001 documentation toolkit

7.5 Documented information ISO 9001

7.5.1 General

The organization’s quality management system shall include:
a) documented information required by this International Standard;
b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.
NOTE The extent of documented information for a quality management system can differ from one organization to another due to:
— the size of the organization and its type of activities, processes, products, and services;

— the complexity of processes and their interactions;
— the competence of persons.

7.5.2 Creating and updating-ISO 9001 documentation toolkit

When creating and updating documented information, the organization shall ensure appropriate:
a) identification and description (e.g. a title, date, author, or reference number);
b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
c) review and approval for suitability and adequacy.

7.5.3 Control of documented information

7.5.3.1 Documented information of ISO 9001

Required by the quality management system and by this International Standard shall be controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable:

a) distribution, access, retrieval, and use;
b) storage and preservation, including preservation of legibility;
c) control of changes (e.g. version control);
d) retention and disposition.
Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and be controlled.
Documented information retained as evidence of conformity shall be protected from unintended alterations.

Procedures of ISO 9001 documentation toolkit

• Quality Manual
• Quality Policy
• Risk Management Procedure
• Non Conformity Procedure
• Internal Audit Procedure
• Management Review Procedure
• Corrective Action Procedure
• Documented Information Procedure
• Knowledge Management Procedure
• Monitoring, Measurement, and Analysis Procedure
• Production Procedure
• Quality Control Procedure
• Sale Procedure
• Production planning procedure
• Warehouse Procedure
• Purchasing Procedure
• Design and Development Procedure
• Human Resource Procedure
• Training Procedure
• Preventive Maintenance Procedure
• Communication Procedure Free
• Supplier Evaluation instruction
• Handling Customer Complaints Instruction
• Customer-Satisfaction-Measuring-Instruction
• calibration instruction
• Identification and Traceability Instruction
• Quality Management Processes ISO 9001 2015

Free ISO 9001 documentats

Are you looking for free downloads of ISO 9001 documentation?

We have placed Free ISO 9001 documentation samples of our procedures, forms, and communication matrices on the free ISODOC page which you can download for free.

Our ISO 9001 Documentation Toolkit contains all the documents you need to implement a quality management system, then download them to save time and money and get started.