zip ISO9001

A zip file containing 134 QMS templates relevant to the International Standard Organisation (ISO) standard 9001: Quality management systems — Requirements

Corrective and Preventative Action SOP

Describes a system, provides instructions and assigns responsibilities for initiating, requesting implementing and verifying the effectiveness of corrective and preventative actions.

Controlled Document List

Lists all documents (including version number) contained within the quality management system.

Equipment Maintenance SOP

This procedure describes the system, provides instructions and identifies responsibilities for maintenance of key process equipment and the support systems

Competency Framework

Identifies all the SOPs that a person is required to be competent in for each role.

Training record

Each member of staff will have a record of all training undertaken. This record lists all training undertaken by a member of staff. For each competency listed there should also be a document describing the requirements for proficiency to be assessed, including frequency of training. Training record aligns with the competency framework for a given […]

Risk Assessment List

List of identified risks, and assessment including mitigation strategies and mechanisms for review

Quality Manual

Describes the quality standards to which the facility adheres, the scope, inclusions and exclusions.

Site Master File

Identify all rooms, buildings, warehouses etc included in the Quality Management System.  May include a site map, organisation chart, an explanation of the people equipment and quality environment as well as a description of the activities that occur in each room of the facility.