Requirements of Documents for Quality Management System ISO 9001 Certification

What is Requirement of QMS Documents? The ISO 9001 documents basic requirements for an organization to establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International StandardISO 9001 documents

Structure of Quality System Documentation Manual Procedures Word Instruction Record and Documents The manual is a series of policy statement for each of the elements of the ISO standard Procedures define the policy in teams of who, what and where. Responsibilities and action are outline Work Instruction define specific steps to accomplish task. To show “USE” of the system

What to Includes QMS Documentation Kit? The QMS standard published by the International Organization for Standardization, has certain Quality Management Systems documentation requirements. The international standard specifies four levels of QMS documentation that an organization must observe to document its quality management system.  Quality Manual  Quality Procedures  Quality Policy  Word Instruction  Record

Quality Management System Manual The QMS system documentation standard prescribes the minimum requirements for the content of a quality manual. The standard recognizes that the structure and format of the manual will depend on the size, culture and complexity of the organization.

Mandatory Procedures for QMS Certification The quality procedures are the essence of the ISO 9001 documentation. The ISO 9001 quality procedures explicitly describe how certain key processes within the company must be performed, and who is responsible for them. Ideally, the quality procedures and the quality manual are combined in a single user-friendly document.

Quality Policy & Work Instruction The ISO 9001 quality policy is the company's policy defining its stance towards quality and customer satisfaction. As such, the ISO 9001 quality policy is the overall guiding principle. A Work Instruction describes how to undertake a specific part of a function, or activity. It is similar to a procedure but is characterized by increased focus and further detail on a particular task. A work instruction is mandatory, and must be subordinate to a procedure.

Forms & Templates for Registration Forms and templates are a way of documenting that the policies, procedures, and work instructions have been followed. Records may be forms that are filled out, a stamp of approval on a product, or a signature and date on some type of document, such as routing sheet. Records are used to provide traceability of actions taken on a specific product or batch of products. They provide data for corrective actions and a way of recalling products, if necessary.

Advantages of Using QMS Documents  By using these documents, you can save a lot of your precious time while preparing the system documents.  Take care for all the section and sub sections of standard and helps you in establishing better system.  Document kit enables you to change the contents and print as many copies as you need. The user can modify the documents as per their industry and create own QMS documents for their organization.  Readymade templates and sample documents are available which can reduce your time in document preparation.  Save much time and cost in document preparation.  The audit questions helps in making perfect audit checklist.  You will get better control in your system due to our proven formats

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