Title: Documents Requirements for Quality System Certification
1Requirements of Documents for Quality Management
System ISO 9001 Certification
2What 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 Standard
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3Structure of Quality System Documentation
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
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4What 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
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5Quality 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.
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6Mandatory 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.
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7Quality 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.
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8Forms 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.
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9Advantages 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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