Classifying Documents for Different Document Levels

GOOD MANUFACTURING PRACTICE (cGMP) QUALITY MANAGEMENT SYSTEMS - ISO 9001:2000
1

Since I am a new ISO baby and I have difficulties to identify the level of documents. Is anyone know or help me to clear up the concept. Thanks~!

Levels

I. Level 1 – Quality Policy and Quality Manual:
II. Level 2 – Quality Procedure;
III. Level 3 – Work Instruction;
IV. Level 4 – Record;
V. Reference Materials
VI. Other document not in the QMS documentation structure

a Computer database backup tapes
b ISO9001:2000 Quality Management Systems – Requirements
c Company Mission Statement
d “Understanding ISO9000” Training materials
e Blank Inspection Checklist Form (in a toys manufacturing company)
f Design Project Files (in a toys manufacturing company)
g Digital Camera Brochures in the product packs (in a digital cameras manufacturing company)
h A list of raw materials exempted from incoming quality inspection
i Contract-specific plan in a consultancy company
j Customer Drawings (with product specifications) (in a toys manufacturing company)
k Linux Programming Manual (in a toys manufacturing company)
l A PCBA sample showing the position of components (such as resistor, capacitor……) to be inserted (for a particular post on a PCBA line).

2

Hi,

Early versions of ISO 9001 were very particular in their language that indicated different levels of documentation. ISO 9001:2000 is less specific. If you see value in classifying documents according to “levels,” then by all means do it. There’s no requirement in ISO 9001 that you do this, however.

There are other standards that specifically require that you define the structure (i.e., levels) of the documentation system. That’s the case with The Coca-Cola Quality System (Evolution 3), which requires that the document control procedure include, “a. Structure and numbering of the documentation system.”

3

I want to classify the documents as

  1. Strategic Documents This may include your quality policy, quality manual
  2. Tactical Documents: This may include your quality procedures
  3. Operational Documents: This may include your Work Instruction
  4. Records: This may include your formats and logs.
    Hope this may help

Prawan Dahal

4

Hi,

Thanks very much for this comment. It help me to think about my ideals.

Tks again and pls keep posting.

If you want to get more materials that related to this topic, you can visit: ISO 9001 document control
http://qualitymanagement.hrvinet.com/iso-9001-document-control

Best regards.

5

The ISO 9000 family of standards is related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to the product.

6

Fundamentally, Levels 1 will be your top quality guide which often defines your current method as well as duty. Levels a couple of will be your Treatments which often defines Who will carry out What and when. Levels 3 are usually your task guidance which often answers How we will work your current techniques. Levels some are usually your current requires with regard to recording details like types, labels, test out studies and so forth. When finished these people grow to be top quality information. You can get all kind of ISO Documents at ISODocumentationTemplate
http://www.isodocumentationtemplate.com/
.