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THE KAVON RESOURCE CENTER

Detailed Standard Description

Name:

ISO 9001
Revision:
2008
Title:
Quality Management Systems - Requirements
Release Date:
2008-11-15
Status:
ACTIVE
Description:
ISO 9001:2008 specifies requirements for a quality management system where an organization

  • needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and

  • aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

Works Cited:

ISO 9001:2008. (n.d.). Retrieved February 15, 2009, from International Organization For Standardization: http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=62405
Superseeded By:
ISO9001:2015
Inactive Date:
2018-09-30

Standard FAQ

Question
   Answer
What documents need to be controlled in ISO 9001:2008?
 

According to the ISO 9001:2008 standard clause 4.2.3 states:

"Documents required by the Quality Management System shall be controlled.
Clause 4.2.1 states:
"The quality management system shall include:
  • documented statements of a quality policy and quality objectives
  • a quality manual
  • documented procedures required by this International Standard
  • documents needed by the organization to ensure the effective planning, operation, and control of its processes
  • records required by this International Standard"

What documented procedures are required by the ISO 9001:2008 quality management system standard?
 

For ISO 9001:2008 the required procedures are:

  1. Control Of Documents
  2. Control Of Records
  3. Internal Auditing
  4. Control Of Nonconforming Product
  5. Corrective Action
  6. Preventive Action
What is a controlled document?
 

A controlled is a document that must be controlled as to its revision level and distribution.
Do you think that organizations, which implement an ISO Quality Management System, do it for the benefits that compliance brings, or is it only for certification?
 

In my experience, I have found that a number of companies & organizations go for ISO certification only because they have to or it is a customer requirement to do business. For medical device manufacturers in the US, FDA GMPs, harmonized with ISO, are mandatory. Top Managements usually look primarily at their bottom lines and see ISO as an expense, not a benefit. They may hire a QA or Engineering Manager to be responsible for ISO enforcement, documentation, and compliance - but primarily to keep the companies out of trouble with customers, government, and regulatory auditors. Only token management support is provided and when they're caught in a non-conformance situation or with a deficient product, they expect the assigned compliance person to get them out of trouble.
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