ISO 9001 contains all of the requirements which an organisation must address within their Quality Management System (QMS) if they wish to be certified against the Standard. The majority of these requirements would be identified by many organisations as 'common sense' topics which they would want to address in order to run their business well e.g. sales, design, purchasing, training, calibration of test equipment, control of records.
ISO 9001 is written by a committee (TC 176) and is designed for use in any type of organisation. This inevitably means that there are compromises in the wording of the Standard and some interpretation is often needed.
There are 8 sections in ISO 9001
3. Terms and definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realisation
8. Measurement, analysis and improvement
ISO 9001 Keys to Success
It is sections 4, 5, 6, 7 & 8 which contain the Requirements themselves and organisations wishing to be certified against ISO 9001 will need to demonstrate that they have addressed all of these requirements.
There are over 250 individual requirements in ISO 9001 that can be condensed into five key statements.
The organisation shall:
1. Determine the needs and expectations of customers
2. Establish policies, objectives and a work environment necessary to motivate people to satisfy these needs
3. Design, resource and manage a system of inter-related processes to implement the policy and attain the objectives
4. Measure and analyse the effectiveness of each process in fulfilling its objectives
5. Pursue the continual improvement of the system from an objective evaluation of its performance.
ISO 9001:2008 Approval
ISO 9001:2008 registration gives the organisation the benefit of an objectively evaluated and enforced quality management system. It is a tangible expression of a firm's commitment to quality that is internationally understood and accepted.
ISO 9001:2008 registration is carried out by certification bodies (registrars), accredited organisations that review the organisation's quality manual and working practices to ensure that they meet the Standard.
Using ISO 9001:2008
It is important that when an organisation is certified to ISO 9001, it is clear which aspects of the organisation are covered by the certificate. This is addressed through the Scope of Registration, and this must clearly identify what is included so as not to mislead.
It is a requirement that all elements of ISO 9001 must be addressed by the organisation. However, there are specific circumstances under which certain requirements of the Standard can be excluded, yet compliance with ISO 9001 still be claimed:
- Any excluded requirements do not affect the ability of the organisation to meet customer and regulatory requirements
- Any excluded requirements do not affect the ability of the organisation to provide conforming products or services
- Any excluded requirements must only come from section 7 (Product realisation) of ISO 9001. An example may be customer property. Clearly if a company never deals with such property then the requirement would not be applicable
The company's quality manual must also clearly identify why specific requirements of ISO 9001 have been excluded and the justification for that exclusion.
What 9001 is not
ISO 9001 is NOT a product Standard - it contains no product requirements. It is a series of generic requirements for quality management systems. Approval to ISO 9001 does not guarantee product or service quality. Customer focused leadership, not standards produce satisfied customers.
Approval to ISO 9001 demonstrates that you meet the minimum requirements of quality management.
How can we help?
Looking for ISO 9001 advice and interpretation?
Check out our Quality Manual: http://www.iso-9001-checklist.co.uk/iso-9001-quality-manual.htm