Quality Assurance

ISO 9001:2008 is an international standard published by the International Organization for Standardization. First time, it was published in 1987 and later revised in 1994, 2000 and in year 2008. In this year 2008, it went through revision in order to accommodate current needs. Hence, it is now referred to as ISO 9001:2008.

ISO 9001:2008 is a standard for the implementation of a quality management system. It provides a benchmarking for organizational performance in terms of product quality.

In ISO 9001, the term “product” refers to both tangible and intangible products. It is applicable to all kinds of organization, whether public, private or non-governmental. It contains eight sections or clauses:

1. Scope
2. Normative reference
3. Terms and definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement

ISO 9001:2008 Documentation Requirements: The ISO 9001 is not focused on documentation. Basically, it views documentation as a medium that supports QMS (Quality Management System) in terms of providing evidence of implementation and conformity to specified requirements.

To fullfill, ISO 9001:2008 documentation requirements, you must establish the following documents, and if you know and understand their functions you will see why:

1. Documented statements of a quality policy and quality objectives

2. A quality manual

3. Below documented procedures required by this International Standard:

– Control of documents
– Control of records
– Control of non-conformances
– Internal audit
– Corrective action
– Preventive action

4. Documents needed by the organization to ensure the effective planning, operation and control of its processes.

5. Records required by your quality management system and this International Standard

Manuals, procedures, work instructions, guidelines, annexures and forms or formats etc. are methods to control a process effectively. They promote uniformity and consistency in the way things are done. They also provide a basis for future reference. They can also be used as a training tool in terms bringing new employees up to speed of the organization’s operations.

Another important part of documentation is Records. These are generated as a result of the implementation of processes. They may exist throughout the quality management system. Records management is a process of ensuring the proper creation, maintenance, use and disposal of records in order to achieve efficient, transparent and accountable management.

A strong and effective records management programme is advantageous because:

1. A well-organized indexing system enables an organization to find information easily.

2. The orderly and efficient flow of information enables the organization to perform its functions successfully and efficiently.

3. Authoritative and reliable records are created and maintained in an accessible, intelligent and usable manner to support the business and accountability requirements of the organization.

4. Efficiency and economy are ensured by eliminating unnecessary duplication of records.

5. A retention and disposal programme ensures that the organization maintains only those records it really needs for functional purposes.

6. Controls are exercised to ensure that only authorized persons have access to the information, thus preventing information and / or the records themselves from being stolen or damaged. This ensures the protection of privacy and confidentiality, and prevents the inappropriate disclosure of information that could harm the organization or infringe the privacy rights of individuals.

Organizations can only be effective and efficient if records management is considered a business process designed to support business objectives, a resource and utilized effectively to achieve business objectives. The organization needs to create and maintain a culture which will promote effective and efficient records management to facilitate efficient and timely decision-making.

Also See:

• Management Principles in ISO 9001:2000
• Revision of ISO 9001:2000 to ISO 9001:2008