What is ISO 9001?
Most of the international standards begin with the letters “ISO”, the acronym for the “International Organization for Standardization.” This worldwide federation of 110 national standards bodies works to promote the growth of manufacturing, trade and communication among business operations worldwide, through the development of generic quality standards.
The most widely recognized standard is ISO 9001, a basic quality management system that can be used in industries of any size, anywhere in the world. Registration to ISO 9001 (or other quality/management standards) provides objective proof that a business has implemented an effective quality management system, and that it satisfies all of the requirements of the applicable standard. An external, impartial expert called a registrar or CB (Certification Body) conducts an on-site audit to determine whether or not a company is in conformance to the standard. If they are found to be in conformance, they will be issued a certificate showing their address, scope of operations and the seals of the accreditation bodies that give the registrar its legitimacy.
The latest revision of the ISO 9001 standard was released in November 2008. The changes are only clarification to existing clauses.
Benefits of ISO 9001 to your business
ISO 9001:2008 aims to provide a practical and workable Quality Management System for improving and monitoring all areas of your business.
Achieving the standard is not about establishing a set of procedures that are complicated and difficult to manage. With the right support and the knowledge of your employees, you will end up with a system that will improve all areas of your organization.
Implementing an effective and robust Quality Management System (QMS) will help you to focus on the important areas of your business and improve efficiency. The management processes that are established throughout your business will provide a sound foundation, leading to increased productivity and profit. This in turn will improve your customer acquisition and retention.
Some of the main benefits include:
- Suitable for both small and large organizations
- Better internal management
- Less wastage
- Increase in efficiency, productivity and profit
- Improved customer retention and acquisition
- Consistent outcomes, measured and monitored
- Globally recognized standard
- Compatible with other ISO standards
A valid ISO 9001:2008 certificate will be a prerequisite for some of your customers and a “nice to have” for others, when they are considering suppliers. It gives your customers confidence that you are working to standards and procedures that will provide them with a high standard of customer service.
Benefits to your customers
The ISO 9001:2008 standard is recognized worldwide and your customers will understand the benefits of working with companies that are ISO 9001:2008 certified. In fact, some of your customers will only do business with certified companies because it gives them assurance that you management systems are constantly assessed and approved.
They will know from experience that working with ISO 9001:2008 certified companies provides many advantages:
- Minimises mistakes
- Improves reporting and communications
- Better quality products and service
- More reliable production scheduling and delivery
- Standards maintained by annual assessments
ISO 9001 Assessment Process
The ISO 9001 standard covers every part of your business management systems. It is therefore vital to appoint an assessor who has the experience to implement ISO 9001 certification across all areas of your organization.
The assessor can be appointed internally from senior management with the relevant authority and expertise, or externally from an accredited certification body. The reality is usually a combination of both.
This will give you the most effective quality management system that will work for your business. It will provide a system that can be constantly monitored and improved upon by your internal team. In addition, an external assessor will bring in expertise and best practice from a wider industry perspective. This will help to ensure that when the audit is done, your management systems comply with the requirements of ISO9001.
Other things you will need to consider:
Gain support from employees throughout the organization
- Allow 3 to 6 months to achieve certification
- Gather information on current systems
- Compare and improve current systems in line with ISO 9001 requirements
- Develop and review your quality manual and ensure it meets the requirements of ISO 9001
- Identify non compliance areas
- Set up a monitoring schedule
- Review any training requirements for employees
- Do a company management review and internal audits
- Set a date for your first audit
ISO 9001 Regular Auditing Procedure
Once you have successfully negotiated your first audit, it is important to continue to monitor the process and improve your systems.
Annual surveillance visits need to be arranged; this will help to ensure that the re-certification audit carried out every 3 years is a formality rather than a major process overhaul.
During the audit you will be assessed on:
- Documentation control
- Records being kept
- Staff and management conformance to the system
- How the system is working in each area of the organisation
- Staff training necessary to meet the requirements
ISO 9001 certification is frequently used in both private and public sectors to increase confidence in the products and services provided by organizations, between partners in business-to-business relations, in the selection of suppliers in supply chains and in the right to tender for procurement contracts.
ISO is the developer and publisher of ISO 9001, but does not itself carry out auditing and certification. These services are performed independently of ISO by certification bodies. ISO does not control such bodies, but does develop voluntary International Standards to encourage good practice in their activities on a worldwide basis. For example, ISO/IEC 17021 specifies the requirements for bodies providing auditing and certification of management systems.
What accredited certification to ISO 9001 means
To achieve conforming products, the accredited certification process is expected to provide confidence that the organization has a quality management system that conforms to the applicable requirements of ISO 9001. In particular, it is to be expected that the organization:
A. has established a quality management system that is suitable for its products and processes, and appropriate for its certification scope
B. analyzes and understands customer needs and expectations, as well as the relevant statutory and regulatory requirements related to its products
C. ensures that product characteristics have been specified in order to meet customer and statutory/regulatory requirements
D. has determined and is managing the processes needed to achieve the expected outcomes (conforming products and enhanced customer satisfaction)
E. has ensured the availability of resources necessary to support the operation and monitoring of these processes
F. monitors and controls the defined product characteristics
G. aims to prevent nonconformities, and has systematic improvement processes in place to
- Correct any nonconformities that do occur (including product nonconformities that are detected after delivery)
- Analyze the cause of nonconformities and take corrective action to avoid their recurrence
- Address customer complaints
- has implemented an effective internal audit and management review processI. is monitoring, measuring and continually improving the effectiveness of its quality management system
What accredited certification to ISO 9001 does not mean
- It is important to recognize that ISO 9001 defines the requirements for an organization’s quality management system, not for its products. Accredited certification to ISO 9001 should provide confidence in the organization’s ability to “consistently provide product that meets customer and applicable statutory and regulatory requirements”. It does not necessarily ensure that the organization will always achieve 100% product conformity, though this should of course be a permanent goal.
ISO 9001 accredited certification does not imply that the organization is providing a superior product, or that the product itself is certified as meeting the requirements of an ISO (or any other) standard or specification.