Every organization would like to improve the way it operates, whether that means increasing market share, driving down costs, managing risk more effectively or improving customer satisfaction. A quality management system gives you the framework you need to monitor and improve performance in any area you choose.
ISO 9000 series of standards
ISO 9000 is one of a series of quality management system standards. It can help bring out the best in your organization by enabling you to understand your processes for delivering your products/services to your customers. The ISO 9001 series of standards consist of:- ISO 9000 – Fundamentals and Vocabulary: this introduces the user to the concepts behind the management systems and specifies the terminology used.
- ISO 9001 – Requirements: this sets out the criteria you will need to meet if you wish to operate in accordance with the standard and gain certification.
- ISO 9004 – Guidelines for performance improvement: based upon the eight quality management principles, these are designed to be used by senior management as a framework to guide their organizations towards improved performance by considering the needs of all interested parties, not just customers.
- The customer's quality requirements,
and
- Applicable regulatory requirements,
while aiming to
- Enhance customer satisfaction,
and
- Achieve continual improvement of its performance in pursuit
of these objectives
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ISO 9001:2008 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.
Who is ISO 9001:2008 applicable to?
Any organisation can benefit from implementing ISO 9001:2008 as its requirements are underpinned by eight management principles:
- a customer focused organisation
- leadership
- the involvement of people
- ensuring a process approach
- a systematic approach to management
- a factual approach to decision making
- mutually beneficial supplier relations
- continuous improvement
Why an organization should implement ISO 9001:2008
Without satisfied customers, an organization is in peril! To keep customers satisfied, the organization needs to meet their requirements. The ISO 9001:2008 standard provides a tried and tested framework for taking a systematic approach to managing the organization's processes so that they consistently turn out product that satisfies customers' expectations.
How the ISO 9001:2008 model works
The requirements for a quality system have been standardized - but many organizations like to think of themselves as unique. So how does ISO 9001:2008 allow for the diversity of say, on the one hand, a "Mr. and Mrs." enterprise, and on the other, to a multinational manufacturing company with service components, or a public utility, or a government administration?
The answer is that ISO 9001:2008 lays down what requirements your quality system must meet, but does not dictate how they should be met in any particular organization. This leaves great scope and flexibility for implementation in different business sectors and business cultures, as well as in different national cultures.
Checking that it works
- The standard requires the organization itself to audit its ISO 9001:2008-based quality system to verify that it is managing its processes effectively - or, to put it another way, to check that it is fully in control of its activities.
- In addition, the organization may invite its clients to audit the quality system in order to give them confidence that the organization is capable of delivering products or services that will meet their requirements.
- Lastly, the organization may engage the services of an independent quality system certification body to obtain an ISO 9001:2008 certificate of conformity. This last option has proved extremely popular in the market-place because of the perceived credibility of an independent assessment.
The organization may thus avoid multiple audits by its clients, or reduce the frequency or duration of client audits. The certificate can also serve as a business reference between the organization and potential clients, especially when supplier and client are new to each other, or far removed geographically, as in an export context.
Benefits of registration:
- Customer satisfaction - through delivery of products that consistently meet customer requirements
- Reduced operating costs - through continual improvement of processes and resulting operational efficiencies
- Improved stakeholder relationships - including staff, customers and suppliers
- Legal compliance - by understanding how statutory and regulatory requirements impact on the organization and its your customers
- Improved risk management - through greater consistency and traceability of products and services
- Proven business credentials - through independent verification against recognized standards
- Ability to win more business - particularly where procurement specifications require certification as a condition to supply
Registration Process:
The process of registration follows three simple steps:
- Application for registration is made by completing the QMS questionnaire
- Assessment to ISO 9001:2008 is undertaken by NQA - the organisation must be able to demonstrate that its quality management system has been fully operative for a minimum of three months and has been subject of a full cycle of internal audits
- Registration is granted by NQA and maintained by the organisation. Maintenance is confirmed through a programme of annual surveillance visits and a three yearly re-certification audit.
Initial Certification Audit:
The assessment process for achieving certification consists of a two stage Initial Certification Audit as follows:
Stage 1 - the purpose of this visit is to confirm the readiness of the organisation for full assessment. The assessor will:
- confirm that the quality manual conforms to the requirements of ISO 9001:2008
- confirm its implementation status
- confirm the scope of certification
- check legislative compliance
- produce a report that identifies any non-compliance or potential for non-compliance and agree a corrective action plan if required.
- produce an assessment plan and confirm a date for the Stage 2 assessment visit.
Stage 2 - the purpose of this visit is to confirm that the quality management system fully conforms to the requirements of ISO 9001:2008 in practice. The assessor will:
- undertake sample audits of the processes and activities defined in the scope of assessment
- document how the system complies with the standard
- report any non-compliances or potential for non-compliance
- produce a surveillance plan and confirm a date for the first surveillance visit
- If the assessor identifies any major non-conformance, the organisation cannot be certified until corrective action is taken and verified.
Benefits of ISO 9001 are like the following.
- Competitive advantage
ISO 9001 should be top-management led, which ensures that senior management take a strategic approach to their management systems. Our assessment and certification process ensures that the business objectives constantly feed into your processes and working practices to ensure you maximize your assets.
- Improves business performance and manages business risk
ISO 9001 helps your managers to raise the organization’s performance above and beyond competitors who aren’t using management systems. Certification also makes it easier to measure performance and better manage business risk.
- Attracts investment, enhances brand reputation and removes barriers to trade
Certification to ISO 9001 will boost your organization’s brand reputation and can be a useful promotional tool. It sends a clear message to all interested parties that this is a company committed to high standards and continual improvement.
- Saves you money
Evidence shows that the financial benefits for companies that have invested in and certified their quality management systems to ISO 9001 include operational efficiencies, increased sales, higher return on assets and greater profitability.
- Streamlines operations and reduces waste:
The assessment of your quality management system focuses on operating processes. This encourages organizations to improve the quality of products and the service provided and helps to reduces waste and customer complaints.
- Encourages internal communication and raises morale
ISO 9001 ensures that employee’s feel more involved through improved communication. Continued Assessment visits can highlight any skills shortages sooner and uncover any teamwork issues.
- Increases customer satisfaction
The ‘Plan, Do, Check, Act’ structure of ISO 9001 ensures that the needs of the customer are being considered and met.
