ISO 9001:2008 Quality Management System
The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.
ISO 9001:2008 is a global quality management standard. Use it to establish and to update your organization’s quality management system (QMS).
It applies to all types of organizations. It doesn’t matter what size they are or what they do. It can help both product and service organizations achieve standards of quality that are recognized and respected throughout the world.
Any organization can benefit from implementing ISO 9001:2008 as its requirements are underpinned by eight management principles:
- a customer focused organization
- 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
Overview of the ISO 9001: 2008 standard
ISO 9001:2008 contains five requirements sections, each dealing with one of the fundamental building blocks required by any process. These are:
Quality Management System: This section details the general and documentation requirements that are the foundation of the management system. The general requirements ask you to look at the processes of the management system, how they interact with each other, what resources you need to run the processes; and how you will measure and monitor the processes. The second part of the section then sets out the requirements for the documentation needed to effectively operate the system and how the documentation should be controlled.
Management Responsibility: The management of the systems is the responsibility of the “top management” at a strategic level in the organization. The “top management” must know customers’ requirements at a strategic level and make a commitment to meeting these as well as statutory and regulatory requirements. “Top management” must also set policies; and to achieve these policies set objectives through planning how the objectives will be met. “Top management” should also ensure that there are clear internal communications and that the management system is regularly reviewed.
Resource Management: This covers the people and physical resources needed to carry out the processes. People should be competent to carry out their tasks and the physical resources and work environment need to be capable of ensuring that the customers’ requirements are met.
Product/Service realization: These are the processes necessary to produce the product or to provide the service. This is the act of converting the input of the process to the output. For a manufacturing organization, this may be the process of converting iron ore to steel via a blast furnace for example. For a service organization, this may be the process of moving a product or person from one place to another, for example, a taxi journey.
Measurement analysis and improvement: These are the measurements to enable the systems to be monitored to provide information on how the systems are performing with respect to the customer, the management systems themselves through internal audits, the processes and the product. Analyzing these, including any defect or shortfall in performance, will provide valuable information for use in improving the systems and products where this is required.
What are the 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
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 organization 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 organization cannot be certified until corrective action is taken and verified.
We help you to go through the entire certification journey very smoothly working with you as team. HTP takes the role of Consultant. We will not just guide you but be part of this journey till you achieve certificate and if required further to maintain the standard, be with you.