It needs to be understood that ISO never issues a certification to a company or an organization. ISO is a body that sets these International Standards across diverse business areas. There are external certification bodies who would certify your compliance to the well-established ISO standards. You need to hire one of these external certification bodies who will create a detailed certification audit and issue the desired accreditation once every compliance parameter is met. Contact HM Consulting for more information or selecting a certification body.
Anyone who has taken the ISO 9001 internal/lead auditor training will tell you about the importance of a Quality Manual as one of the most important documents required for ISO certification. Apart from this manual, you also need a clearly outlined quality policy along with the objectives that you want to achieve. You will also have to maintain records in detail to help auditors ensure compliance with the documented quality policy. Contact HM Consulting for more information or selecting a certification body.
If you’re in India, as per the ISO India website, following are the key stages of the ISO certification process; Application Review & Contract Review; Stage 1 & Stage 2 Audits; Certification Decision; Surveillance Audit (continuous assessment); Renewal Audit; Suspension/Withdrawal/Extension/Reduction of Scope of Certification.now for more details.
QMS purpose is to improve the quality of products and/or services you are providing resulting in enhanced customer satisfaction as well. A quality management system ultimately influences the maintenance and expansion of the customer base and thus the financial performance of the company. With the ISO 9001 standard you can establish processes that define how efficiently your organization operates and addresses a fast and competitive business environment.
When you implement ISO 9001 certification, an independent third party confirms the implementation of a functional QMS in your organization. This requires that the QMS be more stringently assessed than might be the case if it is evaluated internally. The external auditors will use the scientific approach or specific industry practice to evaluate your QMS and will rate you in accordance. Adherence to and regular verification of ISO 9001 requirements leads to more efficiency and better business performance.
The benefits of a certified QM system according to ISO 9001 are:
Clearly defined responsibilities.
Straightforward processes that are generally better implemented.
Greater confidence in management.
Better relationships with suppliers.
Better understanding of customer needs.
Improved leverage regarding visa-vis banks and insurance companies.
Competitive advantage, e.g. in the case of public tenders
The prerequisites for implementing a QM system are:
The will to act systematically.
The will to lead transparently.
Prerequisites for the certification of an ISO 9001 quality management system are:
Understanding of ISO 9001.
The willingness to explain (especially to document) the system.
The willingness to explain (especially to document) activities.
Contact HM Consulting to understand how we can help of on ISO 9001 Implementation
ISO 9001 is a standard that can be applied to any business for the certification of quality management systems. Audits according to ISO 9001, it can be combined with other industry-specific audits for quality management systems as well as other management systems. You can take more advantage of a combined certification. Visit our IMS Implementation page for more details on a combined standard implementation.
ISO 9001:2008 is the previous version of the Quality Management System. Now it is the QMS standard has been updated with ISO 9001:2015. The number clauses are increased from eight to ten. Added the concept of Risk approach for more effective implementation and other many changes/ amendments were made in new standard.
Adoption of a 10-clause structure and core text consistent with all other ISO management systems.
Better compatibility with the service sector and non-manufacturing users.
A need to clearly understand the organization and its context to avoid a “one size fits all” approach to QMS application and implementation.
The recognition that while preventive action was implicit throughout the standard, there was need to make it more explicit through the application of risk-based thinking, i.e. the identification and associated mitigation, both at the strategic and operational levels.
The need to consider additional factors in determining the boundaries and applicability of the QMS to establish its scope.
Improving the understanding and application of the process approach through the application of risk-based thinking in conjunction with the context of the organization.
Greater emphasis on achieving desired process results to improve customer satisfaction.
A somewhat contentious change to the use of the term “documented information” from the terms “documents” and “records”; and secondly providing greater flexibility in the need for providing documented information.
A change in terminology from the use of the terms “purchasing” and “outsourcing” to the term “externally provided products and services”.
A wider scope has been put on seeking opportunities for improvement. While continual improvement still remains a requirement at the operational level to enhance customer satisfaction, the need for strategic improvements through break-through change, innovation, use of new technologies, reorganization and other means to significantly improve products, performance and customer satisfaction, has been added.
The wording of Leadership requirements has been beefed up to put more specificity and emphasis on leadership requirements.
More emphasis on change management throughout the standard.
Contact HM Consulting to understand how we can help of on ISO 9001 Implementation
No, there is no requirement for the structure and terminology used in this Standard, to be applied in developing and documenting an organization’s quality management system. Organizations can choose to use structure and terminology that suits their operations (e.g. using “records”, “documentation” or “procedures” rather than “documented information”; or “supplier”, “subcontractor” or “vendor” rather than “external provider”).
Contact HM Consulting to understand how we can help of on ISO 9001 Implementation
Requirements for specific documented procedures are no longer mentioned; it is the responsibility of the organization to maintain documented information to support the operation of its processes and retain the documented information necessary to have confidence that the processes are being carried out as planned. The extent of the documentation that is needed will depend on the business context.
Contact HM Consulting to understand how we can help of on ISO 9001 Implementation
The new standard does not specifically mention a quality manual; however, it requires the organization to maintain documented information necessary for the effectiveness of the quality management system (QMS). An organization may find it convenient and appropriate to describe its quality management system in a quality manual.
Although the specific requirement for a management representative has been removed, top management must still ensure that roles and responsibilities are assigned for reporting on the performance of the QMS. Some organizations might find it convenient to maintain their current set-up and designations, with a single person carrying out this role. Others might take advantage of the additional flexibility to consider sharing the responsibilities depending on their organizational setup.
Contact HM Consulting to understand how we can help of on ISO 9001 Implementation