ISO 9001 is the most popular international standard published by the International Organization for Standardization. First published in 1987, today it is in its fifth edition. As per a survey conducted by ISO in 2016, globally there are total 1,106,356 organizations certified to ISO 9001.
ISO 9001 prescribes the criteria for a quality management that an organization may want to build. Any type of an organization can refer to these criteria and develop its own quality management system. Once all applicable criteria are addressed, the organization can get this quality management system certified from a third party certification body.
Most organizations develop a quality management system because –
- There is a need to assure their customers that the organization has the capability to produce products / services that meet the customers as well as legal requirements. A certification to ISO 9001 will provide that confidence to the organization’s customers.
- The organizations need to keep on improving internally so that they are able to achieve customer satisfaction. An application of ISO 9001 offers a framework to the organization where continual improvement process is established thereby giving the customers a consistent as well as an ever enhancing experience in terms of product / service delivery.
ISO 9001 helps the organizations build a strong customer focus and ensures consistent top management commitment. It also brings in a risk-based thinking coupled with the process approach wherein the risks to the processes in the system are managed for building efficiency and effectiveness.
The benefits that an organization may get out of the application of ISO 9001 and its certification are mostly based on the management’s intentions of selecting this standard. However, following examples provide some direction about what the ISO 9001 can give the organizations in terms of its benefits –
- Enhanced brand image – An ISO 9001 certified organization is considered to be more reliable than the other similar organizations that are not certified. The certification is globally accepted and is gained by large as well as small organizations hence bring an equality in terms its positioning of brand reliability per say. The certification adds up to the brand recognition.
- Access to markets – There are many organizations who give preference to ISO 9001 certified suppliers. For example, in India, most Government Organizations prescribe ISO 9001 certification as one of the pre-qualification for bidding to their tenders. So, if your organization is certified to ISO 9001, you may be able to bid for many tenders that specify such criteria. If your organization operates in a developing country, then your opportunities for exporting your product/ service to customers from developed countries increase since these customers invariably demand such certification. Non-certified organizations lose out on such opportunities. The certification to ISO 9001 gives a competitive advantage.
- Improved consistency and internal efficiency – The criteria prescribed by the ISO 9001 standard requires organizations to develop processes that bring consistency in operations. The continual improvement efforts are mostly focused towards building efficiency in these processes. Over a period of time the organization witness improvement in the consistency within the business processes as well as the overall efficiency.
- Increase in the trust level of all interested parties – Interested parties of an organization include its customers, owners, employees, suppliers, bankers, etc. All these have certain expectations in terms of the performance of the organization. Due to the improved consistency of the organization after application of ISO 9001 based quality management system, the organization performance becomes more and more reliable. As a result the trust level and confidence of all these interested parties get a boost.
- Cost savings – The need to improve demands careful monitoring and analysis of errors, deviations within the processes of a quality management system built with reference to ISO 9001 requirements. Most organizations do not realize but such errors and deviations cause financial losses due to its direct or indirect impact. After application of ISO 9001 based processes for corrective / preventive mechanism, the errors / deviations reduce considerably thus giving a lot of cost savings for the organizations.
The ISO 9001 standard applies to all types of organizations including commercial organizations, non-profit organizations, Governments, Educational Institutes, NGOs, etc.
Browse through the solutions for different industries based on our experience of some of the types of organizations that we have worked with in the past.
Roadmap to certification
ProcessLOGIX helps the customers from initiation of the quality management system development till certification to ISO 9001.
Following 12-step process describes the high level approach to implementation and certification –
An ISO 9001 Consultant like ProcessLOGIX can help you in many ways in implementing a quality management system (QMS) in your organization and getting it certified by an accredited certification body.
The role of an ISO 9001 Consultant involves some or all of the following activities –
Gap Analysis of existing QMS –
The QMS implementation project is generally started by an ISO 9001 Consultant by conducting a gap analysis to evaluate how much the current system conforms to the requirements of the ISO 9001 standard. This lets the ISO 9001 Consultant determine what documents and processes to be implemented in the client organization so that the conformance to the ISO 9001 standard can be achieved.
The ISO 9001 Consultant helps the client organization create new documents or modify existing ones so that the documentation requirement of the ISO 9001 standard can be fulfilled. Though the ISO 9001 Consultant may have some of these documents already prepared for some other client in a previous projects, it would be recommended that the consultant prepares them freshly in the view of the nature and size of the business the client organization has so that it does not becomes a cosmetic document. Perhaps, this is the major differentiation between other ISO consultants and ProcessLOGIX where ProcessLOGIX’s ISO 9001 consultants deliver a truly customized service for its client organization.
After making required changes in the existing system, the ISO 9001 Consultant designs and delivers appropriate training programmes for the client organization. This in many cases involves delivering a customized ISO 9001 awareness training for the staff, Internal Auditors training for selected managers, specific training related to some of the key requirements from the standard (e.g. risk assessment, setting objectives, developing corrective actions, etc.).
QMS implementation support –
Once the new / changed QMS processes are released, the ISO 9001 Consultant extends necessary support to the Managers, Team Leaders in the client organization so that they are able to roll these processes out in their teams / departments. One-0n-one sessions or specific hand-holding sessions are organized by the ISO 9001 Consultant to help these managers / team leaders to tackle the change management issues in their teams / departments while rolling out the QMS.
ISO 9001 Internal Audit –
If the client organization have competent staff, the ISO 9001 Consultant trains the selected personnel as Internal Auditors and get these auditors conduct an ISO 9001 internal audit or if there is an issue with resource availability then the ISO 9001 Consultant organizes the Internal Audit to be conducted by trained and experienced Lead Auditors from the consulting organization. ProcessLOGIX maintains a great pool of such trained and experienced Lead Auditors who add real value to the client organization’s QMS. The ISO 9001 consultant guides the client organization’s department / functional heads to develop appropriate corrective actions on the nonconformities raised by the Internal Auditors.
Assistance for QMS Management Review –
As part of the system implementation, the ISO 9001 Consultant guides the Department / Functional Heads to prepare process performance and other related reports which then are submitted to the Top Management for the Management Review of the implemented QMS. The ISO 9001 Consultant assists the Top Management to review this information and initiate appropriate decisions and actions to improve the QMS performance.
Assistance during initial Certification Audit
Once all the requirements of ISO 9001 standard are addressed, the ISO 9001 Consultant prepares the client organization for the initial certification audit. This involves closing all pending action points from internal audits as well as management review, completing the formalities for engaging an appropriate accredited certification body, assisting the client organization in coordinating with the engaged certification body for planning and conducting the initial certification audit, assisting the client teams during the certification audit so that there are no confusions and opportunities for mis-c0mmunication.
Post Certification-Audit Support –
Once the initial certification audit is completed, the ISO 9001 consultant guides the client organization to close the audit findings, if any, and follow-up with the certification body for release of the certificate. Once the ISO 9001 certificate is received, the ISO 9001 consultant conducts a sign-off meeting with the client’s Top Management to guide them on the post-certification activities so that the client organization is able to maintain the certification status. If specifically agreed, the ISO 9001 consultant may also deliver annual maintenance services wherein the ISO 9001 consultant visits the client organization on a pre-determined schedule to monitor and assist in maintaining the system and to conduct the schedules activities like audits and reviews.