Benefits of implementing ISO 9001:2015 Quality Management System :
Provides an opportunity to increase value to the activities of the organization
l Improve the performance of processes/activities continually
l Satisfaction of customers
l Attention to resource management
l Implementation of statutory and regulatory requirements related to product/services
l Better management control in business risk
Clause on ISO 9001:2015 Quality Management System :
l Clause 4: Quality management system
< as same as ISO9001:2008 Clause 4 General requirements >
l Clause 5 : Leadership
< as same as ISO9001:2008 Clause 5.1 Management responsibility >
l Clause 6 : Planning
< as same as ISO9001:2008 Clause 5.4.2 Quality management system planning >
New concept : Actions to address risks and opportunities
Risk - combination of the consequences of an event and the associated likelihood of occurrence
prevent, or reduce, undesired effects, and achieve continual improvement.
no requirement for formal risk management
l Clause 7 : Support
< as same as ISO9001:2008 Clause 6 Resource management + 4.2 Control of documents & Records + 7.6 Control of monitoring and measuring equipment >
l Clause 8 :Operation
< as same as ISO9001:2008 Clause 7 Product realization + 8.3 Control of nonconforming product >
l Clause 9 : Performance evaluation
< as same as ISO9001:2008 Clause 5.6 Management review + 8.2.2 Internal audit + 8.2.1 Customer satisfaction + 8.4 Analysis of data >
l Clause 10 : improvement
< as same as ISO9001:2008 Clause 8.5.1 Continual improvement + 8.5.2 Corrective action >
Summary of major changes :
l “product” will be replaced by “goods & services”
l “continual improvement” will be replaced by “continual improvement.”
l “Purchasing” and “outsourcing” will be replaced by “external provision of goods and services”
l “documented procedures” will be replaced by “Documented Information”
l Risk-based approach to determine the type and extent of controls
l Risks which can affect conformity of goods and services as well as customer satisfaction.
l The requirement to use the process approach has been more explicit, Any activity or operation which receives inputs and converts them to outputs can be considered as a process. Almost all activities and operations involved in generating a product or providing a service are processes.
l The standard does not include a specific clause for "Preventive Actions".
l Control of external provision of goods and services address all forms of external provisions.
l The term " Management Responsibility " has been replaced with " Leadership".
l The term " Resource Management " has been replaced with " Support".
l The term " Product Realization " has been replaced with " Operation".
l The term " Measurement, Analysis, and Improvement " has been replaced with " Performance evaluation ".
l The term " Corrective Action " has been replaced with " Nonconformity and corrective action ".
Impact of the changes:
l The impact of ISO9001:2015 will be similar to ISO9001:2000 edition, which was a major change for accreditation bodies, certification bodies and consultants.
l Quality manual may need to be amended by Bright Business Consultants Company Limited.
l A risk management processes may need to be developed
l Determine the level and extent of control for supplier and contractor.
l ISO9001:2015 IQA Internal Auditors will need to become familiar with the revised ISO 9001:2015 standard and so schedule the IQA training with Bright Business Consultants Company Limited.
l Place detailed plans for revising internal processes or procedures, or plan the arrangements for transition or certification to ISO 9001:2015.
l The transition period is expected to be around 2-3 years as there are over one million registered ISO 9001 company.
Top management needs to demonstrate an ongoing commitment to the ISO9001:2015 . Through its leadership and actions, management can create an environment in which different actors are fully involved and in which the management system can operate effectively in synergy with the objectives of the organization. They are responsible for:
l ensuring the ISO9001:2015 is compatible with the strategic direction of the organization;
l integrating the ISO9001:2015 requirements into the organization’s business processes;
l providing the necessary resources for the ISO9001:2015 ;
l communicating the importance of effective business continuity management;
l ensuring that the ISO9001:2015 achieves its expected outcomes;
l directing and supporting continual improvement;
l establish and communicate a business continuity policy;
l ensuring that ISO9001:2015 objectives and plans are established;
l ensuring that the responsibilities and authorities for relevant roles are assigned.