ISO 9001 2015 Certification is a new revised QMS standard published on 15th September 2015, at the 4th edition of ISO 9001 standard.
This new QMS Standard will replace the ISO 9001:2008 and the ISO 9001:2008 will not be valid for certification after 3 years of publication of ISO 9001:2015.
ISO 9001:2015 has added a few new requirements in addition to the requirements said in ISO 9001:2008.
This standard has adopted the methodology of a process approach and Risk base thinking throughout the requirements.
The concept of risk-based thinking specifies requirements for the organization to understand its context and determine risks as a basis for planning. The key objective of the QMS requirements is to act as a preventive tool. The risk-based thinking has enabled some reduction in prescriptive requirements and their replacement by performance-based requirements.
The requirements of ISO 9001 Certification and ISO 90012015 requirements are given below
This standard has 10 clauses, from Clause #1 to Clause # 10, but the requirements for QMS is provided in clause # 4 to 10, where the organization is required to implement the requirements and demonstrate the compliance for third-party certification.
The requirements for ISO 9001:2015 are as under
Context of The Organization
Understanding the organization and its context – The organization shall determine the internal and external issues within the context of the organization and monitor and review the identified issues.
Understanding the needs and expectations of interested parties– where the organization shall determine the needs and expectations of the interested parties. The Interested party many are Customer, Regulatory Body, an employee of the organization, supplier, stakeholders etc.
Determining the scope of the quality management system– where the organization is required to determine the scope of the organization within the context and its applicability Considering the internal and external issues, needs, and expectations of interested parties and product /services of the organization.
Quality management system and its processes– Where the Organization shall determine the Inputs and outputs of the process, sequence the process, established the criteria /Methods for the effective operation of processes. Determine the resource needed and role responsibility. Monitor and evaluate the process and take necessary action for continual improvements. Same time address the Risk and opportunity.
Top management shall demonstrate leadership and commitment with respect to the quality Management system.
Customer focus – Where the organization’s top Management shall demonstrate the leadership and commitments towards customer Focus by enhancing customer satisfaction, meeting the compliance to applicable regulatory requirements, and addressing the Risk & opportunity.
Establishing the Quality Policy – The Top management of the organization shall be established, implement, and maintain the quality policy of the organization which shall be appropriate to the context of the organization. Where top management has the commitments to satisfy applicable requirements and continual improvement of the quality management system.
Organizational roles, responsibilities, and authorities – The Top Management of the organization shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization
Actions to address risks and opportunities – Considering the Internal and External Issues the organization shall determine the Risk and Opportunity. Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.
Quality objectives and planning to achieve them– to demonstrate the compliance to Quality policy the organization established the Quality objective, which shall be measurable and shall be communicated within the organization.
The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system For implication and effective operation the organization required Human Resource, Infrastructure, and Environment for the operation of processes, Monitoring and measuring resources, Organizational knowledge, Competence of Human resource, Awareness, and Communication
Documented information – The organization shall main the documented information required for QMS and retains the documents to demonstrate compliance.
The organization shall create and update the documents – as required and control the documents.
Operational planning and control – where the organization shall plan the resources and processes to meet the requirements for the provision of products and services. Requirements for products and services – The organization shall determine the requirements for products and services to be offered to the customer. Including the review of product/service requirements along with communication with the customer.
Design and development of products and services – which includes the requirements of Design and development planning, design and development inputs, Design and development controls, Design and development outputs, and Design and development changes.
Control of externally provided processes, products, and services – which includes the requirements of Type and extent of control on supplier and Information for external providers
Production and service provision – Control of production and service provision – where the requirements are that the organization shall implement production and service provision under controlled conditions.
Identification and traceability – where the organization is required to identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.
Property belonging to customers or external providers – As per the requirements the organization shall identify, verify, protect, and safeguard customers’ or external providers’ property provided for use. Preservation – as per the requirements the organization shall preserve the outputs during production and service provision. Which can include – identification, handling, contamination control, packaging, storage, transportation and protection
Control of nonconforming outputs – As per requirements, the organization shall make a system in the organization for ensuring that the Non- Confirming product is controlled within the organization, which are produced during manufacturing or created during the service activities. As when non- confirm product identified – it shall be kept in the identified place to ensure that it cannot be mixed with the correct product. When a nonconforming product is identified the responsible person of the organization does the re-inspection and takes the decision of Disposal of product or accepts the same with deviation.
Monitoring, measurement, analysis, and evaluation – as per the requirements the organization has to determine – which is to be monitored and measured. The method of Monitoring and measurements, Frequency of Monitoring, and Measurements. Plan for analysis and evaluation of the result of monitoring and measurements.
Customer satisfaction – as per the requirements the organization shall do the analysis of customer satisfaction to ensure that the degree to which their needs and expectations have been fulfilled
Internal audit – As per requirements, the organization shall conduct the internal audit at the planned intervals to ensure that the Quality Management system of the organization is effectively implemented and maintained.
Management review – The organization shall conduct the Management review meeting at Planned internal to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization.
Where organization shall discuss the points of MRM – which includes the followings (but not limited)
- Status of actions from previous management reviews
- Changes in external and internal issues
- Customer satisfaction and feedback from relevant interested parties
- Process performance and conformity of products and services
- Non-conformities and corrective actions
- Audit results
- Effectiveness of actions taken to address risks and opportunities
- Opportunities for improvement.
As per the requirements – The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.
Nonconformity and corrective action – when there is non-conformity identified the organization shall take necessary corrective action.
Continual improvement – The organization shall consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement.
- Apply to ISO 9001 Certification Body
- Application Review
- Stage-1 Audit
- Stage-2 Audit
- Certification Decision
- Award of ISO 9001 Certification
An organization may select the ISO Certification Body in Delhi, ISO Certification Body near to their Location – Select the ISO Certification Body – who have valid accreditation from Accreditation Body and Accreditation Body has IAF MLA membership.
ISO 9001 implementation
Before Apply for ISO Certification – The shall implementation ISO 9001 in the organization by self or with the Help of ISO Certification Consultants – who can help the organization for Development of Documentation and Implementation of ISO 9001 in the organization.