Transitioning from ISO 9001:2008 to ISO 9001:2015

What are the 7 QM principles?

1. Customer focus:To remain in the business, customer is the important driving factor of the business. It is necessary to focus on the meeting or exceeding the customer needs to ensure long term sustainability of the business.
2. Leadership:It is important to decide if the right things are being done to achieve business goals in-line with vision or mission of the organisation.
3.  Engagement of people:To deliver value, it is necessary to stay focused on building competence and engaging people.
4. Process approach:It is required to understand how the processes work together as a business function so that prediction and consistency of achieving business results can be ensured.
5. Improvement:It is important to understand how the changes in internal and external business environment. The management system should be able to adapt to changes happening in order to continue to deliver value in the changed environment.
6. Evidence-based decision making:It is important to understand and analyse decisions based on the facts than gut feeling to produce desired business results.
7. Relationship management:It is important that how the business establishes plans to manage effective relations with other stakeholders such as suppliers

Why QMS?

Implementing a quality management system will help you:

• Evaluate needs of the organisation
• To identify who is affected
• What are their expectations?
• To state goals and
• To identify new opportunities.
• To ensure that organisation consistently delivers results in order to fulfill or exceed customer expectations. This will help in repeat business, new business and overall reputation of the organisation.
• Process help in developing understanding among the people that leads to increased productivity and profitability.
• Meet the all requirements including functional and regulatory requirements.
• Customers want to assess delivery capability of the organisation before it gives the business.
• Ensure risk management is performed to achieve business objectives.

What is difference between ISO 9001: 2008 and 9001:2015

• New structure to support integration with other management systems
• Higher weight-age to Risk based thinking

ISO 9001:2015 Benefits

• Leadership Engagement
• Risk Management
• Uses simplified language
• Common structure to accommodate multiple management systems
• Supply chain management focus
• User-friendly for services and knowledge-based organizations
• Customers want to assess delivery capability of the organisation before it gives the business.
• Ensure risk management is performed to achieve business objectives.

What can be done :

• Get acquainted to new expectations
• Conduct gap analysis wrt new requirements
• Develop an plan for implementation of new requirements
• Make all parties aware about the key changes to be realised which have impact on effectiveness of organisation.
• Update QMS to meet the revised requirements.
• Get certified as per new requirements

Key Changes:

• Emphasis on Risk-based management
• Preventive action
• Increase emphasis on achieving value for organization and its customers
• Documented Information
• Decreased emphasis on documentation
• Expands concept of documentation
• Replaces Documents and Records
• Organizational Context – Responsiveness to business environment
• Outsourcing is now External Provision
• Enhanced leadership requirements
• No requirement for Management Representative
• No requirement for Quality Manual

What are the changes in terminology:

• Product is now goods or services
• Process approach is now stated requirement
• Risk is defined as effect of uncertainty (ISO 31000)
• Design and Development is now Development
• Monitoring and Measurement are now separate
• Monitoring : Status of system, process or activity
• Measurement : a process to determine value
• Context of organisation

Timelines for upgradation to ISO 9001:2015 from ISO 9001:2008 :

You have a three-year transition period from the date of publication (September 2015) to move to the 2015 version. This means that, after the end of September 2018, a certificate to ISO 9001:2008 will no longer be valid.

Structure of ISO 9001:2015

O-3 Remain same structure 4.      Context of the Organization ·         Understanding the Organization and its context External and internal issues relevant to its purpose and that affect its ability to achieve the intended outcomes of the QMS. ·         Needs and expectations QMS to determine expectations of interested parties: o   Direct customers o   End users o   Suppliers, distributors, retailers o   Regulators or o   any other relevant parties ·         Scope ·         Management system Establish, implement, maintain and improve QMS including the processes needed and their interactions in accordance with standard. This was not there. Earlier clause 4 was Quality Management System 5.      Leadership ·         Management commitment ·         Policy ·         Roles, Responsibility and Authority Top management demonstrates leadership and commitment wrt QMS ·         Ensuring QMS integration into business processes ·         Promoting awareness of process approach ·         Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility Clause 5 in 9001:2008 was Management Responsibility. It is changed to Leadership. 6.      Planning ·         Actions to address risks and opportunities ·         Objectives and plans to achieve them o   Assure the QMS can achieve its intended outcomes. o   Prevent or reduce undesired effects o   Achieve improvement Organisation to plan ·         actions to address these risks and opportunities ·         to integrate and implement actions into QMS  and ·         evaluate the effectiveness of these actions This is new clause coming from planning phase of Product Realization. In 9001:2008 Clause 6 was Resource Management which has now moved into Clause 7 Support. 7.      Support ·         Resources Determine and provide resources to establish, implement, maintain and improve the QMS. Resources may be infrastructure, process environment, monitoring and knowledge. Ensure the following for the same. ·         Competence ·         Awareness ·         Communications ·         Documented Information This is new clause coming from 6 of Resource Management as per 9001:2008 Clause 7 was Product Realisation moved clause 8 Operations. 8.      Operations ·         Operational planning and control Establish criteria of these processes Implement the control of the processes as per the criteria Keep sufficient documented information to demonstrate processes have been carried out as planned. Organisation to control planned and review consequences of untended changes, taking actions to mitigate any adverse effects as necessary. Ensure operation of function or process of organisation by external provider is controlled. Control of external provision of goods and services to satisfy the specified requirements This is new clause coming from 7 of Product Realisation. Clause 8 Measurement, Analyse and Improvement has been split into two as ·         Performance Evaluation ·         Improvement  9.      Performance evaluation ·         Monitoring, measurement, analysis and evaluation ·         Internal audit ·         Management review 10.  Improvement ·         Nonconformity and corrective action ·         Improvement