ISO 9001:2015

The ISO 9001:2015 Management System

The ISO 9001:2015 Quality Management Systems Requirements Standard was published and released in September 2015.  The last major revision to the standard was completed in the Year 2000. Another major revision to the standard was made, and much has changed within our global business environments. The standard has been revised to take this into account and the key changes include:

  • Greater emphasis on building a management system suited to each organization’s particular needs and strategic direction
  • Enhanced requirements and top management accountability aligning quality with wider business purpose and strategy
  • Risk-based thinking and documented requirements making the management system a prevention system for continuous improvement
  • Alignment with multiple standards through the use of a common structure and core text

View our ISO 9001:2015 Complete Support Services 

The ISO 9001:2015 Standard Structure

ISO 9001:2015 is based on the new Annex SL – the high level structure. This is a common framework to be used by all ISO management systems.  This will help organizations within any industry to keep consistent, align different management system standards, mirror sub-clauses and apply common language across all standards.

There are 10 clauses within the standard and these are the changes:

  1. Scope
  2. Normative references
  3. Terms and definitions (subdivided into three parts): high-level structure, identical core text, and common terms and core definitions
  4. Context of the organization
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance evaluation
  10. Improvement

Clause 4: Context of the Organization is new.  Organizations will have to establish the context of the management system and how the business strategy supports this.  Defining the “context of the organization” establishes the impetus to determine internal and external issues.

The organization will determine external and internal issues that are relevant to its purpose and would have an impact on what the organization executes. Secondly, an organization will identify the “interested parties” that are relevant to its management system and monitor and measure relevant information. Each organization will have to identify their own unique set of interested parties and their requirements, including measurement of  applicable information.

Clause 6:  Actions to address risks and opportunities is new.  This new requirement focus is to take actions to address risks and opportunities that are proportionate to the potential impact on the conformity of products and services. Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision. Your management team will have to take actions to address these risks and opportunities, integrate the actions required, and evaluate the effectiveness.

A key change in the 2015 revision of ISO 9001 is to establish a systematic approach to risk.  By taking a risk-based approach, an organization becomes proactive rather than purely reactive, preventing or reducing undesired effects and promoting continual improvement.

ISO 9001:2015 uses risk-based thinking to achieve this in the following way:

Clause 4 (Context) the organization is required to determine the risks which may affect this.

Clause 5 (Leadership) top management are required to commit to ensuring Clause 4 is followed.

Clause 6 (Planning) the organization is required to take action to identify risks and opportunities.

Clause 8 (Operation) the organization is required to implement processes to address risks and opportunities.

Clause 9 (Performance evaluation) the organization is required to monitor, measure, analyse and evaluate the risks and opportunities.

Clause 10 (Improvement) the organization is required to improve by responding to changes in risk.

ISO 9001:2015 provides a competitive advantage

Companies that operate under this standard focus on continuous review of operations, prevention rather than detection, corrective actions and accurate outcomes.  Communication within processes creates risk-based thinking and risk based actions.  A higher level of leadership and management commitment and involvement that supports a customer-focused environment is essential. Many companies also find benefits in their extended processes and functions, which tend to be absent in quality control standards.

These attributes lead to predictable process inputs and outputs, control of business costs, and increased productivity, and reduced waste. It provides the potential of reducing time-consuming supplier and customer audits, and is a powerful marketing tool in today’s highly competitive global marketplace.

A company that is ISO 9001:2015 registered has an improved competitive advantage at home and abroad over its competitors. The standard has become a virtual requirement in many overseas countries, and is increasingly becoming a supplier quality assurance program requirement for companies, including acquiring work from the U.S. Government and world class companies. Registered organizations are authorized to display a special mark or logo, and companies throughout the world understand the significance behind it!

READ MORE: What is the Business Impact?

Implementing ISO 9001:2015

Implementing ISO 9001:2000Adopting the most widely held business management system in the world can be frustrating and costly if not done properly. Interpretation and application of the ISO 9001:2015 Standard requires expert knowledge and a comprehensive approach for effective system and process control documentation.

Our services include:

  • Training: Management Overview, Transition Training, Understanding and Implementing, and Process Based Internal Auditor.  View our courses.
  • Gap Assessment: Conduct a comprehensive external and internal assessment. Determine the gaps necessary to be addressed, and requirements.
  • Onsite and Offsite Consulting: Lead and/or assist your team with the transition and all your implementation needs. This can include: onsite management training, gap analysis and reporting, defining and documenting standard and business requirements, documented system development and improvement, training and internal auditing services.
  • Pre-Assessment Internal Audit: Conduct an onsite internal audit of your management system to ensure conformity and improvement to the applicable standard(s) and business application. Identify process effectiveness, including any process deficiencies’ found for management corrective action. Provide formal report and assist with corrective action review and closure. We can also conduct your onsite internal audits.
  • And More!

Using our methodology turns your ISO certification process into a strategic resource. Besides ensuring that your documented business system meets the requirements of the ISO 9001:2015 Standard, we continuously look for and will identify ways to improve your operations through suggestions that can increase efficiency and effectiveness, reduce overall costs, and increase time to market. We have successfully designed, implemented and improved manufacturing and service industry business systems in many diverse industries.

We are Exemplar Global registered auditors and have years of experience as third party auditors and management representatives. We know what it takes for your business to pass your certification audit and improve your bottom line the first time!

Sustaining Edge Solutions has proven experience designing and implementing many business system standards. Contact us to discuss your specific needs and requirements.

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