Changes to the ISO 9001 quality management system standard are periodically made with intent to enhance the focus on management processes in order to achieve improved performance and make the standards applicable to a wider group of businesses. With the significant ISO 9001:2015 standards, more enterprises should be able to provide quality services and products in a consistent manner. These standards’ ISO 9001 sections are to aid in streamlining processes and efficiency, which are applicable to a variety of organizations.
The following highlights some areas that have been impacted the most in the standard and what could be done from a systems point of view to better address these standards need.
1. Higher Level of Structure
This change aims to broaden the scope of QMS (Quality Management System), while taking account the context of the organization. This involves increasing the ISO 9001 sections from eight to 10 and making revisions to the structure.
Previously the eight section titles were:
Section 1: Scope
Section 2: Normative reference
Section 3: Terms and definitions
Section 4: Quality management system
Section 5: Management responsibility
Section 6: Resource management
Section 7: Product realization
Section 8: Measurement, analysis and improvement
The added and/or re-titled sections highlight aspects of an effective quality management system, as noted below, are leadership, planning, support, operations, performance evaluation, and improvement.
These sections are now titled:
Section 1: Scope
Section 2: Nominative References
Section 3: Terms and Definitions
Section 4: Context of the Organization
Section 5: Leadership
Section 6: Planning
Section 7: Support
Section 8: Operation
Section 9: Performance Evaluation
Section 10: Improvement
Changes made to the standard clauses are made to comply with “Annex SL,” which is a model where the framework used for making the standards is applied. The modification of the structure is believed to help it align with various standards. However, the total process flow must meet the needs of an organization and this should not affect QMS implementation. This can be one of the reasons why attempting to match the standard conditions with QMS documents can be a hurdle.
2. Quality Management System
The new draft puts more emphasis on creating a management system that is to be matched to the needs of the organization. The previous version of the standard had a different section for ″process approach.” The new version has a combined section covering QMS and the processes involved in it.
This does not imply that the process approach is not included anymore in the ISO 9001 standard.
In fact, all the conditions are still present, but come in revised wording. Process approach is a vital part of the standard and this will remain as one of the key components in implementing ISO 9001. The changes made the identification of the required QMS operations and processes. These changes are meant to align services and goods to customer satisfaction.
3. Risk Assessment
The new ISO 9001 standard spotlights "risk-based thinking.” With the risk-based approach, it should be easier to identify the scope and type of controls that should be implemented. Because of these safe guards, observed uncertainties that could cause future problems can be timely addressed.
On the other hand, there is a thing called "positive risks,” which can also be determined using risk based thinking. Though risks are usually viewed as negative, there are also opportunities or positive risks that must be recognized.
With risk based thinking, organizations can determine what must be measured, observed, reviewed and evaluated. This form of thinking can lead to the identification of things that could be changed to positively impact the achievement of goals and objectives.
This may seem like an insignificant change – the new standard has included requirements for upper level managers to take responsibility for efficiency and success of QMS. Most organizations allocate this task to committee members, such as internal audit.
Yet, the expectation will be more established if reports about the effectiveness of existing QMS will come from the top managers. How the management system shall be improved and measured should also come from the top management. This is why the new ISO 9001 sets new standards when it comes to the involvement and accountability of top management.
Though this change will aid in aligning objectives with strategic direction, the function of management representative is eradicated. The benefit is that QMS requirements integration into business processes is strengthened.
The revised ISO 9001 features less rigid requirements in terms of documentation. This implies that organizations can utilize a documentation format they prefer and what information must be included in it. In the new version, a ″quality manual″ is not required.
With the present set of standards, there is a range of necessary printed procedures. However, there is no indication of mandatory documents. Does this imply that these are not required? This is not the case. The new ISO 9000 draft made use of the term “documented information,” referring to the manner when organization must retain or put information into writing.
While there is no condition requiring written procedures for internal audit and records, there is a requisite to keep evidence like documented information – such serves as substantiation of appraisal programs and the evaluation results. Thus, procedures for audit and making records are still favorable ways to yield evidence.
These major revisions to the ISO 9001 are meant to build a higher quality of standards that will promote equitable and sustainable growth and innovation for organizations worldwide.
Integrated Enterprise Excellence (IEE) – A Structured Approach for ISO 9001 Achievement
Often businesses strive to see what should be done to become ISO 9001 compliant (or maintain certification) because of a customer requirement or company’s marketing effort. This approach often views ISO 9001 certification as a list of things that need to be completed (with the least amount of effort) before the auditors arrive. What businesses need is a true business management system that is a useful whole-enterprise approach, which at the same time addresses all the needs of ISO 9001. An approach to accomplish this need is Integrated Enterprise Excellence (IEE).
The IEE system can provide organizations a value chain that integrates processes and documentations with predictive performance metrics. A clickable value chain can provide automatically updated performance metrics integrated with processes; hence, unfiltered information is readily visible to all who have authorization. This form of reporting has many benefits. For example, the IEE transparent reporting methodology could even reduce the risk of issues that can lead to very detrimental business consequences; e.g., BP oil spill and Blue Bell listeria contamination deaths.
The IEE system is a nine-step approach for addressing head-on the ISO 9001 section title stated needs of leadership, planning, support, operations, performance evaluation and improvement.