What are the main changes in ISO 9001?
The new model is similar to the previous one. Although the intention is not to recommend the sequence of activities that an organization follows in the implementation of a management system, each organization is free to interpret the model as it sees fit. The high-level structure proposed in Annex SL for all ISO management systems includes, in addition to the usual 3 introductory clauses, 7 basic clauses common to all management system standards. They are: context of the organization, leadership, planning, support, operation, performance evaluation and improvement. For ISO 9001, they will replace current clauses 4, 5, 6, 7 and 8. It follows the well known PDCA cycle and the process approach from section 4 to 10, in an order that is consistent with organizational planning and process management.

Clause 4 Context of the Organization
4.1 Understanding The Organization And Its Context Annex SL has introduced two new clauses related to the context of the organization: Both clauses require the organization to determine issues and requirements that may have an impact on the planning of the QMS and can serve as input for the development of the system. Although reference is made to the determination of requirements of relevant stakeholders, there are no additional requirements to ensure that goods and services meet the needs and expectations of external entities other than those already identified in ISO 9001:2008. The organization’s top management must be involved directly and actively in the clarification of its mission and vision, considering both the internal and external issues that may affect its ability to achieve the desired results.

The requirements include the consideration of changes and trends, relationships, perceptions and values of stakeholders, strategic priorities, the availability of resources, and other issues which could have an impact on the objectives of the organization. The context of the organization refers to the business environment it is operating in. To do this, it must first decide what are the intended results of its QMS and then determine the relevant internal and external issues that affect its ability to achieve those results. Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional or local. Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

Note: The concept of context of the organization is equally applicable to not-for-profit or public service organizations as it is to those seeking profits.

4.2 Understanding the Needs and Expectations of Interested Parties
This requirement goes beyond what is covered by current clause 7.2, because it does not include only the direct customers but also the endusers, suppliers, distributors, retailers and others involved in the supply chain, regulators and any other relevant interested party. The intention is also to anticipate current and future needs, because it could lead to the identification of opportunities for improvement and innovation. The organization is required to monitor and review the information about these interested parties and their relevant requirements.

4.3 Determining The Scope Of The QMS
Described in terms of:
• products and services
• main processes involved
• sites where processes are operated

Exclusions
This term is not used in ISO 9001:2015. However, the organization must review the standard requirements and decide which, if not addressed, would affect their ability to achieve conformity of products and services.

4.4 Quality Management System And Its Processes
New Requirement:
• Determination of risks and opportunities
• Plan & implement actions to address them
• Change to ‘documented information’ lets the organization decide necessity, type and media. But previous terms, such as quality manual, procedure, record can still be used if the organization prefers them

5.1 Leadership And Commitment
This clause replaces the current clause on management responsibilities. The elimination of the role of ‘management representative’ now requires a more proactive leadership role and greater involvement 8 of top management in identifying risks that can affect the conformity of products, services, customer satisfaction and integrating QMS requirements into its business processes. Top-level commitment and empowerment of senior management has been raised up by the new standard, which means that the responsibility will not lie on one person. The quality policy must include a commitment to improve all relevant aspects of the QMS, not just its effectiveness, and it must provide a framework (that is, a process) for “setting” the quality objectives.

New Description Of Responsibilities
Important Changes:
• Top management to establish, implement and maintain quality policy
• Appropriate to the purpose and context of the organization
• Available to relevant interested parties, as appropriate
• Commitment to improve the QMS
• Communicated, understood and applied within organization
• Maintained as documented information

Clause 6 Planning For The QMS
6.1 Actions To Address Risks and Opportunities
The clause on Planning is much broader than the current one. In clause 6.1 the emphasis is on the planning of actions to address risks identified as per clauses 4.1 and 4.2 . In a ‘note’, it is suggested that the options to address these risks may include avoidance of risk, taking the risk in order to pursue an opportunity, eliminating the source of risk, changing the likelihood or consequences of risk or acceptance of risk by informed decision. Reference to preventive actions is now removed from the standard.

Could Include Avoidance, Mitigation, Elimination Or Acceptance
6.3 Planning Of Changes
Undertake changes in a planned and systematic manner by considering:
• Potential consequences of change
• Integrity of the QMS
• Availability of resources
• Allocation or reallocation of responsibilities and authorities

Clause 7 Support
7.1.1 General
New: 7.1.2 People
7.1.3 Infrastructure
New: 7.1.4 Environment For The Operation Of Processes
7.1.5 Monitoring And Measuring Resources
7.1.6 Organizational Knowledge

7.2 Competence
This clause limits competence to those doing work that affects its quality performance. Competence is achieved by appropriate education, training OR experience. There is no mention of skills as in the current standard. A note suggests different

7.4 Communication
Organization needs to determine:
• Internal and external communication needs
• On what it will communicate
• When to communicate
• With whom to communicate
• How to communicate

Management of all resources is covered under the Support clause. It extends what is covered by the current clause with the same title by adding outsourced products and services, monitoring and measuring equipment and, very important, people and organizational knowledge as a resource. The organization shall provide the necessary manpower for the effective operation of the QMS and its processes. When addressing changing needs and trends it shall consider current knowledge and how to acquire or access additional necessary knowledge. It also makes clear that considerations of work environment is limited to the operations of processes.

Ways to acquire the necessary competence through provision of training, mentoring, re-assignment of currently employed people or hiring or contracting of competent people.

Clause 8 Operation
8.1 Release Of Products And Services
• Implement planned activities at appropriate stages to verify that product and services requirements have been met
• Delivery shall not proceed until the planned arrangements verify conformity, unless otherwise approved by a relevant authority and, where applicable, by the customer

New
• Documented information shall provide traceability to the people authorizing release of products and services for delivery to the customer

New: Clause 9 Performance Evaluation
9.1 Monitoring, Measurement, Analysis And Evaluation
9.1.1 GENERAL
• Determine what to monitor and measure
• Determine methods for monitoring, measurement, analysis and evaluation
• Evaluate the quality performance and effectiveness of the QMS

This new clause covers all monitoring, measurement, analysis and evaluation activities required by the QMS, describing the requirements in more detail. Monitoring of the customer’s perceptions of the degree to which requirements have been met, now must include customer views and opinions of the organization and its products and services. The use of the output of analysis and evaluation is listed in detail and includes input to management reviews. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Integer rutrum mattis mauris nec mollis.

9.2 Internal Audit
The audit program must take into account quality objectives, customer feedback and changes impacting the organization, in addition to the importance of the processes and the results of previous audits. Documented information must be retained as evidence of implementation of the audit programs and audit results, but there is no requirement for a documented procedure. A note refers to ISO 19011 for guidance.

9.3 Management Review
New Requirements
• Planned and carried out, taking into account the changing business environment and the strategic direction of the organization.
• Consider information on the quality performance, including trends and indicators for:
– Non-conformities and corrective actions
– Monitoring and measurement results
– Audit results
– Customer satisfaction
– Issues concerning external providers & interested parties
– Adequacy of resources
– Process performance and conformity of products & services
• Effectiveness of actions to address risks & opportunities
• New potential opportunities for continual improvement

What impact to expect on your management system?
Changes are more significant than for the previous revision the impact of the changes depends on:
• The Management System current maturity
• The organization strategic decision to integrate more the different Management Systems

What is the Transition Process?
• Train your core team (Quality Managers, Internal Auditors, CEO)
• Adapt your management processes to make them compliant
• Integrate parts of other management systems & update documentation
• Monitor the new processes, produce & analyze new KPIs. Act accordingly
• GET THE NEW CERTIFICATION ISO 9001: 2015

The Transition Process takes 6 to 18 months
Note: Starting date to prepare transition (2nd Quarter 2015) And Dead line to move to ISO 2015 Certificate (3rd Quarter 2018).

During the 3-year-transition period, the organization decides when it transitions. An organization can still be recertified to the old standard during this period. Current certificates remain valid until the end of the transition period.

What are your benefits Of the Transition?
• Quality Management is placed at the very core of business governance
• QMS will be closely taillored to each organization specification
• The QMS will be closely aligned with the Core Business Processes to facilitate an effective implementation
• It allows all types of businesses and activity sectors to better benefit from ISO 9001
• It will be easier for you to meet the mandatory requirements from your customers
• Continual improvement
• Less emphasis on documents and Greater motivated employees
• You will assure to deliver high quality products and services
• You will establish sustainable relationships with all relevant stakeholders
• You have more freedom to develop your own way to address the requirements of the standard
• You will ensure long-lasting customer satisfaction dueto improved ‘risk-management’
• Limiting the risks involved in the operation of relevant processes
• The creation of a knowledge-database will ensure the effective internal exchange of company-owned knowledge
• Better and timely decisions based on relevant and pertinent information
• Increasing ability to meet customer and other relevant interested parties requirements
• Higher efficiency of the QMS due to higher involvement of your employees and stakeholders
• Clients’ confidence in your products and services will be strengthened
• Responsibility for quality issues will be shared between several employees
• Anticipation of future and current needs from your stakeholders will lead to an early identification of business opportunities