Analysis: ISO 9001: 2008 Transition to ISO 9001: 2015

ISO 9001 is the world's most recognized management system standards and is currently being used by over a million companies and organizations throughout the world.  This standard provides guidance and tools for organizations to ensure that their products and services consistently meet customer’s requirements and that quality is consistently improved over time.  Regardless of size, industry, or language this standard can be followed in order to improve the management system structure and ensure deliverability of product or service to customers. This standard is based on many quality management principles including the continual improvement, process approach, motivation and implication of top management and customer-driven focus.

Throughout this guide, we will walk you through various sections of ISO 9001 to compare and contrast the new 2015 edition in order to better your understanding of how to prepare your system for your next audit.

Benefits of ISO 9001 Quality Management

1. Increases your competitiveness within your industry.
2. Demonstration of this standard by attaining a certificate of compliance will win business for your organization.Helps meet your customer’s needs and increase customer satisfaction and retention.
3. Employees of your organization will feel more engagement and therefore improve their efficiency and internal processes.
4. Improved operational performance will reduce errors and increase profits.
5. Increases in efficiencies that will save you and your company time, money and valuable resources.

ISO 9001-2015 transition outline

1. Quality Management Principles
   1. ISO 9001: 2008
      1. Customer Focus
      2. Leadership
      3. People involvement
      4. Process approach
      5. System approach to management
      6. Continual improvement
      7. Factual approach to decision-making
      8. Mutually beneficial supplier relationships
   2. ISO 9001: 2015
      1. Customer Focus
      2. Leadership
      3. Engagement of People
      4. Process approach
      5. Improvement
      6. evidence=based decision-making
      7. Relationship management
2. Integration with other ISO Standards
   1. Annex SL Framework, ISO 9001: 2015 has 10 clauses with compliance requirements covered by clause 4 to clause 10.  ISO 14001: 2015, ISO 27001: 2013 and ISO 45001 follow the same framework making the integration of ISO 9001: 2015 easily integrated with these other standards.  This also ensures a better structured PDCA (see chart).

1. The Context of the Organization
   1. Use SWOT (Strengths, weaknesses, opportunities, threats) and PESTLE (political, economical, social, technological, legal and environmental) analysis if required.  Both of these acronyms and management tools can assist you when considering your vision, mission, strategic direction and intended outcome of your QMS. ISO 9001: 2015 is an approach to a unified management system that integrates your business and functions into a system rather than a stand-alone document.
2. External issues and internal issues
   1. Identification of internal and external issues that affect your organization are critical to your current success and continual improvement.  These can be positive or negative but the effect on your organization is critical to understanding how your business evolves over time. After the identification of these factors, determine whether or not there are risks and/or opportunities related to these issues.  Review these factors often to keep your company relevant and topical.
3. Interested Parties
   1. Identify interested parties and stakeholders in your company (suppliers, customers, or competitors.  What is their needs and expectations and impact on your business if these needs and expectations are not fulfilled.
4. Documented information
   1. Control of documents and control of records of ISO 9001: 2008 are now combined as documented information and there isn’t a major change in the expected compliance.  You may decide if a documented procedure is required or not depending on your organization’s needs. It is important however to ensure version control on documents, control on creation, approval, distribution, and changes to documents.  Identify retention period, location, disposal or archival mechanism of records, etc.
5. Quality Objectives
   1. Ensure that quality objectives include objectives covering process/service/product non-conformity and customer satisfaction.  Continue using SMART - Specific, measurable, achievable, realistic and time bound quality objectives determined at relevant functions and levels within the organization.
6. Quality Policy
   1. Your quality policy can be made available to relevant interested parties and you may determine the method for this communication.  Management also should be responsible for the distribution of this quality policy to the employees of the organization and more importantly, that the employees understand and follow this policy.  
7. Quality Manual
   1. ISO 9001:2015 has removed the requirement of having a quality manual in order to replace the documented oriented approach is replaced with a performance-oriented approach.  Why have a quality manual if it is only opened during your annual QMS audit? If however your QM is a live document and is continually used to improve your organization and referenced throughout the year then by all means keep the manual.
8. QMS Awareness
   1. Your organization shall ensure employees are aware of the quality policy and relevant objectives.  The integration throughout your organization is important and for employees to take ownership of the policies and procedures.  This ensures greater effectiveness and usefulness of your QMS.
9. Fewer Prescribed Requirements
   1. There are fewer prescribed requirements and ISO 9001: 2015 edition is no longer a document-oriented approach.  The focus is on performance and achievement. The new addition lets you and your company decide the level of complexity.
10. Mandatory Procedures and Standard Operating Procedures
    1. Six mandatory documented procedures required in ISO 9001: 2008 are now optional and include the following:  control of documents, control of records, control of nonconformity, internal audit, corrective actions and preventive actions.  The decision now lies with your organization on whether or not to document these procedures. If your organization determines not to document these, make sure it is justified and if having them or not having them is a positive or negative for your business.
11. Exclusions
    1. ISO 9001: 2008 used the word “exclusion” while ISO 9001: 2015 uses the phrase “requirements that cannot be applied.”  ISO 9001: 2008 allows exclusions under product realization requirements if they cannot be applied and if doing so doesn’t interfere with its ability or responsibility to meet customer and legal requirements.  ISO 9001: 2015 has a similar approach but is open to all clauses throughout the standard. When taking this approach, be sure to consider the scope of your organization and provide ample justification for any exclusions.
12. Risk and Opportunity
    1. Risk-based thinking is a new concept with ISO 9001:2015 and refined planning process replaces preventive action. This requires identification of risk and opportunities, planning, and review.  There is no requirement to perform a risk assessment but the suggestion to do so is still important. This allows your organization to identify actions to mitigate these risks, review the actions taken and ensure they are effective.  Risk identification also encompases preventative actions which is not a requirement but still recommended.
    2.  
13. Process Approach
    1. Ensure you implement process approach effectively.  In ISO 9001: 2015 QMS, process-based management gets more prominence with the identification of processes in the organization. Input, responsibility, authority, accountability, required knowledge, procedure/execution steps, process output, identification of process effectiveness evaluation parameters, monitoring of those parameters/indicators and risks related to the process are all important.
14. Change Management
    1. Changes that affect your product or service quality, customer satisfaction or business performance must be executed under a controlled environment and to ensure you have a planned approach for any changes within your organization.
15. Suppliers
    1. The word “supplier” has been replaced with a new terminology of “External Provider” and includes outsourced processes as well.  There is no major change in the compliance of suppliers except the terminology.
16. External Property
    1. External property replaces earlier customer property clause and it now also includes supplier/service provider property along with customer property.
    2. This external property to be handled carefully to prevent it from any damage and records to be retained in case it is found unsuitable for use.
    3. External property is now replacing customer property clause and includes supplier/service provider property and customer property.  External property is to be handled carefully to prevent damage.
17. Outsourced Process/Service Providers
    1. More controls over the effectiveness of outsource service providers are required in the new edition of ISO 9001 because this business process is becoming more prevalent and important within the global manufacturing world.  
18. Leadership
    1. The role of leadership and top management has changed in order to incorporate employees of an organization in a more robust and effective way.  The term Management Representative is no longer a mandatory position with the intention of having more employees take ownership of the organizational awareness around the management system.  Top management (defined as a person or group of people who directs and controls an organization at the highest level) can fulfill this role or delegate this to one or more individuals. Top Management is now expected to take a more hands-on approach to the QMS in order to create awareness for the policy, objectives, communication, processes, risk and opportunity, internal audits, management reviews, and evaluation of QMS effectiveness and efficiency.
19. Work Environment
    1. Within ISO 9001: 2008, physical work was only considered.  In the new edition, both social and psychological conditions have been applied to work as well and are considered.
20. Management Review Meeting
    1. Management review meeting become management review.  The formal meeting is not always required.