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ISO 9001:2015 Articles

ISO 9001:2015 FAQ

Copyright askartsolutions 2015 TorontoWhat is the ISO 9001 standard all about?

The ISO 9001 standard incorporates internationally recognized management concepts, principles and practices into a set of standardized requirements for a quality management system (QMS). These standardized requirements define controls that focus on improving an organization’s ability to deliver products or services to:

  • Consistently meet customer’s quality requirements  
  • Meet applicable regulatory requirements  
  • Enhance customer satisfaction  
  • Improve its performance in pursuit of these objectives.  

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Context of the organization

Copyright askartsolutions 2015 TorontoWhat is meant by “context of the organization” in ISO 9001:2015?

Let’s start by paraphrasing the requirements and notes from various parts of the new standard:

1.  As part of its strategic planning, the organization must determine, understand and consider its external and internal contextual issues in determining its risks and opportunities as a basis for planning its QMS and achieve improvement. 

2.   These issues must: 

a.   Be relevant to the organization’s purpose and its strategic direction

b.   Affect its ability to achieve the intended result(s) of its quality management system. 

3.   We must monitor and review information about these external and internal issues. 

4.   The issues we consider can include positive and negative factors and conditions 

5.  To help understand: 

a.   The external context, we can consider issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.

b.   The internal context, we can consider issues related to values, culture, knowledge and performance of the organization. 

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Understanding the needs and expectations of interested parties

Copyright askartsolutions 2015 TorontoWhat are ISO 9001:2015 requirements for “Understanding the needs and expectations of interested parties”?

Let’s start with paraphrasing what the revised standard says and requires:

  1. An organization’s ability - to consistently provide products and services may be affected by relevant interested parties.  
  2. We need to ascertain and identify each interested party and in what way, shape or form they affect this ability.  
  3. We need to find out their specific requirements that impact this ability.  
  4. We need to track, collect and review information about relevant interested parties and their requirements (Copyright material askartsolutions 2015)   
  5. When determining the scope of the QMS, the organization must take into account the requirements of relevant interested parties.  
  6. There is no requirement to widen the QMS scope to include meeting the requirements of relevant parties, other than customers and applicable statutory and regulatory requirements  

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Risk-based Thinking                    

Copyright askartsolutions 2015 TorontoIn ISO 9000:2015, “Quality management systems—Fundamentals and vocabulary,” risk is defined as the “effect of uncertainty.” Notes in the definition further describe risk as a “deviation from the expected,” either positive or negative. The term “uncertainty” is defined as a lack of information or knowledge about a potential event that can be expressed as a result of the likelihood and consequence of such an event. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities. Actions to address opportunities can also include consideration of associated risks  

Copyright askartsolutions 2015 TorontoISO 9001:2015, requires that when planning its QMS, the top management must implement and promote a culture of risk-based thinking throughout the organization to determine and address the risks and opportunities associated with providing assurance that the QMS can achieve its intended result(s); provide conforming products and services, enhance customer satisfaction; promote desirable effects and improvement; prevent, or mitigate, undesired effects.

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ISO 9001 Home
◦  ISO 9001:2015 FAQ
◦  Purpose of the Standard
◦  Scope of the Standard
◦  Normative References, Terms and Definitions
◦  Context of the organization
◦  Understanding the needs of interested parties
◦  Determining the Scope of your QMS
◦  QMS and its processes
◦  Leadership and Commitment
◦  Customer Focus
◦  Quality Policy
◦  Organizational roles, responsibilities and authorities
◦  Risk Based Thinking
◦  Quality Objectives
◦  Planning For Changes
◦  Resources - General
◦  clause 7.1.2 -People
◦  clause 7.1.3 Infrastructure
◦  Environment for the operation of processes
◦  Measuring and Monitoring Resources
◦  Organizational Knowledge
◦  Competence
◦  Awareness
◦  Communication
◦  Documented Information
◦  Operational Planning and Control
◦  Customer Communication
◦  Determining requirements related to products and services
◦  Design and Development Planning
◦  Customer Communication
◦  Review of requirements related to products and services
◦  Design & Development Inputs
◦  True False Questions
◦  Sample Test Questions
ISO 9001 Consulting
◦  How To Select An ISO 9001 Consultant
◦  Compelling Reasons To Use An ISO 9001 Consultant
◦  What Services Can An ISO 9001 Consultant Provide?
◦  How To Select a Certification Body (Registrar)
◦  What Is The Process Approach?
◦  Useful Resources To Help You Implement ISO 9001
◦  What Are Outsourced Processes?
◦  What Are Quality Objectives?
◦  What Is Continual Improvement?
◦  What Is Customer Satisfaction?
ISO 9001 Implementation Guide
◦  Free Resources To Help You Implement ISO 9001
◦  Quality Policy
◦  Quality System Documentation
ISO 9001 Certification

Understanding ISO 9001:2008