Tag Archives: ISO 9001

ISO 9001:2015 Requirements FAQ – Everything you want to know about the new ISO 9001:2015 QMS standard

ISO 9001 Requirements FAQ – Explains the 2015 revision Source: ISO.org 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… Read More »

ISO 9001:2015 Requirements Clause 0.1 – Purpose of the Standard

ISO 9001:2015 Requirements Clause 0.1 – Purpose of the Standard The major purpose of the ISO 9001 requirements for an organization is to identify and meet the needs and expectations of its customers and other stakeholders and to gain competitive advantage. One of the strategies it might use to achieve these goals is to employ… Read More »

ISO 9001 Requirements Clause 6.2 Quality Objectives

ISO 9001 Requirements ISO 9001 Requirements Clause 6.2 Quality Objectives Why do we need quality objectives? From a business perspective, an organization exists to add value to its shareholders, customers, society and various interested parties. To provide such value, it must continually pursue strategies to grow and improve its products, services and business as well… Read More »

ISO 9001 Requirements Clause 6.3 Planning for changes

ISO 9001 Requirements ISO 9001 Requirements Clause 6.3 Planning for changes Here is ISO’s guidance on Change Management: International Organization for Standardization BIBC II, Chemin de Blandonnet 8 , CP 401, 1214 Vernier, Geneva , Switzerland Tel: +41 22 749 01 11, Web: www.iso.org How Change is addressed within ISO 9001:2015 Purpose of this paper:… Read More »

ISO 9001 Requirements Clause 7.1 Resources

ISO 9001 Requirements ISO 9001 Requirements Clause 7.1 Resources Coverage of resources is a big part of ISO 9001 QMS requirements: · In clause 4.4.1d we talked about determining the resources needed for QMS processes and their availability; · In clause 5.1.1e we talked about top management ensuring that the resources needed for the QMS… Read More »

ISO 9001 Requirements Clause 7.1.2 People

ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.2 People The next sub-clause 7.1.2 under resources requires the organization to determine and provide the people (capacity – see definition under 7.2.1) necessary for the effective implementation of its QMS and for the operation and control of its processes. As indicated in the previous clause 7.1.1, human… Read More »

ISO 9001 Requirements Clause 7.1.3 Infrastructure

ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.3 Infrastructure The next sub-clause 7.1.3 under resources requires the organization to plan, provide and manage its infrastructure effectively and efficiently. It should periodically assess the suitability of the infrastructure to meet organizational objectives. Top management should evaluate the following factors in determining its infrastructure resource needs. ·… Read More »

ISO 9001 Requirements – Clause 7.1.4 Environment for the operation of processes

ISO 9001 Requirements ISO 9001 Requirements – Clause 7.1.4 Environment for the operation of processes The term environment in this context refers to the work environment and is used to describe the set of conditionsin which employees perform their work and under which products and services are produced. Conditions can include physical, social, psychological and… Read More »

ISO 9001 Requirements Clause 7.1.5 Measuring and monitoring resources

ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.5 Measuring and monitoring resources (MMR) Let’s begin with some definitions: Measurement – is a process to determine the property or value of something, usually expressed as a quantity, e.g. temperature, speed, weight, dimension, etc. Measurement process – is a set of operations to determine the value of… Read More »

ISO 9001 Requirements Clause 7.1.6 Organizational knowledge

ISO 9001 Requirements ISO 9001 Requirements Clause 7.1.6 Organizational knowledge (OK) OK has been recognized as a vital business asset. It is specific to each organization and can be used as a powerful tool to gain competitive advantage. Many organizations now identify, capture, internalize and leverage relevant OK as an important business strategy. The many… Read More »

ISO 9001 Requirements Clause 7.2 Competence

ISO 9001 Requirements ISO 9001 Requirements Clause 7.2 Competence You will recall under clause 5.1.1e top management is responsible for ensuring the availability of resources which includes human resources. Clause 5.3 requires top management to define the organization and its responsibilities and authorities. Clause 7.1.2 required that adequate resources (e.g. HR) be determined and provided.… Read More »

ISO 9001 Requirements Clause 7.3 Awareness

ISO 9001 Requirements ISO 9001 Requirements Clause 7.3 Awareness You would think that awareness requirements under this clause were well covered from our discussion of previous requirements namely: · In clause 5.1.1f we talked about the role of top management in communicating the importance of effective QMS and conforming to QMS requirements. · In 5.1.1h… Read More »

ISO 9001 Requirements Clause 7.4 Communication

ISO 9001 Requirements ISO 9001 Requirements Clause 7.4 Communication No organization can operate without communications. Communications is like the nerve system of the human body. It reaches into every nook and cranny of an organization. Communications is about people. People communicate at just about every level of an organization. While computers and other electronic devices… Read More »

ISO 9001 Requirements Clause 7.5 Documented information

ISO 9001 Requirements ISO 9001 Requirements Clause 7.5 Documented information ISO has provided substantial guidance on Documented Information. So rather than reinventing the wheel, I will provide you their formal guidance below. I will follow that with specific guidance of my own to wrap this section up. Annex A (Informative) (from the ISO 9001 standard)… Read More »

ISO 9001 Requirements Clause 8.1 Operational planning and control

ISO 9001 Requirements ISO 9001 Requirements Clause 8.1 Operational planning and control Operations relate directly to QMS processes needed (see clause 4.3 – COP’s) to meet the requirements for the provision of product and service (PS) and include – sales and marketing; design and development; production and service provision; shipping; post delivery activities; control of… Read More »

ISO 9001 Requirements Clause 8.2.1 Customer communication

ISO 9001 Requirements ISO 9001 Requirements Clause 8.2.1 Customer communication Before you get into this clause please reread: · Clause 7.4 communications which deals with general requirements for external and internal communications; and · Clause 5.1.2 customer focus – which deals with internal communications of customer requirements and expectations throughout the organization. Clause 8.2.1 deals… Read More »

ISO 9001 Requirements Clause 8.2.2 Determining requirements related to products and services

ISO 9001 Requirements ISO 9001 Requirements Clause 8.2.2 Determining requirements related to products and services Organizations typically offer a range of products and services through their marketing materials, websites, etc. All such products and services must be clearly defined in terms of their various dimensional, functional and other performance characteristics as well as meeting applicable… Read More »

ISO 9001 Requirements Clause 8.3.2 Design and development planning

ISO 9001 Requirements ISO 9001 Requirements Clause 8.3.1 & 8.3.2 – Design & development (DD) – general and planning DD is a systematic approach (set of processes) for creating new (or improving existing) products and services (PS) in order to provide value to the marketplace in terms of new and better products that customers can… Read More »

ISO 9001 Requirements Clause 8.2.3 Review product related requirements

ISO 9001 Requirements ISO 9001 Requirements Clause 8.2.3 Review product related requirements Customer related processes must include controls for determining customer and regulatory requirements, a review of such requirements and communication with the customer. The starting point would be the inputs from customers and potential customers stating their requirements. These could include – purchase orders,… Read More »

ISO 9001 Requirements Clause 8.3.3 Design and development inputs

ISO 9001 Requirements Clause ISO 9001 Requirements Clause 8.3.3 Design and development inputs In defining the specifications for a new or revised PS, your DD process must consider the requirements essential for each new PS to be designed and developed. These considerations include:   Functional and performance requirements  :     ·   Functional  requirements refer to… Read More »

ISO 9001 Requirements Clause 9.1.2 Customer Satisfaction

ISO 9001 Requirements ISO 9001 Requirements Clause 9.1.2 Customer Satisfaction Clause 9.1.2 requires an organization to monitor customers’ perception of the degree to which their needs and expectations have been fulfilled. The organization shall determine the methods for obtaining, monitoring and reviewing this information Clause 5.1.2 requires that the focus on enhancing customer satisfaction is… Read More »

ISO 9001 Requirements – True or false questions

ISO 9001 Requirements – True or false questions ISO 9001 Requirements – True or false questions Exercise – True/False Statements The following sample of 50 statements relate to various ISO 9001 concepts, principles and requirements. Indicate whether these are true or false in the adjacent column. Please note that some statements are deliberately vague. With… Read More »

ISO 9001 Requirements Sample ISO 9001:2015 Test Questions

  ISO 9001 Requirements Sample ISO 9001:2015 Test Questions  1.       Why should your QMS be regularly monitored and evaluated?   2.       What does “interrelated processes” mean?   3.       Name three activities you must do under the “Act” part of your PDCA cycle?   4.       How is “risk-based thinking” integrated into the ISO 9001 standard?  5.       How does an organization provide assurance of conformity… Read More »

ISO 9001 Consulting – QMS Documentation Implementation Checklist

ISO 9001 Consulting QMS Documentation Implementation Checklist Quality Manual Does the Quality Manual: Outline the structure of the quality management system   Include the supplier’s name, address, quality policy and objectives and organization structure?   Define the Scope of the Quality management system for products, services, facilities, applicable quality system standard and elements, and functional… Read More »

ISO 9001 consulting – The Need for ISO 9001 Consultancy

ISO 9001 Consulting The Need for ISO 9001 Consultancy It’s become an increasing challenge for many organizations to develop and maintain management systems. The pressures of daily workload and responsibilities combined with the lack of adequate resources and specific expertise in these standards are key factors that prevent organizations from implementing effective systems in a… Read More »

ISO 9001:2015 Consulting, Training and Auditing eCourse

ISO 9001:2015 Consulting, Training and Auditing eCourse This ISO 9001:2015 eCourse provides in plain English an in-depth explanation of the requirements of the standard in pdf form. This eCourse is targeting ISO 9001 beginners, consultants, auditors, trainers, QMS managers and certification bodies or registrars to help them become experts in this ISO standard. You don’t… Read More »

ISO 9001 Consulting, Training & Auditing Services

ISO 9001 Consulting, Training & Auditing Services The ISO 9001:2015 Standard is a tool that can help you better manage your organization. Like any other business tool, how much it helps will depend on how well you put it to use. This requires your organization to be clear on the benefits to be gained and… Read More »

ISO 9001 Consulting – Can ISO 9001 QMS improve your business?

ISO 9001 Consulting – Can ISO 9001 QMS improve your business? The major purpose of your organization is to identify and meet the needs and expectations of its customers and other stakeholders and to gain competitive advantage. To achieve these goals, your primary long-term focus must be to continuously create and add value by improving the… Read More »

ISO 9001 Consulting-What services can an ISO 9001 consultant provide?

ISO 9001 Consulting ISO 9001 Consulting – What Services Can An ISO 9001 Consultant Provide? ISO 9001 Consulting has been provided ever since the ISO 9001 quality management system standards were first published in 1979.. At present, nearly a million business companies worldwide have been certified to one ISO standard or another. These include ISO… Read More »

ISO 9001 Consulting – How to select an ISO 9001 consultant

ISO 9001 Consulting How To Select And Use An ISO 9001 Consultant 1. What are the benefits of using an Consultant? Companies hire consultants for many reasons. An organization may lack the specific expertise, time, experience, or objectivity to perform the QMS development work without outside assistance. A quality management system (QMS) consultant will: ·… Read More »

ISO 9001 Consulting-Compelling reasons to use an ISO 9001 consultant

ISO 9001 Consulting ISO 9001 Consulting-Compelling reasons to use an ISO 9001 consultant When we market ISO 9001 Consultancy services, business owners often ask, “explain exactly how we benefit from employing your services?” Good question. Implementing an ISO 9001 quality management system (QMS) can provide significant benefits to your company. To realize these benefits, a… Read More »

ISO 9001 Consulting-How to select a certification body (Registrar)

ISO 9001 Consulting How to select a certification body (Registrar) Auditing is an art that is subject to variation among auditors and Certification Bodies (CB’s). Auditor interpretation of requirements and their consistency may have a significant impact on your organization. You need to understand their position on issues important to your business. You want auditors… Read More »

ISO 9001 Requirements-What is the process approach?

Understanding ISO 9001:2015 ISO 9001 Process Approach What is the definition of a process? A “Process” can be defined as a “Set of interrelated or interacting activities, which transforms inputs into outputs”. These activities require allocation of resources such as people and materials. What is the definition of the ‘process approach’? The application of a… Read More »

ISO 9001 Requirements-What are outsourced processes?

ISO 9001 Requirements ISO 9001 Requirements-What are outsourced processes? What is the definition of an outsourced process? An “outsourced process” is a process that the organization has identified as being needed for its operations and quality management system (QMS), but one which it has chosen to be carried out by an external provider outside the… Read More »

ISO 9001 Consulting-What are process variables?

ISO 9001 Consulting QMS Process Variables QMS Variable  Variable Attributes Materials – Raw materials, wip, & finished goods – Inventory management – Non production materials & supplies – Inspections & Tests – Standards & Specifications – Supplier Management – Identification & Traceability – Handling & Preservation Machine – Production equipment & technology – Engineering &… Read More »

ISO 9001 Consulting-Framework for a Process Audit Checklist

ISO 9001 Consulting How To Create and Use ISO 9001 Process Audit Checklists ISO 9001 places heavy emphasis on using a process based approach to implementing your quality management system. To understand what this means, read “Process Approach”. Internal audits are a necessary tool to monitor and maintain the health of management systems. Audits are… Read More »

ISO 9001 Consulting-What are process measureables?

ISO 9001 Consulting Process Measurables QMS Process Metric/Measurable Sales – Incomplete inquiry checklist – Late cost estimates – Revisions to proposals – Incorrect order information – Incomplete/inaccurate database – Sales order entry errors Production – Rework & repair – Excessive cycle time – Unscheduled machine downtime – Excessive variation – Inefficient set-ups/changeovers – Lost time… Read More »