ISO 9001:2000 and Quality Plans

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Performance Improvement Solutions for Your Business Needs October 2007
In this issue

  • ISO 9001:2000 and Quality Plans
  • Operational Excellence Free Online LIVE!
  • CMMI versus ISO 9001
  • Free Online EMS 101
  • Training Courses
  • Greetings!

    Welcome to Sustaining Edge Solutions E- Newsletter

    Our newsletters provide guidance on operational and quality systems ISO 9001, AS9100, ISO/TS 16949, TL 9000, ISO 13485, ISO 14001, and others. This includes process improvement methods Six Sigma, Lean Enterprise, and other topics of interest to our readers.

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    ISO 9001:2000 and Quality Plans
    Quality Plan

    The words “plan”, “planned”, and “planning” are used more than 30 times in the requirement clauses of the ISO 9001:2000 standard. A plan is simply a method you develop before doing something so you are more likely to have a successful result.

    The term “quality plan” is only used once in the standard, in a Note associated with clause 7.1, Planning of Product Realization. The Note refers to a quality plan as a document specifying the processes of the quality management system, as well as, the resources to be applied for a specific product, project, or contract.

    According to ISO 10005:2005, quality plans provide a means of relating specific requirements of the process, product, project, or contract to work methods and practices that support product realization. The benefits of establishing a quality plan include:

    1. Increased confidence that requirements will be met
    2. Greater assurance that processes are in control
    3. Motivation it can give to those involved
    4. Insight into opportunities for improvement

    Development of a Quality Plan

    Your organization should identify the need for a quality plan. For example, a quality plan may be needed for legal or customer reasons, to organize and manage activities, optimize the use of resources, to monitor or assess compliance, or minimize the risk of not meeting requirements. However, in some cases, an organization with a well established system may be able to meet its needs for quality planning without developing separate quality plans.

    After deciding to create a quality plan, it is time to identify its inputs. For example, what are the requirements for the plan, the needs of the people that will use it, the resource requirements, and any risk assessments.

    You must determine what is to be covered by the quality plan and what will be addressed by other documents. The scope of the plan will depend on the extent the plan will be supported by a documented quality management system, as well as, the processes and quality characteristics that are unique to the product, project, or contract being addressed. You will need to name someone as the author of the document and responsible for its preparation. Of course, multiple people may be involved in contributing to its content.

    Content of a Quality Plan

    The quality plan should indicate how the required activities will be carried out, either by including that information, or referring to other documents, for example, documented procedure, project plan, work instruction, checklist, or computer application.

    The quality plan should indicate how the required activities will be carried out, either by including that information, or referring to other documents, for example, documented procedure, project plan, work instruction, checklist, or computer application.

    A quality plan may include the topics listed below or refer to their coverage in other documents:

    • Scope, purpose, and expected outcome
    • Inputs and reference documents
    • Quality objectives and customer satisfaction issues
    • Management responsibilities for activities
    • Document and record controls
    • Resources for successful execution
    • Requirements to be met for product, project, or contract
    • Customer communication and records
    • Plan for design and development
    • Purchasing requirements, methods, and controls
    • Production and service inputs, activities, and outputs
    • Methods for identification and traceability
    • Customer property identification and control
    • Product preservation and delivery
    • Nonconformity control and limits on rework and repair
    • Monitoring and measurement to obtain evidence of conformity
    • Audits to monitor conformity and effectiveness

    The quality plan may be in presented in one of several different structures. For example, it could be a simple text description, a table, a document matrix, a process map, or a work flow. ISO 10005:2005, Guidelines for Quality Plans, includes examples of quality plans in its Annex A.

    Operational Excellence Free Online LIVE!

    Industry Week is hosting a free 12-session, 2-day online conference on Wednesday, October 10 and Thursday, October 11. The one-hour sessions start at 11:00 AM EDT and complete by 5:00 PM EDT each day.

    The sessions on October 10 are:

    1. Manufacturing Execution: Best Practices for Streamlining Global Operations
    2. Improving Operational Availability to Achieve Lean Manufacturing Goals
    3. The Benefits of Wireless Technology for the Factory Floor
    4. Enabling Lean Success through Leadership and Culture
    5. From Plant Floor to Corner Office: Facilitating Seamless Communication
    6. Achieving Process Manufacturing Excellence

    The sessions on October 11 are:

    1. Integral Digital Manufacturing: Better Processes Yield Better Results
    2. Supply Chain Quality Management – A Case Study: Mitigating Risk in a Global Supply Chain
    3. Enabling a Responsive, Demand Driven Supply Chain
    4. How Chemical Regulations Could Disrupt Your Supply Chain: Why You Need to Design for Compliance
    5. Information Advantage: Use Analytics to Gain New Insights from Existing Data Systems
    6. Optimizing People Power: Achieve Exponential Productivity When Employees Embrace Continuous Improvement

    Most of the sessions will give away a complimentary $100 gift certificate to five randomly drawn attendees. To register for one or more of the sessions, go to the Operations Excellence Online LIVE web site.

    CMMI versus ISO 9001

    The 2Q07 issue of the TickIT software quality journal includes the final article of a three part series exploring the relationship between ISO 9001:2000 and CMMI in terms of the benefits gained by undertaking combined surveillance audits.

    The first article explained that a good mapping between ISO 9001 and CMMI would be essential for the combined surveillance audits to work effectively. The first two articles developed this mapping from an ISO 9001 perspective, that is, would an organization with CMMI level 3 satisfy the requirements of ISO 9001.

    In the final article, the mapping is examined from the perspective of CMMI, i.e., would an organization with ISO 9001 (and TickIT) satisfy the requirement of CMMI level 3.

    The author concludes that an organization with CMMI level 3 would stand a reasonably good chance of satisfying the requirements of ISO 9001:2000. However, the converse would not be as easy to say. There is a greatly increased reliance on exactly how an organization implements the requirements of ISO 9001 which will bear on its ability to satisfy CMMI under a SCAMPI appraisal.

    While the two models are very similar, the differences noted in the 2Q07 article may result from their origins and on what is perceived as their goals, or maybe at the way they aim to achieve their goals – that is, driven by customer satisfaction back into processes or driven by processes to give customer satisfaction.

    However, there is some evidence to suggest that organizations with ISO 9001 experience find it somewhat easier to undertake a CMMI-based improvement program and associated appraisal. This probably has little to do with the mapping, but more to do with the cultural understanding of the need for documents, records, processes and procedures, management commitment, involvement, and reviews.

    CMMI is very prescriptive and will invariably provide coverage of ISO 9001:2000 requirements; but ISO 9001 being very high-level and generic cannot be assured of covering all the specific requirements of CMMI.

    You can see the full article (pdf) and color-coded mapping at the TickIT web site.

    Free Online EMS 101

    The Environmental Protection Agency (EPA) web site has an online EMS 101 course that provides an overview of an Environmental Management System. The course also covers how an EMS program can support environmental improvements at facilities that are subject to environmental regulations. The free course takes about one hour to complete.

    In addition, the course describes the EPA’s involvement in supporting EMS efforts at facilities regulated under a number of environmental statutes, e.g., the Resource Conservation and Recovery Act (RCRA).

    The web-based EMS training course has four modules.

    • Module 1: Introduction
    • Module 2: What is an EMS?
    • Module 3: EPA’s Perspective on EMS
    • Module 4: Benefits and Examples of EMS

    Each web page contains directions that help you navigate through the course. Arrows on the bottom of each page control movement from page to page. “Main messages” pop up throughout the module to reinforce its learning objectives. And, a short quiz is included at the end of each module to test your knowledge of the materials.

    Training Courses

    Our October-December course schedule is now posted on our website

    To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units.

    Understanding & Implementing ISO9001:2000
    ISO 9001:2000 Process Based Internal Auditor
    Documenting Your Quality Management System

    Understanding & Implementing AS9100B:2004
    AS9100B: 2004 Process Based Internal Auditor
    Documenting Your Quality Management System

    Understanding and Implementing ISO/TS16949:2002
    ISO/TS16949:2002 Process Based Internal Auditor
    Documenting Your Quality Management System

    Understanding and Implementing ISO14001:2004
    ISO14001:2004 Process Based Internal Auditor

    The Five Pillars of a Lean Workplace Organization
    Continuous Process Improvement
    Lean Six Sigma

    All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

    Contact Us

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