2019

STANDARD ISSUES

GUIDANCE DOCUMENTS

A Well-Known Secret

The often-overlooked guidance documents that can help improve your quality management system

by L.L. “Buddy” Cressionnie and Paul Palmes

Every organization has room to improve its quality management system (QMS), but where can it turn for expert guidance?

What if we said there is a series of secret documents, written by international subject matter experts, designed to help organizations improve their QMSs? It would prevent users from having to start from scratch and question the authenticity of the information they find via internet searches.

International Organization for Standardization (ISO) Technical Committee (TC) 176’s subcommittee (SC) 3 publishes these secret documents that provide guidance related to ISO 9001—the same TC 176 that publishes ISO 9000 terminology in SC 1 and recently released ISO 9001:2015 and ISO 9004:2018 in SC 2.

Of course, these documents aren’t secret at all, but are published standards in the ISO 10000 series. Unfortunately, there is a significant lack of awareness about their existence. Baskar Kotte, chair of U.S. TAG to ISO/TC 176/SC 3, made it clear when he said: “In essence, ISO/TC 176/SC 3 develops supporting technology guidance documents for implementing the ISO 9001 requirement standard.”

To provide visibility and encourage use of the ISO 10000 series, ISO 9001, Annex B includes a description of these documents. The following list briefly details each guidance document:

  • ISO 10001-10004 and 10008 pertain to guidelines for customer satisfaction. The customer is the most important interested party. If an organization doesn’t have customers, it ceases to exist. These standards include guidelines for determining customer satisfaction provisions, handling complaints, resolving complaint disputes, and monitoring and measuring customer satisfaction. They also provide insights for measures, processes and improving customer loyalty. These customer satisfaction standards are:
    • ISO 10001—Quality management—Customer satisfaction—Guidelines for codes of conduct for organizations.
    • ISO 10002—Quality management—Customer satisfaction—Guidelines for complaints handling in organizations.
    • ISO 10003—Quality management—Customer satisfaction—Guidelines for dispute resolution external to organizations.
    • ISO 10004—Quality management—Customer satisfaction—Guidelines for monitoring and measuring.
    • ISO 10008—Quality management—Customer satisfaction—Guidelines for business-to-consumer electronic commerce transactions.
  • ISO 10005—Quality management—Guidelines for quality plans helps organizations isolate and document requirements to provide increased confidence that they will be met.
  • Other key benefits of implementing this guidance document include greater assurance that processes are in control, the motivation it can provide to those involved, and insight into opportunities for innovation and improvement.

    Recent revisions to ISO 10005 include the following key changes:

    • A new structure (not high level) was adopted.
    • The terms and concepts of ISO 9000:2015 are used.
    • It’s aligned with the new requirements of ISO 9001:2015.
    • It promotes a broader applicability of quality plans in different types of organizations and in different circumstances.
  • ISO 10006—Quality management—Guidelines for quality management in projects provides enhanced control of project processes and project products or services to meet customer and other interested party requirements. It recommends how organizations can manage projects and their processes, products and services systematically to enhance coordination and compatibility.
  • Recent revisions to ISO 10006 include the following key changes:

    • It’s aligned with ISO 9000:2015, ISO 9001:2015 and ISO 21500:2012.
    • It employs the process approach, which incorporates the plan-do-check-act cycle and risk-based thinking.
  • ISO 10007—Quality management—Guidelines for configuration management provides a framework and method for conducting configuration management activities, including developing the structure and content of a configuration management plan.
  • This standard is the authoritative source for configuration management for implementation based on an organization’s size and the nature of its products and services, and reflects the needs of specific life cycle phases. It was recently updated with the new ISO 9000 and ISO 9001 language and describes:

    • Responsibilities and authorities for configuration management process, such as planning, identification, change control, status accounting and audit.
    • Management activity that applies technical and administrative direction over a product or service’s life cycle, its configuration identification and status, and related product and service configuration information.
    • Identification and traceability, the status of its physical and functional achievement requirements and access to accurate information in all phases of the life cycle.
  • ISO 10012—Measurement management systems—Requirements for measurement processes and measuring equipment provides guidance for measurement processes and metrological confirmation of measuring equipment. It provides insight into ISO 9001, clause 7.1.5’s requirements on monitoring and measurement resources.

  • ISO/Technical Requirement (TR) 10013—Guidelines for quality management system documentation is under revision. The requirements for documented information changed considerably in ISO 9001:2015.

  • ISO 10014—Quality management—Guidelines for realizing financial and economic benefits provides management application principles, and method and tool selection that enable an organization’s sustainable success based on management principles. The ISO 9001:2015 standard’s management principles reduced from eight to seven, which will profoundly affect this document.

  • ISO 10015—Quality management—Guidelines for training provides additional guidance regarding education and training related to the ISO QMS standards. ISO 9001:2015, clause 7.2 references competence, which includes education and training that would be valuable for an HR department to consider when improving its processes.

  • ISO/TR 10017—Guidance on statistical techniques for ISO 9001 provides guidance on statistical methods that can be observed in the behavior and results of processes, even under conditions of apparent stability. ISO 9001:2015, clause 9.1.3 and AS9100D, the aerospace industry QMS standard, reference ensuring process effectiveness and product conformity.

  • ISO 10018—Quality management—Guidelines on people involvement and competence provides guidance on implementation strategies to engage people in the organization (Quality Management Principle 3) and ISO 9001, clause 7.2 competency requirements. A QMS is effective when competent people are engaged in meeting the strategic direction and objectives of the organization.

  • ISO 10019—Guidelines for the selection of quality management system consultants and use of their services provides guidance on ensuring the competence of acquired consultants and that service expectations are met.

Expert assistance

This diverse set of guidance documents is an excellent illustration of the broad demands of subject and technical writers often brought into the discussion during the revision process. These documents can be invaluable to QMS practitioners searching for expert guidance and support as they grapple with the day-to-day demands of their professions.


Note

U.S. TAG to TC 176 is looking for volunteers to work on these standards. If you’re interested, contact standards@asq.org for further information.


L.L. “Buddy” Cressionnie is President of ASD Expertise, LLC, with industry leadership positions of Americas Aerospace Quality System Committee (AAQSC) chair and AAQSC leader of requirements, projects and AS9100. He is active in standards development as a liaison member to the International Organization for Standardization (ISO) Technical Committee (TC) 176, including writing ISO 9001:2015 and ISO 9004:2018, and participating in the ISO 9001 Interpretations Committee.


Paul Palmes is principal consultant with Business Systems Architects Inc. in Fargo, ND, and Prescott, WI. He is chair of the U.S. Technical Advisory Group to ISO/TC 176, and chair of ISO/TC 176, subcommittee 1, responsible for ISO 9000:2015. He is the coauthor of Business Sustainability: Going Beyond ISO 9004 (ASQ Quality Press, 2018) and ISO 9001:2015: Understand, Implement, Succeed! (Prentice Hall, 2015), and author of Process Driven Comprehensive Auditing, second edition (ASQ Quality Press, 2009) and The Magic of Self-Directed Work Teams (ASQ Quality Press, 2006).


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