ISO 9001:2015 Questions from a recent Webinar Part 1 of 3, Answers by George Hummel, member US TAG to ISO/TC 176

Question:

What is the deadline for being audited to ISO 9001:2015?

 

Answer:

Organizations have until September 2018, to complete the transition and be certified.  Certification Bodies should be informing clients of their exact process soon.  However, to avoid being caught in a “log jam” at the end of this period, it would be advisable to start the transition now.

 

Question:

How can we use our existing quality manual/procedures while incorporating in ISO 9001:2015 revision?

 

Answer:

You are free to incorporate any or all of your existing documentation.  However, it would be wise to check for required documented information you may not have. An effective technique for this is a Gap Analysis.

 

Question:

The new standard is causing a stir in the quality discussions, with some pointing to these clauses as an indication that ISO 9001 is becoming a Business Management Standard.

 

Answer:

ISO 9001 is a Quality Management Standard because of its Scope, which gives the requirements of when an organization “needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements…”

 

Further, ISO provides TC 176, Quality management and assurance, with a design specification for a quality standard.  The committee cannot exceed these inputs.  That is also why ISO 9001:2015 does not address “risk mitigation,” as that is the province of TC 262.

 

Question:

Can you explain Clause 6.1 and its application, as we see the subject of Clause 6 and the risks & opportunities applied to 8.1, 9.1.3, 9.3, and 10.2?

 

Answer:

One of the core concepts of ISO 9001:2015 is the methodology of Plan-Do-Check-Act.  Clause 6 addresses planning with regard to risks and opportunities. Clause 8.1 is “Do.”  Clauses 9.1.3 and 9.3 are “Check.”  Clause 10.2 is “Act.”

The Final Draft International Standard (FDIS) of ISO 9001:2015 has been published.

The FDIS will help you identify what you need to do to get your quality management system aligned to the 2015 version. 

This is the final stage on the revision journey and means you can be confident that the information contained in the FDIS will be in line with the final version, which will be published in September.
 
The new 2015 revision is a significant update to the standard, and it’s a great opportunity to make your organization even more effective. The key new areas covered in the standard are:

  • Greater emphasis on building a management system suited to each organization’s particular needs
  • A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy
  • Risk-based thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement
  • Less prescriptive requirements for documentation: the organization can now decide what documented information it needs and in what format
  • Alignment with other key management system standards through the use of a common structure and core text

With a comprehensive suite of services and support material, IQC can help you embed this new management system into your organization, so you can start to see the results as quickly as possible.


For more information on the revisions, contact Seth at 937-673-3732 or seth@4iqc.com
 

ISO 9001:2015 Transition Planning Guide released by the IAF

The International Accreditation Forum (IAF) has released a transition planning document that provides guidance for the transition from ISO 9001:2008 to ISO 9001:2015. The Transition Planning Guidance for ISO 9001:2015 document was developed in cooperation with ISO Technical Committee 176, Subcommittee 2, Working Group 23, to provide advice to interested parties on transition arrangements to be considered before implementing ISO 9001:20125. It identifies activities that should be considered by relevant interested parties and increases understanding of the context of ISO 9001:2015, which is scheduled for publication in September 2015.

The Transition Planning Guidance for ISO 9001:2015 document reflects the consensus of IAF members on this subject and is intended to support the consistent application of requirements. Because the document is for information purposes only, IAF accreditation body members and conformity assessment body members they accredit are not obligated to use or comply with the document.

IAF and the ISO Committee on Conformity Assessment have agreed to a three-year transition period from the publication date of ISO 9001:2015. ISO 9001:2008 certificates will not be valid after three years from the publication of ISO 9001:2015. The expiration date of certifications to ISO 9001:2008 issued during the transition period needs to correspond to the end of the three-year transition period.

The Transition Planning Guidance for ISO 9001:2015 document recommends that organizations using ISO 9001:2008 take the following actions:

  • Identify organizational gaps* that need to be addressed to meet ISO 9001:2015’s new requirements.

  • Develop an implementation plan

  • Provide appropriate training and awareness for all parties that affect the organization’s effectiveness.

  • Update the existing quality management system to meet ISO 9001:2015’s new requirements and provide verification of effectiveness.

  • Contact their certification body (registrar) for transition guidance.

The document also provides specific guidance for certification and accreditation bodies.

The Transition Planning Guidance for ISO 9001:2015 document can be download free of charge at www.iaf.nu/upFiles/IAFID9Transition9001PublicationVersion.pdf

* IQC can perform your Gap Analysis under this guidance.  Contact us for a quote.