On July 9th 2015, the ISO/FDIS 9001:2015 was issued in 28 pages, the last stage in the ISO 9001 revision process. This is the final draft international standard (FDIS) before the final publication of the standard scheduled on September 23, 2015. The overall opinion is that very little to no change will be taking place between the final draft and the published standard.

Let’s begin our journey by reviewing some of the revised terms and definitions between the current standard and the FDIS.

What’s important to understand here is that Annex A of the FDIS states that organizations can use terms which suit their operations.  For example, using records, or documentation rather than “documented information”, or supplier, or vendor rather than “external provider”.  There is no requirement to mirror the structure (clause sequence) and the terminology of the new ISO 9001 International Standard.

New Terms and Concepts

“The organization shall maintain documented information and control to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned.”

• “maintain” infers procedure
• “retain” infers record

Further eliminated terms include the Quality Manual. This does not preclude the need and value of a Quality Manual. Your Quality Manual and its content should be viewed and utilized as company policies.

Unfortunately, in many cases the Quality Manual is considered a necessary evil of certification compliance, and not valued. An effective quality manual is one that is used for internal and external policy communication, and new employee training source – use it and improve it. Multiple procedures which are valued and have been proven to improve operational effectiveness and reduce operating costs are a resource – use them and improve them. “Documented information to the extent necessary to have confidence”.          

Content of the Organization Clause

The Why, How and What of Your Business Purpose and Objectives. What is the Combination of internal and external factors that can have an effect on an organization’s approach to its products and services …and interested parties?

Determine your issues and requirements that can impact on the planning of the Quality Management System… within the scope of the QMS.

What is relevant is whether or not it has impact on the organization’s ability to consistently provide products and services that meet customer and applicable regulatory requirements; or the organization’s aim to enhance customer satisfaction.

Interested Party Clause

Person or organization that can affect, be affected by, or perceive themselves to be affected by a decision or activity…and their relevant interests.

Examples can be: Customers, Owners, Employees, Suppliers, Regulators, Partners, Community, and Competitors.

Content of the Organization + Interested Party Requirements = Scope of the QMS

Risk- effect of uncertainty on an expected result.

The risks and opportunities and the appropriate actions to address them..

“When planning for the QMS, the organization shall consider the issues referred to in 4.1 [Organization and Context] and the requirements referred to in 4.2 [Interested parties] and determine the risks and opportunities that need to be addressed…”

The organization shall plan actions to address these risks …”

i.e. avoiding, taking, eliminating, changing likelihood or consequence, sharing, retaining.

Let’s now take a look at integration of Clause 4 Context of the Organization

ISO/DIS 9001 Clause 4.1 Understanding the organization and its context.

“The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review the information about these external and internal issues.”

Interpretation: What is your company purpose and direction? This requires you to know yourself inside and outside, including the strategic organizational direction. What are your external and internal business factors affecting you? A much broader look at the role of the management system is now required, and its relative processes. Moving Quality out of the Quality Department is expanding. The Quality Manager as sole responsibility for definition and control will not be sufficient for compliance.

ISO/DIS 9001 Clause 4.2  Understanding the needs and expectations of interested parties

Due to their impact or potential impact on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:

a) the interested parties that are relevant to the quality management system;

b) the requirements of these interested parties that are relevant to the quality management system.

The organization shall monitor and review the information about these interested parties and their relevant requirements.

Interpretation: Identify and take interested parties into consideration (e.g. customers, owners, employees, suppliers, and partners) and their requirements relevant to the QMS, incorporate into the QMS, and monitor information and requirements.

Together these clauses require the organization to determine the issues and requirements that can impact on the planning of the quality management system.

ISO/DIS 9001 Clause 4.3 Determining the scope of QMS

The organization shall determine the boundaries and applicability of the quality management system to establish its scope.

When determining this scope, the organization shall consider:

a) the external and internal issues referred to in 4.1;

b) the requirements of relevant interested parties referred to in 4.2;

c) the products and services of the organization.

Interpretation: The company scope remains required, however with added clarity for boundaries and applicability. The documented information and integration of 4.1 and 4.2 determination will be part of the QMS scope. Products and services referenced could be at a high-level.

We will continue in our September newsletter with further information on ISO 9001:2015.  Stay tuned for information on our future ISO 9001:2015 Training and Supporting Services to ensure your company makes a successful and measurable transition.

The AS9100:2016 Aviation, Space and Defense Standard is undergoing a major revision aligned with the ISO 9001:2015 release of September 2015.

With a slight lag of a few months, it is expected that the AS9100:2016 (including AS9110 Aviation Maintenance Organization and AS9120 Stocklist Distributor) will be released in the second quarter of 2016.  The gap between the published release of the ISO 9001:2015 and the AS9100:2016 standards will create a shorter time period for AS registered organizations to transition to this new standard.

Revision comments by activity with this future standard has been many. For example, the Web Survey from Oasis Suppliers and others, including the Americas Aerospace Quality Group comments has been the largest.

Let’s review the concepts being evaluated by the sub-teams

The disposition of IAQG comments are targeted for the October 2015 timeframe. The launch of ballots are also targeted for December 2015. Publication of AS9100:2016 will be in the spring of 2016.  AS9100:2016 will include a cross reference matrix to AS9100:2009.

We will keep our readers informed with any timeline information we receive.  Our future services will also include AS9100 Standard assistance you may need for a successful and measurable transition.

American Society for Quality

 Audit Division Conference

October 29 & 30, 2015
Peppermill Resort & Casino, Reno, Nevada

We are a Gold Sponsor and Exhibitor at the 24th Annual Audit Division Conference!  As a past company conference sponsor, we have continuously found that the Audit Division Conference is an exceptional event with a wealth of information and top notch value delivered. The Peppermill Resort is  a great location. Looking forward to seeing you there!

Conference Overview: To achieve effective results, auditors are expected to influence managerial decision making with their audit findings.  This conference focuses on the auditor’s role in identifying quality system issues to improve  performance & processes,  revenue, and customer satisfaction, including management planning and the decision making process.

It is also the objective of this conference to keep auditors exposed to realizing and managing risk specific to quality, changes to standards, innovations in communications, and ever-changing material, approaches and techniques

Conference sessions include

• ISO 9001:2015: How Will it Change Your Internal Audits?
• Effective Risk Assessment Auditing
• Closed-loop Risk Based Audit Program Model
• Advanced Interviewing Techniques for Audits
• Internal Audits Using Six Sigma-DMAIC Process
• AND MUCH MORE!

Keynote Speakers include:

• Peter Holtmann, President & Chief Executive Officer Exemplar Global (Formerly RABQSA)
• Ronald Lear, Corporate Quality Director, Booz Allen Hamilton

Tutorials: One, two and three day pre-conference tutorials will be conducted on October 26, 27 & 28, 2015.

Click Here for Full Program 

Early Registration Discounts Available Now

We will be providing valuable information at our conference booth on methods and techniques for effective ISO 9001:2015 risk management internal auditing and free swag.  Look for discounts on all our management systems services, training courses and more!

Elsmar Cove, a discussion forum for both professionals and novices in the business of quality assurance and industry standards, is now closed.  It is clear that the site is already missed by thousands of users, including us!

Elsmar Cove was a free website resource started that allowed users to share and inquire about “how to” with a wealth of quality and improvement methods. Many users openly shared their techniques and files with other users.

What happened to Elsmar Cove?  As noted on the website’s only page now, it’s has been closed as part of a settlement that stemmed from a civil lawsuit filed in Florida. Mr. Marc Smith, who founded the site in the mid 1990’s, is not allowed to reveal any details of the settlement that resulted in the closure of the Elsmar Cove.

Will Elsmar Cove be back?  No, the Elsmar Cove you’ve known will not be returning.  However you will find a number of niche forums are springing up as various moderators create venues based on their areas of expertise. Thank you Marc Smith for all your dedicated work and valued website!

FDA 510k – Six Month Average Approval

Do you have six months? When you’re a medical device start-up company with a new product or even a seasoned manufacturer with a new device you now have a 61% chance of getting your medical device approved by the Food and Drug Administration (FDA).

That’s one point of interesting data to be found in a recent Emergo Group Report that analyzed some 15,000 device clearances between January 2010 and December 2014.  That’s a real leap considering in 2006 that number took about 96 days to get clearance.

The study also finds that third-party reviewers tend to work more quickly than internal agency reviewers. Although not all devices qualify for this program, think about grabbing it if you can. Your device might clear in 68 days, on average, or more than 110 days faster than with an internal FDA reviewer.

View all our online Courses

Don’t see a course or schedule that fits your needs?  Contact us.