Suggestions for Upcoming Revision

As most of us are aware of, ISO 9001 is in the process of being revised, with a planned release date of some time in 2015.  More than three years ago, anticipating the eventuality of a revision, members of ISO Subcommittee 2 (SC 2)—the subcommittee that has responsibility for the revision and maintenance of ISO 9001—began conducting an extensive user survey.

Feedback was sought from every industry and sector, from users of other management system standards, and even from those who have chosen not to implement an ISO 9001-compliant quality management system (QMS).  More than 10,000 responses were received from around the world. Many contained comments that needed to be translated.  All these data were collated, reviewed, and analyzed. Overall, the consensus from respondents was that they felt the standard is good as it is, but it needs to be revised.  There seemed to be little support for wholesale changes, or creating a hierarchical or tiered set of requirements standards similar to Capability Maturity Model Integration (CMMI).

The most commonly received comments from the extensive survey that SC 2 sent to ISO users related to the following:

• Requests to include requirements relating to risk management, financial management, and change management
• Requests for clarification of existing requirements relating to outsourcing, product realization, and the distinction between verification and validation
• Some respondents voiced concern about the ease of use for service and software industry.

In the coming months, the output of the most recent meeting of the WG 24 will be released.  The committee draft (CD) is expected to be for sale some time in June 2013.  At that time, comments will be solicited to ensure that this revision perpetuates the high standard that has been the hallmark of ISO 9001 for more than a quarter of a century.

We will keep you informed on all future information on the ISO 9001 standard revision.

We recently attended a workshop conducted by National Quality Assurance (NQA) in Los Angeles, California.  NQA is a leading global certification body (CB) providing certification services to many global standards.

One of the presentations we attended was in regards to future changes to AS9101D the Aerospace Standard for Audit Requirements for Aviation, Space and Defense Organizations.  The following is information captured regarding this topic currently in Draft Form:

Consolidation of the Forms: “Objective Evidence Record” + “PEAR” = The New PEAR will include both the performance and the conformity assessment results.  The New PEAR will be aligned to ISO definition of “Effectiveness”

• Will capture objective evidence of conformity (planned activities) and performance (planned results)
• Appendices will be referenced as Forms and will not be included in the standard URL link but will be referenced to access the forms.  For multi-sites, opening meetings must include a representative from all sites – physically or electronically.
• The audit team shall record definitions, targets and values of KPIs related to the audited process on the PEAR. The audit team shall record detailed objective evidence (e.g., reviewed procedures, shop orders, training records, products, verification records) on the PEAR (section 3).
• Defined reporting requirements for “combined” and “integrated” audits.
• For combined and integrated audits, separate reports shall be issued for each audit performed for each standard.
• PEAR(s) will be mandatory and created for each top level process audited to AS91XX series requirements. No longer limited to processes associated with Product Realization requirements.
• New Process Evaluation Matrix (PEM)
• Clear definitions to assist auditors when determining process effectiveness levels / numerical conclusions when documenting PEAR’s.

Look for our next post!  We will post further information captured soon on other standards and support documents. 

How do small and medium-sized enterprises (SMEs) compete on a level playing field with the biggest business? Quite simply: by applying International Standards.

It is estimated that more than 90 % of the world’s businesses are SMEs. Surprised? Don’t be. SMEs are, on average, the businesses that are generating growth, creating jobs, growing faster and innovating more. More importantly, they are a good deal less complicated (structurally) and more efficient and flexible than are large firms. International Standards provide as many benefits for small businesses as they do for global enterprises. Their strategic use can make a significant difference to the annual turnover of an SME, sometimes the difference between success and failure.

Given the trend towards outsourcing activities and the growing importance of cooperation in the value chain, effective Management System Standard implementation by SMEs is of key importance in facilitating trade and promoting sustainable development.

Read on and discover why International Standards are of strategic economic importance, and how SMEs (despite all obstacles) stand to gain most from their use.  See the February issue of ISO Focus which highlights the importance of International Standards to the company.

As a prior Quality and Reliability Engineer working for a major supplier to the automotive industry, QMS standards have been a part of our company and professional growth from the prior QS-9000 automotive quality standard in the nineties, to the current ISO/TS 16949 automotive quality standard.

Clearly, with more than a billion estimated road vehicles in use worldwide, the automotive sector uses state-of-the-art standards for aspects such as safety, impact on the environment, and requirements for supply chain partners.  The importance of this challenge is reflected by ISO’s response. Out of a current total of more than 19,500 ISO International Standards for almost all sectors of business and technology, some 900 have been developed for road vehicles and related technologies.

A new ISO brochure, How ISO standards support global car industry, presents a compilation of recent articles from ISO Focus+ magazine and of press releases showing the scale of ISO’s rapid responsiveness to the needs of this important sector. The new brochure includes interviews with top executives from companies such as Kia Motors Corporation, Chrysler Group and Fiat, Daimler and Rolls Royce Motor Cars, who share their perspectives on ISO standards. It also includes a list of ISO standards for the increasingly important sector of electric vehicles.

How ISO standards support global car industry, is now published and available free of charge from the ISO Central Secretariat through the ISO Store.

At this time of year it is natural to reflect on your annual performance and set personal and business goals for the upcoming year.

The question is what kind of results do you want to create for yourself and your business? Do you have customers coming back for more of your product or service? Do you have a set of ideal customers you want to cultivate? Are your business processes in control and capable of producing what you and your customers require on a continuous basis?

The demands of today’s business environment have caused many of us to shift our approach from thinking as a professional to acting as an entrepreneur. Avoiding past mistakes and taking the time to plan your next moves can make the difference between an exceptional year, and a mediocre year for you and your organization.

Being Generic. Do you act, look, and sound like your top competitor? Sales material, customer approach, support center processes, website content, all similar? Look for an edge that breaks you away from the rest of the herd.

The Emperor with no Clothes. How deep are your relationships with your top customers? Can they identify beyond normal business practices how your value to them increased from last year? What types of evidence would they reference? Don’t ever take the crown jewels for granted, your competition is lurking.

Failing to turn your Customers into a Sales Force. Your customers can become your largest asset for customer referrals. It is much easier and cheaper to keep in contact and query your current customers, than for example cold calling.

Putting a Square Peg in a Round Hole. How much time did you spend on sales and marketing actions that didn’t produce results? Is your sales force making promises you can’t keep, or not fully understanding the capability of your business processes?

Same Stuff, Different Day. Are you still marketing yourself the same way you did last year, five years, ten years ago? Which of your marketing decisions drove bottom line increases and what didn’t? Look around your industry, and seek the difference!

Become a Renowned Expert. Successful business people spend their time developing their reputation. They don’t just rely on their business to sell themselves. They use tools to sell themselves and their products – speaking, writing, attending seminars/tradeshows, joining and contributing to professional and community associations.