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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.
In our last newsletter, we previewed some of the requirement changes in the ISO/DIS 9001:2008 standard. Many of our readers asked us for more information on the proposed changes. The changes planned for Edition 4 of ISO 9001 are not just limited to clauses 4 through 8.
ISO 9001:2000 states, “The design and implementation of an organization’s quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed, and the size and structure of the organization.”
The following factors are added to the list by ISO/DIS 9001:2008, “influenced by: its business environment, changes in that environment, or risks associated with that environment; “
Later in section 0.1, ISO 9001:2000 states the standard is used, “to assess the organization’s ability to meet customer, regulatory, and the organization’s own requirements.”
ISO/DIS 9001:2008 changes “regulatory” to “statutory and regulatory requirements applicable to the product.”
0.2 Process Approach
In this section, ISO/DIS 9001:2008 has modified the definition of the process approach by adding “to produce the desired outcome”to the text below:
“The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”.
0.3 Relationship with ISO 9004
The planned revision to ISO 9004:2000 is expected to be issued in 2009 with extensive changes, including a new clause structure that no longer matches that of ISO 9001. As a result, it will no longer forms a “consistent pair” with ISO 9001.
In anticipation of that change, ISO/DIS 9001:2008 no longer refers to the two standards as having, “similar structures in order to assist their application as a consistent pair.”
This section adds that an objective of the ISO 9004 guidance is to manage for the “sustainable success” of an organization. And, instead of saying ISO 9004 is a guide to “move beyond the requirements of ISO 9001”, it now says ISO 9004 is a guide to “extend the benefits of ISO 9001.”
ISO 9001:2000 states ISO 9004 should be used to pursue “continual improvement of performance”, but ISO/DIS 9001:2008 has reworded it to pursue “systematic and continual improvement of the organization’s overall performance”.
0.4 Compatibility with Other Management Systems
The change at this section was to refer to ISO 14001:2004 instead of ISO 14001:1996.
1. Scope 1.1 General
This section still explains that ISO 9001 specifies requirements for a quality management system. It’s a shame that this was not changed to a Business Management System. It refers to the product meeting customer and applicable regulatory requirements, as well as, enhancing customer satisfaction by assuring conformity to customer and applicable regulatory requirements.
ISO/DIS 9001:2008 has changed the two uses of “regulatory” to “statutory and regulatory”.
The Note at this section used to say the term “product” applied only to the product intended for, or required by, a customer. ISO /DIS 9001:2008 has expanded the Note to read “or required by, a customer or the product realization processes.” It goes on to add, “This applies to any intended output resulting from product realization processes, including purchasing”.
A second Note has been added to explain that,“Statutory and regulatory requirements may be expressed as legal requirements.”
ISO 9001:2000 states that any exclusions cannot affect the organization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. ISO/DIS 9001:2008 replaces “regulatory” with “statutory and regulatory”.
2. Normative Reference
Although the text at this section has been significantly reduced, the key change is to reference ISO 9000:2005 instead of the old ISO 9000:2000.
3. Terms and Definitions
The change at this section was to drop the explanation of the supply chain terms, including that “supplier” replaced “subcontractor” and “organization” replacing “supplier”. The explanation was needed when making the transition from ISO 9001:1994 to ISO 9001:2000, but not now.
Table A.1 in the Annex was revised to show the correspondence of ISO/DIS 9001:2008 clauses with ISO 14001:2004 (instead of ISO 14001:1996). Table A.2 shows the reverse correspondence, from ISO 14001:2004 clauses to ISO/DIS 9001:2008 clauses.
The old Annex B that showed the correspondence of ISO 9001:2000 and ISO 9001:1994 has been dropped since the clause structure of ISO 9001:2000 and ISO/DIS 9001:2008 are the same.
The bibliography has been updated with the latest versions of standards, and in a few cases, references to new standards, e.g., ISO 10002:2004 on complaint handling, ISO 10019:2005 on the selection and use of consultants, and IEC 61160:2006 on design reviews.
Have you adequately defined the responsibilities for your quality management system? Clause 5.5.1 of ISO 9001:2000 requires top management to ensure responsibilities and authorities are defined and communicated within the organization.
Responsibilities and authorities should be expressed to implement and maintain an efficient and effective quality management system. Employees should be given this information so they can help achieve the quality objectives and establish their involvement, motivation, and commitment.
The ISO 9001:2000 standard doesn’t require written job descriptions. The responsibilities and authorities can be communicated in a combination of the quality manual, plans, procedures, and instructions. However, most companies do use job descriptions.
Properly written job descriptions not only convey responsibilities, they also help with hiring, retention, and legal compliance.
Bad hires often stem from not clearly defining what is required for the job. The result may be a bad fit, low productivity, poor morale, and eventually, resignation or termination. A good job description helps you and the applicants understand just what the job requires and what it’s like to do it. That makes for hires who are more likely to become competent and happy employees.
J ob descriptions help clarify roles and define relationships. They can provide a basis for analyzing and improving the organizational structure. They also form the basis for the compensation system, including job evaluations and salary levels.
Many a lawsuit has turned on a bad job description. You don’t want to be in front of a jury explaining that you fired someone for doing a poor job at a key task that’s not in the job description. So, if you use job descriptions, review them to ensure they continue to accurately reflect the actual functions of the job.
And, don’t overlook the Fair Labor Standards Act. According to the U.S. Department of Labor, job titles do not determine exempt status. In order for an exemption to apply, the specific job duties and salary must meet all the requirements of the Department’s regulations. The job descriptions should back you up.
Here is a list of some of the common job description mistakes:
1. Writing a job description that describes the person performing the job, not the job itself. It’s easy to think about the person in the job, and write about how he or she has chosen to do the work. A good job description focuses purely on job expectations and outcomes, not how the job is handled by the person doing the job.
2. Using vague wording. It is tempting to quickly write job descriptions by inserting vague language like “takes care of employment.” Does that mean routine recordkeeping, labor negotiations, or executive recruiting? Does that involve responsibility for employment or just participation in the process? Spell it out.
3. Glossing over essential vs. nonessential functions. With the advent of the Americans with Disabilities Act (ADA), it became important to separate the essential functions of a job. This allows persons with disabilities to still be hired if they can carry out those key tasks (sometimes with reasonable accommodation), even if they can’t do lesser tasks. Every job description must make this separation to be ADA-compliant.
4. Failing to update. Change happens. There aren’t many jobs that haven’t changed significantly in the past few years. If job descriptions haven’t kept up, confusion and legal challenges may be headed your way.
According to an article in Safety + Health magazine, the top ten violations cited during fiscal 2007 by the Occupational Safety and Health Administration (OSHA) were:
1. Scaffolding: Failure to provide fall protection; failure to provide proper access; failure to provide adequate platform construction; failure to provide support scaffolding and guard rails.
2. Fall Protection: Failure to provide protection; failure to use fall arrest or safety net; failure to provide protection on roofs and wall openings.
3. Hazard Communication: Failure to maintain a written program; failure to provide training; failure to provide MSDS sheets for each chemical and maintain MSDS sheets in workplace.
4. Respiratory Protection: Failure to establish a program; failure to provide medical evaluation of ability to use respirator; failure to provide respirators and with tight-fitting face piece.
5. Lockout/Tagout: Failure to document and use procedures for control of potentially hazardous energy; failure to conduct periodic inspections; failure to provide training.
6. Powered Industrial Trucks: Failure to take damaged trucks out of service; failure to ensure operators can safely operate trucks; failure to certify operators are trained and evaluated.
8. Ladders: Failure to extend ladder side rails at least 3 feet above landing surface; failure to use on stable and level surfaces; use of top step of ladders as a step.
9. Machine Guarding: Failure to provide machine guarding; failure to anchor fixed machines.
10. Electrical – General Requirements: Failure to install and use electrical equipment per factory instructions; failure to guard equipment; failure to keep work spaces clear.
For more information on the most frequently cited violations for your industry sector, go to this page at the OSHA web site.
A new ISO/IEC Guide to developing service standards for consumers will not only benefit standards developers, but will also be of value to service providers in reducing customer complaints and cutting the business costs of poor service.
ISO/IEC Guide 76:2008, Development of service standards – Recommendations for addressing consumer issues, provides an introduction to how the key consumer principles relate to standards development. These principles are safety, information, choice, the right to be heard, access, fairness, quality, redress, environmental issues and compliance with laws and regulations.
Whether a consumer is buying insurance or finding a new hairdresser, there are several questions which may come to mind, such as “Do I trust the service provider?”, “Have I got enough information to choose between the services on offer?”, “Do I understand the contract (particularly where there isn’t one written down)” and “What can I do if I don’t get the service I expect?”.
The guide provides a series of questions related to all stages of service delivery, from first thinking about the service, through engagement or purchase, service delivery to after sales or post engagement. It then identifies the service elements, such as “communication”, “personnel”, “billing” or “safeguards”, to which the questions relate.
Within each service element, there are a number of related topic areas. For example, the service element “contract” includes related topics of: “clarity and transparency”, “objectivity and fairness” and “format”. A full description is given for each of the topic areas.
For ease of use, checklists are then provided for all topic areas within service elements. These checklists provide a quick way for service standard developers to establish whether their work covers all relevant topics. The checklists are also of benefit to organizations developing a new service or reviewing an existing one.
The ISO/EC Guide is available for purchase at the ISO Store.
To see the course description, schedule, and on-line registration click on the course title below. Courses are awarded Continuing Education Units.
All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?
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- Annex SL – Changes for ISO Standards August 18, 2015
- ISO 9001:2015 Content Review August 1, 2015
- ISO 9001 Moves to Final Draft International Standard (FDIS) July 14, 2015
- Current State of Quality View July 1, 2015
- The IATF Wants to Hear From You! June 12, 2015
- ISO 9001:2015 Begins With Leadership June 1, 2015
- AS9100:2016 – What’s Ahead? May 14, 2015
- Executive Leadership Engagement May 3, 2015
- Have you found the root cause yet? April 13, 2015
- Risk-Based Thinking April 2, 2015
- Where is Risk Addressed in ISO 9001:2015? March 15, 2015
- Profit Improvement Approach March 5, 2015
- ISO 14001 EMS Revision to Final Stage February 22, 2015
- Holistic Performance Excellence February 1, 2015
- Key Manufacturing Trends for 2015 January 22, 2015
- True Culture of Quality January 4, 2015
- Outsourcing Boom Drives New Standard December 14, 2014
- The Next Level of Performance December 2, 2014
- ISO 9001:2015 DIS Receives Approval Moves to FDIS November 10, 2014
- Strategy Deployment November 3, 2014
- ISO Standards Still A Worldwide Priority October 14, 2014
- Quality Standards and Conformance October 2, 2014
- Celebrate World Quality Month September 17, 2014
- Future of Management Systems September 2, 2014
- ISO 14001 Environmental Management System Revision August 13, 2014
- Visual Controls August 1, 2014
- Manufacturing Metrics that Really Matter July 17, 2014
- Global Manufacturing View July 2, 2014
- Call for Public Comments on ISO/DIS 9001:2015 June 19, 2014
- Lean Improvement Methods June 2, 2014
- Lean Methods Digest May 20, 2014
- Management Systems Standard Changes May 5, 2014
- AS9101E QMS Audit Requirements Published April 21, 2014
- Future AS9100 Aviation, Space and Defense Changes April 4, 2014
- IAQG and future AS9100 series March 24, 2014
- Effective Process Audit Questions March 5, 2014
- NQA Auditor/Consultant Conference February 23, 2014
- Manufacturing Metrics February 3, 2014
- Less confidence about corporate strategies January 14, 2014
- What Skills Will You Improve This Year? January 2, 2014
- Risk Management Guidance December 15, 2013
- The Value Added Audit Process December 1, 2013
- Effective Internal Audits November 19, 2013
- Celebrate World Quality Month November 3, 2013
- ISO9K:2015 Revision – From the Source October 22, 2013