What Is ISO 9001:2015?- Guide Test Two

Almost 70 percent of American mothers with children younger than 18 work for pay, but motherhood remains disruptive for many women’s work lives.

American women earn almost 20 percent less per hour than their male peers, in part because women disproportionately take responsibility for raising children. Mothers often experience employment interruptions or reductions in work hours.

When it comes to understanding mothers’ long-term employment patterns, researchers know less. How common is it for mothers to persist working full-time throughout their child-rearing years? Which mothers are most likely to be absent from the labor market over the long term? What do employment patterns look like for mothers who fall in between these two extremes?

Define: What is ISO 9001?

ISO 9001 is an international standard that defines a set of requirements for quality management systems (QMS). It is developed and published by the International Organization for Standardization (ISO), a global federation of national standards bodies based in Geneva, Switzerland.

ISO 9001 is one of four standards in the ISO 9000 family, each of which focuses on an aspect of quality management. It is the only standard in that group to which companies can become certified. ISO 9001 has been developed around eight quality management principles:

“The need for International Standards is very important as more organizations
operate in the global economy by selling or buying products and services from sources outside their domestic market.”
—ISO, “Selection and Use of the ISO Family of Standards”

• Customer focus
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationships

A company that is certified to ISO 9001 can demonstrate to global customers and business partners that its products or services meet customer requirements and continually improve in quality. Although certification to ISO 9001 isn’t mandatory in the way a business license is, many manufacturers require their suppliers to be certified to the standard, and certification has been shown to improve operational efficiency and help companies achieve their business goals.

ISO 9001 was originally published in 1987 and has since gone through three revisions, in 1994, 2000, and 2008, respectively. Each version includes its publication date in its title, e.g., ISO 9001:2008. As of this writing, the fifth revision of ISO 9001 is scheduled for publication in October 2015, at which time ISO 9001:2015 will cancel and replace the 2008 version. The 2015 revision emphasizes risk management.

The standard can be purchased from ISO for 138 Swiss francs (about US$130) or from the American National Standards Institute (ANSI) for $173 (nonmembers).

Learn more
“Selection and Use of the ISO Family of Standards,” ISO 2009
“ISO 9001 Made Easy,” Syed Hasan Jaffrey, Quality Progress, 2004
ISO 9001:2015 Revision, TÜV SÜD
“Quality Management Principles, ISO May 2012

Measure: How is ISO 9001 organized?

The ISO 9001 standard is about 50 pages long in print format and organized into eight sections following a foreword and introduction. The introduction provides an overview of the ISO 9000 family of standards, and explains the plan-do-check-act cycle, risk-based thinking, and how ISO 9001 is compatible with other standards. The eight sections of the standard are:

“ISO 9001:2015 is expected to represent a major change in ISO 9001 philosophy, which means that understanding its intent will be as important as understanding its contents.”
—Umberto Tunesi, “Deconstructing ISO/DIS 9001”

1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning for the quality management system
7. Support
8. Operation

Each section explains aspects of a quality management system and/or specific requirements of the standard. The requirements are written broadly so that they are applicable to most organizations, for example, “Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated, and understood within the organization.” Organizations demonstrate compliance to a requirement within the context of their specific business objectives and customer requirements.

The requirements are presented in an order compatible with a process approach to managing an organization. Requirements focus first on understanding the company’s purpose, business environment, risks, and levels of responsibility. Then they move through processes for fulfilling the company's purpose, including processes for supporting staff, performing operations, and evaluating performance.

The 2015 version of the standard follows what ISO calls a “high-level structure.” This means ISO 9001 has the same sequence of sections and clauses that other ISO management standards do. The standards also share common terms. Information on how ISO 9001 is compatible with other management standards is given in ISO 9001’s Annex A at the end of the document.

Learn more
“ISO/DIS 9001:2015 Translated Into Plain English Praxiom Research Group, Nov. 2014
“Deconstructing ISO/DIS 9001, Umberto Tunesi, Quality Digest Daily, June 2014
“Guidance on Some of the Frequently Used Words Found in the ISO 9000 Family of Standards, ISO, Jan. 2012

Analyze: Why is certification to ISO 9001 valuable?

A technical standard such as ISO 9001 provides organizational best practices that can help a company operate efficiently in a global economy. ISO 9001 is written by experts from businesses, academia, and government; it represents a global consensus on the most effective way to develop a quality management system.

A company that is certified to ISO 9001 demonstrates to potential customers internationally that it can provide quality products and services that meet regulatory requirements. This can be valuable for securing contracts and participating in an industry supply chain. Certification can optimize a company’s processes and save money. It can also remove trade barriers and help a company gain access to new markets.

“We find ISO adopters have higher rates of corporate survival, sales and employment growth, and wage increases than the matched groups of non-adopters.”
—David Levine and Michael Toffel, “Quality Management and Job Quality”

Certification to ISO 9001 also helps to improve the quality of goods and services worldwide, and supports a global culture of continual improvement and business excellence. More than one million companies worldwide are certified to ISO 9001.

Although certification to ISO 9001 is voluntary, some industries require it for suppliers and trading partners.

Learn more
“ISO 9001 As a Business Management Tool,” Oscar Combs, Quality Digest Daily, March 2013
“ISO Standards; What’s the Bottom Line?” ISO, July 2012
“SO 9001: ‘It Really Helps,’” Rob Fenn, Quality Digest Daily, Aug. 2014
“‘Sorry, Not My Area…,’” David Fenn, Quality Digest Daily, April 2014
“Quality Management and Job Quality: How the ISO 9001 Standard for Quality Management Systems Affects Employees and Employers.” David I. Levine, Michael W. Toffel, Harvard Business School, Jan. 2010.

Improve: How does a company become certified to ISO 9001?

The are three broad steps to becoming certified to ISO 9001.

First, a company obtains a copy of the standard and appoints a project team and/or outside consultant to compare a company’s existing quality management system (QMS) to the requirements of the standard (sometimes called a gap analysis). Where a company’s QMS doesn’t meet the requirement of the the standard it will develop and document management processes that meet the requirements outlined in the standard. Collectively, these processes are the company’s quality management system (QMS). Companies should design their QMS and related documentation so that they adhere to the standard’s requirements but are still relevant to their own business objectives, customers’ needs, and operational processes. The standard should serve the company, not the other way around.

Second, the company implements the QMS throughout the organization. Internal audits can be performed to see how effective the system is.

“Registrars estimate that the majority of nonconformances found in external audits are not due to a company’s ability to meet a standard’s requirement, but rather to the company’s inability to meet a requirement in one of its own internal documents.”
—Bretta Kelly, “ISO 9001 Documentation Is Like a Box of Chocolates”

Third, the company hires an outside entity called a certification body, or registrar, to assess the company's QMS. An auditor tours the company’s premises and observes the processes in action. The auditor submits a findings report to the company and the registrar. Depending on the findings, the company is then certified to the standard or required to correct processes that don't meet the standard’s requirements. In the latter case, the company must be audited again before it can be certified.

Companies already certified to ISO 9001:2008 will have three months to recertify to the 2015 version once it's published in October 2015. These companies will need to go through a similar in-house review of their QMS, and hire a certification body to audit them.

Learn more
“Do You Need a Consultant to Achieve ISO 9001 Certification?” Miriam Boudreaux, Quality Digest Daily, Aug. 2009
“ISO 9001:2015—Things You Can Do Now,” Denise Robitaille, Quality Digest Daily, Feb. 2015
“The Process Approach to ISO 9001,” David Muil, Quality Digest Daily, April 2014
“ISO 9001 Documentation Is Like a Box of Chocolates,” Bretta Kelly, Quality Digest, Jan. 2009
“Using an Integrated Management System to Implement ISO 9001:2015,” Chad Kymal, Quality Digest Daily, May 2015
• Webinar: The Impact ISO 9001 Revisions Will Have on Your Business and to Your Quality Management System
Quality Digest Buyers Guide to Registrars

Control: What is an internal audit of ISO 9001?

To maintain certification to ISO 9001, a company must be audited by a registrar every three years. Performing regular internal audits can help keep the QMS in compliance with the standard and ensure that the three-year surveillance audits go smoothly.

Internal audits are conducted by employees within the company to assess the effectiveness of the quality management system. Audits help identify problems, risks, good practices, and opportunities to better serve customers. Internal audits can also prepare companies for an outside audit by a registrar.

Executive management is responsible for ensuring the effectiveness of the internal audit. One of the goals of an internal audit is to provide information that management can use for strategic planning and decisions.

“Audits help you to identify problems, risks, good practices and opportunities to better serve your customers.”
— Denise Robitaille, “The Basics of Internal Auditing”

The audit process consists of:

• Planning the audit beforehand
• Reviewing documentation and previous audit reports
• Developing an audit checklist
• Explaining the audit scope to those being audited
• Performing the audit by observing and asking question
• Writing and submitting the audit report

Learn more
“The Basics of Internal Auditing,” Denise Robitaille, Quality Digest, June 2007
“Making the Most of Internal Audits,” Dennis Abarca, Quality Digest, Feb. 1999
“Maintaining ISO 9001 Certification,” 9001 Council
“What Happens If You Fail Your Audit,” Miriam Boudreaux, Aug. 2009
“Time to Rethink the Checklist Audit,” Jorge Correa, Quality Digest Daily Oct. 2013
ISO 9001:2015 Compliance—How Automation Can Help Quality Digest webinar, March 2015