ISO 9001 Quality Management Systems

What is ISO 9001? How Did it Start?
ISO 9001 is a standard related to quality management systems and is designed to help organizations ensure that they meet the needs of their customers while maintaining compliance to any statutory or regulatory requirements related to the product.

ISO 9001 was originally based on a Department of Defense MIL-Q-9858 standard from 1959. Several iterations to the standard were made and it eventually became the BS 5750 series of standards from British Standards Institute (BSI). BS 5750 was eventually proposed to the International Organization for Standardization (ISO) in 1979 and first published in 1987. ISO 9001 has been revised several times, with the most recent being ISO 9001:2015, which was released in September 2015.

Certifications for ISO 9001 began in 1978 by BSI and 1,058,504 certifications are held throughout the world as of 2017 according to the ISO Survey of Certifications.

What kind of Businesses are Certified?
ISO 9001 is structured in a way that it can apply to any type or size of organization – including machine shops, customer service providers, assemblers, distributors, software developers, food processors, consulting companies, etc. ISO 9001 provides a structured framework that is still flexible enough to aid any company in providing a customer focused business management system that will help increase their business performance.

ISO 9001:2015 is based on the following eight Quality Management Principles, which are incorporated within the requirements of the standard, and can be applied to improve organizational performance:

  • Customer focus
  • Leadership
  • Engagement of people
  • Process approach
  • Improvement
  • Evidence-based decision-making
  • Relationship management

What are the Contents of the ISO 9001:2015 Standard?
The ISO 9001:2015 standard is separated into ten sections, which are listed below. Sections 1, 2, and 3 are non-auditable elements, and Sections 4-10 are the core of the standard.

  • Section 1 – Scope
  • Section 2 – Normative Reference
  • Section 3 – Terms and definitions
  • Section 4 – Context of the Organization
  • Section 5 – Leadership
  • Section 6 – Planning
  • Section 7 – Support
  • Section 8 – Product Realization
  • Section 9 – Operation
  • Section 10 – Performance Evaluation

What’s new in ISO 9001:2015?
– 9001:2015 adopts the new High-Level Structure with 10 clauses that all ISO management system standards are required to use in the future. This helps ensure that all management system standards will have the same look & feel, and make integration easier between systems of different disciplines.
– Increased focus on process management, with greater emphasis on producing desired outputs.
– Simplified language to make it easier to translate into other languages and to help ensure consistent application.
– Significant increased emphasis on risk management and business management.
– Fewer and less explicit requirements for documented procedures. More explicit requirements on documented information.

What do I need to know about the ISO 9001:2015 Transition?
You can be continue to become certified to ISO 9001:2008 for one more year. After that, new certifications will only be given for ISO 9001:2015. Companies have until the end of September 2018 to upgrade to ISO 9001:2015. ISO has published a transition overview here.

We recommend a Gap Assessment to kick off your transition process. During Gap Assessment audit, we evaluate your QMS to determine your current level of compliance with ISO 9001:2015. Companies experienced in ISO 9001:2008 are likely fairly compliant with the new standard but some of the changes are significant and the entirely reorganized so a Gap Assessment is a good place to start. It is also the first step in developing of a quality plan to update your QMS to be fully compliant with the new standard.

ISO 19011 includes guidelines for auditing management systems and is directly referenced in ISO 9001. Two types of auditing are required to maintain registration to the standard:
1. Internal Audits – Audits by internal or contracted staff that are trained to the audit standard and procedures.
2. External Audits – Auditing by an external certification body.

Internal Auditing is they key to continuous improvement of the business. It requires review and assessment to verify that the current quality system is effective – and if not, to correct and prevent any identified issues. Section 9.2 of ISO 9001:2015 is very clear on the requirements of the audit program and includes very clear language regarding impartiality of the auditor, which is a distinct benefit of contract auditors:

“The organization shall conduct internal audits at planned intervals to provide information on
whether the quality management system:
a) conforms to:
1) the organization’s own requirements for its quality management system;
2) the requirements of this International Standard;
b) is effectively implemented and maintained.”

“The organization shall:
a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods,
responsibilities, planning requirements and reporting, which shall take into consideration the
importance of the processes concerned, changes affecting the organization, and the results of
previous audits;
b) define the audit criteria and scope for each audit;
c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;
d) ensure that the results of the audits are reported to relevant management;
e) take appropriate correction and corrective actions without undue delay.”

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