The ISO 9001:2015 standard was designed by The International Organization for Standardization (ISO) to provide a framework for an effective system for organizations in any industry to demonstrate to their customers their commitment to quality and enhanced customer satisfaction. ISO 9001 was developed to facilitate international trade and allow organizations and consumers from all over the globe to understand that when they encounter an organization with an ISO 9001 certification, they can be confident in the quality of products and services they can expect. Subscribing to and becoming certified to an international standard like ISO 9001 means your system produces products and services of consistent and exceptional quality that consumers can rely on time and time again.
Before you can become certified to ISO 9001, you need to implement the management system effectively within your organization. The Standard includes base requirements like the needs and expectations of interested parties within the scope of the standard. The requirements are not industry-specific for ISO 9001, but certain industries like Aerospace do have a specific standard which includes ISO 9001 as the base model with specific industry requirements added for their industry needs.
The requirements of the standard must be met to fully implement an effective Quality Management System (QMS) that allows your organization to consistently produce products or provide services that not only meet your customers’ needs but also subscribe to its globally acclaimed regulatory requirements. If you are looking to become certified for the first time, give yourself adequate time to properly implement your system before you seek certification from a Certification Body, roughly 3 months should give your organization time to implement in house or with the help of a Consultant.
What is a Management System?
According to ISO, “A management system is the way in which an organization manages the inter-related parts of its business in order to achieve its objectives.”
In case that still sounds vague, a quality management system is just a detailed set of processes and policies that are incorporated in the core business area of an organization to ensure that it meets its organizational objectives like consistent service quality, environmental concerns, maximum operational efficiency, etc.
ISO 9001 is one of these Quality Management Systems, arguably the most comprehensive and acclaimed one, which can be applied to organizations in any industry.
What are the 7 Quality Management Principles?
ISO 9001:2015 is primarily guided by 7 principles, below we’ll give you a quick explanation on each of these and why there is focus on them specifically:
Customer focus: An organization can achieve sustained success when it focuses on customer needs and exceeding their expectations.
Leadership: Organizations maintain cohesiveness and internal engagement when they focus on establishing unity of purpose and direction in leaders at all levels.
Engagement of people: Enhanced capability to achieve set quality objectives is possible when employees at all levels are sufficiently informed and engaged.
Process approach: Consistency of quality services is achieved most efficiently when all activities and interrelated processes within the system are managed.
Improvement: Organizations can best maintain and surpass current performance levels by fostering an ongoing policy of continual improvement.
Evidence-based decision making: Organizations can make objectively better-informed decisions in regards to internal processes by analyzing and evaluating existing data and evidence.
Relationship management: Performance optimization is better achieved when organizations effectively manage relationships with supplier and partner networks that are existing/potential stakeholders towards sustained success.
To fully reap the advantages of implementing an ISO standard you should investigate becoming certified to the standard by an accredited, third-party Certification Body (CB). What is involved in becoming certified to ISO 9001? You need to be able to demonstrate to a third-party auditor that your organization adheres to the requirements of the standard. The length and duration of your audit will depend on the size of your organization and the number of locations you have. When you contact a Certification Body for an estimate of cost, they will detail to you the number of days and auditors who will be present and explain to their rationale. Location of the auditor is also important as travel expenses, such as meals will be billable to your organization.
Certification audits happen in a 3-year cycle, year 1 being your first certification audit where the Certification Body auditor conducts a thorough audit of your system to determine if you are compliant with the requirements of the standard and meet the requirements for certification. Year 2 and 3 are “Surveillance Audits” where the CB auditor performs an audit of selected processes and requirements to ensure you are continuing to meet requirements and maintain your certification. By becoming ISO 9001 certified, you will be able to market your ISO certification to advertise your credibility and effective processes. Your company will become more credible to clients and offers you a substantial amount of competitive edge in the market which is especially beneficial when you’re on the lookout for business partners.
To the novice quality manager, ISO jargon can be extremely overwhelming. What is an NCR? What do you mean by OFI? Are we certified or accredited? But before you go and pull out your hair, let’s take a moment to go over some of the most frequently used terms and their definitions with regards to ISO and Management System Certification.