For those who are unaware, ISO 9001 has become the international standard when it comes to putting Quality Management Systems in place. A majority of countries worldwide are already using ISO 9001, as it was agreed upon by many different nations. Any company that wants to have the best policies, processes, and procedures for their goods and services in place would do well to implement this standard, if they have not done so already.
Since the vast majority of countries are already using ISO 9001 and it has become the true standard, there are follow-up questions that need to be answered. For example, there are a number of companies have to know how to conduct a proper audit. Otherwise, their Quality Management Systems are not going to enjoy the same benefits as others.
Once a company is ready to begin auditing to this standard, these are the questions that must be asked:
What Are The Requirements of the Interested Parties?
Yes, the term ‘interested parties’ does have a bizarre ring to it but this is not a concern. Other auditors may decide to simply refer to them as stakeholders, which also makes a world of sense. The best auditors are never going to speak with a lot of impenetrable jargon. That is not the point of an audit. Audits are supposed to be easily understood by both sides of the equation.
Employees, neighbors, regulators, customers, suppliers, business owners, and debt holders are all going to take interest, for varying reasons. The more that the company auditor knows about their requirements before beginning the process, the smoother it will be. If there are any early questions that need to be addressed, an exploratory discussion can put a lot of issues to rest. The more context the auditor has, the better.
What Plans Have Been Put Into Place To Achieve The Desired Objectives?
When it comes to ISO 9001, objectives that can be easily measured are a major aspect of the equation. While these objectives should not be new to any company, the manner in which they plan to achieve them should be. If these plans are not specific and actionable, this is a major problem that has to be addressed before the company can go any further. Otherwise, this is sure to be discussed in any audit.
An auditor needs to be able to explain these plans, in-depth. They should also be able to explain who has proper knowledge of them. Employees must have a strong level of familiarity with the objectives, of course. However, they cannot be left in the dark when it comes to action plans.
How Are Changes Managed?
Changes are a natural part of any company’s ethos. Companies that allow their Quality Management Systems to remain static are risking serious long-term issues. When an ISO 9001 audit takes place, this topic is sure to come up. How does the company identify changes and make them before problems occur? What kind of changes has the company been planning for as of late? These are the types of questions that have to be asked in any audit of this nature, regardless of the company’s long-term standing.
Processes, equipment, regulations, tools, employees, product modifications, there is no shortage of changes that are bound to come to the forefront. The auditor’s job is to review these changes and make sure they are implemented in a proactive manner. Evidence must be provided as well. It is not the company’s place to expect anyone to simply take their word for it. Changes that take place in an unplanned manner can still happen but an audit will seek to prove that they are meeting the necessary requirements.