Is a customer forcing you to be registered to an ISO based standard?

Many companies say that the reason for implementing a standard-based (ISO 9001, ISO/TS 16949, ISO 13485, AS9100, TL 9000, etc.) Quality Management System (QMS) is that it’s a customer requirement.

Here are some Lessons IQC has learned about these situations that we pass on to you:

1.) If you are being forced to obtain certification to an ISO-based QMS ensure that you have full buy-in from all layers of management.
2.) When you form the team, be sure to invest the right amount of time creating a high-performing team atmosphere.
3.) Embrace the idea that quality is everyone’s business. Involve all departments.
4.) The standards are easy to read and must be interpreted as to how it fits your company. Ensure that the leader of the team has done this. Your leader must understand when the team members begin taking ownership. That’s when the leader needs to let go and watch the organization excel.
5.) Create a robust training program early on to capture all the training record requirements. Understand who will benefit from personal and professional growth opportunities through formal education classes in documentation, FMEA, GR&R studies, SPC techniques, and other similar courses, as required by the industry your customer is in.
6.) When people say, “The ISO (blank) standard requires it,” have them show you where it says that. It’s amazing how people use the standard to get all kinds of things approved.
7.) Talk to your customers about a plan to reduce your customer audits. This includes all customers, not just the one that is forcing you down the certification path.

Contact seth@4iqc.com and I will send you a template for an Implementation Plan.

Dear Mr. Frustrated Management Rep,

This was emailed to me by someone who purchased a pre-written Quality Manual:

I have just started the process of ISO 9001 and have several questions in terms of the template I received from XXXXXXX.com.
1) As I read through the QM and the help pages that coincide, I don’t quite understand when I am being given a directive or merely a note:
For example, when it stays “Task Overview: define....” Is a policy supposed to be defined and inserted or is the information within the template the policy? And I only make changes where necessary?
2.) Is it okay to change the wording in the manual so it suits our operations?
3.) Is it okay to leave things status quo if there are no changes?
4.) In terms of procedures, we have many flowcharts already designated for specific procedures, but I do not see how I fold them into the QMS.

Unfortunately there isn’t more explanation as to what needs to be updated, written, etc. As I go along and read the help pages it seems as if I don’t have to change much and that seems impossible! I apologize, but I am very new to this process. Thanks for any help.

--- Mr. Frustrated Management Rep

I emailed back:

Dear Frustrated,

I feel that you have been done a terrible disservice by anyone selling a pre-written Quality Manual or procedure templates. Here is what ISO 9001:2000 itself has to say about that:

“It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.” (0.1 General)

The intent of the Standard is that companies “identify and manage [the] numerous linked activities” the make up the processes within the organization. Once these processes were identified, a Quality Manual can be developed. ISO 9001:2000, 4.2.2 c, states one of the requirements for the Quality Manual: “a description of the interaction between the processes of the quality management system.” Unfortunately, most pre-written Quality Manuals are mere paraphrasing of the International Standard. There is no organization whose Quality Management System looks like ISO 9001:2000!

A Guideline, ISO/TR 10013:2001, entitled, Guidelines for quality management system documentation, states:

“An organization has flexibility in the way it chooses to document its quality management system. Each individual organization should develop that amount of documentation needed to demonstrate the effective planning, operation, control and continual improvement of its quality management system and its processes.” (Introduction)

And, specific to a Quality Manual, “A quality manual is unique to each organization. This Technical Report allows for flexibility in defining the structure, format, content, or method of presentation for documenting the quality management system for all types of organizations.” (4.4.1)

With this freedom, the Quality Manual does not have to be a narrative. IQC suggests a “Master Flow Chart.” This diagram outlines the sequence and relationship of the organization’s processes. This Master Process Flow is developed by the company’s Top Management. It is an outgrowth of their work developing the Quality Policy and Quality Objectives. The Quality Manual becomes “owned” by Top Management and a statement of how their system operates to meet the vision of the policy and the metrics of the objectives.

So, Mr. Management Rep, chalk the template up to experience and start over. Every company has the knowledge and wherewithal to develop a Quality Manual.

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Email george@4iqc.com if you want to see an example of a great Master Process Flow and Quality Manual.