ISO 9001 CRUCIAL STEPS

Implementing an ISO 9001 system represents a major effort. While the first crucial steps of ISO 9000 are relatively easy, the probability for excessive variation in the results is high.

But by following a disciplined process and a systematic approach in these first steps, you will prepare your organization for the more demanding process of integrating the ISO 9001 series within your quality system.

1 - Educate Yourself

The first thing you should do is educate yourself on what ISO 9001:2000 Quality Management Standards (QMS) means, what certification entails, and how ISO certification will help your business.

The best source of information is probably by purchasing a manual from your national standards association, or taking one of the many courses available through accredited certification bodies.

2 - Preliminary Audit

You can perform your own preliminary audit using audit checklists available online as a guideline, or by preparing your own audit checklist based on the manual and training you received in step 1. Use this as a chance to evaluate how things are done now, versus what you would have to change in order to get certified.
A lot of companies should already have in place laboratory manuals, health and safety procedures, staff training and orientation, production process manuals, quality control and other processes that need to be documented for ISO. You can use these same manuals.

3 - Modified house of quality compares quality systems to ISO 9001 requirements

The first step is to compare your quality system to the requirements of the ISO 9001 standard.
This step is designed to identify the gaps between what your organization has in place and what is required under ISO 9001 standard.

You should extract the actual requirements and list them for your reference. Do not just look at the standard and decide which elements of your quality system meet the standard’s requirements; this method will produce results of dubious value.
An effective comparison method is to use a modified house of quality, a quality function deployment matrix in which the standard’s requirements become the “whats” and your organization’s quality system elements become the “hows.”

Once the matrix is created, a cross-functional, multidisciplinary team should be established to determine the actual relationships between the standard’s elements and your organization’s quality system.

The team’s members should have a working knowledge of both the standard and the organization’s internal quality system.

The team looks at each of the standard’s requirements and assesses how useful each of the organization’s quality system elements is in fulfilling that requirement.
By consensus, the team rates each element’s usefulness as strong, medium, or weak. The appropriate symbol for the rating is put into the corresponding box.

This process is repeated for each internal quality system element and each of the standard’s requirements.

The presence of an external resource person can greatly increase the objectivity of the team’s findings.

If these precautionary measures are taken, this comparison method will reveal redundancies in your quality system as well as shortcomings in your organization’s ability to meet the ISO 9001 requirements. And once this preliminary analysis is completed, you will have a good idea of how much work needs to be done to fill in the gaps.

4 - Get Management Support

To effectively build a program and meet the requirements, your organization should carry out a strong process:

• Management Decision and Commitment
• Adequate Training and Evaluation
• Compliance with Appropriate Standards
• Audit and Registration

Once you’ve identified your company’s need for compliance, it is essential for top management to get on board. Management can ensure that quality is documented, demonstrable, effective and maintained.

5 - Establish Staff Roles and resources

Top Management must allocate proper resources to implement the above decision.
You need to establish the roles of various managers and staff in terms of who will be performing audits, who will maintain certain documents and who will conduct management reviews and implement improvements.

An example is:

• Human Resources (Management Representative and Core Team to "prepare, implement, maintain & improve" the Quality System)
• Time (minimum two to three hours per day (of core team) for initial months till achieving ISO Certification and afterwards at-least one to two hours per week
• Financial Resources. (Fees / charges for Trainings, documentation / consultancy (if outsourced) and ISO Certification / audit charges

6 - Plan and Develop Your Program

To build a program and meet the requirements, your organization can begin with effective training for how to create well-defined processes.
You will first want to learn how to identify the objectives necessary to deliver top results. And then you will be ready to put those processes to work.

7 - Formulate Quality Policy

In order to successfully achieve the above, your organization ha to establish and follow a Quality Policy.

8 - Prepare Process Diagrams

Most consultants will recommend you take this organizational approach to planning your application. The act of preparing process diagrams helps you visualize all the inputs and outputs of each product your company produces. This will aid in setting up controls and documentation for each step of each process.

9 - Prepare Documentation

This is the most important part of your ISO 9001 implementation, and it is the most difficult part for most companies.

Take advantage of existing documentation in your company, as mentioned in earlier steps. You will likely find that some documents require updating or minor revisions. Implement these changes and then proceed to preparing your ISO 9001:2000 QMS Manual.

In the manual, you outline how each of the QMS requirements are being met, by referring to the existing (or newly prepared) documents for daily tasks such as ordering, customer relations, production, R&D, quality control and more.
This is the most time consuming step of becoming ISO certified.

• Formulate Six Mandatory Quality Procedures required by ISO 9001:2000 standard
• Formulate other Quality Procedures, departmental work instructions and other documents required to conduct the company operations

10 - Staff Training

Once the QMS manual is prepared and you have all documentation in place, it’s time to train the remainder of staff on the ISO process and what it entails. Passing the audit requires compliance at all levels. Ensure management recognizes their role in setting examples and motivating staff.

Establish and implement a training plan:

• Awareness Training for all employees (as it is a team work and all employees are part of Quality Management System)
• Documentation training for core team
• Internal Auditors training, to at-least three to four members of core team.

11 - Implementation

Now it’s time to implement your ISO 9000 system. During this phase you introduce the new requirements of your Quality Manual and procedures and you get employees to adjust their way of working to any new requirements. This step will be much easier if you did a good job in earlier Steps.

Take one step at a time in your implementation process. You may want to start with the section on Document Control. Explain the requirements in a meeting or memo, or have the appropriate department managers explain to their staff.

12 - Monitor Your Program

After you’ve implemented the ISO program, you should monitor and measure the processes against your own objectives. You can build an effective management system that objectively shows what you’re doing right and wrong.

13 - Conduct first Internal Quality Audit (after a gap of at-least 30 days from the date of implementation of system)

Internal audits are performed by somebody within your company. The job of the auditor is to verify that your company meets the requirements of ISO 9000 as they are described in your Quality Manual.

Audits are an excellent way of training; they will help with your implementation efforts!
Once you have performed a complete internal audit that didn’t uncover any significant problems, you are probably ready for the certification audit!

14 - Certification

Now it’s time to select your registrar! There are many companies offering certification services but be careful: some are not accredited. Start your search on the Internet and compare the different registrars.

Make Application for certification to Certification Body (submit Manuals for approval / Documentation review).

Conduct first Management Review Meeting and then call Certification Body for conducting on-site audit of your Quality System.

15 - Pre-Certification Audit

Performing another internal audit ensures there will be no surprises when the external (third party) auditor comes. By now, you should find only minor non-compliance issues, if any. Address these now, and, if necessary, perform a second internal audit.

16 - Certification Audit

Once you are satisfied you are complying with all the QMS requirements, you are ready for your third party audit by an accredited certification body. If you have followed the guidelines and everything is in place, you should hopefully pass your audit with flying colors!

17 - Original Certificate

It is time to receive original certificate from Certification Body

18 - Reaping the Marketing Benefits

Once you successfully passed the certification audit, you should leverage your certification in marketing. You may want to prepare a press release, send notification cards to your customers, print your certification mark on business cards and letterhead, add the certification to your advertisement or display a banner outside your office building.

19 - Life after Certification: Improve Process Performance

Remember, ISO 9001 certification is not the end, and your registrar will want to perform a surveillance audit once or twice a year. Your ISO 9001 system is designed to continually improve itself. Make sure it remains implemented, continue your internal audits, and we are convinced you’ll see your company’s performance improvements at the bottom line!

With ISO 9001 compliance you can improve the overall process performance of your business. And this can save money while satisfying your customers and increasing profit.