ISO 9001’s Process Approach to Quality Management

ISO 9001 came into being exclusively as a means of incorporating a process approach to quality management systems. Both ISO 9000 and ISO 9004 underwent an amendment in 2000 to put this approach into place.

It is all about process

Where this approach differs from the previous standard is that it improves upon it by offering an appreciably more generic structure that is readily adaptable, acceptable and applicable across virtually all sectors of the economy and sizes of organizations. Another area where it has made life easier is that it explains the requirements in plain and uncomplicated language that is shorn of Quality waffle and is relatable to people for whom it is meant –organizations’ line managers.

The customer is the focal point

The primary focus of ISO 9001:2000 is on improving the effectiveness of a QMS in order to heighten customer satisfaction by meeting customer requirements. It finds its complement in ISO 9004:2000, whose aim is improvement of the effectiveness and efficiency of a QMS by meeting interested party requirements.

Broadly, these are the steps in this methodology:

  • Step 1: Establish the responsibilities for managing the process;
  • Step 2: Define the process;
  • Step 3: Identify customer requirements;
  • Step 4: Establish measures of process performance;
  • Step 5: Compare process performance with customer requirements;
  • Step 6: Identify process improvement opportunities;
  • Step 7: Improve process performance

How is a QMS built?

  • A QMS comprises of four categories of interrelated processes, which make up the process approach:
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis and improvement


ISO 13485 Gap Analysis

ISO 13485 Gap Analysis

Gap analysis is an important aspect of the ISO 13485 audit. The ISO 13485 standard lists out requirements for a wide-ranging management system for the manufacture and design of medical devices. When a medical device organization performs a gap analysis, it is analyzing the gaps that exist in its QMS vis-à-vis that prescribed in ISO 13485.

Why do the gap analysis?

Performing the gap analysis is obviously of very high importance to a medical device company. It helps the business understand the shortfall it has in relation to meeting regulatory requirements set out by ISO 13485. It helps it identify areas of insufficiency.

When should it be done?

It is best advised that organizations carry out the gap analysis before its final QMS is put in place, because identifying gaps at this stage is prudent. When carried out at this stage, it saves resources and time by nipping in the bud issues that could pile up later on. When gap analysis is not done at this stage, it becomes difficult to implement a QMS. As the old saying goes, a stitch in time saves nine!

How to do it?

It is always a great idea to get an ISO consultant to perform your organization’s gap analysis, because the professional knows best. By dedicating that person for this task, you could not only get a neat job done; you could also save on time and your own company resources.

Performing the gap analysis requires answering a set of questions relating to the QMS. The consultant will frame a set of questions that he/she will get you to answer. Some of these questions typically are of this nature:

  • Has the requirement been met?
  • Has the gap been identified?
  • Has remedial action been taken, or is it not necessary?

If the answer is “no” to any of these, it means that further action is necessitated. Leaving your ISO 1385 gap analysis to an expert requires your active support and cooperation.

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Aspects to look out for in your ISO 13485 Quality Manual

Aspects to look out for in your ISO 13485 Quality Manual

Each and every organization that implements ISO 13485, an important ISO standard, has to have a Quality Manualin place. The ISO 13485 sets out requirements for a complete management system for organizations that are in the business of designing and manufacturing of medical devices.

Since ISO is essentially about documentation; a medical device company’s objectives must be clearly defined and documented in its Quality Manual. ISO 13485 states that a Quality Manual must be created and maintained. Three very critical aspects need to be documented:

  • procedural requirements
  • planning, operation and control of processes
  • records that are required to comply with the ISO 13485 Standard

Management Commitment and Responsibility

As part of ISO 13485, a medical device company’s management is responsible for implementing an effectiveQuality Management System (QMS). This, along with its commitment to enforce it, should be part of the Quality Manual. The Quality Manual should reflect commitments of the Quality Policy, which should be on these lines:

It should establish aQuality Policy. This policy should reflectthe purposes of the organization and should be aligned to it.

The Quality Policy must make sure that the organization’s quality objectives are established and adhered to.

The management should periodically conduct management reviews.

It should ensure that resources are made available for this work.

It should meet customer requirements.

Management should identify, document and communicate to the rest of the organization the responsibility and authority to define, implement and monitor processes.

Management has to appoint a representative whowill be assigned the oversight of creating awareness of customer requirements. This representative should also ensure that the processes needed to implement and maintain aQMS are put in place and maintained.

Management should take every step towards facilitating internal communication.

One of the most important tasks for the management is to review the QMS to ensure that it is suitable, adequate and effective. This review is based on a number of parameters, the most important of which are feedback, process performance and product conformity. It should also ensure CAPA.


Contact Detail

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801