ISO 13485:2016 - MANAGEMENT RESPONSIBILITY

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In our last blog, we have seen about ISO 13485:2016, Clause 4. Please check out in the link given below

ISO 13485:2016 - QMS REQUIREMENTS

https://biomedicalviews.blogspot.com/2020/06/iso-134852016-part-1.html?m=1

Our today’s topic will be around Clause 5 of ISO 13485:2016.

Let’s get into the topic with a small introduction about ISO 13485:2016

WHY ISO 13485:2016?

ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that constantly meet customer and applicable regulatory requirements. Such organisations can be involved in Design & Development of Medical Device, Production, Storage  and Distribution, Installation and Servicing of Medical Device or provision for other associated activities (eg: Technical Support).

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CLAUSE 5: MANAGEMENT RESPONSIBILITY

Clause 5 of ISO 13485:2016 gives out the requirements of top management as follows.

1. Implementation and Maintenance of QMS.

2. Planning of QMS.

3. Ongoing review of system to attain customer satisfaction and improvement.

CLAUSE 5 has some Sub Clauses. Let’s see in detail about each sub clauses.

CLAUSE 5.1 LEADERSHIP COMMITMENT REQUIREMENTS

1. Assist the development of organization QMS.

2. Assist the implementation of organization QMS.

3. Assist the maintenance of organization QMS.

CLAUSE 5.2 CUSTOMER FOCUS

1. Ascertain to determine the external requirements.

2. Ascertain that external requirements are being met.

CLAUSE 5.3 POLICY REQUIREMENTS

1. Plan company’s Quality Policy.

2. Draft company’s Quality Policy.

3. Apply company’s Quality Policy.

4. Review company’s Quality Policy.

CLAUSE 5.4 PLANNING REQUIREMENTS

This is again divided into following sub clauses.

CLAUSE 5.4.1 QUALITY OBJECTIVE

1. Develop quality objectives throughout the organization.

2. Make objectives needed to comply product requirements.

3. Make objectives needed to comply regulatory requirements.

CLAUSE 5.4.2 QMS PLANNING

1. Plan how your organization is going to develop QMS.

2. Plan how your organization is going to document QMS.

3. Plan how your organization is going to structure QMS.

4. Plan how your organization is going to manage QMS.

5. Plan how your organization is going to monitor QMS.

6. Plan how your organization is going to control QMS.

7. Plan how your organization is going to implement QMS.

8. Plan how your organization is going to maintain QMS.

CLAUSE 5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION

This is again divided into following sub clauses.

CLAUSE 5.5.1 CLARIFY RESPONSIBILITY AND AUTHORITY

1. Explicit QMS responsibilities and authorities

2. Document QMS responsibilities and authorities.

3. Document interrelationship between QMS policies.

CLAUSE 5.5.2 APPOINT MANAGEMENT REPRESENTATIVE

1. Hire a member of management to supervise organization QMS.

2. Offer management representative with authority and responsibility.

3. Offer management representative with authority and responsibility to document QMS.

4. Offer management representative with authority and responsibility to report to top management

5. Offer management representative with authority and responsibility to promote corporate awareness.

CLAUSE 5.5.3 ESTABLISH INTERNAL COMMUNICATION

1. Develop relevant internal communication process.

2. Boost communication about the effectiveness of organizations QMS.

CLAUSE 5.6 MANAGEMENT REVIEW REQUIREMENTS

This is again divided into following sub clauses.

CLAUSE 5.6.1 PERFORM REGULAR MANAGEMENT REVIEW

1. Develop management review procedures.

2. Plan organizations management reviews after fixed intervals.

3. Review organizations QMS at fixed intervals.

4. Maintain records of management reviews.

CLAUSE 5.6.2 STUDY MANAGEMENT REVIEW INPUT

1. Study information about organizations QMS.

2. Review precedent management reviews and the status of action items from those reviews.

3. Review results of previous audits.

4. Review organization complaint handling issues.

5. Review organization monitoring & measurement activities.

6. Review new or revised regulatory requirements that are relevant with your organization.

7. Review past corrective and preventive actions.

8. Review improvement activities and associated recommendation.

9. Review changes that could influence QMS.

CLAUSE 5.6.3 GENERATE MANAGEMENT REVIEW OUTPUT

1. Develop organizations management review output.

2. Make decisions and actions to improve organizations QMS.

3. Make decisions and actions to improve organizations medical products.

4. Make decisions and actions to update QMS with regulatory changes.

5. Make decisions and actions to fulfill applicable resource needs.

6. Develop a record of organizations management review.

Now I hope you have acquired some knowledge about CLAUSE 5 in ISO 13485:2016. We will see in detail about other clauses in next blog.

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